Justice Alito also has our opinion this morning in caseMutual Pharmaceutical Company versus Bartlett. Responding Karen Bartlett was prescribed Clinoril, the brand name version of the pain reliever sulindac for shoulder pain. Her pharmacist dispensed a generic form of sulindac manufactured by petitioner Mutual Pharmaceutical. The results were disastrous.
Bartlett Posted Mon, June 24th, But when their regulations conflict, federal law prevails. In prior decisions, the Court has recognized that it may sometimes be impossible for a drug company to comply with FDA design and labeling requirements, on the one hand, and state laws on the other — typically because state law authorizes liability for drugs that meet FDA standards.
The conflict is especially acute for generic versions of name-brand drugs. Federal law requires that generic drugs be chemically equivalent to their name-brand counterparts, and it also provides that generic drug labels must be consistent with their name-brand counterparts.
It thus does not permit generic manufacturers to unilaterally make any significant alterations to either the chemical composition or the labeling of their drugs. Mensingthe Court thus held that federal generic drug law preempts state failure-to-warn claims.
Both the majority and the dissents acknowledge that the facts underlying this case are tragic. Karen Bartlett suffered horrific injuries as a side effect of the generic drug sulindac, a non-steroidal anti-inflammatory drug.
She sued the drug manufacturer under New Hampshire law, alleging strict product liability. Court of Appeals for the First Circuit rejected that argument, holding that the manufacturer could comply with both sets of law by simply not selling sulindac in New Hampshire, or by paying the small number of patients who suffer the adverse side effects.
The Supreme Court reversed. In a five-to-four decision by Justice Alito, the Court held that in effect, avoiding liability under New Hampshire law would require the manufacturer to either alter the composition of the drug or alter its label both of which federal law prohibits.
The decision drew two dissenting opinions, which argued that the stop-selling theory is valid, and also that Congress would have wanted to preserve a role for state law in drug regulation.Jun 24, · Details: Mutual Pharmaceutical Co.
v. Bartlett Posted Mon, June 24th, pm by Tejinder Singh The federal government and the states share . Details: Mutual Pharmaceutical Co.
v. Bartlett (Tejinder Singh) Argument recap: Court troubled by tort protections for generic pharmaceutical manufacturers (Ronald Mann) Argument preview: Court to write yet another chapter on tort protections for generic pharmaceutical manufacturers (Ronald Mann). Home» Robert Wood Johnson Univ.
Hosp. v. Thompson. Robert Wood Johnson Univ. Hosp. v. Thompson.
sought reimbursement from Medicare for the Federal Fiscal Year (FFY) using the average hourly wage (a component of the reimbursement rate) of actually expanded the boundaries of the New York City MSA to include Orange.
County. If it. Abraham v. Richland Parish Hosp. Serv. Dist. 1-B — Feb. (Full Text) Judgment rendered February 8, Application for rehearing may be filed.
Federal Power Expanded Through Pharmaceuticals & Progressivism In the case of Mutual Pharmaceutical vs. Bartlett, the United States Supreme Court ruled in a count that federal law prohibits generic drug manufacturers from independently .
We need to leave here with a mutual understanding of where we are and in what direction we should go to meet our common objectives. This was expanded from State border to State border, and then we dropped back down to nonpoint sources. (power, the head of the family) - represents OMB.
0 Sue Ellen (abused, shoved around) - represents the.