In a new “Medicolegal Review” published by the Journal of Minimally Invasive Gynecology, four gynecologists have warned their peers about getting caught up in the litigation around Essure, a permanent birth control implant blamed for causing severe and debilitating side effects.

Doctors Warn About Bayer’s “Learned Intermediary” Theory

Calling Essure an “ongoing target” for personal injury lawsuits, the researchers explain that Bayer has successfully defended itself against some claims by turning to a legal doctrine known as preemption.

Federal courts in Connecticut and New York have dismissed several lawsuits on the basis of preemption, which can protect medical device manufacturers from state-imposed safety requirements in light of federal Food & Drug Administration approval. Bayer’s reasoning has dealt a limited blow to Essure lawsuits filed in a Pennsylvania federal court, where District Court Judge John R. Padova has decided to winnow the claims allowed in court, but refused to dismiss the cases entirely. The company’s preemption argument has proved less convincing in California, where federal and state judges have decided to preserve claims in the face of protest from Bayer.

Despite the doctrine of federal preemption, many Essure lawsuits have been allowed to move forward. In response, Bayer has shifted to a second legal theory, one that could transfer the liability for women’s injuries away from the manufacturer itself and onto the shoulders of gynecologists.

Who Do You Blame?

In recent court filings, Bayer’s defense attorneys have invoked the learned intermediary doctrine. This defense theory holds that a manufacturer’s duty to warn of a product’s risks is satisfied when a “learned intermediary,” like a gynecologist, is given all necessary information on the subject. Once the learned intermediary has all the information, it becomes their responsibility, rather than the manufacturer’s, to adequately inform the product’s end user.

Whether or not this logic will find favor with the judges presiding over Essure lawsuits is unknown, but the idea that Bayer could use gynecologists as a scapegoat has frightened some doctors.

Physicians Defend Themselves Through Informed Consent

With Bayer mapping treacherous new legal terrain, four gynecologists from the University of Texas and Johns Hopkins have created a guide for other doctors, explaining how to provide prospective-Essure patients with adequate informed consent prior to any procedures. The physicians place a premium on documentation, since a gynecologist’s records would likely be subpoenaed in a court case.

More to the point, the experts stress providing patients with all of the details necessary to make a well-informed decision about the birth control device. Adequate disclosure, the doctors write, “entails explaining the risks, benefits and alternatives” to Essure.

Providing adequate informed consent shouldn’t be terribly difficult at this point. In 2016, the US Food & Drug Administration ordered Bayer to create a checklist for doctors to complete with their patients before conducting Essure procedures. While Bayer has yet to release a final version of the checklist, a proposed draft, which appears to be consistent with FDA recommendations, was published on November 7, 2016. Doctors and patients are required to sign the document after completing a thorough discussion of Essure’s known risks, while patients must provide their initials after reviewing each sub-section of the checklist.

State Courts Resist Learned Intermediary Doctrine

The learned intermediary doctrine has served as an accepted exception to product liability for decades. First used successfully by a prescription company in 1948, the legal theory has now been formally adopted by supreme courts in 23 states. The argument doesn’t work everywhere, though. Some state supreme courts have questioned the doctrine’s wisdom in recent years, Law360 reports.

New Jersey’s Supreme Court, for example, notes that many pharmaceutical and medical device manufacturers now advertise their products directly to consumers, without any “learned intermediary” to stand between the manufacturer and patient. The medical system, according to New Jersey’s high court in the 1999 ruling Perez v. Wyeth, has changed a lot since 1948 – and the legal system will have to change accordingly. As then-New Jersey Supreme Court Justice Daniel J. O’Hern wrote:

“Our medical-legal jurisprudence is based on images of health care that no longer exist. At an earlier time, medical advice was received in the doctor’s office from a physician who most likely made house calls if needed. The patient usually paid a small sum of money to the doctor. Neighborhood pharmacists compounded prescribed medicines […] For good or ill, that has all changed. Medical services are in large measure provided by managed care organizations. Medicines are purchased in the pharmacy department of supermarkets and often paid for by third-party providers. Drug manufacturers now directly advertise products to consumers on the radio, television, the Internet, billboards on public transportation and in magazines.”

In view of a massive increase in direct-to-consumer (DTC) healthcare marketing, New Jersey’s Supreme Court created a broad exception to the learned intermediary argument, leaving manufacturers that create DTC advertisements on the hook for failing to warn patients of a product’s risks.

New Jersey Decision Finds Support In West Virginia, New Mexico

Eight years later, West Virginia’s Supreme Court went even further, rejecting the learned intermediary doctrine outright. In the 2007 opinion State ex rel. Johnson & Johnson v. Karl, West Virginia’s high court refused to adopt the exception to product liability, drawing on the logic expounded in New Jersey’s Perez v. Wyeth. Denouncing the learned intermediary argument as “largely outdated and unpersuasive,” the Court held that pharmaceutical manufacturers have the same duty to warn end consumers as every other manufacturer. That’s especially true, Chief Justice Robin Davis wrote, given the unprecedented access to consumers that manufacturers now enjoy through the internet.

DTC Pharmaceutical Marketing Infographic

Noting West Virginia’s rejection of learned intermediary, a federal court in New Mexico declined even to entertain the defense argument in a 2008 case. In its Rimbert v. Eli Lilly opinion, the US District Court of New Mexico refused to consider the doctrine, because it thought New Mexico’s Supreme Court would just reject the argument as “fundamentally inconsistent with New Mexico’s strict liability jurisprudence.”

Contraceptive Manufacturers May Not Find Relief Through “Learned Intermediary”

As we’ve seen, the learned intermediary doctrine has taken a beating in recent years. But the decisions handed down in New Jersey, West Virginia and New Mexico remain in the minority. Most states continue to recognize the learned intermediary argument as a legitimate defense, although only 23 have explicitly adopted the doctrine as such.

There is, however, another nuance in state law that could put a hitch in Bayer’s learned intermediary defense. A number of states have already held that manufacturers who specifically make contraceptive devices can’t be protected from liability through the learned intermediary doctrine.

Federal courts in Massachusetts and Michigan, along with the Eighth Circuit Court of Appeals, have noted a substantial difference between birth control options and other healthcare products. Unlike the majority of pharmaceuticals and medical devices, contraceptives are chosen by “healthy” consumers and aren’t intended to treat an illness or injury. Likewise, physicians are “relegated to a relatively passive role,” the Supreme Court of Massachusetts wrote in the 1985 decision MacDonald v. Ortho Pharmaceutical, as women take more active control of their own prescribing decisions. In this context, courts have found, the learned intermediary doctrine doesn’t make sense, because physicians take a backseat in deciding between various contraceptive options.