Two years after Bayer A.G. halted sales of Essure in the United States, the company announced it would settle outstanding legal claims for $1.6 billion. The proposed settlement will resolve about 90% of the nearly 40,000 claims against Essure manufacturer, Bayer A.G. The settlement did not include any admission of wrongdoing or liability by the German based company.
In a statement, Bayer said, “these U.S. settlements have no impact on pending litigation in other countries, as Bayer’s decision to resolve these cases is based significantly on factors that are specific to the U.S. legal system.”
Bayer’s Federal Preemption Defense Claims
Throughout the litigation process, Bayer has used two well-worn defense tactics to reduce liability. First, Bayer used a complex legal defense known as preemption to challenge plaintiffs’ claims against the company.
In a nutshell, product liability is mostly governed by state law. The U.S. Constitution holds that federal law is superior to, or preempts state law when there is a conflict between state and federal law. For medical devices such as Essure, approval by the U.S. Food and Drug Administration (FDA) can be viewed as preeminent in some situations because the FDA is a federal agency.
Federal preemption is one of the most powerful defenses in product liability. If a court finds that federal law conflicts with a state’s product liability law, it can summarily dismiss the plaintiff’s claim. Dismissal of the state tort claim will eliminate liability against the defendant and any compensation award due to the plaintiff.
Bayer’s Second Claim: “It’s the Doctor’s Fault”
Another common tactic used by product manufacturers to avoid liability is to shift blame to the medical professional who inserted the device. In some cases, Bayer has argued the gynecologist is at fault for failing to follow documented procedure or making an error which caused the device to malfunction or break. If Bayer can convince the court the doctor is at fault, the plaintiffs claim will be dismissed.
Before Essure was recalled, Bayer touted the device as a safe and effective form of birth control that can be inserted into a woman’s fallopian tubes in a doctor’s office in about 15 minutes with no post procedure downtime. Plaintiff’s attorneys have argued implanting Essure is much more complicated than Bayer claims and exceeds the skill level of many practicing gynecologists.
Pain and suffering caused by Essure
Before Essure was pulled from the market, more than 750,000 women received Essure implants and the FDA had received over 32,000 complaints and 10,000 adverse event reports related to Essure problems. Over 300 fetal deaths have been linked to Essure defects because of ectopic pregnancies in women who believed they could no longer become pregnant.
Due to the number of reported complaints, in February 2016 the FDA announced Essure will require a black box warning indicating extreme risks and possible serious injuries associated with its usage. The FDA directed Bayer to hold an extensive post-market study with 2,000 patients to further evaluate the safety of Essure.
Essure “Recall” in Canada and the U.S.
Bayer voluntarily discontinued the sale of Essure in Canada claiming the decision was based on a decline in patient demand, not a product recall. Subsequently, in July 2018, Bayer issued a press release stating that it would halt sales of Essure in the U.S. on December 31, 2018. The press release stated the decision was based on a decline in U.S. sales over the past several years. Clearly Bayer realized the potential mounting liability created by Essure’s defective design outweighed the potential profits it expected to make from the defective product.
Originally hitting the market in 2002, Essure was designed and manufactured by a small U.S. based company called Conceptus Inc., that was later purchased by German conglomerate Bayer A.G. in 2013.
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