[Congressional Record Volume 154, Number 129 (Thursday, July 31, 2008)]
[Senate]
[Pages S7953-S7954]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]

      By Mr. REID (for Mr. Kennedy (for himself, Mr. Leahy, Mr. Dodd, 
        Mr. Harkin, Ms. Mikulski, Mr. Bingaman, Mrs. Murray, Mr. Reed, 
        Mrs. Clinton, Mr. Obama, Mr. Sanders, Mr. Brown, and Mr. 
        Whitehouse)):
  S. 3398. 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. HARKIN. Mr. President, I am proud to join my colleagues in 
introducing 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 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. Toward 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 
complemented 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

[[Page S7954]]

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. Take 
Riegel itself. In 1996, Charles Riegel had an angioplasty performed on 
his right coronary artery. During the procedure, Mr. Reigel's surgeon 
used Medtronic's Evergreen Balloon Catheter. The catheter burst inside 
Mr. Reigel's artery, causing him severe and permanent injuries and 
disabilities.
  Under our system of law, when someone is injured, he or she can 
normally seek redress from the entity that caused him or her harm. Yet, 
because of the Court's decision, Mr. Riegel and his wife will receive 
no compensation for the defective design and inadequate warning.
  It is not just Mr. Riegel. In 2002, Gary Despain was implanted with a 
defective hearing aid Soundtec manufactured. While working as a welder, 
he suffered damage to his right ear, apparently as a result of 
interference between a magnet in his hearing device and some electronic 
welding equipment being used in the plant. The device caused severe 
ringing in his ear, but the labeling for the device failed to warn of 
this potential risk. Mr. Despain had to have the device surgically 
removed and he remains unemployed and disabled as a result of the 
device.
  Nevertheless, two weeks after the Court's Riegel decision, Mr. 
Despain's lawsuit against Soundtec was dismissed and Mr. Despain has no 
ability to seek remedies for his injuries.
  The result of Riegel, therefore, is that in the event the FDA does an 
inadequate job of inspecting and assuring the safety of medical 
devices--and because tort actions are now precluded--then consumers are 
left at extreme risk.
  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 long-standing safety incentives and consumer 
protections that 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 becomes 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.''
  FDA review, moreover, is a one-time event with no reevaluation and 
very little FDA oversight once a device reaches doctors 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.
  The Court fundamentally misread Congress's intent in passing the 
Medical Device Amendments in 1976, and Reigel represents yet another 
victory by big business over consumers. Those injured, however, 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 FDA approved a device or not. 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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