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.

There They Go Again

A lot of people think that Ronald Reagan won the presidency in 1980 in his first debate when he replied jokingly “there you go again” to then-President Carter’s attempt to portray him as some sort of rightwing nut intent upon destroying accepted government programs like Medicare.

Whether one believes that President Reagan’s election was a good thing or a bad thing, there’s no denying that his disarming line was effective in dispelling his opponent’s attempt to sow fear of his then unknown policies.

We’ve confronted similar situations ourselves as, periodically, some law review article or another decides to tilt at the windmill of FDA regulatory informed consent claims in off-label use cases.  Bexis dealt with that topic in a law review article he wrote long before he wised up and started blogging.  Beck & Azari, “FDA, Off-Label Use, and Informed Consent: Debunking Myths and Misconceptions," 53 Food & Drug L.J. 71 (1998) (available here).

Here on the blog, we addressed this topic back in 2007, critiquing an article that advocated informed consent suits against doctors for not discussing the non-FDA-approved status of off-label use, essentially as a means of indirectly punishing drug companies for allegedly promoting such uses too effectively.

We’re pleased to say that nothing came of that 2007 article.  The law is still as we stated back then.  Legal information, like whether a 50 mg dose is FDA approved but a 75 mg dose isn’t, remains beyond the pale of informed consent.  Only the actual medical risks/benefits/alternatives of, say, our hypothetical 50 mg (on-label) versus 75 mg (off-label) are relevant to informed consent:

[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.

Southard v. Temple University Hospital, 781 A.2d 101, 107 (Pa. 2001) (Bexis’ case); accord, Earle v. Ratliff, 998 S.W.2d 882, 891-92 (Tex. 1999); Hansen v. Universal Health Services, 974 P.2d 1158, 1159-60 (Nev. 1999); Packard v. Razza, 927 So.2d 529, 534 (La. App. 2006); Blazoski v. Cook, 787 A.2d 910 (N.J. Super. A.D. 2002) (Bexis’ case); Alvarez v. Smith, 714 So. 2d 652, 654 (Fla. App. 1998); Osburn v. Danek Medical, Inc., 520 S.E.2d 88, 92 (N.C. App. 1999), aff’d mem., 530 S.E.2d 54 (N.C. 2000) (Bexis’ case); Klein v. Biscup, 673 N.E.2d 225, 231 (Ohio App. 1996) (Bexis’s case); Balderston v. Medtronic Sofamor Danek, Inc., 285 F.3d 238, 239 n.2 (3d Cir. 2002) (applying Pennsylvania law) (Bexis’s case); Bogle v. Sofamor Danek Group, Inc., 1999 WL 1132313 *7 (S.D. Fla. April 9, 1999) (Bexis’s case); In re Orthopedic Bone Screw Products Liability Litigation, 1996 WL 107556 (E.D. Pa. March 8, 1996), reconsideration denied, 1996 WL 900351 (E.D. Pa. May 21, 1996) (Bexis’s case); cf. Daum v. Spinecare Medical Group, 61 Cal. Rptr.2d 260, 271-73 (Cal. App. 1997) (FDA regulatory status outside common law informed consent; discussion of status only required where FDA regulations say so).

Since 2007, the only contrary authority that we know of was a rogue South Dakota federal court, predicting (in blatant violation of Erie principles) that South Dakota, uniquely, would allow a regulatory informed consent claim.  We excoriated DeNeui v. Wellman, 2009 WL 4847086 (D.S.D. Dec. 9, 2009), here.  Even in DeNeui, however, the regulatory informed consent claim proved to be a lousy theory.  The plaintiff lost at trial, proving that at least sometimes juries have more sense than judges.

On the good side of the ledger, Maryland’s highest court agreed, in University of Maryland Medical System Corp. v. Waldt, 983 A.2d 112 (Md. 2009), that purported informed consent “expert” testimony, solely on the point that off-label use is not FDA “approved,” was excludable as not “material” in an informed consent case:

[Plaintiffs] proffer was that [their expert] would testify about the approved uses of the neuroform stent. . . .  The intermediate appellate court explained . . . that the only proffered (albeit vaguely) substantive testimony of [plaintiffs'] expert] was that the neuroform stent device was not approved for use on [the patient’s] type of [condition].  This is not a proffer of a risk inherent to the procedure that [the patient] underwent. . . .  We agree with the intermediate court that no testimony was proffered concerning the material risks of the procedure that would make out a prima facie case for informed consent.

Id. at 129-30 (partially quoting lower appellate court).  Thus now, as in 2007, there is no appellate authority, either in federal or state court, supporting a claim for FDA regulatory informed consent anywhere in the country.

But now, here they go again – trying to scare us that off-label use “may not be safe or effective,” and therefore, if doctors don’t use the magic word “unapproved” they should be liable for breach of informed consent.  We've just read a (relatively) new article, Rosoff & Coleman, “The Case For Legal Regulation Of Physicians' Off-Label Prescribing,” 86 Notre Dame L. Rev. 649 (2011), also available online here, that once again attempts to resurrect claims for FDA regulatory informed consent.

