It’s written somewhat strangely – weak at thebeginning, strong at the end – but the Department of Justice’s amicus curiae brief , filedyesterday in Mutual Pharmaceutical Co. v. Bartlett, No. 12-142 (U.S.pending), eventually gets to the right place. That is, even the generally anti-preemption political leadership of thisFDA and DoJ took the only institutionally logical position that they could takeand told the Supreme Court that, yes, state tort claims asserting that anFDA-approved product should have been removed from the market altogether wereimpliedly preempted.
Because we like good news (and still can use someafter Stengel and Weeks), we flip right to the back of the DoJ’s Bartlett brief. The last substantive paragraphstates:
Federal law would preempt a pure defective-drug-designclaim that required a jury to second-guess FDA’s safety determination, withoutany further need to find the existence of new and scientifically significantevidence that rendered the product misbranded under federal law.
DoJ Bartlett br. at 34.
Let’s look at this. First of all, what’s this “pure” design defect business? As we said above, the DoJ brief starts outweakly, trying to turn Bartlett into something it wasn’t in order toavoid what it was. Instead of whatreally went on at trial (the trial court allowing plaintiffs’ counsel to askthe jury to flip a bird at the FDA), the DoJ first portrayed the verdict as based primarily on an“unreasonably dangerous even with warnings” theory under Restatement (Second)of Torts §402A, comment k (1965). DoJ br. at 14-18. The primary purpose of thatargument was to reduce Bartlett to a “nothing to see here” misapplicationof Mensing.
But it wasn’t, and the Court wouldn’t have takensuch a case. Rather, the trial court construed New Hampshire law as allowing a design defect claim based on purerisk utility factors without any need for an alternative design, and the First Circuit converted that theory on appeal to the “remove-from-the-market” claim that theSupreme Court actually granted certiorari toreview. So eventually, DoJ had to cometo grips with what is actually at issue: that the trial court told the jury itcould − and plaintiff’s counsel told the jury it should − find that the FDAshould not have approved a drug that it did approve:
[The District Court] instructed the jury that it . . .was free to give FDA’s approval “as much or as little weight as you think itdeserves. . . .” [Plaintiff’s counsel] “argued that sulindac was a “needless and uselessdrug. . . .” Counselasserted that FDA merely “rubber stamped” the ANDA . . ., and that“no evidence (showed) that FDA has ever done a focused analysis on (s)ulindac”to justify its “be(ing) on the market.” FDA, counsel asserted, lacks “expertise in risk⁄benefit assessment” and“impos(es) a significant risk to . . . the safety of the public”because it is unable to perform its “mission to monitor drug safety for anyclass of drugs.”
DoJ br. at 10-11 (quoting trial record). Given this view of the law and the evidence,it’s hardly surprising that the Bartlett jury, applying only state law,told the FDA to pound sand and decided that an FDA-approved drug simplyshouldn’t be sold at all. That’s the“pure” theory that DoJ addresses in the most interesting part of its brief.
As the first block quote above indicates, the FDA supportspreemption – and does so without any use of “generic” as an adjective. That's important. The FDA states that remove-from-the-marketclaims are preempted as to all drugs(and presumably all other products it regulates):
Brand-name and generic drugs should be treated the same for purposes ofdesign-defect claims. . . . [T]he active ingredient in a generic drug must be the same as that inthe brand-name drug. The genericmanufacturer may not alter that ingredient without prior FDA approval. But thesame is true of the manufacturer of a brand-name drug. for both, anychange that created a new active ingredient would require prior FDAapproval. . . . [P]reemption in the generic-drug context, just as in the brand-name-drug context, should not bedefeated on the rationale that the manufacturer could always comply with statelaw by declining to provide the very drug whose availability Congress sought toprovide.
DoJ br. at 30-31 (citations and footnote omitted)(emphasis added). We’ve received thesame bone-headed response from an appellate court in a branded case, seeWimbush v. Wyeth, 619 F.3d 632, 645 (6th Cir. 2010) (our #1 worst caseof 2010), so we know that allowing state juries to order federally approved drugs offthe market is just as preemptive a conflict (and just as absurd a theory) in branded as in generic cases.
We note that while the DoJ to some extent addressesa straw man – the form of design defect described in Restatement (Third) of Torts,Products Liability §6(c) (1998), which it concedes has not been accepted to “anysignificant degree” (DoJ br. at 20) – this reasoning is also relevant to theeven more extreme so-called “categorical liability” design defect claims that the Third Statementrejected, which are precisely what the plaintiff was permitted to pursue in Bartlett. Since none of these now mostly discreditedmeat-axe design-related theories includes an caveat approaching the “new andscientifically significant evidence that rendered the product misbranded underfederal law” qualifier added by DoJ, the government’s position is effectivelythat all remove-from-the-market theories asserted in tort cases againstFDA-approved products are preempted.
