Essure Injury Lawsuits Filed in Philadelphia Hang On Federal Judge’s Decision

As a growing number of women throughout the U.S. consider bringing Essure lawsuits over complications caused by the controverial birth control implant, a U.S. District Judge in Pennsylvania is considering whether five cases pending in Philadelphia should be preempted by federal law and dismissed.

Essure is a form of long-term birth control, involving bendable coils that are implanted into the fallopian tubes during an outpatient procedure to provide permanent protection against pregnancy. However, thousands of women throughout the United States have experienced painful and debilitating side effects from Essure birth control, including problems with the coils moving out of position, puncturing internal organs or causing severe nickel reactions.

U.S. District Judge John R. Padova is presiding over five separate complaints filed in the Eastern District of Pennsylvania, which were brought by plaintiffs Helen McLaughlin, Ruth Ruble, Melda Strimel, Susan Stelzer, and Heather Walsh.

In an order (PDF) issued January 14, Judge Padova dismissed claims for negligent design and strict liability in the Essure lawsuits, under a federal law known as preemption, which find that if a medical device was approved by the FDA, plaintiffs can not bring product liability lawsuits over defective design agains the manufacturer. However, Judge Padova is still weighing whether to dismiss other charges brought in the complaints, such as breach of warranty.

The preemption argument stems from a 2008 U.S. Supreme Court ruling in a case known as Riegel v. Medtronic, which found that medical device manufacturers should be insulated from design defect lawsuits if the product went through the full FDA approval process.

Plaintiffs have attempted to argue that Essure injury lawsuits should not be preempted, since the FDA was allegedly deceived by false data nad statements made by Bayer and Conceptus, which are the current and original manufacturers of the birth control implant. Plaintiffs indicate that this should invalidate the FDA’s premarket approval of the device and strip away the preemption protection.

According to a report by Philly.com, Judge Padova was “unimpressed” with the plaintiffs’ arguments during a hearing last week, but directed the parties to submit more specifics concerning the warranty claims.

In a joint submission (PDF) filed in January 15, plaintiffs outlined a long list of claims made in Essure advertisements and other documents that were allegedly false, such as claims that there were no pregnancies during clinical trials, that Essure is “worry free” and that the device is made from “safe, trusted material.”

Essure Litigation

While women have been raising concerns over problems with Essure procedures for several years, the momentum for the litigation has increased in recent months, following recent FDA hearings and the discovery of information that suggests the manufacturer withheld information about the risks associated with the device from federal regulators, doctors and women.

Between the date the birth control product was approved in November 2002 and May 31, 2015, the FDA received at least 5,093 adverse events involving Essure complications.

In September 2015, the FDA’s Obstetrics and Gynecology Devices advisory panel evaluated the safety concerns surrounding Essure, hearing testimony from experts and women who described the pain and damage Essure implants have allegedly done to their bodies and lives.

Due to concerns that the risks associated with the implant appear to outweigh the benefits, a number of lawmakers have called for an Essure recall to be issued by the FDA, and legislation has been introduced in the U.S. House of Representatives to revoke the pre-market approval given to the implant’s original developer.

The FDA advisory committee suggested that better safety data is needed, including a patient registry and a new clinical study on safety and effectiveness. They also said Bayer should provide women with more detailed information about the risks of Essure before it is implanted, suggesting that women have review a checklist of possible complications and sign off on it before getting the procedure.

According to allegations raised in several recently filed Essure birth control lawsuits, Bayer and Conceptus violated the terms of the original Conditional Premarket Approval (CPMA) granted by the FDA, arguing that Essure was “adulterated” as a result, and that the manufacturers should have been precluded from selling the product.

“Had Plaintiff known that Defendants were concealing adverse reactions, not using conforming material approved by the FDA, not using sterile cages, operating out of an unlicensed facility, and manufacturing medical devices without a license to do same, she never would have had Essure implanted,” according to a complaint filed by Danielle Patterson in November 2015.

While the outcome of Judge Padova’s decision in Pennsylvania will not have a binding effect on other claims filed in courts throughout the U.S., it may set the stage for an appeal on the issue of whether women who have suffered severe and painful injuries from Essure are able to pursue claims for financial compensation against the manufacturers.