[Congressional Record Volume 155, Number 39 (Thursday, March 5, 2009)]
[Senate]
[Pages S2846-S2848]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]

      By Mr. KENNEDY (for himself, Mr. Leahy, Mr. Durbin, Mr. Dodd, Mr. 
        Harkin, Mr. Bingaman, Mr. Reed, Mr. Sanders, Mr. Brown, Mr. 
        Casey, Mrs. Hagan, Mr. Merkley, Mr. Whitehouse, Mrs. McCaskill, 
        Mr. Johnson, Mr. Schumer, Mr. Udall of New Mexico, and Mrs. 
        Boxer):
  S. 540. A bill to amend the Federal Food, Drug, and Cosmetic Act with 
respect to liability under State and local requirements respecting 
devices; to the Committee on Health, Education, Labor, and Pensions.
  Mr. LEAHY. Mr. President, 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 continues 
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,

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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. 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.
  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's 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.
  Mr. HARKIN. Mr. President, I am proud to join my colleagues in 
reintroducing the Medical Device Safety Act. This legislation reverses 
the Supreme Court's erroneous decision in Riegel v. Medtronic. There, 
the Court misread a statute designed to protect consumers by giving the 
Food and Drug Administration, FDA, the authority to approve medical 
devices as preempting State tort claims when a medical device causes 
harm. Riegel prevents consumers from receiving fair compensation for 
injuries sustained, medical expenses incurred and lost wages, and it 
must be reversed.
  Congressional action should be unnecessary. When Congress passed the 
Medical Device Amendments, or MDA, in 1976, it did so ``[t]o provide 
for the safety and effectiveness of medical devices intended for human 
use.'' In other words, Congress passed the MDA precisely to protect 
consumers from dangerous medical devices. Towards that end, Congress 
gave the FDA the authority to approve, prior to a product entering the 
market, certain medical devices. For over 30 years the MDA has been in 
effect, and over that period FDA regulation and tort liability have 
complimented each other in protecting consumers.
  Given the MDA's purpose, and the fact it has operated successfully 
for 30 years, I was disheartened to find the Court twist the meaning of 
the statute to strip from consumers all remedies when a medical device 
fails. In contorted logic, the Court found that the FDA's requirements 
in approving a medical device preempted State laws designed to ensure 
that manufacturers marketed safe devices. In other words, the Court 
believes that a company's responsibility to its patients ends when it 
receives FDA approval. I strenuously disagree.
  In fact, there is absolutely no evidence that Congress intended that 
under the MDA consumers would lose their only avenue for receiving 
compensation for injuries caused by negligent or inadequately labeled 
devices. Not a single Member or committee report articulated the view 
that the statute would preempt State tort law.
  Nevertheless, because of the Court's decision, it is imperative that 
Congress act to ensure that those harmed by flawed medical devices can 
seek compensation. The bill introduced today addresses the Court's 
action by explicitly stating that actions for damages under State law 
are preserved. Specifically, it amends section 521 of the Federal Food, 
Drug, and Cosmetic Act to state that the section shall not be construed 
to modify or otherwise affect any action for damages or the liability 
of any person under the law of any State. And the bill applies 
retroactively to the date of the enactment of the MDA, consistent with 
Congress's intent when it passed that act over 30 years ago. 
Practically, that means that it applies to cases pending on the date of 
enactment of this legislation or claims for injuries sustained prior to 
enactment.
  The harm from Riegel, unless Congress acts, cannot be more real. In 
the year since Riegel was decided alone, courts across the country have 
dismissed product liability claims. Take Charles Riegel. During an 
angioplasty, a catheter burst and caused him serious injuries and 
disabilities, and a State jury found Medtronic negligent. Because of 
the Supreme Court's decision, however, Mr. Riegel's wife will receive 
no compensation for the defective design and inadequate warning. Take 
Gary Despain. A defective hearing aid caused severe damage to his right 
ear, and he became disabled and unemployed. Because of the Supreme 
Court's decision, Mr. Despain has no ability to see remedies for his 
injuries.
  Recently, a court dismissed the claims of almost 1,500 patients who 
brought suit arising from Medtronic's Sprint Fidelis defibrillator--
specific models of thin wires that connect an implantable cardiac-
defibrillator directly to the heart. In October 2007, the product was 
recalled after lead fractured in several cases and was thought to 
contribute to deaths and serious injuries. Again, because of the 
Court's ruling, injured plaintiffs have no recourse against the company 
that caused the harm.
  While FDA approval of medical devices, moreover, is important, it 
cannot be the sole protection for consumers. FDA approval is simply 
inadequate to replace the longstanding safety incentives and consumer 
protections State tort law provides.
  As a senior member of the Health, Education, Labor and Pension 
Committee, which has oversight over FDA, I have worked hard to ensure 
that the FDA performs its job. No matter how effective the FDA is, 
however, the FDA simply cannot guarantee that no defective, dangerous, 
and deadly medical device will reach consumers. As the former Director 
of the FDA's Center for Devices and Radiological Health acknowledged, 
the FDA's ``system of approving devices isn't perfect, and that 
unexpected problems [with approved devices] do arise.'' In 1993, a 
House report identified a ``number of cases in which the FDA [had] 
approved devices that proved unsafe in use.''
  The fact is, the FDA conducts the approval process with minimal 
resources and simply does not have adequate funds to genuinely ensure 
that devices are safe or to properly and effectively reevaluate 
approvals as new information is available.
  Further, the FDA approval process is based on partial information. A 
principal shortcoming is that the device's manufacturer compiles the 
studies and data supporting an application, and the data is often 
unreliable. And the FDA does not conduct independent investigations 
into a device's safety. A manufacturer, moreover, is not required to 
submit information about development of the device, including 
alternative designs, manufacturing methods, and labeling possibilities 
that the manufacturer considered but rejected.
  In 1993, an FDA committee found flaws in the design, conduct, and 
analysis of the clinical studies used to support applications that were 
``sufficiently serious to impede the agency's ability to make the 
necessary judgments about [device] safety and effectiveness.'' It 
added, ``[o]ne of the main reasons [problems arise after approval] is 
that the data upon which we base our safety and effectiveness decisions 
isn't perfect.'' Likewise, in 1996, the inspector general of the 
Department of Health and Human Services reported ``serious deficiencies 
. . . in the clinical data submitted as part of pre-market 
applications.''
  Moreover, there is very little FDA oversight once a device reaches 
doctors

