Friday, January 18, 2008

Collecting our thoughts on Wyeth v. Levine

We're sure that we'll have plenty more to say about the Wyeth v. Levine case as it makes its way toward final decision later this term. For one thing, the grant means we should know once and for all whether the FDA's right about implied preemption in the prescription drug field by the end of June this year - since the Court almost never carries cases over from one term to the next.

For now, until we get back to full strength, we'll simply gather together everything of substance we've previously said about Levine in one place, so both you and we can find it.

Our most recent substantive (our posts about when things are likely to happen don't count any longer) post was last month, when we analyzed the SG's long awaited brief on whether the Court should take the Levine cert petition. We liked its substance and puzzled a bit at the conclusion that the court should simply hold the petition in abeyance while it decided the Kent (fraud on the FDA) and Riegel (PMA medical device) preemption cases. The Court was probably puzzled too, since it didn't take the SG's advice. But then, contrary to the SG's views, the Court took the Riegel case too.

We prepared a post earlier in December about what we even then thought of as the looming "preemption trilogy" in the Supreme Court. That's probably the best thinking we've done to date about how Levine, Kent, and Riegel fit together, both in the context of preemption and in the context of product liability/mass tort litigation.

It's no slam dunk that the defense position we advocate will prevail in Levine. The scorecard of prescription drug preemption cases since the FDA put preemption squarely on the table with it's preemption preamble in January, 2006 is running pretty close to even. For rank speculation about what might happen if the plaintiffs were to win in Levine, see our post here.

One thing that's sure to come up in Levine is the amount of deference owed to the FDA's opinions about things such as preemption. That's not only because the SG (for the FDA) will certainly be filing a brief on the merits, but also because the FDA took quite a strong position in favor of preemption back in January, 2006. We put up a post on the ins and outs of FDA administrative deference (with specific mention of Levine) back in May. Administrative deference is about as arcane an area of the law as you can imagine, but it's likely to be quite important in Levine.

As far as the FDA's position is concerned, we speculated in October that any filing by the government in Levine would resemble prior amicus briefs that the FDA filed in a number of anti-depressant/suicide cases over the past few years. To read about what the government's briefs - and to judge how close our speculation came to reality in Levine, take a look at that post.

One other thing that's as sure to come up in Levine as the sun is sure to come up tomorrow is the scope of the FDA's regulation allowing drug manufacturers latitude to add or strengthen warnings prior to obtaining FDA approval. That regulation was the linchpin of the Vermont Supreme Court's finding of no preemption in Levine. Literally days before the Court took the case, the FDA had a lot to say about how this regulation should have been interpreted from the beginning. That's because the Agency finally had enough with how the courts (specifically including Levine in Vermont) were reading it too broadly. We blogged on that not very long ago - and also pointed out that the government felt that this regulatory initiative was of sufficient relevance to bring it to the Supreme Court's immediate attention.

On a somewhat less serious note, we pointed out how one of the leading anti-preemption advocates on the plaintiffs' side (yeah, we know, that's redundant), might have a problem in Levine with some statements it made during oral argument in Riegel.

Anyway, that's enough stuff to keep you readers busy on the Levine front for a while - until we come up with some new words of wisdom to share with you. Now, all we have to do is figure out what those words could possibly be.

1 comment:

Doug Bremner MD said...

How can Wyeth say that the FDA’s viewpoints are carefully balanced, when they are guided by advisory panels of physician “key opinion leaders” that are usually on their payrolls as consultants, speakers, and/or advisory board members? And the fact that this advice is skewed can be shown by numerous examples, e.g. the fact that “expert guidelines” recommend the use of statins for the prevention of heart disease in women, when the evidence in the literature clearly shows that there is no benefit, only the risk of harm in the way of side effects?

Preemption would effectively yank the protection that Americans get from the judicial branch of government and leave the executive and legislative branches in charge of protecting them. And what do they know about drug safety? Since the FDA’s leadership is politically appointed, this would put the responsibility for guarding Americans in the hands of a small group of politicians who frequently benefit from donations from pharmaceutical companies. Witness how Dan Troy went from representing pharma to a job as chief counsel at the FDA, where he filed friends of the court briefs on behalf of FDA on the side of pharmaceutical companies whose medications had caused serious injury or death, on the rationale that since the FDA had approved the medications that they had a stake in the outcome. After this little jaunt he then tripped back to a cushy job in pharma.

Or here is another example. George Bush was so concerned about protecting us from potential dangers with prescription medications, that he appointed a veterinarian, Lester Crawford, to run our nation’s drug regulatory body, the FDA. I’m not sure if I feel comfortable having an expert on cows deciding which drugs end up in my medicine cabinet.

Lately we have had to watch senators shouting at the FDA to tell him how much money they needed to keep America safe from Chinese milk or pet food or the latest drug disaster. The Director couldn’t tell him, or more likely wouldn’t, since his marching orders were to keep the budget small.

With the Prescription Drug User Fee Act” (PDUFA) resulting in pharmaceutical companies paying more and more of the budget of the FDA, with PDUFA mandating that less goes to drug surveillance (watching drugs already FDA approved), it is not innappropriate for pharma to think it will be a good idea to have a “single regulatory body”, since the FDA is essentially working for them. And outside reviews of the FDA have said they are putting Americans at risk through regulation of prescription medications.

Another argument against preemption is that taking the issue out of the courts removes a potential way to uncover previously undisclosed information related to clinical trials, something that has come up not just once, but repeatedly, through the discovery process of ongoing trials.

And what is the argument about the law being “impossible to interpret.” If a prescription medication is found to have an adverse outcome, warn doctors and the public, and if is too dangerous, take it off the market. That is what you are paying your doctors and scientists to do, analyze your data and evaluate risk/benefit ratios.

How about

“…reinforce the principle that doctors are entitled to rely on FDA-approved professional labeling.”

Let me translate that one for you:

Physicians, support this proposed ruling, because then you won’t have to worry about covering your asses for prescription medication disasters. How about the idea that somne of us physicians actually CARE about whether we are doing harm or good for our patients.