We've been following Timberlake for a while. See here and here. We mean the product liability case against Synthes, not the pop singer (though, in truth, his appearances on SNL have been consistently superb and have convinced us, against all expectation, that he really is a talented fellow). The plaintiff Timberlake claimed injuries from an allegedly defective artificial intervertebral spinal disc (the ProDisc). What first caught our attention was that the plaintiff sued not only the manufacturer but also a couple of doctor-entrepreneurs who formed the company that researched and developed the ProDisc. We thought the theory of fraud liability against non-manufacturers was worse than novel; it was "funky." The court agreed and dismissed those defendants.
What was left was no longer funky. It became merely familiar. The ProDisc is a Class III medical device. It went through the FDA's rigorous premarket approval (PMA) process. The FDA made many requests for information and insisted on numerous revisions. The ProDisc's full application was approximately 8800 pages long. On August 14, 2006, ProDisc received premarket approval by the FDA. The FDA-approved labeling consisted of a number of documents, including a package insert, technique guide for surgeons, and a patient guide -- the contents of all of which were specified by the FDA.
So why aren't the plaintiff's product liability claims preempted? Last week, the court held that the claims are preempted, and that they are not saved by the dreaded "parallel" claim exception. Timberlake v. Synthes Spine, Inc., 2011 U.S. Dist. LEXIS 17034 (S.D. Texas February 18, 2011). It's a well-reasoned, clear decision, with no strings attached.
In addition to claims for product liability in strict liability and negligence, the plaintiff also alleged breach of express warranty and fraud/misrepresentation. The court concluded that those claims rested either on assertions that the product was defective -- even though the FDA had found the ProDisc was safe and effective -- or that patients and physicians had not been properly warned -- even though the the PMA process necessarily involves a determination that the FDA-approved label for the device is neither "false nor misleading." Timberlake, 2010 U.S. Dist. LEXIS 17034 at *22-24. The plaintiff's argument is in a box. The box is not quite the same box that Justin Timberlake and Andy Samberg sang about, though it is similar because it is a sort of gift for drug and device defendants. It is a preemption box.
But not so fast, said the plaintiff, who offered two arguments: (1) the FDA approved the product and labeling only because it had been lied to, and (2) the defendants violated FDCA requirements, thus committing a parallel" violation. The first argument takes about as long to get rid of as it takes to mouth the two syllables Buck-man. Id. at 26.
The second argument takes a little longer, if only to unpack the plaintiff's argument and scan the evidence ... or the lack of it. To the extent that the plaintiff alleged parallel claims based on violations of the FDA approval process, that would be "equivalent to fraud on the FDA claims, and thus Buckman preemption applies." Id. at * 28. The plaintiff also suggested that the defendants did not manufacture or label the ProDisc in a manner consistent with that approved by the FDA in the ProDisc's PMA. Note our use of the word "suggested." The problem is that the plaintiff failed to offer proof sufficient to create an issue of fact on the parallel claim. The plaintiff "failed to cite to any evidence in the record, including his own experts' testimony, showing that Defendants violated the specifications imposed by the FDA as part of the ProDisc's PMA with respect to the manufacturing and labeling of his ProDisc." Id. at * 33-34 (emphasis in original). The plaintiff's expert stated that the defendants failed an FDA inspection at one of their manufacturing facilities. But the plaintiff offered no evidence that the particular device in question had been manufactured at the facility that failed the FDA inspection. Id. at *34 n. 8.
Timberlake is the latest in a recent string of decision where courts have required specificity to support invocation of the parallel claims exception. See here, for example. Maybe it's a trend. Or maybe it's a case of what goes around comes around. (Yeah, at this point we're sacrificing all logic just to squeeze in another Timberlake song title. Just be grateful that, given the device at issue, we didn't allude to Sexyback. Oops -- darn it.) It reminds us of another pop culture icon, Charlie Sheen, and one of the odd parts of his recent radio rant (okay, the whole thing was plenty odd) where he blurts out that he is "winning." It's nice to be winning and we'd like to think that we're not delusional or intoxicated. Rather, the summary judgment result in Timberlake, especially the hemming in of parallel claims, seems fully justified.
Monday, February 28, 2011
Thursday, February 24, 2011
Pharmacists And The Learned Intermediary Rule
As our readers certainly know, the learned intermediary rule holds that prescription medical product warnings are to be directed to prescribing physicians rather than to end user patients. We’ve discussed the policy reasons for the rule before, and at length, most notably here and here. Briefly, courts have adopted the learned intermediary rule because:
In either case, representing manufacturer defendants, we’d usually not have a pharmacist around complicating the case. A recent decision, Kowalski v. Rose Drugs of Dardanelle, Inc., slip op., ___ S.W.3d ___, 2011 WL 478601 (Ark. Feb. 9, 2011), says we we're right about that, at least in Arkansas. Interestingly, at least from the caption, it appears that Kowalski wasn’t a product liability suit at all, but a simple negligence action. The parties were a doctor, who prescribed a veritable cornocopia of drugs to the decedent, and the pharmacy. Evidently, the decedent took a bunch of these drugs all at once and died from what the court called “mixed drug intoxication.” Slip op. 2 (ordinarily we’d use the Westlaw pagination, but for some bizarre reason WL doesn’t provide any for Arkansas slips). There’s no indication in the opinion whether the decedent made an honest mistake or was trying to get high (as we'll see, several of these drugs were controlled substances).
Anyway, the claim against the doctor wasn’t involved in the Kowalski appeal. The claim against the pharmacy alleged that – even though every one of the prescriptions was regular and proper on its face – the pharmacy had a duty not to fill them because, taken together, the drugs could be fatal. The Arkansas Supreme Court, joining a substantial majority of other jurisdictions, said no. A pharmacist has no duty to inquire behind a facially regular prescription.
The court first rejected a quasi-negligence per se argument grounded in “certain duties imposed by regulations” upon pharmacists. Slip op. at 7. The court declined to base civil liability upon any of these regulations. The Controlled Substances Act, the court held, was designed to prevent distribution of certain drugs “outside the ordinary scope of . . . professional practice.” Id. at 8. The prescriptions in Kowalski, however, were regular – for proper amounts and for legitimate medical treatment. So the Controlled Substances Act did not apply. Id. at 9-10.
Additional federal pharmacy-related requirements were imposed by the Omnibus Budget Reconciliation Act of 1990, but the Kowalski court held that this statute created no private right of action. Slip op. at 11-12. The plaintiff also advanced Arkansas state pharmacy regulations, but none of these created any duty of pharmacists to warn either patients or prescribing physicians. Id. at 13-14.
That left the plaintiff in Kowalski with only common-law arguments that pharmacists should have a duty to warn patients (or prescribers) about regular prescriptions that could possibly cause some sort of harm. The court joined the majority of jurisdictions – basing its decision on the necessary implication of the learned intermediary rule (already adopted in Arkansas) that, if drug manufacturers only had to warn physicians, certainly the obligations on pharmacies could be no broader:
Id. at 18-19 (citations and quotation marks omitted).
We’ve mentioned the “majority rule” rejecting pharmacy liability several times. So we'll prove it - here’s our list of decisions so holding:
Springhill Hospitals, Inc. v. Larrimore, 5 So.3d 513, 518-19 (Ala. 2008); Walls v. Alpharma USPD, Inc., 887 So.2d 881, 886 (Ala. 2004); Orr v. Wyeth-Ayerst Laboratories Co., 1999 WL 33548162, at * 2-5 (Ala. Cir. Aug. 2, 1999); In re Rezulin Products Liability Litigation, 133 F. Supp.2d 272, 292-93 (S.D.N.Y. 2001) (applying Alabama law); Wiggins v. American Home Products Corp., 2001 WL 34013629, at *3 (N.D. Ala. Oct. 2, 2001); Sanks v. Parke-Davis, 2000 WL 33910097, at *4 (M.D. Ala. Oct. 30, 2000); Lansdell v. American Home Products Corp., 1999 WL 33548541, at *5-7 (N.D. Ala. Oct. 26, 1999); Harrell v. Wyeth-Ayerst Laboratories, 1999 WL 33548540, at *1 (S.D. Ala. Feb. 1, 1999).
Kowalski v. Rose Drugs of Dardanelle, Inc., ___ S.W.3d ___, 2011 WL 478601 (Ark. Feb. 9, 2011); Cheatham v. Teva Pharmaceuticals, 726 F. Supp.2d 1021, 1023-24 (E.D. Ark. 2010); Kohl v. American Home Products Corp., 78 F. Supp.2d 885, 892 (W.D. Ark. 1999)
Murphy v. E.R. Squibb & Sons, Inc., 710 P.2d 247, 250-53 (Cal. 1985); San Diego Hospital Ass’n. v. Superior Court, 35 Cal. Rptr.2d 489, 492 (Cal. App. 1994); In re Baycol Products Litigation, 2003 WL 22331294, at *2-3 (D. Minn. May 19, 2003) (applying California law).
Levesque v. Cluett, 2007 WL 4305676, at *3 (Conn. Super. Oct. 16, 2007); Deed v. Walgreen Co., 927 A.2d 1001, 1003-04 (Conn. Super. 2007); Plante v. Lomibiao, 2005 WL 1090180, at *3-4 (Conn. Super. Mar. 31, 2005); Deed v. Walgreen Co., 2004 WL 2943271, at *5 (Conn. Super. Nov. 15, 2004); Nobles v. Astrazeneca Pharmaceuticals, 832 A.2d 1241, 1243 (Conn. Super. 2003), vacated in part on other grounds, 2003 WL 22245379 (Conn. Super. Sept. 10, 2003); White v. Stop & Shop Cos., 1998 WL 559730, at *2 (D. Conn. Aug. 17, 1998).
Raynor v. Richardson-Merrell, Inc., 643 F. Supp. 238, 246-47 (D.D.C. 1986); Ealy v. Richardson-Merrell, Inc., 1987 WL 159970, at *2-3 (D.D.C. Jan. 12, 1987)
McLeod v. M.S. Merrell Co., 174 So.2d 736, 738-39 (Fla. 1965); Estate of Johnson v. Badger Acquisition LLC, 983 So.2d 1175, 1183-84 (Fla. App. 2008); Estate of Sharp v. Omnicare, Inc., 879 So.2d 34, 35-36 (Fla. App. 2004); Johnson v. Walgreen Co., 675 So.2d 1036, 1037 (Fla. App. 1996); Pysz v. Henry’s Drug Store, 457 So.2d 561, 562 (Fla. App. 1984); Bailey v. Janssen Pharmaceutica, Inc., 2006 WL 3665417, at *4 n.2 (S.D. Fla. Nov. 14, 2006); Layton v. SmithKline Beecham Corp., 2006 WL 2194498, at *3 (M.D. Fla. Aug. 2, 2006); In re Diet Drugs Products Liability Litigation, 2004 WL 1824357, at *5-6 (E.D. Pa. Aug. 12, 2004) (applying Florida law); In re Rezulin Products Liability Litigation, 2002 WL 511550, at *1 (S.D.N.Y. Apr. 4, 2002) (applying Florida law);
Chamblin v. K-Mart Corp., 612 S.E.2d 25, 28-29 (Ga. App. 2005); Yarbrough v. Actavis Totowa, LLC, 2010 WL 3604674, at *3-4 (S.D. Ga. Sept. 13, 2010); Walker v. Jack Eckerd Corp., 434 S.E.2d 63, 67-69 (Ga. App. 1993).
Frye v. Medicare-Glaser Corp., 605 N.E.2d 557, 559-61 (Ill. 1992); DiGiovanni v. Albertson's, Inc., 940 N.E.2d 73, 75-78 (Ill. App. 2010); Kasin v. Osco Drug Inc., 728 N.E.2d 77, 78-79 (Ill. App. 2000); Fakhouri v. Taylor, 618 N.E.2d 518, 519-22 (Ill. App. 1993); Leesley v. West, 518 N.E.2d 758, 761-63 (Ill. App. 1988); Eldridge v. Eli Lilly & Co., 485 N.E.2d 551, 553 (Ill. App. 1985); Stephens v. Hook-SupeRx, 359 Fed. Appx. 648, 650 (7th Cir. 2009) (applying Illinois law); In re Yasmin & Yaz Marketing, Sales Practices & Products Liability Litigation, 2010 WL 4904478, at *2-4 (S.D. Ill. Nov. 24, 2010); Stephens v. CVS Pharmacy, 2009 WL 1916402, at *2-3 (N.D. Ill. June 11, 2009); Happel v. Wal-Mart Stores, Inc., 286 F. Supp.2d 943, 946-47 (N.D. Ill. 2003); Jones v. Irvin, 602 F. Supp. 399, 401-02 (S.D. Ill. 1985); Grimmer v. Schmitz, 1985 WL 3031, at *1-2 (N.D. Ill. Oct. 8, 1985).
Allberry v. Parkmor Drug, Inc., 834 N.E.2d 199, 202-03 (Ind. App. 2005); Ingram v. Hook’s Drugs, Inc., 476 N.E.2d 881, 886-87 (Ind. App. 1985); Peters v. Judd Drugs, Inc., 602 N.E.2d 162, 165 (Ind. App. 1992); Bobay v. Walgreen Co., 2009 WL 1940727, at *7-8 (N.D. Ind. June 30, 2009).
Nichols v. Central Merchandise, 817 P.2d 1131, 1133 (Kan. App. 1991); In re Diet Drugs Products Liability Litigation, 2000 WL 1886594, at *2-3 (E.D. Pa. Dec. 7, 2000) (applying Kansas law).
Flint v. Target Corp., 2009 WL 8746, at *3-4 (W.D. Ky. Jan. 13, 2009); Smith v. Wyeth Inc., 488 F. Supp.2d 625, 628-29 (W.D. Ky. 2007); Foister v. Purdue Pharma, L.P., 295 F. Supp.2d 693, 706 (E.D. Ky. 2003).
Gassen v. East Jefferson General Hospital, 628 So.2d 256, 258-59 (La. App. 1993); Kinney v. Hutchinson, 449 So.2d 696, 698 (La. App. 1984); LeBlanc v. Wyeth, Inc., 495 F. Supp.2d 609, 615 (W.D. La. 2007); In re Diet Drugs Products Liability Litigation, 2004 WL 1925010, at *1 (E.D. Pa. Aug. 30, 2004) (applying Louisiana law); In re Rezulin Products Liability Litigation, 133 F. Supp.2d 272, 294 (S.D.N.Y. 2001) (applying Louisiana law); Pilet v. Ciba-Geigy Corp., 1996 WL 89262, at *3 (E.D. La. Feb. 28, 1996).
Tardy v. Eli Lilly & Co., 2004 WL 1925536, at *2-3 (Me. Super. Aug. 3, 2004).
Hofherr v. Dart Industries, Inc., 853 F.2d 259, 263 (4th Cir. 1988) (applying Maryland law); Moore v. Wyeth-Ayerst Laboratories, 236 F. Supp.2d 509, 512-13 (D. Md. 2002).
Cottam v. CVS Pharmacy, 764 N.E.2d 814, 819-20 (Mass. 2002); Kelley v. Eli Lilly & Co., 2007 WL 1238789, at *5, *7 (D.D.C. Apr. 27, 2007) (applying Massachusetts law).
Saukas v. Walker Street Pharmacy, Inc., 2005 WL 1846289, at *1-2 (Mich. App. Aug. 4, 2005); Adkins v. Mong, 425 N.W.2d 151, 152-54 (Mich. App. 1988); Stebbins v. Concord Wrigley Drugs, Inc., 416 N.W.2d 381, 386-88 (Mich. App. 1987); Lemire v. Garrard Drugs, 291 N.W.2d 103, 105 (Mich. App. 1980).
Moore v. Memorial Hospital, 825 So.2d 658, 662 (Miss. 2002); Collins v. American Home Products Corp., 343 F.3d 765, 769 n.1 (5th Cir. 2003) (applying Mississippi law); In re Baycol Products Litigation, 2004 WL 1118642, at *4 (D. Minn. May 17, 2004) (applying Mississippi law); In re Diet Drugs Products Liability Litigation, 2004 WL 966263, at *2-3 (E.D. Pa. May 12, 2004) (applying Mississippi law); In re Rezulin Products Liability Litigation, 2003 WL 21396744, at *3 (S.D.N.Y. June 17, 2003) (applying Mississippi law); In re Diet Drugs Products Liability Litigation, 220 F. Supp.2d 414, 422 (E.D. Pa. 2002) (applying Mississippi law).
Sanchez v. Wal-Mart Stores, Inc., 221 P.3d 1276, 1280-84 (Nev. 2009).
In re New York County Diet Drug Litigation, 691 N.Y.S.2d 501, 502 (N.Y.A.D. 1999); Bichler v. Willing, 397 N.Y.S.2d 57, 58-59 (N.Y.A.D. 1977); Ullman v. Grant, 450 N.Y.S.2d 955, 956-57 (N.Y. Sup. 1982); Winters v. Alza Corp., 690 F. Supp.2d 350, 354 (S.D.N.Y. 2010); Fagan v. AmerisourceBergen Corp., 356 F. Supp.2d 198, 212-14 (E.D.N.Y. 2004); Negrin v. Alza Corp., 1999 WL 144507, at *3-5 (S.D.N.Y. 1999) (applying New York law).
Batiste v. American Home Products Corp., 231 S.E.2d 269, 274-76 (N.C. App. 1977).
Coyle v. Richardson-Merrell, Inc., 584 A.2d 1383, 1386-88 (Pa. 1991); Makripodis v. Merrell-Dow Pharmaceuticals, Inc., 523 A.2d 374, 376-79 (Pa. Super. 1987); Ramirez v. Richardson-Merrell, Inc., 628 F. Supp. 85, 87-88 (E.D. Pa. 1985).
Madison v. American Home Products Corp., 595 S.E.2d 493, 495-96 (S.C. 2004).
