Shelhigh Medical Devices Seized

On April 17th, 2007, investigators from the U.S. Food and Drug Administration (FDA) conducted a seizure of medical devices from Shelhigh, Inc. The seizure was performed in conjunction with U.S. Marshals and was focused on all implantable medical devices manufactured by the New Jersey-based company.

The FDA was investigating Shelhigh manufacturing practices and uncovered a slew of deficiencies capable of compromising product efficacy. Shelhigh failed to take action in response to two separate FDA warning letters, prompting an enforcement action designed to prevent all potentially-compromised medical devices from entering the marketplace.

Shelhigh Manufacturing Violations

The seizure was conducted as a result of Shelhigh’s failure to respond to FDA warnings regarding significant manufacturing violations. Such a seizure is designed to protect consumers from potential injuries or deaths that could occur as a result of serious manufacturing violations. Amongst the violations listed by the FDA included:

  • Failure to adequately test product sterility.
  • Failure to adequately monitor environments for potential contamination.
  • Failure to provide scientific support for device expiration dates.
  • Failure to adequately screen for fever-causing contaminants.
  • Failure to maintain a sterilized manufacturing and processing environment.

Patients with a Shelhigh Implantable Medical Device

Patients who have been implanted with a Shelhigh implantable medical device are advised to consult with their physician regarding an appropriate response to the seizure. More often than not, replacement of the device will pose more of a threat than simply monitoring the patient to ensure that the device continues to function properly and without issue.

Physicians have been advised to consider an alternative option as opposed to using a Shelhigh device currently on market.

Defective Medical Device Lawsuits

If you or a loved one has been victimized by a defective medical device, you may be entitled to receive compensation for your pain and suffering. Medical device manufacturers are responsible for ensuring that their products are both safe and effective for use. Failure to take steps towards protecting consumers from potential defects is viewed as a negligent business practice and grounds for litigation.

The Pensacola personal injury attorneys of Aylstock, Witkin Kreis & Overholtz handle national litigation across the United States for victims injured by defective pharmaceuticals and medical devices. To get more information about your rights as a victim of a defective medical device and learn more about the seized Shelhigh products, contact the law offices of Aylstock, Witkin, Kreis and Overholtz at (844) 794-7402.