Friday, October 31, 2008

Carve Your On-Line Pumpkin

We thought that our "Bodysnatchers" post this morning was pretty cute.

(Yeah, yeah -- we thought so. We know nobody else did.)

We've been outdone by this website:

You can carve your own pumpkin on-line.

Trick or treat.

A Humble Scribe On CNBC

Man, are we busy today!

In addition to doing legal work and writing blog posts, we're hitting the airways, too.

Here's a video clip of one of your humble scribes, Herrmann, on CNBC this morning.

(He's either got star power or an opinion about Wyeth v. Levine. Watch the clip -- it ain't star power.)

Wyeth Letter To Supreme Court re Waxman Report

Here's some breaking news:

Wyeth has just hand-delivered this letter to the Supreme Court responding to the report prepared for Representative Henry Waxman about which we posted yesterday.

Wyeth's letter makes these points:


1. The report is entitled to no persuasive weight, because it was written only by the majority committee staff and was not adopted by any full committee.

2. The report actually supports Wyeth's position about the meaning of the "change being effected" (or "CBE") regulation.

3. The report selectively quotes at least one e-mail.


This blogging stuff really has us pinned down today. How will we ever find time to go trick or treating?

Our Kingdom For A Post (On The Levine Argument)

Neither of us will be attending the oral argument in Wyeth v. Levine on Monday.

We're looking for a volunteer -- someone who's attending the argument and who can provide us with a guest post describing the affair on Monday afternoon.

If you're willing and able, please contact us off-line.

(We will, of course, read the transcript as soon as it becomes available and promptly publish a post based on our reading. We're looking for something even more timely than that.)

Thanks for helping.

Interlocutory Appeal Granted in Knipe

We posted on the adverse preeption decision, Knipe v. SmithKline Beecham Corp., 2008 WL 4090995 (E.D. Pa. Aug. 28, 2008), shortly after it was decided. Well, the other day the court denied reconsideration, but granted an interlocutory appeal to the Third Circuit of the preemption question. See Knipe v. SmithKline Beecham Corp., 2008 U.S. Dist. Lexis 87448 (E.D. Pa. Oct. 29, 2008).

A couple of substantive things:

First, in denying reconsideration, the court now changes its tune with respect to the Kallas FDA amicus brief (in which the FDA took a clear public position on preemption in a pediatric suicide SSRI case). Before, as we pointed out, the court misapplied the Fellner case to ignore the brief entirely. Now the court claims it didn't do that, but instead "took full notice of the FDA's factual and scientific determinations," and determined that it was "entitled" to however much "deference" it deserved. 2008 U.S. Dist. Lexis 87448, at *34-35. Having read both opinions, that sounds like revisionist history to us.

Second, in denying reconsideration, the court also makes the statement, "[b]oth FDA regulations and state tort law ask only whether the manufacturer knows or has reasonable evidence of an association between a drug and the complained-of adverse effect." Id. at *31 (emphasis added). That's hard to square with the court's statement in the prior opinion, "[b]ecause the standard for adding a warning under a CBE requires only reasonable evidence of association of a serious risk with the drug, and because state failure to warn claims under New Jersey law require the more stringent proof of causation between the drug and the injury, only a drug manufacturer who, in fact, possessed such reasonable evidence, yet failed to add a warning, would be potentially liable under state law." 2008 WL 4090995, at *25. So much for the defendant being protected by the greater stringency of state law.

There's more, but we have to get back to work. Suffice it to say, we think the defendant in Knipe will have plenty to tell the Third Circuit on appeal - hopefully after a favorable result in Levine.

A Halloween Special: Bodysnatchers! And Jujyfruits!

We published a quick post last week about In re Human Tissue Prods. Liab. Litig., No. 06-135, MDL No. 1763 (D.N.J. Oct. 22, 2008) (link here).

Now that we've had a chance to read the opinion, we thought we'd do a slightly longer post, and today seemed like the day: The case of the bodysnatchers on Halloween!

These are the ghoulish facts: Biomedical Tissue Services and its principal illegally harvested tissue from human corpses without obtaining the necessary consents or screening the donors for certain infectious diseases. That ain't just scary -- it's against the law!

"Several individuals in the BTS operation were indicted . . . and certain of those individuals have since pled guilty to crimes related to the unauthorized recovery of tissue and falsification of donor records." Slip op. at 7. That doesn't sound scary to us; it sounds more like justice being done.

The many plaintiffs included both folks who received implants made out of the stolen tissue and relatives of the decedents, who were distressed to learn that tissue had been harvested without their consent. Defendants included, among others, the folks who did the crime (and are now doing the time), the funeral homes that gave BTS access to the corpses, and the companies that processed the purloined tissue into medical products.

Maybe it's just because we defend device companies for a living, but naming that last category of defendants sounds pretty scary to us. The companies were not alleged to have actually known about the illegal bodysnatching operation; they were supposedly negligent in failing to detect the criminal scam. (We don't know anything about the real facts in this case, but that allegation smells to us like a pumpkin past its prime.)

The FDA recommended that recipients of the harvested tissue be tested for certain infectious diseases; Medtronic Sofamor Danek (a device company) offered free blood tests to patients who received its implants. Medtronic and the other device companies also routinely disinfected and sterilized their products before distributing them.

In the motion that Judge Martini granted last week, Medtronic and the other device companies
asserted that, even if BTS did not properly screen the tissue donors, no virus could survive the sterilization process and storage at room temperature for a prolonged period of time. Id. at 9.
The judge set aside the sterilization process and addressed only whether tissue stored at room temperature for thirty days could theoretically transmit the relevant viruses or diseases -- hepatitis B, hepatitis C, HIV, syphilis, cancer, and prions.

The parties agreed that there is no study -- epidemiological, cohort, or case-controlled -- that addresses whether unprocessed human bone tissue stored at room temperature for thirty days or more is capable of transmitting infectious diseases to a human recipient. Id. at 27. The court then meticulously reviewed the few marginally relevant epidemiological studies, animal studies, and lab studies that existed. The court ultimately granted the companies' motion to exclude all expert testimony that "unprocessed bone tissue kept at room temperature for thirty days or longer can transmit" the relevant viruses or diseases. Id. at 26. (The court reached a few other scientific issues, too, which we're not discussing here, so we can get home in time to hand out candy.)

