Congressional Democrats draft legislation to reverse pre-emption ruling
WASHINGTON Democrats irritated by a recent Supreme Court decision shielding medical device companies from state liability lawsuits plan to unveil legislation to reverse the ruling, the first of many expected efforts to chop away at federal rules that restrict consumers’ ability to sue, according to published reports.
House Energy and Commerce Health Subcommittee Chairman Frank Pallone, D-N.J., and House Oversight and Government Reform Chairman Henry Waxman, D-Calif., will introduce legislation before the Independence Day recess that would explicitly state that FDA regulation does not trump medical device patients’ ability to seek damages under state law, a Pallone spokesman said.
The two were spurred to act after the Supreme Court ruled in February that patients injured by defective medical devices can not sue for damages in state courts if the FDA approved the marketing of the product.
The justices found that the 1976 Medical Device Amendments pre-empted the right of injured patients to sue for damages in state courts against the most complicated or high-risk devices that undergo FDA’s strictest approval process. Justices are in various stages of weighing pharmaceutical pre-emption cases.
Antibody drug found cost-effective against allergic asthma
NEW YORK A review of seven studies has found the antibody drug Xolair to be cost-effective in treating allergic asthma, according to a report published in the journal Allergy.
The report, by University of Washington researcher Sean Sullivan and Dr. F. Turk of Novartis Pharma showed that Xolair, Novartis’ brand name for omalizumab, showed the drug was cost-effective in treating allergic asthma for which common asthma medications were inadequate.
The studies also found some evidence that Xolair may not be as cost-effective in treating other forms of asthma.
Novartis and Genentech market Xolair in the U.S. Genentech reported U.S. sales of $472 million for the drug in 2007, according to Novartis financial data.
First DataBank settles lawsuit for $1 million
BOSTON First DataBank, a provider of integrated databases of information about medications, has agreed to pay $1 million to settle a lawsuit alleging it conspired with McKesson to manipulate the average wholesale price of drugs.
The case, New England Carpenters Health Benefits Fund vs. First DataBank, filed in 2005, alleges that First DataBank and McKesson “wrongfully increased the so-called wholesale acquisition cost to AWP markup factor applied to numerous prescription pharmaceuticals through a scheme begun in late 2001 and 2002,” which meant that the plaintiffs in the class action lawsuit made “substantial excess payments.”
First DataBank denies any wrongdoing or liability and “has valid and complete defenses to the claims asserted against [it] in the class action,” which it is settling to avoid the expense and inconvenience of further litigation, the settlement says.
The case, filed in the U.S. District Court for the District of Massachusetts, explicitly excludes government entities from joining the class action suit. The San Francisco Health Plan and the state of Connecticut have filed suits with similar charges that McKesson and First DataBank inflated the spread between WAC and AWP from 20 percent to 25 percent, costing state Medicaid and other health programs untold sums.
First DataBank is not named as a defendant in the two new lawsuits. McKesson continues to defend itself in all three cases.