We feel like we post on Mensing at least once a week and we have our quickly growing scorecard to back us up. It is not that surprising really, considering the vast number of cases that were stayed awaiting the Supreme Court’s decision. Having sat on the cases for months, courts around the country are eager to move forward. So far, forward has mostly been in the direction of dismissals – an avenue down which we enjoy a nice long stroll. But, we appreciate that it’s getting to the point where you may be saying – we’ve heard this before – and asking – Don’t you have anything new? The answer today is – nope.
Not only is our post today on another post-Mensing decision. It is also about a case on which we previously blogged – Phelps v. Wyeth, Inc., slip op., No. 6:09-CV-06168-TC (D. Ore. Apr. 24, 2012). But, when a decision is good, we want to make sure you all know about it. And, unlike too much ice cream (stomach ache) or too much alcohol (hangover) or too much exercise (sprained muscles) – we don’t think you’ll be too worse for wear hearing about another good post-Mensing dismissal. But, just in case, we promise to keep it quick and simple.
When we last left Phelps, plaintiffs were trying to use discovery sanctions to get around preemption. When that didn’t work, plaintiffs filed objections to several post-Mensing decisions by the magistrate and last week, the district court judge upheld both the decision dismissing the brand defendants and the decision dismissing the generic defendants.
The brand defendants had previously been dismissed back in 2010, but plaintiffs attempted to revive those claims arguing that Mensing was a game changer. Here is what the court had to say about that:
- Mensing does not overturn the ruling in Foster v. American Home Products Corp., 29 F.3d 165 (4th Cir. 1994) regarding the liability of name-brand manufacturers in cases where only a generic drug was ingested. Phelps, slip op. at 5.
- Under Oregon law, no general duty of care for brand defendants “to cover injuries caused by generic manufacturers’ products.” Slip op. at 7.
- “Foreseeability alone does not create a duty of care” (in reference to arguments that it is foreseeable for physicians and plaintiffs to rely on brand labeling). Slip op. at 8.
- Oregon has a unified product liability statute, ORS § 30.900, under which all products claims are subsumed and “it does not allow for name-brand manufacturer liability unless [plaintiff] can demonstrate that the name-brand manufacturers’ products caused her injury.” Slip op. at 9.
- No innovator liability because plaintiff “never ingested a name-brand formulation of [the drug] nor did the name-brand defendant design the generic formulation.” Id.
We think the court summed it up nicely: “while name-brand defendants are required to provide adequate warnings, they cannot be liable for injuries caused by a generic manufacturer’s products.” Slip op. at 9-10. That’s the first of the court’s one-two punch.
Moving on to the generic defendants’ arguments, the court was unpersuaded by plaintiffs’ narrow reading of Mensing. As with the brand defendants, the court was unwilling to recognize “some” of plaintiff’s claims as non-product claims. Because all of the claims are about an alleged failure to warn, they all fall under Oregon’s product liability statute. Slip op. at 12.
The court was also unwavering on conflict preemption:
Under FDA rules, a generic drug manufacturer may not issue additional warnings through Dear Doctor letters nor imply in any way that there is a therapeutic difference between their product and the name-brand formulation.
Given the broad definition of labeling and the prohibition against generic manufacturers unilaterally altering labels, any state law duty that requires a generic manufacturer to provide additional warnings directly conflicts with state law.
Slip op. at 14 (citation omitted). The plaintiff tried to skirt this application of Mensing by arguing that state law doesn’t require the generic manufacturer to change its label, only that the manufacturer provide adequate warnings. Again, we couldn’t say it any better than the court did:
I fail to understand how defendant . . . can satisfy Oregon’s requirement to provide adequate warnings without changing the label, writing Dear Doctor letters, or otherwise violating the applicable federal regulations. Federal regulations governing generic drug manufacturers directly conflict with, and therefore preempt, state laws that hold generic manufacturers liable for inadequate warning labels on their products.
Slip op. at 15.
And, finally, the court also dismissed plaintiff’s federal claims for misbranding, failure to communicate drug safety information and failure to test and monitor. Slip op. at 17. Here the court relied on the FDCA’s express preemption provision and rejected plaintiff’s reliance on Hughes v. Boston Scientific Corp., 631 F.3d 762 (5th Cir. 2011) as misplaced. Any rejection of Hughes is OK with us. See prior post on Hughes. Rather, the court focused on the holding in Mensing “that a failure to provide information to the FDA or to request assistance in strengthening a name-brand drug’s labeling, assuming such a duty existed, did not change its preemption analysis.” Slip op. at 18.
That’s the follow. Another good decision. We don’t have to say anything else, other than thanks to Habib Nasrullah at Wheeler Trigg O’Donnell for bringing this decision to our attention.