Morgan v. Wal-Mart Stores, Inc., 30 S.W.3d 455, 460-66 (Tex. App. 2000); Wimm v. Jack Eckerd Corp., 3 F.3d 137, 142 (5th Cir. 1993) (applying Texas law); In re Diet Drugs Products Liability Litigation, 2004 WL 1535828, at *9 (E.D. Pa. July 6, 2004) (applying Texas law); In re Rezulin Products Liability Litigation, 133 F. Supp.2d 272, 294 (S.D.N.Y. 2001) (applying Texas law); Speer v. United States, 512 F. Supp. 670, 679-80 (N.D. Tex. 1981), aff’d without op., 675 F.2d 100 (5th Cir. 1982).
Schaerrer v. Stewart’s Plaza Pharmacy, Inc., 79 P.3d 922, 929-30 (Utah 2003).
McKee v. American Home Products Corp., 782 P.2d 1045, 1049 (Wash. 1989); Silves v. King, 970 P.2d 790, 794 (Wash. App. 1990); Luke v. Family Care & Urgent Medical Clinics, 246 Fed. Appx. 421, 425 (9th Cir. 2007) (applying Washington law).
Estate of Baker v. University of Vermont, 2005 WL 6280644 (Vt. Super. May 4, 2005).
Gressman v. Peoples Service Drug Stores, Inc., 1988 WL 619115, at *6-8 (Va. Cir. 1988).
W. Va. Code § 30-5-2; Vagenos v. Alza Corp., 2010 WL 2944683, at *3-5 (S.D.W. Va. July 23, 2010); Ashworth v. Albers Medical, Inc., 395 F. Supp.2d 395, 407-08 (S.D.W. Va. 2005); In re Baycol Products Litigation, 2003 WL 22038708, at *7-8 (D. Minn. Feb. 25, 2003) (applying West Virginia law); Baker v. Purdue Pharma L.P., 2002 WL 34213424, at *3-5 (S.D.W. Va. Mar. 28, 2002); In re Rezulin Products Liability Litigation, 133 F. Supp.2d 272, 294 (S.D.N.Y. 2001) (applying West Virginia law). Note: While the statute will control the precise question, some of the cases apply the learned intermediary rule, which the West Virginia Supreme Court has subsequently rejected.
- Warnings go to physicians because they are the only people who know both a particular patient’s medical history as well as the risk/benefit profile of the drug/device being prescribed.
- Limiting warning duties to physicians makes the common law consistent with warning duties imposed by the FDA.
- Routing prescription drug/device information through the doctor preserves the physician/patient relationship from outside interference.
- The complicated medical terminology necessary to explain the risk/benefit profile of prescription drugs/devices is difficult for ordinary patients to understand.
- Practical difficulties often preclude drug/device companies from direct communication with patients.
But plaintiffs don’t make direct-to-patient warning claims only against drug/device companies. They’ll also tried to get around the learned intermediary rule by claiming that other entities in the drug/device (but mostly drug) distribution chain should have warned patients directly. Such claims have most frequently been made against pharmacies. Sometimes the plaintiffs are really serious about pharmacy warning claims, but more often pharmacies are sued on failure to warn theories for tactical reasons – such as adding a non-diverse (that’s a resident of the plaintiff’s home state, for you non-lawyers) defendant to prevent the case from being removed from state to federal court.
In either case, representing manufacturer defendants, we’d usually not have a pharmacist around complicating the case. A recent decision, Kowalski v. Rose Drugs of Dardanelle, Inc., slip op., ___ S.W.3d ___, 2011 WL 478601 (Ark. Feb. 9, 2011), says we we're right about that, at least in Arkansas. Interestingly, at least from the caption, it appears that Kowalski wasn’t a product liability suit at all, but a simple negligence action. The parties were a doctor, who prescribed a veritable cornocopia of drugs to the decedent, and the pharmacy. Evidently, the decedent took a bunch of these drugs all at once and died from what the court called “mixed drug intoxication.” Slip op. 2 (ordinarily we’d use the Westlaw pagination, but for some bizarre reason WL doesn’t provide any for Arkansas slips). There’s no indication in the opinion whether the decedent made an honest mistake or was trying to get high (as we'll see, several of these drugs were controlled substances).
Anyway, the claim against the doctor wasn’t involved in the Kowalski appeal. The claim against the pharmacy alleged that – even though every one of the prescriptions was regular and proper on its face – the pharmacy had a duty not to fill them because, taken together, the drugs could be fatal. The Arkansas Supreme Court, joining a substantial majority of other jurisdictions, said no. A pharmacist has no duty to inquire behind a facially regular prescription.
The court first rejected a quasi-negligence per se argument grounded in “certain duties imposed by regulations” upon pharmacists. Slip op. at 7. The court declined to base civil liability upon any of these regulations. The Controlled Substances Act, the court held, was designed to prevent distribution of certain drugs “outside the ordinary scope of . . . professional practice.” Id. at 8. The prescriptions in Kowalski, however, were regular – for proper amounts and for legitimate medical treatment. So the Controlled Substances Act did not apply. Id. at 9-10.
Additional federal pharmacy-related requirements were imposed by the Omnibus Budget Reconciliation Act of 1990, but the Kowalski court held that this statute created no private right of action. Slip op. at 11-12. The plaintiff also advanced Arkansas state pharmacy regulations, but none of these created any duty of pharmacists to warn either patients or prescribing physicians. Id. at 13-14.
That left the plaintiff in Kowalski with only common-law arguments that pharmacists should have a duty to warn patients (or prescribers) about regular prescriptions that could possibly cause some sort of harm. The court joined the majority of jurisdictions – basing its decision on the necessary implication of the learned intermediary rule (already adopted in Arkansas) that, if drug manufacturers only had to warn physicians, certainly the obligations on pharmacies could be no broader:
We believe, however, that the better approach is that adopted by the majority of jurisdictions that there is no general duty to warn imposed on pharmacists. Many of the jurisdictions that have refused to impose a general duty to warn have done so on the basis that the learned-intermediary doctrine places the duty to warn with the prescribing physician. Oftentimes, the underlying rationale for applying the learned-intermediary doctrine is to protect the patient-physician relationship by preventing pharmacists from second-guessing the physicians or otherwise interfering with the patient-physician relationship.Slip op. at 16-17 (really long string citation omitted). In addition to protecting the physician patient relationship, the purpose of the learned intermediary rule in ensuring that decisions were made by the person most knowledgeable of both the patient’s condition and the risks and benefits of the proposed therapy also came into play:
The relationship between the physician-patient-manufacturer applies equally to the relationship between the physician-patient and pharmacist. In both circumstances the patient must look to the physician, for it is only the physician who can relate the propensities of the drug to the physical idiosyncrasies of the patient. It is the physician who is in the best position to decide when to use and how and when to inform his patient regarding risks and benefits pertaining to drug therapy. We cannot say that [the defendant pharmacy] had a general duty to warn, to refuse to fill the prescriptions, or to inquire of [the prescribing physician]. The duty to warn of the medications’ dangers was with [the prescriber] who prescribed the drugs.
Id. at 18-19 (citations and quotation marks omitted).
We’ve mentioned the “majority rule” rejecting pharmacy liability several times. So we'll prove it - here’s our list of decisions so holding:
Alabama
Springhill Hospitals, Inc. v. Larrimore, 5 So.3d 513, 518-19 (Ala. 2008); Walls v. Alpharma USPD, Inc., 887 So.2d 881, 886 (Ala. 2004); Orr v. Wyeth-Ayerst Laboratories Co., 1999 WL 33548162, at * 2-5 (Ala. Cir. Aug. 2, 1999); In re Rezulin Products Liability Litigation, 133 F. Supp.2d 272, 292-93 (S.D.N.Y. 2001) (applying Alabama law); Wiggins v. American Home Products Corp., 2001 WL 34013629, at *3 (N.D. Ala. Oct. 2, 2001); Sanks v. Parke-Davis, 2000 WL 33910097, at *4 (M.D. Ala. Oct. 30, 2000); Lansdell v. American Home Products Corp., 1999 WL 33548541, at *5-7 (N.D. Ala. Oct. 26, 1999); Harrell v. Wyeth-Ayerst Laboratories, 1999 WL 33548540, at *1 (S.D. Ala. Feb. 1, 1999).
Arkansas
Kowalski v. Rose Drugs of Dardanelle, Inc., ___ S.W.3d ___, 2011 WL 478601 (Ark. Feb. 9, 2011); Cheatham v. Teva Pharmaceuticals, 726 F. Supp.2d 1021, 1023-24 (E.D. Ark. 2010); Kohl v. American Home Products Corp., 78 F. Supp.2d 885, 892 (W.D. Ark. 1999)
California
Murphy v. E.R. Squibb & Sons, Inc., 710 P.2d 247, 250-53 (Cal. 1985); San Diego Hospital Ass’n. v. Superior Court, 35 Cal. Rptr.2d 489, 492 (Cal. App. 1994); In re Baycol Products Litigation, 2003 WL 22331294, at *2-3 (D. Minn. May 19, 2003) (applying California law).
Connecticut
Levesque v. Cluett, 2007 WL 4305676, at *3 (Conn. Super. Oct. 16, 2007); Deed v. Walgreen Co., 927 A.2d 1001, 1003-04 (Conn. Super. 2007); Plante v. Lomibiao, 2005 WL 1090180, at *3-4 (Conn. Super. Mar. 31, 2005); Deed v. Walgreen Co., 2004 WL 2943271, at *5 (Conn. Super. Nov. 15, 2004); Nobles v. Astrazeneca Pharmaceuticals, 832 A.2d 1241, 1243 (Conn. Super. 2003), vacated in part on other grounds, 2003 WL 22245379 (Conn. Super. Sept. 10, 2003); White v. Stop & Shop Cos., 1998 WL 559730, at *2 (D. Conn. Aug. 17, 1998).
District of Columbia
Raynor v. Richardson-Merrell, Inc., 643 F. Supp. 238, 246-47 (D.D.C. 1986); Ealy v. Richardson-Merrell, Inc., 1987 WL 159970, at *2-3 (D.D.C. Jan. 12, 1987)
Florida
McLeod v. M.S. Merrell Co., 174 So.2d 736, 738-39 (Fla. 1965); Estate of Johnson v. Badger Acquisition LLC, 983 So.2d 1175, 1183-84 (Fla. App. 2008); Estate of Sharp v. Omnicare, Inc., 879 So.2d 34, 35-36 (Fla. App. 2004); Johnson v. Walgreen Co., 675 So.2d 1036, 1037 (Fla. App. 1996); Pysz v. Henry’s Drug Store, 457 So.2d 561, 562 (Fla. App. 1984); Bailey v. Janssen Pharmaceutica, Inc., 2006 WL 3665417, at *4 n.2 (S.D. Fla. Nov. 14, 2006); Layton v. SmithKline Beecham Corp., 2006 WL 2194498, at *3 (M.D. Fla. Aug. 2, 2006); In re Diet Drugs Products Liability Litigation, 2004 WL 1824357, at *5-6 (E.D. Pa. Aug. 12, 2004) (applying Florida law); In re Rezulin Products Liability Litigation, 2002 WL 511550, at *1 (S.D.N.Y. Apr. 4, 2002) (applying Florida law);
Georgia
Chamblin v. K-Mart Corp., 612 S.E.2d 25, 28-29 (Ga. App. 2005); Yarbrough v. Actavis Totowa, LLC, 2010 WL 3604674, at *3-4 (S.D. Ga. Sept. 13, 2010); Walker v. Jack Eckerd Corp., 434 S.E.2d 63, 67-69 (Ga. App. 1993).
Illinois
Frye v. Medicare-Glaser Corp., 605 N.E.2d 557, 559-61 (Ill. 1992); DiGiovanni v. Albertson's, Inc., 940 N.E.2d 73, 75-78 (Ill. App. 2010); Kasin v. Osco Drug Inc., 728 N.E.2d 77, 78-79 (Ill. App. 2000); Fakhouri v. Taylor, 618 N.E.2d 518, 519-22 (Ill. App. 1993); Leesley v. West, 518 N.E.2d 758, 761-63 (Ill. App. 1988); Eldridge v. Eli Lilly & Co., 485 N.E.2d 551, 553 (Ill. App. 1985); Stephens v. Hook-SupeRx, 359 Fed. Appx. 648, 650 (7th Cir. 2009) (applying Illinois law); In re Yasmin & Yaz Marketing, Sales Practices & Products Liability Litigation, 2010 WL 4904478, at *2-4 (S.D. Ill. Nov. 24, 2010); Stephens v. CVS Pharmacy, 2009 WL 1916402, at *2-3 (N.D. Ill. June 11, 2009); Happel v. Wal-Mart Stores, Inc., 286 F. Supp.2d 943, 946-47 (N.D. Ill. 2003); Jones v. Irvin, 602 F. Supp. 399, 401-02 (S.D. Ill. 1985); Grimmer v. Schmitz, 1985 WL 3031, at *1-2 (N.D. Ill. Oct. 8, 1985).
Indiana
Allberry v. Parkmor Drug, Inc., 834 N.E.2d 199, 202-03 (Ind. App. 2005); Ingram v. Hook’s Drugs, Inc., 476 N.E.2d 881, 886-87 (Ind. App. 1985); Peters v. Judd Drugs, Inc., 602 N.E.2d 162, 165 (Ind. App. 1992); Bobay v. Walgreen Co., 2009 WL 1940727, at *7-8 (N.D. Ind. June 30, 2009).
Kansas
Nichols v. Central Merchandise, 817 P.2d 1131, 1133 (Kan. App. 1991); In re Diet Drugs Products Liability Litigation, 2000 WL 1886594, at *2-3 (E.D. Pa. Dec. 7, 2000) (applying Kansas law).
Kentucky
Flint v. Target Corp., 2009 WL 8746, at *3-4 (W.D. Ky. Jan. 13, 2009); Smith v. Wyeth Inc., 488 F. Supp.2d 625, 628-29 (W.D. Ky. 2007); Foister v. Purdue Pharma, L.P., 295 F. Supp.2d 693, 706 (E.D. Ky. 2003).
Louisiana
Gassen v. East Jefferson General Hospital, 628 So.2d 256, 258-59 (La. App. 1993); Kinney v. Hutchinson, 449 So.2d 696, 698 (La. App. 1984); LeBlanc v. Wyeth, Inc., 495 F. Supp.2d 609, 615 (W.D. La. 2007); In re Diet Drugs Products Liability Litigation, 2004 WL 1925010, at *1 (E.D. Pa. Aug. 30, 2004) (applying Louisiana law); In re Rezulin Products Liability Litigation, 133 F. Supp.2d 272, 294 (S.D.N.Y. 2001) (applying Louisiana law); Pilet v. Ciba-Geigy Corp., 1996 WL 89262, at *3 (E.D. La. Feb. 28, 1996).
Maine
Tardy v. Eli Lilly & Co., 2004 WL 1925536, at *2-3 (Me. Super. Aug. 3, 2004).
Maryland
Hofherr v. Dart Industries, Inc., 853 F.2d 259, 263 (4th Cir. 1988) (applying Maryland law); Moore v. Wyeth-Ayerst Laboratories, 236 F. Supp.2d 509, 512-13 (D. Md. 2002).
Massachusetts
Cottam v. CVS Pharmacy, 764 N.E.2d 814, 819-20 (Mass. 2002); Kelley v. Eli Lilly & Co., 2007 WL 1238789, at *5, *7 (D.D.C. Apr. 27, 2007) (applying Massachusetts law).
Michigan
Saukas v. Walker Street Pharmacy, Inc., 2005 WL 1846289, at *1-2 (Mich. App. Aug. 4, 2005); Adkins v. Mong, 425 N.W.2d 151, 152-54 (Mich. App. 1988); Stebbins v. Concord Wrigley Drugs, Inc., 416 N.W.2d 381, 386-88 (Mich. App. 1987); Lemire v. Garrard Drugs, 291 N.W.2d 103, 105 (Mich. App. 1980).
Mississippi
Moore v. Memorial Hospital, 825 So.2d 658, 662 (Miss. 2002); Collins v. American Home Products Corp., 343 F.3d 765, 769 n.1 (5th Cir. 2003) (applying Mississippi law); In re Baycol Products Litigation, 2004 WL 1118642, at *4 (D. Minn. May 17, 2004) (applying Mississippi law); In re Diet Drugs Products Liability Litigation, 2004 WL 966263, at *2-3 (E.D. Pa. May 12, 2004) (applying Mississippi law); In re Rezulin Products Liability Litigation, 2003 WL 21396744, at *3 (S.D.N.Y. June 17, 2003) (applying Mississippi law); In re Diet Drugs Products Liability Litigation, 220 F. Supp.2d 414, 422 (E.D. Pa. 2002) (applying Mississippi law).
Nevada
Sanchez v. Wal-Mart Stores, Inc., 221 P.3d 1276, 1280-84 (Nev. 2009).
New York
In re New York County Diet Drug Litigation, 691 N.Y.S.2d 501, 502 (N.Y.A.D. 1999); Bichler v. Willing, 397 N.Y.S.2d 57, 58-59 (N.Y.A.D. 1977); Ullman v. Grant, 450 N.Y.S.2d 955, 956-57 (N.Y. Sup. 1982); Winters v. Alza Corp., 690 F. Supp.2d 350, 354 (S.D.N.Y. 2010); Fagan v. AmerisourceBergen Corp., 356 F. Supp.2d 198, 212-14 (E.D.N.Y. 2004); Negrin v. Alza Corp., 1999 WL 144507, at *3-5 (S.D.N.Y. 1999) (applying New York law).
North Carolina
Batiste v. American Home Products Corp., 231 S.E.2d 269, 274-76 (N.C. App. 1977).
Pennsylvania
Coyle v. Richardson-Merrell, Inc., 584 A.2d 1383, 1386-88 (Pa. 1991); Makripodis v. Merrell-Dow Pharmaceuticals, Inc., 523 A.2d 374, 376-79 (Pa. Super. 1987); Ramirez v. Richardson-Merrell, Inc., 628 F. Supp. 85, 87-88 (E.D. Pa. 1985).
