Wednesday, October 29, 2008

Everything You Need To Know About Wyeth v. Levine, From A Defense Perspective

The Wyeth v. Levine implied preemption/prescription drug case gets argued next Monday in the Supreme Court. Since at least some media types read our blog, we’ve decided to pull together everything that we’ve written about Levine and put it in one place – as a public (or, at least a press) service.

After all, somebody’s got to give the defense perspective on the Levine case, what with so much misinformation and hysteria out there. And if you can’t get somebody -- well, at least you’ve got us.

Lord knows the press needs it. Some of the commentary has been downright awful – and we don’t say that just because we disagree with somebody else’s viewpoint. That’s not a problem for us. We’re lawyers, and we appreciate that there are (at least) two sides to everything. We’re talking about facts here. Some of the coverage is just so wrong or overblown on the basic facts of Levine that we wonder whether people even know what the case is about. Did they read any of the court papers?

The factual problem’s quite simple, really. The other side’s spreading this myth that Levine is about “whether a patient injured by serious side effects of an FDA-approved prescription drug should be able to file a products liability lawsuit against the drug company.” Heck, even some people that we supposed would be on our side (because we pay them) have suggested that Levine might “eliminate most or all cases against drug makers for any unwarranted health effects of medications.”

They want it to appear as if, after Levine, it's lights out on prescription drug product liability litigation generally.

While we might also say, "from their lips to God's ears," unfortunately, t’aint so.

We wish it were that simple – that stark – but like just about anything in the law it’s not cut and dried. Levine isn’t some incoming asteroid poised to wipe out all life in the world of prescription drug product liability litigation.

A case in point involving folks who should know better is the recent JAMA (Journal of the American Medical Association) editorial on Levine published a little more than a week ago (we’d like to reproduce it, but JAMA sells its content). It turns out that JAMA (or at least these editorial writers) don’t like preemption. Okay, we understand that some docs would like to settle bad malpractice cases cheaply (as in Levine, and in Riegel, too, as we recall), and sic the plaintiffs looking for the big bucks on somebody else. Indeed, JAMA isn’t the first to say this; several medical societies pitched the same point to the Supreme Court in Levine:

It is unlikely that judicial adoption of preemption in favor of pharmaceutical manufacturers will result in the wholesale discontinuation of all lawsuits arising from the use of FDA-approved prescription medications. Rather, a likely consequence of preemption will be that patients are left with no option but to prosecute claims against their physicians.
Medical Association amicus brief in support of Plaintiff, at 4.

Can we blame the docs? Not really. Doctors don’t want to be sued any more than our own clients do. All we ask is, jeez, at least get the facts right.

The JAMA editorial begins with the proposition that “some patients inevitably will continue to experience harm from the use of newly marketed products” as its reason why there shouldn't be preemption in Levine. But Levine doesn't involve a “newly marketed product.” We went through the facts of Levine in excruciating detail here. Phenergan (the drug at issue in Levine) is the polar opposite of a “newly marketed product.” That drug’s been around since 1955 – over 50 years. Heck, it's older than we are.

Not only that, but the specific adverse reaction involved in Levine – gangrene due to arterial exposure – had been known and warned about for almost as long.

Fact: The Phenergan label that the Levine plaintiff attacks repeatedly warned about gangrene, including in boldface, all caps type: “INADVERTENT INTRA-ARTERIAL INJECTION CAN RESULT IN GANGRENE OF THE AFFECTED EXTREMITY.” That’s just one. For a complete listing of the gangrene warnings on Phenergan at the time of plaintiff’s use, see Wyeth’s principal brief, at pp. 17-18 (there are so many warnings, it takes two pages to list them all).

