We just received from defense counsel Matt Wender at Pietragallo Gordon a copy of Moore v. Mylan, Inc., No. 11:1-CV-03037-MHS, slip op. (N.D. Ga. Jan. 5, 2012). It’s another post-Mensing case holding: (1) that the plaintiff can only sue a maker of the drug s/he took (whatever that might turn out to be in this case), and (2) dismissing the generic on the basis of preemption.
As to product identification, Moore, applies well-settled Georgia law:
Moreover, the plaintiff needs to establish that the product that allegedly caused the injury was in fact manufactured or supplied by the defendant. Plaintiffs allegations in her complaint fail to state a claim for strict liability under Georgia law . . . Third, setting aside the lack of specific factual information regarding [defect claims], plaintiff has not even alleged that a phenytoin product designed or manufactured by [one or the other of the defendants] proximately caused plaintiffs injuries. It is unclear from plaintiffs complaint whether [the branded or generic defendant] manufactured, distributed, supplied, or sold the product that the decedent ingested.
Moore, slip op. at 12-14 (citations omitted); accord id. at 32 (additional causes of action). Plaintiff’s complaint was so poorly pleaded that that product identification was wholly lacking as to any defendant. Other branded related rulings are: (1) all warning claims other than as to the plaintiff’s physician are barred by the learned intermediary rule, id. at 9-10; and (2) fraud claims were not pleaded with particularity, id. at 29-30.
As to preemption, the court held that the fact that the defendant generic was also a reference listed drug (“RLD”) did not preclude preemption. As far as we know, Moore is the first decision thoroughly discussing RLD issues. The court holds: (1) that being the RLD for one strength of a generic product does not give the generic manufacturer the ability to change the label unilaterally on another strength of drug. “Thus, because 100-mg and 300-mg are two different products, plaintiff has not shown any authority that would have required [defendant] to change the label of 100-mg to conform to the 300-mg label.” Slip op. at 21-22. (2) The RLD for the strength that the plaintiff used continued to be a branded product, therefore the Mensing rationale for preemption fully applied. Id. at 22. (3) There’s no authority that becoming an RLD gives a generic manufacturer rights to change the label unilaterally:
[P]laintiff has not shown how [defendant] acquired all of the same rights as a brand name drug manufacturer simply by manufacturing one drug that was an RLD. Plaintiff has not shown that [defendant’s] manufacture of one RLD converted [defendant] into brand name drug manufacturer with the right to use the CBE process to change the label of any of its drugs.
Id. at 21-22.
Another notable generic preemption ruling in Moore is that any claim that the defendant should simply have stopped selling its product is preempted. Id. at 34 n.14.
Plaintiff was given leave to file an “amended complaint [that] should address the concerns in this order.” Id. at 37.
We’ll be adding Moore to both our generic preemption and branded/generic scorecards.