South Carolina
Madison v. American Home Products Corp., 595 S.E.2d 493, 495-96 (S.C. 2004).
Texas
Morgan v. Wal-Mart Stores, Inc., 30 S.W.3d 455, 460-66 (Tex. App. 2000); Wimm v. Jack Eckerd Corp., 3 F.3d 137, 142 (5th Cir. 1993) (applying Texas law); In re Diet Drugs Products Liability Litigation, 2004 WL 1535828, at *9 (E.D. Pa. July 6, 2004) (applying Texas law); In re Rezulin Products Liability Litigation, 133 F. Supp.2d 272, 294 (S.D.N.Y. 2001) (applying Texas law); Speer v. United States, 512 F. Supp. 670, 679-80 (N.D. Tex. 1981), aff’d without op., 675 F.2d 100 (5th Cir. 1982).
Utah
Schaerrer v. Stewart’s Plaza Pharmacy, Inc., 79 P.3d 922, 929-30 (Utah 2003).
Washington
McKee v. American Home Products Corp., 782 P.2d 1045, 1049 (Wash. 1989); Silves v. King, 970 P.2d 790, 794 (Wash. App. 1990); Luke v. Family Care & Urgent Medical Clinics, 246 Fed. Appx. 421, 425 (9th Cir. 2007) (applying Washington law).
Vermont
Estate of Baker v. University of Vermont, 2005 WL 6280644 (Vt. Super. May 4, 2005).
Virginia
Gressman v. Peoples Service Drug Stores, Inc., 1988 WL 619115, at *6-8 (Va. Cir. 1988).
West Virginia
W. Va. Code § 30-5-2; Vagenos v. Alza Corp., 2010 WL 2944683, at *3-5 (S.D.W. Va. July 23, 2010); Ashworth v. Albers Medical, Inc., 395 F. Supp.2d 395, 407-08 (S.D.W. Va. 2005); In re Baycol Products Litigation, 2003 WL 22038708, at *7-8 (D. Minn. Feb. 25, 2003) (applying West Virginia law); Baker v. Purdue Pharma L.P., 2002 WL 34213424, at *3-5 (S.D.W. Va. Mar. 28, 2002); In re Rezulin Products Liability Litigation, 133 F. Supp.2d 272, 294 (S.D.N.Y. 2001) (applying West Virginia law). Note: While the statute will control the precise question, some of the cases apply the learned intermediary rule, which the West Virginia Supreme Court has subsequently rejected.
Wyoming
Van Dyke v. United States, 388 Fed. Appx. 786, 793 (10th Cir. 2010).
Wednesday, February 23, 2011
No Automotive Preemption In Williamson v. Mazda.
In our earlier post about Bruesewitz, our first takeaway was that "[e]xpress preemption has more friends on the Court than implied preemption." That proposition was certainly on display today in Williamson v. Mazda, slip op. (U.S. Feb.23, 2011), where an implied preemption argument in the automotive context (whether tort law could demand a spider's web of shoulder belts in multi-passenger minivans) garnered exactly zero votes.
Still, it could have been worse. There had been some speculation that Geier v. American Honda Motor Co., 529 U.S. 861 (2000), the first major implied preemption decision in the product liability field, might be overruled. that didn't happen. To the contrary, just about the entire rationale of Geier was reaffirmed by seven of the eight participating justices (Thomas, of course, wants to abolish implied preemption (at least the "obstacle" kind) altogether). But while Geier lives, it's more or less restricted to similar facts - where the agency was really concerned with preserving manufacturer choice, and said so both at the time of the action and before the Supreme Court. There just aren't that many administrative brouhahas as big as the airbag controversy that spawned Geier.
That was always the Achilles heel of Geier, that the decision to emphasize the really good administrative facts about airbags - needed to win that case - potentially limited its scope. While a win is a win is a win, some prove more useful in subsequent litigation than others.
Another interesting note about Williamson - the supposed presumption against preemption was a no-show here as well, despite the 8-0 vote against preemption. So much for what the decision in Levine referred to as a "bedrock" preemption principle. Bedrock, meet alkahest.
Still, it could have been worse. There had been some speculation that Geier v. American Honda Motor Co., 529 U.S. 861 (2000), the first major implied preemption decision in the product liability field, might be overruled. that didn't happen. To the contrary, just about the entire rationale of Geier was reaffirmed by seven of the eight participating justices (Thomas, of course, wants to abolish implied preemption (at least the "obstacle" kind) altogether). But while Geier lives, it's more or less restricted to similar facts - where the agency was really concerned with preserving manufacturer choice, and said so both at the time of the action and before the Supreme Court. There just aren't that many administrative brouhahas as big as the airbag controversy that spawned Geier.
That was always the Achilles heel of Geier, that the decision to emphasize the really good administrative facts about airbags - needed to win that case - potentially limited its scope. While a win is a win is a win, some prove more useful in subsequent litigation than others.
Another interesting note about Williamson - the supposed presumption against preemption was a no-show here as well, despite the 8-0 vote against preemption. So much for what the decision in Levine referred to as a "bedrock" preemption principle. Bedrock, meet alkahest.
Notes on Bruesewitz
Yesterday we were busy ... or traveling ... or whatever. Presumably everybody reading this already knows that yesterday the Supreme Court was simply busy - and decided the Bruesewitz v. Wyeth vaccine preemption case. Not only that, as everybody knows Bruesewitz was decided favorably to preemption by a 6-2 score. Since we don't get any brownie points on this one as a breaking news event, we'll have to go for analysis.
So here are our takeaways from Bruesewitz.
(1) Express preemption has more friends on the Court than implied preemption.
(2) The great DTP versus DPT controversy has been definitively settled in favor of DTP. As we recall from doing vaccine cases pre-Act, that's a defense win.
(3) Vaccines have successfully staked a claim to the ultimate public good in our sandbox, and the Supreme Court knows it.
(4) Vaccine manufacturers were "immunized" from warning claims before (assuming compliance) and with design claims now barred, the only thing really left for a non-listed-injury vaccine plaintiff is a defective manufacture/violation claim. This result could create pressure to list more injuries as within the program.
(5) The amazing now-you-see-it, now-you-don't presumption against preemption went on walkabout again. It's not mentioned anywhere in the majority or concurring opinions (6 justices), and even the dissent relegates it to a footnote. Dissenting slip op. at 18-19 n.15. Over the last few years the presumption (if that's what it is) has performed the legal equivalent of a roundoff back handspring. It started off as an express preemption concept (a purported means of statutory interpretation) and has ended up as primarily a creature of implied preemption.
(6) "Unavoidable" means what it says. Thus design claims, which would make avoidability a moving target, are gone as a matter of straight-forward statutory interpretation.
(7) There are only three basic products liability claims - manufacturing, design, and warning. The "triumverate" quote, slip op. at 8, at aspect could come in useful in cases where plaintiffs pursue other theories, such as "failure to test."
(8) Pure risk/utility balancing involving alternative designs - a common type of design defect litigation (including the Third Restatement) - takes a hit. The Supreme Court (quite rightly) calls it "amorphous" and impossible to apply, so that as a test, risk/utility "probably ha[s] no real world effect." Slip op. at 8 n.35. The problem is that most alternative tests for design defect are even worse.
(8) Comment k takes a hit, too. It's "defined by a hodge-podge of criteria and a few examples" and suffers from "lack of clarity." Slip op. at 9. Again, the problem is that a world without comment k is worse - see the discussion of risk/utility balancing, above. The Court takes Alexander's approach to the Gordian knot, and simply cuts comment k loose. Id. at 9. That simplifies things, even if it probably does some violence to what Congress actually thought it was doing.
(9) The Court's list of "across the board" comment k states will be useful when we're in those states. Slip op. at 10 n.41. It's basically the same point we made over two years ago with our own state-by-state list, here. The Court comes back to the point on pages 18-20, pointing out that "widespread disagreement" as to the meaning of comment k precludes the use of any judicial gloss on the statutory "unavoidable" language.
(10) Grammarians will love the discussion of "consessive subordinate clauses" on p. 11. The rest of us will feel like we flunked the sixth grade because we didn't diagram enough sentences.
(11) We love this sentence, "But the rule against giving a portion of text an interpretation which renders it superfluous does not prescribe that a passage which could have been more terse does not mean what it says." Slip op. at 12. Just because draftsmen weren't the absolute best isn't a carte blanche to ignore what they did say. In statutory interpretation, the perfect should not be the enemy of the good.
(12) We wish footnote 48 (slip op. at 12) were longer, because if it were, the Bates "use the interpretation that restricts preemption" language probably would have explicitly bitten the dust. As it stands, footnote 48 recognizes it as obiter dictum, labeling it superfluous in the context of Bates.
(13) 90 FDA regulations are enough to "pervasively regulate" vaccine manufacturing. Slip op. at 13. Geez, how many drug regulations do we have?
(14) In order to "cost the manufacturer its regulatory-compliance defense" a regulatory violation must be "material." Slip op. at 13. That could also come in handy in device preemption cases.
(15) "Drug manufacturers often could trade a little less efficacy for a little more safety, but the safest design is not always the best one." Slip op. at 13. We like it - especially since the Court for some reason is referring to "drugs," not vaccines.
(16) The Court's rationale (slip op. at 14) that the relative lack of FDA "guidance" concerning designs, combined with extensive labeling and manufacturing regulations, is supportive of express preemption by omission is another proposition that strikes us as potentially being useful in the context of medical device preemption.
(17) Governmental incentives are an acceptable alternative to tort litigation as a means of encouraging safer product design. Slip op. at 15.
(18) We've often considered warning claims to be the last refuge of the scoundrel (with apologies to Samuel Johnson) plaintiff with no real case. The Supreme Court seems to award that distinction to design defect claims. "[D]esign-defect allegations are the most speculative and difficult type of products liability claim to litigate." Slip op. at 15-16. We'll remember that when a prescription drug design defect claim comes to the Court post-Levine.
(19) Some things never change. Justice Scalia still hates legislative history as a means of interpreting statutes. Slip op. at 16 ("those of us who believe").
(20) The Court blows out "post-enactment legislative history" as not having any place in statutory interpretation. Slip op. at 17-18. Funny how a different author not long ago blithely relied upon 70 years of just such post-enactment history (and by negative implication, no less) in Levine.
(21) "Permitting the legislative history of subsequent funding legislation to alter the meaning of a statute would set adangerous precedent." Slip op. at 18. The Obama administration should file this quote away for possible use with respect to health care reform.
(22) Justice Breyer may not be the most consistently pro-preemption justice, but when he's good, he's very, very good. "To allow a jury in effect to second guess those [government] determinations is to substitute less expert for more expert judgment, thereby threatening manufacturers with liability (indeed, strict liability) in instances where any conflict between experts and nonexperts is likely to be particularly severe." Concurring op. at 5.
Finally, as a purely atmospheric matter, it is refreshing to see the court softening the anti-preemption tone that former Justice Stevens set in Levine. While it's hard to get one's hopes up given the battering that prescription drug preemption has taken since the benighted decision, the Court's comments on design defects leave us some reason for optimism that the extreme conflict cases in the prescription drug area, such as Wimbush and Bartlett, stand a chance of favorable consideration before the Court.
So here are our takeaways from Bruesewitz.
(1) Express preemption has more friends on the Court than implied preemption.
(2) The great DTP versus DPT controversy has been definitively settled in favor of DTP. As we recall from doing vaccine cases pre-Act, that's a defense win.
(3) Vaccines have successfully staked a claim to the ultimate public good in our sandbox, and the Supreme Court knows it.
(4) Vaccine manufacturers were "immunized" from warning claims before (assuming compliance) and with design claims now barred, the only thing really left for a non-listed-injury vaccine plaintiff is a defective manufacture/violation claim. This result could create pressure to list more injuries as within the program.
(5) The amazing now-you-see-it, now-you-don't presumption against preemption went on walkabout again. It's not mentioned anywhere in the majority or concurring opinions (6 justices), and even the dissent relegates it to a footnote. Dissenting slip op. at 18-19 n.15. Over the last few years the presumption (if that's what it is) has performed the legal equivalent of a roundoff back handspring. It started off as an express preemption concept (a purported means of statutory interpretation) and has ended up as primarily a creature of implied preemption.
(6) "Unavoidable" means what it says. Thus design claims, which would make avoidability a moving target, are gone as a matter of straight-forward statutory interpretation.
(7) There are only three basic products liability claims - manufacturing, design, and warning. The "triumverate" quote, slip op. at 8, at aspect could come in useful in cases where plaintiffs pursue other theories, such as "failure to test."
(8) Pure risk/utility balancing involving alternative designs - a common type of design defect litigation (including the Third Restatement) - takes a hit. The Supreme Court (quite rightly) calls it "amorphous" and impossible to apply, so that as a test, risk/utility "probably ha[s] no real world effect." Slip op. at 8 n.35. The problem is that most alternative tests for design defect are even worse.
(8) Comment k takes a hit, too. It's "defined by a hodge-podge of criteria and a few examples" and suffers from "lack of clarity." Slip op. at 9. Again, the problem is that a world without comment k is worse - see the discussion of risk/utility balancing, above. The Court takes Alexander's approach to the Gordian knot, and simply cuts comment k loose. Id. at 9. That simplifies things, even if it probably does some violence to what Congress actually thought it was doing.
(9) The Court's list of "across the board" comment k states will be useful when we're in those states. Slip op. at 10 n.41. It's basically the same point we made over two years ago with our own state-by-state list, here. The Court comes back to the point on pages 18-20, pointing out that "widespread disagreement" as to the meaning of comment k precludes the use of any judicial gloss on the statutory "unavoidable" language.
(10) Grammarians will love the discussion of "consessive subordinate clauses" on p. 11. The rest of us will feel like we flunked the sixth grade because we didn't diagram enough sentences.
(11) We love this sentence, "But the rule against giving a portion of text an interpretation which renders it superfluous does not prescribe that a passage which could have been more terse does not mean what it says." Slip op. at 12. Just because draftsmen weren't the absolute best isn't a carte blanche to ignore what they did say. In statutory interpretation, the perfect should not be the enemy of the good.
(12) We wish footnote 48 (slip op. at 12) were longer, because if it were, the Bates "use the interpretation that restricts preemption" language probably would have explicitly bitten the dust. As it stands, footnote 48 recognizes it as obiter dictum, labeling it superfluous in the context of Bates.
(13) 90 FDA regulations are enough to "pervasively regulate" vaccine manufacturing. Slip op. at 13. Geez, how many drug regulations do we have?
(14) In order to "cost the manufacturer its regulatory-compliance defense" a regulatory violation must be "material." Slip op. at 13. That could also come in handy in device preemption cases.
(15) "Drug manufacturers often could trade a little less efficacy for a little more safety, but the safest design is not always the best one." Slip op. at 13. We like it - especially since the Court for some reason is referring to "drugs," not vaccines.
(16) The Court's rationale (slip op. at 14) that the relative lack of FDA "guidance" concerning designs, combined with extensive labeling and manufacturing regulations, is supportive of express preemption by omission is another proposition that strikes us as potentially being useful in the context of medical device preemption.
(17) Governmental incentives are an acceptable alternative to tort litigation as a means of encouraging safer product design. Slip op. at 15.
(18) We've often considered warning claims to be the last refuge of the scoundrel (with apologies to Samuel Johnson) plaintiff with no real case. The Supreme Court seems to award that distinction to design defect claims. "[D]esign-defect allegations are the most speculative and difficult type of products liability claim to litigate." Slip op. at 15-16. We'll remember that when a prescription drug design defect claim comes to the Court post-Levine.
(19) Some things never change. Justice Scalia still hates legislative history as a means of interpreting statutes. Slip op. at 16 ("those of us who believe").
(20) The Court blows out "post-enactment legislative history" as not having any place in statutory interpretation. Slip op. at 17-18. Funny how a different author not long ago blithely relied upon 70 years of just such post-enactment history (and by negative implication, no less) in Levine.
(21) "Permitting the legislative history of subsequent funding legislation to alter the meaning of a statute would set adangerous precedent." Slip op. at 18. The Obama administration should file this quote away for possible use with respect to health care reform.
(22) Justice Breyer may not be the most consistently pro-preemption justice, but when he's good, he's very, very good. "To allow a jury in effect to second guess those [government] determinations is to substitute less expert for more expert judgment, thereby threatening manufacturers with liability (indeed, strict liability) in instances where any conflict between experts and nonexperts is likely to be particularly severe." Concurring op. at 5.
Finally, as a purely atmospheric matter, it is refreshing to see the court softening the anti-preemption tone that former Justice Stevens set in Levine. While it's hard to get one's hopes up given the battering that prescription drug preemption has taken since the benighted decision, the Court's comments on design defects leave us some reason for optimism that the extreme conflict cases in the prescription drug area, such as Wimbush and Bartlett, stand a chance of favorable consideration before the Court.
Monday, February 21, 2011
The Real Deal on Preemption and TwIqbal
Google Judge Manuel Real of the Central District of California. Go ahead. We'll wait.
Pretty amazing career, right? Since he took the bench in 1966, Judge Real has been at the center of controversies. In the 1970s, he entered an order desegregating the Pasadena school system. Predictably, that gave rise to dispute and criticism. But most of the criticism of Judge Real has come from criminal defense lawyers. And yet, Judge Real has also often found creative ways around sentencing guidelines and mandatory minimums to give first time offenders a second-chance. The Ninth Circuit has made a sport of reversing Judge Real, and has several times gone so far as to order that a new judge handle further proceedings. Of course, that's the Ninth Circuit, so it might amount to a badge of honor. And then there's this: everybody we know who knows Judge Real on a personal level talks about what a warm, caring man he is. And patriotic. Judge Real's chambers are decorated with American flags (Larry Flynt's desecration of a flag during a court proceeding led to one of the more colorful moments in Judge Real's career, the depiction of which by Hollywood was more creative than accurate), and Lincoln memorabilia.
See, there's a President's Day tie-in after all.