So the JAMA editorial simply headed down the wrong track. There’s nothing at all new or novel about the risk in Levine. This a case where the treating physician's assistant: (1) used a less “preferred” method of administration (IV push), (2) then injected twice the maximum labeled dose, and (3) went ahead with the injection despite the plaintiff’s complaints of extreme pain. Another commentator (who's at odds with us on preemption) called these facts a “poster child” for tort reform, because they so favorable to Wyeth. Here’s Wyeth’s own summary of the treatment foibles:

Although Phenergan’s labeling specified a dosage range for nausea of 12.5 to 25 mg, JA 391, [the physician's assistant] gave respondent a 50 mg dose, see JA 105 – double the labeled amount. Moreover, [the physician's assistant] administered the entire 50 mg double dose without pausing, despite respondent’s complaints of pain – pain she later described as “one of the most intense pains that [she] had ever felt” to that point, JA 179-181 – even though the labeling instructed that IV injection should stop immediately if the patient complains of pain. JA 111, 183, 390.
Wyeth Principal br. at 20. We usually take out record citations in our quotes. This time we’ve deliberately left them in to show that everything’s fully supported by the testimony at trial. You can trust the cites because nobody’s dumb enough to lie to the Supreme Court about what’s in the record.

Thus, as we said before, Levine’s a malpractice case miscast as a product liability claim. And the plaintiff’s health care providers darn well knew it – they settled out (relatively cheaply) for $700,000, and the plaintiff (successfully) went for the big score against the drug company. But we’re not doctors, so don’t take our word for it. Go here for a doctor’s view of the atrocious medical treatment that the plaintiff received in Levine.

But just as we’d be incompetent doctors, the JAMA editorialists don’t do a very good job trying to play lawyers. Here’s something else that they had to say about Levine:

Wyeth contends that the lawsuit should be banned because the prescribing information had been approved by the FDA. At issue for the Supreme Court is whether FDA approval of prescription drug labeling “preempts” state law products liability claims against a pharmaceutical manufacturer whose products are later found to have safety risks and cause harm. Specifically, the issue is whether a manufacturer that complies with FDA warning requirements can be held liable under state tort law for not supplying adequate warnings.
JAMA article at pp. 1939-40 (emphasis added).

Not exactly.

Wyeth’s brief doesn't focus on “compliance with FDA warning requirements.” Wyeth’s compliance "with warning requirements" isn’t really in dispute. Rather, Wyeth told the Supreme Court that the liability issue in Levine is failure to contraindicate, not failure to warn – precisely because there were gangrene warnings all over the labeling for Phenergan. Here’s what Wyeth actually said:

FDA did not direct Wyeth to contraindicatei.e., eliminate as a permissible method of administration – IV push or other forms of IV injection, but instead chose to preserve the added effectiveness of intravenous administration. . .by requiring Wyeth to include carefully tailored warnings and instructions on the drug’s labeling. . . . In this case, a Vermont jury was nevertheless permitted to find Wyeth liable for failing. . .to eliminate IV push injection from the approved methods of administration.

Wyeth principal br. at 3 (emphasis added). In a nutshell, Levine is about the FDA saying “yes” to IV push as an indicated use (with lots of warnings), and a common-law jury saying “no” – that Wyeth is liable just because it included that FDA-approved use in its label.

If the FDA can’t decide what the approved uses (and methods of administration) of a drug are, and make that decision stick, then there’s not much left for the FDA to do.

That’s why, in Levine, the conflict between federal law (“yes”) and state law (“no”) can hardly be more direct, more squarely presented, or less cluttered up by the kind of stuff that JAMA editorialized about. In Levine, there’s no emerging, previously unknown risk (gangrene was known for decades). Nor is there any claim that anything was hidden from the FDA or anybody else (the agency reviewed and tinkered with the warnings repeatedly). Not only that, there’s not even an allegation that the risk information in Phenergan’s label was somehow out of date.

For these reasons, the preemption straw man set up in the JAMA editorial bears about as much relation to the actual facts in Levine as a lot of these incessant 30-second TV attack ads do to the records of the politicians they attack – which is to say, not much at all.

If the docs at JAMA can't be counted on to appreciate the difference between a contraindication and a warning, then where's a person to go for accurate information?

Here, of course. (Hey -- we said "accurate;" we didn't say "unbiased.")

