SOUND Devices Act Closes Product Liability Loophole

Scranton, PA, February 23, 2012 – Pennsylvania product liability lawyer Caroline Munley today called for passage of a bill that would enable the U.S. Food and Drug Administration to reject medical devices that are modeled after devices already known to be flawed.

“The SOUND Devices Act closes a loophole that allows medical device manufacturers to basically skirt the FDA approval process,” said Munley, a partner in the regional law firm of Munley, Munley & Cartwright, whose Pennsylvania product liability attorneys represent consumers and patients who are harmed by defective products, including flawed medical devices.

“A process that avoids scrutiny is wrong and should be unnecessary,” Munley said. “Every new medical device submitted for approval for the American marketplace should be able to stand on its own merits.”

The Safety Of Untested and New Devices Act of 2012 (SOUND Devices Act) eliminates a loophole in the Food and Drug Administration's device-approval process known as section 510(k), which says new medical devices do not need to undergo clinical testing in humans before being sold if they are similar to a product already on the market, known as a “predicate.”

The FDA does not have clear authority to reject a 510(k) device application even when the company compares their product to one known to have fundamental design flaws, according to the office of Rep. Edward J. Markey (D-Mass.), a co-sponsor of the bill.

The SOUND Devices Act allows the FDA to reject medical devices if their design is based on a predicate that has been subjected to recall for major safety problems. It calls for the FDA to review the safety of high-risk devices if a product in their “predicate lineage” is recalled.

Reps. Markey, Henry A. Waxman (D-Calif.), Jan Schakowsky (D-Ill.), and Rosa DeLauro (D-Conn.), introduced the SOUND Devices Act, H.R. 3847, earlier this month.

“Adoption of the SOUND Devices Act is a matter of common sense,” Munley said. “Like other loophole-closing legislation, it eliminates a quirk in the law that is unintentional and detrimental. We hope to see this bill move forward. It could save lives.”

The Pennsylvania personal injury lawyers of Munley, Munley & Cartwright have recovered compensation for victims of flawed medical products across Pennsylvania, New York and the Northeast through personal injury and wrongful death lawsuits.

“We will continue to protect the rights of Pennsylvanians and others harmed by defective medical devices,” Munley said. “People in need of medical care and medical products must be able to trust that they are safe and effective, and every act of Congress, every law and regulation, should be geared toward ensuring that that trust is valid.”

About Munley, Munley & Cartwright, P.C.

Munley, Munley & Cartwright, P.C., is a Pennsylvania accident and injury law firm that represents car accident victims and their families throughout the state of Pennsylvania and the Northeast, including those injured in accidents that involve speeding, distracted driving, drunk driving, fatigued driving, aggressive driving and careless driving in hazardous weather conditions. The Pennsylvania personal injury law firm's additional practice areas include trucking accidents, motorcycle accidents, medical malpractice, defective products, toxic chemicals, workplace injuries, nursing home litigation and other serious accidents.

Munley, Munley & Cartwright, P.C., has offices throughout Pennsylvania, including Scranton, Stroudsburg, Carbondale, Plains, Hazleton and Hamlin. To contact the law firm, call (800) 318-LAW1 or visit the firm's online contact form.