Anyway, our own contacts with Judge Real, on both the criminal and civil side, have always left us favorably impressed. Yep, that means we won. But the fact is that Judge Real's rulings are invariably clear and direct. We wrote here not too long ago about an eminently sound decision by Judge Real in Pain Pump litigation, where Judge Real insisted that plaintiffs name which manufacturer made the device at issue, instead of just listing all of them. Shocking, huh?
Last week we received another example of clear, direct thinking in a pacemaker case. In Cohen v. Guidant Corp., No. CV-05-8070-R (C.D. Cal. Feb. 15, 2011), Judge Real dismissed a pacemaker case on grounds of preemption and want of injury, facts, and particularity. The dismissal was with prejudice because this was the second time around.
The plaintiff had a pacemaker implanted in 2004. He later learned from news reports that pacemakers like his were failing. Understandably, that news upset him. The plaintiff faced a tough decision: undergo surgery or wait for something bad to happen. What to do? The plaintiff filed a lawsuit.
In 11 paragraphs, Judge Real explains why the case must fail. We'll try to be at least as brief as Judge Real:
-- The pacemaker is a Class III device, so Riegel preemption applies. The plaintiff cannot avail himself of the "parallel" claim exception because the Second Amended Complaint supplies no "factual detail" as to what FDA law/regulation was violated, and no "causal nexus between the alleged injury and the violation." Guess what? That's true in almost every parallel claim case. Judge Real is right on this issue, and all those judges who spend pages doing their best Jacques Derrida imitation to rescue parallel claims are wrong. Judge Real rejects "boilerplate" allegations of FDA violations. He's right. Those judges who wave by those boilerplate allegations are wrong. (We're talking about you, Bausch.)
-- Fear of future injury is not cognizable under California law. Yeah, there's some some batty California precedent out there, but Judge Real simply says it is "distinguishable and not persuasive." Back of the hand? Yes. Detailed reasoning? Nope. But is Judge Real right? Yes.
-- The plaintiff's fraud claims failed under Fed. R. Civ. P. 9(b) because the alleged frauds either related to other devices or resided on websites that the plaintiff never saw.
-- The Second Amended Complaint offered a "formulaic recitation" of the causes of action. Twombly and Iqbal say that's not enough. Judge Real followed that law.
Maybe somebody someday will find some way to add the Cohen decision to the list of reasons why Judge Real is an especially tough judge. Maybe the better description is that he is a no-nonsense judge. We don't think it's so bad to be against nonsense.
Pretty amazing career, right? Since he took the bench in 1966, Judge Real has been at the center of controversies. In the 1970s, he entered an order desegregating the Pasadena school system. Predictably, that gave rise to dispute and criticism. But most of the criticism of Judge Real has come from criminal defense lawyers. And yet, Judge Real has also often found creative ways around sentencing guidelines and mandatory minimums to give first time offenders a second-chance. The Ninth Circuit has made a sport of reversing Judge Real, and has several times gone so far as to order that a new judge handle further proceedings. Of course, that's the Ninth Circuit, so it might amount to a badge of honor. And then there's this: everybody we know who knows Judge Real on a personal level talks about what a warm, caring man he is. And patriotic. Judge Real's chambers are decorated with American flags (Larry Flynt's desecration of a flag during a court proceeding led to one of the more colorful moments in Judge Real's career, the depiction of which by Hollywood was more creative than accurate), and Lincoln memorabilia.
See, there's a President's Day tie-in after all.
Anyway, our own contacts with Judge Real, on both the criminal and civil side, have always left us favorably impressed. Yep, that means we won. But the fact is that Judge Real's rulings are invariably clear and direct. We wrote here not too long ago about an eminently sound decision by Judge Real in Pain Pump litigation, where Judge Real insisted that plaintiffs name which manufacturer made the device at issue, instead of just listing all of them. Shocking, huh?
Last week we received another example of clear, direct thinking in a pacemaker case. In Cohen v. Guidant Corp., No. CV-05-8070-R (C.D. Cal. Feb. 15, 2011), Judge Real dismissed a pacemaker case on grounds of preemption and want of injury, facts, and particularity. The dismissal was with prejudice because this was the second time around.
The plaintiff had a pacemaker implanted in 2004. He later learned from news reports that pacemakers like his were failing. Understandably, that news upset him. The plaintiff faced a tough decision: undergo surgery or wait for something bad to happen. What to do? The plaintiff filed a lawsuit.
In 11 paragraphs, Judge Real explains why the case must fail. We'll try to be at least as brief as Judge Real:
-- The pacemaker is a Class III device, so Riegel preemption applies. The plaintiff cannot avail himself of the "parallel" claim exception because the Second Amended Complaint supplies no "factual detail" as to what FDA law/regulation was violated, and no "causal nexus between the alleged injury and the violation." Guess what? That's true in almost every parallel claim case. Judge Real is right on this issue, and all those judges who spend pages doing their best Jacques Derrida imitation to rescue parallel claims are wrong. Judge Real rejects "boilerplate" allegations of FDA violations. He's right. Those judges who wave by those boilerplate allegations are wrong. (We're talking about you, Bausch.)
-- Fear of future injury is not cognizable under California law. Yeah, there's some some batty California precedent out there, but Judge Real simply says it is "distinguishable and not persuasive." Back of the hand? Yes. Detailed reasoning? Nope. But is Judge Real right? Yes.
-- The plaintiff's fraud claims failed under Fed. R. Civ. P. 9(b) because the alleged frauds either related to other devices or resided on websites that the plaintiff never saw.
-- The Second Amended Complaint offered a "formulaic recitation" of the causes of action. Twombly and Iqbal say that's not enough. Judge Real followed that law.
Maybe somebody someday will find some way to add the Cohen decision to the list of reasons why Judge Real is an especially tough judge. Maybe the better description is that he is a no-nonsense judge. We don't think it's so bad to be against nonsense.
Friday, February 18, 2011
A Mixed Bag In The Kugel Mesh Litigation
We have mentioned before on occasion rulings in the pretrial phase of the Kugel Mesh Hernia Repair Patch Litigation, MDL No. 1842 (D.R.I.). But we haven’t talked much about the litigation, maybe because we had a hard time figuring out how they made mesh out of kugel, until we learned that the mesh is actually named for Dr. Robert Kugel, its inventor. The defense prevailed in the first trial in that litigation, but the second trial resulted in a verdict for plaintiffs. Thorpe v. Davol, Inc., 2011 WL 470613 (D.R.I. Feb. 4, 2011). The court’s ruling on post-trial motions, like some kugel (but presumably not like Dr. Kugel), has good stuff and not as good stuff in it.
The plaintiff had a hernia, which was repaired with an XL CK Patch in 2005. The plaintiff had problems with the area around the repair over the next three years, and the XL CK Patch was eventually removed in 2008. During the same time period, Davol received and investigated problems with the XL CK Patch, which led to a recall in late 2005 and a conclusion that the instructions for use were deficient. The jury awarded plaintiff $1.3 million and his wife $200,000 for loss of consortium.
The good part is that the court granted defendants’ motion for judgment as a matter of law on the inadequate warning claim. The court found that even if Davol had known its product was defective and its instructions for use were inadequate before plaintiff received the CK Patch, the plaintiffs still had to prove these problems were the proximate cause of the injury – and there was no evidence that different instructions would have prevented the injury. Nothing in the surgeon’s account of the surgery showed that he “handled the patch in a manner that Davol failed to warn against.” Id. at *32. The court found “entirely speculative” the suggestion that the surgeon would not have chosen the XL CK Patch with different instructions. Id. The court’s ruling is a nice reiteration of the idea that proximate cause is not a given in failure to warn cases, even when the warnings are bad and the product was recalled.
The not so good part is that the court rejected the rest of the defense arguments, but the rulings are very fact-specific and should not give plaintiffs much comfort in other cases. The court rejected defendants’ motion to strike plaintiffs’ experts, who were an assistant professor of surgery at Harvard Medical School and a long-time professor of bioengineering and orthopedic surgery research at the University of Pennsylvania. We don’t see many plaintiffs’ experts with those kind of credentials, and their credentials and experience appear to have persuaded the court to overlook an otherwise shaky foundation for their testimony. The court also upheld the jury’s verdict for plaintiffs on the inadequate design claim based on specific testimony and facts of this case, a ruling that will help only other plaintiffs with the same facts, which will be few and far between.
In short, even though the defense ultimately did not prevail, defendants may be able to cite the good parts of this opinion in future litigation without much concern about swallowing the bad stuff.
The plaintiff had a hernia, which was repaired with an XL CK Patch in 2005. The plaintiff had problems with the area around the repair over the next three years, and the XL CK Patch was eventually removed in 2008. During the same time period, Davol received and investigated problems with the XL CK Patch, which led to a recall in late 2005 and a conclusion that the instructions for use were deficient. The jury awarded plaintiff $1.3 million and his wife $200,000 for loss of consortium.
The good part is that the court granted defendants’ motion for judgment as a matter of law on the inadequate warning claim. The court found that even if Davol had known its product was defective and its instructions for use were inadequate before plaintiff received the CK Patch, the plaintiffs still had to prove these problems were the proximate cause of the injury – and there was no evidence that different instructions would have prevented the injury. Nothing in the surgeon’s account of the surgery showed that he “handled the patch in a manner that Davol failed to warn against.” Id. at *32. The court found “entirely speculative” the suggestion that the surgeon would not have chosen the XL CK Patch with different instructions. Id. The court’s ruling is a nice reiteration of the idea that proximate cause is not a given in failure to warn cases, even when the warnings are bad and the product was recalled.
The not so good part is that the court rejected the rest of the defense arguments, but the rulings are very fact-specific and should not give plaintiffs much comfort in other cases. The court rejected defendants’ motion to strike plaintiffs’ experts, who were an assistant professor of surgery at Harvard Medical School and a long-time professor of bioengineering and orthopedic surgery research at the University of Pennsylvania. We don’t see many plaintiffs’ experts with those kind of credentials, and their credentials and experience appear to have persuaded the court to overlook an otherwise shaky foundation for their testimony. The court also upheld the jury’s verdict for plaintiffs on the inadequate design claim based on specific testimony and facts of this case, a ruling that will help only other plaintiffs with the same facts, which will be few and far between.
In short, even though the defense ultimately did not prevail, defendants may be able to cite the good parts of this opinion in future litigation without much concern about swallowing the bad stuff.
Thursday, February 17, 2011
Another TPP RICO Class Cert Denial
You may have heard Einstein’s definition of insanity: doing the same thing over and over and expecting different results. Well, if that’s right, then squirrels must be looking for TPP plaintiffs, because they’re nuts at this point if they think they’re going to get a RICO class certified (in the Second Circuit, at least).
We’ve previously reported on the Second Circuit blowing out a putative class in Zyprexa; in fact, it came in number one on our 2010 Top Ten Opinions list. Now we have more good news to report: a Magistrate Judge Report & Recommendation finding class certification inappropriate in a RICO/consumer fraud class action involving Ketek. See Sergeants Benevolent Assn. Health & Welfare Fund v. Sanofi-Aventis U.S. LLP, Case No. 1:08-cv-00179-SLT-RER (E.D.N.Y. Feb. 16, 2011) (we’re just going to call it Ketek). Hat-tip to Gary Spahn for sending along the opinion.
Ketek is a prescription antibiotic; plaintiffs were third-party payors (TPPs) who alleged the defendant fraudulently marketed Ketek by misrepresenting its safety and efficacy, and when the “truth” came out, prescriptions of Ketek plummeted. Plaintiffs sued on behalf of a nationwide class of TPPs, alleging claims under RICO, the consumer protection laws of forty-four states, and “unjust enrichment.”
The magistrate’s report and recommendation addressed only the RICO claims and deferred the pendent state claims, as plaintiffs suggested. Slip op. at 8 and n.7. The magistrate, following Zyprexa, found that individual issues predominated and doomed class certification.
The magistrate quickly zeroed in on the key issue, and the issue that hung up the Zyprexa TPPs – RICO reliance. “To prove injury by reason of a RICO violation, a plaintiff must demonstrate that the violation caused his injury in two ways: First, that the defendant’s conduct was the prximate cause of his injury – ‘there was a direct relationship between the plaintiff’s injury and the defendant’s injurious conduct.’ Second, that ‘but for’ the defendant’s conduct he would not have been injured. Although a plaintiff’s direct reliance is not a formal element of her RICO claim, there is no question that in cases such as this a plaintiff must allege and prove at least third-party reliance as part of the chain of causation. Because reliance is a necessary part of the causation theory Plaintiffs must be able to prove it through common evidence in order to obtain class certification.” Slip Op. at 18.
The Ketek plaintiffs couldn't make this showing, for the same reason that TPP RICO claims routinely fail to get certified: those pesky prescribing physicians and their intervening decision-making. Plaintiffs tried to get around this indivualized inquiry in a couple ways. According to plaintiffs’ expert Meredith Rosenthal, Ketek prescriptions plummeted in 2005, and then again in 2006 “once the true efficacy and safety risks were made known to the market.” Slip Op. at 18. Rosenthal contended that once this supposed “truth” was known, Ketek was allegedly restricted or removed from three-quarters of all TPP formularies, id., and the prescription drop was thus “common” proof that the alleged fraud must have caused a significant number of purchases. Id. at 21. Plaintiffs also offered the opinions of a number of medical experts, who opined as to Ketek’s safety profile and the information environment available to doctors. Id. at 23. One doctor went so far as to opine that prescribing Ketek was contrary to the applicable standard of care, and Ketek would not have been prescribed had the “truth” been known. Id.
None of that persuaded the magistrate, who efficiently summarized the many individual factors that may go into a particular doctor’s prescribing decision, id. at 24, before concluding: “physicians prescribe medications to their patients based on a variety of factors, which may or may not include information provided by drug companies. Based on the common evidence Plaintiffs proffer there is simply no way to determine whether all, or even most, of the physicians who previously prescribed Ketek for their patients based their decisions on Aventis’s purported misinformation. Indeed, the fact that Ketek sales plummeted…does not mean that prior thereto any physician based her decision to prescribe Ketek on Aventis’s fraud. It may well be that physicians prescribed Ketek based on factors other than Aventis’s fraud, and then later decided to discontinue prescribing Ketek once they knew of the true efficacy and health risks. Plaintiffs’ proffered common evidence simply does not prove reliance.” Id. at 30-31.
The magistrate didn't even need to seriously tangle with the other huge flaws in plaintiffs’ proposed proofs, including the fact that Rosenthal’s model did not attempt to account for other potential causes of the prescription decline, the fact that some doctors continued to prescribe Ketek for certain indications even after FDA withdrew those indications, the fact that other doctors may have switched to an antibiotic that cost as much or more than Ketek, and the fact that P&T Committees, PBMs, and TPPs, just like doctors, consider a host of different factors when deciding how to position drugs on a formulary and reimburse for those drugs. Id. at 25-26, 30-31. In fact, some of the named plaintiffs continued to reimburse for Ketek even after the adverse FDA actions. Id. at 26.
Most significant, of course, the magistrate had cover from the Second Circuit’s opinion in Zyprexa, which rejected a similar RICO causation theory proposed by a putative class of TPPs. Quoting extensively from Zyprexa, the magistrate concluded the same result was appropriate in Ketek – no class certification – and rejected plaintiffs’ specious attempts to distinguish the Second Circuit opinion (the relevant portion of Zyprexa was “purely dicta”? Really?).
This is clearly not the last word on Ketek – it is an R&R, after all, and we need to see what happens before the District Court. And there are still those nagging state-law claims. But this is still a good result, and maybe we’ll start to see a decline in TPP plaintiffs filing prescription drug RICO class actions. Unless they’re nuts, that is.
We’ve previously reported on the Second Circuit blowing out a putative class in Zyprexa; in fact, it came in number one on our 2010 Top Ten Opinions list. Now we have more good news to report: a Magistrate Judge Report & Recommendation finding class certification inappropriate in a RICO/consumer fraud class action involving Ketek. See Sergeants Benevolent Assn. Health & Welfare Fund v. Sanofi-Aventis U.S. LLP, Case No. 1:08-cv-00179-SLT-RER (E.D.N.Y. Feb. 16, 2011) (we’re just going to call it Ketek). Hat-tip to Gary Spahn for sending along the opinion.
Ketek is a prescription antibiotic; plaintiffs were third-party payors (TPPs) who alleged the defendant fraudulently marketed Ketek by misrepresenting its safety and efficacy, and when the “truth” came out, prescriptions of Ketek plummeted. Plaintiffs sued on behalf of a nationwide class of TPPs, alleging claims under RICO, the consumer protection laws of forty-four states, and “unjust enrichment.”
The magistrate’s report and recommendation addressed only the RICO claims and deferred the pendent state claims, as plaintiffs suggested. Slip op. at 8 and n.7. The magistrate, following Zyprexa, found that individual issues predominated and doomed class certification.
The magistrate quickly zeroed in on the key issue, and the issue that hung up the Zyprexa TPPs – RICO reliance. “To prove injury by reason of a RICO violation, a plaintiff must demonstrate that the violation caused his injury in two ways: First, that the defendant’s conduct was the prximate cause of his injury – ‘there was a direct relationship between the plaintiff’s injury and the defendant’s injurious conduct.’ Second, that ‘but for’ the defendant’s conduct he would not have been injured. Although a plaintiff’s direct reliance is not a formal element of her RICO claim, there is no question that in cases such as this a plaintiff must allege and prove at least third-party reliance as part of the chain of causation. Because reliance is a necessary part of the causation theory Plaintiffs must be able to prove it through common evidence in order to obtain class certification.” Slip Op. at 18.
