July 8, 2018
Bayer Paid Doctors Millions for Questionable Birth Control Device
Bayer AG, the pharmaceutical giant responsible for drugs and devices such as Aleve, Aspirin, and Yaz, is facing tens of thousands of lawsuits from women who claim that its new Essure birth control device is dangerous and defective. However, this may not actually be the company’s biggest problem. As recently reported by CNN, Bayer AG is also currently at risk for facing a large-scale federal investigation arising out of its alleged payment of millions of dollars to doctors who recommended Essure.
According to CNN:
“A CNN analysis of federal data, shows that from August 2013 through December 2017, Bayer paid 11,850 doctors $2.5 million related to Essure for consulting fees and similar services.
“These payments are legal but very controversial.”
The CNN report also states that:
“Studies by scientists at the University of North Carolina, Yale University, the George Washington University and Harvard Medical School, among others, show that when doctors are paid by pharmaceutical companies, they’re more likely to prescribe drugs made by those companies.”
However, while Bayer AG may be at risk for millions of dollars in civil or criminal penalties, it may not be the only one at risk. The doctors who accepted payment from Bayer AG could be at risk as well.
When are Payments from Pharmaceutical Companies Illegal?
While CNN’s report asserts that the payments were legal, the information contained in the report is inadequate for readers to draw their own conclusions. Although it is certainly true that OBGYNs and companies like Bayer AG can structure legal compensation arrangements under appropriate circumstances, the line between a legal consulting fee and an illegal kickback is razor thin. Federal authorities such as the U.S. Department of Justice and the U.S. Department of Health and Human Services’ Office of Inspector General (OIG) routinely pursue investigations targeting OBGYNs and other physicians under the Anti-Kickback Statute; and, unless a compensation arrangement falls within a specific safe harbor or exception, it can expose parties on both sides of the transaction to substantial civil and criminal penalties.
Unfortunately, pharmaceutical and medical device companies often target physicians with “attractive” compensation arrangements because they see these doctors not as advocates for their patients, but as potential sources of income. As explained by the OIG:
“As a physician, you are an attractive target for kickback schemes because you can be a source of referrals for fellow physicians or other health care providers and suppliers. You decide what drugs your patients use, which specialists they see, and what health care services and supplies they receive.”
Critically, while the Anti-Kickback Statute requires proof that an OBGYN knowingly and willfully entered into an unlawful compensation arrangement, proving the requisite “mental state” for culpability is not as difficult as this makes it sound. There are a number of ways that federal prosecutors can use testimony and documentary evidence infer intent or demonstrative constructive knowledge; and, if the evidence is insufficient to support charges under the Anti-Kickback Statute, prosecutors may be able to use the evidence uncovered to pursue charges under another federal health care fraud law. Contact a kickback defense attorney to discuss your situation.
When Can OBGYNs Be Held Liable for Recommending and Using Dangerous Medical Devices?
As federal authorities and patients continue to target Bayer AG in connection with its sale of Essure birth control devices, OBGYNs who have recommended the device could be exposed to medical malpractice litigation as well. Medical malpractice lawsuits targeting OBGYNs’ recommendation and use of Essure birth control devices would likely assert claims such as:
- Improper recommendation of Essure based upon the receipt of compensation from Bayer AG rather than the OBGYN’s independent medical judgment; and/or,
- Improper recommendation of Essure once the OBGYN knew, or reasonably should have known, that the device was not safe for its intended use.
With either type of claim, OBGYNs and their malpractice insurance carriers could face substantial liability, and a successful malpractice claim that ties in aspects of an unlawful kickback arrangement could potentially lead to state licensing action as well. Damages caps for medical malpractice claims and the conditions for license suspension or revocation vary by state, and OBGYNs targeted in Essure litigation will need to ensure that they have a clear understanding of their potential exposure.
Did You Accept Payment from Bayer AG in Connection with Essure Birth Control Devices?
If you accepted payment from Bayer AG in connection with Essure birth control devices, or if you are concerned that another doctor in your practice group may have received compensation, it will be important to take a proactive approach to protect your practice. Contact a kickback defense lawyer. In a typical case, this would include:
- Conducting a confidential internal assessment to identify any potentially unlawful payments;
- Reviewing your practice’s compliance program and remuneration policies to determine whether they suffer from any shortcomings;
- Proactively addressing any payments that have the potential to trigger liability, including self-reporting statutory violations if advised to do so by legal counsel; and,
- Developing a defense strategy that you can implement immediately in the event of a federal investigation or civil lawsuit.
For OBGYNs who accepted payment from Bayer AG and recommended Essure birth control devices to their patients, the risks of federal prosecution and medical malpractice litigation are very real. This is equally true for doctors who were knowledgeable about the risks associated with accepting payment and for those who were unaware that they were potentially exposing themselves to legal action. At Oberheiden, P.C., our kickback defense attorneys have a proven record of success representing physicians in federal litigation, and we are prepared to defend OBGYNs in all legal matters involving Bayer AG’s Essure birth control devices.
About the Author, Dr. Nick Oberheiden, Esq.
Dr. Nick Oberheiden is a defense attorney whose practice is devoted to representing physicians and other health care providers in federal civil and criminal matters. He has successfully defended OBGYNs and other physicians in numerous high-stakes federal cases, and he is a staunch and unwavering advocate for clients whose practices are on the line. Contact our proven kickback defense attorney to discuss your case.
Learn more about Dr. Nick Oberheiden, Founder and Managing Partner of Oberheiden, P.C.
Schedule a Free and Confidential Consultation at Oberheiden, P.C.
If you are concerned that you could be facing legal trouble as a result of accepting compensation from Bayer AG, recommending Essure birth control devices to your patients, or accepted other alleged kickbacks, we encourage you to contact us promptly for a free and confidential consultation. To speak with federal kickback defense attorney Dr. Nick Oberheiden in person or by phone, please call (888) 519-4897 or request an appointment online now.