The Rosoff article relies on statistics that “[m]ost physicians don’t keep track of FDA-approved uses of drugs,” p. 652 n.13, and advocates forcing these “ignorant,” id., doctors to learn the FDA regulatory status of all the drugs they use so they can regurgitate that information to their patient.  We don’t think that’s a good use of scarce physician time.  We’d much rather that doctors spend whatever time they have left for education brushing up on the medical risks and benefits of their therapies.  That’s what doctors are trained to do.  Tracking the ins and outs of drug approvals on the FDA’s website should be left to us lawyers.

But leaving well enough alone would mean less litigation, and Rosoff and company can’t have that.  They perceive a need – not presently being met – for the law to “micromanage medical practice.”  Article at 675.  After all, more litigation means more jobs for lawyers.  More jobs for lawyers means that law students might find more jobs.  Ultimately, that might mean more jobs (or at least not fewer jobs) for law professors and law review editors (at least to an economic determinist).  The Rosoff article would require doctors to learn the FDA regulatory status of hundreds of drugs and medical devices and then, on threat of being sued, doctors would have to describe standard of care medical treatments (which many off-label uses are) as “unapproved” so patients will be scared away from such treatments.

At least the Rosoff article recognizes that there are various types of off-label use.  It classifies them as: (1) “OLU justified by high-quality evidence”; (2) “OLU justified by some but not high-quality evidence”; (3) “OLU justified by the need or desire to innovate”; and (4) what they call “unjustified” (we’d say “experimental”) off-label use.  Article at 652.  Indeed, there are literally hundreds of well-accepted off-label uses listed in compendia such as the United States Pharmacopeial Drug Information, and the American Hospital Formulary Service Drug Information for which federal government programs provide reimbursement notwithstanding their off-label status.  Alternatively, the Physicians Desk reference also lists “routine” off-label uses for hundreds of “specific medical problems.”  PDR at “forward.”

So what’s the fuss?  Why should doctors have to go beyond their well-established duties of discussing medical risks and benefits (such as that “experimental” off-label use isn’t backed by any medical evidence that it will be safe or effective) and discuss FDA regulatory status as well?

The Rosoff article counters by stating “it is difficult to imagine that there is not a more material fact than that a proposed treatment’s – in this case, an OLU’s – safety and efficacy have not been established." Article at 654.  That sort of argument stuffs the rabbit deep in the hat.

Established by whom?

There are many drugs – typically generics – and many medical conditions – chiefly uncommon ones – as to which the effectiveness of treatment has been established by decades of clinical experience.  Running the sort of clinical trials that the FDA requires for approval is expensive as all get out (a technical term).  If there’s no patent protection, or only a small market, there won’t be FDA approval no matter how safe or effective the use is.  Again, we’re economic determinists.

Or maybe there is FDA approval.  Suppose a company is pushing a new drug use through FDA channels, which can take years.  On date X the use is off-label, even though a bunch of published studies have been run and the material is being considered by the FDA.  On date X +1, the FDA approves the use.  Why should the informed consent discussion be different on date X, as opposed to date X +2, when every scrap of medical information is identical?  Why should doctors have to keep track of FDA approvals?

We say they shouldn’t.

Whether safety of effectiveness of a particular drug use is “established” for purposes of medical treatment (as opposed to FDA regulatory purposes) depends on the quality of the medical information on which the treatment is based.  That’s what doctors are trained to evaluate.  That’s all we think they should be legally required to discuss with their patients in informed consent discussions.

The Rosoff article runs away at high speed from these situations.  No, they say, we’re worried only about “problematic” off-label use:

It is antithetical to patient welfare to prescribe such products because they may be affirmatively harmful.  Even if they are not, they preclude alternative approaches with a proven track record of effectiveness.  Prescribing problematic OLU is anachronistic medical ethics because modern ethics call for evidence-based medical practice and, correspondingly, preclude experimentation outside of formalized trials with built-in safeguards to protect patient-subject health and decisional autonomy.  By definition, problematic OLU are the opposite of evidence-based medical practice.  And by definition, they are experimental, albeit with more or less of a basis for trusting in the outcome of the experiment depending on the degree of evidentiary support at issue.  On the latter point, it has been well over fifty years since Nuremberg, when societies around the world – including the United States – rejected the notion that experimenting with patients, even ostensibly in their own interests, was permissible in the absence of consent for the experiment.

Rosoff article at 680.  So “problematic’ off-label use is what the Nazis did.  Let’s break out our “definitions” and define it as “non-evidence based” and “experimental” (Rosoff has a philosophy degree, so he knows that he who defines the terms, wins the argument).  That’s what needs greater “regulation” (but they advocate lawsuits, not real regulation), not the well established stuff.  Article at 656-67.  Sorry, we don’t buy that, either.  Who is going to define what’s “problematic” and what’s not?

Lawyers whose sole financial interest is in bringing lawsuits, that’s who.  The Rosoff article’s primary – indeed only – concrete recommendation is to resurrect regulatory informed consent as a cause of action.  Article at 682-84.

That means we get inevitable litigation creep.  Lawyers certainly can’t be trusted to sue only over something truly “problematic.”  Look at what the food fascists sue over in California, one timely example that comes immediately to mind.  Or see our prior post about plaintiffs arguing that doctors have some sort of informed consent duty to tell patients about preemption.  No legal doctrine safe from abuse – certainly not one as malleable as “informed consent.”  Doctors are by and large litigation averse people, and if they weren’t, their insurers are.  Allow a pure regulatory informed consent claim anywhere, and doctors will be forced to subscribe to the Code of Federal Regulations everywhere.  There's a big camel behind that nose.

