An Illinois judge has dismissed Allergan from a lawsuit accusing the pharmaceutical company of manufacturing a dangerous product and failing to warn about its dangers. However, a plastic surgeon who used Allergan’s implants remains a party to the breast implant cancer lawsuit.

The lawsuit filed by Christine D. and Bradley D. on April 30, 2020, in the Circuit Court of Cook County, Ill., raised 25 counts against both Allergan and Michael Epstein. M.D., the plastic surgeon who implanted Christine with the Allergan implants. The complaint claims that Allergan didn’t warn the doctor or patient about the risks associated with its breast implants and that the company didn’t timely report adverse events associated with the implants while continuing to sell the product despite knowing it could cause cancer.

Preemption Bars Claims About Allergan Implants

Circuit Judge John Ehrlich found that the plaintiffs’ claims of negligence, product liability, and loss of consortium are preempted by federal law because “they’re challenging the same manufacturing processes and procedures that the U.S. Food and Drug Administration has exclusive authority to review under the Federal Food Drug and Cosmetics Act,” according to Law360. 

“The simple fact is that is the FDA had approved the design, manufacture and labeling of Allergan’s breast implants,” Judge Ehrlich said. “To require Allergan to provide additional warnings, report adverse events in a timely fashion, recall implants and discontinue selling the implants would impose processes, procedures and restrictions beyond those imposed by the FDA.”

The plaintiffs’ attorney told Law360 that they disagree with the judge’s ruling  because “it would allow Allergan to keep all of the profits it generated from the sale of these dangerous products but avoid any responsibility for the terrible harm they have caused.”

The judge found that it was procedurally necessary to grant Allergan’s motion to dismiss, but denied Epstein’s request.

In his order, the judge wrote, that “at a minimum, there is nothing in the record explaining why Epstein chose to go forward with Christine’s breast implantation knowing the FDA and Allergan were investigating the potential link between the breast implants and cancer. There also exists no record as to why Epstein chose to proceed with Christine’s surgery using Allergan breast implants given his explicit knowledge that Allergan products were subject to FDA investigation.”

Claims Against Plastic Surgeon

The plaintiffs’ lawsuit raised questions about whether Dr. Epstein, the doctor who sold the couple the Allergan implants, had knowledge that they were dangerous.

Christine claimed she initially met with Epstein on Aug. 8, 2011, and nearly a month afterward the surgeon posted information on his website about the FDA investigation into breast implants, and the heightened risk of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL). According to Christine, Dr. Epstein commented in a post on his website that ALCL is “extremely rare,” while assuring patients and prospective patients that the FDA and Allergan were conducting an investigation into the matter.

Despite acknowledging that the products were subject to FDA investigation, Dr. Epstein sold the Allergan breast implants to Christine and surgically implanted them on the same day, Feb. 9, 2012. In May 2018, Christine reportedly began to feel pain in her chest and was subsequently diagnosed with BIA-ALCL, a type of non-Hodgkins lymphoma.

Allergan voluntarily recalled its breast implants in July 2019 due to BIA-ALCL risks.  

Judge Ehrlich’s decision stated, “It is also unknown why Epstein chose to proceed with Christine’s surgery using Allergan implants rather than an alternative product that may not have been a subject of the FDA’s investigation.”

What is BIA-ALCL?

Breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) is a form of lymphoma that has been reported in connection with Allergan implants — specifically textured breast implants. BIA-ALCL is not breast cancer. It is a type of non-Hodgkin lymphoma, a form of blood cancer.

According to the Lymphoma Research Foundation, ALCL occurs when the growth of certain white blood cells cannot be controlled. The illness can spread and be present in breast tissue, lymph nodes, and the skin. A diagnosis can usually be rendered by taking a biopsy. Sometimes a physician will order additional tests to determine the extent of the illness throughout the body.        

Symptoms can include hardening or lumps in the breast or armpits, swelling, and pain. Fluid retention is usually the first symptom to present and tends to occur several years after receiving the implants. 

The FDA requested that Allergan voluntarily recall its BIOCELL and Natrelle textured implant products following its analysis that the implants were linked to BIA-ALCL. It’s a Class I recall, meaning the products posed a serious risk of harm that could result in death.

The Allergan Implants Lawsuit is Dietz et al v. Allergan PLC et al., Case No. 2020-CH-004813, in the Circuit Court of Cook County, Illinois.

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