03.06.09

Leahy Joins Kennedy, Others To Introduce Bill To Reverse Supreme Court Medical Device Decision

WASHINGTON (Friday, March 6, 2009) – On Thursday, Senate Judiciary Committee Chairman Patrick Leahy (D-Vt.) has joined Senator Edward Kennedy (D-Mass.) to reintroduce legislation to reverse last year’s decision by the U.S. Supreme Court that immunized medical device companies from state lawsuits brought by patients who are injured by faulty devices.  The Medical Device Safety Act has 18 sponsors in the Senate.

Last year, the U.S. Supreme Court, for the first time, ruled that medical device companies could not be sued by patients who are injured by certain medical devices in state courts.  The Court’s decision, based on a flawed interpretation of a clause included in the Medical Device Amendments of 1976 (MDA), closed the courtroom doors on thousands of Americans who have suffered injuries from faulty medical devices.  In June 2008, Leahy chaired a Judiciary Committee hearing to examine decisions by the Supreme Court that have led to federal preemption of many state laws established to protect Americans, including laws to shield Americans from dangerous products, and predatory lending practices. 

“This legislation will make explicit that the preemption clause in the medical device amendments upon which the Court relied does not, and never was intended to preempt the common law claims of consumers injured by a federally approved medical device,” said Leahy.  “The extraordinary power to preempt State law and regulation lies with Congress alone. Where the Court reaches to the extent it did in the Riegel decision to find Federal preemption contrary to what Congress intended, Congress is compelled to act, just as it was in the case of Lilly Ledbetter.”  

The introduction of the bill came just one day after the U.S. Supreme Court ruled in Wyeth v. Diana Levine, a case in which a jury in Vermont awarded damages to Levine, a musician from Marshfield, Vermont, who sustained life-altering injuries due to a drug manufactured by the pharmaceutical company Wyeth.  Wyeth sought to overturn the Vermont Supreme Court’s decision, which affirmed a jury verdict in Levine’s favor.  On Wednesday, the Supreme Court announced a 6-3 decision which reaffirmed the ruling, upholding a jury award of $6.7 million to Levine.  Leahy filed an amicus brief with the Supreme Court in connection with the case.

Following the opinion, Leahy said, “This decision to uphold the Vermont Supreme Court’s ruling in Wyeth v. Levine has far-reaching effects on the ability of countless Americans to seek justice in their courts.  The Court’s decision soundly rejects the anti-consumer position of the Bush administration, and reaffirms Congress’ primacy concerning the extraordinary power to preempt state law.  Most of all, the decision reclaims for all American citizens the ability to seek justice in their courts of law.” 

The Medical Device Safety Act, would provide protections for patients from dangerous and defective medical devices.  The bill clarifies that state product liability lawsuits are preserved.  The legislation is also retroactive to the date of enactment of the MDA.

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Statement Of Senator Patrick Leahy (D-Vt.),
On The Introduction Of The Medical Device Safety Act
March 5, 2009

I am pleased to join Senator Kennedy once again in the introduction of this important legislation. The bill that we introduce today will correct the Supreme Court’s decision in Riegel v. Medtronic, which misconstrued the intent of Congress and cut off access to our Nation's courts for citizens injured or killed by defective medical devices.

Last year, the Senate Judiciary Committee held a series of hearings to examine the way in which the Supreme Court's decisions in the areas of retirement benefits, consumer product safety, workplace discrimination, and personal finance have consistently trended against the rights of consumers and in favor of big business. In many cases that have profound effects on the lives of ordinary Americans, the Court has either ignored the intent of Congress, deferred to corporate interests, or sided with a Federal agency's flawed interpretation of a congressional statute's preemptive force to disadvantage consumers. The impact of the decisions that were the focus of those hearings continue to be felt by Americans today, whether they are prohibited from seeking redress in the courts for an injury caused by a defective product, paying exorbitant credit card interest rates and fees with no relief from the laws of their own state, or subjected to the unscrupulous practices of some in the mortgage lending industry. 

These hearings raised awareness in Congress, and among Americans, about the impact the Supreme Court has on our everyday lives.  And I am especially proud that following on these hearings, and through the efforts of a determined and principled congressional majority, we witnessed our constitutional democracy at work when President Obama signed the Lilly Ledbetter Fair Pay Act.  And I am heartened that Congress reclaimed the intent of its original legislation and overrode the Supreme Court to restore the rights of Americans to be free from discrimination in the workplace. 

And just yesterday in the case of Wyeth v. Levine the Supreme Court foreclosed the need for Congress to act in another important area when it validated the views of many by rejecting the Bush administration and the Food and Drug Administration’s extravagant views of a regulatory agency’s ability to pre-empt state law.  I am glad the Court spoke clearly and decisively on this issue.  The Court’s decision was not only a vindication of Congress’s primary authority to pre-empt state law, but a victory for every American who relies upon pharmaceutical drugs and entrusts the manufacturers of those drugs with insuring their safety.  The Court’s decision also vindicated the laws and courts of the State of Vermont, and I am proud to have expressed my views to the Court as to Congress’s intent in this area and on behalf of Diana Levine. 

The bill we introduce today is another important step to correct an erroneous reading by the Court of Congress' intent in enacting the medical device amendments of 1976.   This legislation will make explicit that the preemption clause in the medical device amendments upon which the Court relied does not, and never was intended to preempt the common law claims of consumers injured by a federally approved medical device.

The extraordinary power to preempt State law and regulation lies with Congress alone. Where the Court reaches to the extent it did in the Riegel decision to find Federal preemption contrary to what Congress intended, Congress is compelled to act, just as it was in the case of Lilly Ledbetter.   I hope all Senators will join us in this effort.

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