In Ebert v. C.R. Bard, the United States Court of Appeals for the Third Circuit determined that Pennsylvania state law is unclear on two issues of medical device liability, and sent the issues to the Pennsylvania Supreme Court for review.

In Ebert, a G2 clot filter made by Bard was placed into the plaintiff’s inferior vena cava. Although the filter was set to be removed after three years, it could not be removed because one of its struts broke, grew into the vein wall and was caught in the plaintiff’s pulmonary artery. Thus, the plaintiff was forced to undergo a procedure to remove the filter. The plaintiff then brought suit, alleging negligent design and strict liability.
Continue Reading Third Circuit Sends Questions Regarding Medical Device Liability to Pennsylvania Supreme Court for Review

The SCOTUS decision in Ford Motor Company v. Montana Eighth Judicial District Court[1] is a decision that we believe will alter the legal landscape in the defense of product liability matters with respect to the personal jurisdiction defense. We have reported on this case in prior posts (see The Law of Personal Jurisdiction Is About to Be Changed Again – What Life Science Companies Should Expect), and now that a decision has been handed down by the SCOTUS, we would like to share some of our thoughts on how we believe the decision will impact the defense of life science companies in product liability litigation throughout the United States.
Continue Reading The SCOTUS Decision in Ford v. Montana and Its Impact on the Defense of Life Science Companies

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?