Shelhigh Inc. Medical Device Seizure
On April 17th, 2007, investigators from the U.S. Food and Drug Administration (FDA) seized medical devices from Shelhigh, Inc. The seizure, performed in conjunction with U.S. Marshals, was focused on implantable medical devices manufactured by the New Jersey-based company.
The FDA was monitoring Shelhigh after investigations into manufacturing practices 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 Inc. Manufacturing Violations
The basis of the seizure was Shelhigh’s inaction in responding to FDA warnings regarding significant manufacturing violations. Failure to respond to these FDA warnings resulted in a seizure designed to protect consumers from potential injuries or deaths that could occur as a result of the manufacturing violations. Amongst the violations listed by the FDA included:
- Failure to adequately test product sterility.
- Failure to adequately screen for fever-causing contaminants.
- Failure to provide scientific support for device expiration dates.
- Failure to maintain a sterilized manufacturing and processing environment.
- Failure to adequately monitor environments for potential contamination.
Shelhigh Medical Device Patients
Physicians have been advised to consider an alternative option as opposed to using a Shelhigh device currently on market.
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.
Defective Medical Device Lawsuit
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 lawyers and staff representing Justice Lawyers boast some of the most experienced personal injury attorneys Pensacola, Florida has to offer. 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 Justic Lawyers at 877-810-4808.
The attorneys of the Law Office of Justice Lawyers are personal injury lawyers in Pensacola who protect victims of auto accidents, personal injury, wrongful death, defective drugs, consumer fraud, insurance fraud, product defects and defective medical devices, such as Guidant and Medtronic Pacemakers, and potentially harmful drugs, such as Ortho Evra. When you think of the top personal injury lawyers or car accident lawyers in Pensacola, think of Justice Lawyers.