A new lawsuit over the Essure permanent birth control device has been filed in Allegheny County, adding dozens of plaintiffs to the thousands across the country who have already sued Bayer, claiming fraud and negligence in the marketing and monitoring of the product.
The lawsuits allege that Essure is unsafe and that both Bayer and French company, Conceptus, which created Essure, failed to report to the U.S. Food and Drug Administration thousands of adverse reactions caused by it, including: the device migrating out of position; perforating organs; causing irregular and heavy menstrual bleeding; auto-immune symptoms; severe chronic pain; and hair and tooth loss.
On Friday, 62 plaintiffs from various states — including one in Pennsylvania from Meadville, Crawford County — filed suit in Allegheny County Common Pleas Court. As of Monday evening the lawsuit remained unavailable for review on the court’s online civil docket, and the attorneys who filed it did not return calls Monday seeking comment.
Those plaintiffs are in addition to 10 others who filed a similar case against Bayer and Conceptus in February. That initial lawsuit has been removed from Common Pleas to the U.S. District Court for the Western District of Pennsylvania.
Filed by Pittsburgh lawyers John P. Gismondi and Jason Lichtenstein, the lawsuit now in federal court alleges negligence; failure to warn patients of the potential dangers associated with Essure; fraudulent concealment and misrepresentation; and violations under Pennsylvania’s Consumer Protection Law.
The plaintiffs are seeking monetary damages.
The lawsuit accuses Conceptus of trying to defraud doctors and patients by making false claims and concealing material facts about Essure’s safety, as well as marketing it as safer and more effective than a traditional tubal ligation. It alleges that the “ongoing scheme” required the “knowledge and complicity of personnel at the highest levels of Conceptus and Bayer, including the corporate officers and directors.”
According to Bayer's 2017 annual report, as of Jan. 30, approximately 16,100 Essure users have filed lawsuits against the company across the country. It notes "additional lawsuits are anticipated."
In a statement late Monday, the company said it couldn’t comment specifically on the complaint because it hadn’t yet been served. But the statement did say, “We will vigorously defend the continued availability of Essure, which is an important option for the many women who are seeking permanent birth control. As FDA has repeatedly determined, Essure is a safe and effective medical device that benefits women by providing them with a valuable contraception option.”
Essure, created by Conceptus in 1998, was first approved by the FDA for sale in 2002. It is a permanent type of birth control which features two metal coils that are implanted into a woman’s fallopian tubes through an office procedure. The coils work by expanding, which causes tissue growth in the tubes that block sperm from entering to fertilize the eggs.
The lawsuit said Essure was the only product sold by Conceptus, which was bought by Bayer in 2013 for $1.1 billion.
Bayer announced in September that it would halt Essure sales outside of the U.S., basing the decision, it said, on commercial reasons, unrelated to quality and safety of the product.
Earlier this month, the FDA restricted sales and distribution of Essure. In 2016, the agency required a boxed warning listing severe potential adverse effects for the product, as well as a patient checklist that must be filled out by patients and their physicians acknowledging the risks of Essure. The FDA also made Bayer conduct a study on patient complications.
In an April 9 news release regarding the restricted sales of Essure, the agency said, “The FDA is taking this step after becoming aware that some women were not being adequately informed of Essure’s risks before getting the device implanted, despite previous significant efforts to educate patients and doctors about the risks associated with this device."
According to the FDA, since implementing the new warning and patient checklist, there has been an approximate 70 percent decline in sales in the U.S.
FDA officials said in a news release on Essure that they believe the benefits of the device continue to outweigh the risks associated with it and note that it is the only permanent birth control available that does not require a surgical incision.
The lawsuits allege that Bayer "carefully manipulated its reports to the FDA and presented false and misleading information."
The allegations go back several years and include claims that Conceptus failed to report thousands of adverse patient reactions to the FDA. There is a Facebook group called “Essure Problems” that has more than 35,900 members, the lawsuit said.
"Conceptus knew of thousands of instances where the Essure device had migrated in a woman or perforated a woman's organs, failed to report all of them and then fought the FDA on its reporting obligations once the agency discovered the problem,” the lawsuit alleges.
Conceptus documented at least 508 complaints of perforation between Jan. 1, 2009, and Dec. 8, 2010, the suit said. The company also argued to the FDA that a coil falling out was “not technically a ‘malfunction’ of the device, and therefore it did not need to be reported," according to the lawsuit.
Between Jan. 1, 2008, and Dec. 6, 2010, Conceptus received at least 16,581 complaints relating to Essure, the lawsuit claims. Of those, 16,399 were never reported to the FDA.
"Conceptus' sole purpose was to maintain the marketability of its device by concealing as much adverse safety information related to its device as it could,” the attorneys wrote.
Between January 2011 and May 2013, Conceptus received 16,047 complaints about Essure, the lawsuit said. Of those, 15,712 were withheld from the FDA.
Paula Reed Ward: pward@post-gazette.com, 412-263-2620 or on Twitter: @PaulaReedWard.
First Published: April 23, 2018, 10:34 p.m.
