By Sam Baker - 03/17/13 10:00 AM EDT
Key Democratic lawmakers are at odds with the Obama administration regarding a Supreme Court case on whether patients can sue over dangerous prescription drugs.
“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.
Waxman, however, said the Justice Department is reading into federal law a preemption doctrine that just doesn’t exist.
Congress never intended for FDA approval to preempt lawsuits over drug safety, Waxman said in a court brief. He has unique insight into that question, as the lead author of the laws that govern the generics industry. (Even in formal legal briefs, those laws are often referred to simply as “Hatch-Waxman,” rather than by their official title.)
Congress has never passed a provision stating that FDA approval bars drug makers from tort suits, Waxman argued, and the courts generally defer to Congress on questions of preemption.
"The decision whether to preempt state-law claims, for decades left to Congress, properly remains with Congress," Waxman's brief states.
Both Waxman and the Justice Department say they have Supreme Court precedent on their side.
Waxman cited a 2009 case in which the court upheld the right to sue brand-name drug companies. The court noted in its decision that federal law does not expressly preempt product-liability suits, and also noted that even the FDA had traditionally recognized lawsuits as an important addition to drug safety oversight.
Lawsuits were far ahead of FDA oversight in uncovering information about the risks of drugs like Vioxx, which was pulled from the market in 2004 after it was linked to hundreds of heart attacks.
The Justice Department and the generics industry have a precedent of their own, though, as they head into Tuesday’s argument — last year the Supreme Court blocked most lawsuits involving generic drugs.
Both cases seem to offer strong yet competing precedent for Tuesday’s arguments. But they both deal with a slightly different type of lawsuit than the one at issue now.
Bartlett isn’t arguing that the drug maker failed to warn about the risks she encountered, but rather that it shouldn’t have put its product on the market in the first place because those risks were so great.
Failure-to-warn cases make up about 99 percent of lawsuits against drug companies, Jensen said. So the claims at issue Tuesday are much more rare, but can also carry higher stakes.
Because the court has shielded generics from failure-to-warn suits, the much harder-to-prove charge of a defective product is the only recourse left to police generics’ safety through the courts.
If the court sides with the drug industry in next week’s case, he said, there will be “no incentive for generic drug companies to report information, because there will be no downside if they fail to.”
— This story was updated Monday, March 18. An earlier version incorrectly stated the length of time Karen Bartlett was in a medically induced coma.