In a controversial case filed against a Medtronic manufacturer and a leading provider of bone graft, the U.S. FDA announced a decision against the manufacturer, calling into question the company’s marketing practices. At issue is whether Medtronic intentionally promoted its own product as an effective treatment for conditions that it did not approve, and thus encouraged doctors to treat patients with the product even when it was not appropriate. In addition, the FDA claims the company forced physicians to use its own bone graft system for treatments for which it was not approved, thereby exposing patients to risk of complications. In both instances, the FDA is seeking class action monetary damages and possibly banning the manufacturer from marketing bone graft products in the future.
Medtronic’s attorney, John W. Rice, has strongly condemned the FDA’s actions, claiming that the agency has not proven the company acted with deliberate intent. Rice further claims the FDA lacks the authority to penalize a company based on a decision not to license its product. He further believes the settlements will set a bad precedent for future litigation and inhibit mergers and acquisitions. The FDA’s decision to ban the Medtronic Infuse bone and joint formula has caused a number of lawsuits and drawn sharp criticism from a number of prominent health care professionals, including Dr. James Turner, author of Bone Repair: An American Perspective (NY: Oxford University Press, 2021). Dr. Turner contends that the FDA’s reasoning is based on a flawed legal theory and is premised on the fact that the FDA is not a relevant trier of fact, required to decide liability or whether a product is worthy of approval.
One of the issues facing the company and the manufacturer of the Infuse Bone Graft is whether or not they can be held liable for damages resulting from injuries suffered by a former Medtronic employee. According to the company’s attorney, the fact that the Federal Trade Commission has chosen to decry the company does not alter the fact that the company bears responsibility for the injuries suffered by former employees. The attorneys further maintain that this is only one of several lawsuits filed against the company and that the entire scope of the case is not yet complete. They also point out that this is just the first of what may be many class action lawsuits over the use of the BONES system. The company is facing what some feel is the harassment of the worst kind, as many in the medical community view it as a clear case of physician mismanagement.
Some of the doctors who are featured in the Medtronic infusions lawsuit are noted as having operated on children as young as two. In addition to malpractice and doctor malpractice charges, the devices themselves were deemed defective by the Food and Drug Administration. While the device’s manufacturer retains full ownership of the device, the devices are being sold by a third party. While the FDA did not ban the devices or force their removal from hospitals, the Food and Drug Administration noted the risks associated with the device and issued strict guidelines to health care providers instructing them to carry out quality inspections on their employees before administering the BONES II devices.
There are currently three class action lawsuits against Medtronic and one lawsuit against a Florida doctor. Plaintiffs contend that the devices created a significant public safety and health risk by failing to appropriately address the potential for a patient’s death due to a serious spinal cord disorder known as Spinal Stenosis. In order to resolve the safety issues brought forth by these lawsuits, the devices must undergo quality inspections. This will allow the FDA to further restrict the sale of the infuse bone and fusion device if the manufacturer cannot demonstrate that the device poses no real or perceived danger to the public. The plaintiffs would also like to see monetary damages awarded to them for suffering and medical expenses they have experienced as a result of the injuries.
One of the lawsuits against the company and one of the class action suits were brought against a Florida doctor. In that case, the doctor was accused of prescribing an unapproved bone graft for a patient who later died from his actions. As is typical in these cases, the doctor had previously received the appropriate training to administer the treatment, but was nonetheless found to be in violation of the Food and Drug Administration’s (FDA’s) policy concerning off-label uses of the treatment. While the company has admitted that it violated FDA policy and subsequently lost its license to sell the product, it is believed that other doctors may be potentially affected by the same policy, especially since some doctors are not familiar with the manufacturer’s instructions when providing the treatment.