Suzanne Parisian's testimony was stricken because she did not "adequately explain how her conclusions could be extrapolated from the results or conclusions from any of the studies." Id. at 44. "Her extrapolations from these studies were not tested, were not subject to peer review, and had no known rate of error." Id. at 46. Snickers bar!

John Kowalski's opinion "suffers from the same issues as Dr. Parisian's opinion in that Dr. Kowalski failed to articulate the scientific and medical rationale for extrapolating the results of the available studies to the set of facts in this litigation." Id. at 57. Milky Way!

Andrew Klein tried "to more fully bridge the gap between the existing literature and his conclusion regarding transmission," id. at 67, but the court didn't find his extrapolations "reliable" and they didn't "fit the facts of this case." Id. Judge Martini trots through several studies and discusses Klein's opinions in some detail, but much of that is very fact-specific. Although that analysis wouldn't be of general interest, keep this case in mind if you're ever facing Dr. Klein as an adverse expert in some future case. Three Musketeers!

Dr. Cosme Manzarbeitia suffers the same fate. His "proposed testimony on transmission has no basis in any specific medical literature and is merely based upon his belief." Id. at 77. His testimony was thus excluded. Baby Ruth!

For lack of evidence of general causation, the court thus granted summary judgment on, among other things, all claims relating to the "transmission of HIV, HBV, HCV, cancer, and syphilis through unprocessed human bone tissue that has been stored at room temperature for thirty days or more." Id. at 104. Same result for prion disease, though on slightly different reasoning. Id. Reese's Pieces!

"Multidistrict litigation courts are often confronted with evaluating limited or evolving scientific and medical theories and evidence. . . . . The Rules of Evidence, however, cannot be disregarded even if at a future date, medical and scientific literature proves the contrary. As Judge Richard Posner put it, 'the courtroom is not the place for scientific guesswork, even of the inspired sort. Law lags science; it does not lead it.'" Id. at 103 (citation omitted). 100 Grand bar!

That's quite a treat for the device companies -- an opinion that Krackles. The decision is Good, 'n Plenty of it, although, at 105 pages in length, it could be criticized as being a bit Chunky. For the most part, Almond Joy after reading it. And for defendants facing these experts in the future, the decision could be a true Lifesaver.

Have a Happy Halloween!

Thursday, October 30, 2008

Cong. Waxman Positions for the Levine Argument

It's to be expected, especially since we sort of did it ourselves, but folks with irons in the fire are positioning themselves in advance of next Monday's oral argument in Wyeth v. Levine.


Getting the most play is a "staff report," written by the majority (Democratic) staff of House Oversight Committee for Chairman Henry Waxman - not for the committee as a whole.


Predictably, it's a political document, not approved by the full committee, and just as predictably it's an anti-preemption screed, produced at public expense.


The staff report collects the internal dissents of 2 FDA staffers (Drs. Jenkins and Axelrad), see pp. 2, 4-14, from the agency's conclusion in 2006 that the realities of modern tort litigation - the advent of claims, such as fraud on the FDA, SSRI/suicidality claims, failure to contraindicate, etc., that sought to overturn or ignore in-force FDA decisions - more strongly implicated preemption than in the past.


Two objectors aren't very many in an organization as big as the FDA. Indeed, they are outnumbered, even in the report, by the FDA's preemption supporters (at least Troy, Ray, Bradshaw, Masoudi - probably others, but we're being conservative). The small sample size suggests that Waxman's staff may have chosen to focus only on a couple of career FDA officials who opposed preemption, without mentioning those career officials who supported it. We can't say for sure, since we don't have unlimited taxpayer funding, nor do we wield congressional subpoena power.


But we do know this: In litigation, we often see an advocate choose documents selectively, and the truth only comes out when the entire documentary record is disclosed. Indeed, we hardly see anything else. And we see it here. The report quotes (on p.5) a 6/18/03 email from Dr. Jenkins, to Dr. Axelrad and others, but the appendix, also on page 5, reveals a significant omission:
I agree with the idea that we should preempt state requirements for labeling of drugs. It makes no sense for us not to have a federal system for labeling approved drugs that is based on a careful scientific review of the available data and a consistent application of labeling policies across products. I see this as a legitimate FDA area of involvement given our statutory authority over the drug approval process.
We aren't going over them all - we're not on the taxpayer's dime, after all. But this one example is enough to convince us that we're looking at advocacy, not oversight, in this report.


We also know this: The basic thrust of the report - that the FDA's preemption position is a purely political gambit by the Bush administration, see p.1 - isn't true. The FDA has been going to court advocating preemption at least as far back as 1991, when product liability discovery threatened its voluntary reporting system. The current string of pro-preemption position FDA amicus briefs began in 1999, during the Clinton administration, in response to the burgeoning of fraud on the FDA litigation.


This is all a matter of public record. We've compiled the complete history of FDA pro-preemption amicus briefs, with links to every brief, here. And we didn't spend a dime of taxpayer funds, issue a single subpoena, or write a single threatening letter to the FDA.


Not only that, the FDA has a long history, going back at least to the 1970s, of supporting preemption in various contexts. It's all in the Federal Register - and none of it's in this staff report. But have no fear, we've laid it all out, here. For example, here's a tasty nugget from 1995:
Under the Supremacy Clause of the Constitution, State laws that interfere with or are contrary to Federal law are invalid. Federal preemption can be express (stated by Congress in the statute) or implied. Implied preemption can occur in several ways. Preemption may be found where the scheme of federal regulation is sufficiently comprehensive to make reasonable the inference that Congress left no room for supplementary state regulation, or where the federal interest is so dominant that the federal system will be assumed to preclude enforcement of state laws on the same subject.

Federal preemption may also be found where Federal law conflicts with State law. Such conflict may be demonstrated either when compliance with both federal and state law is a physical impossibility, or when State law stands as an obstacle to the
accomplishment and execution of the full purpose and objectives of Congress. State law is also preempted if it interferes with the methods by which a Federal law is designed to reach its goals.

Additionally, a federal agency acting within the scope of its congressionally delegated authority may preempt state regulation and hence render unenforceable state or local laws that are otherwise not inconsistent with federal law. Federal regulations have no less preemptive effect than federal statutes.

When an agency’s intent to preempt is clearly and unambiguously stated, the Court’s inquiry will be whether the preemptive action is within the scope of that agency’s delegated authority. If the agency’s choice to preempt represents a reasonable accommodation of conflicting policies that were committed to the agency’s care by statute the regulation will stand unless it appears from statute or its legislative history that the accommodation is not one that Congress would have sanctioned. . . .

