Plaintiff May File Amended Complaint in Bid to Avoid Consolidation in Fluoroquinolone MDL

The multidistrict litigation (MDL) for In Re: Fluoroquinolone Products Liability Litigation is being consolidated in the District of Minnesota. This litigation is still in its preliminary stages; however, “a court presiding over an MDL must take steps to ensure that efficiency does not trump fundamental fairness and that the desire for certainty does not deprive any individual party of substantive rights.” This has resulted in short-form complaints filed for individual cases that are being consolidated into the MDL to provide a statement of the individual facts related to the cases, as well as any causes of action that will not be addressed by the MDL.

Jennifer Akman v. Bayer HealthCare Pharmaceuticals Inc., Cobalt Laboratories Inc., also known as Cobalt Laboratories LLC, and Actavis Pharma Inc. Case No. 0: 17-cv-00260-JRT is one of these individual causes of action. In addition to the claims filed against the original manufacturer, the Akman short-form complaint alleged specific complaints against generic manufacturer Actavis. The complaint alleged that the generic manufacturer did not act to modify the warning materials and packaging for its generic drug to match the mandatory changes issued by the Food and Drug Administration (FDA) in regards to the non-generic, original drug.

The defendant Actavis challenged the short-form complaint with a motion to dismiss on the grounds of preemption under the Food, Drug, and Cosmetic Act (FDCA). Under the current court doctrine on the FDCA, if a drug manufacturer faces one standard for labeling and warning on the federal level but a different standard at the state level, an “impossibility preemption” exists to permit the drug manufacturer to comply with the federal standard only. However, the court declined this theory, as the facts as alleged in the complaint indicated that the federal warnings had already changed, and the defendants were out of compliance with both the federal- and state-level mandated warnings. The plaintiffs were given leave to file an amended complaint, and the parties will be required to brief as to the issue of whether this complaint should remain seperate or be consolidated into the MDL.

The plaintiff is represented by Nidel Law PLLC and Paulson & Nace PLLC. The defendants are represented by Ulmer and Berne LLP and Hilliard Martinez Gonzales.