In the past, breast implants were the subject of major mass tort litigation. Now, there may be another wave of lawsuits on the way regarding another breast implant, Biocell.
- Instead of the risk of leakage and rupture, Allergan’s Biocell breast implant is a carcinogen and has now been recalled from the market.
- Biocell breast implants according to the FDA, causes BIA-ALCL which is a type of non-Hodgkin’s lymphoma, a cancer of the immune system.
- ALCL is otherwise known as Anaplastic Large Cell Lymphoma.
- Women who have been sickened by this implant have now begun to file lawsuits against the company.
- The lawsuits are still in their early stages and are part of an MDL in Federal Court in New Jersey.
- Lawsuits can also be filed in state court multi-county litigation in New Jersey.
Allergen Biocell Breast Implant Lawsuit
The Biocell implant lawsuits will take some time to proceed to trial. These lawsuitsare filed against: Allergan, Inc., Allergan USA, Inc., and Allergan plc. Allergen Biocell Breast implant lawsuits are not part of a class action. Many victims are searching google for information about,”textured breast implant lawsuit” as well as “Allegan smooth implants.”
Update- 6/1/2020- “On June 1, 2020, Allergan launched a dedicated multi-channel campaign to contact patients who may not be aware of the July 24, 2019, recall of BIOCELL textured breast implants and tissue expanders. People who are not aware of the BIOCELL recall or do not know the type of implant they have or their implant history, should:
- Contact go to www.BIOCELLinformation.com to reach out to Allergan Aesthetics to determine if the company has their implant information.
- Contact their surgeon or hospital where they received implants to determine if the surgeon or hospital has records of their implant information.” FDA Biocell recall
7/24/19- “Allergan’s announcement on July 24, 2019, of a voluntary worldwide recall of its BIOCELL textured breast implants and tissue expanders. The announcement followed the U.S. Food and Drug Administration’s request to initiate the recall based on the risk of breast-implant associated anaplastic large cell lymphoma (BIA-ALCL) associated with the products. ” TRANSFER ORDER
Multidistrict Litigation in Federal Court
- Name of MDL is “ALLERGAN BIOCELL TEXTURED BREAST IMPLANT PRODUCTS LIABILITY LITIGATION.”
- Court: UNITED STATES DISTRICT COURT DISTRICT OF NEW JERSEY
- Get all case management orders here.
- “These matters having been transferred to this Court by order of the Judicial Panel on Multidistrict Litigation pursuant to its order of December 18, 2019…” INITIAL CASE MANAGEMENT ORDER
- Case No. 2:19-md-02921 (BRM)(JAD) MDL NO. 2921
- Presiding judges: JUDGE BRIAN R. MARTINOTTI , JUDGE JOSEPH A. DICKSON
- Why was case transferred to New Jersey? UNITED STATES JUDICIAL PANEL on MULTIDISTRICT LITIGATION reasoned that, “We conclude that the District of New Jersey is an appropriate transferee forum. Allergan USA, Inc., has its headquarters and principal place of business in this district, and represented at oral argument that significant common evidence, including witnesses, will be located there. Further, centralization in the District of New Jersey enables us to assign this litigation to Judge Brian R. Martinotti, an experienced transferee judge with the ability and willingness to manage this litigation. We are confident he will steer this matter on a prudent course.” Class action
- “All actions share complex factual questions arising from the allegation that Allergan’s BIOCELL textured breast implants and tissue expanders significantly increase the risk of developing BIA-ALCL, and that Allergan failed to warn the FDA, patients, and healthcare providers of this risk. The common factual questions include: (1) whether BIOCELL textured breast implants and tissue expanders can cause BIA-ALCL; (2) whether defendants knew or should have known of the risk of BIA-ALCL; (3) whether they provided adequate warnings as to the risk; and (4) the adequacy of defendants’ product.” TRANSFER ORDER
- Where did the parties request the Federal Court to send the lawsuits? “The Allergan defendants request centralization in the District of New Jersey. Responding plaintiffs variously propose the Central District of California, the Southern District of New York, the Southern District of Florida, and the District of Kansas.” TRANSFER ORDER
New Jersey State Court Allergan Biocell Multicounty Litigation
- “This Notice is to advise that the Supreme Court, after considering the application and the comments received, has determined to designate cases involving allegations against Allergan, Inc., and Allergan USA, Inc. as Multicounty litigation. The Court has assigned this MCL to Bergen County for centralized case management by Superior Court Judge Rachelle Harz.” Notice to bar
- “Allergan Biocell Textured Breast Implants are products alleged to cause breast implant-associated anaplastic large cell lymphoma. On May 5, 2020, the Supreme Court designated pending and future New Jersey state court litigation alleging injuries from implantation of Allergan Biocell Textured Breast Implants as multicounty litigation and assigned it to Bergen County for centralized management.” NJ Courts
- IN RE: ALLERGAN BIOCELL TEXTURED BREAST IMPLANT PRODUCTS LIABILITY LITIGATION
- SUPERIOR COURT NEW JERSEY
- Read the initial case management order here.
