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Nov. 28 — Essure-related suits against Bayer Healthcare Co. have proliferated, following court decisions favoring plaintiffs and the Food and Drug Administration’s heightened warning requirements for the permanent contraceptive.
The newly approved black box warning and patient checklist are “a good step toward recognizing that women weren’t informed of the product risks,” plaintiffs’ attorney Fidelma Fitzpatrick told Bloomberg BNA.
The FDA’s directive is something a court and jury should consider when looking at the Essure warning adequacy, and represents “a giant step forward” in the litigation, said Fitzpatrick, of Motley Rice in Providence, R.I.
Less than a year ago, just a handful of women had sued Bayer.
But as of Oct. 14, about 3,000 Essure users in the U.S. had sued Bayer, the company said in an Oct. 26 interim third quarter report.
Plaintiffs’ attorneys expect more filings.
Bayer, however, told Bloomberg BNA it has had wins in the litigation, and plans to fight the pending suits.
“To date, 23 cases in the Essure litigation have been dismissed in their entirety or significantly narrowed,” the company said.
“We will vigorously defend against the remaining claims and cases, and stand strongly behind the continued availability of this important option for the many women who are seeking permanent contraception,” Bayer said.
“Bayer’s longstanding commitment to women’s health includes ensuring women have access to birth control options that meet their individual needs. We stand behind the positive benefit-risk profile of Essure, the safety and efficacy of which is supported by clinical trials, more than a decade of science and real world clinical experience,” the company said.
Essure consists of two coils that get implanted in the fallopian tubes and cause tissue inflammation, creating a barrier to fertilization.
About 1,000 plaintiffs have cases pending in California state court, where Judge Winifred Y. Smith of the Superior Court for Alameda County combined the Essure proceedings.
The California cases are set for a case management conference in mid-December.
“It is our expectation that the judge will issue a discovery plan that moves the cases along quickly, and allows us to uncover what Bayer knew, what they concealed and the extent of their misconduct,” plaintiffs’ attorney Elizabeth Graham of Grant & Eisenhofer P.A in Wilmington, Del., said.
Fitzpatrick said she would like to see a trial as quickly as possible.
“The dream would be a trial in 16-18 months,” she said.
In Missouri, suits are pending on behalf of about 1,000 plaintiffs. Nearly all have been removed to federal court, although a case by one set of plaintiffs has been remanded, Eric Holland, who represents Missouri plaintiffs, told Bloomberg BNA.
Plaintiffs are trying to get the other suits remanded to state court in the City of St. Louis, Holland said.
That court has gotten a reputation as plaintiff-friendly—with juries handing down big verdicts.
For example, three verdicts against Johnson & Johnson totaling $197 million came from juries in the St. Louis court in 2016 in talcum powder litigation. Missouri law allows out-of-state plaintiffs to combine their claims with those of St. Louis residents.
But “I don’t go along with the idea that St. Louis is a plaintiffs’ Mecca,” Holland said.
Missouri is the show-me state, he said: “You have to convince a jury that there is liability and damages.”
St. Louis jurors found for Altria Group Inc.'s Philip Morris unit in a suit by smokers who alleged they were deceived by Marlboro Lights cigarettes, Holland said. And a St. Louis jury found for Pfizer Inc. in the first Zoloft birth defect trial.
There’s also a cluster of Essure cases in the U.S. District Court for the Eastern District of Pennsylvania, and cases in Illinois Circuit Court, Madison County.
Women allege they suffered adverse events including allergic reactions to nickel in the coils, and pain and perforation of the uterus or fallopian tubes if the device migrated.
Some allege they had to undergo hysterectomies to achieve complete removal of the contraceptives. And some alleged they faced unwanted pregnancies.
The device was approved through the FDA’s premarket approval process, which makes it tough for plaintiffs to overcome Bayer’s defense that federal law bars state law claims.
Early in the litigation, some cases were thrown out on this basis.
“Defendants in device cases always fight claims on preemption grounds even if not well taken. Unfortunately, defendants have made some inroads arguing preemption in cases that are poorly pled, thus providing a body of negative law,” Holland said.
But plaintiffs have also enjoyed wins.
Notably, Judge Smith in California rejected preemption arguments and allowed claims alleging that Bayer failed to report adverse events to the FDA and breached express warranties about device safety.
Other judges have also allowed so-called “failure-to-report” claims.
“Obviously, those decisions had an impact on both injured victims’ knowledge and the legal community’s evaluation of these cases,” Holland said.
New labeling requirements, new patient materials and reports of adverse events involving the device have also aided plaintiffs’ cases.
In February, the FDA ordered new black box warning language for Essure, and a multi-page patient checklist addressing product risks. Those actions followed a September 2015 advisory committee meeting, convened to take another look at the device.
The agency approved the warning and checklist Nov. 15.
The new boxed warning says, in part, “Some patients implanted with the Essure System for Permanent Birth Control have experienced and/or reported adverse events, including perforation of the uterus and/or fallopian tubes, identification of inserts in the abdominal or pelvic cavity, persistent pain, and suspected allergic or hypersensitivity reactions.”
The new warning also cautions that a surgical procedure might be required if the device needs to be removed.
The FDA said in November that it has received 9,900 adverse event reports between Nov. 4, 2002, Essure’s approval date, and December 31, 2015.
The majority of reports received since 2013 have been voluntary reports, mostly from women who received Essure implants.
Product users aren’t required to report adverse events to the FDA.
“FDA continues to monitor the safety of Essure to ensure it does not pose an increased risk to public health and that its benefits continue to outweigh the risks,” the agency said.
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