We find ourselves, once again, hungry for good news. We just canceled a trip to see dear friends outside of Glacier National Park because Montana hospitals are so overfilled with anti-vax COVID patients that anyone with any medical emergency risks being turned away. Afghanistan fell to the Taliban. And, on a more “micro” level, we repaired to the basement late last night in the face of a tornado warning to discover a sheet of water pouring in between the pane and the frame of our brand-new basement window. We assume the thousands of dollars we paid for this window and its companions will entitle us to a replacement, but, suffice it to say, this was not a welcome development. (We feel compelled to reiterate that none of this affects our ongoing gratitude for health, family, and vaccines. But that doesn’t stop us from complaining.)
Once again, we find solace in an aggressive judge sensibly construing Pennsylvania law and displaying no tolerance for the sloppy pleadings that so often survive dismissal. In McGrain v. C.R. Bard, Inc., 2021 WL 3288601 (E.D. Pa. July 30, 2021), the plaintiff alleged that she was injured by the defendant’s inferior vena cava (“IVC”) filter, implanted in her after she was diagnosed with pulmonary embolus and deep vein thrombosis. She alleged that two struts of the IVC filter perforated her inferior vena cava, causing her “pain and discomfort in her abdominal area.” McGrain, 2021 WL 3288601 at *1. She filed suit in the Eastern District of Pennsylvania asserting the usual litany of product liability claims sounding in strict liability, negligence, and breach of warranty, and the defendant moved to dismiss all of the claims because they were not recognized under Pennsylvania law and/or because the plaintiff had not alleged sufficient facts to render the claims plausible.
The plaintiff asserted strict liability design defect, manufacturing defect, and failure-to-warn claims. The defendant moved to dismiss all three, arguing that, under Pennsylvania law, comment k barred strict liability claims against prescription drug manufacturers. Readers of this blog will recall numerous posts about this issue during the past few years. As we have explained, comment k (addressed by the Pennsylvania Supreme Court most recently in its 1996 Hahn decision) bars strict liability claims against manufacturers of “unavoidably unsafe products,” expressly including prescription drugs. Decades of appellate jurisprudence has reached the (obviously correct) conclusion that there is no principled basis upon which to distinguish prescription medical devices from prescription drugs so the preclusive effect of comment k applies equally to prescription medical devices, like the IVC filter.
But a number of Pennsylvania federal district court decisions have gone rogue, in recent years, misconstruing Lance and Tincher to hold that comment k does not bar strict liability claims against medical device manufacturers, while others have stayed the course and continued to reach the opposite (and correct) holding. We explained all of this here, just last week, when we announced that the Pennsylvania Supreme Court had granted review of this very question, certified to it by the Eastern District of Pennsylvania.
The appeal has yet to be heard, but, thankfully, Judge Nitza Quinones, presiding over McGrain, is in the sensible camp, having “previously held that such claims” against device manufacturers “are barred under Pennsylvania law.” Id., citing Lopez v. Ethicon, 2020 WL 5569770 at *5 (E.D. Pa. Sept. 17, 2020). (We apologize for the absence of pin cites. Our Westlaw copy does not include “star page” numbers.) In this case, stating, “Plaintiff provides this court with no reason why it should depart from its previous holding,” Judge Quinones again held that comment k barred the strict liability design defect and warnings claims.
The plaintiff expected this result, and effectively conceded in her opposition brief that these claims were doomed. But she argued that her strict liability manufacturing defect claim was, nevertheless, viable. The court described the split among federal district courts applying Pennsylvania law as to whether such a claim was cognizable against a medical device manufacturer. (Lopez had not addressed this issue.) The plaintiff argued that Tincher permits such claims “provided the evidence is sufficient to prove a [manufacturing] defect.” but the court disagreed, emphasizing that Tincher was not decided in the prescription drug or device context and that the Tincher court acknowledged this with a “but see” citation to Hahn.
