June 2021 - Faegre Drinker on Products

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Pennsylvania Medical Device Strict Liability Claims: Relentless Repetition, Clamoring for Review

A Pennsylvania federal court has again asked that the state’s Supreme Court clarify whether, and to what extent, medical device manufacturers are immune from strict liability claims by virtue of the “unavoidably unsafe products” exemption recognized in Restatement (Second) of Torts Sec. 402A cmt. k (“Comment k”)—only this time with a direct certification.

On Thursday, the Third Circuit Court of Appeals certified that question to the Pennsylvania Supreme Court, along with a question about which negligent design defect theory—or theories—a Pennsylvania plaintiff may assert against a medical device manufacturer. Pet. for Certification of Questions of State Law, ECF No. 50, Ebert v. C.R. Bard, Inc., et al., No. 20-2139 (3d Cir. June 24, 2021) (“Ebert Pet.”). Last spring, Judge Pappert of the Eastern District of Pennsylvania dismissed Ms. Ebert’s strict liability claim, finding her IVC filter “an ‘unavoidably unsafe product’” under Hahn v. Richter, 673 A.3d 888 (Pa. 1996), and she appealed that order granting summary judgment to the Third Circuit.

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District of New Jersey Adopts Local Civil Rule Requiring Disclosure of Third-Party Litigation Funding

The U.S. District Court for the District of New Jersey has adopted new Local Civil Rule 7.1.1, requiring lawyers to disclose details about third-party litigation funding. On June 21, 2021, Chief Judge Freda L. Wolfson signed the order formally amending the Rule to include Section 7.1.1.

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New FDA Policy on Homeopathic Drugs Survives Preliminary Injunction Appeal

Overview

The FDA’s recent policy shift regarding homeopathic drugs was recently supported by the D.C. Circuit Court of Appeals in MediNatura v. FDA, No. 20-5341 (D.C. Cir. 2021), when it upheld the denial of a preliminary injunction to block the FDA from withdrawing a longstanding enforcement policy regarding homeopathic drug products.

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Cosmetics Companies: Beware of PFAS

It’s no secret that the regulatory landscape of cosmetics and personal care products as we know it is changing. Over the last few years, Congress, along with industry and consumer groups, have made a combined effort to push for heightened regulation of these products. The latest effort, introduced in Congress on June 15, 2021, seeks to ban the addition of per- and polyfluoroalkyl substances (generally known as “PFAS”) in cosmetics and personal care products.

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Southern District of Texas Holds Learned Intermediary Doctrine Applies to Clinical Trials

Does the learned intermediary doctrine apply in the context of a clinical trial? According to the Southern District of Texas, it does. The case in question is Butler et al. v. Juno Therapeutics, Inc., a tragic case involving the death of a 19-year-old woman with terminal leukemia who died within days of receiving an experimental cancer drug as a participant in a clinical trial.

In 2015, Juno Therapeutics (Juno) was developing a treatment for advanced blood cancers involving Chimeric Antigen Receptor T-cell (CAR-T) therapy. CAR-T therapy is designed to modify a patient’s white blood cells to target cancer cells with the goal of improving the patient’s condition so a bone marrow or stem cell transplant can be tolerated. In October 2015, Juno entered into a Clinical Study Agreement with MD Anderson (and other hospitals) as part of a Phase 2 clinical trial (the “Rocket Study”) of a drug identified as JCAR015, a CAR-T therapy. Drs. William Wierda and Michael Rytting were the principal investigators of the Rocket Study at MD Anderson.

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The Additional Cost of an Adverse Judgment: Illinois’ New Prejudgment Interest Act

Recent legislation will have a significant impact on the evaluation of personal injury and wrongful death cases across Illinois. For many years, Illinois plaintiffs in personal injury and wrongful death actions have been entitled to statutory postjudgment interest, currently at a rate of 9% per year. (735 ILCS 5/2-1303(a)). Prejudgment interest, however, has not been available under the Illinois judgment interest statute. That is about to change. The Illinois legislature recently passed Senate Bill 72, the Illinois Prejudgment Interest Act, which goes into effect on July 1, 2021, and imposes prejudgment interest on defendants at a rate of 6% per year.

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