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After repeatedly failing to heed U.S. Food and Drug Administration warnings regarding poor manufacturing practices, medical device maker Shelhigh, Inc. was subject to a seizure in April 2007. All of the company's implantable medical devices were seized including pediatric heart valves, annuloplasty rings, surgical patches, and other such products that are commonly used to promote blood flow and repair soft tissue in various surgeries in infants, children, and adults. Unfortunately, many of these devices were manufactured in poorly maintained and constructed facilities or were never adequately tested, which may have compromised the safety and efficacy of the products—especially their sterility. Pediatric patients or those with weak immune systems face the highest risk of developing potentially fatal infection or injury.
If you or someone you love has been implanted with one of Shelhigh's implantable medical devices and suffered injury as a result, it is important to understand your legal rights and options. You may be entitled to compensation for your damages including pain and suffering, medical bills, and more. Please contact us today to get in touch with an experienced Shelhigh implant lawyer who can evaluate your case FREE of charge and determine the best course of action.
The Seized Implantable Devices
The defective medical devices that were subject to the Shelhigh seizure include:
Your Legal Rights
The FDA issued several written warnings to the device maker prior to the Shelhigh seizure. However, the company continued to violate health and safety guidelines, putting many Americans at risk of suffering serious harm resulting from device defects. If you or a loved one has been harmed due to a Shelhigh implantable medical device , you have the legal right to hold the product maker liable for your losses. For more information about your rights and options, please contact us today to consult with a qualified product liability lawyer FREE of charge.
An injunction entered yesterday in the U.S. District Court forbids the Union, N.J. company Shelhigh from distributing the medical devices it manufactures until the company's fac...
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