Wednesday, October 12, 2011

US Supreme Court Rules in Favor of Pharma on Vaccines, Data Mining and Generics. Who is Looking Out for You?

United States: Supreme Court Rules In IMS Data Mining Case
by Maria Buckley

On June 23, 2011, the Supreme Court in Sorrell, Attorney General of Vermont, et al. v. IMS Health Inc. et al1, struck down a Vermont law2 that bans the sale of physicians' prescribing information to pharmaceutical companies and further bans pharmaceutical companies from using such data to market their products. The Supreme Court's 6-3 opinion by Justice Kennedy found that the Vermont law unconstitutionally restricted the pharmaceutical companies' right to free speech.
Vermont's Prescription Confidentiality Law provides that absent the prescriber's consent, pharmacies and other related entities are prohibited from selling prescriber identifiable information for marketing purposes and that such information cannot be used by pharmaceutical manufacturers to market their products. The statue permits other uses of the data, e.g., healthcare research.
The Court found that speech in the process of pharmaceutical marketing is a form of expression protected by the free speech clause of the first amendment. Therefore, the Vermont statue must be subjected to heightened judicial scrutiny of the reasons for the restrictions on speech.
Vermont's justification was that the law was necessary to protect medical privacy, avoid physician harassment by drug company representatives, and to preserve the integrity of the doctor-patient relationship. Vermont further argued that the statute is integral to its efforts to control healthcare costs and improve public health.

Supreme Court Rules in Favor of Vaccine Manufacturers
SCOTUS makes it more difficult to sue manufacturers in autism cases.
By Meghan McCarthy
The Supreme Court Feb 22, 2011 ruled that vaccine companies cannot be sued for design defects, handing the pharmaceutical industry a victory and making it more difficult to bring cases against vaccine manufacturers for allegedly causing autism.
A 1986 law established a federal system for compensating patients injured by "unavoidable" side effects after being given a vaccine. The law aimed to make collecting damages for children injured by vaccines easier and faster by giving the Health and Human Services Department the authority to hear the cases and hand out compensation, funded by an excise tax on pharmaceutical companies making vaccines. President Obama’s fiscal 2012 budget estimated the vaccine fund would have $3 billion. The fund has paid out over $2.5 billion since its inception.
A ruling that allowed suits against the vaccine producers for a "design defect" might have opened up the pharmaceutical industry to thousands of cases alleging that vaccines caused autism in children.
The case heard by the Supreme Court, brought by Russell and Robalee Bruesewitz, alleged that their daughter Hannah was disabled by a diphtheria, tetanus, and pertussis (DTP) vaccine she received as an infant in 1992 manufactured by Lederle Laboratories, now owned by Pfizer Inc.’s Wyeth unit. After the family was denied compensation in the federal vaccine court in 1995, they filed the suit that ultimately reached the Supreme Court, charging that the defective design of the vaccine caused their daughter’s disabilities and that the company could be held liable for negligent design under Pennsylvania law.

Supreme Court Rejects Generic Drug Labeling Suits
Reuters by James Vicini June 23, 2011
(Reuters) - The Supreme Court ruled on Thursday that generic drug companies cannot be sued under state law over allegations that they failed to provide adequate label warnings about potential side effects.
By a 5-4 vote, the justices gave a victory to Israel's Teva Pharmaceutical Industries Ltd, Mylan Inc's UDL Laboratories and Iceland-based Actavis Inc by overturning U.S. appeals court rulings that allowed such lawsuits.
The companies argued that federal law barred such lawsuits because the drug had been approved by the U.S. Food and Drug Administration (FDA). Federal law requires generic drugs to have the same labels as their brand name equivalents.
Justice Clarence Thomas in the court's majority opinion agreed. He said federal drug regulations applicable to generic drug manufacturers directly conflicted with and thus pre-empted state lawsuits.
The Supreme Court decided a related issue in 2009 when it ruled FDA drug regulations do not protect pharmaceutical companies from being sued under state law over drug labeling, a case involving Pfizer Inc's Wyeth unit and its antinausea drug Phenergan.
But in the generic drug cases, the justices reversed separate U.S. appeals court rulings that the lawsuits against the companies could go forward.
The high court agreed with the arguments of the generic drug makers that they had no choice but to use the same drug labels as the brand manufacturer.
Teva, Actavis and the Generic Pharmaceutical Association hailed the ruling.

The court ruled 6-2 to uphold the ruling of the 3rd Circuit appellate court, finding that the federal law preempts all “design-defect claims” made against vaccine manufacturers. Justice Antonin Scalia, writing for the majority, said the statute only holds manufacturers liable for proper manufacturing and labeling, not for the actual design of the drug.

No comments: