On July 24, 2019, the FDA called on pharmaceutical company, Allergan, to issue a global recall of its Biocell textured breast implants and tissue expanders. The recall request came after the implants were linked to anaplastic large cell lymphoma (ALCL), a rare type of cancer. The FDA categorized the recall as a Class I—the most serious designation, where “use of these devices may cause serious injuries or death.” In this litigation guide, we dive into the background of Allergan’s Biocell textured breast implant products, the underlying cancer risks and recall, and the resulting lawsuits. We also discuss key considerations for attorneys developing Biocell lawsuits, including effective strategies for collaborating with expert witnesses.
Statistics tell the story of the rising popularity in breast implant procedures and the growing concern with textured implants. In a normal year, it’s estimated that 400,000 American women get breast implants. About 10% of all implant devices used in the U.S. are textured—with Allergan’s textured implants accounting for less than 5% of market share. Now the focus of multiple ongoing lawsuits, the textured implants make up a very small portion of implants in use nationwide. Around 75% of these procedures are purely cosmetic, the rest are mainly for post-cancer reconstruction.
Allergan, an Irish pharmaceutical company, first developed the Biocell implant products before being recently acquired by U.S. pharma-giant AbbVie. Biocell specifically refers to a proprietary breast implant surface texturing process. The company used this Biocell method to produce breast implants and tissue expanders with a rougher surface than was previously available on implants in the market. The implants and expanders—technically categorized as medical devices—are intended for use in breast augmentations and reconstructive surgeries following mastectomies or other trauma.
The FDA approval process for Allergan implant products is a complex process spanning many years. Allergan first began marketing silicone gel-filled breast implants in the U.S. in 1984. This marketing ceased in April 1992 when the FDA determined there was insufficient data for approval of any of the company’s pending premarket approvals (PMA).
In 1998, Allergan received FDA approval for its silicone gel-filled breast implant product contingent on administering a “Core Study” of implant patients over 10 years. Using the data set collected in this study, many more implant products from Allergan also subsequently received approval. In 2006, FDA approval of the Inamed Silicone-Filled Breast Implants required Allergan to administer another follow up study of implant patients. The study, designed to be separate from the first study, followed 39,330 Allergan silicone gel breast implant patients and 19,605 saline-filled breast implant patients to monitor for “real-world” endpoints. These endpoints included long-term local complications, connective tissue disease (CTD), neurological disease, reproductive issues, lactation issues, cancer, suicide, mammography issues, and rupture results.
Links between breast implants and ALCL started to surface just a few years later. In January 2011, the FDA released a report titled, Anaplastic Large Cell Lymphoma (ALCL) In Women with Breast Implants: Preliminary FDA Findings and Analyses. The report stated, “Although ALCL is extremely rare, the FDA believes that women with breast implants may have a very small but increased risk of developing this disease in the scar capsule adjacent to the implant.” However, the FDA fell short of indicating any imminent danger, explaining, “the totality of evidence continues[s] to support a reasonable assurance that FDA-approved breast implants are safe and effective when used as labeled.”
The 2011 preliminary report also made no special note about textured implants. In fact, the report mentions ALCL is found, “more or less frequently in women with textured breast implants than in women with smooth breast implants.” But just six years later, reports of ALCL in women with textured implants rose substantially. In 2017, researchers estimated that one in one in 30,000 women with textured implants in the U.S. and Europe will develop ALCL. The next year, Allergan implants were banned in 33 European countries, Israel, Brazil, Australia, and Canada. Meanwhile, in the U.S., the FDA announced 414 reports of ALCL in breast implant patients. Nine of these women died. Out of the 272 cases where the implant surface type could be identified, 242 of the women had textured implants.
In 2019, concerns came to a head. In March, at an FDA public advisory committee meeting where numerous patients expressed concern and urgently called for a ban on textured implants, the FDA resisted. The administration stated it did not “believe the product….meets the legal standard for being banned at this time, based on available data and information.”
Finally, a few months later in July 2019, a spike in ALCL case data led the FDA to request the recall of Allergan textured breast implants and tissue expanders from the U.S. market. Allergan notified the FDA it would comply and remove the specified products from worldwide markets.
