The Device and Drug Double Standard is Coming to an End

By: Justin Will, Esq. CIS Compliance Manager
justinwill@cis-partners.com

As the push toward transparency in the healthcare industry is making the world of devices and drugs more and more similar, there still remains a glaring difference that was created by the U.S. Supreme Court several months ago. The discrepancy was put in motion in February of 2008 in Riegel v. Medtronic[1] when the Supreme Court ruled in favor of Medtronic that federal law prohibits suits in state courts for product liability against makers of heart stents, artificial joints and other critical medical devices. Then, in March 2009, in a product liability suit (Wyeth v. Levine[2]) involving a drug maker the court ruled that this type of case is not prohibited. In other words – an injured consumer can sue a drug maker but not a device manufacturer.

On March 5, 2009 - a day after the Wyeth ruling, U.S. Reps. Frank Pallone, Jr. (D-NJ), Chairman of the Energy and Commerce Subcommittee on Health, and Henry A. Waxman (D-CA), Chairman of the Energy and Commerce Committee, introduced legislation in the House that will reverse the U.S. Supreme Court decision in Medtronic that denies injured patients the ability to seek compensation for their injuries and gives medical device makers blanket immunity.[3]

Representative Waxman’s press release states, “The Medical Device Safety Act of 2009 is designed to protect patients from dangerous and defective devices by correcting the Court's flawed interpretation of the MDA. The legislation explicitly clarifies that state product liability lawsuits are preserved.”

Sources:
[1] Riegel v. Medtronic, Inc. 128 S.Ct. 999 (2008)
[2] Wyeth v. Levine 129 S.Ct. 1187 (2009)
[3] Press Release, Rep. Henry Waxman, “Health Leaders Introduce Legislation Reversing Supreme Court’s Medical Device Decision” (March 5, 2009).
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