Keith Jensen obtained the largest verdict in NH history and that case is before the U.S. Supreme Court
By Sam Baker - 03/17/13 06:00 AM ET
Key Democratic lawmakers are at odds with the Obama administration regarding a Supreme Court case on whether patients can sue over dangerous prescription drugs.
The court is scheduled to hear oral arguments Tuesday in a case that deals with lawsuits over generic drugs. A decision in the drug makers’ favor would likely bar patients from arguing in court that a generic drug was too dangerous to be prescribed.“If the drug industry gets their way, the last and only backstop may be gone,” said Keith Jensen, the attorney who argued the lawsuit in lower courts.
The Supreme Court has been especially active over the past five years in deciding when patients can and can’t sue over the side effects of prescription drugs. Tuesday’s case will likely settle lingering questions about a small but high-impact class of lawsuits against generics.
The Justice Department is siding with drug makers, arguing that the courts shouldn’t be able to second-guess approval decisions by the Food and Drug Administration.
But Rep. Henry Waxman (D-Calif.) — who wrote almost all of the country’s laws on generic drugs — and Sen. Tom Harkin (D-Iowa) disagree, arguing that Congress never intended to block lawsuits against potentially unsafe drugs.
The original plaintiff in the case, Karen Bartlett, was badly injured by a generic version of the painkiller Clinoril.
About 60 percent of her body developed severe burns or “turned into an open wound,” according to briefs in the case. She was placed in a medically induced coma two months, tube-fed for about a year and “is now severely disfigured, has a number of physical disabilities, and is nearly blind.”
No one disputes that her injuries were a side effect of the painkiller, which was known to cause the disease she developed. She sued the manufacturer, arguing that it should not have sold the drug because its extreme risks outweighed its benefits.
She won, and an appeals court upheld the decision.
There are 17 other drugs on the market that are just as effective as Clinoril but do not carry the same risk of severe side effects, Jensen said. The initial suit called Clinoril a “needless and useless drug.”
The Justice Department and the drug’s manufacturer, Mutual Pharmaceutical Co., said patients shouldn’t be able to sue on the grounds that a generic drug is too dangerous to be on the market.
That determination belongs solely to the Food and Drug Administration, Justice argued.
"Congress's purposes of ensuring that expert, science-based judgments are made by FDA, and the assurance that FDA approval provides for market participants, would be undermined by ad-hoc reconsiderations on a State-by-State and lawsuit-by-lawsuit basis," the solicitor general's office wrote in a brief to the Supreme Court.
