More New Stuff

Today’s post is of the “this and that” variety − dealing with things we’ve come across that we haven’t yet blogged about this week.

Medical Device Preemption − The Greatest

As defense counsel appreciate, PMA preemption post-Riegel floats like a butterfly and stings like a bee.  Anybody representing PMA medical device clients will want to read (and cite) Ali v. Allergan USA, Inc., 2012 WL 3692396 (E.D. Va. Aug. 23, 2012).  Ali involved a “lap band” − a PMA device that restricts the ability of the stomach to expand, used as a last-ditch weight control measure in cases of morbid obesity.

Ali involves several preemption issues, and is also good on TwIqbal and the Virginia Consumer Protection Act.  On preemption, as usual the battleground was the so-called “parallel claim” exception.  2012 WL 3692396, at *7.  Plaintiffs offered only “a series of conclusory allegations that that [defendant] violated federal law.”  Id.  Not surprisingly, that didn’t cut it. Thus, everything having to do with warnings was dismissed (albeit without prejudice).  Id.

Plaintiffs contended that they based their negligence and implied warranty claims in a manufacturing defect.  Again they faced TwIqbal.  “[T]the plaintiff must allege sufficient facts to support both the inference that the defendant manufactured the device in a way that violated federal regulations and the inference that this violation resulted in the defect that caused the plaintiff's injuries.”  Id. at *8.  The manufacturing defect claim required:  (1) that “the plaintiff identif[y] what went wrong in the manufacturing process and cite[] the relevant FDA manufacturing standards that were allegedly violated,” id., and (2) “sufficient facts to support the inference that the defendant's federal violations resulted in the defect that caused the plaintiff's injuries.”  Id. at *9 (citations and quotation marks omitted).  The Ali complaint didn’t come close, containing only “information and belief” allegations as to violations and nothing at all about causation.  Id. at *10.  As to what was violated, alleging “any regulations promulgated pursuant to the Act” somehow didn’t impress the court.  Id.  Nor do allegations that are nothing more than “simple recitations of regulatory language” enough.  Id. at *11.  Plaintiff can’t get away with copying sections of the Code of Federal Regulations.  That the plaintiff was injured does not mean that an FDCA violation occurred:

[T]he allegation that the [product] eroded does not, by itself, suggest that [defendant] violated federal requirements in manufacturing this device. At the time the [product] obtained PMA, the FDA was aware of [a] risk of erosion and [that it] could cause serious complications. . . .  Ultimately, the FDA determined that [this risk] was a rare occurrence and that serious complication resulting from [it] was an even rarer occurrence, and approved the device despite these risks.

2012 WL 3692396, at *11 (citations omitted).

The plaintiff threw in allegations that the defendant’s first try at PMA had been unsuccessful.  The court essentially held “so what?”  Even if PMA had at first failed, the defendant “obtained PMA more than eight years before it was first implanted in [plaintiff’s] body.  Id. at *12.  That there had been various recalls of similar models didn’t matter since none of them had involved the device in question or the risk in question.  Id.

To get around TwIqbal, the plaintiffs in Ali trotted out Hofts v. Howmedica Osteonics Corp., 597 F. Supp.2d 830 (S.D. Ind. 2009), the case we love to hate. The judge in Ali hated Hofts almost as much as we do:

This Court respectfully disagrees with the Hofts court’s application of the Rule 8 pleading standard. . . .  This Court finds the Hofts court unusually lax in its application of the standard.  In assessing the sufficiency of pleadings, district courts should not take conclusory allegations as true but must require factual support for any legal conclusions offered in pleadings.  Requiring such factual enhancement does not constitute a heightened pleading standard; it is the basic pleading standard established in Rule 8 as interpreted in [TwIqbal].  Without factual allegations supporting inferences of the defendant’s liability and the plaintiff’s right to relief, pleadings fail to provide adequate notice of the grounds upon which the plaintiff's claim rests.  In Hofts, the district court relaxed the facial plausibility standard out of existence with respect to the plaintiff's allegations that the defendant violated federal requirements.  This Court declines to adopt that approach in the context of this case.

This Court also respectfully disagrees with the Hofts court’s approach to the breach of implied warranty claim, where the court placed the burden on the defendant to show that the claim imposed standards different from applicable federal requirements.  Rule 8 places the burden of pleading a plausible claim for relief and the grounds for this claim on the claimant. . . .  This Court agrees with the majority of federal courts in holding, post-Riegel, that the facial plausibility standard applies to the pleading of a federal violation in this context and requires facts indicating noncompliance with federal requirements on the manufacture of the device.

2012 WL 3692396, at *13

The plaintiffs in Ali made a premature demand for discovery before meeting their Rule 8 pleading requirements.  The court had none of it, finding that request to be “precisely the sort of fishing expedition the Supreme Court [in TwIqbal] sought to avoid in requiring the plaintiff to plead facts demonstrating their entitlement to relief and the defendant's liability.”  Id. at *14.

Ali also followed the majority rule on preemption of express warranty claims.  If they impose duties on the purported warrantor that differ from or add to federal requirements, if they challenge the safety and effectiveness of the PMA device, or if they challenge the manufacturer’s FDA-approved labeling, express warranty claims are preempted.  Id. at *15.  The only way am express warranty claim survives is when there are allegations “based on representations made by the manufacturer about the device that was not approved by the FDA.”  Id. at *16.  The plaintiff didn’t plead anything of the sort, so the express warranty claims were also dismissed.  Id.

We’ve also collected cases holding that consumer fraud claims involving drugs and medical devices fail under “regulated activity” safe harbor provisions in the relevant state statutes.  Ali is another such case:

By its own terms, however, the VCPA does not apply to “[a]ny aspect of a consumer transaction which aspect is authorized under laws or regulations of this Commonwealth or the United States, or the formal advisory opinions of any regulatory body or official of this Commonwealth or the United States.” Va. Code Ann. §59.1-199(A).

Plaintiffs’ VCPA claim fails because it challenges conduct that is expressly excluded from the scope of the VCPA.  Plaintiffs base their VCPA cause of action on representations made by [defendant] . . . in advertisements and other marketing materials concerning the safety and effectiveness of the device.  Representations about the [PMA-approved device] in marketing materials for the device are authorized and regulated by the FDA under federal law.  The VCPA, therefore, does not apply to it and therefore no action challenging [defendant’s] marketing practices . . . may be brought under the VCPA.

2012 WL 3692396, at *19.  Gotta love it.  Ali is the greatest.

Prescription Drugs in Texas − You Can’t Get There from Here

We’re somewhat less enamored with Romero v. Wyeth, C.A. No. 1:03-cv-13467, slip op. (E.D. Tex. Aug. 31, 2012), sent to us by Janelle Davis of Thompson & Knight, although we must admit Romero does have its moments.

Romero evaluates a variety of claims purportedly arising under Texas law, in the wake of the big win in Centocor, Inc. v. Hamilton, ___ S.W.3d ___, 2012 WL 2052783 (Tex. June 8, 2012).  On the good side of the ledger, the court throws out all of the usual bread & butter claims in prescription drug product liability litigation − those involving failure to warn (specifically misrepresentation, fraud, negligence, misrepresentation, gross negligence, and consumer fraud).  The Texas statutory presumption of adequacy of FDA-approved warnings controlled, no matter what form the defendant’s information took:

“[I]f a claim is based upon a product’s labeling, its omissions, or inaccuracies, it falls under this purview of the [statutory presumption]. . . .  [Plaintiff] seeks to distinguish failure to warn claims based upon a drug manufacturer’s statements in a warning label from those premised on other representations contained, for example, in promotional and marketing materials. . . .  Because [plaintiff] cites no other authority [besides the lower court decision reversed in Centocor] for the proposition that [the statute’s] provisions should be so strictly applied, the court declines to make such a determination here.  Accordingly, whether [plaintiff’s] failure to warn claims are based on statements made in [defendant’s] labeling or promotional materials, they fall within the purview of [the statutory presumption of adequacy].

Romero, slip op. at 5.

That’s the good part of Romero. The parts responsible for our “you can’t get there from here” comment then follow.  For one thing the court allows a naked failure to test claim to continue.  Abundant precedent, including controlling precedent under Texas law, holds that “failure to test” isn’t a free-standing cause of action.  The Texas Supreme Court dealt with such a claim in American Tobacco Co., Inc. v. Grinnell, 951 S.W.2d 420 (Tex. 1997), twice holding “failure to test” to be “inextricably intertwined” with failure to warn, and rising or falling with it:

The [plaintiffs’] negligent testing claim is predicated on [defendant’s] duty to test and ascertain the dangers inherent in its products about which it must warn consumers. Because the negligent testing claim is inextricably intertwined with the [plaintiffs’] negligent failure to warn claim, we hold that summary judgment was also proper on this claim.

Id. at 437.

The [plaintiffs’] negligent testing claim is also preempted. . . . [Their] negligent testing claim is inextricably intertwined with advertising and promotional materials because the [plaintiffs] allege only that [defendant] should have tested its products to determine the dangerous characteristics about which [defendant] should have warned consumers.

