Products Liability Law Daily Preemption of failure-to-warn claim for testosterone drug upheld
Monday, January 22, 2018

Preemption of failure-to-warn claim for testosterone drug upheld

By Leah S. Poniatowski, J.D.

State-law claims that Pfizer Inc., the successor producer and marketer of the testosterone-replacement drug Depo-Testosterone (Depo-T), failed to warn of risks associated with its use in older patients were preempted by the federal laws governing drug approval, the U.S. Court of Appeals for the Seventh Circuit ruled, affirming the lower court and refusing to revive over 1,000 lawsuits in the multidistrict litigation. In a separate order, the appellate court also remanded forty of the cases for the federal district court in Illinois to sort out jurisdictional issues (Guilbeau v. Pfizer Inc., January 19, 2018, Hamilton, D.).

The Upjohn Company received Food and Drug Administration (FDA) approval for Depo-T in 1979 through the abbreviated new drug application (ANDA) process as the drug was similar to a previously-approved drug, Delatestryl. In 1984, the current federal drug approval process was established by the Hatch-Waxman Act. In sum, there are two paths for drug approval: prospective drugs that have never been marketed must comply with the new drug application (NDA) process; prospective drugs that are "the same as" an existing drug on the market must adhere to the abbreviated new drug application (ANDA) process. Under the ANDA process, the predecessor drug is the reference listed drug (RLD) and, according to the "changes-being-effected" (CBE) regulations, ANDA holders—including RLDs—must obtain FDA approval to change their labels.

The U.S. Supreme Court clarified these rules in two decisions arising from state-law failure-to-warn causes of action. In Wyeth v. Levine, the Court held that federal law did not preempt the claim because the drug at issue was a brand-name drug and unilateral changes to the label were permitted by the CBE regulation. The High Court provided more guidance in PLIVA, Inc. v. Mensing, in which it was held that generic drug manufacturers could not make unilateral changes pursuant to federal law and, thus, the failure-to-warn claim for a generic drug was preempted.

Depo-T had been used by younger men for testosterone replacement and recently had been marketed to older men experiencing declining testosterone production. However, the older patients showed greater incidences of cardiovascular issues, including heart attack and stroke, and many filed lawsuits alleging that the manufacturers failed to provide adequate warning of those risks. In light of the breadth and number of lawsuits filed, the cases were consolidated in 2014. In the cases involving the testosterone replacement drugs approved under the ANDA process, which included Depo-T, the trial court held that federal law preempted the failure-to-warn claims because of the unilateral label change prohibition under federal regulation. The present appeal followed.

Mensing controls. The Seventh Circuit held that the Mensing decision applied to the case at bar and, thus, ANDA holders cannot use the CBE regulation to unilaterally add or strengthen a warning. The appellate court noted that even though the short-hand terms "brand-name" and "generic" had been used by the Supreme Court, Congress, and the FDA, the approval process classifications (NDA and ANDA) are the categories that control because they are derived from the governing law. Additionally, the approval process classification is not changed when a drug, such as Depo-T, is designated as an RLD.

With respect to the CBE regulation, there was no legal support for the argument that there is a difference between RLD ANDA holders and other ANDA holders. Moreover, the FDA proposed a rule following Mensing that "may eliminate the preemption of certain failure-to-warn claims with respect to generic drugs," and clarify that "the duty to maintain accurate product labeling does not differ between an ANDA designated as the reference standard for bioequivalence studies and other approved ANDAs." According to the appellate court, this proposed rule reflects that the FDA did not distinguish between RLD and non-RLD ANDA holders. Consequently, the appellate court declined to recognize a third category "in a highly regulated context where the relevant agency and the Supreme Court have recognized only two."

The Seventh Circuit also held that the statutory requirement of sameness between RLD ANDA drugs and other ANDA drugs illustrates that RLDs are subject to preemption. The appellate court explained that the duty of sameness attaches to the labelling that the FDA had approved, regardless of when the approval was granted. Because the body of law—statutes, regulations, Supreme Court decisions—support Pfizer’s position, the Depo-T label could not have been changed unilaterally and, thus, the lower court’s holding that the failure-to-warn claims were preempted was affirmed.

Jurisdictional order. During the course of briefing this appeal, the parties noted a lack of complete diversity of citizenship in 40 of the cases affected by the lower court’s orders. In each of the forty cases, there is at least one defendant who is a citizen of the same state as the plaintiff, which the Seventh Circuit noted would ordinarily deprive the federal courts of subject matter jurisdiction. The court explained that although some of the cases could involve only one non-diverse defendant, it was possible that some of the cases could be brought against the remaining diverse defendants and that the non-diverse defendants could and should be dismissed to preserve subject matter jurisdiction. Instead of deciding for each of the forty cases the issue of whether the non-diverse defendants were dispensable parties who should be dismissed on appeal, the appellate court remanded the case. Given the number of cases and "the paucity of relevant information …, and the district court’s much greater familiarity with the details of the litigation and its effective management," the Seventh Circuit reasoned that the better course was to have the district court sort out the jurisdictional issues "with more detailed assistance from counsel." Therefore, the court of appeals vacated the final judgments or partial final judgments entered by the district court in the forty cases due to a lack of complete diversity of citizenship and remanded for proceedings consistent with both this order and the opinion issued by the court in the matter and reported above (In re Testosterone Replacement Therapy Products Liability Litigation (Guilbeau v. Pfizer, Inc.), No. 17-2056, per curiam).

The case is No. 17-2056.

Attorneys: Andrea Bierstein (Simmons Hanly Conroy, LLC) for Rodney Guilbeau. Matthew A. Holian (DLA Piper LLP) for Pfizer Inc. and Pharmacia & Upjohn Co. LLC.

Companies: Pfizer Inc.; Pharmacia & Upjohn Co. LLC

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