Massachusetts Says Brand Name Drug Manufacturers Are Not Liable for Generic Drugs, Except . . .  

Jordan Lipp | Attorney, Managing Member | Childs McCune

On March 16, 2018, the Massachusetts Supreme Court weighed in on the issue of whether a brand name drug manufacturer is liable for a plaintiff’s use of the generic form of the drug, and it reached a surprising result.  As discussed in the previous blog post on December 22, 2017, Conte on Steroids, most states conclude that a brand name drug manufacturer cannot be liable for damages caused by the generic version of the drug.  In a detailed analysis, the Massachusetts Supreme Court followed the vast majority of its sister courts, concluding that a brand name drug manufacturer cannot be held liable in product liability or negligence for a plaintiff who ingested the generic version.

But then, borrowing from case law involving such disparate subjects as landowner duties to trespassers and liability releases for sporting activities, the Massachusetts Supreme Court explained that “public policy is not served if generic drug consumers have no remedy for the failure of a brand-name manufacturer to warn in cases where such failure exceeds ordinary negligence, and rises to the level of recklessness.”  Rafferty v. Merck & Co., No. SJC-12347, 2018 Mass. LEXIS 161, at *29 (Mar. 16, 2018).  As such, the Court found that a brand name drug manufacturer can be liable for the generic version of the drug “where, for instance, a brand-name manufacturer learns that its drug is repeatedly causing death or serious injury, or causes birth defects when used by pregnant mothers, and still fails to warn consumers of this danger.”  Id. at *29-30 (Mar. 16, 2018).

The ramifications of this novel approach are significant.  Setting aside the fact that this decision comes from a court in one of the hubs of innovation in the life sciences, it is important to note that the decision is the very first of its kind.  No other court has determined to bar negligence claims yet permit reckless claims with regards to brand name drug liability resulting from generic use.  The Massachusetts Supreme Court even admits that it is “the only court” to make this distinction.  Id. at *32.

While this is a new issue in the context of drug and device litigation, other types of litigation shed light on what the repercussions of this decision may be.  As referenced above, this distinction of not permitting negligence claims but permitting reckless claims exists in the context of both sporting participants who have signed a release and trespassers who claim injury.  On one hand, the higher standards in these types of cases has discouraged lawsuits and made summary judgment easier for defendants to obtain.  On the other hand, requiring a plaintiff to meet a reckless standard certainly does not eliminate litigation.  And, depending upon the situation and insurance policy, the reckless standard can have serious insurance ramifications as some insurance policies do not cover reckless conduct.  The other question, of course, is whether courts in other jurisdictions may start to follow Massachusetts’ novel approach on brand name drug liability.

Regardless, for brand name drug manufacturers, it is a brave new world in Massachusetts.

FDA Pushes Back the Date for Issuing Generic Drug Labeling Rule to April 2017

Jordan Lipp, Esq. | Partner, Davis Graham & Stubb

On Thursday, the FDA again pushed back the date it expected to issue its final rule on generic drug labeling.  The final rule is now expected in April 2017.  The highly controversial proposed rule, as discussed in more depth in earlier posts, would permit generic drug manufacturers to unilaterally change their labels under the changes-being-effected (“CBE”) process.  Besides likely creating a bureaucratic headache and allowing generic and brand-name labels to differ (potentially in violation of the Hatch-Waxman Act), the proposed rule would also threaten to undermine the generic drug preemption decisions by the U.S. Supreme Court.  The proposed rule has generated significant political heat for these reasons, and the date for the final rule has already been pushed back several times.  Although the FDA did not state a reason for pushing back the announcement of its final rule again, the new date of April 2017 is, of course, after the next election.  Whether the final rule will ever be issued, and what it may look like, are open questions.  In any event, the wait continues.

 

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.

FDA Reopens Comment Period on Generic Drug Labeling Proposed Rule

Jordan L. Lipp | Partner, Davis Graham & Stubbs LLP

Bowing to pressure from stakeholders and Congress, on Tuesday FDA announced that it would reopen the comment period (through April 27, 2015) for its proposed rule that would allow generic drug manufacturers to unilaterally change their labels.  And, FDA set a public meeting for March 27, 2015, in order to “provide a public forum for FDA to listen to comments on the proposed rule.”  As discussed in more depth in an earlier post, FDA’s highly controversial proposed rule would permit generic drug manufacturers to unilaterally change their labels under changes-being-effected (“CBE”) process, which not only would result in the potential for generic and brand-name labels to differ, but would also threaten to undermine recent generic drug preemption decisions by the U.S. Supreme Court. Continue reading “FDA Reopens Comment Period on Generic Drug Labeling Proposed Rule”