Conflicts between State and local . . . laws and Federal law . . . justify FDA’s preemption of these laws. Although Congress did not expressly preempt State law in this area, the agency’s action is appropriate because State and local laws significantly interfere with the methods by which the Federal law is designed to achieve its goals.

60 Fed. Reg. 16962, 16965-66 (FDA Apr. 3, 1995) (lots of citations and internal quotation marks omitted). There's lots more where that came from. Again, it's all free of charge, no taxpayer $$$ being used.


The report also attacks the 2008 revisions to the FDA's "changes being effected" regulation. See p.3. But the original administrative history of that regulation, dating back to 1982, make it perfectly clear that the CBE regulation was only intended to apply to drug risks that were newly discovered or newly discovered to be much worse. That's precisely what the 2008 change made explicit in the regulation itself, since courts were distorting it, and ignoring regulatory intent. We've blogged about that, too. Moreover, the four examples in the report relating to the CBE exception, see pp. 12, 15-16, all involved newly discovered risk information - precisely what the regulation was always intended to apply to, and still does after the 2008 amendment.


With respect to the 2008 amendments to CBE regulation, there's just no "there there" in the report. The two more recent situations mentioned on pp. 15-16 raise issues involving the "Highlights" section of post-2006 drug labeling - and do not implicate the CBE regulation.


So we hope the report's intended audience (the Supreme Court and the press - certainly not us) will view the report as the political/advocacy document it is, and treat it with the proper (high) degree of skepticism. The report's omissions are at least as significant as what it includes.

Our Terrible Twos!

The Drug and Device Law Blog turns two today!

We're feeling our age.

Last year, when we turned one, we threw a party. This year, we're turning philosophical.

We think that "blog years" are like "dog years." They don't correspond to the human lifespan or the time it takes for the earth to circle the sun.

Thus, at two, we're middle-aged. We've seen many, many blogs launched after we launched ours, and we've seen a fair number of those close up shop, while we labor on.

We have a question for someone with access to the data: What percentage of legal bloggers stop publishing within 12 months of launching a new blog?

We don't know the answer to that, but we bet it's like small businesses -- most fail within a year.

Why?

First, as we've said before, blogging is hard, hard work. It's not easy to maintain an active legal practice by day and find time at night for massive "recreational" writing. Try writing five or six shorts articles a week (which is what we've averaged) for just one week. Think about what that would feel like for three months. And now imagine what we're celebrating today -- two years cranking out posts at that pace.

(Hey, Bexis -- You're right! We're nuts! What in God's name are we doing?

Shut up, Herrmann -- and keep typing.)

Second, it's hard to find an audience in the increasingly competitive blogosphere. A successful legal blog needs both a niche and a voice. If you pick the wrong niche, no one will visit.

And if you pick the wrong voice -- which means none at all (if your blog is published by committee), too breezy, or too pompous and bureaucratic -- you'll quickly lose your blaudience.

It's no surprise that new bloggers are quickly discouraged. They're spending nights and weekends drafting blog posts, but no one's reading them. It takes time, and luck, to build a readership.

And us?

Thanks for asking.

We attracted between 25,000 and 30,000 pageviews in the last month, depending on how you count the folks who subscribe through our Google e-mail group (over there in the righthand column).

When we started our little experiment, almost all of our traffic came through our most recent post, whatever topic it discussed. Now that we've basically built, over time, an on-line encyclopedia of drug and device law, we see far more folks doing research on the web and entering the blog through one of our older posts.

Finally, the highlights of our second year:

L'Affaire Berenson. What could be better than that?

Proposing a way of looking at the "change being effected" (or "CBE") process, and then seeing that idea codified in a new regulation. That's pretty cool.

Watching the reach of our blog spread -- on the web, in scholarly legal publications, and in the popular press. She's our baby, and we love to see her grow.

And, finally, you. We've met an awful lot of people -- some on-line, some in person -- as a result of our experiment, and we've both enjoyed meeting you and learned from you.

So, thank you.

And, if our strength holds out, we'll survive our terrible twos and be back to celebrate another anniversary on October 30, 2009.

Heaven help us.

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.

Tuesday, October 28, 2008

Welcome, ABA Journal Readers!

We were pleased to see that the November issue of the ABA Journal, in the article titled "Pre-emption Prescription," did not merely quote one of your humble scribes, but also referred to our little experiment as "the authoritative Drug and Device Law blog."

We knew we were something, but we were struggling to come up with the right adjective. Having read it, we now think that "authoritative" sounds good to us.

We extend a warm welcome to our visitors from the ABA Journal. We're glad you decided to visit.

Learned Intermediary Doctrine In Puerto Rico

On some days, we're writing about how Wyeth v. Levine will affect the entire pharmaceutical industry.

On other days, we're writing about a federal court predicting state law on the learned intermediary doctrine in Puerto Rico.

Welcome to day two.

In Mendez Montes de Oca v. Aventis, Civil No. 02-2608, 2008 U.S. Dist. Lexis 75892 (D.P.R. Sept. 30, 2008), Mendez's estate and family members sued Aventis pleading that Mendez developed a cancerous tumor as a result of an injection of the insulin product Lantus.

The package insert for Lantus accurately described the carcinogenicity data for the drug, as developed in animal studies. Id. at *7-*8. Plaintiff's expert "opined in his report that the 'professional product labeling of LANTUS provided to physicians fully disclosed the carcinogenicity potential of the product.'" Id. at *19. The expert opined, however, that the "'product labeling provided to patients did not disclose this important issue.'" Id.

The expert confirmed his thinking at deposition:

Q. You think that the FDA and Aventis did a good job with the end result of the labeling that went to physicians?
A. Correct.
Q. Your criticism is with respect to the information that went to patients, is that correct?
A. Correct.

Id.

That sets up a pretty clean test of the learned intermediary doctrine, doesn't it?

And the doctrine wins.

First, the learned intermediary doctrine "seems to be widely accepted," and "has been applied in Puerto Rico." Id. at *13.

Second, "[b]ecause the warning is directed at the prescribing physician, its adequacy is assessed with reference to the physician, not the patient." Id. at *15.

On this factual record, the court granted Aventis's motion for summary judgment based on the learned intermediary doctrine.

