Washington (cnn) -two women who say they suffered serious medical complications of a generic medicinal product ask Supreme Court to allow their separate lawsuits against pharmaceutical manufacturers to continue. The judges, in oral arguments Wednesday, gave no clear indication where they were biased.
The High Court two years ago said federal requirements warning by the food and Drug Administration does not capture or block, State Court claims against manufacturers of brand-name prescription drugs. These latest test if the lucrative industry of generic medicines can be performed to the same responsibility.
Concerned: generic drug companies must share responsibility with equivalent brand manufacturers to update their labels warning when significant new risks arise?
The financial implications and security of the judgment of the Court of Justice which is due in June, could prove to be enormous. Generic drugs currently represent over 70% of prescriptions filled in the United States. This number should increase over the coming years, with patent protection due to expire on several popular drugs consumption and lucrative, including Lipitor and Viagra. The Bill for the reform of the health of blockbuster defended by President Barack Obama also encourage greater use of generics. About a third of generic medicines have no competitor brand.
The judges gave conflicting comments about whether Congress intended to separate State lawsuits in generic market.
"Do you think Congress really wants to create a market in which consumers can only render brand-named products?" asked Justice Sonia Sotomayor. "Because if that is the case, because nobody ever took a generic? And why the World Congress-or even FDA-create an obligation different brand-named products of generic products "?
But Justice Samuel Alito chased another legal avenue. "The FDA Has made any calculation of the economic consequences of imposing this duty on manufacturers of generic medicines?" he asked. "I don't know if this is good or not, but it seems to me that can significantly increase costs for manufacturers of generic medicines and therefore neutralize one of the objectives of the Statute, which was to provide low-cost generic drugs."
Gladys Mensing of Minnesota and Julie Demahy Louisiana, both were prescribed as Reglan metoclopramide-marketed by Wyeth Pharmaceuticals-to treat your heartburn and acid reflux. Its pharmacists separately full prescribing an equivalent generic made by PLIVA, Inc. and Actavis, Inc.
After four years of taking drugs, women have developed tardive dyskinesia, a neurological disease that causes severe longterm involuntary muscle movements.
They sued manufacturers generic metoclopramide, claiming inadequate warnings were provided about the long-term risks of taking the medicine. It was also argued there was growing evidence of the dangers posed by drugs, but that companies took no step to change the warning labels.
In 2009, the FDA acted on his own and issued an order for manufacturers of brand name and generic versions of metoclopramide to add a specific warning about the increased risk of developing tardive dyskinesia.
Generic drug manufacturers are trying to dismiss the lawsuits. They cite an act of Congress 1984 anticipate credits of "failure to warn" State.
Pharmaceutical companies long claim various doctrines of preference, saying that they are protected against the majority of product liability claims if they met with the approval of safety standards. They argue that federal regulatory rulings Trump State security laws to the consumer, which often are more resistant than the defaults of Washington.
But the Supreme Court had given a major victory for patients and consumer rights groups in 2009, when he decided in favour of the applicant Diana Winn Levine when she sued Wyeth-now owned by Pfizer-after losing an arm to gangrene from a common prescription anti-nausea. She won a judgment of $ 7 million from a Vermont jury for his assertions.
Arguments Wednesday, lawyer Jay Lefkowitz told the Court that generic companies could not have complied with the laws of the State often strict consumer because that would require labeling its products differently than what appears on the drug label tagThey claim it is a violation of federal law.
But Justice Stephen Breyer seemed unconvinced. "So your argument is that, if we run across this huge ... really serious problem, you're saying that the State has no right to say-even if we purposely didn't tell anyone--they can't engage?"
Lefkowitz admitted that it was the law as he understood it and that "Member States simply do not have a business trying to impose those obligations [Federal]."
Justice Ruth Bader Ginsburg dissented. "The federal agency says these [State] suits add-on, they are not in disagreement with the federal scheme, because they give manufacturers an incentive to come forward," she said. "Everyone is interested in making sure that only safe drugs are marketed."
Louis Bograd, who represents the plaintiffs, encountered some resistance from several judges on the effect of increased non-contractual liability on the generic drug industry.
Scalia said manufacturers of generic drugs typically don't have the apparatus for research and monitoring that brand companies — with their higher prices have.
"The argument here is whether it will be the FDA ultimately determines whether there was a risk grave enough to modify label or that call will be made by a State Court to guess what the FDA would have feitocerto?"said. "I don't see how you can blame them [generic companies], while they continued to give the warnings that they had to give".
But Bograd, citing the growing popularity of generics when problems occur, said, "If generics are not responsible for, in many of these cases no one is responsible."
The Obama administration is supporting the plaintiffs, concerned that if State lawsuits are pre-empted by federal law, which will reduce the incentive for generic drug manufacturers to provide the latest security information to the FDA.
Chief Justice John Roberts said manufacturers of generics would find an easy way around this, something that can benefit consumers.
"Each time a generic manufacturer Gets an adverse incident report, which sends it to the FDA, and there will be a cliche phrase at the end of her saying, ' we think you should consider revising the labels because of this ' and thenunder his theory, this manufacturer is completely protected against State suits? "
He said that a flood of such reports would overwhelm the federal agency and make it difficult to separate the serious and immediate concern.
The cases are PLIVA, Inc. v. Mensing (09-993). Actavis Elizabeth, LLC v Mensing (09-1039);. Actavis Inc. v. Demahy (09-1501).
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