For at least two decades, Pennsylvania law has recognized an exemption from strict liability for prescription drug manufacturers based on the state Supreme Court’s interpretation of the Restatement (Second) of Torts Sec. 402A cmt. k. Comment k carves out an exception to traditional strict product liability claims for “unavoidably unsafe products,” or those which bear inherent risks—such as medicines which must be prescribed by a doctor. A less settled question is whether that exemption extends to manufacturers of prescription medical devices, specifically regarding manufacturing defect claims. On June 25, 2019, Judge Robreno of the U.S.D.C. Eastern District of Pennsylvania asked the Third Circuit to answer it.
This winter we discussed new regulatory guidelines intended to increase transparency in Direct-to-Consumer (DTC) advertising including a proposed rule from the Centers for Medicare and Medicaid Services (CMS) that would require pharmaceutical manufacturers to list prices in DTC advertising for drugs costing $35 for a 30-day supply.
For some long-awaited events, a little time and distance can add a measure of clarity. Not always – many still are processing the Game of Thrones finale, with no end in sight. But over the past few weeks pharmaceutical products liability lawyers have had the opportunity to acquire some Zen and enlightenment about the Supreme Court’s highly anticipated preemption decision in Merck Sharp & Dohme, Inc. v. Albrecht, 2019 WL 2166393 (U.S. May 20, 2019). An initial description of the decision is here.
In a trio of recent decisions arising out of cases alleging that an antipsychotic medication, Risperdal, and its generic, risperidone, had caused gynecomastia (breast tissue growth) in men, the United States District Court for the District of Delaware granted motions for summary judgment for defendant Janssen Pharmaceuticals, Inc. The three opinions clarify that Delaware law would not impose innovator liability on a branded drug manufacturer when the plaintiff had used only a generic drug, and addressed “but-for” warnings causation and proximate cause in prescription drug products liability cases. [Disclosure: Drinker Biddle & Reath. LLP attorneys were co-counsel of record in these cases for Janssen.]
Our federal system and the often dysfunctional nature of Congress can be vexing for cutting-edge manufacturers. Emerging technologies are rarely addressed at the federal level, leaving states to pass piecemeal regulations that can frustrate even the most attentive compliance officers. If you’re bringing a product to market nationwide, you need to be aware of which states have the most stringent regulations. When it comes to biometrics, Illinois tops that list.
The Illinois Biometric Information Protection Act (BIPA) generally is considered the most stringent in the United States, and lawmakers in Florida and New York City are currently working on passing similar measures. So just what is the current state of biometric data privacy in Illinois? The answer lies in three rather unexpected topics: roller coasters, robot dogs, and pizza.
Third-party litigation funding has received increased scrutiny over the past several years, particularly in the context of mass torts, class actions, and multidistrict litigation. Most of this scrutiny has focused on pre-litigation or pre-resolution commercial loans to fund the litigation, and particularly whether parties are required to disclose such funding during the course of the litigation.
For example, in February 2019, several U.S. senators reintroduced S.471, the Litigation Funding Transparency Act of 2019, which would require plaintiffs to disclose third-party litigation funding for class actions and multidistrict litigation. This came on the heels of a January 2019 letter from more than 25 major U.S. companies to the Committee on Rules of Practice and Procedure requesting an amendment to Federal Rule of Civil Procedure 26(a)(1)(A) “to require in civil actions the disclosure of agreements giving a non-party or non-counsel the contingent right to receive compensation from proceeds of the litigation.”