And as a practical matter, the claim is totally unnecessary, because doctors already have a duty to be informed about the medical basis of the treatments they prescribe.  It’s called “evidence based medicine.” We’re in favor of it and we discussed it at some length here.  If treatment A is reasonably effective, and treatment B is based on a wing and a prayer, we don’t need any new cause of action to enforce safe medical practice.  Patients should get the comparative medical evidence, and if they don't there's already a cause of action for that, traditional informed consent.

Conversely, if there’s really no well established alternative to an off label use, then what good does it do, after the doctor has said “you’ve got six months to live but a few case reports suggest that treatment X might help,” to add – “oh, by the way, the FDA hasn’t approved it either.”

None. Nada. Zilch. Zip.

You don’t have to believe our pro-defense blather to demonstrate the strong potential for litigation creep.  It’s visible, plain as day, in the Rosoff article itself.  Check out page 672, where the article describes a “pedicle screw used off-label as an ‘internal fixation device’ in the context of spinal fusion surgery” as a form of “experimental OLU” to which its proposed remedies would apply.  The article's discussing bone screws, and we happen to know a little about bone screws.  And the truth about bone screws is that they’re about as far from “experimental” or "problematic" as you can get.

Rather, pedicle screw fixation was, and is, the medical standard of care – so much so that the FDA itself was unable to organize the usual clinical trials, precisely because it would have been unethical to withhold standard of care treatement.  Rather, the FDA had to resort to a retrospective cohort study to resolve the labeling issue and get the approved labeling for bone screws caught up to medical reality.  Again, don’t believe us (if you don't want to).  It’s all laid out in the Federal Register by the FDA itself.  See 63 Fed. Reg. 40025-41 (FDA Jul. 27, 1998).

In that Federal Register publication – not cited in any of the Rosoff article’s 139 footnotes – the FDA “confirmed” that bone screws used for pedicle fixation raise “no new issues relating to the[ir] safety or effectiveness.”  Id. at 40027.  Over four years of FDA analysis, and a huge cohort study, determined:

• The data “reviewed as a whole . . . demonstrate[d] the safety and effectiveness of pedicle screw spinal systems.”  Id. at 40028 (item 2).
•  “[P]edicle screw spinal systems exhibit adequate mechanical strength, rigidity, and fatigue resistance.”  Id. at 40033 (item 17).
• The “incidence” of “adverse outcomes is no greater when a pedicle screw spinal system is used.”  Id. at 40031 (item 4).
• “[P]remarket approval is not necessary to provide reasonable assurance of safety and effectiveness.”  Id. at 40034 (item 22).

So please excuse us when we scoff at the Rosoff article’s claim to limit its proposal to “problematic” off-label uses.  That’s a tissue-paper thin pretext that vanished when the article itself asserts that a use that the FDA actually did approve was nonetheless “experimental.”  If Rosoff et al. couldn’t do their homework well enough to avoid branding well-established (no longer) off-label uses as “experimental,” we have zero confidence that, in practice, lawyers litigating cases (or judges adjudicating them) would be any more careful.  Make no mistake about it, whatever legal restrictions the Rosoff article aims at “problematic” off-label used would also be asserted against all other off-label uses – probably without even a decent period for plausible deniability.

There are, however, a lot of good reasons for off-label use, even of the “problematic variety.  One is the lack of good alternatives. Take Alzheimers, for example.  We saw a story not too long ago in the Science News (about the limit of our capacity to digest technical issues) about some scientific evidence (a mouse study and anecdotal brain scan results) suggesting that certain antidepressants may reduce the plaques that are characteristic of the disease.  That’s certainly not enough for FDA approval, but with no good treatment alternative, what’s unethical about trying it?  We assume that current informed consent – involving medical risks, benefits, and alternatives – is given.  Why is anything more, particularly the fact that the FDA hasn’t approved these drugs for that use, needed?  Why would the Rosoff article equate such a thing with Nazi experiments?  Their home state of North Carolina (article at 665) certainly wouldn’t.  There is no “per se rule requiring the jury to be instructed that a health care provider in every instance has a duty to inform a patient of the experimental nature of a proposed treatment procedure."  Osburn, 520 S.E.2d at 92.

The Rosoff article also bases its proposals to litigate FDA regulatory status on an assertion, admittedly not based on any “empirical” data, that “most patients erroneously believe that the drugs their doctors prescribe for them have been determined – somehow, by someone – to be safe and effective for the uses to which they will be put.”  Article at 673.  It then goes on to argue, based on nothing more than personal prejudices, that doctors have some duty to correct that misconception.  See Id. at 683 (“since it appears that most patients mistakenly believe that FDA approval codes for safety and efficacy . . .  FDA status is medically material information”).  Well, poll after poll after poll (that's actual “empirical” data) has shown that a majority of Americans believe in angels.  Heaven help us if Rosoff’s argument was applied to the clergy.

