Posted by A Medtronic Off Label Use lawsuit is a potential remedy for consumers who have experienced injury or suffered a debilitating illness. This case focuses on the VERTE-STACK, Infuse, and Failure to warn devices and products. A Medtronic Off Label Use lawsuit can be filed against the company for failing to warn consumers or promote devices outside of their labels. In addition, the plaintiff may also file a lawsuit against Medtronic for negligent marketing.
VERTE-STACK
The VERTE-STACK Medtronic off-label use lawsuit alleges that the device, which was FDA-approved for use in the chest and lower back, was improperly used in patients. This off-label use resulted in negative patient outcomes, including pain in the arms and neck. According to the lawsuit, Medtronic was able to receive hundreds of millions of dollars in government payments for this promotion. This case is a unique twist on the legal battle over off-label use.
A whistleblower in the VERTE-STACK Medtronic off-label use lawsuit filed against the company in 2015 claims that Medtronic defrauded the FDA of millions of dollars by marketing and compensating doctors for off-label uses. The company has denied these allegations. However, the lawsuit has a strong chance of prevailing. If the court finds in favor of the whistleblowers, it could result in large damages for Medtronic.
Infuse
A Medtronic Infuse lawsuit claims that the company improperly promoted and sold the device, resulting in injuries and even death in some cases. According to the lawsuit, the company paid medical consultants millions of dollars to write positive reviews and conceal possible risks of the product. These practices are illegal, and the company is accused of paying doctors to endorse the product. In response, the company has aggressively denied these allegations. However, the lawsuit has created a precedent for future lawsuits against medical device companies.
Despite these legal challenges, Medtronic has not yet settled the case. However, it has filed a petition to the U.S. Supreme Court over its immunity from failure-to-warn claims. The device received FDA approval for its intended use, but Medtronic promoted it for uses not approved by federal regulators. Consequently, many MedTech companies have filed lawsuits and received damages. The American Assn. for Justice is currently reviewing the case, and it is expected to rule on the Medtronic Infuse lawsuit soon.
Adverse events
Medtronic is facing numerous Off-Label lawsuits that allege that the company promoted uses for its medical devices that are not approved by the Food and Drug Administration. Off-label use is legal for physicians, but manufacturers can’t promote non-FDA-approved uses. The Medtronic Off-Label Use lawsuit is a great example of this. It claims that the medical device maker intentionally hid serious adverse events from doctors.
According to the company’s CEO, “Medtronic’s diabetes division has been notified of over 70 million new patients every year – about two lives every second.” But a recent ICIJ analysis showed that one in five reported medical device adverse events involved a Medtronic device. Medtronic’s products were linked to more adverse events than any other company. Among the worst manufacturers in countries with the most adverse event reports are France, Norway, Australia, and Japan.”
Failure to warn
A recent case filed by a plaintiff based on Medtronic’s alleged promotion of off-label use for Infuse and Posterior Fusion cardiac devices has reached the U.S. Supreme Court, which may decide whether the company can be held liable for failure to warn. The case could impact many other medical device lawsuits. Let’s take a closer look at what happened in this case.
The plaintiff’s claims stem from his failure to warn of the risks of off-label use of these devices. He claims Medtronic failed to warn him of these risks, despite knowing that these devices have a high risk of bone overgrowth. In addition, the court also considers whether Medtronic failed to warn of an increased rate of serious side effects, which would trigger a warning under California’s failure to warn law.
Federal reprimands
As a result of several federal reprimands for off-label use of medical devices, Medtronic will be required to disclose its off-label use. In 2012, Medtronic agreed to settle shareholder charges alleging the company failed to disclose that more than 85 percent of InFUSE sales were due to off-label uses. While the settlement agreement may not address every complaint, it is significant to note that the company will likely continue to operate under these laws.
These cases have created an uproar, and it’s unlikely to stop there. In the meantime, the legal system needs to recognize that Medtronic’s off-label marketing practices are causing harm to patients. In some instances, such as the recalled Medtronic CR-V, the physician’s motive for prescribing off-label may be based on their own need, while the company’s motivation might be to increase profits. Regardless, the consequences for many patients have been devastating, and one employee of Medtronic decided to take matters into his own hands. He is known as a “qui tam relator,” and is suing the company on behalf of the government.
Trial date
Trial dates for Medtronic Off Label Use lawsuits are set for October 2019. The case is the result of a whistleblower’s lawsuit claiming the company knowingly promoted and sold unapproved medical procedures. The whistleblower received a share of the federal recovery. Despite the whistleblower’s anonymity, this case will serve as a reminder to consumers about the dangers of FDA fraud.
In a previous settlement, Medtronic settled a whistleblower case against it by paying $17.9 million to settle the case. However, the company will now be forced to comply with the terms of the Corporate Integrity Agreement with the Department of Health and Human Services. The case was filed after Medtronic issued a Class I recall of some of its products, including the Synergy Cranial stent and StealthStation S7 Cranial software.