As the McGrain court explained, Hahn addressed strict liability design defect and warnings claims but not manufacturing defect claims. But the comment k language on which the Hahn court relied provided that “unavoidably unsafe products” were not defective or unreasonably dangerous if they were “properly prepared and accompanied by proper . . . warning.” The court held, “Plaintiff has offered no basis, and this Court is unaware of any, on which the Pennsylvania Supreme Court could interpret “properly prepared” any differently than it interpreted and applied “accompanied by proper directions and warning.” Id. Accordingly, bolstered by the language of Lance and a page-long string cite of decisions refusing to differentiate among strict liability claims, the court predicted that the Pennsylvania Supreme Court “would extend its reasoning in Hahn to preclude strict liability manufacturing defect claims against medical device manufacturers.” Id.
The court dismissed the “breach of implied warranty of merchantability” claim for the same reasons, following other courts in the district that had held that there can be no “implied warranty,” whether of merchantability or fitness for a particular purpose, for “unavoidably unsafe products” like prescription medical devices. And just that quickly, simply by viewing the case through the correct lens, the court dismissed the strict liability and warranty claims with prejudice
Next, the court moved on to the plaintiff’s claims sounding in negligence: negligent manufacturing, negligent design, and negligent failure to warn. The defendant’s motion argued that the plaintiff had failed to allege fact sufficient to plausibly plead the requisite elements of any of these claims, and the court agreed. With respect to the manufacturing claim, the court stated, “As Defendants correctly point out, none of [the allegations in the Complaint] alleges facts concerning Defendants’ actual manufacturing process. . . . Without any factual allegation as to the nature of what went wrong during the manufacturing process, Plaintiff cannot plausibly state a claim for negligent manufacturing.” Id. (internal punctuation and citation omitted).
Similarly, the negligent design allegation “fail[ed] to address either the design of Defendants’ product or the availability of safer, feasible alternatives in any level of meaningful detail.” Noting that “courts in this district have consistently dismissed claims resembling Plaintiff’s as insufficiently pled,” the court held, “. . . [B]ecause Plaintiff fails to allege facts sufficient to plausibly state a negligent design claim, this claim is dismissed.” Id.
Finally, with respect to the negligent failure to warn claim, the defendant argued that the claim was “bereft of any facts about the warnings on the [product], its labeling, packaging, or other associated materials.” The court agreed, holding, “[The] allegations do not specify what information was missing from Defendants’ warnings. Nor do any of the allegations address the precise injury posed ty the use of the device. Without this information, Plaintiff has not plausibly stated a connection between her alleged injuries and Defendants’ failure to warn. Plaintiffs’ negligent failure to warn claim is, therefore, dismissed.” Id.
The same fate awaited the plaintiff’s remaining claims: the express warranty claim was dismissed because it did not “specifically cite the language that Defendants used in the promotion of [the] product, establishing the fact or promise created. In fact, it did not “provide any ‘express’ language used in the purported express warranty at all.” The fraudulent concealment claim was dismissed because there is no such independent cause of action under Pennsylvania law – fraudulent concealment is an equitable tolling doctrine, not an independent tort. The fraudulent and negligent misrepresentation claims were “exactly the type of dressed-up failure to warn claims that other courts have rejected.” (citation omitted). Finally, because the plaintiff “acknowledge[d] that she received and used Defendant’s product,” she could not “plausibly state a claim for unjust enrichment.” Id.
In the end, the court dismissed all of the strict liability claims with prejudice, along with claims for breach of implied warranty, fraudulent concealment, and unjust enrichment. The plaintiff was granted leave to amend the negligence, express warranty, and misrepresentation claims, as these claims “suffer[ed] from mere pleading inadequacies.” We love this decision, and we love this judge’s no-nonsense approach to the “rushing water” threatening to sweep this case along notwithstanding the dearth of colorable claims. We have little faith that the plaintiff can cure the deficiencies of her complaint, and we’ll let you know if we see further motion practice. In the meantime, stay safe out there.