But more to the point, there’s no precedent in creating a duty to warn based upon a admittedly “mistaken” belief.  Doctors (or anybody) cannot be held liable for not clearing up a public misconception that they had no part in creating.  The law is (and always has been) that there is no duty to rescue someone from a peril not of the defendant’s own making.  E.g.:

We know of no principle of law by which a person is liable in an action of tort for mere nonfeasance by reason of his neglect to provide means to obviate or ameliorate the consequences of the act of God, or mere accident, or the negligence or misconduct of one for whose acts towards the party suffering he is not responsible. If such a liability could exist, it would be difficult, if not impossible, to fix any limit to it.

Estate of Cilley v. Lane, 985 A.2d 481, 489 (Me. 2009); see generally Restatement (Second) of Torts §314 (1965) (“that the actor realizes or should realize that action on his part is necessary for another's aid or protection does not of itself impose upon him a duty to take such action”).  This isn’t to say that pro-liability law professors haven’t tried to create such a duty, e.g., Weinrib, "The Case for a Duty to Rescue," 90 Yale L.J. 247 (1980), but the law has had too much common sense to adopt such nebulous liability.  The Rosoff article is, plain and simple, an attempt to create a duty to rescue in the particular area of off-label use.

Nowhere is the Rosoff article’s disrespect, bordering on contempt, for the medical profession more apparent than it’s blowing off the argument (as “specious”) that it’s onerous to force doctors to learn, and then discuss with their patients the FDA regulatory status of anything and everything that’s used off-label.  These are the guys, after all, who couldn’t be bothered to learn the correct FDA regulatory status of bone screws before condemning them as “experimental” when in fact that use has been approved by the FDA since 1998.  The pace of medical advance is high and increasing.  So are the numbers of patients a lot of doctors have to see in this era of managed care.  There's less time to talk to patients, so the quality of discussion has to go up, not be diverted into legalisms.  Meanwhile the FDA is being starved of necessary resources (see Wyeth v. Levine, 129 S. Ct. 1187, 1203 n.11 (2009) (collecting data)). Thus, the gap between what doctors can do therapeutically for their patients and what the FDA can do gets ever larger.  We don’t know where Rosoff et al. expect doctors to get all this additional time to look up FDA regulatory information every time they propose what may be an off-label use, see Article at 685, but we’d hope that instead doctors would educate themselves about new medical information.  That’s real “evidence-based medicine” – not using absence of FDA approval as some sort of “proxy” for the real thing.  Article at 683.

Nor is it correct to say, as the Rosoff article does, that if we don’t allow regulation by lawsuit, there’s no regulation of informed consent with respect to FDA regulatory status.  While the FDCA precludes the FDA from regulating off-label use, informed consent practices relating to off-label use (and anything else) are subject to state regulation if the state cares to do so.  Cf. Cordray v. Planned Parenthood Cincinnati Region, 911 N.E.2d 871 (Ohio 2009) (describing state regulation of off-label use of abortifacient drug). No state anywhere has chosen to adopt – legislatively or regulatorily – a informed consent requirement that physicians discuss FDA regulatory status of off-label uses.  The Rosoff article laments the lack of actual state-law regulation, even by medical malpractice:

The best indication of the ineffectiveness of medical malpractice law as a tool to regulate OLU is probably the dearth of published cases, either reported (useful as precedent in future cases) or unreported (officially unavailable as precedent) in which off-label use by a medical provider was a focus of the plaintiff's case.  Furthermore, the substance of the published decisions reinforces the suggestion from the numbers that off-label prescribing is a weak basis for finding liability against a physician.

Article at 666.  Actually, the approach of the states to off-label use goes beyond what the Rosoff article cares to admit.  Most state regulation of off-label use is exactly the opposite of the “cut off reimbursement” philosophy of the article (pp. 688-89, advocating non-reimbursement by both government programs and private insurers), and instead has sought to increase reimbursement of off-label uses.  E.g., N.J. Stat. §26:1A-36.9(c).

We draw a different conclusion than the Rosoff article from the consensus of state laws.  We think that this uniform lack of action by any of the the fifty states is telling.  If no state has chosen to impose a regime of regulatory informed consent, that tells us:  (1) that the supposed “problem” to which the Rosoff article seeks a an admittedly “new” and “controversial” solution (Article at 659), isn't really that much of a problem, and (2) the prevailing common law, limiting informed consent to medical risks and benefits, has gotten it right.  If it ain’t broke, don’t fix it.

Thus, we think that the Rosoff article combines the worst attributes tort triumphalism (a belief that lawsuits can solve anything), with a chilling disrespect for science and medicine – especially the ability of doctors to exercise their professional judgment independently in the best interests of their patients.

Doctors deserve more credit than that. They’re highly trained professionals. If an off-label use is prevalent, that’s usually because it works better than the alternatives.  Indeed, that’s one (of many) reasons that third-party payer cases based on off-label use have almost uniformly failed – because the TPPs can’t allege, let alone prove, that off-label uses for which they seek recovery don’t help patients.  See Our Third-Party Payer posts here.  Thus, in the great majority of cases, the new/old FDA regulatory informed consent cause of action the Rosoff article advocates could serve only to harm to patient treatment – by deterring patients from receiving standard of care medicine (as we showed above, it would be impossible to limit the claim to “problematic” uses) in the mistaken belief that, because the FDA hasn’t passed on the treatment, there must be something wrong with it.  This cause of action would only encourage more lawsuits, and higher costs for everything, without increasing patient safety one iota, since existing informed consent already requires discussions of actual medical risks and benefits – just not the through-a-glass-darkly “proxy” of FDA regulatory status.