The Ketek plaintiffs couldn't make this showing, for the same reason that TPP RICO claims routinely fail to get certified: those pesky prescribing physicians and their intervening decision-making. Plaintiffs tried to get around this indivualized inquiry in a couple ways. According to plaintiffs’ expert Meredith Rosenthal, Ketek prescriptions plummeted in 2005, and then again in 2006 “once the true efficacy and safety risks were made known to the market.” Slip Op. at 18. Rosenthal contended that once this supposed “truth” was known, Ketek was allegedly restricted or removed from three-quarters of all TPP formularies, id., and the prescription drop was thus “common” proof that the alleged fraud must have caused a significant number of purchases. Id. at 21. Plaintiffs also offered the opinions of a number of medical experts, who opined as to Ketek’s safety profile and the information environment available to doctors. Id. at 23. One doctor went so far as to opine that prescribing Ketek was contrary to the applicable standard of care, and Ketek would not have been prescribed had the “truth” been known. Id.
None of that persuaded the magistrate, who efficiently summarized the many individual factors that may go into a particular doctor’s prescribing decision, id. at 24, before concluding: “physicians prescribe medications to their patients based on a variety of factors, which may or may not include information provided by drug companies. Based on the common evidence Plaintiffs proffer there is simply no way to determine whether all, or even most, of the physicians who previously prescribed Ketek for their patients based their decisions on Aventis’s purported misinformation. Indeed, the fact that Ketek sales plummeted…does not mean that prior thereto any physician based her decision to prescribe Ketek on Aventis’s fraud. It may well be that physicians prescribed Ketek based on factors other than Aventis’s fraud, and then later decided to discontinue prescribing Ketek once they knew of the true efficacy and health risks. Plaintiffs’ proffered common evidence simply does not prove reliance.” Id. at 30-31.
The magistrate didn't even need to seriously tangle with the other huge flaws in plaintiffs’ proposed proofs, including the fact that Rosenthal’s model did not attempt to account for other potential causes of the prescription decline, the fact that some doctors continued to prescribe Ketek for certain indications even after FDA withdrew those indications, the fact that other doctors may have switched to an antibiotic that cost as much or more than Ketek, and the fact that P&T Committees, PBMs, and TPPs, just like doctors, consider a host of different factors when deciding how to position drugs on a formulary and reimburse for those drugs. Id. at 25-26, 30-31. In fact, some of the named plaintiffs continued to reimburse for Ketek even after the adverse FDA actions. Id. at 26.
Most significant, of course, the magistrate had cover from the Second Circuit’s opinion in Zyprexa, which rejected a similar RICO causation theory proposed by a putative class of TPPs. Quoting extensively from Zyprexa, the magistrate concluded the same result was appropriate in Ketek – no class certification – and rejected plaintiffs’ specious attempts to distinguish the Second Circuit opinion (the relevant portion of Zyprexa was “purely dicta”? Really?).
This is clearly not the last word on Ketek – it is an R&R, after all, and we need to see what happens before the District Court. And there are still those nagging state-law claims. But this is still a good result, and maybe we’ll start to see a decline in TPP plaintiffs filing prescription drug RICO class actions. Unless they’re nuts, that is.
Wednesday, February 16, 2011
Thinking About Compliance Presumptions
A couple of weeks ago we posted about the recently enacted Wisconsin tort reform statute, which, among a bunch of other things, included a “rebuttable” presumption that a product compliant with federal or state standards isn’t defective. Specifically, the statute provides:
One of our readers questioned whether the other side would gut this presumption by arguing it was meaningless, since what constitutes “rebuttal” is not defined. Plaintiffs bear the burden of proving defect anyway, so might can contend that the same evidence that they have always needed to get to a jury on the defect element of the tort is also sufficient to rebut the presumption.
Will they try it? Of course they will. They’re plaintiffs’ attorneys. Their job is to represent their clients with every bit as much vigor as we on the right side of the “v.” represent ours.
That also means it’s our job not to let them.
So we thought today we’d give the question of statutory compliance presumptions some thought.
First of all, what’s the universe of the statutes we’re talking about? We know of 14 states, and one federal statute, that address compliance with governmental standards, and most of them create presumptions. Some (Michigan and Texas) are stronger than others. Some are broader than others:
The federal statute, for example, applies only to vaccines, and only to warnings. It provides:
The other state statutes that we know of that address compliance in one way or another are: Arizona: Ariz. Rev. Stat. Ann. §12-701 (punitive damages only; mentions only “drugs”; compliance bars an award unless plaintiff proves FDA fraud/bribery by “clear and convincing” evidence); Arkansas: Ark. Code Ann. §16-116-105(a) (compliance generally is “evidence” of non-defectiveness); Colorado: Colo. Rev. Stat. §13-21-403(1)(b) (compliance generally creates rebuttable presumption; whenever facts exist that establish the presumption, the jury is to be charged); Florida: Fla. Stat. Ann. §768.1256 (compliance generally creates rebuttable presumption; special exclusion for products recalled or “seized” by the FDA); Indiana: Ind. Code §34-20-5-1 (compliance generally creates rebuttable presumption); Kansas: Kan. Stat. Ann. §60-3304(a) (compliance generally “deems” a product non-defective “unless the claimant proves by a preponderance of the evidence that a reasonably prudent product seller could and would have taken additional precautions”); Michigan: Mich. Comp. L. §600.2946(4-5) (compliance generally creates rebuttable presumption; FDA approved drugs are not defective unless sold after a recall or plaintiff proves FDA fraud/bribery); New Jersey: N.J. Stat. Ann. §2A:58C-4 (FDA approval of warning creates rebuttable presumption of warning adequacy); North Carolina: N.C. Gen. Stat. § 99B-6(b)(4) (evaluation of reasonableness of drug manufacturer "shall" include extent of FDA compliance); North Dakota: N.D. Cent. Code §28-01.3-09 (compliance generally creates rebuttable presumption); Tennessee: Tenn. Code Ann. §29-28-104 (compliance generally creates rebuttable presumption); Texas: Tex. Rev. Civ. Prac. & Rem. C. §82.007 (FDA approval of warning creates rebuttable presumption of warning adequacy; rebuttal limited to FDA fraud bribery, sales after a recall, and some off-label promotion situations); Utah: Utah Code Ann. §78-15-6 (compliance generally creates rebuttable presumption).
The question of what to do with a compliance presumption once a state has created it involves two separate but related issues.
The first issue is the amount of evidence necessary to overcome the presumption. As is evident from the descriptions we just gave you, the Vaccine Act and Arizona specify that “clear and convincing” evidence is required, while the other states’ statutes are silent.
The second issue is what happens to the presumption once it arguably has been overcome? Is the jury charged on it and allowed to make up its own mind? Alternatively, does the presumption vanish once contrary evidence is introduced, so that the jury never finds out about it?
The response, as we see it, to the first issue begins with some of the most basic canons of statutory interpretation – something we expect is followed in every state – (1) that statutes are not to be read as nullities, and in the same vein, (2) that the legislature is not presumed to act futilely. Another related proposition is (3) that an act is not to be construed to product an absurd result.
By enacting what it called a “presumption,” based upon the defendant’s compliance with relevant governmental standards, the legislature had to intend to benefit the compliant defendant in some way, right? If not, then why do anything at all?
Assuming that the legislature meant its enactment to mean something, then we have to figure out what's the most logical meaning with respect to our clients – in this context, FDA compliant drug/device companies. In this post-Levine world, we’ve largely been relegated to the old FDA standards as “minimum standards” view of the common law. See, e.g., Wyeth v. Rowatt, 244 P.3d 765, 780 (Nev. 2010); Dorsett v. Sandoz, Inc., 699 F. Supp.2d 1142, 1149 (C.D. Cal. 2010); In re Trasylol Products Liability Litigation, 2010 WL 4259332, at *4 (S.D. Fla. Oct. 21, 2010), and other depressing precedents.
What these compliance presumptions do after Levine is flip the common law default position regarding the effect of FDA compliance. Under Levine, compliance with FDA warning approval is presumptively not binding in a common-law case “absent clear evidence that the FDA would not have approved” a label change in the nature of what the plaintiff advocates. Wyeth v. Levine, 129 S. Ct. 1187, 1198 (2009). But in states where the legislature has enacted a presumption of non-defectiveness by reason of FDA (or other) compliance, the “minimum standard” analysis is upended. Under those statutes, compliance with the FDA’s approval of a warning now is presumptively binding in a common-law case – unless the plaintiff proves whatever the statute says s/he has to prove to overcome the presumption. So in those states, we’re dealing with Levine in reverse.
The logic of a statute creating a Levine in reverse situation (where the statutory presumption is that FDA compliance equals non-defectiveness), is that to rebut the presumption, a plaintiff should have to present the same degree of “clear evidence” as required by Levine. This analogy, which we think is to the closest relevant presumption in an FDA compliance case, would of course only apply where the legislature is silent (unlike Arizona or the Vaccine Act) as to the quantum of proof necessary to overcome the presumption. But again that’s closely analogous to Levine. Just as Congress in Levine was silent as to the preemptive effect of FDA compliance, most of the state compliance statutes are equally silent as to how much rebutting it takes to rebut a rebuttable presumption (or how much wood could a wood chuck chuck).
The Levine analogy is just that – an analogy. It’s not mandated by either statute or common-law postulate. But neither is anything else. So we think there are good logical reasons to apply the Levine “clear evidence” rebuttal standard to FDA compliance presumptions with respect to the quantum of evidence question. For one thing, this standard prevents the statutory presumption from being treated as a nullity, which is precisely what would happen if a plaintiff didn’t need to meet anything more than the pre-existing burden of proof in order to rebut the presumption. For a second thing, there’s symmetry. Levine applied a “clear evidence” standard to rebut the presumption against preemption in an FDA compliance context where the default was that compliance wasn’t controlling. Where a state legislature has determined that compliance is controlling, it makes sense to apply the same rebuttal standard, only in reverse. Third, the Levine “clear evidence” standard is consistent with the legislative judgment in those two instances (Vaccine Act and Arizona) where a statute actually did address the quantum of proof issue, suggesting that, if other legislatures had bothered to think about the issue, they most likely would have come out the same way.
Now we’ll turn to the second issue. What happens to a “rebuttable” presumption once it – arguably at least – has been rebutted by evidence of whatever it is that the legislature has provided should constitute rebuttal (which ranges from FDA fraud/bribery in a number of states, to unspecified “additional precautions” in Kansas). Only one of the compliance statutes, Colorado’s, deals expressly with this issue. Colorado law provides:
In the other states, where the legislature is silent, the question of whether the jury is charged on the presumption where some rebuttal evidence has been received will depend on how the state’s law (or possibly federal law in a diversity case, if this question is considered “procedural”) treats presumptions.
There are two theories of presumptions – the more traditional “bubble bursting” theory and the more recent persistent presumption approach. A bubble bursting presumption vanishes when it is rebutted and the jury is not thereafter instructed on it:
The other, more modern approach declares that some rebuttable presumptions are in the nature of substantive law, and it is for the jury to determine whether or not they are rebutted:
In this context, the federal approach is about as clear as mud. See McCormick §344 (“Despite the best efforts of legal scholars, instead of having one rule to govern all presumptions in all proceedings, we are left in some ways in a more confusing state than that which existed prior to the adoption of the Federal Rules.”); Hjelmaas, “Stepping Back from the Thicket: A Proposal for the Treatment of Rebuttable Presumptions & Inferences,” 42 Drake L. Rev. 427, 447 (1993) (“The [federal] rule is unclear . . . concerning the effect of rebuttal evidence on challenges to an established presumption. . . . The adoption of Federal Rule of Evidence 301 has not clarified this area of law”); Louisell, “Construing Rule 301: Instructing the Jury on Presumptions in Civil Actions and Proceedings,” 63 Va. L. Rev. 281 (1977) (Fed. R. Evid. 301 adopts a traditional, bubble-bursting approach, but can be interpreted broadly enough to permit an inference instruction); Mueller, “Instructing the Jury Upon Presumptions in Civil Cases: Comparing Federal Rule 301 with Uniform Rule 301, 12 Land & Water L. Rev. 219 (1977) (arguing against the traditional bubble bursting interpretation of Rule 301).
We think that compliance presumptions should persist – and that the jury should be charged on them – in any case where there is a jury question as to compliance. There are two reasons for that. First, the traditional bubble bursting approach arose, as McCormick points out in the part of the quote that we highlighted; where the presumption was created to assist a party bearing the burden of proof to avoid a “directed verdict at the end of his case.” Legislatures have passed compliance presumptions to assist defendants, who do not bear the burden of proof (except as to compliance itself). Thus the statutory compliance presumptions do not fit the rationale of the bubble bursting theory.
Conversely, compliance presumptions are the epitome of the “policy” based presumption, which is created for a reason other than to address a burden of proof problem. In this respect, we recommend the analysis of the Indiana Supreme Court in a non-drug case Bexis worked on, involving what weight to give the Indiana compliance statute (which, as we've indicated, was silent):
In the case of the brand new Wisconsin compliance presumption – and, indeed, in the case of compliance presumption statutes generally – the plaintiffs’ side can be expected to seek judicial interpretations that these statutes are meaningless nullities. They will do this by: (1) arguing that the presumption is rebutted by the same quantum of evidence that they already have to present to meet their pre-existing burden of proof, and (2) arguing that once they have put on any evidence at all of non-compliance, the presumption “bursts” and drops from the case.
We have to offer persuasive contrary arguments that preserve what the legislature actually wanted to do when it took the affirmative step of changing the common law with respect to FDA (and other) compliance. Lawmakers didn’t intend to enact a nullity, so the plaintiffs should have to meet the same “clear evidence” standard where state law says compliance equals lack of defect as we do when state law says otherwise. Furthermore, because legislatures only enact presumptions to favor parties not bearing the burden of proof for substantive policy reasons (because defendants don’t otherwise need them), juries should always be charged on a statutory compliance presumption except in the unusual situation where failure to comply is undisputed.
Evidence that the product, at the time of sale, complied in material respects with relevant standards, conditions, or specifications adopted or approved by a federal or state law or agency shall create a rebuttable presumption that the product is not defective.§895.047(3)(b).
One of our readers questioned whether the other side would gut this presumption by arguing it was meaningless, since what constitutes “rebuttal” is not defined. Plaintiffs bear the burden of proving defect anyway, so might can contend that the same evidence that they have always needed to get to a jury on the defect element of the tort is also sufficient to rebut the presumption.
Will they try it? Of course they will. They’re plaintiffs’ attorneys. Their job is to represent their clients with every bit as much vigor as we on the right side of the “v.” represent ours.
That also means it’s our job not to let them.
So we thought today we’d give the question of statutory compliance presumptions some thought.
First of all, what’s the universe of the statutes we’re talking about? We know of 14 states, and one federal statute, that address compliance with governmental standards, and most of them create presumptions. Some (Michigan and Texas) are stronger than others. Some are broader than others:
The federal statute, for example, applies only to vaccines, and only to warnings. It provides:
[A] vaccine shall be presumed to be accompanied by proper directions and warnings if the vaccine manufacturer shows that it complied in all material respects with all requirements under the [FDCA and the Vaccine Act] applicable to the vaccine and related to vaccine-related injury or death for which the civil action was brought unless the plaintiff shows –
(A) [fraud or bribery against the FDA], or
(B) by clear and convincing evidence that the manufacturer failed to exercise due care notwithstanding its compliance. . . .42 U.S.C. § 300aa-22(b)(2). Note that, unlike the Wisconsin statute, the federal law explicitly addresses the amount (we lawyers say “quantum”) of evidence necessary to overcome the presumption.
The other state statutes that we know of that address compliance in one way or another are: Arizona: Ariz. Rev. Stat. Ann. §12-701 (punitive damages only; mentions only “drugs”; compliance bars an award unless plaintiff proves FDA fraud/bribery by “clear and convincing” evidence); Arkansas: Ark. Code Ann. §16-116-105(a) (compliance generally is “evidence” of non-defectiveness); Colorado: Colo. Rev. Stat. §13-21-403(1)(b) (compliance generally creates rebuttable presumption; whenever facts exist that establish the presumption, the jury is to be charged); Florida: Fla. Stat. Ann. §768.1256 (compliance generally creates rebuttable presumption; special exclusion for products recalled or “seized” by the FDA); Indiana: Ind. Code §34-20-5-1 (compliance generally creates rebuttable presumption); Kansas: Kan. Stat. Ann. §60-3304(a) (compliance generally “deems” a product non-defective “unless the claimant proves by a preponderance of the evidence that a reasonably prudent product seller could and would have taken additional precautions”); Michigan: Mich. Comp. L. §600.2946(4-5) (compliance generally creates rebuttable presumption; FDA approved drugs are not defective unless sold after a recall or plaintiff proves FDA fraud/bribery); New Jersey: N.J. Stat. Ann. §2A:58C-4 (FDA approval of warning creates rebuttable presumption of warning adequacy); North Carolina: N.C. Gen. Stat. § 99B-6(b)(4) (evaluation of reasonableness of drug manufacturer "shall" include extent of FDA compliance); North Dakota: N.D. Cent. Code §28-01.3-09 (compliance generally creates rebuttable presumption); Tennessee: Tenn. Code Ann. §29-28-104 (compliance generally creates rebuttable presumption); Texas: Tex. Rev. Civ. Prac. & Rem. C. §82.007 (FDA approval of warning creates rebuttable presumption of warning adequacy; rebuttal limited to FDA fraud bribery, sales after a recall, and some off-label promotion situations); Utah: Utah Code Ann. §78-15-6 (compliance generally creates rebuttable presumption).
The question of what to do with a compliance presumption once a state has created it involves two separate but related issues.
The first issue is the amount of evidence necessary to overcome the presumption. As is evident from the descriptions we just gave you, the Vaccine Act and Arizona specify that “clear and convincing” evidence is required, while the other states’ statutes are silent.
The second issue is what happens to the presumption once it arguably has been overcome? Is the jury charged on it and allowed to make up its own mind? Alternatively, does the presumption vanish once contrary evidence is introduced, so that the jury never finds out about it?
The response, as we see it, to the first issue begins with some of the most basic canons of statutory interpretation – something we expect is followed in every state – (1) that statutes are not to be read as nullities, and in the same vein, (2) that the legislature is not presumed to act futilely. Another related proposition is (3) that an act is not to be construed to product an absurd result.
