Synthes, the manufacturer of Synex II vertebral body replacement devices, distributed this product in the United States from May, 2007 to September, 2009. Numerous patients underwent spinal surgery with Synex vertebral replacements in the hopes of regaining health and eliminating back pain. However, in November 2009 the FDA issued a Class I recall of the Synex II vertebral body replacement device due to serious health risks. The vertebral implant had decreased in height or collapsed inside the spines of six patients, causing pain, neural damage and spinal instability. Several patients had to undergo additional surgery to remove the defective device and repair spinal damage.

Because the law requires medical device companies to provide consumers with reasonably safe products, Synthes might be liable for the pain and suffering it caused to unsuspecting patients. If victims can prove that the company acted negligently, Synthes could be compelled to provide just compensation for their medical expenses, physical and psychological suffering, lost wages, diminished future income and diminution in lifestyle.

Synthes Recall: Liability

Several reports indicate that Synthes knew about the potential side effects of Synex II vertebral body replacement devices several months before the FDA recall. In September, Synthes sent a letter to its sales representatives and many hospitals, cautioning them against marketing and using the Synex II vertebral replacements. Synthes explained the potential side effects and asked hospitals to return any unused Synex II vertebral body replacement devices.

Sadly, Synex FDA recall is not the first withdrawal of Synthes products. Several Synthes lawsuits were filed and recalls initiated after the FDA learned about illegal clinical trials of another Synthes product, Norian bone cement. The company had disregarded very specific FDA warnings and performed Norian bone cement testing on 200 patients, three of whom died on the operating table. In 2009, Synthes was indicted in a Pennsylvania federal district court after years of federal investigations.

Consulting a Skilled Synthes Lawyer

If you have received a Synex vertebral body replacement and continue to experience pain, the problem might be the defective device. You should consult with a physician as soon as possible to begin any necessary treatments. You should also contact an experienced Synex attorney in order to discuss your legal rights. Additional medical treatments might place a great financial and psychological burden on you, and a dedicated lawyer might help you hold those responsible for your suffering liable.

During the initial meeting with your Synex lawyer, he or she will carefully evaluate your situation, explain your rights and describe your legal options. The attorney will help you select the most appropriate course of action, such as filing a Synex lawsuit. By initiating prompt legal action and aggressively representing your rights, Synthes lawyers might be able to obtain sizeable compensation for you financial, physical and psychological injuries.

Synex Attorneys at Viles & Beckman

Viles & Beckman, LLC is home to several highly experienced personal injury lawyers who have helped many individuals secure multi-million dollar settlements and jury verdicts. Please contact their offices today at 1-800-64-VILES to discuss how the Synthes FDA recall affects your legal rights and to initiate prompt legal action.

 

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