Id. at 439.  Then there’s the Fifth Circuit.  In Dow Agrosciences LLC v. Bates, 332 F.3d 323, (5th Cir. 2003), reversed on other grounds, 544 U.S. 431 (2005) (preemption), the court held that, “a negligent testing claim is, as a matter of Texas law, a variation of an action for failure to warn.”  Id. at 333.  And again, in Skotak v. Tenneco Resins, Inc., 953 F.2d 909 (5th Cir. 1992):

[N]egligence claims, such as the alleged failure to adequately test [the product], are subsumed within this two-part standard. . . .  [Plaintiffs] were required to prove that an inadequate warning was given and that the inadequate warning was the cause of the injury.  [Plaintiffs] do not argue otherwise, nor do they assert here an independent, or separate, negligence claim.

Id. at 912 n.5 (affirming summary judgment).

Oh well, so much for appellate precedent.  Citing general “reasonable care” negligence cases and an old asbestos case involving failure to warn, Romero concocts some sort of “independent negligence cause of action based upon [defendant’s] failure to test” that no Texas court has ever allowed.  Slip op. at 7-8.  It may be our favorite legal proposition, and it sure applies here - a federal court sitting in diversity is not supposed to invent new, expansive state-law causes of action.

“[I]n hazarding an Erie guess, our task is to attempt to predict state law, not to create or modify it. The practical effect of adopting an exception like the one [plaintiffs] propose is the creation of a previously nonexistent state law cause of action.  Therefore, [plaintiffs] carry a heavy burden to assure us that we would not be making law.

Memorial Hermann Healthcare System Inc. v. Eurocopter Deutschland, GmbH, 524 F.3d 676, 678 (5th Cir. 2008) (applying Texas law).  We’re sure there’s plenty more where that comes from.

Romero also allows a design defect claim, holding that Restatement (Second) of Torts §402A, comment k should be applied on a case by case basis.  Slip op. at 11-12.  It gets to that result by characterizing comment k as an “affirmative defense” even though no Texas law says so (we reiterate the Erie federalism point) and in Centocor the Texas Supreme Court unanimously and emphatically rejected a similar argument about the learned intermediary rule:

The learned-intermediary doctrine is not an affirmative defense. . . .  While the learned intermediary doctrine shifts the manufacturer’s duty to warn the end user to the intermediary, it does not shift the plaintiff’s basic burden of proof.  Doing so would create an anomalous situation where, once the defendant prescription-drug manufacturer invokes the learned intermediary doctrine, the plaintiff would be relieved of proving a key burden in any product warning case - that the product warning was inadequate.

___ S.W.3d ___, 2012 WL 2052783, at *20.  With comment k, the analysis is the same, only it involves design rather than warning claims.  Several federal courts under Texas law cases have applied comment k to all prescription medical products, not requiring the individualized sort of product by product analysis demanded in Romero.  Reyes v. Wyeth Laboratories, 498 F.2d 1264, 1273 (5th Cir. 1974) (vaccine); Woodhouse v. Sanofi-Aventis United States LLC, 2011 WL 3666595, at *3-4 (W.D. Tex. June 23, 2011); Holland v. Hoffman-La Roche, Inc., 2007 WL 4042757, at *3 (N.D. Tex. Nov. 15, 2007); Carter v. Tap Pharmaceuticals, Inc., 2004 WL 2550593, at *2 (W.D. Tex. Nov. 2, 2004); Hackett v. G.D. Searle & Co., 246 F. Supp.2d 591, 595 (W.D. Tex. 2002) (applying Texas law). Tellingly, Romero does not cite a single Texas prescription medical product case for its contrary proposition.

There’s more we could discuss but for now, suffice it to say that with respect to the non-warning claims, we don’t think Romero can get there from here under what Texas law really is rather than what plaintiffs might want it to be.

We Think That’s About Right

Finally, from our home turf here in Pennsylvania, we offer the decision in Boeynaems v. LA Fitness International, LLC, ___ F. Supp.2d ___, 2012 WL 3536306 (E.D. Pa. Aug. 16, 2012), which we received internally today.  This is not a drug case, but it is a class action in which the plaintiffs were harassing the defendants with massive pre-certification discovery requests.  The defendant asked the judge to require the plaintiffs to pay for that discovery themselves, and the court agreed, holding:

[T]he Court mandates cost allocation as fair and appropriate.  The Court concludes that where (1) class certification is pending, and (2) the plaintiffs have asked for very extensive discovery, compliance with which will be very expensive, that absent compelling equitable circumstances to the contrary, the plaintiffs should pay for the discovery they seek.

Id. at *11.  The court essentially told the plaintiffs that they had to put up or shut up − no more one-way discovery, at least pre-certification in class actions:

If the plaintiffs have confidence in their contention that the Court should certify the class, then the plaintiffs should have no objection to making an investment.  Where the burden of discovery expense is almost entirely on the defendant, principally because the plaintiffs seek class certification, then the plaintiffs should share the costs.

Id.

We think that’s just about right.  If the class isn’t certified because the claims are bogus, the defendant isn’t going to be able to recoup this sort of massive expense from the class plaintiffs, and the attorneys will try to walk away from the case.  If the case is good, then the common fund doctrine will plaintiffs’ counsel recoup their expense.  So as Ron Weasley might say, “put your Galleons where your gob is.”

Odd Facts Should Not Make Bad Law

When we saw the first one we thought, that’s odd, but it’s mostly a malpractice claim pretty far from our sweet spot.  When we saw the second one, we thought, maybe we should blog about this now….  But the result was mostly unfavorable, and other, more significant things were happening.  But now that we’ve seen a third one, well we think we finally have to comment.  We don’t want the odd facts that the plaintiff pleaded (we have some difficulty believing their truth) in Schiff v. Hurwitz to mess up Pennsylvania law − any worse than it already is, that is.

First, some legal propositions:

Proposition one − No separate duty to test theory exists under Pennsylvania product liability law − period.  The relevant cases, all in our duty to test cheat sheet, are:  Lance v. Wyeth, 4 A.3d 160, 168-69 (Pa. Super. 2010), appeal granted, 15 A.3d 429 (Pa. 2011); Viguers v. Philip Morris USA, Inc., 837 A.2d 534, 541 (Pa. Super. 2003), aff’d, 881 A.2d 1262 (Pa. 2005) (per curiam); Oddi v. Ford Motor Co., 234 F.3d 136, 143-44 (3d Cir. 2000); Wolfe v. McNeil-PPC, Inc., 773 F. Supp.2d 561, 570 (E.D. Pa. 2011); Sykes v. Glaxo-SmithKline, 484 F. Supp.2d 289, 318 n.32 (E.D. Pa. 2007); Stitt v. Philip Morris, Inc., 245 F. Supp.2d 686, 694 (W.D. Pa. 2002).

Proposition two − The Food, Drug & Cosmetic Act (“FDCA”) does not give private persons a right of action to enforce it.  Buckman Co. v. Plaintiffs Legal Committee, 531 U.S. 341, 352 (2001); In re Orthopedic Bone Screw Products Liability Litigation, 193 F.3d 781, 791 (3d Cir. 1999); Gile v. Optical Radiation Corp., 22 F.3d 540, 544 (3d Cir. 1994); Sandoz Pharmaceuticals Corp. v. Richardson-Vicks, Inc., 902 F.2d 222, 231 (3d Cir. 1990); Green v. Dolsky, 685 A.2d 110, 115 (Pa. 1996); 21 U.S.C. §337(a).

Proposition three − Strict liability does not lie against the maker of a prescription medical product under Pennsylvania law − not for any type of defect (except possibly manufacturing).  Hahn v. Richter, 673 A.2d 888, 889-90 (Pa. 1996); Baldino v. Castagna, 478 A.2d 807, 810 (1984); Incollingo v. Ewing, 282 A.2d 206, 219-20 & n.8 (Pa. 1971), Lance, 4 A.3d at 164-65; Creazzo v. Medtronic, Inc., 903 A.2d 24, 31 (Pa. Super. 2006); Sykes, 484 F. Supp.2d at 318 & n.31; Soufflas v. Zimmer, Inc., 474 F. Supp.2d 737, 750 (E.D. Pa. 2001).

Proposition four − Strict liability does not lie against health care providers in Pennsylvania.  Cafazzo v. Central Medical Health Services, Inc., 668 A.2d 521, 537-38 (Pa. 1995); Coyle v. Richardson-Merrell, Inc., 584 A.2d 1383, 1386 (Pa. 1991); Kelly v. St. Mary Hospital, 694 A.2d 355, 358 (Pa. Super. 1997); Podrat v. Codman-Shurtleff, Inc., 558 A.2d 895, 897 (Pa. Super. 1989); Makripodis v. Richardson-Merrell, Inc., 523 A.2d 374, 378 (Pa. Super. 1987); Flynn v. Langfitt, 710 F. Supp. 150, 152 (E.D. Pa. 1989); Eby v. Milton S. Hershey Medical Center, 31 Pa. D. & C.4th 121, 125 (Pa. C.P. 1996).

