PHILADELPHIA – According to a panel trio of judges from the U.S. Court of Appeals for the Third Circuit, the Supreme Court of Pennsylvania, and not itself, must decide two unresolved questions of medical device product liability law.
In a June 24 petition for certification authored by Third Circuit Judge Cheryl Ann Krause alongside colleagues Peter J. Phipps and Julio M. Fuentes, the judges identified those two questions in an action titled Ebert v. C.R. Bard.
“First, what standard the Pennsylvania Supreme Court would apply to negligent design claims against prescription medical device manufacturers, and second, whether prescription medical device manufacturers are categorically subject to strict liability under Pennsylvania law or may instead be immune from strict liability in certain circumstances,” Krause said.
“This panel, having read the briefs and submissions of the parties and having reviewed the applicable decisions of the Pennsylvania courts, believes that both questions represent important and unresolved issues of state products liability law appropriate for certification. We therefore respectfully request that the Supreme Court of Pennsylvania accept this certification.”
Plaintiff Melissa Ebert, diagnosed with deep vein thrombosis in 2008, a life-threatening blood clot. Subsequently, to catch any blood clots before they could reach Ebert’s heart or lungs, her treating physician implanted an inferior vena cava filter in her manufactured by C.R. Bard, Inc., known as a G2 IVC filter.
The filter was set to be removed after three years, but could not be, because one of its struts had fractured and grown into the wall of Ebert’s vein. Eventually, the strut moved to Ebert’s pulmonary artery, necessitating removal surgery.
Though Ebert did not suffer permanent heart or lung damage, she sued the filter’s manufacturer, Bard, over claims of negligent design and strict liability.
However, Krause explained that it was “unclear” what level of care could apply to such implantable medical devices.
“First, with regard to negligent design, it is unclear what standard of care should be applied to implantable medical devices like the G2 filter under the Court’s decision in Lance v. Wyeth. Second, with regard to strict liability, it is unclear whether and in what circumstances an implantable medical device like the G2 filter is subject to strict liability under Hahn v. Richter and Tincher v. Omega Flex, Inc.,” Krause said.
In Lance v. Wyeth, the Supreme Court of Pennsylvania ruled that pharmaceutical companies violate their duty of care if they sell drugs with “actual or constructive knowledge” that a given drug causes harm when used by anyone.
“The question raised by this appeal is whether Lance means that a plaintiff may prevail in a negligent design claim against a medical device manufacturer only by showing that the device was ‘too harmful to be used by anyone,’ or whether such a plaintiff may also prevail on another theory of negligent design – here, for example, that there was ‘an alternative safer design’ that was feasible at the time,” Krause said.
“Put simply, does Lance set the floor or the ceiling for negligent design claims against prescription medical devices? Courts in Pennsylvania have divided over that question.”
On the question of strict liability, Krause said the federal and Pennsylvania courts have been divided on the subject, thus offering more than one interpretation to deal with the instant case.
“These cases suggest three alternative ways to analyze strict liability in this context: (1) implantable medical devices could be categorically subject to strict liability under Tincher’s holding that ‘the presumption is that strict liability may be available with respect to any product, provided that the evidence is sufficient to prove a defect,’ (2) implantable medical devices could be categorically immune from strict liability under Hahn on the ground that prescription medical devices are legally indistinguishable from prescription drugs and therefore fall within the scope of Hahn’s holding; or (3) implantable medical devices could be immunized under comment k [of the Restatement (Second) of Torts Section 402A] on a case-by-case basis,” Krause said.
“Moreover, if this third alternative is the proper approach, there are also two possible methods for that case-by-case analysis. One method would focus on the general type of device at issue.”
James M. Beck, Senior Life Sciences Policy Analyst at Reed Smith in Philadelphia, says that the Tincher v. Omega Flex, Inc. decision led to hope that it would overturn “more than 35 years of pro-plaintiff Pennsylvania idiosyncrasy that had removed the issue of whether a product defect was ‘unreasonably dangerous’ under Restatement Section 402A from the jury’s purview, on the now-discredited proposition that negligence and strict liability were absolutely separate and that evidence of negligence was improper in a case raising only strict liability.”
“The effect of the existing no-strict liability rule in the Hahn/Incollingo line of cases was to insulate our sandbox – prescription medical product liability litigation in Pennsylvania – from the jurisprudential depredations of the Azzarello era of super-strict liability,” Beck said.
“We were never faced with arguments by plaintiffs that any dichotomy between negligence and strict liability meant that, say, the compliance of a drug or device with FDA requirements was ‘irrelevant’ in strict liability and could not be made known to the jury. Nor were our clients subjected to strict liability-based arguments that they could be liable for alleged product risks that were not scientifically discovered until much later.”
Beck referred to Sullivan v. Werner Co., a key case on the inadmissibility of government and industry standards in strict liability which was recently denied re-argument, as possibly also coming before the state Supreme Court if it is appealed.
“To us, the potential synergy between Ebert, on the strict liability question, and Sullivan, on the inadmissibility of government and industry standards in strict liability, raises the stakes in both appeals considerably,” Beck said.
“Anyone involved in pelvic mesh litigation knows how exclusion of FDA compliance evidence there has created an FDA-free fantasy world that misleads juries and has allowed plaintiffs free reign to make arguments at odds with what the FDA required. Imagine having to deal with a similar situation in every future drug and device case in Pennsylvania. That’s what is now at stake,” Beck said.
U.S. Court of Appeals for the Third Circuit case 20-2139
U.S. District Court for the Eastern District of Pennsylvania case 5:12-cv-01253
From the Pennsylvania Record: Reach Courts Reporter Nicholas Malfitano at nick.malfitano@therecordinc.com