If you are a parent, you’ve probably thought (more than once) that you speak a language your children do not understand. After all, when you say “put your shoes away” or “stop hitting your sister” or the more recent addition of “no iPads at dinner” – you believe these to be simple, easily understood directions. But when you’ve said them 5 times in the span of one hour, you start to question your own command of the language. What is it that is not getting through? What don’t they understand? You look for acknowledgement from your significant other that he/she understands you. While you take comfort in knowing that other adults comprehend, they are on your team already. You don’t need to convince your own side. But how do you finally drive it home to them.
How about when them are the plaintiffs? How many different courts, over how many years, in how many different ways can say the same thing – Pennsylvania does not recognize strict liability for prescription medical products. We are quickly approaching 20 years since Hahn v. Richter, 673 A.2d 888 (PA 1996) banned strict liability for prescription drugs and the extension of that ban to medical devices has been on solid footing for at least the last 10 years as well. But because the Pennsylvania Supreme Court has yet to explicitly state that the reasoning and ruling of Hahn applies equally to medical devices, plaintiffs keep filing strict liability device claims in Pennsylvania courts. And, appropriately, the courts keep shredding them.
Last week saw two such decisions from the Eastern and Western Districts of Pennsylvania. One case involved a spinal implant – Wilson v. Synthes USA Prods., LLC, 2015 U.S. Dist. LEXIS 92347 (E.D. Pa. Jul. 15, 2015). The other involved a hip implant – Cogswell v. Wright Medical Tech., Inc., 2015 U.S. Dist. LEXIS 92461 (W.D. Pa. Jul. 16, 2015). In both, plaintiffs tried to argue that Pennsylvania’s ban on strict liability did not apply to medical devices. In Wilson, plaintiff focused on the idea that medical devices could be “altered” to be more safe. Wilson at *7. The court was unpersuaded, finding instead that both drugs and devices are “unreasonably dangerous, but should not be subjected to strict liability because they benefit certain members of society.” Id. Plaintiff in Cogswell tried a similar argument contending that medical devices are different because the risks could have been avoided. Cogswell at *5. Again, the court was unpersuaded.
The Cogswell plaintiff, however, took the argument further. First, he tried to argue that prescription products are only covered by comment k (the basis for the strict liability ban in Pennsylvania) if certain caveats are met. Those caveats were not recognized by the Pennsylvania Supreme Court and therefore, weren’t recognized by the district court either. Id. at *6. Next, he attempted to distinguish a strict liability manufacturing defect claim as permissible, arguing that Hahn only applied to failure to warn. Not a new argument, but also not one that the court was willing to entertain. “Had the Pennsylvania Supreme Court intended an exception to the strict liability rule, it presumably would have articulated one.” Id. at *8.
Taking strict liability out of play in both cases, the courts looked at what was left. In Wilson, that was negligent manufacturing defect, design defect and failure to warn claims that all survived the motion to dismiss. As did a negligence per se claim which the court deferred until the summary judgment stage. But plaintiffs also brought a negligent marketing claim. Negligent marketing in Pennsylvania is limited, however, to claims of over-promotion. With no over-promotion allegations, the court dismissed the marketing claim as well.
Plaintiff in Cogswell, also brought express and implied warranty claims. The court first dismissed the express warranty claim relying on the ruling in Hahn, that where the issue is adequacy of warnings, “the manufacturer’s negligence is the only recognized basis of liability.” Id. at *10. On implied warranty, Pennsylvania courts have disallowed it in prescription drug cases and like with strict liability, federal courts have found the logic should extend to medical devices. Plaintiff tried to argue that his hip implant is not an unavoidably unsafe product and therefore he should be permitted to pursue his implied warranty claim. That argument didn’t work for strict liability, and it didn’t work for implied warranty. Id. at *12. The only surviving claim in Cogswell is negligent misrepresentation.
We think Pennsylvania judges are starting to feel like broken records on this point — no strict liability in medical device cases. It is really difficult to say it more clearly. And rather than trying to sneak one by (like one quick text at the dinner table), plaintiffs should better spend their time narrowing their claims and only bringing those that aren’t outright prohibited. That won’t stop defendants from moving to dismiss the claims that are brought – but do we really need to brief Hahn one more time!