The holiday season has thus far not been good for Bayer Corp. on the company’s Essure litigation front. The company has suffered multiple legal setbacks rolling toward year’s end, as it continues to defend its controversial contraception device being blamed by a wave of women for injuries suffered while using the product.
In Missouri, a previously dismissed lawsuit is back on. Also in that state, Bayer’s attempt to remove a collection of plaintiffs from state to federal court has failed.
And, of course, the pharmaceutical manufacturer continues to feel the heat from Washington D.C., where lawmakers are looking for answers about the birth control device that has been pulled from shelves globally, but remains available in United States.
Dismissal Reversal, Litigation Back On
Jessica Williams had an Essure device implanted into her fallopian tubes in 2013. The 33-year-old Boonville, Ill., resident experienced severe pain and later had the device removed.
During the removal process, Williams learned some disturbing information. An x-ray revealed that a metal coil from the Essure device had broken and perforated her uterus. She underwent a hysterectomy to deal with the resulting pain.
This plaintiff’s case against Bayer Corp. had previously been dismissed. But in early December, the Missouri Western District Court of Appeals reversed that decision, ruling that the lower court had erred in its dismissal. The case is now back on.
Essure Cases Stay in State Court
Shortly before suffering this litigation setback, the state of Illinois had handed Bayer another loss. In late November, the pharmaceutical manufacturer lost a bid to have a collection of nearly a hundred lawsuits moved from state court to federal court.
A total of 92 women are involved in this particular collection of claims. Each blames Essure for medical complications they contend were caused by the product; plaintiffs are citing improper warnings and tainted clinical trials.
In November, the Missouri Supreme Court heard arguments in this case. Bayer was looking to have the case removed to federal court, arguing that only a handful of the plaintiffs resided in the state of Missouri.
Specifically, the pharmaceutical manufacturers’ legal team was seeking to move the matter to federal court on the grounds of the Class Action Fairness Act (CAFA). The CAFA, a 2005 act, served to remove many class action suits, especially ones involving potentially large sums of money and many plaintiffs, to federal court.
The plaintiffs, meanwhile, argued their case did belong in Illinois state court. They pointed to the fact that Bayer conducted clinical trials for Essure in the state, and also created a national marketing campaign in Illinois.
U.S. District Judge Ronnie White sided with the plaintiffs. In his Nov. 29 ruling, the judge allowed plaintiffs to remand their case to St. Louis City Circuit Court.
White also indicated in his ruling he did not think the defense’s CAFA argument was relevant. He said he agreed with a “long line of cases” in circuit court that allow for plaintiffs to file cases involving fewer than 100 plaintiffs in order to avoid removal to federal court.
Essure Litigation Losses and Political Pressure
These latest legal developments for the embattled Essure — effectively drops of water in a much larger pool — continue a rough stretch for Bayer. A stretch full of litigation losses and political pressure.
Essure was first approved by the U.S. Food and Drug Administration in 2002. Widely used for years, it has in recent time been the subject of thousands of lawsuits filed by women who claim the device is responsible for injuries such as abdominal pain, bleeding and uterine perforations; there are also charges of device failure, leading to pregnancy.
In December 2016 the FDA reported it had received 14,919 reports related to Essure. Correspondingly, Bayer racked up more than $400 million in litigation losses last year.
A recent financial statement from Bayer revealed that the pharmaceutical manufacturer is facing 3,700 Essure lawsuits. As of October, that number had climbed above 10,000 in the U.S. alone.
Essure, considered too dangerous, has been pulled from shelves globally. Bayer, in fact, announced in September they would only market the device stateside.
Legislators in Washington D.C. are curious as to why the controversial Essure is still available in the U.S. And why the FDA hasn’t done more to address the issue.
In an Oct. 30 letter to the FDA, Rep. Rosa Delauro (D-Conn.), Rep. Jan Schakowsky (D-Ill.) and Rep. Louise Slaughter (D-N.Y.) challenged the agency’s handling of Essure. They cited “widespread safety concern” and called its work involving Essure a “a prime example of systemic medical device oversight shortfalls and insufficient enforcement within the agency.”
The legislators urged the FDA to hold Bayer accountable going forward. They also requested to meet with the agency to discuss how best to handle Essure, which they described as “dangerous.”
“We are deeply concerned,” the representatives wrote.