Article at a Glance
- In late July, CNN reported that Bayer had paid doctors $2.5 million to push its Essure system between 2013 and 2017.
- Essure has been associated with nearly 27,000 injury reports to the FDA and 16,000 lawsuits. With sales declining, Bayer has decided to discontinue sales of Essure in the United States at the end of the year.
- Doctors who accept such payments from pharmaceutical companies risk compromising their independent judgment, placing their own financial or professional interests over patients’ health.
Pharmaceutical giant Bayer was recently caught paying millions of dollars to doctors to help push its Essure system, a permanent birth control device that has been the subject of nearly 27,000 complaints to the U.S. Food and Drug Administration (FDA) and more than 16,000 pharmaceutical liability lawsuits since its introduction in 2002.
Conduct like Bayer’s raises the question of whether the doctors receiving pharmaceutical company funding are prescribing drugs and medical devices with patients’ best interests in mind or based on their own financial or other interests. Patients should not be exposed to dangerous medical products merely because their doctor is receiving compensation from the manufacturer.
What is the Essure System?
Essure is a small birth control device implanted into a woman’s fallopian tubes. Once in place, the body develops scar tissue around the device, preventing sperm from fertilizing the woman’s eggs. It is the only nonsurgical form of permanent birth control currently available in the U.S.
Between 2002 and 2017, the FDA received 26,773 medical device reports concerning Essure. These reports listed several health problems experienced by women who had had Essure implanted, the most common of which were:
- Pain/abdominal pain;
- Heavier menstruation or other menstrual irregularities;
- Fatigue; and
- Weight fluctuations.
The FDA has also highlighted some other serious risks associated with Essure, including “persistent pain, perforation of the uterus and fallopian tubes, and migration of the coils into the pelvis or abdomen”—and even, albeit rarely, death.
Although the FDA could not confirm “whether [Essure] actually caused” the injuries recorded in the medical device reports it received, in April the agency restricted Essure’s availability. To ensure that “each and every woman who receives Essure has been informed of the risks,” the FDA required that Essure be distributed only to health care providers who follow an FDA-developed risks checklist.
On July 20, ostensibly in response to declining sales, Bayer announced that it would no longer sell Essure in the United States after December 31, 2018.
Bayer’s Payments to Physicians
One week after Bayer announced that it would discontinue Essure in the United States, CNN reported that Bayer had paid nearly 12,000 doctors $2.5 million between August 2013 and December 2017 to help push Essure in the marketplace. Although framed as payments for “consulting . . . and similar services,” these were often paid to doctors for “educating physicians”—that is, for marketing.
The payments were sometimes significant. In fact, CNN found that for three doctors, the total amount received by Bayer to push Essure exceeded $100,000 during the period studied.
But as bad as that sounds, the scope and scale of this kind of behavior is much worse than CNN’s story may make it seem.
Big Pharma Payments to Doctors Are Common (And Not Just from Bayer)
Bayer is not the only big pharmaceutical company to make payments to doctors like those described by CNN. The U.S. Center for Medicare and Medicaid Services (CMS) tracks many such payments in its Open Payments database. That database lists more than 2,000 companies that have made more than $30 billion in payments to nearly 1,000,000 doctors just since 2013.
As an NPR report from 2015 illustrates, those payments can dwarf what CNN found in its report on Bayer. For example, NPR cited the case of one doctor from New Hampshire who received almost $600,000 from 29 pharmaceutical companies during 2014 alone.
Comment: The Problems with Payment
What’s wrong with these payments? CNN’s article quotes an expert who gets to the crux of the issue:
Dr. Martin Makary, a professor of surgery and patient safety expert at Johns Hopkins Medicine, said that although it’s ethical for a pharmaceutical company to pay a doctor for genuine research, he doubted that the more than 11,000 doctors paid by Bayer were involved in such efforts. “That looks like a bribe,” he said. [Emphasis added.]
Dr. Makary is right, but the problems with Bayer’s payments go deeper than that. It doesn’t actually matter whether Bayer intended to bribe the doctors it was paying, nor does it matter whether the doctors understood the payments as such.
The problem is that by accepting the payments, the doctors suddenly had a professional and financial stake in the success of Essure. To the extent that the doctors were paid for “educating physicians” about Essure, they had publicly committed themselves to the product’s safety. And by accepting Bayer’s money, they were also financially invested in the product’s success.
That’s why it’s no surprise that, as CNN points out, numerous studies have shown that doctors are more likely to prescribe a company’s drugs if they’re receiving payments from that company.
This should not be happening. Patients should be able to expect their doctors’ undivided loyalty and unclouded judgment. Doctors who take that responsibility seriously should think twice before accepting questionable payments from big pharmaceutical companies to push their products.
Can I Sue if I Was Injured by the Essure System?
Lawsuits against Bayer for Essure injuries and Bayer’s failure to adequately warn patients about the risks of using Essure are ongoing. If you have suffered pain, injuries, or complications you feel are due to Essure implantation, you should contact an experienced Ohio products liability attorney like Plevin & Gallucci immediately. The law limits how long you have to file a claim, so act quickly.