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Generic Drugs Meet Levine

By James M. Beck and Mark Herrmann

One silver lining from the severe pruning that prescription drug preemption took in Wyeth v. Levine, is that there may now be less incentive to expand the common-law liabilty of pioneer manufacturers in generic drug cases - something we've discussed in posts that readers can find under the "product identification" "generic drug" and "Conte" labels in the right-hand margin of the blog.

In Schrock v. Wyeth, slip op., 2009 WL 635415 (W.D. Okla. Mar. 11, 2009), the court basically gave the preemption arguments made by generic drug manufacturers the back of its hand, holding:

Defendants in this case have proffered similar, if not identical, arguments concerning the obstruction of the purposes and objectives of federal drug labeling regulation. As in Wyeth, however, this Court finds that there is a longstanding coexistence of state and federal law in the regulatory history and background relevant to this case. Therefore, the Court finds that this state-law action does not obstruct the purposes and objectives of Congress. . . . As to any remaining basis which defendants have presented in the instant matter, the United States Supreme Court has clearly concluded that Congress did not intend the preempt state-law failure-to-warn actions.

Slip op., 2009 WL 635415, at *3. After Levine we're not particularly surprised at this result.

What's of greater interest to us (since we don't represent generic drug manufacturers) is the court's grant of summary judgment to the pioneer manufacturer - on the entirely reasonable ground that the plaintiff never took its drug. The court cites the usual state-law proposition that manufacturers aren't liable for defects in products they didn't make. Slip op., 2009 WL 635415, at *4-5. It also follows the federalist principle we've advocated previoiusly (see "Erie doctrine" label): "As a federal court, we are generally reticent to expand state law without clear guidance from its highest court." Slip op., 2009 WL 635415, at *4. We love all that, but what follows may be even more significant in the long run:

Finally, plaintiffs opine that they would be denied of any remedy if the generic manufacturers are not responsible due to federal preemption, and the brand name manufacturers are similarly not responsible. The Court finds, however, that this is no longer an issue in light of the earlier finding that plaintiffs are not preempted by federal law from pursuing their state law claims.

Slip op., 2009 WL 635415, at *4 (emphasis added). We've long been of the opinion that the source of most of the pressure in generic drug cases on traditional tort principles that limit manufacturer liability to their own products has been the strength of the generics' preemption arguments, and corresponding judicial reluctance to throw generic-using plaintiffs out of court entirely.

If, however, the preemption arguments of the generic manufacturers don't fare any better after Levine than they did in Schrock, the urge that some courts have felt to distort well-settled tort principles to sock it to pioneer (non-)manufacturers may well abate.

It's certainly an unintended consequence, but to this extent Wyeth v. Levine may prove to be of at least some benefit to defendants.

Full post as published by Drug and Device Law on March 17, 2009 (boomark / email).