Overview: A California judge has denied Medtronic’s attempt to pursue litigation without a trial based on preemption in a case alleging Medtronic promoted the off-label use of its bone growth product, Infuse. The off-label use and marketing of Infuse has been surrounding the controversial product since 2008.
- The California Health Department is investigating a Pomona Valley Hospital following accusations of off-label promotion and experimental procedures with Medtronic Infuse and two Stryker products
- Judge Michael Linfield has denied Medtronic’s motion for summary judgment on the basis of preemption, stating that the plaintiff is suing on the count of federal, not state, violations
- Medtronic has been faced with a number of lawsuits alleging it promoted the off-label use of Infuse, which has been associated with life-threatening complications
Product: Medtronic Infuse Bone Graft
Manufacturer: Medtronic, Inc.
Side Effects & Complications
- Difficulty breathing, swallowing
- Uncontrolled bone growth
- Nerve injury
- Male sterility
- Retrograde ejaculation
Medtronic Request for Summary Judgment Denied
On Monday, Judge Michael Linfield denied Medtronic’s motion for summary judgment on the basis of preemption, meaning that federal law supersedes state law. Summary judgment is when a court rules that there is no need for an actual trial because all factual issues remain settled. Medtronic had tried to use a previous ruling showing that federal law preempts state regarding the performance of an approved device before it is put on the market. But Judge Linfield said that in this particular suit, “Plaintiff’s claim is not based on allegations that Medtronic’s device violated state tort law notwithstanding compliance with the relevant federal requirement…In contrast, plaintiff here is alleging that Medtronic promoted the use of its device in violation of federal requirements”
The case involves April Cabana, a California woman who claims that Medtronic and Stryker encouraged their bone growth products for unapproved uses for her back surgery. Allegedly, the “experimental” use of their products caused excessive bone growth and worsened her pain.
Medtronic Infuse and Off-Label Use
Medtronic has been dealing with off-label issues over Infuse since 2008, when the U.S. Food and Drug Administration (FDA) warned that using the product in the cervical spine could lead to life-threatening complications, such as swelling of the neck and throat. Thereafter, the company has been faced with shareholder lawsuits claiming that the Medtronic falsely inflated its stock by failing to disclose that most of Infuse’s revenue is generate through off-label procedures. In March, Medtronic settled one of these suits for $85 million.