Our bottom line is this. There are good reasons why appellate court in the country that's considered whether to expand informed consent to include FDA approval status has said "no."  There are good reasons why no state statute or regulation requires anything of the sort.  The law of informed consent already requires patients to be told about medical risks and benefits – regardless of FDA regulatory status.  If the situation is so dire that some experimental treatment with unknown risks is indicated, then patients should be told about that medical uncertainty.  Do off-label uses have medical risks? Absolutely, but so do all prescription drugs, which is why they require prescriptions in the first place.  In both on- and off-label use situations, patients should be (and legally are required to be) told about those medical risks directly.  They should not be bothered with an FDA legal status that often means only that research into new drugs is more profitable than research into drugs with little or no patent protection left.

The only people who profit from injecting legal information such as FDA regulatory status into medical informed consent discussions are lawyers.  For anyone actually needing medical care, as opposed to needing a legal job after graduating from law school, we think that’s a truly lousy idea.

Twice Nice?

Every now and then there’s a piece of litigation that boldly goes where no court has gone before and opens up a host of new legal issues.  Bone Screw was like that, with plaintiffs inventing new causes of action (fraud on the FDA and regulatory informed consent) and our side having to invent new defenses.  We also felt that way while we were involved in the Fagan v. AmsourceBergen litigation involving the then novel concept of liability of non-counterfeitors for injuries caused by counterfeit drugs.

We’ve just seen another opinion, Kapps v. Biosense Webster, Inc., ___ F. Supp.2d ___, 2011 WL 4470701, slip op. (D. Minn. Sept. 27, 2011), that makes us feel the same way.  We can’t recall ever seeing an opinion previously that addressing liability issues in the context of a reprocessed medical device that allegedly failed due to defects introduced by the reprocessing.

Kapps involves something analogous to the aftermarket for automobile parts, only in the medical device field.  The product, a heart catheter, was originally manufactured as a single-use product – expressly stated in the product’s original labeling.  2011 WL 4470701, at *3.  Apparently the FDA has chosen not only to tolerate, but to affirmatively allow the particular type of off-label use:  the reprocessing and reuse of products whose labeling is limited to single use.  Id. at *5-6 (describing FDA regulation of reprocessing/reuse of single-use devices).  After being completely relabeled and refurbished according to relevant FDA regulations, the heart catheter was reused and broke inside the plaintiff’s heart.  Id. (refurbishing changed the device’s serial number, and replaced its labeling with its own).  Plaintiff sued both the aftermarket and original equipment manufacturers.

The 68-page Kapps opinion raises, and in some cases decides for the first time, many fascinating issues.

Futile Dear Doctor letters:  In a claim analogous to what we’ve been seeing post-Mensing against generic drug manufacturers (indeed, the court references generic drugs explicitly, 2011 WL 4470701, at *24), the plaintiff claimed that the original manufacturer should have issued a Dear Doctor letter warning against use of reprocessed products.

The court assumed a duty and then assumed that such a letter was permissible under FDA regulations – but still blew out the claim.  There was no possible causal effect in warning heart surgeons to be especially careful during heart surgery:

[I]f a plaintiff's proposed warning would not have changed anyone’s behavior, a product cannot be defective for lacking that warning.  Would a doctor who is manipulating a catheter inside a patient’s heart near the mitral valve become more careful if he read a warning saying, “Be careful not to get this catheter trapped in the mitral valve”?  Surely doctors know, based both on their training and on common sense, that they must be “very careful” when manipulating an instrument inside a human heart.

2011 WL 4470701, at *24.  Whoop!  Whoop!  Common sense alert!

There was also “not a shred of evidence” that this kind of content-free advice would have changed the result, id., particularly since, after learning the hard way the very information the Dear Doctor letter would have provided, the surgeons in question hadn’t changed their behavior in any way.  Id. at *25.

Regulatory informed consent asserted against a manufacturer. Say what?  We've seen plaintiffs sue doctors claiming that they wouldn’t have consented to a treatment if they knew it was off-label.  That’s one of the claims we killed in Bone Screw.  In Kapps, however, the plaintiff tried to turn the same argument on a manufacturer, claiming that since the prescriber testified he wouldn’t have used the product had he known there was no FDA approval (this argument assumes that minor modifications = unapproved), then the learned intermediary rule gives him a cause of action against the manufacturer.  2011 WL 4470701, at *20.

Umm....  No it doesn't.

First we find a ringing endorsement of the learned intermediary rule as a shield, not a sword:

The learned-intermediary doctrine is a defensive doctrine, not an offensive one.  It is raised by makers of drugs or medical devices who are accused of failing to warn about the dangers associated with their products.

2011 WL 4470701, at *20.  The court follows with equally good language about the limits of the duty to warn under the rule:

A manufacturer does not have a duty to communicate any and all information that might affect a customer’s decision to use one of its products.  For example, a manufacturer does not have to communicate that the product was made with child labor or that the manufacturer’s president has been convicted of fraud, even though such “warnings” might induce customers not to use the product.  The duty to warn is much narrower . . . .:  (1) The duty to give adequate instructions for safe use; and (2) the duty to warn of dangers inherent in improper usage.  [Defendant’s] alleged failure to warn that its reprocessing techniques had not been approved by the FDA breached neither of these duties.

