New Jersey Allergan Biocell Textured Breast Implant Lawsuits Consolidated in New Jersey Superior Court

July 10, 2020, 7:30AM. By Anne Wallace

Parallel litigation over breast implant side effects

Hackensack, NJOn July 7, the initial case management conference for In Re: Allergan Biocell Textured Breast Implant Products Liability Litigation (the “MCL”) was held before Judge Rachelle Harz in New Jersey Superior Court in Bergen County. The consolidation of state law actions is intended to permit speedy, cost-effective and consistent management of the common issues that the breast implant side effects lawsuits are expected to share. This multicounty litigation will proceed in parallel with the multidistrict federal lawsuits (the “MDL”) that have been consolidated in Newark.

As dry as procedural issues can be, there is a reason why court opinions tend to deal with them first. Otherwise, the substance may not make a lot of sense.

Why are there two consolidated actions?      

     
At the outset, it is important to note that one (the MCL) is in state court and the other (the MDL) is in federal court. They may, in fact, depend on the same questions law and very similar facts. At this early stage, all hope that these questions can be resolved in a consistent and coordinated way. This is certain to cause lots of motion practice.

Parallel proceedings are necessary because, as a fundamental legal rule, not all lawsuits can be heard in federal court. If the issues do not involve federal law or the parties all reside in the same state, it can only go to state court. An individual who lives in New Jersey and sues a New Jersey business for a breach of New Jersey law (most product liability laws are state laws) must, in all likelihood, do so in New Jersey state courts.

For the cases that could go to either a state or federal court, there may be strategic reasons, including caps on possible jury awards, that would cause a plaintiff to prefer one jurisdiction or another. Defendants often contest this choice.

How is this going to work?

The cases consolidated in the MCL have a lot in common. There were six when attorneys applied for consolidated treatment in February, but the group is ultimately expected to top 100.

They involve claims with common, recurrent, and complex issues of law and fact. All involve Biocell Products and make similar claims concerning dangerous, defective design and undisclosed risks. The patients, themselves, also suffered similar injuries and costs. The fruits of discovery in one case may, therefore, be relevant to other cases.

Once discovery is completed and pretrial motions decided, the court will select several for trial – “bellwethers” – that will test how juries are likely to react. Bellwether lawsuits often give opposing counsel some idea of the likely result, including the potential for a jury award.

Often, at that point, most of the remaining lawsuits in consolidated litigation settle in a way that is consistent with the jury treatment of the bellwether cases. Those that do not settle may proceed to litigation individually, but with preliminary motion practice and discovery phases behind them.

Did Allergan’s textured implants cause breast implant-associated anaplastic large cell lymphoma (BIA-ALCL)?

Most patients who are dealing with breast implant side effects are far more focused on the substance of their lawsuits, rather than the procedural questions. Two substantive questions loom large:

• did something about the design of the implant make it particularly likely to cause this rare form of cancer; and
• did Allergan give adequate warning of the danger to doctors and their patients, so that they could make informed decisions about treatment.

Was the design of the textured implant unreasonably dangerous or defective?

Allergan's Biocell Products are associated with BIA-ALCL, a rare form of non-Hodgkin's lymphoma. In most cases, the cancer is found in the scar tissue and fluid near the implant, but in some cases, it has spread through the body. Evidence about causation can be very suggestive, but it is rarely conclusive. This phase of the trial is likely to involve highly technical medical evidence and dueling experts.

Even though deaths are rare, the damage that BIA-ALCL can wreck on a body is clear. The cancer is treated with surgery to remove the implant and surrounding tissue. The patient may require additional treatment including chemotherapy, radiation therapy, and more interventions. The diagnosis and treatment are invasive and may involve many procedures. The symptoms may appear years after the implant was first placed.

This can be psychologically as well as physically destructive for the victims, many of whom have already survived breast cancer and undergone mastectomies. The MCL plaintiffs include women who have suffered from BIA-ALCL, who are currently suffering from the cancer, and who fear that they may develop it at some point in the future because they had Allergen textured breast implants.

Did Allergan know about the danger and yet fail to warn doctors and patients?

Allergan was granted premarket approval by the FDA in 2000 to market the first segment of the Biocell line of products. Subsequent approvals followed in 2006 and 2013 for additional designs.

Concern about the safety of Allergan textured breast implants escalated sharply in July 2019 when Allergan announced a worldwide recall of Biocell Products. The recall was initiated at the request  of the FDA and is based solely on the link between Allergan textured breast implants and BIAA-ALCL. Questions are sure to arise concerning the information that was available to Allergan in the 19 intervening years and whether it was made available to medical professionals.