By enacting what it called a “presumption,” based upon the defendant’s compliance with relevant governmental standards, the legislature had to intend to benefit the compliant defendant in some way, right? If not, then why do anything at all?
Assuming that the legislature meant its enactment to mean something, then we have to figure out what's the most logical meaning with respect to our clients – in this context, FDA compliant drug/device companies. In this post-Levine world, we’ve largely been relegated to the old FDA standards as “minimum standards” view of the common law. See, e.g., Wyeth v. Rowatt, 244 P.3d 765, 780 (Nev. 2010); Dorsett v. Sandoz, Inc., 699 F. Supp.2d 1142, 1149 (C.D. Cal. 2010); In re Trasylol Products Liability Litigation, 2010 WL 4259332, at *4 (S.D. Fla. Oct. 21, 2010), and other depressing precedents.
What these compliance presumptions do after Levine is flip the common law default position regarding the effect of FDA compliance. Under Levine, compliance with FDA warning approval is presumptively not binding in a common-law case “absent clear evidence that the FDA would not have approved” a label change in the nature of what the plaintiff advocates. Wyeth v. Levine, 129 S. Ct. 1187, 1198 (2009). But in states where the legislature has enacted a presumption of non-defectiveness by reason of FDA (or other) compliance, the “minimum standard” analysis is upended. Under those statutes, compliance with the FDA’s approval of a warning now is presumptively binding in a common-law case – unless the plaintiff proves whatever the statute says s/he has to prove to overcome the presumption. So in those states, we’re dealing with Levine in reverse.
The logic of a statute creating a Levine in reverse situation (where the statutory presumption is that FDA compliance equals non-defectiveness), is that to rebut the presumption, a plaintiff should have to present the same degree of “clear evidence” as required by Levine. This analogy, which we think is to the closest relevant presumption in an FDA compliance case, would of course only apply where the legislature is silent (unlike Arizona or the Vaccine Act) as to the quantum of proof necessary to overcome the presumption. But again that’s closely analogous to Levine. Just as Congress in Levine was silent as to the preemptive effect of FDA compliance, most of the state compliance statutes are equally silent as to how much rebutting it takes to rebut a rebuttable presumption (or how much wood could a wood chuck chuck).
The Levine analogy is just that – an analogy. It’s not mandated by either statute or common-law postulate. But neither is anything else. So we think there are good logical reasons to apply the Levine “clear evidence” rebuttal standard to FDA compliance presumptions with respect to the quantum of evidence question. For one thing, this standard prevents the statutory presumption from being treated as a nullity, which is precisely what would happen if a plaintiff didn’t need to meet anything more than the pre-existing burden of proof in order to rebut the presumption. For a second thing, there’s symmetry. Levine applied a “clear evidence” standard to rebut the presumption against preemption in an FDA compliance context where the default was that compliance wasn’t controlling. Where a state legislature has determined that compliance is controlling, it makes sense to apply the same rebuttal standard, only in reverse. Third, the Levine “clear evidence” standard is consistent with the legislative judgment in those two instances (Vaccine Act and Arizona) where a statute actually did address the quantum of proof issue, suggesting that, if other legislatures had bothered to think about the issue, they most likely would have come out the same way.
Now we’ll turn to the second issue. What happens to a “rebuttable” presumption once it – arguably at least – has been rebutted by evidence of whatever it is that the legislature has provided should constitute rebuttal (which ranges from FDA fraud/bribery in a number of states, to unspecified “additional precautions” in Kansas). Only one of the compliance statutes, Colorado’s, deals expressly with this issue. Colorado law provides:
In a product liability action in which the court determines by a preponderance of the evidence that the necessary facts giving rise to a presumption have been established, the court shall instruct the jury concerning the presumption.Colo. Rev. Stat. §13-21-403(1)(b)(4). So in Colorado, once the defendant had proven compliance, then the presumption of non-defectiveness is always charged to the jury, and it is a jury question whether the plaintiff has rebutted it.
In the other states, where the legislature is silent, the question of whether the jury is charged on the presumption where some rebuttal evidence has been received will depend on how the state’s law (or possibly federal law in a diversity case, if this question is considered “procedural”) treats presumptions.
There are two theories of presumptions – the more traditional “bubble bursting” theory and the more recent persistent presumption approach. A bubble bursting presumption vanishes when it is rebutted and the jury is not thereafter instructed on it:
[U]nder what has become known as the Thayer or “bursting bubble” theory, the only effect of a presumption is to shift the burden of producing evidence with regard to the presumed fact. If that evidence is produced by the adversary, the presumption is spent and disappears. In practical terms, the theory means that, although a presumption is available to permit the party relying upon it to survive a motion for directed verdict at the close of its own case, it has no other value in the trial.McCormick on Evidence §344 (footnote omitted) (emphasis added).
The other, more modern approach declares that some rebuttable presumptions are in the nature of substantive law, and it is for the jury to determine whether or not they are rebutted:
The “bursting bubble” theory has been criticized as giving to presumptions an effect that is too “slight and evanescent” when viewed in the light of the reasons for the creation of the rules. Presumptions, as we have seen, have been created for policy reasons that are similar to and may be just as strong as those that govern the allocation of the burdens of proof prior to the introduction of evidence. These policy considerations may persist despite the existence of proof rebutting the presumed fact. . . . If the policy behind certain presumptions is not to be thwarted, some instruction to the jury may be needed despite any theoretical prohibition against a charge of this kind.Id. (footnotes omitted) (emphasis ours).
In this context, the federal approach is about as clear as mud. See McCormick §344 (“Despite the best efforts of legal scholars, instead of having one rule to govern all presumptions in all proceedings, we are left in some ways in a more confusing state than that which existed prior to the adoption of the Federal Rules.”); Hjelmaas, “Stepping Back from the Thicket: A Proposal for the Treatment of Rebuttable Presumptions & Inferences,” 42 Drake L. Rev. 427, 447 (1993) (“The [federal] rule is unclear . . . concerning the effect of rebuttal evidence on challenges to an established presumption. . . . The adoption of Federal Rule of Evidence 301 has not clarified this area of law”); Louisell, “Construing Rule 301: Instructing the Jury on Presumptions in Civil Actions and Proceedings,” 63 Va. L. Rev. 281 (1977) (Fed. R. Evid. 301 adopts a traditional, bubble-bursting approach, but can be interpreted broadly enough to permit an inference instruction); Mueller, “Instructing the Jury Upon Presumptions in Civil Cases: Comparing Federal Rule 301 with Uniform Rule 301, 12 Land & Water L. Rev. 219 (1977) (arguing against the traditional bubble bursting interpretation of Rule 301).
We think that compliance presumptions should persist – and that the jury should be charged on them – in any case where there is a jury question as to compliance. There are two reasons for that. First, the traditional bubble bursting approach arose, as McCormick points out in the part of the quote that we highlighted; where the presumption was created to assist a party bearing the burden of proof to avoid a “directed verdict at the end of his case.” Legislatures have passed compliance presumptions to assist defendants, who do not bear the burden of proof (except as to compliance itself). Thus the statutory compliance presumptions do not fit the rationale of the bubble bursting theory.
Conversely, compliance presumptions are the epitome of the “policy” based presumption, which is created for a reason other than to address a burden of proof problem. In this respect, we recommend the analysis of the Indiana Supreme Court in a non-drug case Bexis worked on, involving what weight to give the Indiana compliance statute (which, as we've indicated, was silent):
[T]he [compliance] presumption recognized in the statute is not a conventional presumption at all. A presumption . . . relieves the party with the burden of proof on a presumed fact from having to produce evidence of the presumed fact once that party has proved a basic fact. . . . But under the statutory presumption at issue here, the presumed fact is the presence or absence of defect and negligence. And the plaintiffs. . ., not the defendant. . ., have the burden to prove defect and negligence in a product liability action. . . . Is another implication of this anomaly that, except at the summary judgment stage, there simply is no presumption to be given continuing effect. . .? We think not. The point of giving “continuing effect” to a presumption through a jury instruction is to further the policies that give rise to the presumption in the first place. By authorizing the instruction here, we recognize the policy embodied by the Legislature in Indiana Code §34-20-5-1, regardless of whether the provision conforms to the conventional definition of a legal “presumption.”Schultz v. Ford Motor Co., 857 N.E.2d 977, 985-86 (Ind. 2006) (footnotes omitted).
In the case of the brand new Wisconsin compliance presumption – and, indeed, in the case of compliance presumption statutes generally – the plaintiffs’ side can be expected to seek judicial interpretations that these statutes are meaningless nullities. They will do this by: (1) arguing that the presumption is rebutted by the same quantum of evidence that they already have to present to meet their pre-existing burden of proof, and (2) arguing that once they have put on any evidence at all of non-compliance, the presumption “bursts” and drops from the case.
We have to offer persuasive contrary arguments that preserve what the legislature actually wanted to do when it took the affirmative step of changing the common law with respect to FDA (and other) compliance. Lawmakers didn’t intend to enact a nullity, so the plaintiffs should have to meet the same “clear evidence” standard where state law says compliance equals lack of defect as we do when state law says otherwise. Furthermore, because legislatures only enact presumptions to favor parties not bearing the burden of proof for substantive policy reasons (because defendants don’t otherwise need them), juries should always be charged on a statutory compliance presumption except in the unusual situation where failure to comply is undisputed.
Tuesday, February 15, 2011
The Advocate Messes Up
It has just been brought to our attention by a sharp-eyed lawyer at Holland and Knight that an article Bexis wrote and published five years ago (in 2006) concerning problems with Rule 26, has recently been republished in by the Florida Bar Trial Lawyers Section in a publication called "The Advocate" (see the most recent issue from the choices on this webpage). The article is titled, "Testifying Experts and Privileged Material – Waiver Is Easier Than You Might Think," and was prompted by a troubling case in our neck of the woods, Synthes Spine Co., L.P. v. Walden, 232 F.R.D. 460 (E.D. Pa. 2005), that set the stage for all kinds of maneuvering over expert disclosures.
That article was accurate - indeed, cutting edge - back in 2006. However, the problems Bexis described were sufficiently serious that the Federal Rules Committee acted and amended Rule 26 (again) effective in December, 2010 to address (and largely do away with) the expert disclosure problems discussed in that 2006 article. As this was an issue of continuing interest, we blogged about this most recent amendment to Rule 26, here.
Anyway, the point is - caveat emptor - with a free publication (or a free blog for that matter) you get what you pay for. We don't want anybody to be confused by the Advocate's unfortunately timed republication to think that what Bexis wrote back in 2006 is an accurate description of expert discovery as it stands in 2011. It isn't. That problem has been (about 95% of it, anyway) fixed.
That article was accurate - indeed, cutting edge - back in 2006. However, the problems Bexis described were sufficiently serious that the Federal Rules Committee acted and amended Rule 26 (again) effective in December, 2010 to address (and largely do away with) the expert disclosure problems discussed in that 2006 article. As this was an issue of continuing interest, we blogged about this most recent amendment to Rule 26, here.
Anyway, the point is - caveat emptor - with a free publication (or a free blog for that matter) you get what you pay for. We don't want anybody to be confused by the Advocate's unfortunately timed republication to think that what Bexis wrote back in 2006 is an accurate description of expert discovery as it stands in 2011. It isn't. That problem has been (about 95% of it, anyway) fixed.
Monday, February 14, 2011
Res Ipsa and Preemption Meet Cute
It's Valentine's Day, so we blow a kiss towards our true love, preemption. But while we love preemption, we must confess ill will toward the "parallel claim" end-run around preemption. We have had our flings with some other doctrines, such as res ipsa loquitur. See, e.g., No Trout in the Milk. Like a meet-cute RomCom, a recent case brought all these themes together in one nice little package. Last week a federal court dealt with an interesting effort by plaintiffs to establish a parallel claim via res ipsa loquitur. Cafferty v. Cayuga Medical Center et al., 2011 U.S. Dist. LEXIS 12245 (N.D.N.Y. Feb. 8, 2011). The opinion is pretty straightforward. You might even say it speaks for itself.
A plaintiff underwent eye surgery, involving clear lens extraction of the left eye with implantation of an interocular lens. After the surgery, the plaintiff presented with certain symptoms and was later diagnosed with Toxic Anterior Segment Syndrome ("TASS"). TASS is related to "an unwanted material gaining access to the anterior segment of the eye." Cafferty, 2011 U.S. Dist. LEXIS 12245 at * 5. It's pretty hard for the unwanted material to get to the anterior segment of the eye except during a surgical procedure. But none of the experts in the case could identify the specific cause of the plaintiff's TASS, even after viewing a video of the eye surgery.
The surgery included use of a couple of Class III medical devices for which one of the defendants had been granted premarket approval by the FDA. That defendant did what we would do -- it shouted "preemption!" And the plaintiffs did what we would expect them to do -- they shouted "parallel claim!" More specifically, the plaintiffs argued that their negligent manufacturing claim was not preempted by the MDA because "they allege that one or more of Alcon's products deviated from the manufacturing process and was manufactured improperly in violation of federal regulations. Accordingly, Plaintiffs contend, said claim parallels, rather than adds to, federal requirements." Id. at * 10.
What makes a claim parallel? This question is garbed with theoretical majesty. We are reminded of our high school geometry teacher, who tried in vain to explain non-Euclidean geometry to us. The dissipations of the last 35 years probably prevent accurate recollection, but we seem to recall that everything hinged on how many lines could go through a point and be parallel to another line. Euclidean geometry said there could be only one such parallel line. One mathematician said there were two. Another said none. Lobachevsky and Riemann figured in there somewhere, but don't ask us where. And Deborah Harry had something to do with parallel lines. Anyway, there's a reason why we went to law school.
But we don't even have to answer the knotty theoretical question. We just want -- courtesy of our old friends Twombly and Iqbal -- actual facts as to the parallel federal violation. Some courts have allowed plaintiffs to spew conclusions that the defendant violated the FDCA, without specifying the violation or providing a single fact. And our contempt for that position is a matter of record. It speaks for itself.
The court in Cafferty confronted this issue at the summary judgment stage. So it insisted not only on a specific factual allegation of a parallel federal violation -- it actually insisted on an evidentiary showing. Plaintiff's opposition to summary judgment argued that "Alcon most likely violated federal regulations and requirements in connection with the manufacturing" of the devices in question. Id. at *12. Yet, "Plaintiffs fail to direct the court to any evidence in the record that Alcon violated any federal regulations, much less regulations governing the PMA process." Id.
Here's where the plaintiffs got clever. One of their negligence claims in the case was grounded on res ipsa loquitur. As a quick refresher, res ipsa loquitur is an evidentiary doctrine providing that a prima facie case of negligence exists where (1) the event is of a kind that ordinarily does not occur in the absence of someone's negligence; (2) the event is caused by an instrumentality within the exclusive control of the defendant; and (3) the event must not have been due to any voluntary action of the plaintiff. Think of the left-behind scalpel example. Basically, the plaintiffs in Cafferty contended that TASS is like a left-behind scalpel. There would've been no TASS absent contamination during the surgery, and there would've been no contamination absent some sort of manufacturing defect. And, in fact, the court permitted the plaintiffs to proceed with their overall res ipsa loquitur negligence claim.
It turns out that the court in Cafferty was pretty clever in its own right. The court took the preemption point seriously and dismissed the negligence claim relating to the alleged manufacturing defect of the Class III medical devices. The court read the Supreme Court's Riegel decision to acknowledge "that under the federal law governing the PMA process, there is no demand that a product be risk-free, only that its benefits, if manufactured according to specifications, outweigh its risks." Id. Consequently, "one may not infer a manufacturing defect without creating a duty that adds to, rather than parallels, federal requirements in contravention of Supreme Court precedent." Id. at *13. As we say, that's pretty clever. We might've taken the simpler (simplistic?) route and said that there have to specific facts supporting a parallel claim, and that res ipsa loquitur cannot be a substitute for such facts -- particularly, as here, where res ipsa loquitur just meant that something likely went wrong during the operation, and not necessarily a manufacturing defect.
We're not keeping a "Preemption vs. Latin Phrase" scorecard (Mens rea? Alea iacta est? Ad nauseam? Or the motto of our high school cafeteria, fidem clam scit?), but if we did, preemption is up 1-0.
A plaintiff underwent eye surgery, involving clear lens extraction of the left eye with implantation of an interocular lens. After the surgery, the plaintiff presented with certain symptoms and was later diagnosed with Toxic Anterior Segment Syndrome ("TASS"). TASS is related to "an unwanted material gaining access to the anterior segment of the eye." Cafferty, 2011 U.S. Dist. LEXIS 12245 at * 5. It's pretty hard for the unwanted material to get to the anterior segment of the eye except during a surgical procedure. But none of the experts in the case could identify the specific cause of the plaintiff's TASS, even after viewing a video of the eye surgery.
The surgery included use of a couple of Class III medical devices for which one of the defendants had been granted premarket approval by the FDA. That defendant did what we would do -- it shouted "preemption!" And the plaintiffs did what we would expect them to do -- they shouted "parallel claim!" More specifically, the plaintiffs argued that their negligent manufacturing claim was not preempted by the MDA because "they allege that one or more of Alcon's products deviated from the manufacturing process and was manufactured improperly in violation of federal regulations. Accordingly, Plaintiffs contend, said claim parallels, rather than adds to, federal requirements." Id. at * 10.
What makes a claim parallel? This question is garbed with theoretical majesty. We are reminded of our high school geometry teacher, who tried in vain to explain non-Euclidean geometry to us. The dissipations of the last 35 years probably prevent accurate recollection, but we seem to recall that everything hinged on how many lines could go through a point and be parallel to another line. Euclidean geometry said there could be only one such parallel line. One mathematician said there were two. Another said none. Lobachevsky and Riemann figured in there somewhere, but don't ask us where. And Deborah Harry had something to do with parallel lines. Anyway, there's a reason why we went to law school.
