Saturday, November 28, 2009

Mensing - Brand Name Wins, Generics Lose

The Eighth Circuit gave brand name drug manufacturers cause to give thanks yesterday, but for generics, is was Black Friday. In Mensing v. Wyeth, Inc., No. 08-3850, slip op. (8th Cir. Nov. 27, 2009), the court answered two questions: (1) can a brand name manufacturer be liable for an alleged inadequate warning on a generic drug, where the plaintiff never used the brand name product, and (2) are warning claims against generic manufacturers preempted by the FDCA requirement that generic drugs have the "same" labeling as their brand name bioequivalents.

The court in Mensing said "no" to the first question and "no" again to the second.

Mensing, like almost all the recent branded/generic cases, involves Wyeth's drug Reglan - also sold generically as metoclopramide. The plaintiff used the drug a long time and suffered tardive dyskinesia. Her lawsuit attacking the warnings for this condition named both the generic and brand name manufacturers. The district court entered summary judgment - for non-use of the product (no duty of care) for the brand name and on preemption because the generic warnings would no longer be "the same" for the generic manufacturerer.

The preemption ruling, frankly, doesn't surprise us. Like the "impossibility" argument in Levine, the "sameness" argument in generic drug preemption depends upon Bush-era FDA statements in the Federal Register. The beating that the FDA's 2006 preemption preamble took in Levine pretty much presaged the same treatment for these other FDA statements about "sameness" and the ability of generic manufacturers to alter their warnings. See Mensing, slip op. at 9 n.4. Significantly, the first case that the Eighth Circuit cites is Bartlett v. Mutual Pharmaceutical Co., ___ F. Supp.2d ___, 2009 WL 3126305 (D.N.H. Sept. 30, 2009). Mensing, slip op. at 4. The moment we saw Bartlett, we thought "the generics better have better preemption arguments than they showed here." We remember feeling that way once before - when we first saw the Vaccine Act-based, anti-preemption arguments in the DTP litigation almost 20 years ago. We didn't have a good answer then, and we lost. We have yet to see a good answer from the generics to the arguments raised in Bartlett.

The Eighth Circuit accepts in Mensing essentially the same simplistic argument that the Supreme Court bought in Levine - that because there's no express preemption in Hatch-Waxman (the FDCA amendments that authorized generic drugs), it presumably was content to leave FDA-regulated generic warnings subject to tort attack. Mensing, slip op. at 7.

As far as unilateral label changes are concerned, the court held that generics may maintain "sameness" by simultaneously seeking changes in both generic and brand name labeling for the same compound - completely separate from the "changes being effected" (CBE) process. Id. at 8-9 ("generic defendants could have at least proposed a label change that the FDA could receive and impose uniformly on all metoclopramide manufacturers if approved"). That's the Bartlett argument for which we haven't seen the generics offer a good answer. In other words, "§201.57(e) does not permit generic manufacturers passively to accept the inadequacy of their drug's label as they market and profit from it." Mensing, slip op. at 9.

Implicit in these comments is the FDA's expectation that generic manufacturers will initiate label changes other than those made to mirror changes to the name brand label and that the agency will attempt to approve such proposals quickly. The availability of one particular procedure (the CBE process, on which the district court expended the majority of its discussion) is immaterial to the preemption analysis in light of this clear directive to generic manufacturers and the availability of the prior approval process.

Mensing, slip op. at 10-11. On more or less the same rationale, the court also held that nothing in federal law prohibits generics from requesting the FDA to send out "Dear Doctor" letters about risks beyond those that appear on a drug's labeling. Id. at 11-12.

The court in Mensing then holds that there's no "obstacle" preemption because strengthening warnings does not necessarily require the sorts of expensive clinical trials that Hatch-Waxman did a way with for generic drugs. In this particular case, the preemption defense was undercut by the FDA, after the fact, requiring a stronger warning about the risk in question:
[T]he FDA did not conduct its own studies when it mandated an enhanced warning for metoclopramide. It simply referenced studies published elsewhere. Requests for label changes must be supported by scientific substantiation, but there is nothing to indicate that the information must be acquired through a manufacturer's own clinical tests.

Mensing, slip op. at 14. Imposing the same requirements to monitor ongoing clinical and research experience that pioneer manufacturers must undertake, the court held, did not present any preemptive "obstacle." Id. at 15.

That's the bad news for generics. The good news for brand name manufacturers is in the second half (third?) of the opinion. The court followed the "ovewhelming majority" of courts (including the Minnesota court of appeals - see our branded/generic scorecard) in rejecting an duty of care owed by a brand name manufacturer to any plaintiff that did not consume the branded product. Mensing, slip op. at 16-17. The court rejected the "determinative" weight given to supposed prescriber reliance in the (grotesque) Conte case from California. Mensing, slip op. at 17. Tort law ain't estoppel - it requires a duty:

"[C]entral" to a fraudulent misrepresentation claim under Minnesota law is "a suppression of facts which one party is under a legal or equitable obligation to communicate to the other, and which the other party is entitled to have communicated to him." In other words, regardless of whether her doctor relied upon the [branded] label, [plaintiff] must show that the name brand manufacturers owed her a duty of care. Duty is a threshold requirement for all of the tort claims [plaintiff] asserts.

Mensing, slip op. at 17 (citation and quotation marks omitted). There was no case plaintiff could cite that imposed liability on a defendant that had not, at least, "intended" to communicate with the plaintiff. Id. at 17 n.9. Unlike Conte bare "foreseeability" isn't enough. To extend a duty to warn about a competing product would "stretch[] the concept of foreseeability too far." Mensing, slip op. at 18. In short, good-bye Conte.

Unless the generics can show us a whole lot better preemption argument than we've seen to date, in the post-Levine era, we think they're unlikely to prevail on this ground. Conversely, with the generics likely to be subject to suit for their own labeling defects, the pressure that motivated the judicial tort activism seen in Conte is unlikely to recur. Thus, Mensing is probably the shape of things to come.

Belated tip of the cyberhat to Jeff Pilkington of Davis Graham for letting us know about Mensing.

1 comment:

Anonymous said...

It's surprising that drug defense lawyers know so little about the actual regulations that govern those products.