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ManuFACTS: Federal Regulation of Medical Devices

Legislation Would Discourage Innovation, Drive Up Medical Costs

• H.R. 1346, the Medical Device Safety Act of 2009, was introduced on
March 5, 2009 by Representative Frank Pallone (D-NJ), chairman of the
House Energy and Commerce Subcommittee on Health. Similar legislation,
S. 540, was introduced by the late Senator Edward Kennedy (D-MA).

• H.R. 1346/S. 540 would overturn the Supreme Court’s 2008 Riegel v.
Medtronic, Inc. decision, which confirmed that medical devices pre-approved by
the Food and Drug Administration (FDA) could not be the subject of state
product liability suits or held subject to different state restrictions.

• The FDA spends an average of 1,200 hours reviewing each application and,
under federal law, can grant pre-market approval of a medical device only if it
finds a “reasonable assurance” of the device’s “safety and effectiveness.” The
FDA must also consider “any probable benefit to health from the use of the
device against any probable risk of injury or illness from such use.”

• Industry remains concerned that passage of H.R. 1346/S. 540 would:

— subject companies to a hodgepodge of up to 50 different regulatory
regimes governing development and use of medical devices;
— allow potentially endless litigation at the state level against manufacturers
whose products have been deemed “safe and effective” by the FDA; and
— discourage innovation in the development of breakthrough medical devices,
undermining the effectiveness of medical care and driving medical costs
even higher.

How Congress Can Help

• Oppose H.R. 1346/S. 540, the Medical Device Safety Act of 2009.

If adopted, the legislation would ultimately:

• restrict patient access to essential medical technologies;
• produce a chilling effect on medical innovation;
• encourage more lawsuits at the state level; and
• increase health care costs for all Americans.

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More Information Act pre-empt any state "requirement" that "relates to the safety
or effectiveness" of a medical device and "is different from, or
in addition to, any requirement applicable under" the MDA.
Current Law
A medical device manufacturer may seek pre-market approval (PMA) In Riegel, the plaintiff alleged that a balloon catheter that had
malfunctioned was designed, labeled and manufactured in a
by the FDA, which studies the device’s design, method of manu-
manner that violated New York common law. The defendant argued
facture and proposed label. Upon receiving PMA, the device is
that the FDA's pre-market approval established federal require-
no longer subject to the varying regulations of individual states
ments that pre-empted state tort liability, because such liability
including private tort lawsuits that challenge the design, manufac-
would be a state requirement different from or in addition to the
ture, or labeling of the device that would have the effect of con-
federal requirements. In its February 2008 decision, the High
flicting with federal regulation, except when a product is assembled
Court ruled, in an 8-1 decision, that FDA pre-market approval
improperly or a company withholds information/misleads the
does establish a requirement under federal law and pre-empts
government about the safety or effectiveness of the device.
the suit under state law.
To retain pre-market approval, the devices are subject to extensive
As the Court noted, "State tort law that requires a manufacturer's
reporting requirements. Manufacturers are required to inform the
catheters to be safer, but hence less effective, than a model the
FDA of new clinical investigations or scientific studies concerning a
FDA has approved disrupts the federal scheme no less than state
device and to report incidents in which a device may have caused or
regulatory law to the same effect." The Court suggested that tort
contributed to death or serious injury or malfunctioned in a manner
law, applied by juries, is "less deserving of preservation" than
that would likely cause or contribute to death or serious injury if it
statutory law or regulations, because juries, unlike federal or
reoccurred. Additionally, the FDA must approve any design
state officials, do not take into account the benefits of a particular
changes related to the safety or effectiveness of these devices.
product design along with its risks.
The FDA has the power to withdraw pre-market approval based
on newly reported data or existing information and must withdraw
approval if it determines that a device is unsafe or ineffective
under the conditions in its labeling. Bottom Line
This ill-conceived legislation would not improve patient safety but
Riegel v. Medtronic, Inc. would certainly increase litigation against U.S. medical device
The U.S. Supreme Court in 2007 heard arguments in Riegel v. manufacturers. More than 30 years ago, Congress recognized the
potential damage of permitting several states to set and enforce
Medtronic, Inc. regarding whether a private tort lawsuit in state
different standards for medical devices, and it wisely entrusted
court may challenge the design, manufacture, or labeling of a
the FDA with this responsibility.
device or whether such a suit is pre-empted by federal law. The
Medical Device Amendments (MDA) to the Food, Drug and Cosmetic

NAM Resources
For more information on this issue, please visit

NAM Contact
Rosario Palmieri, Vice President, Infrastructure, Legal and Regulatory Policy or (202) 637-3177

July 2010