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Guilbeau v. Pfizer Inc.

United States Court of Appeals, Seventh Circuit

January 19, 2018

Rodney Guilbeau, et al., Plaintiffs-Appellants,
v.
Pfizer Inc. and Pharmacia & Upjohn Company LLC, Defendants-Appellees.

          Argued October 23, 2017

          Appeal from the United States District Court for the Northern District of Illinois, Eastern Division. MDL No. 2545 Master Docket Case No. l:14-cv-1748 - Matthew F. Kennelly, Judge.

          Before Bauer and Hamilton, Circuit Judges, and Darrow, District Judge [*]

          Hamilton, Circuit Judge.

         In Wyeth v. Levine, the Supreme Court held that claims against a manufacturer of a brand-name prescription drug for failure to warn adequately of the drug's dangers were not preempted by federal law. 555 U.S. 555, 581 (2009). In PUVA, Inc. v. Mensing, the Supreme Court held that such failure-to-warn claims against manufacturers of generic drugs are preempted by federal law. The different results, the Court explained in Mensing, are based on the different regulatory requirements and processes for approving and labeling prescription drugs. 564 U.S. 604, 614, 618, 625 (2011).

         This appeal arises from the district court presiding over thousands of related claims against manufacturers of testosterone replacement therapy drugs. We must consider how to apply Levine and Mensing to a manufacturer of a drug that does not fit neatly into the colloquial dichotomy between brand-name and generic drugs. We must look at the more precise legal and regulatory context underlying those terms, focusing on whether the U.S. Food and Drug Administration (FDA) approved public sale of the drugs through the "new drug application" or NDA process, or instead through the "abbreviated new drug application" or ANDA process. We have tried to minimize use of impenetrable acronyms, but readers are warned that some are unavoidable.

         Testosterone replacement drugs have been sold for more than sixty years as prescription drugs with the approval of the FDA. The drugs have long been used to treat low testosterone production in younger men. In recent years, though, manufacturers have found a new market for these drugs to counteract the effects of declining testosterone production in older men. Older men experience a higher incidence of heart attacks, strokes, and other cardiovascular events than younger ones. Numerous lawsuits have been filed against testosterone drug manufacturers alleging that the drugs increase these health risks. One theory in such cases is that the drug manufacturers have failed to warn doctors and patients adequately about the risks, a tort theory arising under state product-liability laws. Such cases pending in federal district courts have been consolidated for discovery and pretrial proceedings in a multi-district litigation (MDL) docket before Judge Kennelly in the Northern District of Illinois. See 28 U.S.C. § 1407.

         The district court granted a motion to dismiss brought by the manufacturers of one testosterone replacement drug, Depo-T, on the ground that failure-to-warn claims are preempted by federal law. The district court found that Depo-T's manufacturers could not change their drug labels to add additional warnings because FDA regulations prohibit them from "making a unilateral labeling change." In re Testosterone Replacement Therapy Products Liability Litig., 142 F.Supp.3d 747, 754, 755 (N.D. 111. 2015). Plaintiffs appeal that decision, as well as the district court's related decision to deny further discovery related to the preemption defense. We affirm both decisions.

         Part I explains the regulatory approval process for prescription drugs and the particular historical context and procedural background needed to understand the issues in this appeal. Part II analyzes the defendant drug-makers' preemption defense. Part III reviews the district court's decision to deny further discovery on the preemption defense.[1]

          I. Factual Background and Procedural History

         A. Regulatory Background

         Prescription drugs in the United States must be approved by the Food and Drug Administration (FDA) before they can be sold. 21 U.S.C. § 355(a). Prospective drugs can follow one of two general paths to obtain FDA approval. Anew drug that has never been marketed before must be approved through the new drug application (NDA) process. The NDA process requires an extensive series of safety and effectiveness trials before a new drug can be sold. See § 355(b)(1).

         If the prospective drug is "the same as" an existing drug already on the market, however, the maker can obtain approval through the shorter and less onerous abbreviated new drug application (ANDA) process. See § 355(j)(2)(A). The ANDA process requires proof that the drug in question has the same active ingredients, effects, and labeling as a predecessor drug that the FDA has already approved. Id.; 21 C.F.R. § 314.94(a) (2015). The predecessor drug that has already received FDA approval is known as the reference listed drug (RLD). 21 C.F.R. § 314.3(b). In many cases, the reference listed drug is the original drug that pioneered a new active ingredient or a new treatment and gained FDA approval through the new drug application process. If the original pioneer drug has been discontinued, the FDA will typically designate the remaining market-leading drug to take its place as the reference listed drug for that particular category of drugs. See below at 17.

          NDA-approved drugs are often referred to as "brand-name" drugs and ANDA-approved drugs as "generic" drugs. These colloquial terms are not quite precise enough for our purposes in this case, though. The 1984 Hatch-Waxman Act established the current drug approval processes and the associated patent protection for truly new drugs. Drug Price Competition and Patent Term Restoration (Hatch-Waxman) Act of 1984, Pub. L. 98-417, 98 Stat. 1585; H.R. Rep. No. 98-857, at 14-15 (1984); Mensing, 564 U.S. at 612 & n.2.[2] Depo-T, the drug at issue in this appeal, has a trademarked name and was approved long before the 1984 changes, but the FDA has classified Depo-T as an ANDA-approved drug (i.e., a "generic") under current law. See Supp. App. at 41, 55.

