Allergan Misled FDA With “Junk Science”, According To Breast Implant Lymphoma Lawsuit

According to allegations raised in a recently filed product liability lawsuit, Allergan engaged in a campaign to push “junk science” for years to pursuade regulators and plastic surgeons that lymphoma problems linked to breast implants were a result of surgical technique, instead of the design of the product itself.

More than 75 breast implant lymphoma lawsuits have been filed against Allergan over the past year, after federal regulators concluded in July 2019 that the company’s Biocell line of textured implants were linked to nearly all cases of a rare type of cancer that has been reported in the breast tissue for women after receiving implants, which has come to be known as breast implant-associated anaplastic large cell lymphoma (BIA-ALCL).

In a complaint (PDF) filed late last month in the U.S. District Court for the District of New Jersey, Kim Crespo indicates that Allergan attempted to delay a breast implant recall by promoting research papers written by paid consultants, which were not scientifically reliable and only advanced to protect the company’s profits.

Crespo indicates she was received Inamed Style 115 breast implants in 2007, which featured a Biocell textured shell. In about 2015, she noticed problems with the breast implant, but was told that there was no need to worry. However, in May 2016 she was diagnosed with cancer and the breast implants were removed, after which the breast tissue tested positive for BIA-ALCL.

Although there were concerns for years that reports of lymphoma among women with breast implants may be linked to the textured Biocell design, Allergan continued to promote information that was false and misleading, according to the lawsuit. However, in July 2019, the manufacturer was finally forced to issue a worldwide breast implant recall, impacting the entire Biocell line of implants

“To ward off a ban or recall, Allergan sought to defend the Biocell implants based upon the research papers written by Allergan’s paid consultants,” the lawsuit states. “All of Allergan’s medical claims are not scientifically reliable and were advanced to protect profits and direct attention away from the defective Allergan implants—the Biocell textured implant fraught with adulterated and contaminated silicone particles and foreign implant materials on the surface of the implant at the time of sale.”

Allergan Breast Implant Litigation

The case filed by Crespo joins a number of similar complaints filed against Allergan over the past year, which have been consolidated before U.S. District Judge Brian R. Martinotti in the District of New Jersey, as part of a federal MDL, or multidistrict litigation.

To prepare the court for the complexities of the litigation, Judge Martinotti issued a case management order (PDF) on the same day Crespo filed her complaint, scheduling a “Science Day” for August 14.

In complex product liability litigation, it is common for courts to scheduled such scientific presentations early in the case, to educate the court about issues and concepts that will come up during the proceedings. The presentations are designed to be educational, not adversarial, and typically are not part of the official record or subject to cross examination.

Each side will have 90 minutes to make their presentations, and they will focus sole on the scientific and medical issues at play in the litigation, and will not involve liability, claims or defenses involved in the lawsuits.

Given common questions of fact and law raised throughout the litigation, it is expected that Judge Martinotti will select a small group of representative claims for early trial dates to help the parties gauge how juries may respond to certain evidence and testimony that is likely to be repeated throughout the litigation. However, as more women discover that they have BIA-ALCL or decide to have the breast implants removed, the size and scope of the litigation is expected to continue to expand over the coming months.