Some may have thought the preemption debate was settled last year by the US Supreme Court, but Johnson & Johnson's McNeil PPC unit hopes to persuade the justices to take a closer at a case involving the 1999 death of a 16-year-old boy, who had taken its Tylenol Cold med, and a Florida law that does not allow a drugmaker to unilaterally change its product labeling by adding a warning.
For those unfamiliar, preemption is the notion that FDA approval of a drug supercedes state law claims challenging safety, efficacy, or labeling. Drugmakers and the FDA unsuccessfully argued last year before the US Supreme Court that preemption exists by maintaining the agency’s actions are the final word on safety and effectiveness. At issue was whether patients can sue a drugmaker through state law when a product has already been approved by the FDA. The matter was decided in lawsuit brought against Wyeth by a Vermont musician named Diana Levine, who sued for inadequate labeling and won (background here).
In the J&J case, Armando Valdes collapsed during a roller hockey game after taking the McNeil over-the-counter-med, which contained pseudoephedrine, for a head cold, along with a caffeinated beverage, earlier that day. He suffered a heat stroke and cardiorespiratory arrest that caused brain injury and hypoxic ischemic encephalopathy. He was left Armando completely disabled, so he and his parents sued McNeil, contending the product increased the heart-related risks and heat-related illness" when combined with a caffeinated beveraged and athletic activity in a hot environment. The family contends McNeil’s failure to warn of the risks breached Florida law.
Initially, the case was dismissed in McNeil's favor. As the FDA Law blog notes, federal court in Miami decided it would have been "impossible" for McNeil to comply with federal regulations covering warning labels for OTC meds including pseudeophredine and state law findings. But last December, a federal appeals court reversed the decision, citing the Wyeth v. Levine case. McNeil, by the way, argued the circumstances were different, in part, because this involved an OTC med, not a prescription drug. And so now McNeil is asking the Supreme Court to decide.
Why? The drugmaker contends the Levine ruling was misapplied. "The appellate court in Valdes ignored the fact that prescription and OTC drugs are subject to different federal regulatory regimes," the drugmaker's attorneys wrote. "The appellate court failed to recognize that federal laws applicable to manufacturers of OTC products do not provide a mechanism similar to the CBE (changes being effected) procedure that would permit a manufacturer to unilaterally change the warnings on product labeling crafted by the FDA...Without preemption, OTC drug manufacturers would be deprived of the ability to rely on FDA’s directives as to matters that Congress delegated to the agency and that fall within the agency’s unique regulatory and scientific expertise” (read the petition here).
What do you think?
Should Preemption Extend To OTC Products?
- Yes (54%, 31 Votes)
- No (46%, 26 Votes)
Total Voters: 57
7 Comments
Ah, my favorite topic....
I would add this proviso to Ed's good summary. Even the dissenters in the Levine case (Alito, Roberts, Scalia) did not agree "that preemption exists by maintaining the agency’s actions are the final word on safety and effectiveness."
The dissent was narrower than that. The records of FDA and company'sinteractions also had to show that there was adequate review of the relevant risk in question. The existence of an FDA-approved label was not, in itself, sufficient grounds for preemption.
Only Michigan law has the kind of broad preemption in which FDA approval, in itself, is the "final word."
The CBE issue is an interesting one since the majority in Levine affirmed that the label "belongs" to the company and thus companies are always in a position to revise it, independent of FDA. Without knowing more particulars, I would ask whether OTC manufacturers really don't have equivalent ways to revise the label if they are so inclined.
The claim, JiM (with which I do not agree, BTW) by J&J's lawyers, is that a wrinkle in Florida law PROHIBITED the adding of a warning to the OTC product.
Honestly, that argument barely passes the "straight face" test [i.e., can barely be made without a sheepish grin.]
Here's McNeil/J&J's purported money quote (from a Seventh Circuit -- Posner J. -- opinion):
. . . .Without pre-emption, McNeil, and all other OTC drug manufacturers, would be deprived of the ability to comply simultaneously with their federal and state obligations or even to ascertain what those obligations are without resort to litigation. . . .
So, if one starts THERE, as J&J does, it is pretty easy to see how the cards get stacked to argue that even if we accept a very broad reading of preemption, post Wyeth v. Levine, J&J (McNeil) will be in a pickle.
Of course, the answer is to reject the premise.
It simply is not true that Florida law prevents warnings. It doesn't. There may be economic disincentives created under Florida's warning scheme -- but that differs from a prohibition.
Hope this is helpful.
Namaste
OMG,.. One day Pharma will give up!!
I don't think so, Lisa, especially in the "current climate." I think they are just getting started...(good to "see" you, btw!)
thanks, Condor. As I understand what you wrote, and being the country non-lawyer I am, it sounds like the same kind of conflict preemption that was claimed in Levine. Of course, the Bush FDA rewrote CBE (or tried to) in a way that would create the situation argued here. But that was after Levine lost her arm. And the majority in Levine rejected with contempt (I think that's the right word) the whole house o' cards of the of the preemption argument via that administration. Even the dissent ignored it, as I recall.
p.s. Since the vote here heavily favors preemption, it would be nice to hear the arguments of some of those folks.
I would find it more credible if they could produce a case in which an OTC manufacturer _did_ add a warning and then FDA, or some authority in Florida, made them change it back. (Not that it would have cost them anything even if that happened, but the argument as a whole would have more credibility beyond the imaginary).
Any such case?
JiM-Not sure if anyone reading this would have enough access to a drug co.'s discussions with FDA to respond to this, especially on the record. It's fair to say FDA would be extremely unhappy with anyone changing a label without its approval, no matter what the change was.
This is the problem: FDA is a bureaucracy that is understaffed & can't even adhere to the deadlines it's financially incentivized to adhere to. If there's a lag of >6 mos. between a safety signal & a label update, who is responsible for potential liabilities that take place during that time? No member of the federal government, including one of the nine in black roles, is going to blame another part of the federal government, even if it would be justified. So the drug co. is hung out to dry.
SP--I must disagree with you, although I do not have insider experience of a company's dealings with FDA.
What I think we do know is that the whole point of the CBE regulations is precisely to allow companies to change the label (particularly re: adding warnings) _before_ FDA approval. FDA may then concur or not. If it does not, then the label is changed back.
From what I gather, there has never been a case of a company suffering in any way whatsoever from following these CBE procedures. That is part of why the Supreme Court rejected the notion that there was something "prohibitive" about a company adding warnings independent of prior FDA approval.