Today we have a guest post (her second – she’s a glutton for punishment) from fellow Reed Smith associate Danielle Devens. This one brings together recent precedent recognizing post-Levine preemption in cases involving non-generic prescription drugs (there are a couple our readers may not have seen before). As always with our guest posts, the author gets all the credit, and any blame, for the contents of his/her work.
As this blog has been explaining for a while, the rationale in Mensing – that “[t]he question for ‘impossibility’ is whether the private party could independently do under federal law what state law requires of it” – could apply to innovator (brand-name) pharmaceutical manufacturers and not just to generics. 131 S. Ct. 2567, 2579 (2013). About a year ago, this blog reported on cases in which defendants argued for the application of the impossibility preemption doctrine outside of the context of generic drugs. Since that time, there have been several new decisions involving innovator pharmaceutical manufacturers arguing for the application of impossibility preemption principles. It makes sense at this point to condense the available information into one post and assess the question “where are we now?”
First, the relevant statutes in a nutshell: to obtain FDA approval for a new drug, an innovator manufacturer must prove the safety and efficacy of its product through lengthy clinical testing, while generic drugs can gain FDA approval by showing that the product is equivalent to a brand-name drug that has already been approved by the FDA. 21 U.S.C. §355(j)(2)(A). (One caveat – there may be drugs legally marketed today that were not subject to these requirements, such as drugs evaluated prior to 1962 which were instead subject to the FDA’s Drug Efficacy Study Implementation program). This, of course, is not a complete description of the requirements, but you get the gist. The generic drug application must also show that the safety and efficacy labeling proposed is the same as the labeling approved for the innovator drug. 21 U.S.C. §355(j)(2)(A)(v).
Once approved, “major changes” to the labeling of a pharmaceutical product again require FDA preapproval. 21 U.S.C. §314.70(b); FDA, CDER, “Guidance for Industry: Changes to an Approved NDA or ANDA,” 2004 WL 3199016 (FDA, April 1, 2004). Other changes are sometimes permitted through the “changes-being-effected” (“CBE”) process. Id. A change made through the CBE process does not require preapproval by the FDA. Rather, the manufacturer must file a supplemental application with the FDA while simultaneously making the necessary changes to the label. §314.70(c)(6). In order to make a change under the CBE regulation, the change must: 1) reflect newly required information; and 2) be for the purpose of accomplishing at least one of five objectives listed in §314.70(c)(6)(iii). Such objectives include a change intended to “add or strengthen a contraindication, warning, [or] precaution,” 21 CFR §314.70(c)(6)(iii)(A)(2006), or “add or strengthen an instruction about dosage and administration that is intended to increase the safe use of the drug product,” §314.70(c)(6)(iii)(C). For a full description of “major” changes versus those which can be made through the CBE process, see this post. The FDA will ultimately decide whether to approve the supplemental application. If not accepted, the manufacturer must change the label to comply with FDA direction.
Following Wyeth v. Levine, 555 U.S. 555 (2009), it appeared that to argue preemption successfully, a brand-name manufacturer must provide “clear evidence” that the FDA would have rejected the relevant label changes. Then in Mensing, the Supreme Court decided that failure to warn claims against generic manufacturers were preempted, rejecting plaintiff’s argument that a generic manufacturer can be liable for failing to request FDA assistance in changing the labeling to include stronger warnings. 131 S. Ct. at 2578-81.
Mensing held that requesting FDA assistance would not have satisfied the manufacturer’s state law duty to provide adequate labeling as the manufacturer could then comply with state labeling requirements “if, and only if, the FDA and the brand-name manufacturer changed the brand-name label to do so.” Id. at 2578. The Court then explained, “[t]he question for ‘impossibility’ is whether the private party could independently do under federal law what state law requires of it.” Id. at 2579. “[W]hen a party cannot satisfy its state duties without the Federal Government’s special permission and assistance, which is dependent on the exercise of judgment by a federal agency, that party cannot independently satisfy those state duties for preemption purposes.” Id. at 2580 – 81. Accordingly, as phrased by the Court in Mensing, the preemption analysis turns on whether the manufacturer could independently make the labeling changes required by law, or whether assistance from a third party (a.k.a. the federal government) would be required to comply with all legal obligations.
This principle could certainly apply to innovator manufacturers as well in circumstances where the manufacturer could not make the proposed changes without government assistance.
Mutual Pharmaceutical Co., Inc. v. Bartlett then reinforced this line of reasoning as to brand-name manufacturers. 133 S. Ct. 2466 (2013). In holding that plaintiff’s design defect claim against a generic prescription drug manufacturer is preempted, Bartlett states, “[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 provided in the approved application.” Id. at 2471 (emphasis added).
As this blog covered here, at oral argument for Bartlett, Justices Kagan and Sotomayor both noted that a brand-name manufacturer would not be able to change the FDA approved design of the product without FDA approval. So, as Justice Kagan asked, “as to design, don’t the brand-name and the generics go hand in hand?” As the emphasized language emphasizes, the court responded that they did.
Several lower courts since then have also agreed that they do go hand in hand.
The Ortho-Evra MDL has been a strong source of opinions finding that design defect claims against brand-name manufacturers are preempted. In Booker v. Johnson & Johnson, 54 Supp. F.3d 868 (N.D. Ohio 2014), the court applied Bartlett in holding that where the state law requires remedial action by the manufacturer, design defect claims are preempted as federal law prohibits the manufacturer from changing the composition of the drug. For posts discussing Booker, see here and here.
