Allergan Inc. can’t escape the lawsuits filed in New Jersey state court by plaintiffs who claim that the company's Biocell breast implants were defective, which caused in developing a type of non-Hodgkin's lymphoma among them.
The company appealed to dismiss the complaint by stating that some variants of the implant are protected under the U.S. Food Drug and Cosmetic Act. However, Judge Rachelle L. Harz denied Allergan's motion on preemption grounds.
In this multicounty litigation, the plaintiffs allege that the breast implants were defective and have a risk of developing breast implant-associated anaplastic large cell lymphoma, a subtype of non-Hodgkin's lymphoma.
As mentioned in Allergan's motion, the company claims that stricter regulations are necessary for the pre-market authorization system of the U.S. Food and Drug Administration.
Even the judge agreed with the company's claims that FDA approved the products, even after Allergan failed to conduct clinical studies and provided information during the pre-market approval process.
On March 19, U.S. District Judge Brian R. Martinotti, presiding over the federal Allergan Biocell breast implants litigation, ruled that Allergan, Inc. must face manufacturing defect, negligence per se, and other claims as they were not preempted.
According to a 121-page opinion, which was a response to the company's dismissal motion, Judge Martinotti tossed failure-to-warn claims and other allegations on preemption grounds but rejected the bid to knock out the class allegations over the Biocell textured breast implants.
The company had filed a supplemental brief on January 5 in the U.S. District Court for the District of New Jersey, asking the federal judge to dismiss claims against its breast implants because the consolidated lawsuits are preempted by federal law.
Breast implants are used in both breast augmentation surgery (to increase the breast size) and in breast reconstruction (to replace breast tissue that has been removed due to cancer or trauma or that has failed to develop properly due to a severe breast abnormality).
Allergan Inc.’s breast implants include saline and silicone devices used in breast augmentation and reconstruction. The company is one of the largest breast implant manufacturers in the world and started selling breast implants in 2006. Allergan’s flagship breast implant brand is Natrelle, but it also sells implants under its subsidiaries Inamed and McGhan. The manufacturer received approval from the U.S Food & Drug Administration (FDA) on 11/17/2006.
The popular product, its textured implants, is linked to a rare type of cancer called breast implant-associated anaplastic large cell lymphoma, or BIA-ALCL. The disease is a type of non-Hodgkin lymphoma.
On July 24, 2019, Allergan announced a global recall of Biocell textured breast implants and tissue expanders after the U.S. Food and Drug Administration (FDA) requested the recall.
The recall came after a rare type of cancer called anaplastic large-cell lymphoma (ALCL) has been linked to textured breast implants. Lymphoma is a cancer of the lymphatic system. Currently, 38 other countries have recalled this implant because of its link to ALCL.
The judge even laid some stricter regulations on pre-market approval of the products to prevent people from getting affected by the implants.
The plaintiffs' attorney even alleged that the company used a different scrubbing process, which was not in compliance with the FDA approval. Finally, the judge dismissed Allergan's motion for breach of express warranty and consumer fraud.
