Fosamax Ruling: “A Small Win for Defense, A Big Win for Plaintiffs”

SCOTUS Fosamax Ruling (May 20, 2019)

Issue: Whether a state-law failure-to-warn claim is pre-empted when the Food and Drug Administration rejected the drug manufacturer’s proposal to warn about the risk after being provided with the relevant scientific data, or whether such a case must go to a jury for conjecture as to why the FDA rejected the proposed warning

Small Win for Defendants

Defendants Won the argument that a Judge not a jury is the proper authority to decide impossibility preemption arguments arising under the FDCA (Food and Drug Cosmetics Act, Title 21). However, the win on this one issue is a hollow victory for defendants considering the entirety of SCOTUS order and opinion.

SCOTUS ruled that judges not juries are the proper authority to decide the issue however, SCOTUS also placed significant limits on what those lower court judges could and could not consider when ruling on impossibility pre-preemption arguments like those raise by Merck in the Fosamax Case.

JUSTICE THOMAS SUMMARY OF RULING

JUSTICE THOMAS, concurring:

I join the Court’s opinion and write separately to explain my understanding of the relevant pre-emption principles and how they apply to this case.

“Because Merck points to no statute, regulation, or other agency action with the force of law that would have prohibited it from complying with its alleged state-law duties, its pre-emption defense should fail as a matter of law”

Big Win for Plaintiffs

SCOTUS ruled that Judges decide however, SCOTUS went much further and defined limits on what facts and information could be considered by lower court judges when making decisions related to impossibly preemption arguments like those raised by Merck in Fosamax.

SCOTUS opinion limits the clear and convincing evidence standards to OFFICAL Acts taken by the FDA which would in general rise1. If the defendant did not go through the CBE process and make the change (the exact warning plaintiffs allege was needed) and the FDA later told them to remove the warning, then FDA OFFICALLY told them to remove the warning, then no pre-emption exists.

1. If the defendant did not go through the CBE process and make the change (the exact warning plaintiffs allege was needed) and the FDA later told them to remove the warning, then FDA OFFICALLY told them to remove the warning, then no pre-emption exists.

2. If the defendant did not ask to make the specific label change (which plaintiffs allege was needed) having provided the FDA all relevant information, and the FDA OFFICIALLY denied the label change, then no pre-emption exists.

Arguments that postulate “hypotheticals” (absent either of the above official actions (facts)) are not to be considered. Communications between the defendant and the FDA, Statements by the FDA that do not constitute an official act under the law, are not to be considered.

The pre-emption question dates back to the original Fosamax case, which was filed by patients who suffered femoral fractures while taking the osteoporosis drug. Merck added language to the product’s label about the risk in 2011, but more than 500 patients claimed that their injuries occurred before then, and Merck should have warned them sooner.

In January 2019, the full Supreme Court heard arguments in Merck Sharp & Dohme Corp. v. Albrecht, a case arising out of the In Re: Fosamax (Alendronate Sodium) Products Liability Litigation. Fosamax is a drug used to treat osteoporosis, with a cited adverse event being that it may inhibit bone repair, which could result in an atypical femoral fracture.

The central claim at issue concerns the Fosamax warning label, which initially did not warn of the risk of an atypical femoral fracture. Plaintiffs contend that the label should have included such a warning, while Merck counters that it tried to add language addressing the risk of a “Low-Energy Femoral Shaft Fracture,” but was prevented from doing so by the FDA, who affirmatively told Merck to “hold off” on adding any such language until the FDA could decide on “atypical fracture language, if it is warranted.”  Ultimately, the FDA rejected Merck’s proposed warning label, stating that the justification for such language was “inadequate.” The FDA reversed course the following year, and Merck then added a risk of atypical femoral fracture to Fosamax’s label.

Based on these facts, Merck moved for summary judgment on the plaintiff’s failure-to-warn claims, arguing that such claims were preempted under Wyeth v. Levine because “clear evidence” demonstrated that the FDA would not—and did not—approve of the proposed label change.  The District Court agreed, but the Third Circuit did not, holding instead that: (1) Levine’s reference to “‘clear evidence’ referred solely to the applicable standard of proof,” which Merck failed to satisfy; and (2) the issue of whether the FDA would have rejected the label change was a fact question for the jury, (see Fosamax [Merck] Appeal U.S. Court of Appeals 3rd Circuit).

SCOTUS RULED 9-0

Additional Concurring Opinion on the judgment only (Jury vs Judge only) from Justices Cavanaugh, Alito’s  and Chief Justice Roberts could be interpreted as allowing lower court Judges to consider other Official acts by the FDA other than those delineated above however, the additional opinion did not define what official acts other than the two discussed could be considered and inasmuch as these two official actions are constitute the limit of the powers relevant to such matters, delegated to the FDA by Congress, it is doubtful that a defendant could show a lower court Judge any other document (without posing hypotheticals) that would constitute an official action taken by the FDA that would have prevented the defendant from meeting its State Law duties (impossibility preemption).

In that the only powers delegated to the FDA by Congress (powers under the law) are those defined in the two types of actions listed above, relevant to the type of impossibility preemption arguments that were raised in Fosamax, based on unofficial actions, communications and statements from the FDA (and that defendants hoped to raise in numerous other cases) the Fosamax ruling taken in its entity, is a major blow to defendants hoping to open major cracks in Wyeth v Levine.

