The U.S. Supreme Court declined to hear an appeal from Medtronic Inc. meant to halt a product liability lawsuit.

The Medtronic complications lawsuit was filed by a now-deceased man from Arizona who claimed that a medical device caused him permanent paralysis. His wife continues as a plaintiff in the Medtronic lawsuit.

Medtronic attempted to have the case dismissed based on an abstract legal concept that severely limits the ability to sue a manufacturing company for injuries caused by an FDA-approved product. This legal theory is called the FDA pre-emption.

Medtronic argued that the FDA’s pre-market approval process was best suited to oversee and regulate medical devices and drugs, and is therefore in charge of ensuring the general public is not exposed to any danger. Legal experts state that the Supreme Court’s decision to not hear the appeal was important because it did not expand its interpretation of FDA pre-emption. However, the Supreme Court’s decision does not force any other federal courts to follow its decision and because of its refusal to hear Medtronic’s case, the motion can be reviewed by federal courts. Class action lawsuit attorneys are hoping that through time, all courts will adopt the standard that manufacturing companies are responsible for injuries caused by their products, and must be held accountable when if they fail to report adverse effects to the FDA.

Medtronic is also currently under legal fire for a bone graft device named Infuse. According to numerous Infuse bone graft lawsuits, Medtronic aggressively marketed the device for purposes not approved by the FDA.

Overview of Infuse Bone Graft Complications

Medtronic’s Infuse Bone Graft is typically used for certain spinal surgeries to stimulate bone growth and to replace damaged spinal disks. It was marketed and sold as an alternative method to harvesting bone particles that was used for these surgeries. While effective, it has been discovered that if the device is used for surgeries not approved by the FDA, it can cause severe permanent damage, cause the need of multiple revision surgeries, and require extended hospital stays. These complications include:

• Difficulty breathing, swallowing or speaking
• Compression of the airway
• Respiratory depression
• Nerve damage
• Death
• Swelling of the neck and throat
• Infection
• Bone injury
• Infertility
• Cyst formation
• Cancer

Medtronic Infuse class action lawsuits allege Medtronic has been marketing the Infuse bone graft  system to healthcare providers to be used for unapproved surgeries. While it is not illegal for doctors to used products and drugs for off-label purposes, it is illegal for companies to promote those uses. Medtronic is facing hundreds of Infuse lawsuits.