We begin by introducing a new Drug and Device Little Rescue Dog. We lost the oldest of our rescued angels – a perfect soul we will miss as long as we are breathing – in the fall. Our other dog was sad and lonely, so we set out to adopt a companion for him. Our checklist was simple: 15 pounds max (to be a size match for our remaining dog), young-ish, and anything but a terrier. We report that “JoJo” is a 20-pound terrier mix. And he is eight years old. With a scruffy face and a head that tilts back and forth when you talk to him. And huge ears. And we are smitten. As we always say, a new dog can’t fill the hole left by a treasured companion of so many years. But he digs his own space and fills that up. And everyone starts smiling again.
“Smitten” would overstate our reaction to today’s case. But we like a lot of it. In Mikula v. C.R. Bard, 2021 U.S. Dist. LEXIS 241659 (W.D. Pa. Dec. 17, 2021), the plaintiff alleged that he was injured by the defendant’s inferior vena cava (“IVC”) filter. He asserted the usual litany of product liability claims for negligence, strict liability, breach of warranty, and negligent misrepresentation. The defendant moved to dismiss all of the claims.
We will get to other rulings in a second, but we jump first to one of our pet issues: whether or not comment k to Section 402A of the Restatement (Second) of Torts bars strict liability claims against medical device manufacturers. Regular readers of this blog will recall that Pennsylvania’s federal district courts have split on this issue. Some have followed decades of Pennsylvania state court decisions (and dozens of federal district court decisions) that have predicted that the Pennsylvania Supreme Court will adopt the reasoning of the Pennsylvania Superior Court’s Creazzo decision and will hold that comment k’s bar to strict liability claims against prescription drug manufacturers applies equally to manufacturers of prescription medical devices. Others have conjured wholly illogical distinctions to hold to the contrary. (You can see some of our posts here and here and here and here and here). Back in August, after the Third Circuit certified the question to the Pennsylvania Supreme Court, the Court granted review of the issue. For a while, we anxiously awaited that decision, but as we noted recently in our end-of-the-year review, it settled.
The Mikula court has weighed in on the correct side of the scale. The defendant argued that comment k barred the plaintiff’s strict liability claims. The court began its analysis by explaining the Third Circuit’s mandate that “where, as here, jurisdiction in federal court is based on diversity of citizenship, we must give serious consideration to the decisions of the intermediate appellate courts in ascertaining and applying state law.” In that vein, the court cited Creazzo for the (incontrovertible) proposition that there is “no reason why the same rationale applicable to prescription drugs may not be applied to medical devices.” Mikula, 2021 U.S. Dist. LEXIS 2419659 at *12-13 (internal punctuation and citation omitted). Citing the string of recent correct decisions by Pennsylvania’s federal courts (and ignoring the cases going the other way), the court concluded
Here, the Court is persuaded that the current state of strict liability law, based upon Pennsylvania Superior Court precedent and decisions by other federal courts in Pennsylvania, compels a prediction that the Pennsylvania Supreme Court would preclude strict liability claims against medical device manufacturers.
Id. at *14-15. And it dismissed the strict liability claims with prejudice, and the implied warranty claim along with them. The court explained that “Pennsylvania law has recognized an interconnectedness between strict liability and implied warranty claims” in the contexts of prescription drugs and medical devices, id at *14 (citation omitted): because the products are “unavoidably unsafe,” there can be no implied warranty.
Needless to say, we love this portion of the decision. As we have said on previous occasions, there is no straight-faced basis for a distinction between prescription drugs and prescription medical devices for comment k purposes. If the former are “unavoidably unsafe,” in the words of the comment, so are the latter, and decisions finding otherwise represent poor reasoning and misapplication of Pennsylvania law.
The rest of the Mikula court’s holdings are a mixed bag. With respect to the negligent design claim, the court held that the plaintiff’s allegations “failed to address either the design of [the defendant’s] product of the availability of safer, feasible alternatives in any level of meaningful detail.” The negligent market claim failed because, “without any factual allegation as to the nature of what went wrong during the manufacturing process, there is no plausible road to recovery for negligent marketing.” Id. at *9 (internal punctuation and citation omitted). The court dismissed both claims without prejudice. But the court found that the plaintiff had stated a claim for negligent failure to warn by alleging that the defendant “did not warn [the plaintiff’s] physician about the dangers and risks associated with the [IVC filter],” id. at *12, and by setting forth the specific warnings the defendant allegedly should have provided.
Finally, the court addressed the negligent misrepresentation claim. The defendant argued that the plaintiff had not pled the claim with the specificity required by Fed. R. Civ. P. 9(b), that the claim was a failure-to-warn claim in the guise of fraud, and that Pennsylvania’s learned intermediary doctrine negated the reliance element of the claim.
With respect to the second argument, the court acknowledged that courts routinely dismiss fraud claims in medical product cases, holding that they are disguised failure-to-warn claims. But the court emphasized the distinction between negligent misrepresentation claims and fraud claims – the latter includes an element of intent – and held that precedent (including Hahn) did not mandate the dismissal of the negligent misrepresentation claim. The court also rejected the third, learned intermediary, argument, holding that “a defendant may still be held liable under a theory of negligent misrepresentation if Plaintiff can prove that Defendants breached their duty to Plaintiff’s prescribing physician.” Id. at 23 (citation omitted). The court agreed, however, with the first, pleading-related, argument. The complaint, including only conclusory allegations “without the requisite specificity as to the reported representations, their falsity, or [the plaintiff’s or his physician’s] alleged reliance,” did not satisfy Rule 9(b), which applied to claims labeled “negligent misrepresentation” as well as “fraud.” Id. at *18. The court dismissed the claim without prejudice and granted the plaintiff leave to amend the claim (along with the negligent design and manufacturing claims).
On balance, we are pleased. Mikula got the comment k issue right, which matters more now that no appellate resolution of that question is imminent. And Rule 9(b) applies to negligent misrepresentation, which is useful. And as always, as we wade through Omicron, stay safe out there. And get your booster.