Thursday, February 25, 2010

Bruesewitz Reconferenced

Remember Bruesewitz v. Wyeth?  That's the case about the Vaccine Act and express preemption.  It made our top ten list last year.  Bruesewitz and it's evil twin, Wyeth v. Ferrari, appeared for a while to be headed for the Supreme Court together - there being a direct conflict between the two.  Then the plaintiff in Ferrari got cold feet.  Despite having won below, Ferrari was voluntarily dismissed with prejudice to avoid Supreme Court review.

That left Bruesewitz.  The Supreme Court listed Bruesewitz for conference way back in early November.  Then nothing happened - for a long time.  We even commented upon this holding pattern.

Well, today something possessed us to look again at the Supreme Court's docket for Bruesewitz.  There's finally something to report.  The petitioners (plaintiffs) filed a supplemental brief on February 12, 2010.  Then on February 17, 2010, Bruesewitz was distributed (for a second time) for consideration at the Court's March 5, 2010 conference.

Stay tuned.

Qui Tam Action Looks Like A Ripoff

One of the interesting things about blogging is that a lot of people seem to consider us part of the “press” – whether that’s the “health” press or the “legal” press. As a result, we get sent a lot of unsolicited press releases, maybe a couple of dozen a week. Most of them are from various small medical-related companies announcing this or that medical advance. Since we’re lawyers, not doctors, we’re not competent to evaluate such things, nor would product reviews be what our chosen audience wants to read. Those emails get the “delete” button, even though they've occasionally offered us money for reviews.

But part of the litigation dance these days also involves the press. One thing that the other side does is try to make itself as obnoxious as possible to our clients any way they can.  There's good reason for it.  It’s part of the game; their rationale being that anything that annoys our clients increases the settlement value of their cases.  Even if a case is lousy and has only a nuisance value – the bigger the nuisance, the bigger that value will be.  Or so a lot of folks on the other side thinks.

Among other things, plaintiffs’ lawyers pursue this annoyance function by trying to generate negative buzz about our clients in the media.  So they (or their PR flacks) send out press releases too. And they send them out to bloggers and other media types who aren’t really competent to make heads or tails of what they’re getting.  In particular, the other side throws adjectives like “illegal” and “fraudulent” around as if they’re so much confetti – or, if (like us) you’re less inclined to be charitable, a smokescreen. Toss in a few vague but dark hints about safety risks, and the other side hopes it can generate negative press. We know all about this as lawyers; it’s part of the drill, especially in the major litigation that we get called upon to defend.
But sometimes the plaintiff side's offerings to the press find their way to us - as bloggers.

Thus, it’s interesting to experience plaintiffs' annoyance function from the receiving end – as recipients of their press releases.  It’s especially interesting where the topic is something that we’re at least marginally competent to evaluate, and not conflicted from doing so. Yesterday we received an email that started out like this:

Thought you should be aware that a qui tam lawsuit against device maker, Medtronic was recently unsealed by the U.S. District Court in Boston.  The key takeaway in this particular case is that lawsuit suggests that Medtronic knowingly made a mockery of the FDA and its 501(k) process. . . .
The email went on to make various other allegations along the same lines.

We don’t do qui tam work, so ordinarily we’d have binned this too. But we are interested in off-label use, and thus we have taken on qui tams that would seek to penalize off-label use. This looked like it might be one of those cases, so we took a look.

The plaintiffs’ publicist is blatantly trying to direct the gullible press recipients of the email – most of whom don’t know jack about the FDA, off-label use, device approvals, or anything else that’s relevant – to the point of hand-feeding them a “takeaway.” Being defense lawyers, you can’t expect us to take away the same thing. Here are two takeaways we have from the email:
  • Any qui tam action filed in the District of Massachusetts (“U.S. District Court in Boston”) should be automatically suspect. If ATRA ever did a hellhole jurisdiction analysis of qui tam actions, that district would rank number one. It’s notorious for letting plaintiffs get away with cases that would be thrown out of court elsewhere.
  • The allegation “knowingly made a mockery of the FDA and its 501(k) process” is hauntingly familiar to us. That sounds almost exactly like the claim made against the defendants in the Bone Screw litigation – and which, when presented as a state-law claim, was unanimously held preempted in Buckman Co. v. Plaintiffs’ Legal Committee, 531 U.S. 341 (2001).
With those two takeaways in mind, we thought we’d take a closer look.

But before we get into this particular case, a couple of preliminary points:  First, we’re defense lawyers. If you don’t want a critical review of this case, go somewhere else.  Second, although we’re defense lawyers, we’re not representing Medtronic on this or on any product liability matter at the moment. These are our reactions, unfiltered by client interest and unfettered by client conflicts.

