Approval of drugs and procedures protects patients’ lives

There are countless medical breakthroughs and medications to be thankful for. They save lives every day and protect us from illness. But in order for drugs and treatments to be used among patients, it’s crucial and legally required that they are approved by government safety officials such as the Food and Drug Administration.

Without FDA approval, not even the best, licensed doctors should feel they have the right to administer a drug or treatment to a patient. Jumping the gun by using an unapproved treatment endangers patients and puts their lives at risk. At least two patients at the center of wrongful death lawsuits lost their lives, possibly due to the unapproved medical treatment they underwent by their doctors.

Both patients, 83, died on the operating table after their blood pressures dropped during surgical procedures on their spines. Doctors put something called bone cement into the victims’ spines, which is a process that the FDA has not approved.

The company that produces the bone cement is accused of promoting the bone cement and training doctors in its use despite the fact that it is not approved. The families of the victims are suing the company for allegations including elder abuse and wrongful death. The company paid fines and penalties of about $24 million to settle criminal charges related to a previous bone cement-related incident. The surgeons who were working on the two patients when they died were not named in the lawsuit; rather, it’s the company that is the target. For the current lawsuit, the attorney representing the two deceased patients did not specify how much in damages the families were requesting, but did say that the families are “furious and deeply hurt” because they recently discovered the true cause of their loved ones’ deaths. So far, a trial date has not been set.


The Inquirer: “Synthes sued over deaths in connection with bone cement,” David Sell, Mar. 2, 2012

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