A federal judge late last week rejected an effort by Lilly and Sandoz to dismiss a lawsuit stemming from the August 2004 suicide of a 26-year-old California man who was taking a generic version of the Prozac antidepressant. The lawsuit was filed by Noe Carrasco's mother, who claims the drugmakers failed to warn of the suicide risks associated with the pill.
The drugmakers argued that preemption was a defense, and Sandoz also maintained that, as a generic maker, it wasn't legally allowed to voluntarily revise its label without prior FDA approval. But in a 30-page opinion, Judge Howard Matz wrote Sandoz’s argument "lacks merit" and the drugmakers offered "nothing but theoretical assumptions of what the FDA would have done, and that is not enough to warrant a finding of preemption." He also noted that "at no point prior to Carrasco's suicide did Lilly request to add suicidal language to the Prozac label and so the FDA never rejected such a request."
Preemption, you may recall, 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.
However, Matz opined that "Lilly's argument fails, because Lilly ignores its burden here. To establish a preemption defense, a drug manufacturer must produce ‘clear evidence that the FDA would not have approved a change to (the drug’s) label.' ...A mere possibility that the FDA might not have allowed an enhanced suicidality warning for Prozac...is not enough to warrant preemption.”
photo courtesy of walknboston on flickr creative commons
7 Comments
The Levine case lives on...
Recently reread the decision and dissent. The core of it comes down to who is responsible for what is on the label. Even if FDA must finally approve it--and has more power to change it unilaterally since FDAAA--majority argued strongly that company is always ultimately responsible.
The empirical fact that they will always know sooner and better than FDA about potential trouble, along with the legal fact that CBE provides a way to change label (even the version revised under Troy), were both key. And, of course, the historical fact that no company has ever suffered anything by FDA as a result of strengthening a warning.
Of course, the additional wrinkle here concerns a generics, which does complicate matters, I agree.
Ahhhh, Justice is in his/her element here.
The bottom line in these cases has always been that not one SSRI maker ever asked the FDA to allow it to add a suicide warning. So the argument should have been a non-starter from day one.
Daniel Troy writing a brief claiming the FDA would have refused such a request should never have carried any weight.
This preemption BS dragged SSRI plaintiffs through the court system for years, in all types of lawsuits, while the evidence of on-going harm remained sealed by court orders.
In SSRI litigation, the judicial system was as corrupt as the FDA and Big Pharma.
Dare I remind us that the "preemption BS" remains fully in place in the device arena and in the state of Michigan, home of this dude.
This comment in response to Evelyn's above.
In reading the current case, I was interested to learn that Wyeth did unilaterally add a pediatric suicide warning on Effexor in 2003. Glaxo added a general one on Paxil in 2006.
Both of these instances were used in this case to demonstrate that it is, indeed, possible for a manufacturer to add a suicide warning on its own initiative. While FDA can then refuse the change, that rarely happens. It certainly did not happen in these two instances.
It is not the case that a manufacturer has to "ask the FDA" for such a change, although in practice companies and FDA generally revise labels in tandem.
Justice
One quick thought on the subject of preemption and generics. If the manufacturer of a generic medication is equally responsible for updating the warning label then why is Lilly a defendant in this case? While I am generally opposed to preemption the more lawyers target increasing number of defendants, the more the system will breakdown. Although I have not conducted an in-depth analysis of this case it would appear that Lilly is included because they initially introduced Prozac. Given the fact that Prozac no long enjoys patent protection it is probable that the sale of Prozac does not generates much of Lilly's income and even if it does, they were not the manufacturers in the above referenced case. If I were the company who held the initial patent on a specific drug and as result my revenue stream on that drug has pretty much dried up due to the expiration of the patent I would, as a preventive measure, implement the most strict label warning possible so as to protect myself from future liability. The practical affect would be that every drug coming off patent will have similarly enhanced warnings thus having the affect of diminishing the value of any of the warnings. While I was generally opposed to Wyeth and more specifically the Bush Administration in Wyeth v Levine, the more I think about the ruling the more I believe that the decision should have been more narrowly drawn. The dangers associated with the use of phenergan utilizing the IV Push method were generally known and as such the Supreme Court decision should have simply rejected the broad case of preemption introduced by the Bush Administration and found that while preemption laws are not affected by our decision this is a case where the defendants are not culpable as the lable was sufficient and the rsiks were well known in the medical community.
Hi JimK--With the usual provision that I'm not a lawyer, I'll try to respond to some of the issues you raise. Perhaps others can add.
As I read the case, it looks like the original claim was against Sandoz, not Lilly. Lilly became involved down the line, for reasons that are not entirely clear to me. Certainly, there are other cases--Colaccico v. Apotex, most prominently--in which only the generic company is named.
While it seems logical that Lilly would "defensively warn" as you describe, and preemptors almost always argue that will happen, it essentially never does. I wonder myself why it doesn't. Internal discussions within FDA that came out before Levine was decided (yes, partly a political move by Waxman) seemed to confirm that defensive warning doesn't happen. My only thought is that "shotgun" warnings, if they did happen, might themselves be considered inadequate exactly because they did not adequately highlight the most important risks. And, indeed, were the regulatory equivalent of "intentional grounding." But this is purely speculative.
On Levine, the Court was not in a position to make a call about the merits of Levine's original case. Their task was only to rule on Wyeth's motion to overrule the Vermont Court on the basis of preemption _as a doctrine_. And, indeed, the minority (Alito, Scalia, Roberts) did defend doctrinal preemption, but on a narrow basis (within what is a spectrum of ways to construe preemption). They did not argue the view, which is Michigan's law, that FDA approval/compliance is, in itself, enough to preempt tort liability.
For whatever it means, FDA strengthened the warning on IV push for Phenergan some months after the Levine case. Their reasoning was similar to Levine's--that, while there was risk info there, it was not stated clearly and strongly enough. I guess there's "knowing" and "knowing," from their perspective.