Medtronic, one of the world’s largest medical device manufacturers, faces a whistleblower lawsuit that claims it sought Food and Drug Administration approval for its devices under false pretenses — and that the devices have been regularly used for a purpose that was never intended by regulators.
“They were labeled, ‘not for cervical spine use,’ and yet in everything about them, including emails from their marketing folks, it makes clear that they were meant to be and were used in the cervical spine,” said Dr. Vikas Saini, president of the Lown Institute, a Boston health care think tank, who has followed the case.
Medical devices are lightly regulated by the FDA [read “Anecdotal Evidence Good Enough to Approve Medical Devices According to Lawmakers”; http://sco.lt/58AwLp and “99% of Medical Devices Approved by FDA with Shockingly Little or No New Research”; http://sco.lt/7W7p0D), and once they have been cleared by the agency, physicians may use them however they see fit. Patient advocates say the case highlights the shortfalls of the regulatory system. Medical devices, unlike prescription drugs, are not subject to clinical trials, as is the case with prescription drugs.
Medtronic has been beset by personal injury lawsuits. Corporate filings to the Securities and Exchange Commission in June show that at least 6,000 people have sued the company — or plan to — for INFUSE-related personal injuries, among them bone and nerve injury, urinary problems, male sterility, and infection. Some patients have reported excessive and painful bone growth.
“The case illustrates the unfortunate imbalance of influence that companies like Medtronic exercise over everything from patient safety to doctors and hospital systems and the government health care system … and then as well as regulatory bodies that are supposed to hold them in check,” said John Parker, an attorney with Cutter Law, who is one of the attorneys for the whistleblower.
The FDA “didn’t have any data about safety or effectiveness or even whether it would fit where it was supposed to,” Diana Zuckerman, president of the National Center for Health Research, said. “The truth is, FDA is doing such an inadequate job of reviewing devices that if it weren’t for the lawsuits, even more patients would be harmed.”