Now, what we know about the workings of qui tam actions isn’t much. But we do know this. The law (called the “False Claims Act”) was first enacted during the Civil War to prevent the government from getting ripped off by defense contractors. In order to do that, the law appeals to greed. That is, anybody who tips off the government that it’s being scammed gets a share of any recovery of ill-gotten proceeds. The people that the plaintiffs’ lawyers like to call “whistleblowers” can also be described as “disgruntled ex-employees out for a buck.”

The intent of the qui tam statute is to make sure:  (1) that the government gets good stuff (not moldy food, non-functional rifles, or broken-down horses), and (2) the government gets a fair price for the good stuff it’s bought. In the area of prescription drugs and medical devices that means – to us anyway – that the products the government pays for should work for what they’re being used, and that those products are safe (recognizing that all prescription products have risks) for the people using them.  And since the qui tam act has a financial aspect, we’ll add a third purpose:  (3) the government also shouldn't be getting overcharged.

Beyond that, whether there’s been “illegal” promotion of off-label use isn’t any more the concern of private qui tam plaintiffs than it is of private tort plaintiffs, private RICO plaintiffs, or private Lanham Act plaintiffs. As to all of them, whether it’s called “preemption” (in state law litigation) or “standing” (in federal question litigation), we say “go away.”

In the FDCA, Congress said explicitly that the FDA and only the FDA (all right, technically the Department of Justice) has the right to take enforcement action against violators of the Act.  See 21 U.S.C. §337(a).  We did a long post recently, called “What To Do With Unpreempted Fraud On The FDA Claims,” detailing just how Buckman’s policy arguments concerning preemption are equally valid in the context of private parties (such as qui tam plaintiffs) purporting to use other federal statutes to pursue FDCA violations.  In short, private federal fraud on the FDA suits are just as meritless as state-law ones - we just can’t use the word “preemption.”

So – keeping the three points we just mentioned (effectiveness, safety, and price) in mind – we followed the link provided in the email to the qui tam plaintiffs’ lawyers’ website.

The first thing we see is that, while the action against Medtronic has been “unsealed,” there’s no mention in the propaganda piece of the government taking over the suit. That’s an important distinction in this area, and one that most of the “press” recipients of this sort of email wouldn’t know about. If the government thinks there’s anything to a qui tam plaintiff's allegations, it has the right (while the suit’s still under wraps) to take over prosecution of the case. That evidently didn’t happen here, which immediately suggests to us that there isn’t much “there there” – at least in a qui tam/false claims sense – to the plaintiff’s claims.

The second thing we see is a statement way at the end quoting the Wall Street Journal to the effect that “the lawsuit appears to parallel a federal investigation by the Department of Justice in Boston into marketing of the biliary stents.” That’s also important. The qui tam act doesn’t want tag alongs; it denies any share of the swag to people who only tell the government old news. So putting aside anything else, that’s another indication that there’s a lot less to this action than the plaintiffs’ publicist would have the press believe. If the Department of Justice, the folks with proper authority to enforce the FDCA on the FDA's behalf, are already are looking into this, then this stab at private enforcement is superfluous.

The plaintiffs’ propaganda, not surprisingly, is liberally strewn with “wrongfullys,” “fraudulentlys” “deceptivelys” “unlawfuls,” and the like. That’s par for the course with this kind of thing. Nothing unexpected there. There’s also a paragraph about “serious adverse events.” That’s more interesting to us than any lawyer’s purple prose.  That paragraph lists various complications that allegedly attend the use of these stents.  Okay.  All prescription medical products, particularly anything that has to be implanted in the human body, have risks, up to and including death in many instances.  If there weren’t any risks, you wouldn’t need a prescription to get one. We frankly can’t tell from the plaintiff lawyer’s propaganda whether there’s any worse risk in using these stents in this way than might be the case with any alternative product. That’s telling.  Since this is propaganda, if there were any way to spin the facts in order to claim such a worse risk, well, we’d expect to see the lawyers trumpeting that to the skies. There isn’t a peep, so we doubt there’s anything of this sort.

The guts of the plaintiffs’ legal claim, moreover, look quite close to the allegations that the Supreme Court unanimously booted in Buckman. The propaganda piece claims that the defendant defrauded the FDA (“submitted false certifications and statements to the FDA”) in order to get these stents approved (“circumvent government regulations. . .for approval of high-risk medical devices”). Given the reference to “high-risk,” we surmise that the claim might be exactly like Buckman – where those plaintiffs alleged that the defendant improperly used the FDA’s “substantial equivalence” (so-called “§510(k) clearance”) procedure to get a device approved for marketing with the intent of selling it for some other use. We’ll have to look at the complaint to be sure.

