[Congressional Record (Bound Edition), Volume 154 (2008), Part 13]
[Senate]
[Page 17821]
[From the U.S. Government Publishing Office, www.gpo.gov]




                       MEDICAL DEVICE SAFETY ACT

  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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