The court noted the supposed exception to the learned intermediary doctrine "in cases of direct to consumer advertisement by the drug manufacturing companies." Id. at *18. That approach, however, "has not been widely accepted." Id. Even if the Puerto Rican court recognized this exception, the Mendez "case is devoid of any evidence intimating that decedent even saw informational material regarding Lantus prior to his visit to Dr. Trabanco." Id. at *21. "At no point do any of the plaintiffs specifically indicate . . . that decedent was swayed by advertising promoted by Aventis to the general public which promotion led Mr. Mendez to request the product from his physician." Id. The direct-to-consumer advertising exception thus probably doesn't exist; even if it does, it wouldn't change the result.

Mendez may not be earth-shaking news, but it's nice to have another case come down on the good side of the ledger.

Monday, October 27, 2008

Does Tort Litigation Improve Drug Safety?

There are many eyes to the preemption storm.

But one of those eyes is surely this: Does tort litigation improve the safety of drugs?

The plaintiffs' bar screams yes: It insists that lawsuits unearth new information that protect the public.

Is that true?

We haven't seen any empirical scholarhip on this point (though, Lord knows, it might exist, and we simply haven't come across it). And it's pretty hard to research this question, given the nature of what you're looking for.

But we've found a few authorities that suggest that tort litigation rarely contributes to protecting public health.

Thus, for example, Richard Epstein recently wrote:

"The drugs that usually generate the most litigation -- such as Rezulin and Vioxx -- usually are withdrawn before litigation commences. Indeed the plaintiffs' bar rightly free rides on FDA determinations, reducing the social gain from litigation."

Richard A. Epstein, "The Case For Field Preemption Of State Laws in Drug Cases," 103 Northwestern University Law Review Colloquy 54, 59-60 (2008) (and the usual link).

Epstein's not alone. Anita Bernstein wrote last year:

"[N]ot since the litigation-hastened demise of the very dangerous Dalkon Shield intrauterine device in 1974 has any pharmaceutical product demonstrated that personal-injury liability can be a source of social utility. Take Vioxx as an exemplar of what personal-injury liability has not achieved. Plaintiffs' lawyers did not discover its dangers; the drug had already left the market before a jury verdict came in against it; increases in talk about improving drug safety policy also had predated liability for this drug; and personal-injury litigation did not generate information to benefit the consuming public."

Anita Bernstein, "Enhancing Drug Effectiveness and Efficacy Through Personal Injury Litigation," 15 J.L. & Pol'y 1051, 1055 (2007) (here's a link through Hein Online, but we're not sure if everyone will be able to click through it). (Note that we disagree with Bernstein's suggestion that the solution is to increase tort liability on manufacturers. We cite the piece only for its recognition that the current state of tort law seemingly does little to improve drug safety.)

Peter Schuck writes, in a forthcoming article in the Roger Williams University Law Review:

"FDA regulation of drug risks is subject to many monitoring institutions, both specialized and generic, other than tort law. In this specific area, it would be surprising indeed if lay plaintiffs' lawyers originated this information -- as distinguished from marshalling and shaping information unearthed by others into more focused, tendentious forms for litigation purposes."

Peter H. Schuck, "FDA Preemption of State Tort Law in Drug Regulation: Finding the Sweet Spot," __ Roger Williams University Law Review __ (2009) (available at SSRN here).

This leaves us with a thought and a suggestion:

The thought: If it hasn't already been done, someone should undertake some empirical research on this question. The result could be an important piece that could inform public policy.

And the suggestion: Until the empirical data exist, defendants should not concede that pharmaceutical tort litigation improves the public health. What little we've found on the subject suggests that it does not.

Friday, October 24, 2008

Federal Circuit Upholds "Reverse Payment" Patent Settlements

Kevin McDonald and Larry Rosenberg of Jones Day contributed this guest post, for which we thank them. As always, since it's a guest post, blame them, not us! (Yeah, yeah -- they get the credit, too.) The views expressed in this post, as you would expect, reflect only the views of the authors, and not necessarily the views of their clients or firm:


On October 15, 2008, the Federal Circuit joined the growing list of federal courts to hold that the use of cash payments to settle Hatch-Waxman patent litigation does not violate the antitrust laws as long as (1) the settlement excludes no more competition than would the patent itself and (2) the claim for patent infringement and/or validity is not a “sham,” that is, not “objectively baseless.” In In re Ciprofloxacin Hydrochloride Antitrust Litigation, No. 08-1097, 2008 WL 4570669 (Fed. Cir. Oct. 15, 2008), a unanimous panel of the United States Court of Appeals for the Federal Circuit affirmed the summary judgment granted to Bayer by the United States District Court for the Eastern District of New York, holding that Bayer’s settlement of patent litigation with a generic pharmaceutical manufacturer did not violate the antitrust laws.

The Federal Circuit’s decision is another defeat for those in the FTC and plaintiffs’ bar who have attacked patent settlements in cases brought under the Hatch-Waxman Act that contain so-called “reverse payments,” that is, payments made by the patent holder to the generic challenger. The Federal Circuit now joins the Second and Eleventh Circuits, as well as other notables such as Judge Richard Posner, in emphatically rejecting the plaintiffs’ theories that such settlements are anticompetitive.

These cases arise, in the words of the In re Ciprofloxacin District Judge, as a “natural byproduct” of the FDA’s Hatch-Waxman procedures, which govern FDA approval of generic versions of branded drugs. In this case, Barr Laboratories sought permission to market a generic version of Cipro before the expiration of Bayer’s patent on Cipro’s active ingredient. To get around the patent listed for Cipro, Barr certified that Bayer’s patent was invalid. Bayer then filed a patent infringement suit against Barr, which by statute stayed the FDA approval of Barr’s generic drug for 30 months. The parties later settled the patent suit. Bayer made cash payments to Barr and granted it a license to enter the market with a generic version six months before the patent expired, while Barr dropped its challenge to the validity of Bayer’s patent.

After the settlement with Barr, Bayer had the Cipro patent successfully reexamined by the PTO, and then litigated the validity of the patent against three other generic challengers, winning each time. Nonetheless, private plaintiffs later brought over 40 separate class action complaints against Bayer and Barr, asserting that the use of “reverse payments” from patent holder to challenger in the settlement was illegal under the antitrust laws. Based on two early enforcement actions by the FTC, similar cases were brought against other Hatch-Waxman litigants around the country.