Before we do, let’s assess the plaintiffs’ propaganda by our three key qui tam points.
  • (1) Do the devices work (part one of did the government get good stuff)?  We think so.  There’s nothing at all in on the plaintiff’s website claiming that these stents aren’t effective for whatever off-label uses to which they’ve been put.  If there’s even a slim argument that they didn’t do the job, we’d expect plaintiffs to shout that from the rooftops. They don’t, so we assume they work.
  • (2) Are the devices safe (part two of did the government get good stuff)?  The plaintiffs mention various risks and call the devices “high risk.”  But remember these are implantable stents.  All implants have risks and failure rates.  We don’t see any claim that these devices were less safe than any alternatives, and again if that argument could be made any competent plaintiff’s side lawyer would make it – loudly.  So our strong suspicion is that this off-label use isn’t any less safe than available alternatives.
  • (3) Did the government get overcharged? Funny, there’s nothing at all about pricing in the plaintiff’s propaganda. What’s that Sherlock Holmes said about it being “curious” that some dog didn’t bark?  It’s equally curious that there’s no hint of an overcharge claim here.  Frankly, an overcharge seems implausible (yes, we mean that in the Twombly/Iqbal sense) to us.  To the contrary, we suspect that the government got a bargain.  There’s only one reason to go the “substantially equivalent”/§510(k) route rather than seek FDA pre-market approval.  That’s because the first way is a lot easier and cheaper.  In product liability, it’s much better to have a PMA device, because then there’s preemption.  Remember Riegel v. Medtronic, Inc., 552 U.S. 312 (2008)?  So a defendant using §510(k) would probably pass some of the cost savings on to its customers.  In other words, if the defendant had done what plaintiffs’ claim it should have, the government probably would have paid more than it did.
At this point, we’re thinking that this lawsuit is a bleached on the beach, tickle your peach ripoff of the legal system.  But we’ll look at the complaint just to be sure.  We’ve provided the link so you can follow along if you're so inclined.

So what do we see?

1. Yup, it’s an off-label promotion case. U.S. ex rel. Nowak v. Medtronic Complaint ¶¶3, 28-29.

2. Double yup, it’s a reprise of Buckman. The claim is that the defendant got these stents cleared as “biliary stents,” didn’t really intend to sell them for that “intended use,” but rather for an off-label use.  Complaint ¶¶4, 6, 19, 22-23, 31, 57, 62.  There’s even the old Buckman “they changed the approved design” claim.  Id. ¶59.  The specific allegation is that, instead of their being “biliary” stents, the product should have been approved for marketing as “vascular” stents, which require PMA as “high-risk Class III” devices.  That’s where the “high risk” riff comes from.

3. As we suspected, there’s no evidence that these stents are particularly dangerous when used off label.  The Complaint characterizes them as “potentially harmful.”  Complaint ¶9.  Every prescription product is that.  More importantly, there’s nothing suggesting that these stents are more dangerous – or less effective – than alternative products, just that, because of their approval route, they haven’t been tested as much as a PMA device would have been.  Id. ¶60.

Supposedly, an “increased” number of MDRs (“medical device reports” of adverse events) happened.  Complaint ¶¶38, 126, 138.  Again, consider the source.  An increase in reports is to be expected if more doctors believe the devices work and choose to use them more often.  More use = more reports.  As we’ve discussed, among other places such as here, the FDA itself says that adverse event reports can’t establish causation.  And jeez, we don’t think these plaintiffs can do math very well – they actually allege that an off-label use representing “90%” of product use produces “81%” of malfunction reports and “87.9%” of all adverse events that are reported.  Complaint ¶137.  On a per-use basis, that indicates (as much as anecdotal reports indicate anything) that the off-label uses are safer than the labeled uses.

The situation appears to be pretty much a reprise of Bone Screw/Buckman – involving an off-label use that is simultaneously the medical standard of care.  See Complaint ¶108 (stating that procedures involved are “standard of care”).  It would be highly unlikely (albeit not impossible, but then it’s possible for the LHC to create black holes that would destroy the earth) for such a use to be less effective or less safe than alternatives.  Widespread off-label use is highly indicative of a simple fact.  The product in question works for the widely accepted use.  That’s because tt’s exteremely difficult to fool the collective clinical experience of the entire medical community for very long.

4. Yup, forum shopping is the only reason this case was filed in the District of Massachusetts.  The plaintiffs are both from California, and defendant is headquartered in Minnesota.  Complaint ¶¶11-13.  Maybe with the Supreme Court’s recent clarification of what “principal place of business” means, see Hertz Corp. v. Friend, 2010 WL 605601 (U.S. 2010), the defendant can get the case moved to a more neutral forum.