But we don't even have to answer the knotty theoretical question. We just want -- courtesy of our old friends Twombly and Iqbal -- actual facts as to the parallel federal violation. Some courts have allowed plaintiffs to spew conclusions that the defendant violated the FDCA, without specifying the violation or providing a single fact. And our contempt for that position is a matter of record. It speaks for itself.
The court in Cafferty confronted this issue at the summary judgment stage. So it insisted not only on a specific factual allegation of a parallel federal violation -- it actually insisted on an evidentiary showing. Plaintiff's opposition to summary judgment argued that "Alcon most likely violated federal regulations and requirements in connection with the manufacturing" of the devices in question. Id. at *12. Yet, "Plaintiffs fail to direct the court to any evidence in the record that Alcon violated any federal regulations, much less regulations governing the PMA process." Id.
Here's where the plaintiffs got clever. One of their negligence claims in the case was grounded on res ipsa loquitur. As a quick refresher, res ipsa loquitur is an evidentiary doctrine providing that a prima facie case of negligence exists where (1) the event is of a kind that ordinarily does not occur in the absence of someone's negligence; (2) the event is caused by an instrumentality within the exclusive control of the defendant; and (3) the event must not have been due to any voluntary action of the plaintiff. Think of the left-behind scalpel example. Basically, the plaintiffs in Cafferty contended that TASS is like a left-behind scalpel. There would've been no TASS absent contamination during the surgery, and there would've been no contamination absent some sort of manufacturing defect. And, in fact, the court permitted the plaintiffs to proceed with their overall res ipsa loquitur negligence claim.
It turns out that the court in Cafferty was pretty clever in its own right. The court took the preemption point seriously and dismissed the negligence claim relating to the alleged manufacturing defect of the Class III medical devices. The court read the Supreme Court's Riegel decision to acknowledge "that under the federal law governing the PMA process, there is no demand that a product be risk-free, only that its benefits, if manufactured according to specifications, outweigh its risks." Id. Consequently, "one may not infer a manufacturing defect without creating a duty that adds to, rather than parallels, federal requirements in contravention of Supreme Court precedent." Id. at *13. As we say, that's pretty clever. We might've taken the simpler (simplistic?) route and said that there have to specific facts supporting a parallel claim, and that res ipsa loquitur cannot be a substitute for such facts -- particularly, as here, where res ipsa loquitur just meant that something likely went wrong during the operation, and not necessarily a manufacturing defect.
We're not keeping a "Preemption vs. Latin Phrase" scorecard (Mens rea? Alea iacta est? Ad nauseam? Or the motto of our high school cafeteria, fidem clam scit?), but if we did, preemption is up 1-0.
Friday, February 11, 2011
Why Drug/Device Manufacturers Should Join PLAC
This post is mostly directed to our in-house readership, although you out-house folks can feel free to pass along what we say to your clients.
Our point today is to urge drug/device companies who aren't members of the Product Liability Advisory Council ("PLAC") to join. Annual membership in PLAC costs $6500, which is a pittance compared to the amount of a single verdict - heck, a single settlement - in a significant product case. It's less than a third of the cost that PLAC pays (and it only pays bargain-basement prices to start with) to file a single brief.
PLAC is not an industry group, it's a topical group, and its topic is product liability. Its primary function is to file amicus curiae ("friend of the court") briefs in appellate cases that are likely to have a significant impact on product liability litigation. Those are mostly (but not always) product liability cases.
Bexis has sat on PLAC's nationwide case selection committee for over a decade now. He knows what PLAC does and how it helps his clients - and similarly situated product liability defendants everywhere.
How would your company's litigation be without the learned intermediary rule? In recent years, PLAC has filed amicus briefs supporting adoption of the rule in the Supreme Courts of Kentucky, Georgia, Connecticut, and Texas (at least). Unfortunately, nobody told PLAC about West Virginia.
How would your company's litigation be without Daubert? PLAC helped invent Daubert, and because it's a topic group, not an interest group, it's been in all the Supreme Court's Daubert decisions - whether the product is a drug, or a tire, or something else. PLAC has even filed in criminal cases (the validity of drug-sniffing dog evidence), where significant Daubert issues were raised. PLAC has been in state court expert testimony cases, too - fighting the good fight - whether the product is benzene . . . or Doritos.
How would your company's litigation be if there were personal injury class actions? PLAC's been in the thick of that fight - in the Supreme Court asbestos cases that turned the tide against class-action-based litigation abuse, and in just about every court of appeals case that's followed, whether the product is medical devices . . . or cigarettes. There's a reason why no personal injury class action has survived a contested appeal in the entire federal system since Ortiz/AmChem, and PLAC is a big part of that.
How would your company's litigation be if there were federal preemption - or for you PMA manufacturers out there - if there weren't? PLAC's been in all of those cases, too, win or lose, whether they involve, drugs, medical devices, vaccines . . . or cars.
How would your company's litigation be if federal regulatory compliance precluded punitive damages? If there were no due process aspect to punitives? PLAC's been fighting that battle for years - in the Supreme Court and elsewhere - almost entirely in non-drug cases. However, the next key punitive damages case could involve a drug or device.
How would your company's litigation be if plaintiffs could take your confidential product formulations and distribute them freely to the press? PLAC's fought that battle, too. It comes up most frequently in tire litigation, but PLAC's also been there when the issue was redaction of identifying information in adverse event reports.
How would your company's litigation be if there was no comment k "unavoidably unsafe" defense - or if that defense applied to all drugs/devices across the board. PLAC's fought that fight, too.
How would your company's litigation be if there were no consumer protection claims? PLAC just helped win that issue in one of the least defense friendly jurisdictions in the country - West Virginia. PLAC was in there swinging that these claims were incompatible with FDA approval, and that's what the West Virginia court held. PLAC's also been out there supporting a reliance element where it can (such as Pennsylvania), and individualized causation element where it can't (New Jersey, Illinois). The results have been encouraging.
Market share liability? Public nuisance? Alternative designs? Successor liabilty? Negligence per se? Subsequent remedial measures (such as recalls)? Admissibility of regulatory compliance? Res ipsa loquitur? PLAC's weighed in on all these issues, often in cases far removed from drugs and devices. But take it from us - read our posts on these subjects - all of these issues can have major reprecussions in this or that drug/device case.
$6500 a year is a pittance. For that, not only does a PLAC corporate member get PLAC providing cover on major legal issues across the country, but it gets unlimited attendance at PLAC's two annual meetings, which provide enough sophisticated CLE to satisfy any state's requirements, and does so on cutting edge topics that companies need to know about. You won't fall asleep during a PLAC conference.
There's more. PLAC has a listserv of hundreds of active product liability defense attorneys at practically every major firm in the country. Need information on an opposing expert? Need your own expert? Need to know about some peculiar issue? Seek help in the PLAC listserv and you shall find. In fact, the type of information sharing that goes on within the PLAC listserv was a major inspiration for this blog.
Anyway, if we've convinced anybody, we're happy. Any company interested in joining (for regular defense attorneys there's a substantial waiting list) can call PLAC at (703) 264-5300, and ask for Hugh Young. He can send you more information. You can also email Bexis (Jim Beck) through the links on the blog, if you want to discuss PLAC.
Do it. You'll be glad you did. The next $10 million verdict PLAC helps get overturned might be yours.
Our point today is to urge drug/device companies who aren't members of the Product Liability Advisory Council ("PLAC") to join. Annual membership in PLAC costs $6500, which is a pittance compared to the amount of a single verdict - heck, a single settlement - in a significant product case. It's less than a third of the cost that PLAC pays (and it only pays bargain-basement prices to start with) to file a single brief.
PLAC is not an industry group, it's a topical group, and its topic is product liability. Its primary function is to file amicus curiae ("friend of the court") briefs in appellate cases that are likely to have a significant impact on product liability litigation. Those are mostly (but not always) product liability cases.
Bexis has sat on PLAC's nationwide case selection committee for over a decade now. He knows what PLAC does and how it helps his clients - and similarly situated product liability defendants everywhere.
How would your company's litigation be without the learned intermediary rule? In recent years, PLAC has filed amicus briefs supporting adoption of the rule in the Supreme Courts of Kentucky, Georgia, Connecticut, and Texas (at least). Unfortunately, nobody told PLAC about West Virginia.
How would your company's litigation be without Daubert? PLAC helped invent Daubert, and because it's a topic group, not an interest group, it's been in all the Supreme Court's Daubert decisions - whether the product is a drug, or a tire, or something else. PLAC has even filed in criminal cases (the validity of drug-sniffing dog evidence), where significant Daubert issues were raised. PLAC has been in state court expert testimony cases, too - fighting the good fight - whether the product is benzene . . . or Doritos.
How would your company's litigation be if there were personal injury class actions? PLAC's been in the thick of that fight - in the Supreme Court asbestos cases that turned the tide against class-action-based litigation abuse, and in just about every court of appeals case that's followed, whether the product is medical devices . . . or cigarettes. There's a reason why no personal injury class action has survived a contested appeal in the entire federal system since Ortiz/AmChem, and PLAC is a big part of that.
How would your company's litigation be if there were federal preemption - or for you PMA manufacturers out there - if there weren't? PLAC's been in all of those cases, too, win or lose, whether they involve, drugs, medical devices, vaccines . . . or cars.
How would your company's litigation be if federal regulatory compliance precluded punitive damages? If there were no due process aspect to punitives? PLAC's been fighting that battle for years - in the Supreme Court and elsewhere - almost entirely in non-drug cases. However, the next key punitive damages case could involve a drug or device.
How would your company's litigation be if plaintiffs could take your confidential product formulations and distribute them freely to the press? PLAC's fought that battle, too. It comes up most frequently in tire litigation, but PLAC's also been there when the issue was redaction of identifying information in adverse event reports.
How would your company's litigation be if there was no comment k "unavoidably unsafe" defense - or if that defense applied to all drugs/devices across the board. PLAC's fought that fight, too.
How would your company's litigation be if there were no consumer protection claims? PLAC just helped win that issue in one of the least defense friendly jurisdictions in the country - West Virginia. PLAC was in there swinging that these claims were incompatible with FDA approval, and that's what the West Virginia court held. PLAC's also been out there supporting a reliance element where it can (such as Pennsylvania), and individualized causation element where it can't (New Jersey, Illinois). The results have been encouraging.
Market share liability? Public nuisance? Alternative designs? Successor liabilty? Negligence per se? Subsequent remedial measures (such as recalls)? Admissibility of regulatory compliance? Res ipsa loquitur? PLAC's weighed in on all these issues, often in cases far removed from drugs and devices. But take it from us - read our posts on these subjects - all of these issues can have major reprecussions in this or that drug/device case.
$6500 a year is a pittance. For that, not only does a PLAC corporate member get PLAC providing cover on major legal issues across the country, but it gets unlimited attendance at PLAC's two annual meetings, which provide enough sophisticated CLE to satisfy any state's requirements, and does so on cutting edge topics that companies need to know about. You won't fall asleep during a PLAC conference.
There's more. PLAC has a listserv of hundreds of active product liability defense attorneys at practically every major firm in the country. Need information on an opposing expert? Need your own expert? Need to know about some peculiar issue? Seek help in the PLAC listserv and you shall find. In fact, the type of information sharing that goes on within the PLAC listserv was a major inspiration for this blog.
Anyway, if we've convinced anybody, we're happy. Any company interested in joining (for regular defense attorneys there's a substantial waiting list) can call PLAC at (703) 264-5300, and ask for Hugh Young. He can send you more information. You can also email Bexis (Jim Beck) through the links on the blog, if you want to discuss PLAC.
Do it. You'll be glad you did. The next $10 million verdict PLAC helps get overturned might be yours.
To The Congressional Civil Justice Caucus
The Blog of Legal Times today includes the following story:
Well, it's about time. We're tired of having to report about such lunacy as abolishing the learned intermediary rule (actually just reintroduced with zero co-sponsors), abolishing medical device preemption, or reverting to pre-TwIqbal pleading standards. We'd much rather report on legislation we actually like.
We've got a lot of pet peeves, but one that's at the forefront right now - and something as to which federal legislation would be particularly appropriate - is punitive damages. Specifically, we'd like to see legislation that compliance with federal regulatory standards (to us, that's mostly the FDA, but there are a lot of other federal regulations that would also qualify) should preclude any state-law-based award of punitive damages. Compliance, of course, should be as determined by the affected agency and not in state litigation.
We don't even think that's "conservative." Since most of these regulatory standards were enacted in legislation supported by "liberals," liberals ought to support additional incentives for compliance with such standards. There's no reason that "liberal" has to be synonymous with "tort-stupid."
But in any event, think big, guys. We over here at DDLaw are rooting for you on this.
Conservative lawmakers are organizing in a more formal way to promote an array of changes to the civil justice system, including proposals related to medical malpractice reform, venue and federal pleading standards.
Well, it's about time. We're tired of having to report about such lunacy as abolishing the learned intermediary rule (actually just reintroduced with zero co-sponsors), abolishing medical device preemption, or reverting to pre-TwIqbal pleading standards. We'd much rather report on legislation we actually like.
We've got a lot of pet peeves, but one that's at the forefront right now - and something as to which federal legislation would be particularly appropriate - is punitive damages. Specifically, we'd like to see legislation that compliance with federal regulatory standards (to us, that's mostly the FDA, but there are a lot of other federal regulations that would also qualify) should preclude any state-law-based award of punitive damages. Compliance, of course, should be as determined by the affected agency and not in state litigation.
We don't even think that's "conservative." Since most of these regulatory standards were enacted in legislation supported by "liberals," liberals ought to support additional incentives for compliance with such standards. There's no reason that "liberal" has to be synonymous with "tort-stupid."
But in any event, think big, guys. We over here at DDLaw are rooting for you on this.
Thursday, February 10, 2011
Depositions - When Can You Talk To Your Own Witness?
We had the issue of when a lawyer can, and can’t, confer with his/her own witness during a deposition come up recently in one of our cases. It caused a bit of scrambling since – typically – it came up in the middle of a deposition, so now that the issue is behind us in this particular case, we thought we’d blog about it
Unlike a lot of the stuff we talk about here, this issue is one that, depending on the circumstances, we could easily find ourselves on either side. That means we don’t have a particular axe to grind, and we’re more concerned with knowing when we’re on solid ground (either conferring or objecting to same), and when we’re likely to run into problems.
Well, the grand-daddy of all cases on this question is from right here in our back yard in the Eastern District of Pennsylvania, called Hall v. Clifton Precision, 150 F.R.D. 525 (E.D. Pa. 1993), written by the late Judge Robert Gawthrop (also an accomplished singer and actor). Hall involved one common situation – where the deponent (that’s the guy answering the questions, for you non-lawyers) and his lawyer stopped an ongoing deposition to confer amongst themselves. Indeed, one of these conferences occurred while there was a question pending (again, for non-lawyers that means after the question was asked but before it was answered). The side taking the deposition objected to these conferences, and the matter was brought before Judge Gawthrop.
To use another technical term, Judge Gawthrop went ballistic (not all that uncommon with him) – and the Hall opinion was the result. It probably didn’t help that the conferring attorney took a rather extreme position, “that an attorney and client have the right to confer with one another at any time during the taking of the client's deposition.” 150 F.R.D. at 526 (emphasis ours).
Judge Gawthrop laid down some law – at least as he saw it.
One of the interesting things about Hall is that, for these propositions, very little (and sometimes none) precedent is cited. So basically Hall was Judge Gawthrop making it up as he went along. Not all judges see it the same way, even here in the Eastern District of Pennsylvania. A recent example we’ve found – at least involving drug/device (if not product liability) litigation – is In re Flonase Antitrust Litigation, 723 F. Supp.2d 761 (E.D. Pa. 2010) (Brody, J.). The Flonase issue was a little different: opposing counsel was acting on the dictum in the Hall footnote and trying to pierce an asserted privilege, but the in-deposition conference issue was pretty much the same.
Because – unlike Hall – a privilege was directly implicated, Judge Brody first had to apply state law (that’s required by Fed. R. Evid. 501, since the federal rules use state privileges). There wasn’t much of a fight, so the court used Pennsylvania law.
As an aside, the Pennsylvania state courts have, as far as we can tell, not followed Hall. See Acri v. Golden Triangle Management Acceptance Co., 142 Pitts. L.J. 225, 228 (C.P Allegheny Co. 1994) (rejecting Hall in toto) (Wettick, J.). Some parts of Hall were adopted in AmerisourceBergen Drug Corp. v. CuraScript Inc., 83 Pa. D. & C.4th 362 (C.P. Phila. Co. 2007) (attorney could inquire into “subject matter” but “not substance” of conference during break in deposition where circumstances suggested coaching – the first question after the break prompted the witness to change testimony), but that case was reversed “in part” on appeal in one of those fine quirks of Pennsylvania jurisprudence – an uncitable memorandum Superior Court decision. See 945 A.2d 753 (Pa. Super. 2007) (table). So we have no idea what was affirmed and what wasn’t, and whatever was affirmed isn’t precedential.
Anyway, back to Flonase. Unlike Judge Gawthrop, who didn’t cite anything, Judge Brody looked at the law and found “no indication that such communications [off-the-record conferences] fall outside the attorney-client privilege.” 723 F. Supp. at 764. The court found a privilege on the facts – a former employee of the client of the counsel with whom the witness conferred. Id. at 764-65. Other facts (unlike Hall) were favorable for the conferring side: the witness “testif[ied] under oath that no witness coaching took place during those conversations.” Id. at 765.
So now, that’s clear as mud, so we’ll try taking a look at what other courts have done. One other thing to keep in mind – does the length of the adjournment of the deposition matter? Both Judge Gawthrop and Judge Brody were dealing with nothing more than brief interruptions of questioning. What if, for completely unrelated reasons, the deposition was continued for several days? Several weeks? At some point in time we would expect the rationale for Hall to start breaking down and issues concerning a deponent’s right to counsel take on more weight.