Proposition five − Strict liability cannot be reimported into prescription medical products/health care services under the guise of a consumer fraud claim brought under the Pennsylvania Unfair Trade Practices & Consumer Protection law (“UTPCPL”), because the act is inapplicable to medically-related activities.  Walter v. Magee-Women’s Hospital, 876 A.2d 400, 407-08 (Pa. Super. 2005), aff’d, 906 A.2d 1194 (Pa. 2006); Foflygen v. Zemel, 615 A.2d 1345, 1354 (Pa. Super. 1992); Gatten v. Merzi, 579 A.2d 974, 976 (Pa. Super. 1990), Kee v. Zimmer, Inc., 2012 WL 1758618, at *4 (E.D. Pa. May 17, 2012); Zafarana v. Pfizer, Inc., 724 F. Supp.2d 545, 557 (E.D. Pa. 2010); Smith v. Bristol-Myers Squibb Co., 2009 WL 5216982, at *5-6 (D.N.J. Dec. 30, 2009) (applying Pennsylvania law); Heindel v. Pfizer, Inc., 381 F. Supp.2d 364, 374 (D.N.J. 2005) (applying Pennsylvania law); Kester v. Zimmer Holdings, Inc., 2010 WL 2696467, at *14 (W.D. Pa. June 16, 2010); Albertson v. Wyeth, Inc., 63 D. & C.4th 514, 538-39 (Pa. C.P. 2003); Crossen v. Peretz, 2002 WL 34576549 (Pa. C.P. Oct. 17, 2002); Luke v. American Home Products Corp., 1998 WL 1781624, at *8 (Pa. C.P. Nov. 18, 1998); see Beyers v. Richmond, 937 A.2d 1082, 1088 (Pa. 2007) (favorably citing and applying medical professional UTPCPL precedent to hold that lawyers were also not within the scope of the UTPCPL).

Proposition six − Hospitals have no common-law obligation to obtain informed consent to medical procedures from patients.  Valles v. Albert Einstein Medical Center, 805 A.2d 1232, 1239 (Pa. 2002); Watkins v. Hospital of the University of Pa., 737 A.2d 263, 268-69 (Pa. Super. 1999); Friter v. Iolab Corp., 607 A.2d 1111, 1114 (Pa. Super. 1992).

Proposition seven − In Pennsylvania the informed consent doctrine is not unlimited.  It extends only to the risks and benefits of surgery, specifically not including any obligation to explain the FDA regulatory status of prescription medical products to patients.  Southard v. Temple University Hospital, 781 A.2d 101, 107 (Pa. 2001).  Nor does the informed consent doctrine require disclosure of a physician’s financial interests.  Duttry v. Patterson, 771 A.2d 1255, 1259 n.2 (Pa. 2001); Corrigan v. Methodist Hospital, 874 F. Supp. 657, 659 (E.D. Pa. 1995).

Proposition eight − and probably the most important for present purposes − federal judges exercising diversity jurisdiction have no business “predicting” novel expansions of state-law liability.  They follow, and do not lead, state courts.  Day & Zimmermann, Inc. v. Challoner, 423 U.S. 3, 4 (1975); Sheridan v. NGK Metals Corp., 609 F.3d 239, 253 (3d Cir. 2010); Travelers Indemnity Co. v. Dammann & Co., 594 F.3d 238, 253 (3d Cir. 2010); City of Philadelphia v. Beretta U.S.A. Corp., 277 F.3d 415, 421 (3d Cir. 2002) Camden County Board of Chosen Freeholders v. Beretta, 273 F.3d 536, 541 (3d Cir. 2001); Leo v. Kerr-McGee Chemical Corp., 37 F.3d 96, 101 (3d Cir. 1994); City of Philadelphia v. Lead Industries Ass’n, 994 F.2d 112, 123 (3d Cir. 1993).

Second, we’ll take a look at the facts in Schiff v. Hurwitz, 2012 WL 1971320 (W.D. Pa. June 1, 2012) (hospital institutional review board’s (“IRB) motion) (“Schiff III”); Schiff v. Hurwitz, 2012 WL 1828035 (E.D. Pa. May 18, 2012) (medical device manufacturer’s motion) (“Schiff II”); and Schiff v. Hurwitz, 2012 WL 1355613 (W.D. Pa. April 18, 2012) (doctor’s motion) (“Schiff I”), as they’re pleaded. That’s all we have to go on since all three Schiff opinions decide Rule 12 motions to dismiss.  Maybe these weird allegations will become less beguiling when the pleadings can be pierced.  Here's hoping, anyway.

The plaintiff’s allegations in Schiff − which we have a hard time believing − are that the defendant medical device manufacturer sold a Class II device (that means no preemption under Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996)) called “Invasix” that the FDA had cleared for marketing and labeling for certain uses.  The plaintiff, however, allegedly did not use the device for any of those labeled uses.  Instead, the plaintiff alleges that she was provided the device in the context of some sort of underground, non-FDA authorized clinical trial of a new use.  This underground trial purportedly was conducted like a clinical trial, in that her surgeon was an “investigator” and the trial was carried out under the auspices of the defendant hospital IRB.  In accordance with the usual trappings of a clinical trial, the plaintiff signed a written agreement under which she was to receive money for participating in the trial and any medical expenses from adverse events suffered in what amounted to a medical experiment would be paid for.  Plaintiff alleged that the manufacturer defendant, in order to avoid the FDA's clinical trial requirements, falsely represented (it's not clear to whom) that the new use had no safety issues.  The plaintiff further claims that she was not informed of any safety risks by anyone − in particular that the defendant surgeon’s informed consent discussion omitted mention that she didn’t fit within the trial’s protocol and didn’t mention any safety risks.  Then, of course (since this is a product liability action), plaintiff suffered injury from those risks.  Plaintiff also claimed she wasn’t informed that the defendant surgeon “was a paid investigator.”  Schiff I, 2012 WL 1355613, at *1-2; Schiff II, 2012 WL 1828035, at *1-2; Schiff III, 2012 WL 1971320, at *1-2.  We’ve seen a lot of claims in several decades of practice, but we've never encountered allegations of an under-the-table or off-the-books clinical trial before.  That's the source of our skepticism about whether the pleaded facts in Schiff are true, or even could be true.  But there’s always a first time….

On these purported facts, the plaintiff in Schiff alleged (at least) the following general theories:  (1) against the treating surgeon:  UTPCPL violations; (2) Against the manufacturer (Invasix): negligence, strict liability, breach of warranty, and misrepresentation; (3) against the hospital IRB:  UTPCPL violations and intentional infliction of emotional distress.  Plaintiff may well assert other claims − these are just what was discussed in the Schiff set of opinions.

Third, and the whole point of this post, here is why we’re bothered by what’s been going on in Schiff.

From our perspective, it appears that these weird FDA/clinical investigation allegations have mesmerized the court, at least as far as the pleadings are concerned.  By that we mean that these allegations have induced a federal judge into permitting causes of action − for strict liability, for negligence, and under the UTPCPL − that have at best never been recognized under Pennsylvania law, and at worst are flatly rejected by controlling precedent.

It’s no isolated occasion. Precedentially unconstrained rulings typify the three Schiff opinions.

Let’s dispel the haze, shall we?

We will assume for purposes of this argument − although the Pennsylvania Supreme Court has never spoken on the subject − that under some circumstances, Pennsylvania would allow a negligence per se-type cause of action for at least some violations of the FDCA.

But not these.

Why?

Start with legal Propositions 1 and 2 − Pennsylvania recognizes no duty to test, and there exists no private FDCA cause of action.  A clinical trial, whether FDA approved or not, is simply a very formal a method of testing a product for safety and effectiveness.  Pennsylvania courts have said over and over again, that unless a product is otherwise defective, it doesn’t matter whether it was properly tested, or indeed tested at all.  If one assumes the rather fantastic allegations in Schiff that a surreptitious clinical trial of an experimental use was being conducted, that’s just an elaborate attack on the testing (or lack of same) of the product.

But plaintiff's argument that the purported clinical trial should have been conducted under FDA auspices is simply an claim that the defendants violated the FDCA.  As a private individual seeking damages, plaintiff simply can’t do that − not unless the claim resembles a recognized, pre-existing tort.  That’s been looked at over and over again in medical device preemption cases (we’re not arguing preemption here because it’s a class II device), and the lack of an FDCA private right of action restricts plaintiffs to FDCA-related claims that “parallel” state law.  We’ve done lots of posts on parallel claims, and most of our medical device preemption scorecard is devoted to what is or isn’t a “parallel” claim, so we won’t delve deeply into that here.

Since a duty to test doesn’t exist under Pennsylvania law, the FDCA violation claims in Schiff can’t possibly be parallel to any recognized Pennslyvania product liability claim.  The defendant manufacturer might have violated the FDCA from here to kingdom come (or at least to Israel, where it’s based) but that’s for the FDA to sort out.  As we’ve recently posted, private plaintiffs simply don’t have standing to raise FDCA violations that don’t also amount to traditional common-law claims − and the underground clinical trial allegations here aren't even in the vicinity.