The central issue in this case concerns federal preemption, which as relevant here, takes place when it is “‘impossible for a private party to comply with both state and federal requirements.’” Mutual Pharmaceutical Co. v. Bartlett, 570 U. S. 472, 480 (2013). See also U. S. Const., Art. VI, cl. 2. The state law that we consider is state common law or state statutes that require drug manufacturers to warn drug consumers of the risks associated with drugs. The federal law that we consider is the statutory and regulatory scheme through which the FDA regulates the information that appears on brand-name prescription drug labels. The alleged conflict between state and federal law in this case has to do with a drug that was manufactured by petitioner Merck Sharp & Dohme and was administered to respondents without a warning of certain associated risks.

FOSAMAX HISTORY

Merck developed Fosamax to strengthen bones and reduce the risk of fractures from osteoporosis. However, numerous studies have linked the medication to an elevated risk of abnormal femur fractures. Furthermore, plaintiffs in the litigation argue that Merck had an intrinsic obligation to its consumers to provide stronger warnings that users could experience femur fractures from little or no trauma while taking the medication. This includes falling from standing height or less.

Merck introduced Fosamax in 1995, and the company didn’t add a thigh bone fracture risk warning label to the drug until 2011. Plaintiffs claim Merck knew about the risk for years but concealed it to maximize sales and profits.

Fosamax was a blockbuster drug with annual sales of over $3 billion, until the company  lost its exclusive patent rights in 2008, even then the brand name drug still brought in $284 million in sales in 2016.

MERCK SHARP & DOHME CORP. v. ALBRECHT Opinion of the Court(excerpt)

III

We turn now to what is the determinative question before us:

Is the question of agency disapproval primarily one of fact, normally for juries to decide, or is it a question of law, normally for a judge to decide without a jury?

The complexity of the preceding discussion of the law helps to illustrate why we answer this question by concluding that the question is a legal one for the judge, not a jury. The question often involves the use of legal skills to determine whether agency disapproval fits facts that are not in dispute. Moreover, judges, rather than lay juries, are better equipped to evaluate the nature and scope of an agency’s determination. Judges are experienced in “[t]he construction of written instruments,” such as those normally produced by a federal agency to memorialize its considered judgments. Markman v. Westview Instruments, Inc., 517 U. S. 370, 388 (1996). And judges are better suited than are juries to understand and to interpret agency decisions in light of the governing statutory and regulatory context. Cf. 5 U. S. C. §706 (specifying that a “reviewing court,” not a jury, “shall . . . determine the meaning or applicability of the terms of an agency action”); see also H. R. Rep. No. 1980, 79th Cong., 2d Sess., 44 (1946) (noting longstanding view that “questions respecting the . . . terms of any agency action” and its “application” are “questions of law”). To understand the question as a legal question for judges makes sense given the fact that judges are normally familiar with principles of administrative law. Doing so should produce greater uniformity among courts; and greater uniformity is normally a virtue when a question requires a determination concerning the scope and effect of federal agency action. Cf. Markman, 517 U. S., at 390–391.

We understand that sometimes contested brute facts will prove relevant to a court’s legal determination about the meaning and effect of an agency decision. For example, if the FDA rejected a drug manufacturer’s supplemental application to change a drug label on the ground that the information supporting the application was insufficient to warrant a labeling change, the meaning and scope of that decision might depend on what information the FDA had before it. Yet in litigation between a drug consumer and a drug manufacturer (which will ordinarily lack an official administrative record for an FDA decision), the litigants may dispute whether the drug manufacturer submitted all material information to the FDA.

But we consider these factual questions to be subsumed within an already tightly circumscribed legal analysis. And we do not believe that they warrant submission alone or together with the larger pre-emption question to a jury. Rather, in those contexts where we have determined that the question is “for the judge and not the jury,” we have also held that “courts may have to resolve subsidiary factual disputes” that are part and parcel of the broader legal question.  Teva Pharmaceuticals USA, Inc. v. Sandoz, Inc., 574 U. S. ___, ___–___ (2015) (slip op., at 6– 7). And, as in contexts as diverse as the proper construction of patent claims and the voluntariness of criminal confessions, they create a question that “‘falls somewhere between a pristine legal standard and a simple historical fact.’” Markman, 517 U. S., at 388 (quoting Miller v. Fenton, 474 U. S. 104, 114 (1985)). In those circumstances, “‘the fact/law distinction at times has turned on a determination that, as a matter of the sound administration of justice, one judicial actor is better positioned than another to decide the issue in question.’” Markman, 517 U. S., at 388 (quoting Miller, 474 U. S., at 114). In this context, that “better positioned” decisionmaker is the judge.

 IV

Because the Court of Appeals treated the pre-emption question as one of fact, not law, and because it did not have an opportunity to consider fully the standards we have described in Part II of our opinion, we vacate its judgment and remand the case to that court for further proceedings consistent with this opinion.

It is so ordered.

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How Big Pharma’s cadre of lobbyists and congressional insiders attempt to reap major dividends, as we address the Fosamax ruling remains to be seen, but considering the wide-open lack of federal oversight for pharmaceutical and medical device manufacturers by the current administration, it would appear that Big Pharma investments in the FDA and related oversight agencies is paying off very well.

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