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

 

Legislation Will Protect Patients From Dangerous And Defective Devices

 

WASHINGTON (Friday, August 1, 2008) – The chairmen of two Senate panels Thursday night introduced legislation to reverse a U.S. Supreme Court decision handed down earlier this year which immunized medical device companies from state lawsuits brought by patients who are injured by faulty devices.  Senator Edward Kennedy (D-Mass.), who chairs the Senate Health, Education, Labor and Pensions Committee, and Senator Patrick Leahy (D-Vt.), who chairs the Senate Judiciary Committee, introduced the legislation Thursday.

 

In February, 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 suffering from faulty medical devices.  In June, the Judiciary Committee held a hearing to examine decisions by the Supreme Court have led to federal preemption of many state laws established to protect Americans, including laws to shield Americans from dangerous products, medical liability, and predatory lending practices.  Two witnesses, Bridget Robb and Maureen Kurtek, testified about how recent rulings by the Supreme Court have limited the rights of consumers to seek recovery for harmful practices by medical device companies and HMOs. 

 

The Kennedy-Leahy legislation, 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.

 

“I am pleased to join with Senator Kennedy to introduce this legislation to make explicit that the preemption clause in the Medical Device Amendments that the Supreme Court relied upon is not, and never was, intended to preempt all common law claims of consumers injured by a federally approved medical device,” said Leahy.  “I hope this legislation is passed quickly to send the strong signal that the Senate intends to hold the Court accountable to the American people who are being shut out of courtrooms across the country.”

 

The Judiciary Committee has held two hearings this year to examine the impact of Supreme Court decisions on Americans’ daily lives.  In addition to the June 11 hearing examining faulty medical devices, Leahy chaired a hearing on July 20 exploring the shield recent Supreme Court decisions have provided for corporate misconduct, favoring big business over consumers.

 

Companion legislation was introduced last month in the House of Representatives by Reps. Frank Pallone, Jr. (D-N.J.), chairman of the House Energy and Commerce Subcommittee on Health, and Henry Waxman (D-Calif.), chairman of the House Oversight and Government Reform Committee.

 

Statement Of Sen. Patrick Leahy (D-Vt.),
On The Medical Device Safety Act

Senate Floor

August 1, 2008

 

Mr. LEAHY. Mr. President, I am proud to join Senator Kennedy and other Senators in the introduction of this legislation. The bill that we introduced yesterday will correct a decision of the Supreme Court that misconstrued the intent of Congress and cut off access to our Nation's courts for citizens injured or killed by defective medical devices.

The Senate Judiciary Committee held a hearing on June 11 to examine the way in which the Supreme Court's decisions in the areas of retirement benefits and consumer product safety 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, or sided with a Federal agency's flawed interpretation of a congressional statute's preemptive froce to disadvantage consumers.

It is regrettable that an anonymous Republican Senator objected on procedural grounds to the committee completing that hearing. And it is disappointing that the same party that engages in so much partisan rhetoric complaining about activist judges refuses to hear about the judicial activism when it comes from the judges whose activism they embrace as sound judicial philosophy. The impact of the decisions that were the focus of that hearing are being felt by Americans today, whether they are prohibited from seeking redress in the courts for an injury caused by a defective product, or left without remedies to enforce rights granted by Congress relating to nondiscrimination, or retirement and health care benefits.

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

As I noted in the Judiciary Committee's recent hearing, many of the Court's decisions that have the most far reaching impact on Americans' wallets, retirement and health benefits, or access to justice, are the least publicized. But Americans should be deeply concerned when decisions of the Supreme Court override the policy judgments made by their elected representatives in Congress and negatively affect their day-to-day lives in significant ways. The extraordinary power to preempt State law and regulation lies with Congress alone. And as the Supreme Court has said on many occasions, the fundamental inquiry into whether a Federal statute preempts State law is the intent of Congress. I hope the introduction of this legislation sends the strong signal that some Senators intend to hold the Court to its own often-repeated pronouncements about this important principle.
 

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