Allergan Sold Biocell Implants Until they Were Recalled
Allergan was the manufacturer of a breast implant called Natrelle Biocell. The company was one of the leaders in the global market for female breast implants. Although the company’s sales figures for this product were not notionally large, they were one of the larger worldwide makers of breast implants. Before the product ran into major trouble, annual sales were over a quarter of a billion dollars. Allergan started selling breast implants in 2006 and immediately moved to a position of market leadership. Thus, there are many thousands of women worldwide who have these particular Biocell implants in their bodies. The FDA estimated the number at hundreds of thousands.
Implants textured instead of smooth
The Allergan breast implants were different from many other breast implants on the markets in that they were textured instead of smooth. The reason why the implants are textured is to allow scar tissue to stick to the implant. This will make it less likely to move around in the body. However, they do take longer to settle into the body.
Biocell Implants Were Linked to a Rare Form of Cancer
For Allergan, the problems with Biocell implants began when data showed that women who had these implants were more likely to develop a certain rare type of cancer. The first reports of the elevated risk were made by the FDA itself, but the regulator did not order the product pulled from the market. In January 2018, a Dutch research study actually quantified the risk that a woman would develop ALCL from these implants.
In November 2018, NBC News investigated and found that there were over 400 adverse event reports filed in the FDA system that linked these breast implants with cancer. These adverse event reports detail 33 deaths from this type of cancer linked with breast implants.
Anaplastic large cell lymphoma (ALCL)
The actual cancer that these women were found to have was not breast cancer. Instead, it was a form of cancer called Anaplastic large cell lymphoma (ALCL). This is a rare type of blood cancer. ALCL is so rare that only 1,400 cases of it per year were previously diagnosed. Depending on the type of ALCL, the five-year survival rate is between 70-90%. Nonetheless, the disease is a form of cancer that exposes patients to a potentially deadly condition and takes away from their quality of life.
At the time that NBC News broke the story about the elevated risk of ALCL tied to textured breast implants, the FDA was already in the middle of its own investigation. However, as is usually the case with potentially dangerous medications and medical devices, it was the European regulators who acted first.
Allergan Pulled the Product Off the European & American Market
Not long after public reports of the cases of ALCL, French regulators asked Allergan to withdraw the product from the market and took away its approval to sell the product in France. This took textured breast implants off the market in all of Europe. The FDA lagged behind European regulators in taking action. Initially, the FDA indicated that it did not intend to recall the product in the U.S. However, in July 2019, the FDA asked Allergan to recall its textured breast implants from the market. The company recalled all of the styles of its Natrelle Biocell breast implants that it produced.
Allergan’s products was six times that of the other textured implants
According to the FDA, while all textured implants raise the risk of ALCL, the risk associated with Allergan’s products was six times that of the other textured implants. The FDA noted that a large majority of ALCL cases from breast implants were from Allergan’s textured implants. The regulator did not advise that women who already had these implants get them removed. Instead, they advised women to work with their healthcare provider to continue to monitor the situation.
Even after Allergan issued the recall, the company still did not fulfill its obligations to the FDA after the recall. The company was required to complete a safety study as a condition of its approval for the product by the FDA. However, almost a year after the recall, Allergan was not making sufficient progress in the studies. As a result, the FDA issued a warning letter to Allergan.
Over 100 Lawsuits for ALCL Have Been Filed Against Allergan to Date
Women are beginning to file lawsuits against the company for the harm that they allegedly suffered from Allergan breast implants. Currently, there are a number of lawsuits concentrated in New Jersey. There are federal lawsuits that have been granted multidistrict status. In addition, there are state lawsuits that have just been granted multicounty status by New Jersey state court.
At the time that the plaintiffs’ attorneys filed the request to consolidate into a multicounty lawsuit, there were six state court lawsuits outstanding. There are expectations that up to 100 state court lawsuits may be filed in the future.
The federal multidistrict litigation is in the District of New Jersey
The federal multidistrict litigation is in the District of New Jersey. The initial status conference was held in January 2020 and the court continues to hold status conferences in the case. Currently, Allergan is working on motions to dismiss the case, even though these cases rarely end up being dismissed. As of July 2020, there were 143 actions pending in this MDL. These cases are still in their early phases, and it may be some time before they proceed to trial.
$5 million Biocell class action lawsuit in Florida
In addition, two women filed a $5 million class action lawsuit in Florida in connection with the allegedly defective implants. This case was related to the cost of surgery to replace implants that are already in women’s bodies. This is different from the product liability personal injury lawsuits that have been consolidated in federal and state courts in New Jersey. Thus, there are both consumer and injury lawsuits open right now.
Court restricted how Allergan could communicate with potential class members
Even after the lawsuit had been filed, Allergan was accused of conduct that, if true, would border on the unethical. Allergan contacted potential class members who had received the textured implants and offered to replace their implants free of charge. Included in the offer was the fact that the women would be releasing Allergan from liability if they accepted the new implants. The women accused Allergan of trying to trick them into waiving their lawsuit rights. As a result, the court issued an order that restricted how Allergan would be able to communicate with potential class members, presumably to prevent the company from trying to persuade class members to waive their litigation rights.
Breast implant lawyer
If you are a woman who has received Biocell implants from Allergan, you should be vigilant about any symptoms that you are not well. You should proactively work with your physician to monitor your condition. Legally, if you have developed ALCL after receiving Allergan breast implants, you may be entitled to substantial financial compensation. You should contact a product liability lawyer to learn more about your legal rights and how you would file your own lawsuit against the company.