Conflict of Interest Haunts Metal-on-Metal Implants
There have been many problems associated with metal-on-metal (MoM) hip implants. Clients ask me how such surgeries continue to this day even though much is known about the dangers of MoM hip implants. Since 700,000 or more such surgeries occur annually, this is a valid question. There are two reasons this happens.
Poor Reporting by Doctors
There is no requirement for physicians or patients to report medical device problems to the FDA. This limits the FDA’s ability to warn medical professionals. Despite a lack of reporting, many complaints about hip implants from doctors and patients were documented in the year between 2008 and 2009, signaling an expanding problem.
Marketing and Conflicts of Interest
Without clinical trials, companies often turn to other ways to introduce doctors to their products. Such introductions can involve consulting agreements. However, a consulting agreement used to convince a doctor to use a company’s product is against federal anti-kickback laws that are in place in this country.
These laws make it illegal for a company to use financial incentives to increase product usage. Such consulting agreements require little work, if any, by the surgeon. Doctors may not tell patients they are being paid by a medical device company to use the device the patient would receive. This is a widespread practice. Hospitals, from 2004 to 2006 alone, received payments for hip implants from Medicare totaling $14 billion.
In 2007, after an investigation that began in 2005, four companies manufacturing hip implants were charged by the U.S. government with providing incentives to doctors. The companies were:
- DePuy Orthopaedics
- Zimmer
- Biomet
- Smith & Nephew
Stryker, a fifth company that was investigated, cooperated with the Justice Department and was not charged. However, these five companies produce 95 percent of all hip implant devices.
Agreements and Civil Settlements
The four medical device companies entered agreements with the Justice Department. The charges would be dropped if the companies abided by the elements stipulated in the agreements. Stryker agreed to the requirements imposed on the others, and if upheld, would not be charged.
The agreements specified that the companies would follow procedures that complied with the anti-kickback statute. To ensure that the procedures were followed, the companies also agreed to federal monitoring for 18 months. In addition, the companies signed onto to a Corporate Integrity Agreement. Under this agreement, the HHS-OIG would supervise additional procedural reforms.
Civil charges against the four companies resulted in big fines. DePuy agreed to pay $84.7 million; Biomet, $26.9 million, Zimmer, $169.5 million and Smith & Nephew agreed to pay $28.9 million.
What Did the Agreements Accomplish?
The results of this investigation and prosecutorial demands made it less likely that a medical device would be used because of monetary incentives. Doctors who took such incentives could be subject to charges of violating anti-kickback statutes under Medicare. Whether the surgery was needed was never part of the concern federal officials had. From their standpoint, the cost of health care might be affected. At the very least, this type of activity was illegal.
Being a patient when you must wonder if your doctor is involved in a kickback agreement with a company that manufactures the device you will receive is daunting. Questions about the safety of the device are amplified. Talking with a hip implant lawyer is one way to understand how this affects you.
Related Articles by Ed Smith:
Sacramento Metal on Metal Hip Hip Implant Injury Lawyers
I’m Ed Smith, a Sacramento Metal-on-Metal hip implant attorney, and I know how upsetting it can be to be injured due to negligence and greed. You can call me at (916) 921-6400, or call our toll-free number at (800) 404-5400. I am here to answer your questions with friendly and free advice.
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