In a statement at the time of recall, the FDA explained, “Although the overall incidence of ALCL appears to be relatively low, once the evidence indicated that a specific manufacturer’s product appeared to be directly linked to significant patient harm, including death, the FDA took action to alert the firm to new evidence indicating a recall is warranted to protect women’s health.” The FDA also indicated it will continue to monitor and assess the risks of ALCL.
Legal trouble for Allergan began even before the FDA recall. In December 2018, Allergan acknowledged over 12 pending lawsuits in its SEC 10K filing. Here, the company reported, “Certain Company subsidiaries are defendants in more than a dozen cases alleging that Allergan’s textured breast implants caused women to develop a rare condition known as anaplastic large cell lymphoma (ALCL).”
Since the recall, additional lawsuits have followed and many appear to have been consolidated into a case before the district court in New Jersey. In December 2019, four cases against Allergan—in the Central District of California, the Central District of Illinois, the Southern District of New York, and the Middle District of Tennessee—were consolidated into a multidistrict litigation in the federal district court in New Jersey. The case consolidation intends to conserve time and resources and to rely on one presiding judge for consistent rulings. In this suit, the plaintiffs seek financial damages to cover implant removal surgery, diagnostic testing, and medical monitoring. As of late April 2020, 66 cases are part of the consolidated case pending before NJ US District Judge Brian R. Martinotti as part of MDL 2921, IN RE: Allergan Biocell Textured Breast Implant Products Liability Litigation.
This consolidated case is currently proceeding, with 11 case orders so far. The orders range from the initial Case Management Conference on January 13, 2020 to the “Science Day” scheduled for August 20, 2020 where the parties will provide the court with “an overview of general medical and scientific issues in this litigation, presented in an objective format without advocacy for the sole purpose of educating the Court.”
In a suit filed in the Middle District of Florida on October 22, 2019, the two plaintiffs are seeking $5 million in damages and class action status. The women want to be paid for the expenses of removing the breast implants, which they claim Allergan has not offered to cover. According to reports, Allergan has refused to cover the costs of invasive diagnostic testing and medical monitoring for patients who do not agree to replace their implants after removal.
The lawsuit further claims that Allergan does not plan to monitor at-risk individuals for cancer, even though the FDA issued a recall due to this risk. The lawsuit also alleges that victims are being misled and asked to sign their rights away by the manufacturer.
Hillary Corts and Cari Dietzel filed separate lawsuits in the Los Angeles Superior Court, claiming that Allergan neglected to properly advise consumers on the implant risks and concealed and misrepresented the dangers for decades. Neither woman has ALCL, but seek monetary damages for themselves and other women with 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 ALCL.”The mention of seeking damages for “other women” implies a possible class action.
The FDA estimates hundreds of thousands of American women have Allergan Biocell breast implants. Though it is not clear what percent have the textured devices. Regardless, the potential plaintiff universe could be sizable.
The questions of when the FDA and Allergan knew or should have known about the risks of the use of textured breast implants will be at the heart of case investigations. Was enough attention paid to the use of textured shells in the approval process? Did the company do enough to understand the potential risks of introducing textured implant shells that allow natural tissue to grow into the rough surface of the implant? Were the right questions asked, or did the science err in not focusing soon enough on non-breast cancer risks?
To answer these questions, lawyers and their experts will likely need to spend a significant amount of time investigating the data in the Allergan studies and other sources used by the FDA in the approval process.
With the possibility of a case ultimately being consolidated in the New Jersey federal court, lawyers will want to consider how this impacts their representation. How much interaction will there be with co-counsels? Are there nuances in the New Jersey court or with the presiding judge that may impact the presentation or case process?
It will be important for lawyers heading up Allergan lawsuits to consider early-on the kinds of expert consultants and witnesses the case will require. Allergan textured breast implant cases will undoubtedly present complex factual issues on oncology, plastic surgery, FDA approval processes, biomedical engineering, medical device products liability—not to mention the obvious need for specialists on the use of textured shells for breast implants. Developing a case strategy for Allergan Biocell litigation will depend on a solid understanding of complicated medical issues. Lawyers will want exceptional experts with the credibility and expertise to help them win.
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