Minnesota residents may be interested in a recent federal investigation involving a manufacturer of medical devices. The investigation, which relates back to a whistleblower lawsuit that was unsealed in 2008, is noteworthy because of the danger to public health involved.
U.S. Senate investigations revealed that Medtronic allegedly influenced research-related articles to support a prime product used for spine surgery. Medtronic supposedly paid $210 million to the doctors who wrote articles on bone-graft material.
The Senate Finance Committee's report revealed that Medtronic, based in Fridley, Minnesota, may be responsible for misconduct for editing, shaping and drafting the text for articles published in medical journals. These articles conveyed information regarding a product named Infuse. All articles were authored by physicians who were allegedly paid to write them.
The Finance Committee's chairman issued a statement that the actions of Medtronic have breached the trust that the patients have while undergoing medical treatment. However, Medtronic has strongly denied they were involved in improperly influencing the published articles. The company has also denied omitting from the articles any harmful effects in patients who underwent treatment with Infuse.
In 2008, the U.S. Food and Drug Administration had issued a health warning to the public regarding the off-label use of products: the FDA had warned the doctors against the using Infuse for procedures other than those stipulated by the FDA.
The committee's report alleges Medtronic officials used language in the articles that promoted the use of Infuse in advanced surgical techniques, emphasizing the fact that the an older technique involved a lot of pain. However, the company issued a statement that it had reported all potential adverse events, and that all risks were stated on the product's label, which was approved by the FDA.
The Senate Finance Committee report originated from an inquiry conducted in June 2011 regarding the company's influence in the articles published in medical journals. Investigators are also looking into the possibility that Infuse researchers may have improper financial ties with the company.
Individuals who work within companies that are violating federal law are entitled to protection as whistleblowers. Those who have suffered retaliation from their employers because of their whistleblower activities should consult an experienced attorney to discuss their rights.
Source: TwinCities.com, "Medtronic accused of shaping articles about spine surgery product, Senate report says," Christopher Snowbeck, Oct. 25, 2012