So the FDCA regulatory haze in Schiff is just that − a smokescreen of basically irrelevant allegations that do nothing but confuse and obfuscate the plaintiff’s common-law causes of action − or lack of same.

One of those other causes of action would seem to be informed consent.  If, as plaintiff Schiff claims, she was not told the underlying medical risks and benefits of the surgery in question, then that would support a traditional informed consent action against the surgeon.  Moreover, if the procedure in question was really “experimental” − in the sense that its risks and benefits were unknown − then the law requires patients to be told this fact.  See Proposition 7.  However, as the Pennsylvania Supreme Court has pointed out “the doctrine of informed consent is a limited one.”  Valles, 805 A.2d at 1240 (quoting Duttry, 771 A.2d at 1258).  Informed consent obligations are owed only by doctors, not by hospitals, and certainly not by manufacturers.  See Proposition 6.  The learned intermediary rule, at the heart of most of the cases in Proposition 3, limits a manufacturer’s informational obligations to warning the treating physicians.  If those choose not to pass along information, that’s both their prerogative and their responsibility.

Thus, the apparent holding in Schiff III, 2012 WL 1971320, at *3, that some sort of “negligence” based warning claim (exactly what is never articulated) exists against the hospital IRB is simply contrary to Pennsylvania law governing the informed consent obligations of hospitals.  The only negligence theory (we'll put aside that "informed consent" in Pennsylvania sounds in battery, not negligence) that might even arguably exist to impose liability on a hospital for inadequate patient information would be under Friter, supra − that a hospital voluntarily agreeing to participate in an FDA-regulated clinical trial voluntarily assumes, and must perform reasonably, the informed consent obligations stated in FDA regulations.  But the allegations in Schiff are antithetical to any Friter-based cause of action, since plaintiff asserts that the defendants sought to circumvent FDA clinical trial regulations, not follow them.  Again, we’re left with a bare allegation that the hospital (and its IRB) should have complied with the FDCA, which must fail since it’s not “parallel” to any liability Pennsylvania law has ever recognized against a hospital.

Could there be a claim against the hospital in Schiff?  It’s hard to tell, and we don’t have a lot of experience in this area, but IRBs are supposed to supervise clinical trials.  To the extent plaintiff claims that she fell outside of the alleged study’s alleged protocol, well, at least compliance with protocol sounds like something that’s within the scope of an IRB’s supervisory duty.  So maybe.

The departures from established Pennsylvania law are even worse in Schiff II, with its holding that the alleged FDCA violations somehow provide an informational claim that can bypass the learned intermediary rule, see 2012 WL 1828035 at *6 (“defendant was negligent for failing to follow FDA regulations regarding investigative devices and failing to properly test the . . . device”).  We've already dealt with the non-existent "duty to test."  As for the rest, let’s be blunt.  Once a physician/patient relationship is in place, for forty years Pennsylvania has not recognized any exception to the learned intermediary rule, not for pharmacists, not for contraceptives, and certainly not for clinical trials.  Once again, there is no “parallel” direct-to-patient warning duty in Pennsylvania.  It’s a bare FDCA violation claim that the plaintiff in Schiff has no standing to pursue.

What could conceivably be pursued, buried beneath all the FDA-related dross in the Schiff complaint, is a claim that the manufacturer withheld information about safety and effectiveness (or the lack of data supporting same) from the prescribing surgeon.  That would state a claim under Pennsylvania law, but Schiff II wanders so far afield from anything recognizable as a Pennsylvania cause of action, that its hard to tell if a normal claim is even being alleged.  Also, the plaintiff in Schiff asserts a breach of contract claim, that the manufacturer agreed to pay for certain things, and then didn’t.  That could also be a viable claim, assuming the accuracy of the pleading (which is questionable).

Likewise, Schiff II purports to tease some sort of “strict liability” claim from the plaintiff’s FDCA-related allegations:

Plaintiff argues that, because the strict liability claim is based on more than a failure to warn theory, the claim is permitted to go forward.  Plaintiff argues that the “risk of thermal injury rendered the device unsafe, defective and dangerous as well as [defendant manufacturer’s] failure to consider the factors set forth in the FDA Guidance Document on RF medical devices” also permits for recovery for strict liability.  At the Motion to Dismiss phase, this Court finds that plaintiff has adequately pled a claim for strict liability.

2012 WL 1828035, at *5.  We've read this quote several times, and it’s still so vague and garbled that we can’t even figure out what kind of strict liability (design, warning, manufacturing?) is at issue.  Schiff II doesn't mention design.  It doesn't mention manufacturing.  But it nevertheless states that there's something "more than a failure to warn."  But the only thing mentioned aside from an inherent risk (which can only be warned about - see Viguers, supra, for the proposition that inherent risks aren't design defects), is the purported FDCA violation.

We do know this − Propositions 3 and 4.  Strict liability does not exist in Pennsylvania in the context of medical procedures involving prescription medical products.  That’s been the law, without exception (where the bar to strict liability has been asserted; we know a couple of cases where it wasn't) in Pennsylvania since Incollingo in 1971.  The absence of strict liability has been reaffirmed regularly by appellate courts applying Pennsylvania law.  Indeed, the most significant pending controversy in prescription medical product liability litigation in Pennsylvania is whether a negligence claim exists for design defect.  Even the very pro-plaintiff Lance decision (now before the Pennsylvania Supreme Court) agreed that no strict liability claim of any sort exists.  The fight in Lance is solely over negligence.

And then there’s fraud/UTPCPL.  As the abundant precedent cited in support of Proposition 5 holds, the Pennsylvania consumer fraud statute doesn’t apply to medical procedures of any sort or in product liability actions involving prescription medical products that physicians use in such procedures.  But in all three Schiff decisions allow novel UTPCPL or fraud causes of action to proceed against persons against whom that such claims have never before been allowed − and once again, the bizarre FDCA violation claims are at the heart of the allegations. In Schiff I:

Here, [plaintiff] avers that confusion and deceptive conduct surrounded the affiliation, connection, and association [defendant surgeon] had with the [defendant manufacturer] and the “BodyTite Procedure” as well as Plaintiff’s lack of knowledge of the clinical trial involving the Invasix device.  Furthermore . . . [the surgeon] allegedly failed to warn [plaintiff] of the potential dangers of the Invasix Device and, critically, allegedly misrepresented that the FDA approved, or was at least involved in the clinical trial, of the Invasix Device.

2012 WL 1355613, at *4 (emphasis added).  The “critical” UTPCPL allegations − indeed the only facts actually cited − all have to do with the purported non-FDA clinical trial.

In Schiff II, instead of the UTPCPL, plaintiff alleged, and the opinion allowed, a “misrepresentation” claim where “some of the alleged misrepresentations were made regarding the classification of the device.”  2012 WL 1828035, at *7.  There's the FDA again.  Once again, however, this claim is completely incompatible with controlling Pennsylvania law − our supreme court’s unanimous Southard decision cited in Proposition 7 above.  There the court held:

[T]he FDA labels given to a medical device do not speak directly to the medical issues surrounding a particular surgery. The category into which the FDA places the device for marketing and labeling purposes simply does not enlighten the patient as to the nature or seriousness of the proposed operation, the organs of the body involved, the disease sought to be cured, or the possible results.  The FDA administrative label does not constitute a material fact, risk, complication or alternative to a surgical procedure. It follows that a physician need not disclose a device’s FDA classification to the patient in order to ensure that the patient has been fully informed.

781 A.2d at 107 (emphasis added).

Not material....

Need not be disclosed to the patient....

It's safe to say that, as a matter of controlling Pennsylvania law, the supposed FDA “classification” of a regulated product “does not constitute a material risk” and “need not [be] disclose[d].”  It’s hard to get clearer than Southard that "misrepresentations . . . regarding the classification of the device" are immaterial and cannot possibly be the subject of any viable fraud claim, since such information doesn't have to be disclosed in the first place.

In Schiff III, once again, the UTPCPL allegations deemed most important are those involving the purported FDCA violations:

The Complaint further avers that [the IRB] engaged in unfair trade practices because the FDA had not given prior approval for [these] devices in . . . plastic surgery procedures.  These facts, in addition to others in the Complaint, are sufficient to state a claim for unfair trade practices and negligence.

2012 WL 1971320, at *4.

But yet these FDCA violation allegation have no analogy in any legal claim recognized in Pennsylvania, given Proposition 5 − that the UTPCPL simply doesn’t apply to medical providers.  Here, in a slightly different guise, we have the same bare FDCA regulatory violation (that private plaintiffs can’t pursue, Proposition 2) being passed off as something else, this time the violation of another statute.  Plaintiff can’t do that either − it’s been tried.  As the Third Circuit has held:

[Plaintiff’s] position would require us to usurp administrative agencies’ responsibility for interpreting and enforcing potentially ambiguous regulations.  Jurisdiction for the regulation of OTC drug marketing is vested jointly and exhaustively in the FDA and the FTC. . . . and what the FD & C Act and the FTC Act do not create directly, the Lanham Act [a federal statute] does not create indirectly.

