NJ Supreme Court Hears Significant Preemption Case

Beth S. Rose, Esq. | Sills Cummis & Gross P.C.

On April 11, 2016, the New Jersey Supreme Court heard oral argument on an issue of importance to manufacturers of generic drugs. The issue concerns whether failure to warn claims are preempted when there is a gap between the time the brand manufacturer changes its label and the time the generic manufacturer updates its label to match that of the brand.  Plaintiffs argued  that where there is a delay in the  generic manufacturers’ label update,  warnings claims are not preempted by the U.S. Supreme Court’s decision in Pliva v. Mensing. They maintained that in such a situation, it is not “impossible” for the generic manufacturers to update their labels to match those of the brand.  Defendants, on the other hand, argued that such claims are impliedly preempted by the U.S. Supreme Court’s decision in Buckman, the FDA’s exclusive enforcement authority, and other New Jersey case law, because the claims are based on an alleged violation of a federal requirement, namely the duty of sameness.

Although defendants’ reasoning  correctly flows from the FDCA and preemption jurisprudence, the Justices seemed extremely skeptical of the generics’ position. From the outset, the Court seemed concerned that if it ruled for the generics, then consumers would be left without a cause of action. Chief Justice Rabner’s first question presented a scenario where the brand manufacturer changed its label, and the generic waited two years to update its label to match the brand.  The Chief Justice asked whether a consumer who took a generic drug prior to the update and was injured had a remedy other than “calling the FDA.” The questions posed by other Justices suggested that they believed that plaintiffs could prove their warnings claims without referencing federal law, and that Buckman was distinguishable. They seemed predisposed to the approach of the 6th Circuit, which has accepted plaintiffs’ argument. The Justices also seemed interested in whether the FDCA or its regulations identified a specific time frame for generics to update their labels, and why FDA had not taken any enforcement action against generics that had not promptly updated them. They did not seem to fully appreciate that the label goes to the doctor (the learned intermediary) as opposed to the consumer. Also,  it seems highly unlikely that plaintiffs could prove such a claim without reference to federal law. Similarly, plaintiff’s so-called failure to warn claims do not fit within the New Jersey Product Liability Act and the corresponding jury charges. If the Court agrees with plaintiffs’ position, trials in such cases are likely to be complicated, unwieldy and contort New Jersey law.

What Scalia’s Passing Means to Life Sciences Companies

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.

Preemption

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.

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