In Yates v. Ortho-McNeil Pharmaceuticals, Inc., another Ortho-Evra case, the district court held that preemption is not restricted to only generic drugs, rather “[t]he Supreme Court specifically stated that ‘once 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 provided in the approved application.’ 2015 WL 66423, at *5 (N.D. Ohio Jan. 5, 2015) (emphasis original (same as us)). The Court 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 *5. [e previously discussed Yates here.
Other cases outside of Ortho-Evra have found similarly. In Shah v. Forest Laboratories, a case from the Lexapro MDL, the court agreed with defendant’s argument that per Bartlett, the United States Supreme Court has held that design defect claims involving pharmaceutical products are preempted. 2015 U.S. Dist. LEXIS 67554 at *17 (N.D. Ill. May 15, 2015). [We covered Shah here. Similarly, Amos v. Biogen Idec, Inc. is a case involving a brand-name pharmaceutical product which held that design defect claims against drug manufacturers are preempted as a matter of law. 28 F. Supp.3d 164, 168-69 (W.D.N.Y.2014) We covered Amos here.
So where are we now? Where a design defect claim is brought against an innovator manufacturer, various courts have found that such claims are preempted. This is a favorable trend for manufacturer defendants, and it is continuing to develop.
What about failure to warn claims? While this area is less defined, one lower court recently cited Bartlett in finding impossibility preemption for brand-name pharmaceuticals facing claims of inadequate warnings. Surprisingly, the case came from the typically plaintiff-friendly First Circuit.
In Marcus v. Forest Laboratories, plaintiffs alleged that defendant manufacturer of brand-name antidepressant Lexapro omitted material efficacy information from the drug label in violation of California’s consumer protection laws. 779 F.3d 34 (1st Cir. 2015). [You can find our analysis of Marcus here. According to the First Circuit, Mensing requires an analysis of whether the changes required to avoid liability could be independently made using the CBE regulation or whether prior FDA approval was required. The court explained that the “CBE procedure is only available to make changes that, among other things, are based on ‘newly acquired information.’” Id. at 41-42. Newly acquired information means data, analysis, or other information not previously submitted to the agency. Id. As the complaint in this case contained only two fleeting references to academic articles published after the FDA’s approval of the Lexapro label, the changes alleged by Plaintiffs were not based on “newly acquired information,” and, accordingly, the manufacturer could not have used the CBE procedure to change its label. Id. at 42. Thus, the manufacturer could not independently make the labeling changes Plaintiffs would require, rendering the claims preempted by federal law.
While Marcus involved consumer protection claims, the court’s analysis essentially turned this into a failure to warn issue. So, circling back again to the question posed at the outset, where does this leave us?
The strongest preemption argument that can be made by a brand-name manufacturer in a failure to warn case is that the relevant change was or would have been rejected by the FDA. (For examples of such a case, see Dobbs v. Wyeth, 797 F. Supp. 2d 1264 (W.D. Okla 2011), where the court found that FDA had rejected a similar warning proposed by defendant through the CBE process, covered here, and Glynn v. Merck Sharp & Dohme Corp., 951 F. Supp. 2d 695 (D.N.J. 2013), where the court found that evidence that the FDA had rejected a similar change submitted through a prior approval supplement was sufficient to show the CBE would have been rejected). In the absence of such evidence or in the alternative, brand-name manufacturer defendants can argue that under the language of Mensing/Bartlett and using the reasoning from Marcus, plaintiff claims that a brand-name manufacturer should have changed its labeling are preempted unless the CBE process was available to effectuate the change.
Other favorable “clear evidence” preemption cases include: Robinson v. McNeil Consumer Healthcare, 615 F.3d 861, 873 (7th Cir. 2010) (discussed here); Rheinfrank v. Abbott Laboratories, Inc., ___ F. Supp.3d ___, No. 1:13-CV-144, 2015 WL 4743056, at *10-12 (S.D. Ohio Aug. 10, 2015) (after plaintiff’s injury FDA rejected proposed label change twice as insufficiently supported; brand spanking new); Kaleta v. Abbott Laboratories, Inc., No. 14-cv-847-NJR-SCW, slip op. at (S.D. Ill. Feb. 20, 2015) (same facts as Rheinfrank); In re Fosamax Alendronate Sodium Products Liability Litigation, MDL No. 2243, 2014 WL 1266994, at *14-17 (D.N.J. March 26, 2014) (discussed here); In re Fosamax (Alendronate Sodium) Products Liability Litigation, 951 F. Supp.2d 695, 703-704 (D.N.J. 2013) (discussed here); and Lofton v. McNeil Consumer & Specialty Pharmaceuticals, 682 F. Supp.2d 662, 678 (N.D. Tex. 2010) (dictum), aff’d, 672 F.3d 372 (5th Cir. 2012).
As discussed here, according to FDA Guidance the CBE process is unavailable for any “major change.” Such changes include those based on postmarketing study results or those based on data from preclinical studies. As the FDA requires that submissions are made in accordance with the most restrictive reporting category, brand-name defendants have a potential preemption argument where the proposed warning changes fall under these categories. There’s been one favorable major change case: Thompson v. Allergan USA, Inc., 993 F. Supp.2d 1007 (E.D. Mo. 2014) (discussed here).
Further, under Marcus, the CBE process is unavailable where the change is not based on “newly acquired information.” So where plaintiff argues that defendant should have updated its warning information, but fails to provide examples of relevant information obtained after the product was cleared by the FDA, an argument can be made that the CBE process was not available and the claim is preempted.
Brand-name defendants have had less success making preemption arguments in failure to warn cases where the proposed change was not previously rejected by the FDA. Following Marcus, however, there is reason to believe that brand-name manufacturers may find some success where they can argue that the proposed change is of a type that could not have been effectuated through the CBE process. Let’s hope this line of reasoning continues.