Schlichter, Bogard & Denton, LLP Law Firm Comments on Proposed FDA Rule that would Change Landscape of Generic Pharmaceutical Litigation

Share Article

Kristine Kraft, a partner within the Pharmaceuticals and Medical Device Litigation Department at Schlichter, Bogard & Denton, LLP representing victims of dangerous pharmaceutical medications and unsafe medical devices, comments on the FDA's proposed new rule that would change the landscape of pharmaceutical litigation as it pertains to generic pharmaceutical drugs. In particular, FDA's proposed new rule would overturn Pliva v. Mensing and bring relief to people injured by defective generic drugs.

Schlichter, Bogard & Denton, LLP represents victims of dangerous pharmaceutical medications and unsafe medical devices.

Approximately 80% of all prescriptions in the United States are filled with generic drugs. Yet the recent decision of the United States Supreme Court in Pliva v. Mensing nearly immunized generic drug manufacturers from liability for the injuries caused by their products, by holding that state-law tort claims alleging failure to warn (i.e., failure to provide adequate warning labels) brought against manufacturers of generic medications are preempted by federal drug regulations. On November 13, 2013, the Food and Drug Administration (“FDA”) issued a proposed rule titled “Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products,” in an attempt to remedy this injustice.

The Supreme Court’s ruling in Mensing meant that a person’s ability to obtain relief for injuries caused by defective pharmaceutical products often depended on whether his or her prescription happened to be filled with a generic or brand name drug – something that can be outside of a patient’s knowledge or control. It also meant that generic drug manufacturers had little to no incentive to ensure the continued safety of their products. Kristine Kraft of Schlichter, Bogard & Denton, LLP comments that "by issuing this proposed rule, the FDA has recognized and is attempting to fix this problem."

Kraft explains that the new rule proposed by the FDA would permit manufacturers of generic drugs and biological products to initiate changes to product labeling after the drug has already been approved, known as a Changes Being Effected (“CBE”) supplement. Kraft also adds that it would require manufacturers of generic drugs to conform their product labeling to an approved CBE supplement within 30 days, whereas the previous FDA regulations only required manufacturers of generic drugs to do this as soon as possible. Finally, manufacturers of brand name drugs and manufacturers of generic drugs now may use the CBE process to add new warnings to the “Highlights” portion section of drug labels, which had been restricted by former FDA regulations.

"If the FDA’s proposal is adopted, it will eliminate the preemption of many claims brought against generic drug manufacturers," states Kraft. Further, she adds that "the changes proposed by the FDA will help to ensure that people harmed by defective drugs have access to the courts, regardless of whether their prescriptions were filled with generic or brand name medications."

The public has 60 days in which to comment on the proposed rule, ending on January 13, 2014. After which time, the FDA will review all of the comments and publish a final rule.

About Schlichter, Bogard & Denton, LLP
Schlichter, Bogard & Denton, LLP is a unique law firm that aggressively represents its clients injured as a result of dangerous pharmaceutical medications and unsafe medical devices. With hard work, creative thinking, and strong trial skills, we have earned an outstanding nationwide reputation by representing thousands of individuals who have suffered serious injuries. If you or a loved one has suffered from complications arising from the use of a pharmaceutical product, please contact the attorneys at Schlichter, Bogard & Denton, LLP toll-free at 1-800-873-5297 for your confidential and free consultation.

The choice of a lawyer is an important decision and should not be based solely on advertisements. Past results afford no guarantee of future results and every case is different and must be judged on its own merits.

Share article on social media or email:

View article via:

Pdf Print

Contact Author

Kristine K. Kraft
Visit website