Well here's the verdict, generics in effect don't have to explain anything says the Supreme Court of the United States. We've all seen the ads that at length explain the harmful side effects that can happen to a person that ingests them for the greater good. We've seen the three page magazine ads taken out by pharma companies doing the same. We've also paid tons for money for "designer" drugs, fully aware that there are generic alternatives. The new court ruling protects generic drugs in a move consistent with newly implemented Federal Policy modernization actions.
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.
Generic drugs account for more than 70% of all prescriptions filled in the United States.
In a statement that will possibly set a precedent for years to come, by a 5-4 vote, the supreme 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.
Here are some reported public record examples of how this works:
One case involved Julie Demahy, who sued Actavis (generic Reglan) and said it should have warned her of the risks of developing a neurological movement disorder from metoclopramide, a generic drug for heartburn, nausea and vomiting.
In another case, Gladys Mensing sued the three generic drug makers in federal court in Minnesota after allegedly developing the same disorder after taking generic versions of Reglan.
The Obama administration supported the two women. It said the companies could have sought changes to the drug's label.
Here is what the FDA says specifically (link also below):
"New drugs, like other new products, are developed under patent protection. The patent protects the investment in the drug's development by giving the company the sole right to sell the drug while the patent is in effect. When patents or other periods of exclusivity on brand-name drugs are near expiration, manufacturers can apply to the FDA to sell generic versions."
The FDA ordered warnings about the movement disorder be added to Reglan and metoclopramide in February 2009.
Liberal Justices Sonia Sotomayor, Ruth Bader Ginsburg, Stephen Breyer and Elena Kagan dissented.
Sources: The U.S. Food and Drug Admistration and Pliva v. Mensing, No. 09-993, Actavis v. Mensing, No. 09-1039 and Actavis Demahy, No. 09-1501
Written by Sy Kraft