Experimental Surgery Performed Without Disclosure

The Medtronic Infuse Bone Graft was approved in 2002 and is used to stimulate bone growth in the lumbar. It was approved for this limited use only and not for use in other areas like the cervical or thoracic spine.

A recent lawsuit including almost 100 plaintiffs has been filed against a doctor and the Medtronic company, claiming that the device has been harmful to their health. The suit alleges that the surgeries patients underwent to have Medtronic Infuse Bone Grafts (BMP-2) implanted were unnecessary, experimental, and that these medically unnecessary surgeries put them at risk of medical complications for no reason. Patients claim that false marketing was used to make additional used for the device seem credible.

One doctor is facing serious allegations in a medical malpractice lawsuit including more than 88 patients concerning Medtronic Infuse bone graft devices. The lawsuit makes several allegations against this and other doctors, in addition to the Medtronic company. First, the lawsuit alleges that 88 patients were given unnecessary medical procedures using the Medtronic medical devices. Second, that the doctor in question is a paid consultant for the Medtronic company. And that the Infuse bone graft device was implanted inside the patients for off label uses that the patients never specifically consented to. Lastly, the suit alleges that the doctor falsified records of the surgeries so that he would be paid.

In the lawsuit the plaintiffs make allegations against Medtronic as well, claiming they were harmed by the device. Also, that Medtronic marketed the device falsely and claimed it was approved for use in cervical and thoracic spines when it was not actually approved for these particular uses. According to the lawsuit, very serious side effects are associated with the bone graft device. The side effects include cancer, spinal stenosis, pain, and problems breathing. Within 2 weeks of surgery many reported complications arising out of the surgery.

There have been similar instances where similar practices were used and false information about the device was disseminated. In 2009, The Wall Street Journal reported that doctor another doctor forged signatures of co-authors on a study that he performed regarding the Medtronic Infuse device. According to the Journal, the doctor used the data based on this false information in his study that was published in 2008 in the Journal of Bones and Joint surgery. Once the misinformation was uncovered, the article is retracted in 2009. The Wall Street Journal also notes that this doctor is also a consultant for Medtronic. However, Medtronic claims that does they was not a consultant at the time the study was conducted.

Medical device manufacturers have a legal responsibility to make sure that the devices they make are safe and tested, and they are also responsible for marketing their products in a truthful manner, fully disclosing risks. And doctors must be up front with patients as well regarding the risks of a surgery, potential side effects, and whether or not a surgery is experimental. In this situation the device was never approved for the uses the doctor was intending and patients deserved to be aware of this.

St. Louis Medical Malpractice Lawyers

As a patient, when you experience medical malpractice or medical negligence by a physician or surgeon, you can file a medical malpractice lawsuit against the negligent doctor. Medical malpractice is defined as professional negligence either by an act or by omission, wherein a medical provider fails to meet the accepted standard of care.

The results of medical negligence can be catastrophic. It is important to have a successful medical malpractice lawyer on your side. If you have been a victim of medical malpractice, contact the Zevan and Davidson Law Firm as soon as possible. Our experienced medical malpractice attorneys the proven ability to handle even the most complex medical malpractice cases.

Call us at (314) 588-7200 and schedule your free and private consultation.

photo credit: phalinn