Photo of Rachel B. Weil

We write from Tampa, Florida, where we attended the bridal shower of a lifelong friend’s daughter.  In a happy coincidence, the event fell on the last weekend of a two-week stretch of dog shows in which our puppy’s sire, a spectacular white corded Standard Poodle named Joel, was being shown.  A lovely interlude, except for the cold, rainy raw weather today and the mostly-equally-unpleasant decision in today’s case.  In D’Addario v. Johnson & Johnson, et al., 2023 WL 239395 (D.N.J. Jan 18, 2023), the plaintiff was implanted with the defendant’s textured breast implant after undergoing a mastectomy.  The defendant’s tissue expanders were used to prepare the plaintiff’s body for the implant.  The plaintiff alleged that the products caused her to develop Breast Implant-Associated Large Cell Lymphoma (“BIA-ALCL”), a rare form of cancer.  The plaintiff asserted claims under the Connecticut Product Liability Act (“CPLA”) for manufacturing defect, breach of implied warranties, negligent misrepresentation, and failure to warn.  The defendant moved to dismiss all of the claims.

The plaintiff’s breast implants were class III medical devices, subject to the FDA’s full premarket approval (“PMA”) process.  (The tissue expanders were class II devices, subject to the less rigorous 510(k) clearance process.)  Under Riegel v. Medtronic, as the D’Addario court explained and as readers of this blog are aware, the express preemption provisions of the FDCA preempt most state-law product liability claims against manufacturers of Class III medical devices.  As the court explained, there is a “narrow” exception for so-called “parallel” claims – claims that are based on violation of an FDA requirement, not on state requirements that are “different from, or in addition to,” the federal ones.  In other words, “where a . . . claim for violating a state-law duty ‘parallels’ a federal-law duty under the MDA, the MDA will not preempt the state-law claim. . . ” if the plaintiff can link the alleged violation to her alleged injury.  D’Addario, 2023 WL 239395 at *4 (internal punctuation and citation to Riegel omitted).  Remember, the “parallel claim” exception is a “narrow one,” as the court emphasized, and as it promptly forgot.

In her “manufacturing defect” claims, sounding in both strict liability and negligence, the plaintiff alleged that the defendant’s manufacturing processes violated several of the FDA’s Current Good Manufacturing Practice regulations governing the manufacturing of medical devices.  The defendant argued that these claims were preempted because the plaintiffs failed to demonstrate how the defendant’s manufacturing processes deviated from those approved by the FDA, and that the plaintiffs’ citations to regulations, without more, were not sufficient to overcome preemption.   The defendant also argued that the manufacturing defect allegations were really just re-packaged design defect claims (which are preempted) and that the manufacturing defect claim failed because it did not claim that the plaintiff’s implants were defectively manufactured, but, rather, that the defendant’s manufacturing process itself was defective.  (This last is really important:  the gravamen of a properly-pled manufacturing defect claim is that the particular product unit a plaintiff received was not manufactured in compliance with the processes the manufacturer used for the universe of identical products.  That is not what the D’Addario plaintiff alleged.)

And D’Addario muffed the analysis.  Citing conclusory allegations that the manufacturing process for the universe of identical implants failed to comply with the PMA and with FDA regulations, it concluded, “Plaintiffs have therefore plausibly pled that the product was defective and that the defect existed when the product left the manufacturer’s control. . . .  Accordingly, D’Addario concluded that the [complaint] sufficiently alleged that the implants and tissue expanders contained a manufacturing defect.”  Id., at *5.  Sorry, but this is a non-sequitur.  Nowhere did D’Addario explain how the plaintiff satisfied the elements of a manufacturing defect claim, yet it allowed the claim to proceed.  And we agree with the defendant:  if the claim alleged anything, it alleged a design defect which, for the Class III implants, was preempted.

And D’Addario rested on the same flawed reasoning to hold that the plaintiff’s implied warranty claim was not preempted.  In their motion, the defendants argued that that the plaintiffs’  negligent misrepresentation and implied warranty claims were preempted because, while packaged as misrepresentation and warranty claims, both just asserted the same (preempted) conclusory “safety and effectiveness” defect allegations.  D’Addario held that warranty claims were not preempted because they were tied to the manufacturing defect claim already allowed to survive.  In the one bright spot, D’Addario did dismiss the negligent misrepresentation claim, holding, “. . . Plaintiffs’ negligent misrepresentation claim cannot succeed because failing to disclose a risk by not complying with the reporting regulations or federal disclosure requirements does not satisfy the standard required to sufficiently claim negligent misrepresentation.”  Id. at *7.  The court also held that the claim, sounding in fraud, failed to satisfy the heightened pleading requirement of Rule 9(b) because it “[did] not specify the statements that Plaintiffs contend[ed] were fraudulent, identify the speaker, state where and when the statements were made, and explain why the statements were fraudulent.”  Id.

Finally, D’Addario allowed the plaintiff’s failure-to-warn claim to proceed.  While the plaintiff conceded that the defendant included warning labels with its devices, she argued that the particular implant provided to her doctor lacked the warning label.  The defendant argued that the allegation was implausible (we agree) but the court held that it created a fact issue allowed the claim to survive a motion to dismiss. Ironically, this “warning” claim is the closest thing in the case to a real “manufacturing defect” claim.

A mostly bad decision, plagued by reasoning that lacks the rigor demanded by preemption analysis.  We will keep you posted on further developments.  Meanwhile, cross your fingers for sun for the last day of the dog show, and stay safe out there.