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According to allegations raised in a recent investor class action lawsuit, Allergan falsely inflated the company’s value by failing to disclose that certain types of breast implants may increase the risk of a form of cancer, which is now commonly referred to as breast implant-associated anaplastic large cell lymphoma (BIA-ALCL).
The complaint (PDF) was filed late last month in the U.S. District of the Southern District of New York by Steve Klein, seeking class action status on behalf of investors, alleging Allergan knowingly avoided telling the public about the link between breast implants and lymphoma which has developed in a growing number of women.
Allergan PLC, the company’s president and chief executive office, Brenton L. Saunders, and the company’s chief financial officer, Maria Teresa Hilado, are all named as defendants in the breast implant class action lawsuit.
“Throughout the Class Period, Defendants made materially false and misleading statements regarding the Company’s business, operational and compliance policies,” Klein’s lawsuit states. “Specifically, Defendants made false and/or misleading statements and/or failed to disclose that: (i) textured breast implants manufactured by Allergan were linked to ALCL; (ii) the foregoing link to cancer, when revealed, would foreseeably force Allergan to recall those textured breast implants from the market; and (iii) as a result, the Company’s public statements were materially false and misleading at all relevant times.”
The lawsuit notes that on December 18, France’s National Agency for the Safety of Medicines and Health Products (L’ANSM) announced an Allergan textured breast implant recall after a deadline passed for the manufacturer to renew its license to sell the devices in the European Union. However, French regulators noted that the breast implants were linked to a risk of BIA-ALCL.
Following the announcement, Allergan announced it was removing its textured breast implants from the European market. The company’s stock price fell nearly seven percent, about $10.20.
Breast Implant Cancer Concerns In the U.S.
On January 26, 2011, in the U.S. the FDA first released a report about case studies and epidemiological research that suggested there was a link between breast implants and ALCL.
The agency then issued a statement about emerging information on the breast implant lymphoma problems last year, and a number of subsequent studies have confirmed that the breast implant ALCL cancer risk is real.
In June 2017, a study published in the medical journal Plastic and Reconstructive Surgery suggested that certain textured breast implants may increase the risk of anaplastic large cell lymphoma anywhere from 10 to 14 times, when compared to smooth breast implants.
In October 2017, a study published in the medical journal JAMA Surgery warned that many breast implant cancer cases worldwide have likely not been reported, and noted that doctors and patients may not be aware of BIA-ALCL.
In March 2018, the FDA indicated that it was aware of more than 400 cases of breast implant-related cancer. As more information becomes public about the breast implant cancer cases, experts have warned that the number of cases reported will likely increase significantly.
As regulators and researchers worldwide continue to evaluate the specific cause of the breast implant lymphoma problems, other women are also raising serious questions about why certain products appear to be more likely to be associated with the development of cancer, and how manufacturers failed to address potential design defects earlier.
Product liability lawyers in the U.S. are now reviewing other potential breast implant cancer lawsuits for women diagnosed with anaplastic large cell lymphoma in recent years, alleging that manufacturers knew or should have known about the risk, yet withheld warnings from consumers and the medical community.