What's actually going on in Levine is that the plaintiff simply disagrees with the FDA’s risk/benefit assessment of IV push as a method of administering Phenergan. That’s precisely what her lawyer told the Levine jury in closing argument: (1) Wyeth “should have pulled their drug. . .from intravenous use. At a minimum, they should have required that you use a free-flowing IV.” JA 211. (2) “Thank God we don’t rely on the FDA to. . .make the safe[ty] decision. You will make the decision.” Id. (3) “The FDA doesn’t make the decision, you do.” JA 212. “JA” stands for joint appendix, if anybody wants to check.

Who makes the “safety decisions” about prescription drugs? The FDA or innumerable state-court juries? That’s what Levine is all about. It’s a naked attempt – that the Vermont courts should have thrown out on multiple, purely state law grounds – at using a state jury verdict to override and obliterate an FDA risk/benefit determination.

The Supremacy Clause doesn’t let states do that to a federal agency. That’s what conflict preemption is all about. That’s the most fundamental reason why we think Wyeth will – and, if the federal system of drug oversight is to keep operating, should – win the Levine case.

What Levine isn’t about (at least not much) are all those things that concerned JAMA. A pro-preemption ruling affirming the FDA’s power to determine the approved uses of a drug in Levine isn’t going to override and obliterate all prescription drug product liability litigation. JAMA’s position that “patients must have a means to seek recourse through tort litigation” (editorial at p. 1941) simply isn’t implicated by Levine.

All Levine will establish is that tort claims involving prescription drugs can be preempted if they conflict with the FDA’s decisions. It won’t establish that all such claims will be. A pro-preemption ruling in Levine only lets the proverbial camel’s nose into the tent. It doesn’t flatten the tent itself.

Frankly, we wish it were otherwise. We’d like Levine to be just as sweeping a preemption win as Riegel. That's one possible result, but it's hardly guaranteed – because Levine is failure to contraindicate more than failure to warn. It’s not Zyprexa, or Rezulin, or many of the other drug cases. And because Levine isn’t any of those, it may take ten years of litigation after Levine to sort out which warning-related claims are, and aren’t, preempted.

After Levine is decided, we’d love to be able to shut this blog down (get some greatly needed sleep) and go back to representing manufacturers of things that go “clank.” But that won’t happen. The plaintiff’s side is peddling apocalyptic Kool-Aid to folks like JAMA for purely political reasons. They want to get Congress riled up about something – universal preemption – that has less chance of happening than John McCain carrying both of our hometowns (Herrmann lives in Chicago, Bexis in Philly) in the upcoming election.

Now that we’ve got that off our chests – and at the same time given you a thorough description of the facts of Levine (see, we can multitask) – here’s a more organized version of our Levine CARE package for the press.

The players: Arguing for defendant-petitioner Wyeth is Seth Waxman, who is counsel of record on Wyeth’s brief.

The Solicitor General, Greg Garre (or, more likely, Ed Kneedler), also has been granted time to argue separately, according to the Supreme Court’s docket.

David Frederick is listed on respondent Levine’s brief as counsel of record. Plaintiff’s representation is, according to this article, being funded by ATLA.

The Court: There have been no recusals (that we know of), so we’re assuming there will be a full bench. That way we’ll avoid the fiasco in Warner-Lambert v. Kent where the Court (minus Chief Justice Roberts) split 4-4 and didn’t decide anything. Since Levine is being argued relatively early in the Term, a decision could be handed down as early as February, 2009.

But don’t hold your breath.

Levine’s a big-deal case; we don’t expect it to be unanimous; and if there’s a close division in a big case, we could be waiting until close to the end of the current term (in June 2009) for the result.

The election: Assuming John McCain doesn’t carry our hometowns, and there’s a change in administrations, there’s a zero percent chance that a new Democratic administration will have any direct effect on Levine. As we’ve recently discussed, the brand new SG isn’t going to throw his/her (a woman SG would be a nice change) credibility with the Court out the window by abruptly changing the government’s stated position for transparently political reasons.

Repeat after us – that won’t happen.

Moreover, as we’ve also discussed, because Levine involves implied preemption arising from a federal/state conflict, and not express preemption arising from a statute that Congress could amend, a new, more heavily Democratic Congress wouldn't find it easy to change the result in Levine.