Id. (citation and quotation marks omitted) (emphasis added).  We love it when FDA-regulatory-status claims get dismissed.

Buckman-FDCA private right of action.  In a unique setting, plaintiffs challenged the reprocessor’s decision to “extend” its line of reprocessed products to include the catheter in question by means of a “minor modification” procedure (it wasn't one of the 68 that the FDA actually approved for reprocessing).  We’ve always had some liability worries about the minor modification process, where the device manufacturer decides to act, essentially unilaterally, by means of its own memo to file.  The court refused to allow the claim, first finding that approval-related violations couldn’t possibly prove a tort:

Whether [defendant’s] reprocessing procedures damaged the failed catheter is an entirely separate question from whether [it] sought FDA approval for those procedures through the proper route.  That is, even if [defendant] had received 510(k) approval for reprocessing [the] catheters, [it] could still be liable for selling a defective . . . catheter if, in reprocessing a particular catheter, [defendant] damaged the catheter and rendered it defective.  And, conversely, if [defendant] did not damage a catheter during reprocessing, then even if [it] should have sought 510(k) approval for its reprocessing procedures, [its] failure to seek such approval would not render an undamaged catheter defective.

2011 WL 4470701, at *19. This is an important point, since practically any claim founded on a “you didn’t get the right FDA approval” argument will fail under the same analysis.  The court went on to hold that allegations of misuse of the minor modification procedure were nothing more than an improper attempt to enforce the FDCA despite its lack of a private right of action.  Id.

Meeting a similar fate is an alleged duty to warn doctors about the purported FDA lack of approval.  Such a warning has nothing to do with a state-law tort claim, but rather is “superfluous,” since if the product was defective, no FDA regulatory status warning could save the manufacturer, and if it’s not defective, then the FDA regulatory status couldn't create liability.  2011 WL 4470701, at *21.

Negligence per se. You can’t have negligence per se under the FDCA unless there’s an analogous state law claim.  We’ve harped on this, so we’re always pleased to encounter additional supportive precedent.

In a negligence per se case, the plaintiff seeks to hold the defendant liable because the defendant violated a statute.  And that is why a claim of negligence per se cannot be based on a violation of the FDCA . . . .  [T]o avoid preemption under Buckman, a state-law tort claim must be premised on the type of conduct that would traditionally give rise to liability under state law – and that would give rise to liability under state law even if the FDCA had never been enacted.  A negligence-per-se claim that is predicated on an alleged violation of the FDCA is, by definition, a claim that would give rise to liability under Minnesota law only because of the FDCA’s enactment.  Such a claim is preempted under Buckman.

2011 WL 4470701, at *19.  The context may be new, but the principle isn’t.  Approval-based claims can’t be negligence per se because they’re a form of licensing claim, and tort law has nothing to do with licensing.

Warning claims in a reprocessing situation:  The opinion offers some interesting dictum that, since the reprocessor had removed the original manufacturer’s warnings and substituted its own, the reprocessor had “usurped” the manufacturer’s “function” and any prior failure to warn would be non-causal:

[I]f [plaintiff’s] claim depended on an argument that [defendant] negligently failed to include certain warnings in its instructions for use, [that] warning-defect claim against [defendant] would fail for lack of causation:  [Plaintiff’s] damages could not have been caused by the omission of a warning from [defendant’s] instructions for use, because [the reprocessor] replaced [the manufacturer’s] instructions with its own, and thus [the original] instructions did not accompany the catheter that injured [Plaintiff].

2011 WL 4470701, at *23.

Nor was the original manufacturer obliged to warn that reprocessing was dangerous.  The label already explicitly stated that the devices were intended for single use only:

Even if it is true that reprocessing renders [defendant’s] catheters unsafe, the Court finds, as a matter of law, that in light of the fact that [defendant] warned doctors not to use reprocessed catheters at all, [it] had no duty to emphasize that it was serious about its warning or to elaborate on the reasons for its warning.

2011 WL 4470701, at *25.  More common sense.

Can someone become a manufacturer by estoppel?  The reprocessor gave its own manufacturer’s warranty and had marketing materials in which it stated “legally and practically, we are the manufacturers of our reprocessed and remanufactured devices.”  2011 WL 4470701, at *4.  Even though the reprocessor claimed that it only provided a service, and had contracts to that effect, the court held that it could be considered a manufacturer for purposes of strict liability:

[S]everal aspects of [the reprocessor’s] business strongly suggest that it should be treated as a manufacturer.  First, [it] removed [the manufacturer’s] instructions for using the . . . catheter and substituted its own instructions. . . .  Second, [the reprocessor] removed [the manufacturer’s] lot number from the catheter, thus preventing subsequent users from learning about the catheter’s manufacturing history.  Third, [the reprocessor’s] entire marketing strategy depended on convincing customers that devices reprocessed by [it] were exactly equivalent to, and perfect substitutes for, devices made by original equipment manufacturers. . . .  Fourth (relatedly), [the reprocessor] warranted the functionality of the catheter. And finally, [the reprocessor] tells doctors that “legally and practically, we are the manufacturers of our reprocessed and remanufactured devices.”

