Whenever a loved one undergoes surgery, Connecticut families may certainly have some hesitations about the dangers of the procedure, but many families also trust doctors' suggestions and decide that certain risks must be taken in order to help a loved one to become a healthier person.
However, Fairfield families and other families throughout the entire U.S. may forget to question the motives of pharmaceutical companies and medical device makers when these companies encourage doctors to perform certain procedures with their products or to prescribe certain drugs to patients. Families may not realize that a company could be encouraging doctors to use a product for other purposes that have not been approved by regulators. Or perhaps a company has an inkling that its new drug could cause serious injury or death to patients, but instead of pulling the drug off of shelves to study it further, the company may continue to sell the dangerous drug.
Recently, the U.S. Food and Drug Administration sent a warning letter to Synthes Inc. informing the medical device company that it must promptly address and fix its violations of safety regulations otherwise the agency will take regulatory action against the company, according to Reuters. The warning was issued after it was discovered that the company failed to properly address consumer complaints about its medical devices and other products. Since the warning letter was issued, a lawsuit has been filed against the medical device maker claiming that the company encouraged doctors to perform unsafe surgeries.
The lawsuit was filed earlier this month after two patients died during the same type of spine surgery. According to the wrongful death lawsuit, Synthes encouraged doctors to use its bone cement product while performing certain spinal procedures on patients. Although the company's bone cement product is approved by the FDA for use in other procedures, it has not been approved for spinal surgeries.
An attorney representing the two families who lost their loved ones during the unsafe procedures stated, "The victims' families are furious and deeply hurt over their recent discovery of the true cause of their loved ones' deaths." He continued, "I have never seen such despicable conduct by a corporation so desperate to make profits and maintain a competitive edge at the expense of human lives."
According to reports, Johnson & Johnson has plans to purchase the medical device company for more than $20 billion.
Source: The Philadelphia Inquirer, "Synthes sued over deaths in connection with bone cement," David Sell, March 2, 2012