At the same time that a federal judge in Missouri has tossed the bulk of Essure plaintiffs from a product liability case and a French study has deemed the permanent birth control device safe, legal activist Erin Brockovich will soon sit down with the U.S. Food and Drug Administration and ask the same question recently posed by lawmakers: ‘Why is Essure still on the shelves?’
All but three of the Essure plaintiffs involved in litigation in Missouri recently saw their claims tossed out of court. A federal judge sided with drug manufacturer Bayer Corp., deciding that 92 of the women claiming injury due to use of the birth control device did not have the residential credentials to file suit in the state of Missouri.
Meanwhile, further south, two Fort Lauderdale attorneys are taking their concerns about Essure to the U.S. Food and Drug Administration. The Florida attorneys plan to meet with the agency’s head in February — and they’re bringing legal activist and media darling Brockovich along for the discussion.
No Essure Litigation in Missouri
With U.S. District Judge Stephen Limbaugh, Jr.’s decision to toss 92 plaintiffs, the bench claims against Bayer just got a lot thinner. According to the Jan. 23 decision, only three of the 95 women filing claims in the case actually have a right to do so due to the fact that they live outside of Missouri.
This is exactly what Bayer had been asking for. The pharmaceutical company had argued that most of the plaintiffs involved in the case should be tossed due to their out-of-state residency.
The out-of-state plaintiffs, meanwhile, maintained that they should have the right to file claims in the state because Bayer conducted clinical trials for Essure in the state and also ran a national marketing campaign from Missouri. A St. Louis Circuit Court judge agreed with that logic in 2016 and allowed the case to proceed with the out-of-state plaintiffs in tow.
Judge Limbaugh disagreed, however. The federal judge ruled that any claims of injury originating with out-of-state residents could not be tied to Missouri.
Essure’s Brockovich Factor
Erin Brockovich came to fame for her work exposing corporate pollution in California and working to defend victims harmed by that pollution. More specifically, the untrained legal clerk gained celebrity status via the 2000 film “Erin Brockovich,” in which actress Julia Roberts portrayed her in her fight against Pacific Gas and Electric Company in the early 1990s.
These days Brockovich uses her celebrity status to bring attention to issues ranging from environmental matters, to natural disasters and, in this instance, a medical issue. In February, she will apparently be turning her public attention to Essure, accompanying two Florida attorneys to talk with the head of the FDA.
Marcus Susen and Justin Parafinczuk, of the firm Koch Parafinczuk Wolf Susen, plan to speak with the FDA about the dangers of Essure. They will point out the fact that Bayer has removed Essure from every market except the United States and ask why the product is still on the market when the agency is requiring additional safety studies. Ultimately, the Florida attorneys plan to request that the FDA remove Essure from the market.
Susen and Parafinczuk are no strangers to Essure. The attorneys currently represent more than a 1,000 women claiming injury from the product and first began representing such clients in 2014. The pair was involved in suits that resulted in a black-box warning on the product detailing side effects such as perforation of the uterus.
French Study Says Essure is Safe
Essure — first approved in the U.S. in 2002 — began attracting legal attention a few years ago, when women began claiming injuries like abdominal pain and internal bleeding were due to their use of the product. Bayer is currently facing more than 10,000 such lawsuits aimed at Essure.
In 2016, Bayer experienced north of $400 million in litigation losses due to Essure. Also that year, the FDA received 14,919 reports related to Essure.
Considered too dangerous for markets globally, Essure has been pulled from shelves around the world. In 2017, Bayer announced that the device would only be marketed in the United States; the company cited market forces as the reason for limiting Essure’s availability.
Last October, a group of legislators in Washington D.C. dug into the Essure issue. They wrote a letter to the FDA and challenged the agency’s handling of the device. They described its work surrounding Essure as “a prime example of systemic medical device oversight shortfalls and insufficient enforcement within the agency.”
The lawmakers described Essure as “dangerous” and cited “widespread safety concern.” They also stressed that they were “deeply concerned” about the drug and requested a meeting with the FDA.
However, a recent study played down concerns being raised about Essure. The study from France concluded that the Essure implants are relatively safe and do not significantly increase the risk of side effects or other health issues.
Dr. Eve Espey, chair of obstetrics and gynecology at the University of New Mexico School of Medicine, who wrote an editorial that accompanied the study in the January issue of the “Journal of the American Medical Association,” noted that the study supported the device remaining on the market. In his support of Essure, the doctor also downplayed the associated concerns that many have about the device.
“I do hope calmer minds will prevail,” Espey noted about the current debate surrounding Essure, “and we don’t lose a very valuable technique that’s helped lots and lots of women.”