As evidenced by our generic preemption scorecard the post-Mensing scales have been heavily tipped in favor of the generic manufacturers who have racked up dismissals across the country. But not every court is willing to jump on the “complete dismissal” side of the seesaw. We reported on the Fisher v. Pelstring case from the District of South Carolina back in October and now that court’s neighbor to the north has decided to follow suit – focusing on factual uncertainties regarding timeliness to deny the generic defendants’ motion to dismiss. Couick v. Wyeth, Inc., 2012 U.S. Dist. Lexis 3699 (W.D.N.C. Jan. 11, 2012) (brand manufacturers previously dismissed).
The Couick court divided plaintiffs’ claims into three general categories: product liability claims under the North Carolina Product Liability Act; express and implied warranty claims; and other claims – which in this case were negligent failure to test or surveil and breach of a special duty to abide by FDA requirements. Id. at *5-6. Let’s get rid of the “others” first. North Carolina doesn’t recognize a cause of action for failure to test or surveil. Id. at *20. Claims for private enforcement of FDA requirements are preempted under Buckman. Id. at *21. Both of those claims were dismissed, but as to the rest of plaintiffs’ claims, the court found factual issues existed that challenged whether in fact it was impossible for the generic defendants to comply with both state and federal law.
For instance, on the failure to warn claim, the court found that the defendants had not “provided any proof . . . that their package inserts matched [the brand’s] throughout the period that Plaintiff alleges she took [the drug].” Id. at *9. Because there were conflicting allegations regarding when the plaintiff was prescribed the drug and when defendants adopted certain labeling changes, the court was unwilling to find the claims preempted on the pleadings:
But if Defendants' PIs did not match the brand, there are at least some changes to their PIs that federal law would allow, or even require, Defendants to make. A state law claim for failure to include such warnings would not be preempted by federal law where the FDA would have permitted, or even required, such changes.
Id. at *14.
Similarly on the breach of express warranty claim, defendants argued that the alleged express warranty language was required by federal law to be included in their labeling. Id. at *18. However, “[t]he Court [could not] find impossibility on the record before it. Without proof of what Defendants' and [brand’s] PIs stated, Defendants cannot show that this language was required.” Id. at *17-18. So, on these claims the court decided that it would need to look beyond the four corners of the complaint and examine facts that were not before it on a motion to dismiss.
In denying defendant’s motion on breach of implied warranties, the Couick court found the claims weren’t preempted by Mensing because they “are not dependent on the content of Defendants’ PIs.” Id. at 18.
While Defendant's labeling and warnings may play a role in establishing their products' intended purpose or their customers' reliance, Plaintiff's claim is not that Defendants failed to adequately warn about the risks. These claims are not preempted by federal warning label requirements under Mensing.
Id. at *19. To our knowledge, this is a novel ruling, contrary to the other precedent in our generic preemption scorecard. And, one we hope won’t hold up under further scrutiny.