Sandoz Pharmaceuticals, 902 F.2d at 231 (cited in Proposition 2).  In this respect, the UTPCPL as alleged in Schiff is no different than the Lanham Act claim alleged in Sandoz − both try to create forbidden private FDCA violation claims “indirectly” under cover of another statute.

So as we see it the FDCA-related allegations in the Schiff litigation about the purported surreptitious conduct of a clinical trial are both, (1) irrelevant, since there’s no FDCA-based cause of action paralleling any recognized claim under Pennsylvania law, and (2) immaterial, since the Pennsylvania Supreme Court has already held that FDA regulatory status is not information that need be disclosed to patients at all.

More fundamentally we believe that the repeated allowance of novel and often already-rejected supposed “Pennsylvania law” causes of action in Schiff needs to stop.  That’s Proposition 8.  Schiff is merely diversity-jurisdiction-based state-law litigation.  The Supreme Court and the Third Circuit have repeatedly and vehemently held that federal courts just cannot do what’s been going on in Schiff − allowing novel theories of liability that state courts have not recognized.

[A] federal court is not free to apply a different rule however desirable it may believe it to be, and even though it may think that the state Supreme Court may establish a different rule in some future litigation.

Hicks v. Feiock, 485 U.S. 624, 630 n.3 (1988).

A federal court in diversity is not free to engraft onto those state rules exceptions or modifications which may commend themselves to the federal court, but which have not commended themselves to the State in which the federal court sits.

Day & Zimmerman, 423 U.S. at 4 (1975).

 Unlike our role in interpreting federal law, we may not act as a judicial pioneer in a diversity case. 

Sheridan , 609 F.3d at 253.

As a federal court sitting in diversity, we are charged with predicting how another court – in this case, the [relevant state] Supreme Court – would rule on the record presented to us. . . .  [I]n reaching our conclusion we have exercised restraint in accordance with the well-established principle that “where two competing yet sensible interpretations” of state law exist, “we should opt for the interpretation that restricts liability, rather than expands it, until the Supreme Court of [the state] decides differently.”  To hold here, as [plaintiff] urges. . . would undoubtedly subject manufacturers and dealers to greater liability. . . .  Given the muddled state of [state] law on this point, we must decline [plaintiff’s] invitation.

Travelers Indemnity, 594 F.3d 238, 253 (3d Cir. 2010) (quoting Werwinski v. Ford Motor Co., 286 F.3d 661, 680 (3d Cir. 2002)).

[I]t is not the role of a federal court to expand state law in ways not foreshadowed by state precedent.  Instead, a federal court follows the precedents of the state’s highest court and predicts how that court would decide the issue presented.

City of Philadelphia v. Beretta U.S.A. Corp., 277 F.3d 415, 421 (3d Cir. 2002).

In a diversity case . . . federal courts may not engage in judicial activism. Federalism concerns require that we permit state courts to decide whether and to what extent they will expand state common law. . . . Our role is to apply the current law of the jurisdiction, and leave it undisturbed.

Leo v. Kerr-McGee Chemical Corp., 37 F.3d 96, 101 (3d Cir. 1994) (quoting City of Philadelphia v. Lead Industries Ass’n, 994 F.2d 112, 123 (3d Cir. 1993)).

At bottom, Schiff doesn’t strike us as that hard or complicated of a case.  There’s a question of whether the defendant adequately warned the prescribing surgeon of the risk (or perhaps of it's unknown nature) that the plaintiff encountered.  If not, did the surgeon already know the risk from his own clinical experience or elsewhere?   Did the surgeon adequately pass along the relevant risks to the plaintiff as part of his informed consent discussion?  If some sort of experimental surgery was involved, was plaintiff adequately informed by the surgeon that the relevant risks could not be accurately estimated on the basis of what was known?  And if there was some sort of protocol-based investigation going on (whether FDA-authorized or not), did the defendant surgeon follow the protocol and inform the patient that she was being enrolled in such a study − and did the defendant IRB adequately ensure that study protocols were being followed?  That’s it.  That sounds like what Schiff was (or should be) about.  The rest, all the regulatory brouhaha, is a smokescreen at best and an invitation to error at worst.  Right now, it unfortunately appears that the invitation is being accepted.  We hope that changes.

Federalism Revisited And Reinforced

To our readers:

Sorry about that.  Blogger was down for almost 24 hours yesterday and this morning.  In almost five years, we've never experienced that during business hours.  Anyway, that combined with Bexis having to fly to the west coast for the ALI annual meeting, kept us from posting until now.

Here's the post we were planning on uploading yesterday.

******************

We try to keep abreast of what’s happening out there.  Our goal, not always met, is to check the federal courts of appeals’ websites every day.  We run searches and check some other things, too.  But we can’t follow everything, especially if it’s not directly drug/device related.  That’s why we’re indebted to our readers, such as Jeff Yeatman at DLA Piper, for sending us items that they think we should know about – and even telling us why.


The Fourth Circuit’s recent decision in Rhodes v. E.I. du Pont de Nemours & Co., 636 F.3d 88 (4th Cir. 2011), is an example.  Sure, we’d seen the blurbs about it from BNA and other sources, but Rhodes is an environmental contamination (alleged) case, so we’d let it go by.  But there’s something else about Rhodes that touches on something near and dear to our hearts – federalism in the context of state-law tort litigation in federal court.

It turns out that Rhodes was one of these made-for-litigation would-be class actions where nobody was really hurt.  The plaintiffs brought claims – not because anybody had any disease, but merely because (they claimed) they had an elevated level of a certain chemical in their blood that was linked to that claimed pollution.

That kind of claim reminds us of the question, “What is the sound of one hand clapping?”  Purely on the basis of elevated blood levels, the plaintiffs in Rhodes sued for “negligence, gross negligence, battery, trespass, and private nuisance.”  There was also a claim for medical monitoring, but the plaintiffs dismissed that after class certification was denied (raising other interesting issues worthy of their own post).  636 F.3d at 93.

The district court threw out all of the claims under West Virginia law, for the perfectly logical reason that they didn’t have any injury.  The plaintiff’s position was straight out of the movie “Minority Report” – we can sue you now, because you’re going to injure us in the future – as if somebody can be tagged for drunk driving solely on the basis of blood alcohol level, before ever getting into the car.

We’re traditionalists here. No injury; no lawsuit – only the sound of one hand clapping.

On appeal in Rhodes the Fourth Circuit agreed.  Negligence law in West Virginia was pretty much the same as negligence law anywhere, the plaintiff “is required to prove that he or she sustained an injury caused by the defendant's allegedly negligent conduct.”  636 F.3d at 94.  Plaintiffs admitted they had nothing more than elevated blood readings.  They didn’t present any precog evidence (we suppose Agatha was unavailable), so the court affirmed dismissal because no injury had happened or was “reasonably certain.”  Id. at 95.  If that was all the case was about, however, Jeff wouldn’t have sent it to us, nor would we be blogging about it.

Rather, plaintiffs claimed that battery did not require actual harm – merely “physical impairment” that wasn’t really impairment at all – but only “any alteration in the structure or function of any part of the body, even when such structural change does not cause other harm.”  636 F.3d at 95 (citing Restatement (Second) of Torts §15, comment a (1964)).

Current West Virginia law, however, requires “actual physical impairment” for battery.  636 F.3d at 95.  Mere exposure and fear of injury aren’t enough.  Id.  Undeterred, plaintiffs asked the court to predict that the West Virginia Supreme Court (technically “of Appeals”) would overthrow current law and adopt the broader Restatement view.

Here’s where we get interested.

The Fourth Circuit refused to make the prediction.  We’re a federal court, it held.  It’s not our job to “expand the tort of battery under West Virginia law to include any chemical exposure that results in potentially dangerous, detectable levels of that chemical in a person’s body.”  Id. at 95.  Eschewing judicial triumphalism, the court accepted its “limited” role of applying existing state law:

[O]ur role in the exercise of our diversity jurisdiction is limited. A federal court acting under its diversity jurisdiction should respond conservatively when asked to discern governing principles of state law. Therefore, in a diversity case, a federal court should not interpret state law in a manner that may appear desirable to the federal court, but has not been approved by the state whose law is at issue. Mindful of this principle, we decline the plaintiffs’ invitation to predict that the West Virginia Supreme Court of Appeals would adopt the specific provisions of the Restatement advanced by the plaintiffs.

Id. at 96 (citing Day & Zimmermann, Inc. v. Challoner, 423 U.S. 3, 4 (1975)).

All right!  Rhodes isn’t just a no-injury case, it’s a federalism case.  The Fourth Circuit turned down flat an opportunity to play the activist and predict an expansion of state tort law beyond the limits of current precedent.  Not only that, it did so for West Virginia, where before 2010, at any rate, we’d have given higher odds on any type of expansive prediction coming true than just about anywhere else in the country.