In March 2005, Judge David Trager ruled that the settlement did not violate the antitrust laws because the settlement excluded no competition beyond the exclusionary scope of the patent. See In re Ciprofloxacin Hydrochloride Antitrust Litig., 363 F. Supp. 2d 514 (E.D.N.Y. 2005). As to reverse payments, Judge Trager pointed out that the Hatch-Waxman procedures create a scenario in which the generic challenger can potentially invalidate a valuable patent without even entering the market. The generic thus has everything to gain (free entry) and the patent holder everything to lose (the patent). As a result, the consideration required to settle such a case, whether in the form of cash, a license, or something else, necessarily flows from the patent holder to the generic challenger. The real question for antitrust purposes is whether the settlement keeps out any lawful (that is, non-infringing) competition. Because the antitrust laws do not protect competition that infringes a patent, the court concluded that the settlement of a patent claim brought in good faith (i.e., not a “sham”) that is no broader than the exclusionary scope of the patent itself cannot harm competition.

The Federal Circuit affirmed in all respects. Judge Prost wrote for the panel that, whether a patent settlement is analyzed under the antitrust laws or the patent laws, the same principle guides the inquiry: In the absence of evidence of fraud before the PTO or sham litigation, the question is “whether the agreements restrict competition beyond the exclusionary zone of the patent.” 2008 WL 4570669, at *9. The court held that because any anticompetitive effects of the settlement agreement were within the scope of the Cipro patent, the agreements could not violate the antitrust laws. The court also rejected plaintiffs’ argument that other generic challenges had been precluded by the settlement from entering the market, noting that the Cipro patent had been subsequently challenged multiple times and held to be valid by district courts and the Federal Circuit.

The FTC has taken the position that all of the court decisions ruling in favor of antitrust defendants on this issue are wrong, and has sought Congressional legislation to overturn them. The plaintiffs in In re Ciprofloxacin may ask the Supreme Court to review the case, although the Court has denied certiorari in all four of the federal appellate cases previously decided on this issue. In one of those cases, Schering-Plough Corp. v. FTC, 402 F.3d 1056 (11th Cir. 2005), the FTC filed its own cert. petition after losing in the 11th Circuit, whereupon the Solicitor General and the DOJ, when asked by the Supreme Court for their views, opposed the FTC’s petition.

An ER Doc's Take On Preemption

There's been a lot written about drug preemption in the last couple of weeks, and they'll be more in the next two, as Wyeth v. Levine heads for argument in the Supreme Court on November 3.

But we thought this was an interesting perspective -- from an emergency room physician who has experience injecting Phenergan, and who doesn't think that IV push administration should be contraindicated.

Hat tip to Point of Law.

Interesting New PMA Device Preemption Case

Everybody defending PMA medical device defendants should read Parker v. Stryker Corp., 2008 U.S. Dist. Lexis 84938 (D. Colo. Oct. 22, 2008), granting a preemption-based Rule 12(b)(6) motion to dismiss.

Parker contains a number of useful holdings:

(1) Under Twombly a plaintiff can't state a claim simply by alleging that the defendant "violated FDA regulations" without alleging some facts to back up the claim. Id. at *8.

(2) A "parallel" violation claim is not stated by "by reference to provisions of the FDCA that govern the sale of adulterated and misbranded devices because there is no private right of action under the FDCA." Id. at *9. For more on the tension between "parallel" violation claims and the lack of a private FDCA right of action see our post here.

(3) Alleging warning letters is not sufficient to state a claim without some facts tying the letters to the plaintiff's case. Id. at *10-11.

(4) Express warranty claims based on statements made in FDA-approved product labeling are preempted. Id. at *12-15.

Thursday, October 23, 2008

Partial SJ in "Bodysnatcher" cases

In a lengthy opinion available here, Judge Martini in the In re Human Tissue Products Liability Litigation MDL has ruled the plaintiffs' expert causation opinions (including the ubiquitous Suzanne Parisian, M.D.) inadmissible under Daubert with respect to the most serious diseases at issue in the litigation (HIV, hepatitis B&C, syphillis, prion disease, and cancer), and has granted partial summary judgment. Lots of good stuff about extrapolation.

Thanks to Tony Vale for passing the good news along.

Sleeper Case, Sleeper Issue

It got hardly any attention in the blawgosphere at the time – aside from us, 360, and the hardcore Supreme Court junkies over at SCOTUSBlog (and even they buried it in the middle of a routine post) – but earlier this month the Supreme Court indicated interest in the certiorari petition from the Farm Raised Salmon case. They asked the Solicitor General for his views. See Albertsons, Inc., v. Kanter, No. 07-1327 (U.S. Oct. 6, 2008).
That’s the fish – read, food – preemption case that we blogged about several months ago when it was decided by the California Supreme Court.

As we alluded to in those prior posts, Albertsons/Farm Raised Salmon is – or at least could be – of significant interest to those of us on the drug and device side of the FDA’s regulatory reach.

How come?

Because lurking beneath the food-specific aspects of the case, Albertsons/Farm Raised Salmon presents questions regarding the proper interpretation and application of the exclusive enforcement provision of the Food, Drug and Cosmetic Act (“FDCA”), 21 U.S.C. §337(a).

We’ve gone through Albertsons/Farm Raised Salmon before in some detail, so you’ll have to go there for the full skinny. For present purposes, we’ll only briefly review the bidding: (1) plaintiffs – so-called “private attorneys general” under the state consumer fraud statute – sued defendants alleging that they improperly used coloring agents in fish in violation of FDA food standards; (2) defendants said “you can’t do that” because §337(a) limits FDCA enforcement to the federal government; (3) the Supreme Court said “yes, they can” because: (a) 21 U.S.C. §343-1(a) allows state enforcement of FDCA violations in the food area, and (b) a private action for violating the state consumer fraud statute, incorporating the standards of California’s “little FDCA” statute (also known as the Sherman Act), which in turn just happens to incorporate the FDA’s food standards, is a matter of “state,” not “federal,” enforcement. In re Farm Raised Salmon Cases, 175 P.3d 1170, 1175, 1178, 1181-82 (Cal. 2008).

