Worth our note is a recent preemption decision in  In re Fosamax (Alendronate Sodium) Products Liability Litigation, 2022 WL 855853 (D.N.J. March 23, 2022).  The case is noteworthy because it contains a cogent and well-reasoned exploration of many of the issues flowing from the Supreme Court’s decision in Merck Sharp & Dohme Corp. v. Albrecht, 139 S. Ct. 1668 (U.S. 2019).  Albrecht, of course, clarified some of the language in Wyeth v. Levine, 555 U.S. 555 (2009), particularly with regard to the need in a warnings context that there should be clear evidence that the FDA would have rejected the plaintiff’s proposed alternative label.

Since Wyeth, plaintiffs facing preemption motions have advanced a litany of arguments trying to turn the clear evidence language into an insurmountable hurdle, no matter the procedural posture, and no matter how clear the record before the agency.  When all else failed, plaintiffs argued that there were “fact issues” that had to go to a jury.  Albrecht ended that one, noting preemption is a legal issue for the court, even as to subsidiary fact questions.  Fosamax addresses many of the other typical arguments, including reconfirming the only commonsense reading of Wyeth, that the manufacturer does not have to actually request that the agency adopt plaintiffs’ label, but that preemption may be established by reference to what the FDA would have done if faced with a label change.  Of course, out of  the many decisions since Albrecht, none appears to have agreed with plaintiffs on this point.  The court also confirmed that enough is enough: that is, while plaintiffs argued that the defendant could have, perhaps, theoretically, changed the FDA’s decision had defendant somehow not taken “no” for an answer but went on engaging with the Agency or invoked other procedural mechanisms, that is not required.  Importantly, the possibility of a possibility is not enough to defeat preemption. And there is no need to force these obviously litigation-driven steps.

We also like, in the discussion of whether the FDA was fully informed of the risk that plaintiffs are now complaining about, how the court noted that the FDA alone is the arbiter of which data and information is or is not material to its decision to approve or reject a change to a drug’s label; it is the FDA’s view of the evidence that matters, as opposed to only plaintiffs’ experts’ view.  Typically, plaintiffs will hire a “regulatory expert” who tries to opine about not only what the FDA would have done or said, and what the agency really meant to say, but also what evidence the FDA would have considered relevant or material, regardless of Agency regulations, guidance, and statements about what they considered and what they find important.

When the FDA is fully informed, from whatever source, of the alleged risks, then a huge hurdle exists for plaintiffs trying to show that a manufacturer could have changed the label unilaterally.  It is the inability to do so that sets up the conflict, the impossibility of complying with plaintiffs’ view of state law (requiring a warning) and federal law (dictating the label as is).  A CBE change, the court reiterated, permits a drug manufacturer to unilaterally add a precaution to its label, but only if newly acquired information provides reasonable evidence of a causal association of a clinically significant adverse reaction linked to a drug. If the FDA was fully informed at the relevant time, then there is no newly acquired information.

Another common plaintiff argument has been that the agency must reject the formal request of the kind plaintiff thinks the manufacturer should have made, procedurally.  But the court explained that a rejection of a PAS request subsumes any request under the CBE avenue.  And final agency action, for preemption purposes, can include a “complete response letter” because it reflects the FDA’s complete review of the data submitted.  Importantly, for  preemption purposes, it is mostly irrelevant whether the the FDA letter was of a merely tentative or interlocutory nature or needed some additional FDA action to close out the record, or leave some procedural door open for a party to ask again.

Finally, and this is a drum we have been banging on for a while, silence can be golden.  That is, the FDA has a statutory obligation to respond to any product-related information it receives, from any source, such as Adverse Event Reports, published studies, etc.  Plaintiffs want the courts facing preemption challenges to simply ignore the FDA’s raison d’etre to regulate drug safety,  and its independent legal duty to notify a manufacturer as soon as it becomes aware of new safety information that the FDA believes should be included in the labeling of a drug, and to initiate discussions about new labeling. Courts should not simply assume that the FDA has not done what the statute requires it to do, as opposed to having done it and come to a conclusion (no action needed) that plaintiffs do not like.  Indeed, said the court, the only valid inference is that the FDA was unconvinced of an issue requiring amendment, here that the Agency did not believe there was reasonable scientific evidence of a causal association between bisphosphonate use and atypical femoral fractures. And related to this, the FDA will not approve a warning simply out of an abundance of caution whenever a manufacturer posits an association between a drug and an adverse event. As the FDA has long recognized, exaggeration of risk, or inclusion of speculative or hypothetical risks, could discourage appropriate use of a beneficial drug. Because labeling that includes theoretical hazards not well-grounded in scientific evidence can cause meaningful risk information to lose its significance, the FDA prohibits a change to labeling, either through the PAS or CBE process, to add a Precautions warning in the absence of sufficient reasonable evidence of an association. This represents a more conservative approach than state tort law, which generally incentivizes a manufacturer to warn about every conceivable hazard to limit liability.

Photo of Sean Wajert Sean Wajert

Sean P. Wajert is a partner at Shook, Hardy & Bacon LLP, and the Managing Partner of Shook’s Philadelphia office.  He concentrates his complex litigation practice on the defense of companies from a variety of industries, including the chemical, consumer product, drug and…

Sean P. Wajert is a partner at Shook, Hardy & Bacon LLP, and the Managing Partner of Shook’s Philadelphia office.  He concentrates his complex litigation practice on the defense of companies from a variety of industries, including the chemical, consumer product, drug and medical device industries.  His practice focuses on complex commercial litigation, mass tort, toxic tort and product liability litigation, and appellate work. For a decade he served as Chair of the Products Liability Group of his prior firm.  Sean also taught complex litigation issues for ten years as a Lecturer-in-Law at the University of Pennsylvania Law School.