Pfizer Inc. is one of the world’s largest pharmaceutical companies and is one of the thirty companies used to calculate the Dow Jones Industrial Average. In a class action, over one thousand lawsuits have been filed against Pfizer, claiming that certain testosterone replacement drugs increase the risk of heart attacks and strokes. ((Diana Novak Jones, 7th Circ. Won’t Revive Claims of 1,000 Pfizer Suits in MDL, Law 360 (Jan. 19, 2018), https://www.law360.com/articles/1004005/7th-circ-won-t-revive-claims-of-1-000-pfizer-suits-in-mdl.)) Testosterone replacement drugs have been around for over sixty years and were usually prescribed to young men who had unusually low testosterone. However, these drugs have been prescribed to older men to combat diminishing testosterone levels. Since older men are already at an increased risk of heart attack and stroke, negative side effects of these drugs could be potentially life threatening. The class action lawsuit claimed that the drug manufacturers failed to warn doctors and patients about these risks and sought compensation under tort law. ((Rodney Guilbeau v. Pfizer Inc., No. 17-2056, (7th Cir. 2018), available at https://law.justia.com/cases/federal/appellate-courts/ca7/17-2056/17-2056-2018-01-19.html.))
The cases were brought as part of a multi-district litigation centralized in federal court in Illinois. The case was first brought in 2015, but the district court dismissed the case under the reasoning that failure-to-warn claims are preempted by federal law. The manufacturers of one testosterone replacement drug, Depo-T, made the successful argument that it could not add any more warnings to the drug label since the FDA prohibits unilateral labeling changes. ((Id. at 3.))
The plaintiffs appealed that decision as well as the district court’s decision to deny any further discovery. The 7th Circuit heard the appeal and began by looking at the regulatory approval process for prescription drugs. ((Id. at 4.)) All prescription drugs must be approved by the FDA. New drugs go through a rigorous process which involves numerous trials to test the drugs’ safety and effectiveness. However, if a drug is the same as an existing drug it does not have to go through the same process. Instead it goes through an abbreviated process that is much shorter and less comprehensive. ((Id.)) The 7th Circuit examined two other cases to determine the correct precedent. 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).)) However, in PLIVA, Inc. v. Mensing, the Supreme Court held that such claims were preempted by federal law. ((564 U.S. 604, 618 (2011).)) Wyeth applies when the drug has gone through the trial process for new drugs and Mensing applies when the drug is generic and goes through the abbreviated process.
Thus, a key issue in resolving the plaintiffs’ claims the determination of which process the testosterone replacement drugs in question underwent. Due to slight differences in physical composition, Depot-T was classified as reference listed drugs. ((Rodney, supra note 2 at 8.)) This requires that a drug be bioequivalent before it can go through the abbreviated approval process. The 7th Circuit focused in on the Mensing Court’s reasoning that these generic drugs have a federal duty of sameness and did not give rise to the ability to change the warning label. ((Id. at 14.)) The court went on to say that this same duty of sameness also applied to reference listed drugs and that additional warnings could not be added to the testosterone replacement drugs. The court dismissed the case, saying that their theory pushed for a third category of drugs while the Supreme Court only recognized two. (Id. at 20.))
Finally, the 7th Circuit examined the plaintiffs’ request for discovery regarding Pfizer’s communications with the FDA. The court noted that the general rule was that discovery was generally left to the district court and the court would only reviewing for an abuse of discretion. ((Id. at 25.)) The court reasoned that since preemption is a legal question, discovery of facts might not be very important. It determined that additional discovery would unlikely provide what the plaintiffs needed to continue their case since the Freedom of Information Act already provided them with adequate information. ((Id. at 27.))
Looking forward, this decision could have a large impact on how drug companies act. If a company knows that it wants to expand the warning label, it now knows that it cannot use the reference listed classification to achieve this. More importantly, the decision emphasizes how important initial trials are for new drugs. Since the generic drugs that follow can’t add on to the warning labels, it is imperative that the original warning labels are able to inform doctors and potential consumers.