That’s as it should be.
We particularly recommend DoJ’s discussion of whyfailure to withdraw claims inherently conflict and interfere with the FDA’sparallel post-marketing processes – because plaintiffs (including in Bartlett)have made contrafactual statements about the FDA’s post-marketing authority,leading some courts into error as to “pharmacovigilence”:
Congress has further charged FDA with monitoring post-marketingdrug safety. A manufacturer mustmaintain extensive clinical records and make numerous reports toFDA. . . . Those dutiesapply to manufacturers of generic drugs as well as the brand-namedrug. . . .
The Act provides that FDA shall withdraw approval of adrug if, inter alia, it finds thatthe drug is not safe for the uses identified at the time of the drug’s approvalor is not effective as claimed for those uses. Approval may be withdrawn only following procedures that afford the manufacturerdue process and the opportunity for a hearing. Since 2007, FDA may also require (not merely request) labeling changes.
FDA’s ongoing risk-benefit analysis will sometimes takeinto account the availability of more effective or less risky alternatives. . . . FDA did notrequest withdrawal of sulindac. . . .
In the face of this elaborate regulatory regimeinstituted to safeguard the national market and protect consumers throughoutthe United States, and the extensive commitment of public and private resourcesto those ends, it would be inconsistent with the FDCA to conclude that amanufacturer must abandon a market it has been approved by FDA to enter inorder to avoid violating a duty recognized by a jury under state tort law that deemsits product unsafe.
By requiring a jury independently to balance the healthrisks and benefits of FDA-approved uses of a drug and to determine if the drugis “unreasonably dangerous” for those uses, a state with a pure design-defect product-liabilitylaw would force the jury to second-guess FDA’s safety determination, whichbalances the drug’s therapeutic risks and benefits for its labeled uses. Such ad-hoc reconsiderations on astate-by-state and lawsuit-by-lawsuit basis would undermine FDA’s drug-safetydeterminations, which are made based on sound scientific judgments by an expertfederal agency with appropriate access to pertinent safety data, and theassurance that FDA’s approval provides for all participants in the market.
DoJ br. at 26-28 (various stuff omitted).
DoJ also distinguished the heck out of Wyeth v.Levine, 555 U.S. 555 (2009), which is probably the worst prescription drugdecision of all time (at least as to preemption):
- Levine didn’t adopt any “general no-preemption rule.” Rather, Levine (like any other case) depends on “context.” DoJ br. at 31.
- Levine involved “newly acquired information undermining its drug’s safety” that the defendant had “failed to strengthen its labeling as specifically contemplated by FDA’s CBE regulation. Id.
- Levine found no obstacle preemption in “FDA’s labeling approvals, and the mere possibility that FDA would disapprove a manufacturer’s subsequent enhanced warning.” Id. at 32.
- Levine “does not categorically extend to all claims,” and in particular does not extend to design claims, because “because a manufacturer cannot unilaterally alter the design (unlike the labeling) of a drug.” Id.
- Unlike the FDA’s position in Levine, FDA drug approval as a “an expert judgment that the drug’s therapeutic benefits outweigh its risks” is a “longstanding interpretation” of the FDCA. Id. at 32-33.
- Levine involved “traditional” warning-based litigation, whereas design-based claims have been “rare” and “unusual.” Id. at 33.
- The claims at issue in Bartlett fit within Levine’s “recogni[tion] that some state-law claims might well frustrate the achievement of congressional objectives.” Id. (quoting Levine, 555 U.S. at 581).
So the good news is that, after some hemming andhawing, the DOJ did the right thing in Bartlett.
The bad news is the hemming and hawing. Whether a state-law jury should be allowed tosay “no” to the marketing of a product after the FDA has said “yes” is hardly “difficultand close.” DoJ br. at 12. This type ofabsolute and utter conflict between state and federal law is a no-brainer,since 1913, when the Court decided in McDermott v. Wisconsin, 228 U.S.115 (1913), that a state couldn’t ban FDA-approved dairy products.
Moreover, it was egregious and unnecessary for DoJto advocate exceptions for Levine branded labeling claims or Riegelparallel claims, br. at 23-24, since as the brief admits, “neither of theforegoing theories is available here.” Id.at 24. Even worse is DoJ’s backhandedendorsement of a “state-law duty not to market the drug in the samecircumstances,” parallel to federal “misbranding” law as not preempted. Id. Not only was (1) no such claim raised in Bartlett, and (2)“parallel” claims analysis isn’t an implied preemption concept, but generallythere is no state-law cause of action for failure to recall, as we discussedhere and here,among other places. We hope the SupremeCourt won’t have time for such irrelevant nuances when it decides Bartlett,but anything that gives comfort to bizarre new tort theories we can’t stomach.
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