Not only that, the Fourth Circuit invoked federalism more than once in Rhodes.   Plaintiffs also advocated following a Restatement position over current West Virginia law in the context of public nuisance – another “tort” notorious for its susceptibility to expansive liability (real or imagined).  Rhodes refused to hold that, just because a case is called a “class action,” the actual harm requirement of public nuisance (called “special injury”) could be read out of the law.  Federalist principles again precluded such an argument:

We are not persuaded by this argument, because it fails to acknowledge that the Supreme Court of Appeals of West Virginia has not recognized a class action exception to the “special injury” requirement. We decline to recognize such an exception in the first instance because, as we have stated, a federal court in the exercise of its diversity jurisdiction should act conservatively when asked to predict how a state court would proceed on a novel issue of state law.

636 F.3d at 97-98 (again citing Challoner).

So Rhodes is a federalist two-fer.

Rhodes also got us thinking.  We’ve been touting federalism in diversity tort cases for almost as long as we’ve been blogging.  One of our very first posts, way back in November 2006, cited not only Challoner, but examples of pro-federalist precedent in every federal court of appeals.

We thought we’d go look and see if there are any more recent decisions like Rhodes out there.

Right off the bat we know of a couple of others, in our home Third Circuit.  Bexis has been pushing the federalist principle in the Third Circuit for almost twenty years now, back as far as Philadelphia v. Lead Industries Ass’n, 994 F.2d 112, 123 (3d Cir. 1993), one of his first ever PLAC amicus assignments.  As we blogged about at the time, in Sheridan v. NGK Metals Corp., 609 F.3d 239 (3d Cir. 2010), the court refused to expand Pennsylvania law in another exposure-only case:

A federal court under Erie is bound to follow state law as announced by the highest state court. . . . Unlike our role in interpreting federal law, we may not “act as a judicial pioneer” in a diversity case.

Id. at 253-54 (quoting Lead Industries; other citation and quotation marks omitted).  And then there’s M.G. v. A.I. Dupont Hospital for Children, 393 Fed. Appx. 884 (3d Cir. 2010), which we blogged about here, after excoriating the (now reversed) district court opinion here.  Bexis also briefed that one for PLAC, and the Third Circuit took notice.  In M.G., the Third Circuit “note[d] the well-established principle that a federal court sitting in diversity, when called upon to make a prediction of state law, should act conservatively” in reversing a prediction that Delaware would adopt medical monitoring.  Id. at 893 n.7.

So here’s what our little search turned up:

Third Circuit:  Still more good law out of the Third:  Refusing to abrogate economic loss rule in New Jersey – “[I]n reaching our conclusion we have exercised restraint in accordance with the well-established principle that where two competing yet sensible interpretations of state law exist, we should opt for the interpretation that restricts liability, rather than expands it, until the Supreme Court of that state decides differently.”  Travelers Indemnity Co. v. Dammann & Co., 594 F.3d 238, 253 (3d Cir. 2010).

Fifth Circuit:  Refusing to create new exception to Texas economic loss rule – “[I]n hazarding an Erie guess, our task is to attempt to predict state law, not to create or modify it.  The practical effect of adopting an exception like the one [plaintiffs] propose is the creation of a previously nonexistent state law cause of action.  Therefore, [plaintiffs] carry a heavy burden to assure us that we would not be making law.”  Memorial Hermann Healthcare System Inc. v. Eurocopter Deutschland, GmbH, 524 F.3d 676, 678 (5th Cir. 2008).

Sixth Circuit:  Refusing to grant standing under Ohio declaratory judgment statute to uninjured persons – “[W]hen given a choice between an interpretation of state law which reasonably restricts liability, and one which greatly expands liability, we should choose the narrower and more reasonable path.”  Aarti Hospitality, LLC v. City of Grove City, 350 Fed. Appx. 1, 6 (6th Cir. 2009).

Seventh Circuit:  Refusing to abrogate impact rule in Illinois medical malpractice cases – “[F]ederal courts are loathe to fiddle around with state law.  And that is especially true when it comes to important matters of state tort law, where there is an inherent danger in us intruding on the state's development of its own law.”  Barnes v. Anyanwu, 391 Fed. Appx. 549, 553 (7th Cir. 2010).

Eighth Circuit:  Refusing to broaden the universe of persons considered “clients” in legal malpractice cases – “Our duty is to conscientiously ascertain and apply state law, not to formulate new law based on our own notions of what is the better rule.”  Leonard v. Dorsey & Whitney LLP, 553 F.3d 609, 612 (8th Cir. 2009).

Ninth Circuit:  Refusing to create a new exception to California’s implied warranty privity requirement – “We decline this invitation to create a new exception that would permit [plaintiff’s] action to proceed.  So doing, we acknowledge that state courts have split on this privity question, and that the requirement may be an archaism in the modern consumer marketplace.  Nonetheless, California courts have painstakingly established the scope of the privity requirement . . . and a federal court sitting in diversity is not free to create new exceptions to it.”  Clemens v. DaimlerChrysler Corp., 534 F.3d 1017, 1023-24 (9th Cir. 2008).

District of Columbia Circuit:  Refusing to recognize negligent infliction of emotional distress in the District – “Were we to allow [plaintiff] to recover for IIED, we would be substantially expanding the scope of the third-party IIED tort under District of Columbia law. Of course, in considering common law claims, federal courts must apply existing law-we have no power to alter or expand the scope of D.C. tort law.” Pitt v. District of Columbia, 491 F.3d 494, 507 (D.C. Cir. 2007).

Looking at things, we have to say that federalism is alive and well – if not always successful – in the federal appellate courts. In somewhat less than five years since our first look at the subject, we’ve found new precedent in over half of the circuits, the Third, Fourth, Fifth, Sixth, Seventh, Eighth, Ninth, and DC circuits, all refusing to expand the scope of state-law claims at least in part for federalism reasons under the Erie rule. Thus, we continue to think that anytime that a novel tort theory is asserted in a diversity case in federal court, defendants should include federalism-based arguments in opposition to the claim.

We Dare Defend Established Alabama Law

We have to admit that we’re scratching out heads about a recent decision out of Alabama that – contrary to everything else we’ve seen – concluded that the manufacturer of a branded drug could be liable in a case where it never sold the generic product that was all the plaintiff every took and thereby (allegedly) suffered injury.


It’s not like this issue hasn’t been litigated before in Alabama.

The first Alabama case we know of to consider the issue was Barnhill v. Teva Pharmaceuticals USA, Inc., 2007 WL 5787186 (S.D. Ala. April 24, 2007), a Stephens-Johnson case where the plaintiff took cephalexin, a generic form of Keflex, but nevertheless tried to sue the manufacturer of branded Keflex.  The court held that no non-manufacturer product liability cause of action existed under Restatement (Second) of Torts §402B (a strict liability form of misrepresentation), for negligent failure to warn, for negligent failure to test (which shouldn’t exist at all), for negligent design, for negligent marketing and sale, for negligent manufacturing, for negligent failure to training physicians, and breach of express and implied warranty.  The court found all of these theories “essentially nonexistent” against a non-manufacturer, and that there was no evidence that the branded defendant was somehow an licensee, agent, or co-conspirator with the generic manufacturer.  Id. at *1-2

That’s one.

Next, in Green v. Wyeth Pharmaceuticals, Inc., 2007 WL 6428717 (Ala. Cir. May 14, 2007), an Alabama state court judge reached the same conclusion in a metoclopramide/Reglan case:

The majority of courts that have considered the issues presented in this case have found that only the manufacturer of the generic drug which was sold are liable.  The cases cited by defendants are persuasive that [non-manufacturing] defendants . . . are not liable.

Id. at *1.

That’s two.

Fast forward a few years, and in Mosley v. Wyeth, Inc., 719 F. Supp.2d 1340 (S.D. Ala. 2010), another metoclopramide/Reglan case, the court threw out negligent misrepresentation, fraud, and warranty theories against manufacturers of both branded and generic products that the plaintiff admittedly never used.  In Mosley the plaintiffs claimed:  (1) that the FDCA made branded manufacturers “primarily responsible” for labeling even for drugs they didn’t sell, and (2) that the branded manufacturer “created a sense of security and safety” through dissemination of supposedly “false” information about its own drug.  Id. at 1344.

Mosley accepted that plaintiffs, having fled from product liability, “did not argue that the defendants’ product caused them harm, but rather that their dissemination of false and misleading information, which they knew would be relied upon by the generic manufacturers in generating their own labels, was a direct and proximate cause of plaintiffs' injuries.”  Id. at 1344-45. That didn’t turn out to change the bottom line in Mosley - no liability.

Rather, Mosley dismissed the misrepresentation claim because the Alabama Supreme Court had never included product manufacturers within the category of persons who could be liable for “supply[ing] information” as “part of their business or profession” for “the guidance of others in their business transactions.”  Id. at 1346 (construing Restatement (Second) of Torts §552).  Product liability plaintiffs are not suing over “business transactions,” and the Alabama Supreme Court has only applied §552 in “limited circumstances” that did not include product warnings made to non-customers.  Id.

