Medtronic bone graft lawsuits have centered on Medtronic’s INFUSE Bone Graft. Bone grafting involves replacing fractured or broken bones with either new bone or a bone substitute. Medtronic introduced INFUSE in 2002 for specific types of spinal procedures. It was a revolutionary product because it included a synthetic protein that was designed to promote bone growth. This was a great alternative to grafting bone from the hip. INFUSE filled spaces where the bone was needed.
Promoting Off-Label Use
The Federal Drug Administration (FDA) also approved INFUSE for tibia repairs and in dental procedures. However, Medtronic was also encouraging doctors and patients to use INFUSE in procedures where it has not been approved. In fact, some estimates states that off-label use provided increased sales of roughly $3 billion.
INFUSE Side Effects
Patients have also suffered an array of dangerous side effects, and they accused Medtronic of concealing these side effects from doctors and the FDA. Potential side effects include:
- Bone and nerve injuries
- Urinary problems
- Sterility (particularly in males)
- Increased cancer risk
- Airways swelling
- Respiratory depression
- Excessive bone growth (particularly in children)
- Cyst Formation
Generally, the side effects will appear between 2 and 14 days after the surgery occurs, but this is not always the case.
Medtronic Bone Graft Lawsuits Ensue
Once patients and doctors realized that INFUSE was causing so many problems, patients turned to the legal system for help. Both patients and doctors questioned Medtronic’s business practices and their failure to inform them of very serious side effects. They accused Medtronic of hiding reports of adverse side effects from the FDA and the medical community as a whole.
Medtronic Bone Graft lawsuits have several of the same allegations in common. These include:
- Manufacturing and selling a defective product
- Failure to warn of adverse side effects
- Negligent product design and manufacturing
- Fraud claims
- Medical malpractice and medical negligence
- Breach of express and implied warranty
Medtronic has seemed relatively eager to settle these types of claims. In 2014, Medtronic settled 950 lawsuits for $22 million. They have also set aside an additional roughly $130 million to settle thousands of additional claims.
Medtronic has also had to face lawsuits from its own shareholders. Shareholders have sued in regard to Medtronic’s fraudulent actions and the drop in its stock prices following several investigations.
Medtronic Investigation: Department of Justice (DOJ), FDA, and U.S. Senate
The DOJ, FDA, and the Senate have all insisted that Medtronic and Medtronic’s marketing practices of INFUSE be investigated. As a result of the investigation, Medtronic admitted to paying authors of INFUSE safety studies over $200 million in “consulting fees.” This huge conflict of interest has also been addressed in many Medtronic bone graft lawsuits.
Your Legal Remedies
If you or a loved one has been affected by a Medtronic bone graft product, then you should speak with an experienced medical devices attorney. At The Dixon Injury Firm, our attorneys offer a free case evaluation to determine if you are a candidate for a Medtronic bone graft lawsuit. Call 855-552-2337 today.
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