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So far it has cost pharmaceutical giant Medtronics a $2.5 million dollar grant to the prestigious Yale Medical School and its Open Data Access Project (YODA) to conduct an “independent” study to validate the research conducted on its artificial bone generator InFuse. Infuse Bone Stimulator uses 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. Leer en Español.

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The investigation is being conducted under the supervision of Dr. Harlan M. Krumholtz–a professor of investigative health and public health. Initially the results of Dr. Krumholtz’s long-awaited investigation were due in February. For some reason they have yet to be released.  One reason, I suggest, might be that the research team is having difficulty verifying Medtronic’s pre-market clinical research and corroborate the results in light of the enormous number of reported adverse incidents.  Of course, there could be additional explanations.

It seems likely that Medtronic will face litigation from thousands of injured patients from across the country. If their legal offensive succeeds, Medtronic’s next few fiscal quarters may be less impressive.

MEDTRONIC INVESTIGATED BY SENATE FINANCE COMMITTEE

YODA’s highly unusual audit of InFuse’s premarket studies comes after investigations by both the United States Justice Department and Senate Finance Committee that began in 2008. They found that Medtronic had illegally recommended that physicians use InFuse for off-label surgeries such as cervical procedures.

The Justice Department’s investigation led to a formal 16-month inquiry by the Senate Finance Committee, headed by Max Baucus of Montana. In the course of the Senate’s investigation, the Committee found Medtronic had improperly collaborated with the physician consultants who performed InFuse’s research by rewriting the results of the testing in such a manner that they hid many of the risks associated with InFuse.

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Senator Baucus’s investigation, also known as the Baucus-Grassley Investigation, found that Medtronic paid over $200 million in consulting fees directly to the very same surgeons who were involved in the InFuse safety research and testing. The investigators relied heavily on an issue of the The Spine Journal, the preeminent medical peer-reviewed publication in the field of orthopedic spine surgery, which reported that doctors who were funded by Medtronic falsified the results of their studies by hiding many of the risks of the use of Infuse, including male sterility and uncontrolled bone growth at or near the surgical site. In addition, the Senate also inspected many of Medtronic’s internal documents, concluding that their claims that InFuse provided a better alternative to bone-grafting procedures were unfounded.

zzbaucus.jpgAccording to Senator Baucus: “Medtronic’s actions violate the trust patients have in their medical care. Medical journal articles should convey an accurate picture of the risks and benefits of drugs and medical devices, but patients are at serious risk when companies distort the facts the way Medtronic has,” Senator Baucus said. “Patients everywhere will be better served by a more open, honest system without this kind of collusion.”

The case was settled by Medtronic in December 2011 with an agreement that the company would pay $23.5 million to resolve the DOJ’s investigation of four post-market studies.  Medtronic made no admission that any of the studies were improper or unlawful.  To read Medtronic’s press release click here. 

Approving and then introducing new medications and medical devices are processes that keep our country in the forefront of medical innovation. Those processes often depend on the combined and choreographed efforts of manufacturers, medical doctors, and academics. When that synergy works, revolutionary and life-saving innovations are brought to the market, improving and extending lives. Yet as with any new medical device like InFuse or artificial hips, the success and safety of new medications and medical devices depend in turn on the integrity and ethics of all parties. For example, corrupted, inaccurate, or falsified data can lead to the release of dangerous and even deadly medical devices to an unsuspecting public.

In approving medications and devices, the FDA issues guidelines for their use–yet it is legal and common for doctors and surgeons to use certain drugs or medical devices for “off-label” use. Off-label use can be of help to both patients and drug makers. It might provide the patient relief that other medications cannot, as well as increase the profits of drug makers by creating more sales. While this practice is perfectly acceptable, it does place an added burden on doctors to know more about the benefits and risks of a given medication or device. That is necessary because the FDA prohibits manufacturers from directly promoting the unapproved use of their products. To learn more about how the FDA approves drugs and medical devices in our country, please read my recent blog for the Huffington Post: “The FDA’s Dangerous Death Race.”

FRAUD FOUND FOR GLAXO

Last year in a completely separate case, involving another pharmaceutical giant, 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. The fines resulting from promotion of off-label uses might strike some drug companies merely as the cost of doing business.

Medtronic, for example, which describes itself as the world’s largest independent medical technology company–making medical devices like the Infuse bone growth stimulator, pacemakers, and defibrillators–released just last week its better-than-expected fourth-quarter earnings of nearly $1 billion in net profit. What makes that figure even more astounding is that Medtronic is currently mired in one of the most egregious scandals in modern pharmaceutical history–the conditions surrounding the research they used to promote the use of their Infuse medication.

If you have received InFuse during an operation, you may be entitled to compensation. Our lawyers are currently investigating claims on behalf of victims across the country. If you have any questions about a potential claim against Medtronic or InFuse, please contact Spencer Aronfeld a Miami InFuse claims lawyer, for a free initial consultation regarding your legal rights. Call toll free: 866-597-4529 or 305-441-0440 today.

To learn more about Medtronic and the InFuse Bone Generator please read my recent blog for the Huffington Post: “Medtronics Manipulates Safety Data–When a Fine Should Become a Crime.”