As far as §343-1(a) is concerned, maybe the salmon makers get eaten by the bears – or maybe not – it’s not our fight. But we’re very interested indeed in how the Solicitor General/DOJ/FDA, and ultimately the Supreme Court, might respond to item (2), that §337(a) limits FDCA enforcement to the feds, and item 3(b), that all it takes to get around §337(a) is for a state to “incorporate” FDCA standards verbatim.

We know from Buckman Co. v. Plaintiffs’ Legal Committee, 531 U.S. 341 (2001), that §337(a) has preemptive effect. But we’ve been pondering for some time exactly what kind of preemptive effect that is. Now, we think we’ve figured it out. The key is – surprise – what Buckman had to say about §337(a). And what the Court held is, first, §337(a) “leaves no doubt that it is the Federal Government rather than private litigants who are authorized to file suit for noncompliance with the medical device provisions” and, second, the provision is “clear evidence that Congress intended that the [statute] be enforced exclusively by the Federal Government.” Buckman, 531 U.S. at 349 n.4 (for the first quote), 352 (for the second).


Exclusively.

In our prior post on Albertsons/Farm Raised Salmon we described §337(a) preemption as “really powerful – perhaps the most sweeping available. . .under the FDCA” and that “it essentially ousts all private litigation.”

We probably should have taken our analysis one step further, but that post was mostly about the California decision, not §337(a).

What does the Buckman language sound like?

Field preemption. A small field (limited to the enforcement of FDCA violations), to be sure, but a strategically situated one.

The classic definition of field preemption is that “state law is pre-empted where it regulates conduct in a field that Congress intended the Federal Government to occupy exclusively.” English v. General Electric Co., 496 U.S. 72, 79 (1990) (emphasis added). See, e.g., Sprietsma v. Mercury Marine, 537 U.S. 51, 64 (2002) (quoting English); American Insurance Ass’n v. Garamendi, 539 U.S. 396, 420 n.11 (2003) (“field preemption might be the appropriate doctrine. . ., without reference to the degree of any conflict, the principle having been established that the Constitution entrusts [the subject] exclusively to the National Government”) (emphasis added); Zschernig v. Miller, 389 U.S. 429, 442 (1968) (field preemption involves “a domain of exclusively federal competence”) (emphasis added). Field preemption has been found as a consequence of “overpowering federal policy in the civil enforcement provisions” of a federal statute. Rush Prudential HMO, Inc. v. Moran, 536 U.S. 355, 375 (2002), albeit a statute other than the FDCA.

The more we think about it, what §337(a) does is demonstrate Congress’ intent to carve out enforcement of the FDCA as a field from which state activity is simply excluded. Only the federal government can institute legal action to enforce allegations of violations of the FDCA:
Except as provided in subsection (b) of this section, all such proceedings for the enforcement, or to restrain violations, of this chapter shall be by and in the name of the United States.
21 U.S.C. §337(a). Food producers run into trouble with subsection b – which lists as exceptions a bunch of provisions (21 U.S.C. §§341, 343(b), 343(c), 343(d), 343(e), 343(f), 343(g), 343(h), 343(i), 343(k), 343(q), or 343(r)) relating to food.

Drug and device companies don’t have that problem, which – as we explained in our prior post – is why the California Supreme Court had to jump through all the hoops it did to avoid preemption.

So with this point in mind, we look at the defendants’ certiorari petition in Albertsons/Farm Raised Salmon. Because it’s filed by a food defendant, the petition naturally targets the disconnect between the “state” enforcement allowed by §337(b) and the “private attorney general” action permitted by the California Supreme Court.

But §337(a) is lurking through out. Right up front, in the statement of the case, the petition states: “When Congress enacted the FDCA in 1938, it deliberately and consciously rejected the possibility of private enforcement in favor of exclusive federal enforcement.” Petition at 3. That’s something we read as field preemption more or less. The petition goes on, necessarily, to discuss the 1990 food-related amendment, id., but for us drug/device types, we don’t have to worry about that. There’s a whole lot more:

From its inception in 1938, the FDCA was intended to be enforced by the federal government – and not by private parties. In fact, Congress considered and rejected a version of the statute that would have allowed a private right of action. [citations omitted] It opted instead for a provision mandating that “all” proceedings “for the enforcement, or to restrain violations” of the FDCA “shall be by and in the name of the United States.” 21 U.S.C. § 337.

In keeping with its plan of exclusive federal enforcement, Congress afforded the Food and Drug Administration (“FDA”), the responsible federal agency, a wide range of enforcement options. . . . As part of its careful design, Congress also gave the FDA the power not to prosecute “minor violations of [the Act] whenever [it] believes that the public interest will be adequately served by a suitable written notice or warning.” 21 U.S.C. §336. Congress thus ensured that the federal government would decide whether and how to enforce the law.

Courts interpreting the FDCA’s enforcement framework before it was amended in 1990 held that Congress had deliberately excluded private claims by placing enforcement exclusively in the hands of the federal government, see, e.g., Pacific Trading Co. v. Wilson & Co., 547 F.2d 367, 370 (7th Cir. 1976) (“[T]he statute does not provide a cause of action for private parties suing for civil damages.”), even those claims brought under state law, see, e.g., National Women’s Health, 545 F. Supp. at 1181 (holding that a private right of action to enforce FDCA standards is “inconsistent with the federal regulatory scheme, whether the right is based in federal or state law”); Animal Legal Defense Fund Boston, Inc. v. Provimi Veal Corp., 626 F. Supp. 278, 283 (D. Mass. 1986) (same).


Cert. petition at 4-5, see also id. at 14-16 (more discussion of cases holding that §337(a) precludes various forms of private enforcement). Thus the petition takes the position that §337(a) in its original form – the form that applies to drugs and devices – precludes private FDCA causes of action and similar actions under both state and federal (usually Lanham Act) law. Again, that sounds like a field preemption argument to us.

And we know there are lots and lots more of these types of cases than just the few cited in the petition, because they’re in Bexis’ book. If we had infinite time, we’d cite them all, but we don’t.

There must be a couple hundred cases for the no-private-cause-of-action proposition. They’re in Bexis’ book §4.02[1] footnote 14.

Section 336, the “minor violations” provision cited in the petition, gives the government “rather broad discretion – broad enough undoubtedly to enable [it] to perform [its] duties fairly without wasting [its] efforts on what may be no more than technical infractions.” United States v. Sullivan, 332 U.S. 689, 694 (1948); see Bexis’ book §4.02[1] footnote 11.

