California Appeals Court Nixes Preemption Defense
5 CommentsBy Ed Silverman // September 29th, 2008 // 7:53 am
A California appeals court ruled that drugmakers can be sued for failing to warn of potential dangers, even if product labeling was okayed by the FDA. As a result, the court reinstated a lawsuit against Purepac Pharmaceutical over its generic version of the Reglan heartburn drug, The San Francisco Chronicle informs us.
Carlyne McKenney claimed she develoed tardive dyskinesia, which causes involuntary muscle movements, after taking metoclopramide, which was made by Purepac Pharmaceutical from November 2001 to December 2002. In her lawsuit, she alleged Purepac failed to warn of the risk by downplaying info on the labeling. A lower judge dismissed the case, noting the label contained all warnings required by the FDA.
However, the appeals court ruled 3-0 that an FDA-approved label isn’t necessarily the last word on the risks and dismissed Purepac’s preemption defense. Preemption is the legal notion that FDA approval of a drug supercedes state law claims challenging safety, efficacy, or labeling. Drugmakers and the FDA argue preemption exists by maintaining the agency’s actions are the final word on safety and effectiveness. The US Supreme Court will review a preemption case on November 3 (back story).
“Nothing in the McKenney’s fourth amended complaint alleges that Purepac should have given warnings about the use of metoclopramide that the FDA expressly precluded Purepac from giving. The superior court therefore erred in sustaining the demurrer,” the appeals court wrote. “Nor has Purepac cited to us any appellate court decision holding that a generic manufacturer of a prescription drug can never be held strictly liable in tort for failure to warn when the generic manufacturer utilizes FDA-approved labeling.” Here is the ruling.
A lawyer for Purepac tells the paper that the generic drugmaker will seek a rehearing and, if unsuccessful, would appeal to the state Supreme Court. He adds that a broad Supreme Court ruling in favor of drugmakers would require dismissal of the Purepac suit, but in any event, Purepac has a strong case because federal law requires generic makers to use only FDA-approved labels.
“Our hands are tied,” says Purepac lawyer Richard Dean. “They (the plaintiffs) want to put us in jeopardy for adhering to clear federal regulations.”
The appeals court said, however, that a generic drugmaker has the same ability as a brand-name manufacturer to ask the FDA to require further labeling info. McKenney’s lawyer, Laurence Masson, praised the ruling and disputed the claim that Purepac’s hands were tied. “They’re the ones who are most knowledgeable about side effects,” he tells the paper. “It’s in patients’ interest to have the most accurate information.”
Justice in MI
This appears to be a Levine-like case - that is, there is no suggestion (at least based on summary here) that the company is being accused of unreasonbly withholding or delaying communication of risk info they had either to FDA or public more generally. (That need not be willful fraud, btw, but at least lesser negligence.)
As I recall, the issue of a generic company’s responsibilities also came up in Colacicco. At least one court ruled pretty definitively that a generic company cannot be held liable for not making changes brand company didn’t.
Antoine Clarke
So the FDA provides a false sense of security to US patients. 1) The FDA does not (cannot?) oversee the quality of all pharmaceutical products (think fake heparin) before they reach the US market. 2) Manufacturers hide behind FDA compliance, as in pre-emption, not inspecting suppliers in China (heparin again). 3) Patients trust the label and find it isn’t comprehensive or they don’t trust the label because they know the FDA “must” be hiding something. Bad either way.
I can’t see a solution that doesn’t involve shutting down the FDA and letting drugmakers face the music when they get it wrong. So either pre-emption and the FDA does its job (if that’s possible, which I doubt), or no pre-emption and close down the FDA’s quality oversight role.
Jaynesday
Antoine Clarke,
I agree with your prescription for the FDA and pharma. We need to put drug/device companies and the buying public face to face, eyeball to eyeball. No intermediary. If your product works, my friends and I (the American public) will buy it. If it doesn’t, it is so revealed and your product sets on the shelves. No loop holes, no second chances, no sweet deals with the government, no protection from the buyer’s prerogative.
Justice in MI
I would strongly oppose closing down FDA. That was the preemptors’ goal (which they lost) in the mid-90s. For all its warts, FDA has done much more good than bad, and it has saved industry’s butt from its own worst inclinations more than once.
Some talk about the “price of regulation” and never imagine the price of deregulation - and I’m talking about dollars in this instance, not lives.
Antoine Clarke
Justice in MI,
So no one died from fake heparin on the FDA’s watch? Or suffered AEs from Vioxx? The price of regulation is public complacency and death.
You seem to think it’s out of the question to close down the FDA. That, of course, is one of the problems. If an agency did a good job in 1978, that is not a reason to assume that it works or can work in 2008.
For example, until recently, people wanting a range of opinions (good and bad) about a drug had to rely on word of mouth or official government sources. Now you can check out the sidebar of this blog alone, to get a range of opinion (to say nothing of Facebook patient groups of people actually using the drugs). And a big chunk of people don’t trust any information the government puts out, especially when the president is from the other party. Memo to Bush haters: the FDA isn’t suddenly going to become more competent at spotting fake ingredients because President Obama is in the White House, unless the FDA’s staffers have been deliberately punishing America for Florida 2000.
Tort lawyers are (much of the time) a diabolical nuisance: they create litigation insurance and compliance costs, which are a significant part of the reason prices go up. But are they better motivated to hunt down and punish negligent drugmakers, than the FDA is? You better believe it! One third of the settlement amounts is a powerful motivator. And the payouts hit share prices therefore bonuses. An FDA DTC non-compliance fine two years late? Ha!
On pharmacoviligance, if not the original licensing of a drug, the FDA is not good enough, and I argue, can never be good enough. DTC monitoring is another joke: it would be better if the US public was told: these ads may be full of lies, we don’t know so take them with a pinch of salt. And scrap DTC monitoring.
Look at it another way: if you had to pick only one function of the FDA that it does effectively and could not be done better by Public Citizen, ambulance chasing lawyers and blogger, which would it be? The FDA should focus on the thing it has to do, and not pretend to provide perfect safety all the time for everyone. Unicorns don’t exist.