Drug and device companies often push for looser FDA regulations and faster approval processes, typically under the premise that strict regulations hamper patients’ access to essential treatments. It’s an important debate to have, but it’s not an excuse for drug and device manufacturers to disregard FDA regulations that protect those very patients.
An ongoing whistleblower case involving device maker Medtronic has reinforced the dangers of FDA fraud. It has also demonstrated that when employees of major device manufacturers witness fraud, it is critical that they speak up about it.
The VERTE-STACK Spinal System
Medtronic is one of the largest medical device companies worldwide. It manufactures advanced surgical products such as bone grafts, coronary stents and pacemakers.
There’s no doubt that innovating medical technology is an important task, but Medtronic appears to be compromising the integrity of its products–and the safety of patients–with a lack of transparency in the marketing process.
6,000 individuals have sued Medtronic over personal injuries related to one product category.
These lawsuits concern a system called the INFUSE Bone Graft, which helps patients with lumbar degenerative disc disorder. The VERTE-STACK Spinal System is a cage implant that facilitates the implementation of the INFUSE system. According to the FDA, VERTE-STACK systems are “intended for use in the thoracolumbar spine,” which is located below the cervical spine.
In 2009, patient Jerome Lew received a VERTE-STACK bone graft at UCLA Medical Center. The graft was used to repair nerve complications that affected Lew’s hands. It was implanted into the cervical spine, in his neck.
Documents that were later released indicate that a Medtronic sales representative was in the room during Lew’s surgery. In addition, emails may have been sent from Medtronic representatives to UCLA Medical Center suggesting that surgeons in other hospitals were using VERTE-STACK in the cervical spine, even though that use was not FDA-approved.
Instead of improving his numbness and pain, the unapproved use of VERTE-STACK allegedly worsened Lew’s existing symptoms and gave him new ones. The device allegedly caused pain and weakness in his arms and neck, in addition to the symptoms that already plagued his hands. The University of California reached a $4.2 million settlement with Lew; he also received a settlement from Medtronic.
Medtronic faces scrutiny from the inside out
Doctors are permitted to make judgement calls about whether unapproved uses of drugs and devices could be beneficial for individual patients. Manufacturers and their sales representatives are not permitted, however, to recommend or promote unapproved uses.
While a physician’s motive to implement a treatment in an off-label manner would generally be based on the needs of the patient, the motive of the manufacturer may be to increase profits by increasing the scope of the drug or device. That can clearly create a conflict-of-interest.
Many patients, like Lew, found the consequences of Medtronic’s alleged off-label marketing to be devastating. Eventually, at least one Medtronic employee decided to try righting this wrong.
The qui tam relator, which may be one or more Medtronic employees, has sued the company on behalf of the government.
Devices like the VERTE-STACK system are expensive, and if the company knowingly requested Medicare and Medicaid reimbursements for these products, it could be guilty of False Claims Act violations. The penalties for such violations are typically a fine of triple the amount defrauded.
The relator’s qui tam suit alleges that Medtronic deliberately misled the FDA about the intended uses of certain products, and that it engaged in off-label marketing. This can be a serious allegation, particularly if it is proven that off-label marketing led to negative patient outcomes and patient deaths. As serious as these allegations are, it’s not the first time Medtronic has been accused of murky marketing schemes.
Years of fraud allegations
This is not the first time Medtronic has been accused of fraud.
Medtronic has its own page in Taxpayers Against Fraud’s Hall of Shame. From 2006 to 2015, the device maker paid over $150 million settlements to resolve False Claims Act lawsuits related to its products. The company’s alleged infractions include bribing physicians to use its pacemakers, lying to Medicare about which procedures were performed, and deliberately promoting an unapproved procedure.
Like many major drug and device manufacturers, Medtronic may well resolve all of its current legal battles and continue with business as usual. The company noted in a 2014 annual report that it created a $140 million budget for INFUSE litigation.
This is a common practice in major industries. Companies with very high profit margins may therefore have little incentive to change destructive policies and patterns unless their reputations and profits are significantly threatened.
Should medical devices be subject to stricter approval processes?
Though medical devices are often subject to clinical trials, the process for receiving FDA-approval can be less extensive than it is for prescription drugs.
For a device to be approved, it has to first be classified based on whether similar products exist on the market. The manufacturer may then need to submit a Premarket Notification, known as a 510(k). If the FDA reviews the 510(k) and deems the product ‘SE’, or substantially equivalent to similar existing products, the agency can issue an approval.
There have been critiques of the FDA’s review process, primarily that it may not be sufficiently thorough. With more thorough clinical research, it could be possible, for example, for the FDA to issue more explicit instructions about how medical devices should not be used. That could potentially discourage or diminish off-label marketing, or even harmful off-label implementation of medical devices.
Cases like the Medtronic lawsuit are important to bear in mind, because FDA approval processes may soon change significantly. The 21st Century Cures Act, which was passed by the House of Representatives in 2015, requests that FDA regulations be loosened so that drugs and devices can be approved faster.
Instead of requiring long clinical trials, eligible drugs and devices could be approved based on very few expert opinions. As critics of the bill have pointed out, allowing so little research may not impact patients positively.
It could negatively impact patients who are already underrepresented by clinical trials. What works for one or two patients, after all, is not always a reliable indicator of what will work for a thousand others. Unsurprisingly, the bill is heavily supported by drug and device manufacturers.
Greater efficiency should always be a priority for agencies like the FDA, but it’s also important for the American public and healthcare workers to stay alert to the industry influence behind proposed legislation like the 21st Century Cures Act.
Companies like Medtronic may not be completely deterred by qui tam lawsuits and federal reprimands, but it’s crucial that our legal system recognizes harmful business practices. Without laws in place to put patient safety before profits, it may be even harder to stop corporate interests from negatively impacting public health.