Medtronic Infuse Case Returned to Minnesota Federal Court

Medtronic Infuse Case Returned to Minnesota Federal Court
Medtronic Infuse Case Returned to Minnesota Federal Court

A federal appeals court brought back litigation from investment funds maintaining that Medtronic misled investors and physicians by concealing known risks from the controversial Infuse bone graft medical device, reports the Star Tribune.

Intended Use for Infuse

The Infuse medical device is designed to stimulate bone growth and has been used in more than one million surgeries worldwide. Infuse is normally used in a procedure in which two or more vertebrae in a patient’s back are fused to relieve pain from degenerative disc disease. The initial purpose of Infuse is to make the fusion proceed more reliably and with less pain for the patient. However, company-funded studies did not reveal risks that independent studies subsequently reported, according to the Star Tribune.

Infuse Legal Background

Lead plaintiff West Virginia Pipe Trades Health & Welfare fund, along with three investment funds, are accusing Medtronic of securities fraud for allegedly conspiring in a scheme to conceal Infuse’s safety risks and mislead investors about future Infuse sales. Minnesota’s chief federal judge, John Tunheim, threw out the case on procedural grounds last year.

Personal injury attorneys at Parker Waichman LLP are actively reviewing potential lawsuits on behalf of individuals who have suffered injury from Medtronic’s Infuse bone growth stimulator.

Recent Legal Developments

Several days ago, a three-judge panel of the 8th U.S. Circuit Court of Appeals in St. Louis unanimously overturned the Minnesota ruling and returned the case to federal trial court in Minnesota. Medtronic relocated its legal address to Ireland last year, but has retained corporate offices in the state.

The groups suing Medtronic were pleased by the recent development with its movement in an advantageous direction for their purposes.

This means the case will get back onto the track it was on before it was dismissed. The plan is for the litigation to move forward toward an eventual trial, barring some unforeseen circumstance.

The lead plaintiff in the class action shareholder litigation against UnitedHealthGroup, based in Minnetonka, ultimately led to settlements of over $925 million in 2008, the Star Tribune reports.

When asked about a potential settlement in the Medtronic issue, neither the plaintiff nor a Medtronic spokesman felt one was likely, reports the Star Tribune.

The three plaintiffs in the case are the aforementioned West Virginia pipe fitters’ union health and welfare fund, Union Asset Management Holding AG, a German-based asset manager, and the State of Hawaii Employees’ Retirement System.

In an unrelated, but similar case, Medtronic found out earlier this month, that it will likely have to go to trial in the first of thousands of patients’ personal injury lawsuits initiating from the use of Infuse.

On December 8, 2016, a state appeals court judge in St. Louis ruled that the plaintiff’s allegations that Medtronic fraudulently marketed Infuse, should go to trial. Medtronic Infuse manufacturer denies any liability in the plaintiffs’ cases and has moved to settle thousands of the 6,000 injury claims that are pending against it over Infuse, according to the Star Tribune.

Former Medtronic Legal Issues

Medtronic has mostly been able to circumvent litigation by arguing that the federal preemption clause of the Federal Food, Drug, and Cosmetic Act prevents them from being sued over injuries. Although other courts have rejected this argument, the 10th Circuit court of appeals agreed.

A three-judge panel was split on the decision. While two of the judges felt that state claims protecting citizens from defective medical devices were preempted by the Food, Drug and Cosmetic, the presiding judge thought otherwise. He remarked that the act is meant to “promote the safety of medical devices through honest labeling and promotion.” The presiding judge disagreed with the majority opinion finding that Medtronic’s misrepresentations to the plaintiff or her doctor were irrelevant. The judge stated that the plaintiff “incorporated allegations, supported by facts, that Medtronic misbranded Infuse in violation of federal law because it sold Infuse for an intended use not approved by the FDA.  This would make its labeling no longer necessarily ‘adequate’ under federal law.”

Medtronic Infuse Case Returned to Minnesota Federal Court
Medtronic Infuse Case Returned to Minnesota Federal Court

A ruling in 2008 found that individuals may file lawsuits against medical device manufacturers under state rules that are deemed “parallel” to federal requirements. This logic was used by the 9th Circuit Court of Appeals in San Francisco, California, who discovered that a Medtronic lawsuit met these guidelines and allowed the case to proceed.

Legal Help for Medtronic Infuse Bone Growth Stimulator Recipients

Parker Waichman LLP has had years of experience representing clients in numerous allegedly defective medical device lawsuits. The firm offers free, no-obligation legal case evaluations to anyone with questions about filing a lawsuit over Medtronic Infuse medical devices. We urge you to contact us at 1-800-YOURLAWYER (1-800-1968-7529).