Like the rest of you, we have enjoyed streaming new video offerings as we stave off social deprivation. But, more often than not, we find ourselves resorting to our “go to” stalwarts (we have mentioned Season 5, Episode 9 of Downton Abbey), among which we choose depending on the particular chord that needs to be struck. A favorite old standby, whatever our mood, is the 2003 uber-chick flick, “Love, Actually.” It is the first film we purchased to reside permanently on our new DVR when we switched cable services (the second was “The American President” – back in the day we could recite Michael Douglas’s final press briefing speech verbatim) and it has it all. It has comedy (Bill Nighy’s beyond-brilliant portrayal of aging rocker Billy Mack), tragedy (watch Liam Neeson’s face as he speaks at his character’s wife’s funeral), poignancy (Mark’s Christmas Eve flip chart declaration of hopeless love for Juliet, Karen’s realization that her gift box contains a Joni Mitchell CD, not the beautiful gold necklace she saw in husband Harry’s coat pocket) and romance (Jamie’s proposal to Aurelia, in hilariously subtitled Portuguese, at the restaurant where she is waiting on tables). It is a deeply satisfying melting pot, and it never disappoints.
Similarly including several favorite themes – and doing justice to most of them, with one exception – is today’s case. (Shout out to the team at Nelson Mullins for the win and for sending us the decision.) In Ebert v. C.R Bard, Inc., 2020 WL 2332060 (E.D. Pa. May 11, 2020), the plaintiff was implanted with the defendants’ inferior vena cava (“IVC”) filter to prevent pulmonary embolism. The filter eventually fractured – a risk described in the Instructions for Use (“IFU”) – and a piece of it migrated to the plaintiff’s pulmonary artery. The plaintiff underwent successful surgery to remove the filter, including the fractured portion. She asserted the usual product liability claims, including claims sounding in negligence (design defect and failure to warn), breach of express warranty, negligent misrepresentation, and strict liability, and the defendants moved for summary judgment.
Negligent Design Defect
As the court explained, the Pennsylvania Supreme Court’s 2014 Lance decision held, for the first time, that negligent design defect claims are cognizable in prescription drug cases, and Pennsylvania’s federal district courts broadened the holding to apply to prescription medical devices. But, as the defendants argued in Ebert, Lance held that the relevant duty of care was narrow: “[u]nder Pennsylvania law, pharmaceutical companies violate their duty of care [only] if they introduce a drug into the marketplace . . . with actual or constructive knowledge that the drug is too harmful to be used by anyone.” Ebert, 2020 WL 2332060 at *3 (citation to Lance omitted). The plaintiff disagreed, citing language from Lance to the effect that “the law of negligence establishes a duty, on the part of manufacturers, which can be viewed as a continuum” from graduated strengths of warnings “through non-marketing or discontinuance of marketing” when the manufacturer knows or should know “that the product should not be used in light of its relative risks.” Id.
The court wasn’t buying it. Noting that “Lance’s ‘continuum’ language is dicta explaining the range of duties of care applying to negligence claims generally,” id. at *4 (emphasis in original), the court “agree[d] with [the defendants’] reading of Lance,” which held “that a prescription medical device manufacturer violates its duty of care, as it applies to negligent design defect claims – when it tenders into the market a drug which it knows or should know is so dangerous that it should not be taken by anyone.” Id. (internal punctuation and citation to Lance omitted). The court held that there was no record evidence that the defendants placed their filter into the market with actual or constructive knowledge that it was too harmful to be used by anyone. Further, the Plaintiff could not cure this void, and create an issue of fact, by attempting to demonstrate the existence of a safer alternative design. As such, the court granted summary judgment in favor of the defendants on the negligent design defect claim.
Negligent Failure to Warn
Regular readers of this blog know that we have a soft spot for a good warnings causation decision. In Ebert, the court began its discussion by emphasizing that, even if a defendant had a duty to provide adequate warnings and didn’t provide them, “plaintiffs must further establish proximate causation by showing that had the defendant issued a proper warning to the learned intermediary, he would have altered his behavior and the injury would have been avoided.” Id. at *5 (citations omitted). We thought this was a very good start.
