[Drug and Device Law] Another Decision Applying Bartlett Preemption to All Drugs
Just last month we collected all the favorable precedent applying impossibility preemption under Mutual Pharmaceutical Co. v. Bartlett, 133 S. Ct. 2466 (2013), to innovator drugs – although the precise subject of that post was preemption of design defect claims involving §510(k) medical devices. We were aware of four such rulings, all in the last year or so: Yates v. Ortho-McNeil Pharmaceutical, Inc., 76 F. Supp.3d 680, 686-88 (N.D. Ohio 2015); Shah v. Forest Laboratories, Inc., 2015 WL 3396813, at *5 (N.D. Ill. May 26, 2015); Booker v. Johnson & Johnson, 54 F. Supp.3d 868, 874-75 (N.D. Ohio 2014); Amos v. Biogen Idec, Inc., 28 F. Supp.3d 164, 168-69 (W.D.N.Y. 2014).
We think the argument that Bartlett intended for implied impossibility preemption extend to all drugs – generic and innovator – is painfully obvious. The Court in Bartlett went out of its way to state, “[o]nce a drug − whether generic or brand-name − is approved, the manufacturer is prohibited from making any major changes to the ‘qualitative or quantitative formulation of the drug product, including active ingredients, or in the specifications.’” 133 S. Ct. at 2471 (quoting 21 C.F.R. §314.70(b)(2)(i)) (emphasis added). After all, why else would the Court have specifically mentioned “brand name” drugs if not to indicate that the same preemptive logic included them?
Yet another court has now agreed. Readers may recall that not too long ago we posted about a 95% favorable opinion in Rheinfrank v. Abbott Laboratories, Inc., ___ F. Supp.3d ___, 2015 WL 4743056 (S.D. Ohio Aug. 10, 2015). In that opinion, as we discussed, the court granted summary judgment against design defect claims on the ground that plaintiffs had no alternative design as required by Ohio law. Id. at *27-28. Well, the plaintiffs sought reconsideration, and in a classic case of “be careful what you ask for,” received it. See Rheinfrank v. Abbott Laboratories, Inc., No. 1:13-cv-144, slip op. (S.D. Ohio Oct. 2, 2015). Rather than parse through the plaintiffs’ attempt to obfuscate the facts concerning the basis (or lack thereof) for the design defect claim, the court instead held that claim preempted, a defense argument that had not been reached the first time around:
[E]ven if the Court did misconstrue Plaintiffs’ burden of coming forward with evidence of an alternative design, there is no error in outcome. As noted above, the Court did not fully consider Defendants’ preemption argument in ruling on the design defect claim. . . .
In their motion for summary judgment, Defendants argued that Plaintiffs’ suggestion that [the manufacturer] could tweak the Depakote molecule to make it safer . . . is preempted under Mutual Pharmaceutical Co. v. Bartlett, 133 S. Ct. 2466, 2471 (2013). The Supreme Court in Bartlett held that . . . “state-law design defect claims . . . that place a duty on manufacturers to render a drug safer by either altering its composition or altering its labeling are in conflict with federal laws that prohibit manufacturers from unilaterally altering drug composition or labeling. Id. at 2479. Creating an alternative design would require changing the composition of an FDA-approved drug, which is prohibited by federal law. ida 2479. Creating an alternative design would require changing the composition of an FDA-approved drug, which is prohibited by federal law. Id. at 2479.
Although Plaintiffs argue this holding is limited to generic drugs and does not extend to brand drugs, the language of Bartlett is not so restrictive. The Court adopts the reasoning . . . in Yates v. Ortho-McNeil Pharmaceutical Inc.:
[block quote and citation from Yates omitted – you can read all about Yates here]
Rheinfrank, slip op. at 8-9.
So now there are five decisions holding innovator drug design defect claims preempted under Bartlett. Here’s hoping that many more follow, and that we bloggers find out about them as quickly as we learned of Rheinfrank.
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Posted By Bexis to Drug and Device Law at 10/05/2015 05:00:00 PM --
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