Id. at *30. If it quacks like a duck, it’s a duck.  We don't begrudge the plaintiff this one.

The expert who didn’t do his homework.  The court blew out most of a really horrible expert report.  The expert invented some pretty wild hypotheses about a smear of polyurethane glue on the recovered part of the product, but didn’t bother to learn anything about polyurethane or how it interacted with the chemicals useds in reprocessing.  There’s nice “ipse dixit” language.  2011 WL 4470701, at *16.  Ultimately some of the expert’s testimony was allowed in support of a res ipsa manufacturing defect theory – which, since oftentimes an expert’s testimony isn’t needed at all – is just about the lowest and worst use of an expert.  Id. at *18.

Punitive damages:  Reprocessing a single use medical device isn’t enough to support a punitive damages claim, since the FDA allows this to be done:

Given that the FDA regulates the medical-device-reprocessing industry and [finds benefit to reprocessing], the fact that [defendant] reprocesses catheters that [the original manufacturer] markets for a single use cannot be a basis for awarding punitive damages.

2011 WL 4470701, at *33.  We like decisions that find FDA regulatory approval preclusive of punitive damages.  Nor was a mere “regulatory mistake” (plaintiff’s attack on the minor modification process) anything suggesting “deliberate disregard” for patient rights.  Id. We like that even better.

Res ipsa: You can’t bring a res ipsa claim against the original manufacturer of a reprocessed medical device, because the reprocessing and reuse, contrary to labeling, are an obvious other cause for any post-reprocessing malfunction.  2011 WL 4470701, at *22.

Heeding presumption:  Minnesota doesn’t recognize a heeding presumption, but in any event, warning someone to be careful, when they probably already are, doesn’t show any different result whether the warning is heeded or not.  2011 WL 4470701, at *25 n.22.

Some of the issues in Kapps are completely novel.  None of them have (as far as we know) been raised in the context of the reprocessing of single use devices.  For this reason, Kapps should be required reading for anyone defending a case involving a reprocessed device – whether representing the original manufacturer or the reprocessor.

Deformed Consent

We’ve heard about a new plaintiffs’ informed consent theory that’s making the rounds.  It’s similar to, if even goofier than, the FDA regulatory status (that is, off-label use) theory that the plaintiffs tried with notable lack of success in the Bone Screw litigation (which we’ve discussed here and here).


As with all informed consent theories in product liability cases, this new theory is fundamentally an attempt by plaintiffs to stir up trouble between device manufacturers and the doctors who use their products.  Thus, we’d like to offer our thoughts on how to beat it.

The ultimate target – not a great surprise – of this new theory is federal preemption as applied to so-called “IDE” (investigational device exemption) devices being tested in FDA-regulated clinical trials.  As we’ve applauded earlier, most courts since Riegel v. Medtronic, Inc., 552 U.S. 312 (2008) (and even before) have found tort claims involving investigational devices to be preempted.  E.g., Robinson v. Endovascular Technologies, Inc., 119 Cal. Rptr.3d 158, 164-65 (Cal. App. 2010); Burgos v. Satiety, Inc., 2010 WL 4907764, at *2 (E.D.N.Y. Nov. 30, 2010); Williams v. Allergan USA, Inc., 2009 WL 3294873, at *2-5 (D. Ariz. Oct. 14, 2009); Dorsey v. Allergan, 2009 WL 703290, at *5-7 (M.D. Tenn. Mar. 11, 2009).

Justifiably worried that they’ll lose against IDE device manufacturers on preemption grounds, plaintiffs have started to allege that it’s somehow fraudulent, a misrepresentation or a violation of informed consent for (usually) the doctors who are serving as IDE investigators not to tell their patients about, of all things, preemption.

The new theory is particularly obnoxious because its damned-if-you-do-damned-if-you-don’t reasoning seeks to use doctors’ compliance with federal IDE informed consent regulations against them.  Specifically, the doctors (“investigators” in FDA parlance) are obligated by regulation (in addition to whatever state informed consent parameters they operate under) to provide informed consent to patients who volunteer to be subjects in clinical trials.  See 21 C.F.R. §812.100 (investigators are “responsible for seeing that informed consent is obtained in accordance with Part 50 of this Chapter”). Part 50, in turn specifies that investigational informed consent forms cannot seek waivers of patients’ legal rights:

No informed consent . . . may include any exculpatory language through which the subject [patient] . . . is made to waive or appear to waive any of the subject’s legal rights, or releases or appears to release the investigator, the sponsor [the device manufacturer], the institution [the hospital], or its agents from liability for negligence.

21 C.F.R. §50.20.

To comply with §50.20, from what we know, most investigating doctors simply make sure that their informed consent forms contain language that paraphrases the regulation, reciting something like “This informed consent does not waive any of your legal rights or release [list study investigator, institution, and sponsor] or any of their agents from liability for negligence.”

Plaintiffs – purporting to equate federal preemption under the Medical Device Amendments (“MDA”) with “waiver” or “release” under §50.20 – now claim that such compliant language is either fraudulent or failed to provide informed consent because it didn’t mention preemption.

That’s hogwash.