There was also no viable fraud claim in Mosley under Alabama law where the defendant was not a manufacturer of the product that injured the plaintiff.  Alabama has rejected market share liability and similar non-manufacturer theories in cases involving alleged product-related injuries.  Id. (citing Franklin County School Board v. Lake Asbestos of Quebec, Ltd., 1986 WL 69060, at *6 (N.D. Ala. Feb. 13, 1986)).  No fraud claim had ever been permitted in Alabama to hold a manufacturer liable for injuries caused by the products of a competing manufacturer:

The plaintiffs present no evidence or argument tending to establish that a relationship existed between [plaintiffs] and the [non-manufacturer defendants].  The plaintiffs cite no binding authority for the assertion that a manufacturer of brand-name drugs owes a duty to consumers of the generic version of their products.  Nor do [they] cite any binding authority for the contention that an injury resulting from consumption of a generic version of the drug can be considered a “proximate consequence” of a manufacturer's alleged misrepresentation regarding the brand-name version of the drug.

Mosley, 719 F. Supp.2d at 1347.

Nor did the FDA’s regulatory scheme mandate that brand name manufacturers be liable for competing generic products.  Nothing in the FDCA revealed an intent to change common-law duties.  Rather “generic manufacturers bear the same burden as brand manufacturers of providing a warning that adequately describes the risks associated with the particular drug they are manufacturing.”  Id. at 1348.

Likewise express and implied UCC warranty claims fail where there isn’t any contact between the plaintiffs and the “goods” that were allegedly subject to the breached warranties:

[Plaintiff] cite no authority holding that [UCC] §7-2-318 . . ., as adopted in any other jurisdiction-provides a cause of action to plaintiffs who were neither purchases, users, or consumers of, nor in contact with, goods produced by the manufacturer against whom they claim breach of warranty resulting in personal injury.

719 F. Supp.2d at 1351.  The court in Mosley refused plaintiffs’ “invitation” to be come the first court to do so.  Id.

That’s three – and the third one was a whopper.

Next, in Simpson v. Wyeth, Inc., 2010 WL 5485812 (Mag. N.D. Ala. Dec. 9, 2010), adopted, 2011 WL 10607 (N.D. Ala. Jan. 4, 2011), yet another metoclopramide/Reglan case, the plaintiffs conceded negligence, strict liability, and warranty.  Instead they argued that, by virtue of prior branded drug sales, the non-manufacturer “entered into a relationship with plaintiffs’ prescribing physicians that required them to notify those physicians of” allegedly suppressed information, even in the absence of prescription in a particular case.  Id. at *2.  They further claimed that if the prescribers had known of the “true” risks of the branded drug, they would not have prescribed the generic either.  Id.

In Simpson plaintiffs claimed that a general fraud proposition – that fraud can pass through intermediate “third parties” – allowed a non-manufacturer claim, when tied to the learned intermediary rule.  Id.  No way, said the court.  There was no duty.  The learned intermediary rule was a product liability doctrine, and plaintiffs could not cloak themselves in a product liability doctrine while at the same time violating the fundamental tenet of product liability, which is that manufacturers are the liable parties:

“[U]nder the learned intermediary doctrine, a manufacturer’s duty to warn is limited to an obligation to advise the prescribing physician of any potential dangers that may result from the use of its product.”  Thus, the duty to warn of risks related to the use of a drug is owed to the prescribing physician by the drug manufacturer, not some other manufacturer of the same or a similar product.  As a matter of law, the manufacturers of [a drug] have no duty to communicate any information regarding the risks of taking this product to anyone other than their own customers.

2010 WL 5485812, at *5 (quoting Walls v. Alpharma USPD, Inc., 887 So.2d 881, 883 (Ala. 2004)) (emphasis added).

That’s four.

Finally, in Overton v. Wyeth, Inc., 2011 WL 1343392 (Mag. S.D. Ala. March 15, 2011), adopted, 2011 WL 1343391 (S.D. Ala. April 7, 2011), pretty much the same result ensued, after the plaintiff was forced to amend her complaint to identify who did and did not manufacture the metoclopramide she took.  “[I]t is abundantly clear . . . that Plaintiff cannot state a claim against the Brand Name Defendants.”  Id. at *5.

Misrepresentation under Ala. Code. §6-5-101 required that a duty to disclose be owed to the particular plaintiff.  As in Mosley and Simpson, the non-product liability fraud claims foundered on lack of either duty or causation.  There is “no binding authority for the assertion that a manufacturer of brand-name drugs owes a duty to consumers of the generic version of their products.”  2011 WL 1343392, at *7.  Nor can “an injury resulting from consumption of a generic version of the drug can be considered a ‘proximate consequence’ of a manufacturer’s alleged misrepresentation regarding the brand-name version of the drug.”  Id.

Overton also rejected the FDA-created duty theory.  Id. at *7 n.9.  UCC warranty claims also failed because the statute’s anti-privity language required the plaintiff to have been “affected” by “the goods” themselves, not merely by purported “negligent misrepresentations in the warning labels.”  Id. at *7.

That’s five – including three – Mosley, Simpson, and Overton, that specifically addressed and just as specifically rejected the plaintiffs’ non-product liability theories that did not depend upon any “defect” in the generic product or its warnings.

So what just happened in Weeks v. Wyeth, Inc., 2011 WL 1216501 (M.D. Ala. March 31, 2011)?

For one thing, we’d have to say that that federalist concerns for the power of state courts to develop state tort law got mugged.

Weeks was essentially indistinguishable from, at least, Mosley, Simpson, and Overton, since plaintiffs suing over the same drug in the same situation asserted the same product liability and non-product liability theories of liability.  First, the Weeks court conceded that “a brand name manufacturer has no duty to warn a consumer about a generic manufacturer's drug.” 2011 WL 1216501, at *3, and dismissed all the product-related claims.  However, the court interpreted the plaintiff’s allegations as asserting an independent duty to warn “prescribing physicians,” including the doctor who prescribed the drug to the plaintiff, irrespective of product use.  In the words of the court:

[Plaintiffs’] claims center, however, on statements the brand name defendants made or failed to make to [the] prescribing physician. Specifically, [plaintiffs] argue that the brand name defendants had a duty to disclose information about Reglan, the product they did manufacture, to [the] physician. . . . They also claim that the brand name defendants’ failure to adequately warn prescribing physicians about Reglan’s side effects caused [the prescriber] to prescribe generic MCP for extended use.

When framed in this way, [plaintiffs] would not be required to demonstrate that the brand name manufacturers had a duty to warn about generic MCP. [Plaintiffs] would not even have to demonstrate that the brand name defendants owed a duty to [the patient] himself, only that the brand name defendants owed a duty to the prescribing physician to adequately disclose and warn about the risks associated with Reglan.

Weeks, 2011 WL 1216501, at *3 (emphasis added).

Whoa!  Let’s think about that.

That analysis isn’t a restatement of the learned intermediary rule – at least not any learned intermediary rule we’re familiar with.  Rather than a duty to warn the prescriber of the drug that injured the plaintiff, Weeks postulates that drug manufacturers have some broad, nebulous duty to warn the medical community as a whole, totally divorced from what drug any particular doctor actually prescribed to any particular patient, since this purported duty extends to situations where the defendant’s drug was not in fact prescribed to the patient.

Is that something that Alabama recognizes?  We don't think so.

Alabama has followed the learned intermediary rule since Stone v. Smith, Kline & French Laboratories, 447 So.2d 1301, 1305 (Ala. 1984).  In Stone, the Court was explicit that the learned intermediary rule involved “the manufacturer’s” duty involving “the use” of its “drug”.  “[T]he manufacturer’s duty to warn is limited to an obligation to advise the prescribing physician of any potential dangers that may result from the drug’s use.”  447 So.2d at 1304 (quoting Reyes v. Wyeth Laboratories, 498 F.2d 1264, 1276 (5th Cir. 1974)) (emphasis added).

The learned intermediary rule next came up in Morguson v. 3M Co., 857 So.2d 796 (Ala. 2003), involving a device that included some tubing.  Again, the duty to warn under the learned intermediary rule was limited to the physician actually using the defendant’s product.  “[Defendant’s] duty was to warn the physicians and perfusionists at [the hospital] who used the vent tubing.”  Id. at 802 (emphasis added).

In Walls v. Alpharma USPD, Inc., 887 So.2d 881, 883 (Ala. 2004), the Court decided that the learned intermediary rule precluded liability against a pharmacist for failing to warn the plaintiff.  The Court once again stated the rule in terms of warnings about the uses of particular products:

Under the learned intermediary doctrine, a manufacturer’s duty to warn is limited to an obligation to advise the prescribing physician of any potential dangers that may result from the use of its product.  This standard is an understandable exception to the Restatement's general rule that one who markets goods must warn foreseeable ultimate users of dangers inherent in his products.

Id. at 883 (quoting Toole v. Baxter Healthcare Corp., 235 F.3d 1307, 1313-14 (11th Cir. 2000) (applying Alabama law)) (emphasis added).

