(July 25, 2018) Bayer can’t keep Essure cases in federal court, said a Pennsylvania federal judge on Monday. The judge ordered 16 consolidated Essure lawsuits back to state court. The cases were brought by women who allege they were hurt by Bayer’s Essure birth control / sterilization device. The judge found Bayer had failed to establish federal jurisdiction over the lawsuits. The Big Pharma giant – now trying to buy the much-despised Monsanto juggernaut – had filed a petition in an attempt to keep the Essure cases in federal court.
In his ruling against Bayer, U.S. District Judge John R. Padova cited a piece of the U.S. Supreme Court’s controversial Riegel v. Medtronic decision. The judge said that ruling made clear that Congress intended the state courts to resolve cases like those of the women suing Bayer over Essure. The women’s suits claim Bayer AG violated state laws that parallel federal requirements for medical devices. According to the high court’s Riegel opinion, under the 1976 Medical Device Amendments Act — which regulates medical devices for safety and effectiveness — state claims in medical device cases are barred only if they seek to impose non-federal requirements.
Judge Padova said, “[U]nder the congressionally-designed scheme, the MDA permits individuals to bring state law causes of action alleging violations of duties that parallel the federal requirements. (It) would be entirely inconsistent with this structure to conclude that Congress intended all such state law causes of action to be brought in federal court.”
The judge’s using Riegel v. Medtonic to rule against a corporation’s wishes is more than a little ironic; the Riegel ruling by the nation’s highest court virtually erased liability for most medical device makers, if their device had been approved by the FDA. In a scheme known as “preemption,” Medtronic had argued – in a nutshell – that it was impossible to fulfill both state and federal obligations regarding a warning label. It was a specious argument at best, but it was enough to give a majority of the U.S. Supreme Court cover to back corporate immunity at the expense of injured U.S. citizens.
Judge Padova’s ruling in this case recalls Macbeth’s hesitation in pondering the murder of Duncan. He wisely worries, “That we but teach bloody instructions, which, being taught, return to plague the inventor.” Thus Riegel v. Medtonic has returned to plague the inventors, corporations angling for total immunity from liability.
Judge Padova sent the 16 Essure lawsuits back to the Court of Common Pleas of Philadelphia County, where they had first been filed.
Bayer Halts Essure Sales
Bayer’s Essure birth control — or sterilization — device is a medical coil placed in a woman’s fallopian tubes to prevent pregnancy. On July 20, 2018, Bayer said it had decided to stop selling or distributing Essure in the U.S. by the end of the year. The company said in a statement that it had concluded its Essure business was no longer sustainable after years of declining U.S. sales, though Bayer was quick to note that it still stood by the safety and efficacy of Essure.
In April 2018, the FDA required an unusual limitation on Essure sales. The agency said Essure can be used only if patients are directly informed of its potentially serious side effects. Essure’s most serious risks – including perforation of the uterus or fallopian tubes – are listed on a black box warning which has appeared on Essure’s label since 2016.
The 16 women in these cases claim Essure migrates from the fallopian tubes and then breaks into pieces. The claimants allege that they’ve suffered severe and permanent injuries.
The women also charge that Bayer negligently trained doctors to implant the Essure device. They claim Bayer failed to tell the FDA about Essure’s adverse event reports, and failed to include them in the company’s own risk analysis.
Bayer Can’t Keep Essure Cases in Fed. Court
The judge also rejected Bayer’s argument that the cases present substantial disputes of federal law. He said Bayer didn’t elaborate on what those would be.
Judge Padova said, “Moreover, it has not established that the resolution of any dispute would have ramifications in federal cases outside of the Essure context or is otherwise important to the ‘federal system as a whole. (We) conclude that Bayer has failed to identify any federal issue that holds significance for anyone other than the parties.”
The case is McLaughlin v. Bayer Essure Inc. et al., case number 2:14-cv-07315, in the U.S. District Court for the Eastern District of Pennsylvania.