         The approval process is central to both the preemption issue here and the difference between the Supreme Court's preemption decisions in Levine and Mensing. Those decisions turn on whether a drug-maker may or may not change its label to add a warning without prior approval from the FDA. Levine held that if the drug-maker may make such unilateral changes, then federal law does not preempt a state-law claim based on an inadequate label. Federal law thus would not prevent the drug-maker from complying with a state statute or court decision requiring more cautious warnings than appear on the FDA-approved label. 555 U.S. at 573 (rejecting preemption defense for NDA-holder).

         The issue is governed by an FDA regulation known as the "changes-being-effected" (CBE) regulation, which permits "changes in the labeling to reflect newly acquired information" in advance of later FDA approval. 21 C.F.R. § 3l4.7O(c)(6)(iii). The regulation allows a unilateral change "to add or strengthen a contraindication, warning, precaution, or adverse reaction for which the evidence of a causal association" meets FDA standards. § 3l4.7O(c)(6)(iii)(A). The Supreme Court has interpreted the CBE regulation to be available only if the drug in question was approved through the NDA process, but not if it was approved via the ANDA process because ANDA-approved "generic" drugs may change their labels only with the FDA's approval or at the FDA's request. See Mensing, 564 U.S. at 614-15, 623-26 ("We ... conclude that the CBE process was not open to the [ANDA holder] Manufacturers for the sort of change required by state law.").[3] The Mensing Court held that this difference in approval procedures is decisive for preemption:

We recognize that from the perspective of [plaintiffs] Mensing and Demahy, finding pre-emption here but not in Wyeth [v. Levine] makes little sense. Had Mensing and Demahy taken Reglan, the brand-name drug prescribed by their doctors, Wyeth would control and their lawsuits would not be pre-empted. But because pharmacists, acting in full accord with state law, substituted generic metoclopramide instead, federal law preempts these lawsuits.

Id. at 625. The Mensing decision did not address the concept of reference listed drugs (RLDs) in any meaningful detail. See id. at 612, 614. With this background, we turn to the specific drugs in this appeal.[4]

         B. FDA Approval of Depo- Fes tos terone

         In 1953, the Food and Drug Administration approved a new drug, Delatestryl, as a testosterone replacement injection. Its original purpose, according to the new drug application filed on its behalf, was to treat men whose bodies did not produce enough testosterone naturally. This NDA came before many of today's regulatory requirements, though Delatestryl later passed effectiveness screening in the 1960s as required under the then-new Drug Efficacy Study Implementation program.

         In 1979, the FDA approved the Upjohn Company's abbreviated new drug application (ANDA) for Depo-Testosterone, a testosterone injection similar to Delatestryl. Depo-T, as the product is still called, produced safety and effectiveness results equivalent to those of Delatestryl. Under the drug approval process at the time, similar results sufficed for streamlined ANDA approval. But because of a slight difference in its physical composition that made it not quite the same as Delatestryl, after the 1984 statutory changes were implemented, Depo-T became the reference listed drug (RLD) for its precise kind of testosterone injection. This meant that any drugs seeking to follow in Depo-T's footsteps had to demonstrate bioe-quivalence to (i.e., that they were the same as) Depo-T to qualify for the streamlined approval process of an abbreviated new drug application. See above at 4; see also 21 U.S.C. § 355(j)(2)(A)(iv); 21 C.F.R. § 314.3(b). When these lawsuits were filed, defendant Pfizer had taken over production and marketing of Depo-T, and the drug remained the reference listed drug. More than half a dozen other testosterone drugs have followed Depo-T's lead since its approval in 1979.

         C. Procedural History

         Testosterone replacement drugs like Depo-T gained new life in recent years as doctors began prescribing them to aging men with health conditions possibly related to low testosterone levels (known in some marketing campaigns as "Low T"). By 2014, however, a sizable number of men treated with testosterone replacement drugs had filed suits against drug-makers alleging that the drugs caused heart attacks, strokes, and other cardiovascular problems. In June 2014, such cases pending in federal courts were transferred to the Northern District of Illinois for consolidated discovery and pretrial proceedings under the title In re: Testosterone Replacement Therapy Products Liability Litigation (MDL 2545). See 28 U.S.C. § 1407. The broader MDL against the makers of testosterone replacement products continues, involving numerous products and defendants and thousands of plaintiffs.

         This appeal is limited to just one issue about one drug: whether failure-to-warn claims under state law against Depo-T's maker are preempted by federal law. The plaintiffs allege that the testosterone replacement drug-makers violated state product-liability law when they failed to warn the plaintiffs and their doctors adequately about the potential side effects of the drugs. These warnings, the plaintiffs allege, should have appeared in the drug's labeling.

         The district court decided that federal law preempted state failure-to-warn claims for all drugs approved pursuant to an abbreviated new drug application. The court granted a motion to dismiss all such claims, which covered claims against Depo-T 142 F.Supp.3d 747, 754 (N.D. 111. 2015). The court rejected plaintiffs' effort to avoid preemption by emphasizing that Depo-T was also the reference listed drug: "RLD ANDA holders are prohibited under federal law from unilaterally changing their drugs' warning labels" just like any other ANDA holder. Id. The district court also denied further discovery into two instances from the 1990s where it seemed that Depo-T's label was changed through the changes-being-effected ...


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