Under the law of, we suspect, every state, both waiver and release involve the relinquishment of existing rights. We’re in Pennsylvania so we took a quick look, and sure enough “Waiver is an intentional and voluntary relinquishment of a known right.”  Commonwealth v. Lucarelli, 971 A.2d 1173, 1179 (Pa. 2009).  “[A] release is the giving up or the abandoning of a claim or right to the person against whom the claim exists or the right is to be enforced.”  Tindall v. Friedman, 970 A.2d 1159, 1165 (Pa. Super. 2009).

That’s nothing like preemption. Where preemption applies, it extinguishes legal rights as a matter of law.  The doctrine is in no way dependent upon “exculpatory language” of any sort.  And the regulatory history of §50.20 deals only with attempts to insert such language in informed consent forms:

Fourth, the HEW regulations forbid use of exculpatory language through which the subject is made to waive, or appear to waive, any legal rights, including a release of the investigator from liability for negligence.  FDA has no comparable regulation, although actual agency policy has been similar to the HEW rule.

44 Fed. Reg. 47713, 47716 (FDA Aug. 14, 1979).  With preemption, there’s no right left, let alone a “known” right, left to be waived.  There's nothing "voluntary" about the operation of the Supremacy Clause.  Nor is preemption any form of release, since any affected rights were simply abolished by act of Congress, not signed over to anyone else.

Case law interpreting §50.20 is even more explicit in distinguishing between claims that are and aren’t preempted.  The regulation’s waiver/release provisions apply only to unpreempted claims:

[Section] 50.20 preserves the patient’s common law rights outside of the limited scope of the preemption provision. It does not repeal the preemption provision itself. . . . [T]he consent regulation should be read to prevent patients from waiving legal rights which are not preempted under federal law.  That is, those common law rights which are retained by a patient and not preempted by the federal scheme may not be waived by the patient.

Gile v. Optical Radiation Corp., 22 F.3d 540, 543 (3d Cir. 1994) (emphasis original).  See also Slater v. Optical Radiation Corp., 961 F.2d 1330, 1334 (7th Cir. 1992); Hunsaker v. Surgidev Corp., 818 F.Supp. 744, 750 (M.D. Pa. 1992), both of which are discussed in Gile.

Since preemption has nothing whatever to do with waiver or release, there’s no way that an informed consent document discussing only the latter could be “fraudulent” – an intentional tort – for not mentioning the former.  Even so, lawsuits are expensive to litigate, so going forward investigators might want to check with the FDA to see if the Agency would permit some sort of additional language in informed consent documents such as “Some rights or remedies may, however, be preempted by operation of federal law,” or something similar. We have no idea whether the FDA would permit such language, or not, but all in all litigation is better avoided than defended.

The second theory, that informed consent somehow has to discuss the legal, as well as the medical ramifications of investigational medical treatments, is also hooey.  Doctors simply aren’t lawyers, and they have no professional obligation to advise patients of legal – as opposed to medical – risks.  We litigated a similar issue, whether the FDA regulatory status of a device, that is it’s being used off-label, was a medical “risk” that had to be disclosed as part of informed consent.  Fortunately, the courts pretty unanimously said “no.”  Again, we’ll stick to Pennsylvania, which we know best, but our prior posts collect all those cases. In Pennsylvania, legal issues are not “risks” that have to be disclosed under the rubric of informed consent:

We see no reason to expand the information that surgeons traditionally impart to their patients to encompass a device’s FDA regulatory status. . . .  FDA labels given to a medical device do not speak directly to the medical issues surrounding a particular surgery . . . .  [They] do[] 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 regarding the procedure.

Southard v. Temple University Hospital, 781 A.2d 101, 107 (Pa. 2001) (emphasis added). Thus, a “risk” for purposes of informed consent means a “medical issue” not a legal one.

Trying to shoehorn preemption into informed consent is even worse than the FDA regulatory status rejected in Southard and the other Bone Screw cases.  The FDA regulatory status of a device was at least something determinable at the time the device was used.  Preemption is simply one of many possible defenses to a lawsuit that may or may not ever happen, and in most cases won’t.  There are lots of equivalent legal issues. For example, in Hahn v. Richter, 673 A.2d 888 (Pa. 1996), the court killed off a bunch of legal theories, holding that only negligent failure to warn is allowed in prescription drug cases.  Id. at 891 (“the failure of the manufacturer to exercise reasonable care to warn of dangers, i.e., the manufacturer’s negligence, is the only recognized basis of liability”).  Hahn applies to medical devices.  E.g., Creazzo v. Medtronic, Inc., 903 A.2d 24, 31 (Pa. Super. 2006).  MDA preemption only knocked out the one theory that was left.  Is a doctor supposed to tell a patient that Pennsylvania law wipes out far more “rights” than preemption?  The absurdity of expanding informed consent to legal matters is obvious – as doctors cannot be expected to act as lawyers and advise patients of legal rights.

Thus, there is not even a colorable claim under the law of any state that medical informed consent somehow has to encompass a purely legal doctrine such as preemption.  It’s just another example of plaintiffs blowing smoke.  But the thicket of FDA regulations is something that most medmal defense attorneys (thankfully) don’t have to deal with regularly.  We’re used to it here, so we hope our colleagues can use these pointers to prevent such a colorable claim from ever arising.