In order to change a conflict-based result in Levine, Congress would have to eliminate the conflict itself. It can’t just write a new and different savings (meaning “anti-preemption”) clause into the FDCA. That might work with the express preemption Riegel case, but it won’t work with an implied preemption case like Levine, as we explained here (last random thought in the post).

No, to eliminate the conflict, Congress would have to gut the FDA’s substantive powers by giving the states express power to override FDA labeling or risk/benefit decisions. To do that Congress would have to buck a century-long trend, up to and including the 2007 FDAAA, toward giving the FDA more, not less, power.

Could it happen? We suppose – but it would be tricky, would require controversial legislation gutting the FDA (burning political capital better spent elsewhere), and would involve a lot of out-of-character acting like state's rights conservatives.

The process: “Cert.” is an abbreviation (that means use a period after it). It is short for “certiorari” – a form of discretionary appeal that the Supreme Court chose to, but was not obligated to, accept. Here’s our post about the Court granting the certiorari petition in Levine.

Levine has been around longer than most Supreme Court cases. As our long-time readers will recall, the Court took the Levine appeal last term, but pushed Levine back to this term because last year’s argument calendar was full. Here’s our post about that.

For any truly anal types, here are our posts about the Levine briefing schedule.

The briefing: We don’t analyze plaintiff-side briefing – since anything we say here could, and would, be used against us in our own cases. Thus, we’re not going to tell you that we think any plaintiff-side arguments are meritorious. We’re defense lawyers; expect us to play the part.

Reporters who want to review the plaintiff-side briefing can find a pretty good selection here or here.

We do analyze defense-side arguments, and if we think a particular position is bad enough (meaning that we’d never be caught dead making the argument), we’ll tell you so. Our coverage of the defense side in Levine is as follows:

  • Wyeth’s original petition for certiorari is here, and you can find our (minimal) discussion of the petition here. Even then, we called Levine the “800-pound gorilla.” (In retrospect, that's probably 200 pounds heavier than your typical lurking gorilla. Oh, well. Everyone writes stuff they later regret.)

  • The SG’s brief on Wyeth’s petition for certiorari is here, and you can find our discussion of that brief here. At the time, the SG wanted the Supreme Court just to hold Levine pending its decisions in Riegel and Kent. The Court chose to accept the case for a hearing on the merits anyway.
  • Wyeth’s principal brief on the merits is here, and you can find our discussion of it here.
  • Wyeth’s reply brief is here, and you can find our discussion of that brief here.

  • We discussed the slew of defense side amicus curiae filings here and here (because we missed a few the first time around). Here are links to the various defense side amicus briefs: Most important is the FDA/DOJ brief because, well, it's by the government . Government briefs are different because of the deference issues they raise. Other defense side amici are: PLAC, PhRMA/BIO, WLF/American College of Emergency Physicians, US Chamber of Commerce, DRI, the Generic Pharmaceutical Ass’n, and Chalfee, et al.
The issues in Levine: Recently, we wrote a post that included a list of issues that the Supreme Court conceivably could decide in Levine. That list is still good, so we’ll just repeat it here. To be sure, the Court won’t decide all these issues – some are mutually inconsistent – but it will decide some of them. Here, again, are the potential issues the Court could reach:

  • Because the plaintiff in Levine sued for failure to contraindicate a use that the FDA looked at and approved, the most fundamental question in Levine is once the government says “you can do X,” can tort plaintiffs sue you on a theory that you shouldn’t have done X? Beyond just drugs, the same preemption question comes up in lots of cases – from cars to chemicals to cigarettes to securities – where the government’s telling people what they can or can’t do with things they sell to the public. For more on conflict preemption, you can go here or back to the first part of the recent post, here.
  • Another core dispute in Levine is whether FDA requirements are “minimum” or “optimum” standards, or a “floor” versus a “ceiling.” We’ve discussed the issue before here and here, and it’s a major issue for the government, too. The Court's distinction (if it draws one) between “minimum” and “optimum” warnings would affect lots of other government-approved warnings.
  • Levine also presents the question whether there is a presumption against preemption in an implied preemption case. We discussed that issue before, and PLAC did an especially nice job on this point in its Levine amicus brief. Obviously, a decision about the presumption against preemption, however it goes, will affect the slope of the playing field in every future implied preemption case.
  • The Court may decide whether there are any differences in scope between the two flavors of implied preemption – “impossibility” and “obstacle.” An answer would necessarily affect the future scope of any claim of “obstacle” preemption, and that's most implied preemption claims involve these days. This question was a major focus of Wyeth’s principal merits brief, and in our discussion of that brief.
  • Plaintiff in Levine argues that there’s no conflict where a manufacturer can choose to keep doing what the government tells it to do, but at the "mere" cost of paying tort judgments. This ... umm ... position is one of the last general arguments against all tort preemption that the Court hasn’t already explicitly shot down. Were the Court to adopt this view, there wouldn’t be much implied preemption left in tort cases, but we don’t see much likelihood of the Court buying such tripe. The Court rejected that argument in Cipollone v. Liggett Group, Inc., 505 U.S. 505, 521-22 (1992), and ignored the same argument when plaintiffs resurrected it in Riegel.
  • The defendant (and the FDA) assert(s) a government policy against “overwarning” in Levine. Is preventing overwarning a valid basis for implied preemption? We think so. The issue has significant implications because all labeling decisions involve both what goes in and what’s left out. Whatever the Court says (if anything) about overwarning would also apply to other government-approved warnings.
  • How broadly will the FDA’s “emergency situation” (so-called “changes being effected”) exceptions to its pre-clearance requirements be interpreted? We’ve blogged about this issue several times, here, here, and here. Other statutes with similar exceptions would be affected by an answer to this question.
  • Because the two sides disagree about how to interpret the CBE regulation, and the FDA has weighed in on the construction of its own regulation, the amount of deference a court should give to an agency’s construction of its own preemptive power is implicated. We addressed the ins and outs of agency deference here. Needless to say, whatever the Levine Court says about deference would affect anything that any other agency has said or is going to say about preemption. Given the impending election, it will be interesting to see who takes what position on administrative deference.
  • The plaintiff side in Levine criticizes the FDA a lot – echoing what it did at trial. Our side argues that, even if those criticisms were true, state law has no power to force Congress to fix flawed administrative agencies. If the Court were to say anything about this, it could affect the validity and weight of complaints by tort plaintiffs about the conduct of other federal agencies.
  • Plaintiff argues in Levine that government acceptance or rejection of a warning on a particular subject doesn’t preclude common law liability for not using a slightly differently phrased warning on the same subject. How the Court analyzes that question could affect the size of the preemptive shadow cast by a lot of decisions by agencies other than the FDA.
  • There’s another CBE-related dispute in Levine – whether a defendant must actually file a CBE and have it rejected before there can be preemption. The outcome could have significant practical effects on the number of petitions of this sort that are filed, and thus the workload facing federal agencies.

Who’s doing what to whom in the meantime: Preemption-watchers should consult our drug (and vaccine) preemption scorecard for a summary of how the lower courts have been approaching implied preemption issues while (and before) Levine is pending. We’re up to 70 cases – both pro and con – as of last Friday.

Rank speculation as to the import of Levine: Last, and probably least, we’ve considered what might happen after Levine, both if the good guys (Wyeth) win, and if the bad guys (plaintiffs) win. So if all else fails, go ahead, compare your speculation with ours.

7 comments:

Anonymous said...

The 800 pd gorilla is the post FDA approval that results in a side effect that can be more damaging then the initial ailment. My wife followed her doctors advice and took premarin for 10+ yrs for hot flashes. She subsequently developed breast cancer in spite of no family history. The physician immediately stopped the Premarin saying it, at a minimum, fed and advanced the cancer.

Tell me Levine will not preclude our pending suite! Especially when there is evidence that Wyeth suppressed its early on knowledge of the dangers.

Anonymous said...

Sorry, I read most of today's post as disingenuous.

