The process of approving medical devices for use in human beings in this country very often requires a combined and choreographed effort between manufacturers, medical doctors, and academics. When that synergy works, revolutionary and life-saving innovations can be brought to the market, improving and extending lives. As with any new product, however, the success and safety of a new medical device rely upon the integrity and ethics of all parties. However, as a lawyer who investigates claims against pharmaceutical companies, I know that If and when data is corrupted, inaccurate, or falsified, it can lead to the release of dangerous and even deadly medical devices to an unsuspecting public.
When the FDA approves any device, it issues guidelines for approved use. However, it is perfectly legal and common for physicians to prescribe medication and medical devices for "off-label" use. This can benefit both the patient and the drug manufacturer. It might provide the patient relief that other medications cannot, as well as increase the profits of drug makers by creating more sales. And while this practice is perfectly acceptable, it puts an added burden on doctors to know more about the benefits and risks of a given medication or device since the FDA prohibits manufacturers from directly promoting the unapproved use of their products.
Last year, drug maker GlaxoSmithKline paid $3 billion -- the largest health-care fraud settlement in history -- in response to charges that they had promoted the use of Paxil to children and adolescents even though it had not been approved and studies had found that its use was potentially dangerous.
Some drug companies may view the fines for promoting off-label use simply as an expense associated with the cost of doing business. For example, last week Medtronic -- self-described as the world's largest independent medical technology company, and the maker of medical devices like the Infuse Bone Graft stimulator, pacemakers and defibrillators -- released its better-than-expected fourth-quarter earnings: net profits of nearly $1 billion. What makes this news even more astounding is that Medtronic is currently mired in one of the most egregious scandals in modern pharmaceutical history -- the research promoting the use of their Infuse bone graft device.
Infuse bone grafts use a man-made version of human protein to stimulate bone growth. It was originally approved by the FDA to treat degenerative disc disease in the lower spine as well as for oral and dental procedures. Since then it has been used by unsuspecting orthopedic spine surgeons in "off-label" surgeries such as for cervical neck disease.
In 2008 the U.S. Justice Department began a formal investigation of Medtronic for illegally recommending that physicians use Infuse for off-label surgeries. The Justice Department's investigation led to a formal 16-month inquiry by theSenate Finance Committee, headed by Max Baucus (D-Mont) and Chuck Grassely (R-Iowa). In the course of the Senate's investigation, the Committee found Medtronic had improperly collaborated with the physician consultants that performed InFuse's research by rewriting the results of the testing in such a manner that they inaccurately reflected InFuse's risks.
The Senate inquiry revealed that Medtronic paid over $200 million in consulting fees, royalties, and other payments directly to the doctors who were involved in the research. The Senate relied in large part on a recent issue of The Spine Journal, the preeminent medical peer-reviewed publication in the field of orthopedic spine surgery, rich in spinal care articles on research and treatment. The Journal found that research performed by the doctors who were funded by Medtronic failed to accurately report the findings of the research and failed to reveal that one of the primary risks of the use of Infuse is male sterility, particularly when the product is used "off-label." Additional possible side effects and catastrophic complications associated with the "off-label" use of Infuse Bone Grafts include the following:
• Uncontrolled bone growth at or near the site of the surgery
• Chronic radiating pain in the legs or arms
• Retrograde ejaculation, or other urogenital injuries
• Difficulty Breathing, Swallowing or Speaking
• Compression of the Airway
• Respiratory Depression
• Nerve Damage
During its inquiry the Senate reviewed Medtronic's internal documentation, finding that it had falsely claimed that Infuse was a superior alternative to traditional bone-grafting surgeries because it was less painful and eliminated the need for a second surgical site.
Not surprisingly Medtronic repudiated the Senate's finding, and in fact sent $2.5 million to Yale Medical School's Open Data Access Project (YODA) to conduct an "independent" study on the efficacy of Infuse and to fact-check its research, under the direction of Dr. Harlan M. Krumholtz -- who, ironically, is a cardiologist and professor of investigative health and public health, but not an orthopedic surgeon. The results of the investigation were promised for release in February 2013. According to Yale's YODA website, the results of Dr. Krumholtz's long-awaited investigation are finally due sometime this month. The extended delay seems to suggest that Dr. Krumholtz and his team financed by Medtronic may have had some difficultly reconciling Medtronic's research with the large number of reported adverse incidents.
In the meantime, Medtronic is facing thousands of injured patients from across the country who are mounting a legal offensive that, if successful, might adversely affect Medtronic's next few fiscal quarters, ideally transforming the consequences of manipulating and falsifying medical safety data from a mere fine to a crime.