For the second time, a federal court judge in Pennsylvania has pared down the number of claims that will be allowed to proceed in five Essure lawsuits consolidated in Philadelphia. On February 22, 2017, the Honorable John R. Padova threw out allegations that Bayer has been negligent in manufacturing Essure, the Legal Intelligencer reports. However, claims that Bayer failed to warn of Essure’s risks and negligently misrepresented the device’s safety and effectiveness have been left untouched.
Federal Judge Trims Away At Essure Legal Arguments
While women will certainly celebrate the survival of these Essure lawsuits, Judge Padova has narrowed the scope of possible legal theories that could underpin several key allegations against Bayer.
Count 1 – Negligent Training
On a count that Bayer had failed to comply with FDA guidelines in training physicians who would implant Essure, Judge Padova ruled out arguments that:
- Bayer failed to ensure that doctors are knowledgeable hysteroscopists prior to training
- Bayer failed to ensure that doctors monitor their patients after their completion of training
- Bayer failed to ensure that implanting doctors are “certified”
However, the women will still be able to claim that Bayer’s training program was negligent in several ways. Judge Padova is allowing three legal theories to stand, including the company’s alleged failure to ensure that physicians read and understood Essure’s training manual. An allegation that Bayer failed to ensure that doctors successfully complete an Essure simulation training will also move forward.
Count 2 – Negligent Risk Management
In their second count, the five women accuse Bayer of failing to establish a reasonable risk management protocol that would have allowed the company to identify and analyze adverse event reports related to Essure.
Judge Padova has dismissed one aspect of plaintiffs’ argument – that a proper risk management protocol would have led to Essure’s recall and thus prevented the plaintiff’s injuries. But Bayer’s second contention, that Count 2 simply duplicates the allegations outlined in Count 4 (which accuses the company of failure to warn), did not convince Judge Padova. As the Judge notes, “Count II does, in fact, allege that Bayer breached certain duties that are not alleged to have been breached in Plaintiffs’ failure to warn claim.” As a result, the Judge denied Bayer’s motion to dismiss Count 2 entirely.
Count 3 – Breach Of Express Warranty
In Count 3, Plaintiffs accuse Bayer of breaching a number of express warranties. In order to make their choice of birth control, women relied on statements made in advertisements, both in product brochures and on TV, which claimed that Essure was “worry free” and “more effective than tying your tubes,” Plaintiffs argue. The women contend that these statements formed the basis of a bargain, a promise that Essure would perform to the specific standards outlined by Bayer. In reality, Bayer’s claims about Essure were false, the Plaintiffs say, basing their contention in part on recent studies that have called the efficacy of Essure in question. In light of these allegations, women claim, Bayer should be held liable for violating its end of the bargain.
In part, Judge Padova agrees. As the Judge writes, Plaintiffs have provided sufficient facts to support their underlying contention – that Bayer’s warranties formed the foundation of a bargain between the company and patients. Several specific warranties, however, have been ruled out of the case. Two warranties, in particular, are “plainly directed only at physicians,” the Judge says, and thus cannot be used in Plaintiffs’ argument:
- “In order to be trained in Essure, you must be a skilled operative hysteroscopist. You will find the procedure easier to learn if you are already proficient in operative hysteroscopy.”
- “The Essure Training program is a comprehensive course designed to provide information and skills necessary to select appropriate patients, perform competent procedures and manage technical issues related to the placement of Essure.”
A number of other warranties have been allowed to remain, including “you never have to worry about unplanned pregnancy” and representations that Essure is “worry free.” Judge Padova was not swayed by Bayer’s claim that these statements should be taken as “opinions,” rather than “facts, promises or descriptions.” In sum, the Judge has granted Bayer’s Motion to Dismiss Count 3, but only insofar as the claim rests on the two warranties directed at physicians.
Count 4 – Fraudulent Misrepresentation
Count 4 takes the statements noted in Count 3, which alleged a breach of express warranty, and casts them as misrepresentations, inaccuracies about Essure’s safety and efficacy that Plaintiffs argue amount to fraud. The problem, Judge Padova says, is that many of these statements are nearly indistinguishable from representations approved by the US Food & Drug Administration. In effect, the Court will not allow the women to “seek to hold Bayer liable for what are, in essence, FDA-approved statements.”
On this logic, the Judge has denied Plaintiffs the ability to use most of Bayer’s alleged misrepresentations in support of Count 4. Two specific statements, however, have not been dismissed, including a line from an Essure brochure that read: “there was no cutting, no pain, no scars.” Judge Padova allowed this specific representation to stand because, as he wrote, it was “arguably inconsistent with federally-approved statements[,] including that there may be ‘mild to moderate pain’ or a ‘little pain’ associated with the Essure procedure.”
Count 6 – Negligent Manufacturing
In their complaints, the five women argued that Bayer had been negligent during the manufacture of Essure implants, using nonconforming materials in unsanitary conditions. This claim has now been dismissed in its entirety. According to Judge Padova, the lawsuits present “no causal connection between the alleged mislabeling and unsanitary conditions and plaintiffs’ injuries.”
As a tenet of Pennsylvania law, plaintiffs must allege a “causal connection between a defendant’s allegedly negligent conduct and the plaintiff’s resulting injury,” the Judge writes. Plaintiffs have argued that Essure’s materials deviated from explicitly-prescribed manufacturing standards. These quality issues, the women say, caused the device to migrate after implantation. Judge Padova found this explanation “vague and non-specific,” insufficient to ground a viable claim for damages. As a result, Count 6 has been struck down entirely.
Federal Pre-Emption Proves Repeat Hurdle In PA
This is Judge Padova’s second pass at the issue of federal pre-emption, a legal theory that has hindered progress for plaintiffs in the Essure litigation. In March of 2016, the Judge threw out a majority of the claims leveled against Bayer, Law360 reports, but allowed the women to amend their allegations.
Approved under the FDA’s Pre-Market Approval pathway, which is reserved for devices that could pose significant risks, Essure has gained legal protection from product liability lawsuits that base their allegations in tenets of state law. Instead, women must prove that Bayer violated requirements of state law that are “parallel” to ones established and enforced by the Food & Drug Administration, a federal agency. In short, the claims leveled against Bayer cannot impose requirements upon the company that are “different from, or in addition to” those set forth as federal requirements.
This legal concept, federal pre-emption, has proved a significant hurdle for Essure lawsuits, impacting cases filed from Pennsylvania to California. There is reason for hope, however. While several judges have winnowed the number of legal theories available to injured Essure patients, many of their claims have survived to fight another day. Claims being pursued in a California state court, for example, have seen marked success. In October of 2016, a California state judge agreed to consolidate over 50 Essure lawsuits, allowing plaintiffs’ to work together closely in furthering their best interests. To learn more about the Essure lawsuits pending in California, click here.