You have noted several times your hope that Levine leads to "reasonably broad preemption." According the the Wall Street Journal, the Chamber of Commerce (your 'side') calls Levine the "business case of the century." Wyeth's own release on Levine emphasizes that there would still be litigation over "manufacturing defects," which obviously suggests that they anticipate, post Levine, there would _not_ be litigation over virtually everything else (including the whole "failure to warn" arena).

So, if there is "hysteria" about Levine, it is not coming from those who oppose preemption. It is coming from the hot-to-trot enthusiasm of its proponents. There has never been any real secret about that.

And then there is the matter of what we learned today top FDA officials actually think about the entire preemption argument. Absolutely stunning......but perhaps you'll take that up in another post.

Beck/Herrmann said...

To anonymous comment 1: As in every case, whether your particular suit is subject to preemption depends upon FDA's review of the drug and the risk in question. Beyond that, because one of us is involved in HRT litigation, we can't comment further.

To anonymous comment 2: It's not disingenuous. It's an internal conflict between our heart (we'd like to see a lot of preemption), and our head (we understand what the Levine case is really about). We mentioned that at least twice in the post (God's ear; things that go clank), but perhaps we weren't clear enough.

And we're suer we've said somewhere (we don't know how to do links in comments) that genuine manufacturing claims - where the product isn't what the manufacturer intended - aren't preempted. So we'd have to agree with Wyeth there.

Beyond that, it's entirely possible that one side's hysteria can prompt some on the other side to respond in kind. There's an old saying that there's nothing in the middle of the road but yellow lines and dead armadillos. Regardless of what others may say, we stand by our moderate reading of Levine.

And if you're talking about the Waxman staff report - yes, we have something in the works.

Anonymous said...

You are disingenuous, and saying you are not does not make it so. You attempt to limit the scope of the case in this post, but your wording and the history of this site undermines it.
First, your JAMA editoral analysis is silly and not relevant; you could have just told us about a misplaced comma, and you would have accomplished as much.
Second, manufacturing defects are brought in product liability cases (products that go "clank"), not in drug cases.
Third, every reasonble observer recognizes the implications of this case, and most find it a blockbuster case--as you do--not because it is limited to some fine point of preemption, as you pretend to do (or said diffrently, you pretend it will not, for the most part, end mass drug litigation, which it will).
Finally, (and this one shows you misrepresent your own views here), go back and look at how you described ("ho, ho, ho") the SG's brief and the scope of the ruling it sought.

Beck/Herrmann said...

The JAMA editorial simply has nothing to do with Levine. What they profess to be worried about (except that docs will get sued more) isn't in the Levine case.

There are manufacturing defects in drug/device cases. Just look at what happened recently with Heparin imported from China. Same with the Sulzer Hip litigation. Those cases typically get settled, because there's not really much of a defense.

What makes Levine important is two things. First, as we mentioned, it will establish whether there is, or is not, implied preemption in cases involving FDA-regulated products. We freely admitted that ("camel's nose") in our post.

The other thing that makes Levine important is the nature of implied preemption (see our "point of the spear" post). Levine is important to the business community generally because principles of implied preemption go beyond the particular administrative scheme. Levine has the potential to impact other industries if, for example, the Court rejects the presumption against preemption in conflict preemption cases. That's plenty important, but it has nothing to do with the point we're making - which is that Levine won't (at least we don't think - we'd love to be wrong) generally eliminate prescription drug product liability litigation.

But drugs/devices (and vaccines) are the focus of this blog. Our point is that we think the impact of Levine on our field of interest is being exaggerated (mostly but not completely) by the other side. If you find that disingenuous, so be it.

We think it's not only logical, but most likely correct (otherwise we wouldn't have said it). We'll find out in a few months.

neal said...

Levine has also contributed perspectives on broader themes dealing with the Defence. Levine is long considered a pre-eminent criminal defense law firm in Michigan in bring a wealth of experience and perspective to each matter.
-------------------------

jnnywllms

Internet Marketing

substance abuse said...

It is known that some prescription drugs can cause harmful side effects to the body, which eventually leads to drug abuse. Then there must be something done in order to ensure the safety of the people. It is because this is a very serious matter, which can help provide information to the society