Finally, in Springhill Hospitals, Inc. v. Larrimore, 5 So.3d 513 (Ala. 2008), the Court provided its most recent interpretation of Alabama’s learned intermediary rule in another pharmacist situation – where a pharmacist voluntarily provided information about the same drug that the plaintiff in fact took.  The Court once again refused to expand warning duties under the learned intermediary rule beyond a manufacturer’s “customers”:

In those cases [Stone and Walls], the duty at issue was a drug manufacturer's or a drug dispenser’s duty to warn customers.  Here, the duty at issue is not a duty to warn a customer . . . of potential risks or side effects, but a duty of care, allegedly breached by [a pharmacist] when he gave [a prescriber] allegedly incomplete dosing information.

Id. at 518 (emphasis added).  The alleged warning duty – going beyond “customers” – did not exist:

In light of the foregoing, we are unpersuaded by the estate’s argument that [the pharmacist] voluntarily assumed a duty of care when he answered [the prescriber’s] question. . . .  Because we find the principles articulated in Walls and Stone applicable to this case, we hold that the learned-intermediary doctrine precludes [the pharmacist’s] liability for harm resulting from any mistakes on [the prescriber’s] part in prescribing [the drug].

Id. at 521 (emphasis added).

Thus, in all four cases in which the Alabama Supreme Court has interpreted the state’s learned intermediary rule, it has never once suggested that the scope of a manufacturer’s duty to warn extends beyond those persons actually using the drug that the manufacturer's warnings accompanied.  The quote from Toole, that the Alabama Supreme Court adopted in Walls, demonstrates that the Eleventh Circuit has likewise not expanded liability in the way envisioned in Weeks.  No Alabama law case has applied the learned intermediary rule to allow liability where the doctor in question never treated the plaintiff with products that the defendant actually made.  See also Toole v. McClintock, 999 F.2d 1430, 1433 (11th Cir. 1993) (breast implant maker owed duty to physician who implanted its product) (applying Alabama law); Southern v. Pfizer, Inc., 471 F.Supp.2d 1207, 1218 (N.D. Ala. 2006) (drug reps cannot be liable under learned intermediary rule, even where their employer’s drugs were prescribed); Bloodsworth v. Smith & Nephew, 2005 WL 3470337, at *7 (M.D. Ala. Dec. 19, 2005) (same with respect to device manufacturer’s representative); Emody v. Medtronic, Inc., 238 F. Supp.2d 1291, 1296 (N.D. Ala. 2003) (no liability under learned intermediary rule where doctor failed to follow manufacturer’s warnings about its own product).  In Alabama, the learned intermediary rule has never previously been construed as creating duties to the “medical profession” in the abstract.

That’s not to say that plaintiffs haven’t argued before in favor of a broad duty owed to the medical profession as a whole.  They used to, but to no avail.  For instance, in Lindsay v. Ortho Pharmaceutical Corp., 637 F.2d 87, 91 (2d Cir. 1980), the court rejected such an argument under New York law:

It is somewhat misleading to say that defendant owed a duty to warn the “medical profession”.  We are not concerned here with whether adequate warnings were given to chiropodists in California or orthopedists in Arizona.  [Plaintiff] contends that [the defendant’s] drug was defective as to her because [defendant] did not adequately warn her doctors.  So far as these plaintiffs are concerned, if [defendant] adequately warned [plaintiff’s] doctors, the drugs were not defective.

Id. at 91.  Likewise, in Desmarais v. Dow Corning Corp., 712 F. Supp. 13 (D. Conn. 1989), the court, applying Connecticut law, held:

Warnings to the medical profession generally rather than to individual prescribing physicians would be illogical and contrary to the very policy and purpose underlying the learned intermediary doctrine and the duty to warn.  Unless the individual prescribing physician receives specific, relevant warnings, she cannot make a careful, balanced assessment of the risks and benefits to her patient, nor can the patient herself be adequately informed.  Thus, the learned intermediary doctrine does not alter the duty of a manufacturer to provide adequate warnings of risks with each product sold; rather, the doctrine simply substitutes the physician for the consumer as the person to receive those warnings.

Id. at 18.

There is thus no basis in Alabama law (or any other state’s law, save maybe the bizarre California Conte case) for expanding the learned intermediary rule to the medical profession generally, without regard to what doctor prescribed what drug to what patient.  Indeed, the court in Weeks admits that there is no “case on point.”  2011 WL 1216501, at *6.  The plaintiff's claim in Weeks was allowed to proceed only after the court imposed a burden on the defendant to come up with precedent affirmatively debunking the existence of this novel cause of action:

[T]he Court finds that neither side has provided a case on point.  The defendants' cases do not establish that a relationship between [plaintiffs] and the brand name defendants is required when the plaintiff’s claims are based on fraud perpetrated against the prescribing physician.  Therefore, the defendants have not demonstrated, based on this argument, that [plaintiffs] fail to state a claim for which relief can be granted.

Id.

Thus the root cause of this Alabama muddle is the same fundamental Erie doctrine principle upon which we have harped time and time again. The Weeks court failed to respect Alabama’s right, as a co-sovereign in our federal system, to decide when and if to expand its own tort liability.  When in doubt – and even Weeks conceded that there is doubt – a federal court sitting in diversity should refrain from expansive interpretations of state-law tort liability:

A federal court in diversity is not free to engraft onto those state rules exceptions or modifications which may commend themselves to the federal court, but which have not commended themselves to the State in which the federal court sits.

Day & Zimmerman, Inc. v. Challoner, 423 U.S. 3, 4 (1975); see Seaboard Surety Co. v. Garrison, Webb & Stanaland, P.A., 823 F.2d 434, 438 (11th Cir. 1987) (in a “federal forum” a plaintiff “must abide by federal determination as to the present state of [state] law”); Lee v. Hunt, 631 F.2d 1171, 1175 (5th Cir. 1980) (quoting and following Day & Zimmerman).

We can only hope that appropriate appellate supervision - preferably by the Alabama Supreme Court - isn't long in coming.

Hogan's Heroic

Usually, when we've had occasion on this blog to touch on the Erie doctrine, it has been in the context of castigating one federal court or another for adopting an expansive view of state tort law in the absence of state court authority for that interpretation.

But there's more to Erie than that, and the recent case, Hogan v. Novartis Pharmaceuticals, Inc., 06 Civ. 0260 (BMC) (RER), slip op. (E.D.N.Y. April 6, 2011), illustrates what else Erie entails.  "Erie" is a shorthand for a famous U.S. Supreme Court case, Erie Railroad Co. v. Tompkins, 304 U.S. 64 (1938), that established the modern framework for deciding what law governs - state or federal - in case removed from federal to state court under diversity jurisdiction.

At the risk of being almost misleadingly simplistic, Erie essentially says that the substantive rules of decision for diversity cases are governed by state law (that's why expansive interpretations of state law come under the doctrine), whereas "procedural" matters - especially those encompassed by the various federal rules of this or that - are governed by federal law.

Among the items designated as "procedural" are the Federal Rules of Evidence - or so the plaintiff in Hogan found out when she tried to argue otherwise.  Like most prescription drug cases, Hogan involves failure to warn.  It's a Zometa case, and after the plaintiff stopped using the drug, the FDA changed the label to toughen the relevant warnings.

As we've discussed before, a subsequent label change is a "subsequent remedial measure" - a post accident change intended to increase the safety of, here, the product at issue.  For various reasons, chiefly not to deter defendants from making things safer, the prevailing rule is that subsequent remedial measures aren't admissible to prove that the defendant was negligent before, for not having done what it later did.  The post-1997 version of Fed. R. Evid. 407 (the relevant federal rule) explicitly states that post-accident changes to a product are not evidence that earlier versions of the product was defective.

Hogan, however, comes from Rhode Island, where at some point in the past, the plaintiffs side hijacked the state's rules committee and produced a version of Rule 407 that's diametrically opposed to the federal (and almost every other state's) version.  Rhode Island's rule expressly allows subsequent safety changes to be admissible into evidence.  R.I. R. Evid 407 ("[w]hen, after an event, measures are taken which, if taken previously, would have made the event less likely to occur, evidence of the subsequent measures is admissible").  For technological advances and other safety improvements, Rhode Island is thus something of a stalag. 

In Hogan, the plaintiff took a Sgt. Shultz attitude towards federal Erie practice - knowing nothing and seeing nothing.  Fortunately the court shot her down.  Essentially, for Erie purposes, a rule is a rule is a rule.  If it's in the federal rules, then it controls in a diversity case removed to federal court:

Plaintiffs claim that the Rhode Island Rule must govern because it is substantive rather than procedural misses the mark. The inquiry begins and ends with the federal rule; Hanna teaches that if the federal rule is valid, the Court will apply it.  To determine the rule's validity, the Court must ask what it regulates:  If it governs only the manner and the means by which the litigants' rights are enforced, it is valid; if it alters the rules of decision by which the court will adjudicate those rights, it is not.

Hogan, slip op. at 4-5 (quotation marks omitted).  Needless to say, Hogan was not about to strike down Rule 407 as unconstitutional.

Thus, Hogan stands for two important principles.  First, that subsequent label changes are excludable under Rule 407, and second, that in general in federal court a favorable federal rule will trump an unfavorable state rule on the same subject.