Congressional preclusion of private enforcement “cannot be overstated” – because to allow courts to “provide remedies for violations of [the FDCA] solely because the violation of the federal statute is said to be a ‘rebuttable presumption’ or a ‘proximate cause’ under state law” would “flout, or at least undermine, congressional intent.” Merrell Dow Pharmaceuticals, Inc. v. Thompson, 478 U.S. 804, 812 (1986); see Bexis’ book §4.02[2] footnotes 42-47.

As for the Lanham Act:
[P]ermitting [plaintiff] to proceed on the theory that the defendants violated [the Lanham Act] merely by placing their drugs on the market would, in effect, permit [plaintiff] to use the Lanham Act as a vehicle by which to enforce the Food, Drug, and Cosmetic Act (“FDCA”) and the regulations promulgated thereunder. An attempt, by ingenious pleading, to escape one principle of law by making it appear that another not truly appropriate rule is applicable appears to have been attempted.
Mylan Laboratories, Inc. v. Matkari, 7 F.3d 1130, 1139 (4th Cir. 1993); see Bexis’ book §4.02[2] footnote 41.

Thus, we’ll be very interested in how the FDA and the Department of Justice interpret the preemptive effect of §337(a) generally – presumably before they get around to addressing the food-related aspects of the Albertsons/Farm Raised Salmon appeal.

We’re also interested in the other issue, whether FDCA-based violation claim can be “laundered” through a state statute so that it avoids §337(a) even though the state standards are substantively identical to the FDA’s standards. That issue is not treated in any great legal detail in the certiorari petition, but is preserved, with a footnote listing cases nationwide involving other state statutes where the same violation laundering could be attempted. Petition, at 23-26 & n.5.

Our view (not surprisingly, since we’re defense lawyers) is that substance controls – not form. The Congressional intent to preclude private enforcement that led it to insert an exclusivity provision in the FDCA cannot be so easily overcome by merely slapping a “state law” label on a federal standard. In this respect (and only in this respect), we think we’re helped by the language of the food provision, §343-1(a), which states, in pertinent part: “no State or political subdivision of a State may directly or indirectly establish. . . .” (emphasis added). Plainly, Congress wasn’t intending to allow states to do by indirection what they could not do directly under §337(a) – that is, to enforce FDCA standards.

The laundering of federal violation claims through state statutes incorporating those same federal standards verbatim is the same sort of “ingenious pleading” that courts such as Mylan Laboratories have already rejected in the Lanham context in cases where §337(a) fully applies. We think that, should it take the case, the Supreme Court would also be unlikely to view such slight of hand very indulgently.

So we’ll be very interested in what the FDA/DOJ has to say about this issue as well, when it responds to the Supreme Court’s invitation. The plot is only thickened by the two issues we’re following not necessarily being outcome determinative in this particular case. While it’s hard to see how the defendants in Albertsons/Farm Raised Salmon could prevail if the government took an unfavorable position on the exclusivity and violation laundering issues, it’s not that difficult to envision a brief where the government went our way on these two underlying issues, but still allowed food defendants to be sued purely on food-specific grounds.

We now come to the crux of the matter. We’ve told you that we’re very interested in these two issues that arise in Albertsons/Farm Raised Salmon. Now we’ll tell you why.

Recent preemption developments concerning drugs and devices have painted a great big target on §337(a)’s back in our area. In Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996), the Court apparently didn’t consider §337(a) when it decided that “parallel requirements” claims were not expressly preempted with respect to “substantially equivalent” medical devices:
Nothing in §360k denies Florida the right to provide a traditional damages remedy for violations of common-law duties when those duties parallel federal requirements. . . . The presence of a damages remedy does not amount to the additional or different “requirement” that is necessary under the statute; rather, it merely provides another reason for manufacturers to comply with identical existing “requirements” under federal law.
518 U.S. at 495 (emphasis added). “Identical” state requirements might be just peachy under 21 U.S.C. §360k, but if they amount to attempts at state enforcement of FDCA violations, then (we would argue) they fall smack within that narrow field preempted by §337(a).

The Court in Buckman recognized that §337(a) could be a barrier to the types of claims discussed in Lohr, but given all of the other things that it found wrong with fraud-on-the-FDA claims, the Court didn’t have to resolve the tension between “parallel” claims and FDCA enforcement exclusivity:

Notwithstanding the fact that [Lohr (the Court uses “Medtronic,” but there are so many Medtronic cases that we think the plaintiff name is less confusing)] did not squarely address the question of implied pre-emption, it is clear that the [Lohr] claims arose from the manufacturer’s alleged failure to use reasonable care in the production of the product, not solely from the violation of FDCA requirements, however, the fraud claims exist solely by virtue of the FDCA disclosure requirements. Thus, although [Lohr] can be read to allow certain state-law causes of actions that parallel federal safety requirements, it does not and cannot stand for the proposition that any violation of the FDCA will support a state-law claim. In sum, were plaintiffs to maintain their fraud-on-the-agency claims here, they would not be relying on traditional state tort law which had predated the federal enactments in questions.

531 U.S. at 352-53 (emphasis added). As we’ve discussed elsewhere and will not repeat here, Buckman thus disposed of the fraud-on-the-FDA claims because they were not “parallel” to anything in traditional state law, and thus did not have to resort directly to §337(a) preemption.

Then the Court in Bates v. Dow Agrosciences LLC, 544 U.S. 431, 447-48 (2005), took the “parallel requirements” concept from Lohr and applied it to a different statute (FIFRA) that didn’t have a counterpart exclusive enforcement provision like §337(a).

Then, through happenstance, the Court in Riegel v. Medtronic, Inc., 128 S. Ct. 999 (2008), recognized express preemption of just about all claims against PMA medical devices except “parallel” requirements. The Court didn’t find that such claims necessarily escaped preemption, but only that plaintiffs waived the issue entirely. Id. at 1011.

To top everything off, as we’ve discussed, there are no “parallel” claims asserted in Wyeth v. Levine. Thus we don’t expect the Supreme Court to address that topic in the Levine case either. If our side wins in Levine, “parallel” FDCA violation claims would undoubtedly become more important on the drug side as well.

So, as anybody who follows drug/device preemption law knows full well, “parallel” claims involving claimed FDCA violations are one of the hottest topics around, especially on the device side, where for PMA devices they’re now just about the only game in town.