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and patients. In fact, even the best designed and most reliable 
clinical studies by their very nature cannot duplicate all aspects and 
hazards of everyday use. Moreover, while manufacturers are supposed to 
report defects and injuries, the FDA has admitted that there is 
``severe underreporting'' of defects and injuries.
  Given the FDA's limitations, it is crucial that an individual have a 
right to seek redress. When defective medical devices reach the market, 
whether or not approved by the FDA, patients are often injured. Those 
injured are often left temporarily unable to work or to enjoy normal 
lives, and in many cases never fully recover. State tort law provides 
the only relief for patients injured by defective medical devices and 
should not be foreclosed.
  Not only does access to State court mean that a person injured can 
receive fair compensation, but there are other advantages. Such suits 
aid in exposing dangers and serve as a catalyst to address their 
consequences. Through discovery, litigation can help uncover previously 
unavailable information on adverse effects of products that might not 
have been caught during the regulatory system. Litigants can demand 
documents and information on product risks that might not have been 
shared with the FDA. In this way, the public as a whole is alerted to 
dangers in medical products.
  Finally, providing the ability to sue when injured provides an 
important incentive to manufacturers to use the utmost care. 
Additionally, threat of product liability suits creates continuing 
incentives for product manufacturers to improve the safety of their 
device, even after FDA approval.
  As the Supreme Court recognized this week, in Wyeth v. Levine, in 
holding that failure to warn claims involving FDA approved drugs are 
not preempted, ``[s]tate tort suits uncover unknown drug hazards and 
provide incentives for drug manufacturers to disclose safety risks 
promptly. They also serve a distinct compensatory function that may 
motivate injured persons to come forward with information.'' The Court 
continued, ``the FDA has long maintained that state law offers an 
additional, and important, layer of consumer protection that 
complements FDA regulation.''
  The same consumer protection that State courts provide which the 
Court recognized as important in the context of faulty drug warnings is 
equally important for those consumers harmed by faulty medical devices.
  In conclusion, sadly the Court fundamentally misread Congress's 
intent in passing the Medical Device Amendments in 1976, and Reigel 
appears to represent yet another victory by big business over 
consumers. That is not, however, the final say on the matter. To quote 
Chief Justice Roberts, ``every area involving an interpretation of a 
statute, the final say is not with the Supreme Court, the final say is 
with Congress. And if they don't like the Supreme Court's 
interpretation of it, they can change it.''
  Make no mistake, moreover, it can be done. Last year, Congress passed 
and the President signed the ADA Amendments Act, reversing decisions in 
which the Court consistently misconstrued the will of Congress and held 
that the ADA does not protect many people with serious disabilities 
from discrimination. This year, we were successful in reversing the 
Court's draconian Lilly Ledbetter decision, making clear that those 
discriminated against do have a recourse in law.
  Those injured by faulty medical devices deserve to have their day in 
court and are entitled to compensation when they are injured by faulty 
medical devices, have medical expenses to pay and lost wages, 
regardless of whether the FDA approved a device. We must reverse this 
erroneous decision and ensure that those who have suffered serious 
injury at the hands of others receive justice.
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