This post comes from only the Dechert side of the blog, as Reed Smith is involved in this litigation.
* * * *
The New Jersey NuvaRing litigation, which involves a combination hormonal contraceptive, recently produced an opinion that granted the defense summary judgment in seven separate cases. That’s a pretty big win for the defense. But a broader win can be found in the reasoning of the court. The defense didn’t win on one overarching argument. It won for a variety of reasons.
Failure to Warn
Two of the seven cases were dismissed because the court found that the NuvaRing label’s warning on venous thromboembolism (VTE), the alleged side effect, was adequate as a matter of law. The plaintiffs in these two particular cases were New Jersey residents, and so the court applied the New Jersey Product Liability Act (PLA). The PLA contains a presumption for adequacy of any FDA-approved warning:
If the warning or instruction given in connection with a drug or device or food or food additive has been approved or prescribed by the federal Food and Drug Administration . . . a rebuttable presumption shall arise that the warning or instruction is inadequate.
Slip Op. at 31 (citing NJSA §2A:58C-4). New Jersey caselaw has established two types of evidence that can rebut this statutory presumption, both relate to post-approval actions by the defendant: (1) evidence that the defendant deliberately concealed or failed to disclose after-acquired knowledge of harmful effects of the drug (the Perez exception), or (2) evidence that the manufacturer engaged in an economically-driven manipulation of the post-market regulatory process (the McDarby exception). Id.