Justices to Rule on Power of FDA OK: Does It Shield Firms from State Laws?
Murray, Frank J., The Washington Times (Washington, DC)
The Supreme Court agreed yesterday to decide if Food and Drug Administration approval of life-sustaining devices immunizes the maker against lawsuits under state laws.
The case involves a claim of a young woman in Florida who was totally dependent on her heart pacemaker and was injured when a "defective" part approved by the FDA failed, requiring surgery twice to implant new ones.
Medtronic Inc. of Minneapolis, the world's leading producer of heart pacemakers, told the justices the case has "profound significance" to the industry in its appeal of the 11th U.S. Circuit Court of Appeals ruling that Lora Lohr's case be heard by a jury under Florida law.
Medtronic spokesman Dick Reid said the ruling the company appealed is at odds with those in several other circuits. The 11th Circuit ruled that the 1976 Medical Device Amendments forbid states to impose different or additional standards but found no conflict between Florida's law and federal law.
"You could end up with 50 different sets of rules on safety and effectiveness," said Steve Speil, a vice president of the Health Industry Manufacturers Association, which believes progress will be chilled if the FDA seal of approval does not apply nationwide.
He said a Supreme Court ruling upholding pre-emption "would be a great benefit not so much to the industry but to the patients who rely on our companies to keep a steady flow of lifesaving products coming."
In the justices' last effort this term to fill their smallest docket in 40 years, they also took eight other cases at yesterday's conference.
Among them will be a decision on whether national credit-card companies may charge late fees to customers living in states that forbid them, and a residual case from the savings and loan bailout that could cost the government another $10 billion in damages for breaking agreements with companies that acquired failed S&Ls.
The likelihood for the 1995-96 term that ends in June is that the high court will produce 78 signed opinions, four fewer than last term and the fewest in 40 years.
Justices also consider some 7,000 appeals without ordering hearings each term, down by 10 percent from last term. They include thousands of cases from prisons and death row.
"At this rate, they'll be out of business by the year 2049," Northwestern University law professor Dan Polsby joked to an Associated Press reporter seeking explanations for the decline. …