For several years patients who suffered devastating side effects as a result of Medtronic Infuse Bond Grafts have been filing lawsuits against the company claiming that the devices are defective and were improperly used in “off-label” or unapproved manners.
Now, damaging evidence contained in documents made public by U.S. Senate investigations may be providing these victims a “smoking gun” in their allegations that company officials were aware of these dangerous side effects and attempted to downplay these dangers by paying off doctors.
“Medtronic’s actions violate the trust patients have in their medical care,” Senate Finance Committee Chairman Max Baucus (D-Mont.) was quoted as saying in media reports about the findings. “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.”
The revelations, legal experts say, can be expected to generate a wave of new Medtronic Infuse Bone Graft lawsuits seeking compensation for “off-label” use that victims say has caused severe health problems, including nerve problems, neck swelling, breathing difficulties, digestive problems, sexual issues and constant pain, particularly in the arms and legs.
The controversial Medtronic internal documents outlining a campaign to pay doctors to endorse the company’s products and downplay the dangerous side effects was profiled in many major media, including the Wall Street Journal. As you sort through this report it becomes obvious how committed Medtronic was to sway public opinion and how much it was willing to spend:
A report by the Senate Finance Committee based on thousands of documents it subpoenaed from Medtronic Inc. raises new questions about the integrity of the medical research underpinning one of the medical-device maker’s products.
Medtronic was “heavily involved in drafting, editing and shaping the content of medical journal articles” about the product—a bone-growth protein used in spine surgery called Infuse—even as it was paying the physicians who wrote those articles a total of $210 million for unrelated work, the Senate report alleges.
In one instance, a Medtronic employee recommended to one of the physicians not publishing a list of side effects associated with Infuse in a 2005 journal article, company emails show. Medtronic marketing officials also urged inserting language into other journal articles touting the use of Infuse as better for patients than using bone harvested from their pelvises because of the pain associated with the latter, other company documents show.
Medtronic’s influence extended to preparing a physician’s 2002 speech to a panel advising the Food and Drug Administration on whether to approve the drug, the report alleges. The physician’s disclosure to the panel at the time suggested his testimony was independent, but the company had in fact helped him draft it and paid him as a consultant the previous year, company documents show. Medtronic later hired the physician as an executive.
In response to the Senate report, Medtronic issued a statement saying it “vigorously” disagreed with any suggestion that “it improperly influenced or authored any of the peer-reviewed published manuscripts.” The company also denied that it “intended to under-report adverse events” associated with Infuse.
Infuse, which is used to spur the fusion of vertebrae to reduce back pain, once brought up to $800 million in annual sales for Medtronic. But the drug has been a source of controversy for the company since 2008, when reports began surfacing of patient deaths linked to its use in the neck.
The FDA approved Infuse in 2002 only for use in one particular type of surgery involving the lower spine. But it became widely used in other types of surgeries, including neck procedures, after a series of medical-journal articles depicted those other uses as safe and effective. Doctors are free to use drugs beyond their official uses, but companies can’t promote such “off-label” uses.
Medtronic issued a statement saying it ‘vigorously’ disagreed with any suggestion that “it improperly influenced or authored any of the peer-reviewed published manuscripts.”
Those journal articles have since come under a cloud. Last year, Eugene Carragee, a professor of orthopedic surgery at Stanford University School of Medicine, published a study showing that 13 of the articles failed to report serious complications associated with Infuse and a sister drug called Amplify that hasn’t been approved by the FDA. Dr. Carragee’s study prompted the Senate inquiry that led to Thursday’s report.
Although it was known that Medtronic had financial relationships with some of the physicians who wrote journal articles, the scale of the payments and how far back they went in time had not been fully disclosed until now.
Medtronic says the payments weren’t connected to the journal articles. Rather, it said, “the vast majority” were “royalty payments made to compensate physicians for their intellectual property rights and contributions” to other company products.
The documents obtained by the Senate committee show that Medtronic paid four of the article authors—Scott D. Boden, Regis W. Haid, Volker Sonntag and Thomas A. Zdeblick—between $22 million and $34 million each from 1996 to 2010. Medtronic also paid a limited liability company connected to two other authors, John R. Dimar and Steven D. Glassman, nearly $65 million over the same period.