Courtney A. Stevens | Senior Attorney, Loss Control | Medmarc Insurance Group
The recent passing of Justice Antonin Scalia, the Court’s longest-serving justice, means more than just political scuttlebutt over who will get to appoint his replacement. For life sciences companies, it means the loss of a real ally in matters of tort liability and a powerful force in intellectual property.
Scalia authored the 8-1 majority opinion in Riegel v. Medtronic, 552 U.S. 312 (2008), a pivotal decision in preemption jurisprudence that held that the Medical Device Amendments to the Food, Drug and Cosmetic Act (FDCA) preempted state-law claims relating to the safety and effectiveness of pre-market approval (PMA) devices. This effectively shields makers of PMA devices from products liability claims.
In Wyeth v. Levine, 555 U.S. 555 (2009), which undermined preemption in holding that FDA approval of a medication does not preempt state law failure-to-warn claims, Scalia joined the dissent (authored by Justice Samuel Alito). The dissent argued that this holding was inconsistent with their previously-adopted “conflict preemption” analysis.
Scalia also authored several patent decisions affecting drug, biologic, and medical device makers and intellectual property holders. These included the 2007 decision in MedImmune v. Genentech, 549 U.S. 118, which facilitated patent challenges by holding that a patent licensee is not required to terminate or breach its license agreement in order to challenge the subject patent’s validity.
He also wrote for a unanimous court in Merck KGAA v. Integra Lifesciences I, Ltd., 545 U.S. 193 (2005), which held that use of a patented compound in experiments that are not themselves included in a submission of information to the FDA is not infringement.