In re Stratosphere Corp. Securities Litigation, 182 F.R.D. 614 (D. Nev. 1998), did not involve any deposition conduct, but instead a prophylactic set of standards for depositions yet to take place. I n that context, Stratospheric cut Hall down to size. The court prohibited conferences only during breaks “initiated” by the deponent or his/her counsel. Otherwise:
Id. at 621 (emphasis added). Obviously, there was no loss of privilege for conferences allowed by the court. Id. at 622 (“disagree[ing] with the contention that any conference counsel may have with the deponent during a deposition waives the claim of privilege”).
Other courts seem to agree more with Stratosphere than with Hall, and allow deponents to confer with counsel during breaks in the action (such as for lunch or at the end of a day) not undertaken solely for the purpose of conferring. State ex rel. Means v. King, 520 S.E.2d 875, 882 (W. Va. 1999) (“an attorney may confer with his or her client witness during a recess or break in a discovery deposition, so long as the attorney did not request a break in the questions or request a conference between a question and an answer for an improper purpose”); Yoskowitz v. Yazdanfar, 900 A.2d 900, 906 (Pa. Super. 2006) (no sanctions for conferring “during a break, and not during questioning”); Ecker v. Wisconsin Central Ltd., 2008 WL 1777222, at *3 (E.D. Wis. April 16, 2008) (“the mere fact that counsel . . . conferred with the witness during a break after the [opposition] completed his examination does not warrant sanctions”); Henry v. Champlain Enterprises, Inc., 212 F.R.D. 73, 92 (N.D.N.Y. 2003) (refusing on privilege grounds to require disclosure of what “counsel said to [the deponent] during the break in the deposition”); Odone v. Croda International PLC, 170 F.R.D. 66, 69 (D.D.C. 1997) (a court “cannot penalize an attorney for utilizing a five-minute recess that he did not request”); Tex. R. Civ. P. 199.5(d) (allowing conferences during otherwise scheduled breaks); In re PSE&G Shareholder Litigation, 726 A.2d 994, 997 (N.J. Ch. Div.1998) (deponents allowed to confer with counsel during recesses between days of depositions, but not during lunch break and other breaks during the day of deposition; deferring any privilege issues). At least one ethical opinion that we've found also rejects Hall's no-coaching rationale for prohibiting in-deposition conferences.
On the other hand, in United States v. Philip Morris Inc., 212 F.R.D. 418, 420 (D.D.C. 2002), the court held that, as long as “there is no temporal interruption and the deposition is continued on a day-to-day basis with no intervening passage of time,” that there were to be no overnight consultations between the witness and counsel. Id. at 420. If, however, the deposition “cannot be held on consecutive days” conferences were allowed. Id.
The longer the break, the less likely it is that Hall-type restrictions upon deponent-counsel consultation will be imposed. In McKinley Infuser, Inc. v. Zdeb, 200 F.R.D. 648 (D. Colo. 2001), the court declined to impose any restrictions where the gap between direct and cross might be “several weeks”:
Most of the precedent following Hall deals with interruptions by the deponent’s counsel during questioning for the sole purpose of conferring: ReedHycalog UK, Ltd. v. Diamond Innovations Inc., 2010 WL 3238312, at *7 (E.D. Tex. Aug. 12, 2010) (listing, as one of many bases for sanctions, conferring with a deponent “during a break in his deposition, which led him to change his answer to an important question, and then refused to let him answer questions about the discussion with counsel”); BNSF Railway Co. v. San Joaquin Valley Railroad Co., 2009 WL 3872043, at *3-4 (E.D. Cal. Nov. 17, 2009) (sanctioning an “unscheduled break . . . for the witness when a question was pending”); Plaisted v. Geisinger Medical Center, 210 F.R.D. 527, 534-35 (M.D. Pa. 2002) (opposing counsel allowed to inquire into substance of conferences that occurred while questions were pending); Applied Telematics, Inc. v. Sprint Corp., 1995 WL 79237 (E.D. Pa. Feb. 22, 1995) (conferring while a question was pending); Armstrong v. Hussmann Co., 163 F.R.D. 299, 303 (E.D. Mo. 1995) (not entirely clear, but conferences seem to be during questioning); Langer v. Presbyterian Medical Center of Philadelphia, 1995 WL 79520, at *11 (E.D. Pa. Feb. 17, 1995) (“confer[ing] with [the] witness constantly during [the] deposition” was sanctionable), vacated on reconsideration on other grounds, 1995 WL 395937 (E.D. Pa. July 3, 1995); Alaska R. Civ. P. 30(d)(1) (prohibiting “[c]ontinual and unwarranted off-the-record conferences between the deponent and counsel following the propounding of questions and prior to the answer”); N.J. Ct. R. 4:14-3(f) (no conferences “while testimony is being taken except with regard to the assertion of a claim of privilege, a right of confidentiality or a limitation pursuant to a previously entered court order”); Holland v. Fisher, 1994 WL 878780, at *6 (Mass. Super. Dec. 21, 1994) (an attorney has no right to confer with a deponent while a question is pending); cf. Ngai v. Old Navy, 2009 WL 2391282, at *4-5 (D.N.J. July 31, 2009) (text messages sent between counsel and deponent during deposition and during breaks during day were not privileged).
So putting all this together, what can we say?
First, conferring with the deponent (on anything other than privilege) while a question is pending is asking for trouble. The weight of authority puts that on the wrong side of the line.
Second, taking a break during questioning for the sole purpose of conferring with the deponent has also drawn quite a bit of judicial fire. Expect trouble if doing this, although sanctions may well be avoided if the witness testifies that no coaching occurred.
Third, conferring over lunch or other breaks during the deposition taken for unrelated reasons is more likely to be viewed as OK. Again, if you’re willing to have the witness testify that no coaching occurred, so much the better.
Fourth, just as the weight of authority is against conferring with questions pending, once we get to overnight breaks, the weight has shifted decisively to such conferences being allowable. There’s some contrary precedent, but not much.
Fifth, once we get into the realm of multi-day adjournments, except possibly in South Carolina (and Delaware, if less than five days), conferences between counsel and the deponent are all right.
Unlike a lot of the stuff we talk about here, this issue is one that, depending on the circumstances, we could easily find ourselves on either side. That means we don’t have a particular axe to grind, and we’re more concerned with knowing when we’re on solid ground (either conferring or objecting to same), and when we’re likely to run into problems.
Well, the grand-daddy of all cases on this question is from right here in our back yard in the Eastern District of Pennsylvania, called Hall v. Clifton Precision, 150 F.R.D. 525 (E.D. Pa. 1993), written by the late Judge Robert Gawthrop (also an accomplished singer and actor). Hall involved one common situation – where the deponent (that’s the guy answering the questions, for you non-lawyers) and his lawyer stopped an ongoing deposition to confer amongst themselves. Indeed, one of these conferences occurred while there was a question pending (again, for non-lawyers that means after the question was asked but before it was answered). The side taking the deposition objected to these conferences, and the matter was brought before Judge Gawthrop.
To use another technical term, Judge Gawthrop went ballistic (not all that uncommon with him) – and the Hall opinion was the result. It probably didn’t help that the conferring attorney took a rather extreme position, “that an attorney and client have the right to confer with one another at any time during the taking of the client's deposition.” 150 F.R.D. at 526 (emphasis ours).
Judge Gawthrop laid down some law – at least as he saw it.
- “[A] lawyer and client do not have an absolute right to confer during the course of the client's deposition.” Id. at 528.
- “[P]rivate conferences . . . tend, at the very least, to give the appearance of obstructing the truth.” Id.
- “To allow private conferences initiated by the witness would be to allow the witness to listen to the question, ask his or her lawyer for the answer, and then parrot the lawyer's response.” Id.
- “These rules also apply during recesses. . . . Private conferences are barred during the deposition, and the fortuitous occurrence of a coffee break, lunch break, or evening recess is no reason to change the rules.” Id. at 529.
- “To the extent that such conferences do occur . . . [they] are not covered by the attorney-client privilege, at least as to what is said by the lawyer to the witness. Therefore, any such conferences are fair game for inquiry by the deposing attorney to ascertain whether there has been any coaching and, if so, what. Id. at 529 n.7 (dictum).
- The only exception is a conference to determine if a privilege needs to be asserted. Id. at 529-30 (“assertion of a privilege is a proper, and very important, objection during a deposition, [so] it makes sense to allow the witness the opportunity to consult with counsel”).
There’s more stuff in Hall about other types of claimed deposition shenanigans, but the during-deposition conference is what we’re about today.
One of the interesting things about Hall is that, for these propositions, very little (and sometimes none) precedent is cited. So basically Hall was Judge Gawthrop making it up as he went along. Not all judges see it the same way, even here in the Eastern District of Pennsylvania. A recent example we’ve found – at least involving drug/device (if not product liability) litigation – is In re Flonase Antitrust Litigation, 723 F. Supp.2d 761 (E.D. Pa. 2010) (Brody, J.). The Flonase issue was a little different: opposing counsel was acting on the dictum in the Hall footnote and trying to pierce an asserted privilege, but the in-deposition conference issue was pretty much the same.
Because – unlike Hall – a privilege was directly implicated, Judge Brody first had to apply state law (that’s required by Fed. R. Evid. 501, since the federal rules use state privileges). There wasn’t much of a fight, so the court used Pennsylvania law.
As an aside, the Pennsylvania state courts have, as far as we can tell, not followed Hall. See Acri v. Golden Triangle Management Acceptance Co., 142 Pitts. L.J. 225, 228 (C.P Allegheny Co. 1994) (rejecting Hall in toto) (Wettick, J.). Some parts of Hall were adopted in AmerisourceBergen Drug Corp. v. CuraScript Inc., 83 Pa. D. & C.4th 362 (C.P. Phila. Co. 2007) (attorney could inquire into “subject matter” but “not substance” of conference during break in deposition where circumstances suggested coaching – the first question after the break prompted the witness to change testimony), but that case was reversed “in part” on appeal in one of those fine quirks of Pennsylvania jurisprudence – an uncitable memorandum Superior Court decision. See 945 A.2d 753 (Pa. Super. 2007) (table). So we have no idea what was affirmed and what wasn’t, and whatever was affirmed isn’t precedential.
Anyway, back to Flonase. Unlike Judge Gawthrop, who didn’t cite anything, Judge Brody looked at the law and found “no indication that such communications [off-the-record conferences] fall outside the attorney-client privilege.” 723 F. Supp. at 764. The court found a privilege on the facts – a former employee of the client of the counsel with whom the witness conferred. Id. at 764-65. Other facts (unlike Hall) were favorable for the conferring side: the witness “testif[ied] under oath that no witness coaching took place during those conversations.” Id. at 765.
So now, that’s clear as mud, so we’ll try taking a look at what other courts have done. One other thing to keep in mind – does the length of the adjournment of the deposition matter? Both Judge Gawthrop and Judge Brody were dealing with nothing more than brief interruptions of questioning. What if, for completely unrelated reasons, the deposition was continued for several days? Several weeks? At some point in time we would expect the rationale for Hall to start breaking down and issues concerning a deponent’s right to counsel take on more weight.
In re Stratosphere Corp. Securities Litigation, 182 F.R.D. 614 (D. Nev. 1998), did not involve any deposition conduct, but instead a prophylactic set of standards for depositions yet to take place. I n that context, Stratospheric cut Hall down to size. The court prohibited conferences only during breaks “initiated” by the deponent or his/her counsel. Otherwise:
This Court will not preclude an attorney, during a recess that he or she did not request, from making sure that his or her client did not misunderstand or misinterpret questions or documents, or attempt to help rehabilitate the client by fulfilling an attorney's ethical duty to prepare a witness. So long as attorneys do not demand a break in the questions, or demand a conference between question and answers, the Court is confident that the search for truth will adequately prevail.
Id. at 621 (emphasis added). Obviously, there was no loss of privilege for conferences allowed by the court. Id. at 622 (“disagree[ing] with the contention that any conference counsel may have with the deponent during a deposition waives the claim of privilege”).
Other courts seem to agree more with Stratosphere than with Hall, and allow deponents to confer with counsel during breaks in the action (such as for lunch or at the end of a day) not undertaken solely for the purpose of conferring. State ex rel. Means v. King, 520 S.E.2d 875, 882 (W. Va. 1999) (“an attorney may confer with his or her client witness during a recess or break in a discovery deposition, so long as the attorney did not request a break in the questions or request a conference between a question and an answer for an improper purpose”); Yoskowitz v. Yazdanfar, 900 A.2d 900, 906 (Pa. Super. 2006) (no sanctions for conferring “during a break, and not during questioning”); Ecker v. Wisconsin Central Ltd., 2008 WL 1777222, at *3 (E.D. Wis. April 16, 2008) (“the mere fact that counsel . . . conferred with the witness during a break after the [opposition] completed his examination does not warrant sanctions”); Henry v. Champlain Enterprises, Inc., 212 F.R.D. 73, 92 (N.D.N.Y. 2003) (refusing on privilege grounds to require disclosure of what “counsel said to [the deponent] during the break in the deposition”); Odone v. Croda International PLC, 170 F.R.D. 66, 69 (D.D.C. 1997) (a court “cannot penalize an attorney for utilizing a five-minute recess that he did not request”); Tex. R. Civ. P. 199.5(d) (allowing conferences during otherwise scheduled breaks); In re PSE&G Shareholder Litigation, 726 A.2d 994, 997 (N.J. Ch. Div.1998) (deponents allowed to confer with counsel during recesses between days of depositions, but not during lunch break and other breaks during the day of deposition; deferring any privilege issues). At least one ethical opinion that we've found also rejects Hall's no-coaching rationale for prohibiting in-deposition conferences.
On the other hand, in United States v. Philip Morris Inc., 212 F.R.D. 418, 420 (D.D.C. 2002), the court held that, as long as “there is no temporal interruption and the deposition is continued on a day-to-day basis with no intervening passage of time,” that there were to be no overnight consultations between the witness and counsel. Id. at 420. If, however, the deposition “cannot be held on consecutive days” conferences were allowed. Id.
The longer the break, the less likely it is that Hall-type restrictions upon deponent-counsel consultation will be imposed. In McKinley Infuser, Inc. v. Zdeb, 200 F.R.D. 648 (D. Colo. 2001), the court declined to impose any restrictions where the gap between direct and cross might be “several weeks”:
The relief requested . . . here is particularly inappropriate. It would have the effect of barring [the deponent] from conferring with his counsel for the entire period between the sessions of his deposition, in this case several weeks. Taken to its logical extreme, [it] would bar consultation between a party and his lawyer from the time of his deposition through trial, because there might be “coaching” which would cause a party-witness to alter his deposition testimony at trial. That result is absurd.Id. at 650. Del. Super. R. Civ. P. 30(D)(1) (no conferences during “recesses or continuances” in depositions “of less than five calendar days”). We haven’t found any cases, and only one court rule (S.C.R. Civ. P. 30(j)(5), see In re Anonymous Member of South Carolina Bar, 552 S.E.2d 10, 16-17 (S.C. 2001) (discussing rule)) that prohibits conferences during breaks in depositions without regard to the length of the adjournment).
Most of the precedent following Hall deals with interruptions by the deponent’s counsel during questioning for the sole purpose of conferring: ReedHycalog UK, Ltd. v. Diamond Innovations Inc., 2010 WL 3238312, at *7 (E.D. Tex. Aug. 12, 2010) (listing, as one of many bases for sanctions, conferring with a deponent “during a break in his deposition, which led him to change his answer to an important question, and then refused to let him answer questions about the discussion with counsel”); BNSF Railway Co. v. San Joaquin Valley Railroad Co., 2009 WL 3872043, at *3-4 (E.D. Cal. Nov. 17, 2009) (sanctioning an “unscheduled break . . . for the witness when a question was pending”); Plaisted v. Geisinger Medical Center, 210 F.R.D. 527, 534-35 (M.D. Pa. 2002) (opposing counsel allowed to inquire into substance of conferences that occurred while questions were pending); Applied Telematics, Inc. v. Sprint Corp., 1995 WL 79237 (E.D. Pa. Feb. 22, 1995) (conferring while a question was pending); Armstrong v. Hussmann Co., 163 F.R.D. 299, 303 (E.D. Mo. 1995) (not entirely clear, but conferences seem to be during questioning); Langer v. Presbyterian Medical Center of Philadelphia, 1995 WL 79520, at *11 (E.D. Pa. Feb. 17, 1995) (“confer[ing] with [the] witness constantly during [the] deposition” was sanctionable), vacated on reconsideration on other grounds, 1995 WL 395937 (E.D. Pa. July 3, 1995); Alaska R. Civ. P. 30(d)(1) (prohibiting “[c]ontinual and unwarranted off-the-record conferences between the deponent and counsel following the propounding of questions and prior to the answer”); N.J. Ct. R. 4:14-3(f) (no conferences “while testimony is being taken except with regard to the assertion of a claim of privilege, a right of confidentiality or a limitation pursuant to a previously entered court order”); Holland v. Fisher, 1994 WL 878780, at *6 (Mass. Super. Dec. 21, 1994) (an attorney has no right to confer with a deponent while a question is pending); cf. Ngai v. Old Navy, 2009 WL 2391282, at *4-5 (D.N.J. July 31, 2009) (text messages sent between counsel and deponent during deposition and during breaks during day were not privileged).
So putting all this together, what can we say?
First, conferring with the deponent (on anything other than privilege) while a question is pending is asking for trouble. The weight of authority puts that on the wrong side of the line.
Second, taking a break during questioning for the sole purpose of conferring with the deponent has also drawn quite a bit of judicial fire. Expect trouble if doing this, although sanctions may well be avoided if the witness testifies that no coaching occurred.
Third, conferring over lunch or other breaks during the deposition taken for unrelated reasons is more likely to be viewed as OK. Again, if you’re willing to have the witness testify that no coaching occurred, so much the better.
Fourth, just as the weight of authority is against conferring with questions pending, once we get to overnight breaks, the weight has shifted decisively to such conferences being allowable. There’s some contrary precedent, but not much.
Fifth, once we get into the realm of multi-day adjournments, except possibly in South Carolina (and Delaware, if less than five days), conferences between counsel and the deponent are all right.
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