The Evolution of Innovator Liability for Pharmaceutical Manufacturers
Brand-name drug manufacturers are not unfamiliar with the concept of Innovator Liability, under which they can be held liable for injuries caused by a product they did not make. In other words, Innovator Liability holds a manufacturer liable by virtue of being an innovator.

Innovator Liability, usually brought under a failure to warn theory, can be traced back to a 2008 California case, Conte v. Wyeth, Inc., where the Court of Appeal held that a branded drug manufacturer’s duty to warn extends to patients taking the generic counterpart. The court reasoned that it is foreseeable that physicians and pharmacists may rely on the brand drug’s label to prescribe the drug’s generic counterpart for patients.[i] Conte has been rebuffed nationwide. By July 2014, more than 100 courts in 49 states, including the U.S. Courts of Appeals for six different circuits, rejected Innovator Liability.[ii] The Supreme Court of Iowa described Innovator Liability as “deep-pocket jurisprudence [which] is law without principle.”[iii]

Continue Reading Never-Ending Liability Under Novartis

On March 16, 2018, Massachusetts’s highest court , the Supreme Judicial Court, issued a ruling that we believe will increase the product liability risk exposure for pharmaceutical manufacturers in the state. In the case of Rafferty v. Merck & Co., SJC-12347 (March 16, 2018), the Supreme Judicial Court held that a user of a generic drug may not bring a simple negligence claim against the brand-name manufacturer for failure to warn, but the user could bring a failure to warn claim against the brand-name manufacturer if it could show that that the brand name manufacturer intentionally failed to update a label on its drug, “knowing or having reason to know of an unreasonable risk of death or grave bodily injury associated with its use.” The Supreme Judicial Court’s holding requires a plaintiff to show that the brand-name manufacturer’s actions were reckless, as opposed to only negligent, which is a more stringent standard to prove. The Court’s decision sought to balance protection for the consumers of generic drugs in light of the U.S. Supreme Court decision in Pliva Inc. v. Mensing,[1] while taking into account the burden on brand-name manufacturers. However, by its own admission, this latest decision from Massachusetts’s highest Court stands in the minority of courts that have ruled on this issue. The decision is an important one, however, because brand-name manufacturers can now be held liable to the users of the generic versions of its drug under a theory of reckless failure to warn. It will be interesting to see if other jurisdictions that have not addressed the issue will follow the Massachusetts high court.
Continue Reading Rafferty v. Merck Expands Potential Liability for Drug Manufacturers in Massachusetts

Previously on this blog, Wilson Elser attorneys have written several posts about 3D printing technology and the law. We have predicted that this new technology has the potential to change the landscape of product liability law. This is happening, and especially so with respect to implantable medical devices, which are revolutionizing the health care industry with their unlimited potential for customization.

While there are still no published opinions for product liability cases involving 3D printed medical implants (or any 3D printed medical devices for that matter), we recently had the opportunity to defend a manufacturer client on product liability and negligence causes of action asserted against its 3D printed, custom-made orthopedic prosthesis. We obtained summary judgment for the client.

Continue Reading 3D Printed Medical Implants: Should Laws and Regulations Be Revolutionized to Address This Revolutionary Customized Technology?

ventilator-operating-room136369331TSI am writing to report about a recent dismissal of a manufacturing defect claim made against a medical device manufacturer in the USDC for the Eastern District of Pennsylvania. This decision is favorable to our clients that are involved in defending medical devices. We believe this case may dissuade plaintiffs from filing cases against medical device manufacturers in Pennsylvania in the future, at least in federal court.

It has been a long-standing principle in Pennsylvania that the doctrine of strict products liability does not apply in cases involving prescription drugs. This principle was recently affirmed by the Supreme Court of Pennsylvania in the case of Lance v. Wyeth, 15 A3d 434 (PA 2014), which was decided earlier this year. As was stated in Lance, for policy reasons strict products liability claims are barred against manufacturers of prescription drugs under Pennsylvania law. However, the Supreme Court of Pennsylvania has yet to rule whether this ban also applied to prescription medical devices. Before the decision in Lance was made earlier this year, the federal courts in Pennsylvania had ruled that manufacturing defect claims were permissible in cases involving prescription medical devices.

Continue Reading Does Pennsylvania Permit Manufacturing Defect Claims Involving Medical Devices?

Assorted Pills_SS_46658200Plaintiff’s expert is excluded for relying on a “novel” methodology to support opinion that antidepressant drug causes birth defects. 

On June 27, 2014, in In Re: ZoloftU.S. District Judge Cynthia Rufe of the Eastern District of Pennsylvania issued an opinion excluding an expert in a case that bears a striking resemblance to the facts of Daubert v. Merrell Dow. We think Judge Rufe’s decision in Zoloft will serve as useful precedent to the defense bar and their clients in future pharmaceutical product liability litigation.

Continue Reading Daubert Déjà Vu