But just about all of those parallel precedential lines lead inexorably back to that narrow, but strategically situated field that, we believe, §337(a) reserves “exclusively” to actions brought by and in the name of the federal government. In short, under §337(a), the type of “parallel” violation claims that the Court in Lohr hypothesized might exist may well not exist at all, and certainly not in any great numbers.

That is, (1) if there’s field preemption, or something similar, created by §337(a)’s “exclusive” grant of FDCA enforcement to the federal government, and (2) private plaintiffs can’t avoid preemption by laundering FDCA violation claims through state statutes.

Those are precisely what we see as the sleeper issues that lurk in what, so far, has been a sleeper case.

And since those are two of the questions posed by the certiorari petition in Albertsons/Farm Raised Salmon, we will very interested indeed to find out how the Solicitor General addresses them when it the DOJ and (through DOJ) the FDA respond to the Supreme Court’s invitation.

Kotler's Alternative to Standard Preemption Analysis

Here's another post along the lines of "all preemption, all the time."

Professor Martin Kotler of Widener University School of Law has posted on SSRN his manuscript Shared Sovereign Immunity as an Alternative to Federal Preemption: An Essay on the Attribution of Responsibility for Harm to Others. Professor Kotler argues that courts ought not to look to Congressional intent to determine whether preemption exists. Rather, the question is one of sovereign immunity: If a government has sufficiently constrained a company's ability to act, then the company ought not to be faulted for what the government compelled. The government should "share" its sovereign immunity with the manufacturer.

Here's the money quote:

"If a defendant is confronted with liability resulting from conduct which was compelled by congressional mandate or regulatory command, fairness considerations demand that the sovereign immunity available to the governmental entity also be made available to the private actor. In the absence of compulsion, however, there is no reason that state tort law should not be permitted to demand that individuals and entities accept responsibility for having caused harm."

Hat tip to Torts Prof.

Wednesday, October 22, 2008

National Politics And Product Liability Settlements

Everyone knows that uncertainty induces settlement.

The parties know it: File a dispositive motion; then, open settlement talks.

The judges know it: Have a stack of unresolved motions in limine, or a summary judgment motion, sitting on your desk; then, invite the parties in to discuss settlement.

Given that truth, should we be seeing an increase in pharmaceutical product liability settlements over the next two weeks?

Uncertainty is surely in the air. It's drifting about along with the autumn leaves.

How will the Supreme Court rule in Wyeth v. Levine?

If the decision favors industry, then who will be the next president, and how will he feel about preemption? (We have, of course, already spoken on that score.)

Will the Democrats gain a filibuster-proof majority in the Senate?

(The argument raised in Levine is constitutional in nature, grounded in the Supremacy Clause of the Constitution. Clever legislators could, however, surely draft mere statutes that would effectively undo any protection that a favorable decision provided to drug companies. A filibuster-proof Senate would allow the dominant party, if it were so inclined, to introduce and pass that type of bill.)

As we said, uncertainty's in the air.

We saw the Bextra and Celebrex cases settle last week.

Perhaps the anvil is hot for more settlements to be struck between now and Election Day.

Tuesday, October 21, 2008

Obama Wins!

You read it here first!

It's hard to scoop the mainstream media, so we're jumping the gun to give ourselves a chance: We're calling Barack Obama the winner of the 2008 presidential election.

If North Carolina and Indiana are seriously in play, then this election is over, and Obama won it handily.

(Then again, if we'd been alive in 1948, we'd have called that puppy for Dewey. So take our prediction for what it's worth.)

Also: The Democrats have won 58 seats in the Senate! (We're basically just picking a random number here between 51 and 60. But, if we're wildly wrong, no one will remember. We are, after all, just drug and device lawyers. On the other hand, if we're right, you'll see us on "Meet the Press" on November 9, because we'll be the hottest political pundits of this election cycle.)

Now we'll turn to what interests us: What's the effect of Obama's win on drug and device law?

First, Obama's election will have no effect on the pending case of Wyeth v. Levine. Levine is being argued on November 3. The election is not until November 4. Obama won't be sworn in until January 20.

If changing the face of the FDA is President Obama's first priority, then the country chose pretty poorly. The global economy is collapsing and we're fighting a pair of wars. We're as fascinated by the FDA as the next guy, but the FDA ain't gonna be job one in the Obama administration.

Even if it were, it would take a while to nominate a new FDA Commissioner and to get that person confirmed. And even if the new Commissioner violently opposed preemption, the Solicitor General's office would not change its position in a pending case.

We'll get a decision in Levine some time in the first half of 2009, and a changed administration will have no impact on the result in that case.

Will the Obama administration change the Supreme Court in a way that matters?

There are plenty of Supreme Court scholars who can answer that question better than we can. But our ignorant guess is that Roberts (age 53), Alito (58), Thomas (60), Scalia (72) and Kennedy (72) aren't retiring soon or in a Democratic administration.

The three justices most likely to retire are Stevens (88), Ginsberg (75 and rumored to be in poor health), and Souter (69, but rumored to be considering retirement).

Obama is thus likely to have an opportunity to replace three moderate-to-liberal justices with three new moderate-to-liberal justices. (Remember? We called the Senate at 58 Democrats. If the Democrats win 60 seats, the filibuster-proof majority might be able to replace three moderate-to-liberal justices with three avowedly liberal justices. Even then, that wouldn't dramatically change the result in most cases.)

That covers Wyeth v. Levine and the Supreme Court. What about Congress? We do think that a new administration is far more likely to be able to enact laws (such as the one proposed to undo the effect of Riegel v. Medtronic) than the current divided government can. You might see a change there.

Finally, administrative agencies. A Democratic presidency would make life much easier for the FDA. The FDA has aptly been described as a slow-moving animal that bleeds profusely when wounded. That makes the FDA a favorite target for Congress when it wants to attack an executive branch from a different party. The FDA thus went under seige when the Republicans controlled Congress and Clinton was in the White House, and the agency was again attacked when the Democrats controlled Congress and Bush (II) was in the White House.

Under the new Obama administration, the Democrats will control both the executive and legislative branches, so the FDA will drop out of the spotlight for a while. The agency will have a chance to re-group until we enter the next period of divided government.

If we're right about any of this, maybe we'll go into fortune-telling. It's kind of fun.

Come to think of it, contact us off-line if you'd like our pick for the World Series.