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March 22, 2021 News

Berger Montague Announces That Many Claims for Injuries Arising from the Recall of Allergan’s BIOCELL Textured Breast Implants Will Now Proceed to Discovery

PHILADELPHIA, March 22, 2021 – The national plaintiffs’ law firm Berger Montague is pleased to announce that the U.S. District Court in New Jersey has just issued a 121 page opinion and order in the Allergan BIOCELL Textured Breast Implant Products Liability Litigation, No. 2:19-md-02921, MDL No. 2921 (D.N.J.), regarding Allergan’s motions to dismiss the case, and decided that many of the claims asserted on behalf of over 246,000 women potentially affected by Allergan’s recall of its textured breast implants, can proceed to discovery.

The litigation involves the recall of Allergan’s textured breast implants and tissue expanders after it became public that the products were tied to cases of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL). The multi-district litigation includes class action claims for economic injuries and medical monitoring as well as many individual cases for personal injuries, including claims that the implants led to the development of BIA-ALCL or to surgeries to have the recalled implants removed. The plaintiffs also claim physical injuries including tissue damage, a collection of fluid built up under the skin called a seroma, inflammation, swelling, and capsular contracture.

Allergan moved to dismiss the litigation based on federal preemption grounds arguing the claims were mostly foreclosed because the breast implants are Class III medical devices subject to federal oversight. The Court, however, held the plaintiffs’ allegations of violations of state law duties, if in parallel with federal requirements, are not preempted. Thus, the Court found that while the plaintiffs’ label-based failure to warn claims are preempted, the plaintiffs’ claims based on Allergan’s alleged failure to make proper adverse event reports to the FDA are not preempted and can proceed.

The Court also permitted the plaintiffs to move forward with their claims of manufacturing defects, finding them not preempted. For example, the plaintiffs allege the debris, including silicone particles, on the implants’ surface is not an intended part of the design for the BIOCELL implants and further allege violations of Good Manufacturing Practices and other statutory standards by Allergan, all of which will now be subject to the discovery process.

The Court found the plaintiffs’ negligence per se claims based on the alleged violation by Allergan of the Federal Food, Drug, and Cosmetic Act, as well as claims for breach of express and implied warranties, negligent misrepresentation, and breach of state consumer fraud and deceptive trade practice statutes, are not preempted, and can also proceed to discovery. The Court found:

  • The manufacturing defect claims may proceed at this time on behalf of women nationwide;
  • The negligence per se claims may proceed on behalf of women residing in Alabama, Arizona, California, Delaware, District of Columbia, Illinois, Mississippi, Missouri, New York, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Virginia, Wisconsin;
  • The report-based failure to warn claims may proceed on behalf of women residing in California, Delaware, Hawaii, Illinois, Indiana, Idaho, Kentucky, Louisiana, Maryland, Minnesota, Mississippi, Missouri, Nevada, New York, Pennsylvania, Rhode Island, Texas, Vermont, Washington, Wisconsin;
  • The negligent misrepresentation claims may proceed on behalf of women residing in Alabama, Florida, Georgia, Mississippi (under its product liability statute), Ohio, Tennessee, and Texas;
  • The claims for breach of warranty may proceed on behalf of women residing in Alabama, Arizona, California, Florida, Georgia, Idaho, Indiana, Kentucky, Michigan, Nevada, New York, Ohio, Tennessee, Washington; and
  • The claims for medical monitoring may proceed on behalf of women in 39 states.

Shanon J. Carson, a Managing Shareholder of Berger Montague, is one of the Court-appointed Co-Lead Counsel in the MDL litigation and issued this statement:

“We are privileged and honored to have the opportunity to help lead this important litigation on behalf of women affected by Allergan’s BIOCELL textured breast implants and look forward to the next phase of the case, which is engaging in full discovery of Allergan’s conduct relating to its development, manufacture, sale, and recall of the breast implants. We will work tirelessly to hold Allergan responsible for any injuries it has caused, and we are available to speak with any person in the country who has questions about the case.”

Women who believe they have been injured by Allergan’s BIOCELL textured breast implants can contact Berger Montague for a free evaluation of their claims. Because of statute of limitations concerns, Berger Montague encourages all women who were implanted with the recalled products and believes they were harmed to contact the firm as soon as possible by emailing [email protected] or by telephone at (833) 721-4092.

More information about the case, including copies of case documents such as the Court’s opinion on the motions to dismiss, is available at, including the list of recalled Allergan textured breast implant products. Berger Montague has a large team devoted to the case and all inquiries will be handled on a confidential basis free of charge.

Mr. Carson has been with Berger Montague for 21 years and co-chairs its Consumer Protection and Mass Tort Departments. In 2009, he was selected as one of 30 “Lawyers on the Fast Track” in Pennsylvania under the age of 40 and has repeatedly been selected as one of the top 100 lawyers in Pennsylvania as reported by Thomson Reuters. In 2018, Mr. Carson was named to the Philadelphia Business Journal’s “Best of the Bar: Philadelphia’s Top Lawyers.” Mr. Carson has overseen as lead or co-lead counsel dozens of successful class actions and other complex cases on behalf of injured parties across the country.

Berger Montague is a national law firm headquartered in Philadelphia with additional offices in Minneapolis, Washington, D.C., and San Diego. The firm litigates complex civil cases and class actions in federal and state courts throughout the United States. Berger Montague has played lead roles in major cases for more than 50 years and has recovered over $36 billion for its clients and the classes they have represented.