Washington, D.C. – The U.S. Supreme Court justices last Monday questioned whether people can sue companies that mislead or defraud the federal government.
At issue in Buckman Co. v. Plaintiffs’ Legal Committee is a Pennsylvania lawsuit in which more than 5,000 people accused the Buckman Co. of fraudulently winning approval from the Food and Drug Administration for marketing bone screws used in spinal surgery.
Chief Justice William Rehnquist and Associate Justice Ruth Bader Ginsburg, who are often on different sides of legal issues, were both skeptical about expanding the right to sue. Rehnquist called the reasoning behind the lawsuit an ‘extraordinary application’ of existing legal precedent.
But Michael Fishbein, an attorney representing the plaintiffs, argued the claim is based on well-established principle and ‘not derived from some new fangled principle of tort law.’
He said the FDA has ‘extensive prosecutorial discretion’ but the lawsuit option should be kept available as a backup.
Ginsburg said there has ‘never been an instance of the FDA relying on individuals’ to enforce fraud actions against companies.
Kenneth Geller, an attorney for Buckman, said allowing fraud lawsuits would result in juries second-guessing the FDA and give state courts too much power.
The lawsuit alleges that Buckman, a consultant for medical device manufacturers, used misrepresentations to get the FDA’s go-ahead in 1986 for marketing a device known as the Variable Screw Placement Spinal Plate Fixation System.
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 indicated that the screw would be used in arm and leg bones rather than in the spine, was approved.
The plaintiffs alleged they suffered permanent damage to their back when orthopedic bone screws were inserted into their spines. The cases were consolidated in Philadelphia.
Associate Justice Stephen Breyer said allowing juries to assume too much of a regulatory role sets a dangerous precedent.
District Asks Court to Block Takeover Again
Harrisburg – Harrisburg school officials asked the Commonwealth Court last week to block a planned takeover of their district as the mayor said he expected to name a board that would assume control within the next two weeks.
The embattled school district filed motions in seeking injunctions temporarily blocking the planned takeover by the panel, to be appointed by Mayor Stephen R. Reed.
State Education Secretary Eugene W. Hickok cleared Reed to appoint the panel for the city takeover while simultaneously putting the Allentown school district on formal notice that it could fall under state control within the next three to four years if its 16,000 pupils do not improve on statewide skills tests.
Hickok cited two years of faltering test scores in placing Allentown on the watch list along with nine others statewide. A 10th district, Chester-Upland in Delaware County, was already placed under state control.
In the motion, a lawyer for the school district said the planned takeover would stigmatize Harrisburg’s approximately 10,000 pupils, waste taxpayer funds and create a ‘potential for chaos’ in the middle of the school year.
A judge temporarily barred Harrisburg from assuming control of the district in July, ruling that the state’s takeover law violated the state constitution by specifically targeting the capital city’s schools for an immediate takeover.
The General Assembly two weeks ago approved a new bill that applied to only the district but did not identify it by name.
Reed said he had already lined up four of the panel’s five members but declined to identify them. Once named, they will have the ability to reshape the district’s administrative structure and even fire employees, he said.
Both Allentown and Harrisburg are considered eligible for takeover because more than half of their students scored in the bottom quarter statewide on standardized tests over a two-year period.
Newspaper: Judges Not Reporting Sentencings
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