It’s been a long, and uncertain road for Heather Walsh, who filed the first Essure lawsuit against Bayer HealthCare nearly two years ago, in July of 2014. Her journey has been a struggle from the start. Many legal observers thought her lawsuit would never make it inside a court room. But a recent legal victory has given her case, and similar ones being filed nationwide, the chance to live another day.
Want to share this infographic on your own site? Good; these details are important. Just copy and paste the code below, and make sure to provide attribution to BirthControlProblems.com when you do.
Doomed From The Start?
In 2008, Walsh says she underwent a failed implantation attempt, during an appointment she was told a Bayer representative would supervise. The rep never showed up, Walsh claims, and her doctor’s attempt to place the device was unsuccessful. Several more attempts would follow and, although the Bayer rep never materialized, her doctor was eventually able to implant the two coils on his own. Soon after, though, Walsh began suffering from a litany of adverse reactions, ultimately learning that one of the implants had lodged in her colon. To make matters worse, Walsh says that a CT scan revealed three Essure implants, not two, had been implanted inside her.
Something, of course, had to be done – to warn other women about the potential dangers of Essure, Walsh would later write in her legal complaint. Thousands of women have attested to similar problems, and many, like Walsh, have been forced to undergo complete hysterectomy procedures to have the implants removed.
Until recently, however, Essure’s labeling information failed to warn patients of the device’s risks, Walsh and several other plaintiffs have alleged. It sounds, by all accounts, like a legitimate lawsuit, a chance for many women to regain some of what they’ve lost through the civil court system.
Bayer “Protected” By Federal Preemption
But Essure is different. Unlike most medical devices, which are treated to scant FDA review and approved largely on the success, or failure, of prior similar products, the implants were considered “high-risk.” As such, the product’s original manufacturer, a company called Conceptus (now wholly-owned by Bayer) had to push Essure through the FDA’s “Pre-Market Approval” (PMA) process.
PMA, in the regulatory agency’s own words, is “the most stringent type of device marketing application required by FDA.” It’s that stringency, and the fact that the US Food & Drug Administration is a federal authority, which has created significant hurdles for those harmed by these devices.
Why? Because most product liability lawsuits are based on a variety of state laws that require manufacturers to adequately, and truthfully, describe the safety and efficacy of their products. But with the federal government’s sanction, and an approval based on the FDA’s “most stringent” review process at that, challenges based on state law are “preempted.” In short, those challenges don’t work anymore, and the device’s manufacturer is shielded from liability.
Heather Walsh certainly knew of these difficulties before filing her lawsuit, but of course, justice was at stake. Moreover, her allegations actually go deeper than any claims of failure to warn based on state law.
Beyond breaching the duties entrusted to it by state law, Bayer violated the terms of Essure’s Pre-Market Approval, Walsh claims. In her words, the company failed to keep up with FDA reporting requirements, withheld multiple adverse event reports, concealed implantation failure rates and left damning clinical trial evidence out of patient marketing materials. All of which, she says, means that Bayer should lose any legal protection afforded to it under the PMA.
Eventually, Walsh was joined by 4 other women, women who say they suffered debilitating complications after receiving Essure, and their lawsuits were transferred to a federal court, the US District Court of Pennsylvania. More than that, the lawsuits had been “consolidated,” placed before the Honorable John R. Padova for coordinated pre-trial proceedings. From here on out, the five plaintiffs would progress through the important legal steps that come before a trial together.
But the possibility of preemption was already foremost in Padova’s mind, and the federal judge ordered that the issue would have to be resolved before any discovery took place. It wasn’t until April 29, 2015, however, that Bayer actually went for its “checkmate,” arguing in an Omnibus Motion for Judgment that the allegations of fraud, misrepresentation and failure to warn were preempted by Essure’s Pre-Market Approval.
On January 11, 2016, oral arguments were head, with legal representatives for both the plaintiffs and Bayer gathering before Judge Padova. At first, the outlook wasn’t promising, as Philly.com reported two days after the hearing. “Padova sounded unimpressed with some of the legal arguments submitted by lawyers for the five women,” staff writer Marie McCullough said, even asking one of the attorneys to “resubmit part of the case with more specifics.”
With Padova’s Order, Essure Lawsuits Begin Discovery
Two months would pass before Walsh or the four other women would have the answer. But when a decision was finally handed down, it would be one to rejoice.
Padova has allowed the lawsuits to proceed on two counts, allegations that Bayer falsely advertised Essure and failed to warn women of the implants’ risks. Although Padova has chosen to dismiss another ten claims, he has done so “without prejudice” in some cases, allowing the women to rework legal arguments supporting five of their allegations, including those that Bayer manufactured Essure negligently and failed to properly train implanting physicians.
In a statement to the press, co-founder of the group Essure Problems Angie Firmalino wrote: “we have been fighting to expose the truth about the dangers of, and the corruption behind this device. To finally hear that we will have our day in court was cause for celebration.” Heather Walsh certainly has reason to celebrate, as do the four other plaintiffs who are now preparing to begin the discovery phase of their lawsuits.