Fw: US Supreme Court Says Law Bars Suits on Medical Devices

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From: ilena rose <ilena@...>

Sent: Monday, February 26, 2001 10:43 AM

Subject: US Supreme Court Says Law Bars Suits on Medical Devices

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>

> US Supreme Court Says Law Bars Suits on Medical Devices

>

> WASHINGTON (Reuters Health) Feb 21 - The US Supreme Court on Wednesday

> ruled that individuals cannot sue manufacturers of medical devices for

> allegedly defrauding the US Food and Drug Administration (FDA) in order to

> win marketing approval.

>

> The unanimous ruling was a victory for the US Justice Department, which

had

> argued that federal regulation of medical devices precludes lawsuits

> alleging fraud on the FDA.

>

> The case involved a lawsuit in which more than 5,000 individuals accused a

> company of fraudulently winning federal approval for marketing bone screws

> used in spinal surgery.

>

> The lawsuit alleged that the Buckman Co., a consulting firm for medical

> device manufacturers, used misrepresentations to get FDA approval in 1986

> for marketing a device known as the Variable Screw Placement Spinal Plate

> Fixation System.

>

> The ruling also was a victory for the company.

>

> Chief Justice Rehnquist said for the court that a US appeals court

> had been wrong in reinstating the claims against the company and allowing

> the lawsuit to go forward.

>

> Allowing such lawsuits might expose manufacturers of medical devices to

> " unpredictable civil liability, " he said.

>

> Rehnquist said the federal regulatory scheme amply empowered the FDA to

> punish and deter fraud against the agency, and that the FDA used its

> authority to achieve a delicate balance of objectives that can be skewed

by

> allowing such lawsuits.

>

> " The FDA...has at its disposal a variety of enforcement options that allow

> it to make a measured response to suspected fraud upon the agency, "

> Rehnquist said in the opinion.

>

> He said this flexibility was a critical component of the framework under

> which the FDA pursues its objective of regulating marketing and

> distribution of medical devices.

>

> Rehnquist said state law fraud claims inevitably conflict with the FDA's

> responsibility to police fraud.

>

> He said companies complying with the FDA's detailed regulatory regime, but

> then facing possible lawsuits under the laws of 50 states, might be

> deterred from seeking approval of devices with potentially beneficial

uses.

>

> In the case at issue, the FDA had rejected Buckman's two previous

> applications, made on behalf of AcroMed Corp., for marketing the device.

>

> But a third application, which separated the device into its component

> parts and which said the screws were intended to be used in the arm and

leg

> bones, won FDA approval.

>

> The plaintiffs claimed they were injured when their doctors implanted the

> device into their spines and alleged that Buckman had perpetrated a fraud

> on the FDA. The individual claims seeking monetary damages were

> consolidated into one lawsuit.

>

> The lawsuit said that Buckman won FDA approval under a pretext because the

> intention all along had been to market the bone screws for use in spinal

> surgery. The FDA did not approve the marketing of bone screws for spinal

> surgery until 1995.