Washington, D.C. - AdvaMed President and CEO, Steve Ubl, today issued the following statement regarding the U.S. Supreme Court's decision regarding Wyeth v. Levine:

"Today's decision does not impact medical devices approved under the Food and Drug Administration's (FDA) Pre-market Approval Process (PMA).

"In 1976, Congress, recognized that complex medical devices warranted federal regulatory oversight that differed from federal regulation of pharmaceuticals. It enacted the Medical Device Amendments to provide a uniform framework for the regulation of the medical device industry. Today's decision acknowledges this important distinction.
"The MDA does not provide device manufacturers with blanket immunity from tort claims. Patients may sue if a manufacturer fails to follow the FDA's requirements for manufacturing, labeling and selling of PMA-approved devices.

"In a 2008 decision, (Riegel v Medtronic) the Supreme Court held by an 8-1 majority that that the MDA provides limited preemption of lawsuits brought against PMA products. The Court's decision builds on well-established jurisprudence. Six of the seven Federal Circuit Courts of Appeal to consider the issue upheld limited preemption for PMA-approved products.

"For more than 30 years, the MDA has struck the appropriate balance between promoting patient safety, and furnishing doctors and patients with access to cutting-edge medical technologies that help patients live longer, healthier lives."

AdvaMed member companies produce the medical devices, diagnostic products and health information systems that are transforming health care through earlier disease detection, less invasive procedures and more effective treatments. Our members produce nearly 90 percent of the health care technology purchased annually in the United States and more than 50 percent purchased annually around the world. AdvaMed members range from the largest to the smallest medical technology innovators and companies. For more information, visit www.advamed.org.

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