So a failure-to-warn plaintiff must satisfy two tests: the warning must have been inadequate, and the inadequacy must have proximately caused the plaintiff’s injury. In Ebert, it was undisputed that the defendants’ IFU warned of the risk of filter fracture. Nevertheless, “notwithstanding the fact that the IFU warned of the specific complication that [the plaintiff] experienced, she contend[ed] that the warnings were still inadequate” because the defendants did not provide comparative failure rates between their filter and other devices.Id. at *6.
But the plaintiff’s doctor testified that he never read the IFU in its entirety, and that he couldn’t recall if he had read any of it before the plaintiff’s implant surgery. “Thus,” the court held, “even assuming that the warnings were inadequate, more detailed warnings, such as comparative failure rates, would have made no difference” in the doctor’s decision to implant the defendants’ filter in the plaintiff. Simple stuff: if the doctor didn’t read the warnings, it didn’t matter what they did or didn’t include – they couldn’t have affected his prescribing decision. No proximate cause, no failure-to-warn claim – summary judgment for the defendants. Hard to believe so many courts get this wrong.
Breach of Express Warranty/Negligence Misrepresentation
The plaintiff alleged that an express warranty was created by statements in the IFU representing that most filter fractures did not have adverse clinical consequences. In Pennsylvania, an express warranty “is created by any 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.” Id. at *7 (citations omitted).
The court emphasized that there was no evidence that the plaintiff ever read or saw the IFU or received any information from the defendants before her implant surgery, so no such information could have been part of the “basis of the bargain” when she agreed to the surgery. Nor could the plaintiff defeat summary judgment by arguing that she “indirectly relied on the warranty” by relying on the information conveyed to her by her doctor in the informed consent process. Even if such a warranty-once-removed could form the basis of a breach of warranty claim, there was no evidence that the doctor conveyed the information to her, let alone that it was a “basis of the bargain.”
Similarly, the court held that the plaintiff could not prevail on her negligent misrepresentation claims. She argued that the defendants’ sales training manual misrepresented the filter’s risks, but there was no evidence that she or her doctor “justifiably relied” on the statements, or was even aware of the manual’s existence. She also argued that the doctor “justifiably relied” on misrepresentations in the IFU, but, like the warnings claim, the doctor’s admitted failure to read the IFU defeated this argument.
And so we come to the court’s only misstep, significant in helping to create bad law though it did not affect the defendants’ good result.
Most of you are familiar with comment k to Section 402(a) of the Restatement (Second) of Torts. Comment k bars strict liability claims against the manufacturers of “unavoidably unsafe products,” explicitly including prescription drugs. In its 1996 Hahn decision, the Pennsylvania Supreme Court adopted comment k. Since then, decades of decisions have conceded that prescription medical devices are just like prescription drugs, for comment k purposes.
As we have reported in several recent posts (like this one and this one and this one), Pennsylvania’s federal courts have wrestled of late with this most obvious of propositions, some declining to extend comment k protection to the manufacturers of prescription medical devices. Misconstruing the holdings of both Tincher and Lance, the Ebert court jumped on this bandwagon, predicting that the Pennsylvania Supreme Court would analyze comment k’s applicability to prescription medical devices on a case-by-case basis “determined by each case’s developed factual record,” id. at *10, and would not apply it to medical devices across the board. (As we have explained in these pages, neither Lance nor Tincher limited the application of comment k to medical devices. Lance held only that comment k did not apply to negligence actions, and Tincher did not deal with pharmaceutical products at all.) But just as the bowling ball careened into the gutter, the bumpers deflected it back, at least for purposes of the defendants’ motion. Conducting its “analysis” on the basis of “a fully developed factual record,” the Court “conclude[d] that the . . . filter is an ‘unavoidably unsafe product’ such that the Pennsylvania Supreme Court would apply comment k to [it], thereby shielding [the defendants] from a strict liability claim.” Id. at *11. It reached this conclusion by reviewing literature confirming that the device carries risks. As do all medical devices, right? We know – none of this, except the defendants’ result, makes any sense. And the decision’s “case by case analysis” edict falls resoundingly on the wrong side of the teetering comment k scale.
But the bottom line is that the court granted summary judgment in the defendants’ favor on all of the plaintiff’s claims. And that is a very good result. Time to fire up the DVR – stay safe out there.