The Rottenstein Law Group is fully supportive of the efforts of Congressman Edward J. Markey to achieve “closure of dangerous medical device loophole.”
Congressman Edward J. Markey (D-Mass.) late last month released a comprehensive new report titled “Defective Devices, Destroyed Lives: Loophole Leaves Patients Unprotected from Flawed Medical Devices.” Rep. Markey’s report highlights the federal loophole that requires the Food and Drug Administration (FDA) to clear medical devices that demonstrate their similarity to an earlier model, even if that previous model was recalled for a major safety defect. This loophole in the 510(k) device approval process—named after its section in the law—has enabled a number of defective products to enter the market and cause serious harm, and in some cases even death.
According to a March 22 release from his office, “The 510(k) process should really be called ‘510 pray’ since patients should hope and pray that the medical device implanted in them won’t cause serious harm,” said Rep. Markey, a senior member of the Energy and Commerce Committee, which has jurisdiction over the FDA. “The SOUND Devices Act closes a major loophole in the current 510(k) device approval process. I will fight to include this bill in the FDA legislation that Congress will consider this summer as part of the Medical Device User Fee Act to ensure that medical devices are not repeating known defects.”
The 510(k) process should really be called ‘510 pray’
In February Reps. Markey, Henry A. Waxman (D-Calif.), Jan Schakowsky (D-Ill.), and Rosa DeLauro (D-Conn.) introduced H.R. 3847, the Safety Of Untested and New Devices Act of 2012 (SOUND Devices Act). This bill would close a major loophole in the device approval process known as the 510(k) by ensuring that a new device is not cleared by the FDA if it is based on an earlier product that was pulled from the market for causing serious harm to patients. The SOUND Devices Act provides FDA the ability to reject a device application based on a predicate that has been recalled or is in the process of being removed from the market for major safety problems.
Rochelle Rottenstein, principal of the Rottenstein Law Group, says, “This is just the sort of corrective legislative action we need now. The public will benefit immeasurably if Congress addresses this problem, and the sooner the better.”
The Rottenstein Law Group meanwhile implores anyone with a friend or relative who has received a dangerous medical device to reach out to that person and recommend that he or she consult a physician immediately and then speak to a qualified personal injury lawyer.