Personal injury lawyers strive to prove deliberate negligence or malicious intent in product liability lawsuits. Medical device manufacturers have a duty to conduct rigorous safety tests prior to releasing a product to market and to communicate all known risks to consumers.
Determining what breast implant manufacturer Allergan did or didn’t know is at the center of breast implant litigation underway in the Eastern District of Michigan and elsewhere around the country. If attorneys can prove Allergan knew or should have known of cancer risks associated with their textured breast implants but either negligently or willfully concealed these risks, it could spell greater financial compensation for personal injury victims and their families.
Women File Breast Cancer Lawsuits Against Allergan
Breast cancer lawsuits against Allergan are just starting to appear in courts around the U.S.
- Half a dozen women filed a class-action lawsuit in the Eastern District of Michigan. The women all suffer from a rare condition known as Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL). The women had received the defendant’s Biocell saline and silicone breast implants prior to diagnosis.
- Plaintiff Carol Burnside in Colorado filed a lawsuit. Burnside underwent a double mastectomy in 2004 after being diagnosed with precancerous lesions. She underwent breast reconstructive surgery with breast implants a year later. After one of the implants ruptured, she received Allergan’s McGhan style 410 implants. She had the implants removed in April 2017 after experiencing years of swelling and pain. It was then that she discovered she had the rare form of BIA-ALCL cancer.
- In August 2019, two women from Arizona and Illinois filed lawsuits against Allergan in the U.S. District Court of New Jersey. The women seek monetary damages for themselves and other women adversely affected by the implants because they “will be forced to expend substantial sums for the removal of the recalled implants, surgical and diagnostic fees, and/or medical monitoring and invasive diagnostic procedures required as a result of their exposure to the risk of contracting BIA-ALCL.”
- As of January 15, 2020, a total of 36 Allergan Biocell textured breast implant lawsuits were consolidated in New Jersey, before U.S. District Court Judge Brian R. Martinotti.
Given the fact that tens of thousands of adverse events were reported to the FDA’s database, many more lawsuits are expected in the coming year, particularly as details emerge that Allergan may have known about the issue all along, but chose the unthinkable — to put profits over people.
What Did Allergan Know?
On July 24, 2019, the U.S. Food and Drug Administration requested that Allergan voluntarily recall BIOCELL textured breast implant products. These implants were designed with a sandpaper-textured outer shell to prevent slippage and form a fibrous scar capsule that would hold the implant in place, but a number of patients had reported chronic inflammation – which later resulted in a specific type of lymphoma.
This rare form of cancer causes malignant cells within the fluid surrounding the implant and within scar tissue, which then affects the immune system through the lymph nodes. Other types of breast cancer directly affect the breast tissue itself. The primary symptom of BIA-ALCL is unusual, but painless, swelling of the breast within two to 28 years after implant surgery. The prognosis is good if detected and treated early.
According to the FDA safety communication, “Of the 573 cases of BIA-ALCL, 481 are reported to have Allergan breast implants at the time of diagnosis.” Further, they said the “risk of BIA-ALCL with Allergan BIOCELL textured implants is approximately 6 times the risk from any other manufacturer.” Continued distribution of the product “would likely cause serious, adverse health consequences and potential death.”
At least 33 reported deaths have been blamed on Allergan BIOCELL textured implants. There is no denying the danger now.
But what did Allergan know prior to the recall?
According to lawsuit allegations, Allergan has known since the 1990s that side effects of the implants could cause cancer. At this time, the first case of BIA-ALCL had been diagnosed.
In November 2008, the Journal of the American Medical Association published retroactive case studies of 11 patients with BIA-ALCL dating back to 1994 to 2006. Since then, a number of respected medical reports linked breast implants with cancer.
The FDA first reported case studies and epidemiological research suggesting a link between breast implants and BIA-ALCL in 2011 but further clarified that women with certain textured implants had 10 to 14 times the risk of developing the cancer compared to those with smooth implants.
Most disturbing of all is the claim that Allergan “buried” reports to hide possible safety risks from the FDA and the public. Lawsuits allege that Allergan used fake names like “Costa Rica” and “Santa Barbra” instead of “Allergan” to avoid flagging the company for safety risks. Further, Allergan reportedly logged these safety incidents as “alternative summary reports” so they would filter to a hidden database, rather than the publicly-searched Manufacturer and Use Facility Device Experience (MAUDE) database.
When the FDA tightened its reporting requirements in 2017, the number of breast implant-related adverse events skyrocketed from 200 to 4,567, reaching 8,242 by mid-2018.
How many doctors and their patients during that time period chose Allergan textured implants over other competing products because they simply didn’t know any better? Lawsuits filed against Allergan claim the defendant “purposefully failed to comply with their clearly-established post-market surveillance obligations” and exposed hundreds of thousands of women to the life-altering risk of cancer.
What Happens Next?
Allergan has offered patients a “free replacement” or a limited amount of compensation for diagnostic and surgical fees among those who wish to keep their implants. They are not offering to pay for the outright removal of defective implants, however.
Many women feel they have no choice but to sue for “failure to warn” and “negligent, fraudulent concealment” to gain compensation for the unnecessary hardship they have suffered and put this matter behind them.
Contact Showard Law Firm to speak with a breast implant lawyer, obligation- and risk-free, at no upfront cost to you. You can learn more about the pending litigation, the strengths of your particular case, and how much compensation you can expect by joining the litigation. Should you agree to have Showard Law Firm represent your case, you pay nothing unless we secure a settlement or jury award on your behalf.