A California judge has allowed a set of consolidated Essure injury lawsuits to continue over defendant Bayer’s objection that the plaintiffs’ state law claims are preempted by federal law.

The decision allows 11 different Essure injury lawsuits brought by 14 different women to proceed.

Superior Court Judge Winifred Y. Smith determined the plaintiffs’ claims for failure to warn were not preempted by federal law.

The plaintiffs’ allegations of causation in their failure to warn claims were sufficient for pleading purposes, the judge decided.

The claims brought by plaintiffs for breach of express warranty, fraud and negligent misrepresentation are also not preempted, the judge said, to the extent they were based on an alleged inconsistency between statements in the defendants’ promotional materials and other statements in approved FDA materials.

The judge granted Bayer’s demurrer to the plaintiffs’ claims for manufacturing defect and for negligent training of physicians. The judge said that although those claims are not necessarily preempted, the plaintiffs’ factual allegations were insufficient to state a cause of action.

Plaintiffs will have an opportunity to revise and resubmit pleadings for these claims.

These Essure injury lawsuits take issue with complications that the plaintiffs attribute to the Essure birth control device.

Essure consists of a pair of implants designed to be inserted permanently in the fallopian tubes, where they stimulate the growth of new tissue that occludes the tubes and prevents fertilization.

Plaintiffs claim that Bayer allegedly failed to report over 32,000 complaints and adverse events to the FDA. They argue that failure to report violated a California law that requires companies to report such complaints to the FDA.

Essure Injury Lawsuits Survive Preemption Defense

Bayer had argued that the plaintiffs’ state law claims for failure to warn were preempted by the federal Food, Drug and Cosmetic Act.

Although a California appeals court had found that very similar claims were not preempted in an earlier case called Coleman v. Medtronic, Bayer argued that Coleman was decided incorrectly.

Judge Smith disagreed. After a complex legal analysis, the judge found that the plaintiffs failure to warn claims were “factually indistinguishable” from the claims in Coleman, to the extent they are based on alleged failures by Bayer to satisfy its obligations of reporting to the FDA.

The claims were therefore neither expressly nor impliedly preempted, the judge said.

As for the claims for manufacturing defect, Judge Smith found that they failed to allege a specific defect, whether in the specific Essure implants that the plaintiffs received or in Essure devices in general.

The judge determined that the claims for negligent training of physicians failed to allege any causal connection between the alleged inadequate training and the plaintiffs’ injuries.

Earlier in March 2016, another group of Essure injury lawsuits survived a preemption defense when a federal judge in Pennsylvania dismissed some of the five plaintiffs’ claims while allowing others to continue.

U.S. District Judge John R. Padova allowed the plaintiffs’ claims to go forward on theories of negligence, fraud, and breach of warranty. Other claims were dismissed as either preempted or inadequately pled.

The Essure Injury Lawsuits are Case Nos. RG16809860, RG16809292, RG16813262, RG16813616, RG16809875, RG16812313, RG16810409, RG16809878, RG16804887, RG16804878, RG16809876 in the Superior Court of California, Alameda County.