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We write today from a room in a rehabilitation facility, where we just shared the Drug and Device Law Dowager Countess’s lunch.  The Countess, nearly 88, plunged down a flight of eight concrete stairs 12 days ago and managed to emerge with three broken ribs (one in two places) and no other injuries.  A painful injury with a long recovery time, but miraculous all in all.  And we are out of the hospital (first the step-down ICU then a regular room) and six days into rehab.  We offer this comment:  those who choose to enter the nursing professions – RNs, LPNs, aides – deserve a special place in any afterlife your beliefs include.  These are thankless, grueling jobs requiring unflagging alertness, judgment, compassion, and kindness, along with the tricky balance between empathy and objectivity.  In the past two weeks, notwithstanding burdens imposed by pervasive staffing shortages, we are grateful to have met many spectacular examples (mostly, but not all, women) of people perfectly suited for their professions.

We think the judge in today’s case is similarly well suited for her seat on the federal bench, if today’s decision is an accurate barometer.  In MacSwain v. Merck & Co. Inc., 2022 WL 1415031 (W.D.N.Y. May 4, 2022), the plaintiff alleged that the defendant’s osteoporosis drug, Fosamax, caused her to suffer serious injuries, including osteonecrosis of the jaw and atrial fibrillation.  She asserted the usual litany of product liability claims, including failure to warn, design defect, breaches of express and implied warranties, fraudulent misrepresentation, and fraudulent concealment.  The defendant moved to dismiss all but the warnings claim.

Design Defect

The plaintiff alleged that the defendant’s drug was “defective in its design and/or formulation, as the foreseeable risks exceeded the benefits associated with its design and/or formulation” and because it “posed a greater risk than other similar medications.”  MacSwain, 2022 WL 1415031 at *4 (citations to Complaint omitted).  Under New York law, to state a claim for design defect sounding in either negligence or strict liability, a plaintiff must allege, inter alia, that “it was feasible to design the product in a safer manner” at the relevant time.  Id. (citation omitted).   The defendant moved to dismiss the design defect claims on the ground that the plaintiff had not adequately pled the existence of a safer, feasible alternative design.  The Court agreed, holding that the plaintiff’s conclusory allegation that there were “several alternative safer products available” did not satisfy her pleading burden.  Moreover, the court held, while the plaintiff’s brief could be construed to argue that the drug could have been designed more safely if it did not contain nitrogen, the plaintiff was not permitted to “amend her pleading through her brief to transform this statement into a proposed alternative design.”  Id. at *5 (citation omitted.)  And while the court conceded that the plaintiff was not required to ‘establish the elements of her claim at the pleading stage,” id. at *6 (citation omitted, emphasis in original), it emphasized that she was still required to “plausibly plead them.”  Id.   Because she had not “plausibly pled” the existence of a safer, feasible alternative design, her design defect claims failed as a matter of New York law.

In an interesting side discussion, the court explained that the defendant had moved to dismiss the design defect claim on the alternative ground that the design defect claims were preempted by federal law.  In Mut. Pharm. Co., Inc. v. Bartlett, 570 U.S. 472 (2013), as readers of this blog are aware, the United States  Supreme Court held that a state law design defect claim against a generic drug  manufacturer was pre-empted because the manufacturer could not “redesign” a drug to comply with state law tort duties without first obtaining FDA approval.   After Bartlett, courts split on whether the holding should be extended to preempt design defect claims against branded drug manufacturers,  with the Sixth Circuit’s decision in Yates v. Ortho-McNeil-Janssen Pharms, Inc., 808 F.3d 281 (6th Cir. 2015), leading the charge in the “yes” column.  Because the MacSwain court had already dismissed the design defect claim on other grounds, it declined to rule on the preemption question.

Breaches of Express and Implied Warranties, Fraud-Based Claims

Plaintiff alleged that the defendant breached an express warranty because it “expressly represented” to the plaintiff, “through its advertising and otherwise” that its drug “had been adequately tested, was to be prescribed in accordance with its intended uses, was of merchantable quality, and was not dangerous.”  Id. at *8.  The defendant argued that these allegations did not adequately plead a breach of express warranty claim, and the court agreed.  Under New York law, as the court explained, “an express warranty is an affirmation of fact or promise made by the seller to the buyer which relates to the goods and becomes part of the basis of the bargain.  To assert a breach of express warranty claim, [a p]laintiff must plausibly allege . . . a specific affirmation of fact or promise that is false and misleading.”  Because the plaintiff “fail[ed] to identify any specific affirmation or promise” the defendant made to the plaintiff about the drug’s safety, the court held that the plaintiff’s “generic allegations” did not state a claim for breach of express warranty.  Id.

 The implied warranty claim did not meet the same fate.  As the court explained, a breach of an implied warranty of merchantability “may arise from ‘a manufacturing flaw, improper design, or a failure to provide adequate warnings regarding use of the product.”  Id. at *9.  Because the defendant did not move to dismiss the failure-to-warn claim, a basis for the breach of implied warranty claim survived the dismissal of the design defect claim.

Finally, the court held that the fraud claims were not pled with the particularity Rule 9(b) requires.  The Rule requires that the complaint “detail the statements (or omissions) that the plaintiff contends are fraudulent, (2) identify the speaker, (3) state where and when the statements (or omissions) were made, and (4) explain why the statements (or omission) are fraudulent.” *10 (citation omitted).  “In this case, [the plaintiff included] only vague allegations of misrepresentations and omissions and woefully misse[d] the 9(b) particularity mark: no statements or omissions [were] specified, no speaker [was] identified, and no time or place of the statements or omissions [was] identified.”  Id. at *10 (internal punctuation and citation omitted).

A nice, sensible opinion, we think.  The court granted the plaintiff leave to amend, and we will keep you posted on further developments,particularly on the Yates preemption issue.  In the meantime, stay safe out there.