We have news to report. No, we don’t mean the resignation of New York’s governor, though we can’t say we’ve shed many tears. And we certainly don’t have much good news about Greece, where we are supposed to be headed in a few weeks. Between Delta (Greece is now back in the CDC’s “Level Four”) and the catastrophic fires in Greece and Turkey that have filled the skies over our destination island with dense smoke, Greece is suffering through scary and challenging times, and we are keeping that beautiful country and its people in our thoughts.
Our news is of the first-world professional sort, but it is right in our wheelhouse and has the potential to benefit all of us who represent medical device manufacturers. (It has the opposite potential, too, but we are in a glass-half-full mood.) As we lamented a little over a year ago, in a post about a case called Ebert v. C.R. Bard, 2020 WL 2332060 (E.D. Pa. May 11, 2020) (as well as here and here and here and here), Pennsylvania’s federal district courts have spent the past several years in a ludicrous and unnecessary debate. Courts have split over whether the “unavoidably unsafe product” exception of comment k to Section 402(A) to the Restatement (Second) of Torts, which expressly bars strict liability design defect claims against manufacturers of prescription drugs, also bars those claims against manufacturers of prescription medical devices. Why is this debate ludicrous and unnecessary? Because there is no conceivable basis on which to draw a principled distinction between prescription drugs and prescription medical devices for purposes of comment k’s exemption. Of course comment k bars strict liability claims against device manufacturers. There is no colorable argument otherwise, and decades of Pennsylvania appellate jurisprudence (stopping short of the Pennsylvania Supreme Court, but stay tuned) agrees with us.
Ebert went the wrong way on the comment k question. But it went the right way on another disputed issue: the scope of the Pennsylvania Supreme Court’s 2014 Lance decision, which held, for the first time, that negligent design defect claims are cognizable in prescription drug cases. (Pennsylvania’s federal district courts broadened the holding to apply to prescription medical devices.) The Ebert court agreed with the defendants that the relevant duty of care is narrow – that manufacturers breach their duty only if they introduce into the marketplace a drug that is too harmful to be used by anyone. (The plaintiff disagreed, citing language from Lance to the effect that the duty can be viewed as a continuum with breaches of duty possible all along the continuum.)
Last month, we told you that the Third Circuit had certified both questions to the Pennsylvania Supreme Court. Just last Thursday, the Supreme Court granted review of both questions. The Order states:
The Court shall consider the following issues: (1) Under Pennsylvania law, must a plaintiff bringing a negligent design claim against a prescription medical device manufacturer prove that the device was too harmful to be used by anyone, or may the plaintiff also prevail on other theories of liability where appropriate? (2) Under Pennsylvania law, are prescription implantable medical devices categorically subject to strict liability, categorically immune from strict liability, or immune from strict liability on a case-by-case basis? If they are immune on a case-by-case basis, what test should a court apply to determine whether a particular device is immune?
We are watching anxiously, cautiously hopeful that the Court will adopt the narrow construction of Lance and will hold that comment k applies across the board to bar strict liability design defect claims against prescription medical device manufacturers. (Our personal opinion is that applying comment k on a case-by-case basis is of little value, as this analysis nearly always involves fact issues that preclude summary judgment.) We will let you know as soon as the Court decides the appeal. We may even attend the argument, if it is “in person,” and we will let you know if we do. In the meantime, stay safe out there.
This will be the last post we write for a while, as we are about to head to trial in a product liability case. The plaintiff says that a medical device has caused her to suffer pain and other injuries. What else would you expect? Her case has gotten as far as it has because an expert will come to court and act as a credentialed and highly-paid oath-helper. He will say that the device is, indeed, the culprit. Again, what else would you expect? But we think his opinions lack support and don’t quite get to where they need to go. For that reason, we will keep a copy of Gottlieb v. C.R. Bard, Inc., 2021 U.S. Dist. LEXIS 141280 (E.D. Va. July 31, 2021), near at hand.
Gottlieb was about an implanted IVC filter. (Our case also involves an implant, but not an IVC filter.). The IVC filter fractured and migrated. The plaintiff in Gottlieb alleged that such fracturing/migration of the filter caused her to suffer from anxiety, abdominal pain, chest pain, and shortness of breath. Her complaint included the usual catalogue of causes of action, including negligent design, failure to warn, breach of warranty, and misrepresentation. The plaintiff sought compensatory and punitive damages. The defendant filed a motion for summary judgment, with the primary argument being that the plaintiff could not prove proximate causation.
It is clear under the law of Virginia (and every other place we’ve litigated) that a plaintiff needs a medical expert to establish medical causation. In Gottlieb, the plaintiff had such an expert. The issue was whether that expert said what needed to be said. To be sure, the medical expert pronounced that all of his opinions were held to a reasonable degree of medical certainty. The necessary incantation was uttered. There also does not seem to be any deficiency in the expert’s qualifications. He was a doctor, not a quack. He was apparently even a doctor in the right specialty. So far so good.
The plaintiff medical expert looked at the appropriate medical records. He testified that the IVC filter fractured and migrated just a bit north of the retrieval hook. Okay, then what? Herein lies the problem with the expert’s opinions. His only real opinion regarding the plaintiff’s alleged injuries is that she “will need to have close clinical follow-up.” He does not specifically tie the alleged injuries (anxiety, pain, shortness of breath) to the fractured filter. At most, the expert offered “speculative testimony regarding the potential ramifications of Plaintiff’s filter’s movement” — which the court held was “insufficient.”
Perhaps the plaintiff medical expert in Gottlieb should be congratulated for not overextending. But we doubt that the plaintiff or her lawyers are offering such congratulations, because the testamentary gap prompted the court to grant summary judgment in favor of the defendant: “Here, Plaintiff offers no expert testimony that her IVC filter caused her injuries, and is therefore unable to create a jury issue as to causation. Without any expert testimony that the complications associated with her IVC filter caused her alleged injuries, Plaintiff’s claims must fail.”