5. Heck, it’s even worse than we thought.  It’s just like that Hopper case we blogged about a couple of months ago.  The allegations are that every off-label use, no matter how much it helped the patient who received a stent, is supposedly a “false claim.”  Complaint ¶¶28, 42-47, 140, 174.

In that respect, plaintiffs’ allegations remind us of those weird handgun nuisance cases that Congress thankfully got rid of.  They’re claiming that knowing promotion of off-label use can be presumed from oversupply – that more “biliary” stents are made than the “biliary” market supposedly can absorb.  Complaint ¶35, 92, 100.

6. Ooey-gooey!  The complaint asserts the most broad and constitutionally indefensible reading of the FDA’s “intended use” regulation, 21 C.F.R. §801.4, possible – that simply knowing about likely off-label use is a form of “illegal promotion.”  Complaint ¶¶8, 20, 28, 73.  As we’ve mentioned, even the FDA swore off that reading in its response to the Allergan suit.  FDA Allergan Mot. at 22 (“[i]n practice, FDA usually does not treat an unapproved use as an intended use solely because the manufacturer knows that the unapproved use is taking place”).

That these qui tam plaintiffs claim illegal off-label promotion predicated on a regulatory construction that the FDA not only doesn’t use but has repudiated, brings their suit squarely within Buckman’s reasoning and may well explain the government’s lack of interest.  It’s a really bad idea to have private plaintiffs going around claiming that defendants are violating the FDA’s regulations basis on a reading of those regulations that conflicts with how the Agency applies those same regulations.  We think that’s a much more important takeaway than anything mentioned in the plaintiffs’ email.

7. Yup again.  Plaintiffs are claiming that, because the defendant used the cheaper §510(k) clearance procedure rather than the more expensive PMA, it undercut its competition.  Complaint ¶¶8, 21-22, 36, 63 (“achieved an unfair competitive advantage”).  In other words the government supposedly got ripped off because it got charged less!!  Words fail us, so we’ll just remind everyone how wise Twombly/Iqbal were to require “plausibility” as a pleading standard.

8. Yuk. Plaintiffs cite to Dan Schultz, Complaint ¶¶34, 127-28, an FDA official who recently resigned under a cloud involving funny business with – you guessed it – device approvals.  For more about that see here and here (among other places).

Here, then, are the “takeaways” that us defense lawyers would offer after a quick read of the complaint in Nowak:

There shouldn’t be any qui tam case here.  First, there’s not even an allegation that the medical devices the government bought didn't work.

Second, the allegations don’t establish lack of safety either.  If anything the off-label uses seem to be relatively less productive of adverse events than these stents’ on-label uses.  There’s no allegation that other products were significantly safer.  In short, the government bought and paid for good stuff.

Third, the government wasn’t ripped off.  The Complaint suggests that these devices were cheaper (Remember the allegation about “competitive advantage”?) than other products that could treat the same conditions.

Fourth, The Nowak case is simply an attempt to piggy-back on, and make some money from, a government investigation of off-label promotion.  The Hopper case, discussed here, makes it crystal clear that purportedly off-label promotion, by itself, can’t be a false claim.

Fifth, to interpret the qui tam/False Claims act as the plaintiffs do would be to impose huge, statutory penalties upon off-label use – off-label use that helps patients – simply due to allegations of “off-label promotion” that supposedly violate the FDCA.  Such a result not only invades the FDA’s jurisdiction to prosecute claimed violations, but would also be harmful to everyone involved in the healthcare system, that is everyone except for parasitic plaintiffs such as these.

Sixth, we’re not saying anything one way or another about the purported off-label promotion.  We’ve already stated our views long and loud that truthful (and only truthful) promotion should protected by the First Amendment.  We continue to believe that the proper way to deal with the regulatory issues arising from widespread off-label use (promoted or otherwise) is for the FDA to establish dollar or percentage benchmarks and then to require off-label uses that exceed those benchmarks to be submitted for Agency review.

All in all, we’re reminded of Judge Weinstein’s recent words when he threw out another overreaching off-label promotion case:
The social value of the product at issue in this litigation is also noteworthy. . . .  [Defendant] has created a product with substantial benefits that even now-after many years of litigation, research, testing, and controversy-is still favored by many physicians and patients. . . .  [T]his lawsuit is an effort. . .to obtain a windfall:  to recoup money [] spent covering a prescription drug for Medicaid beneficiaries even though it does not claim that the drug injured them or that it failed to work. . . .

If allowed to proceed in their entirety, [these] claims could result in serious harm or bankruptcy for this defendant and the pharmaceutical industry generally.  For the legal system to be used for this slash-and-burn-style of litigation would arguably constitute an abuse of the legal process.  Constitutional, statutory, and common law rights of those injured to seek relief from the courts must be recognized.  But courts cannot be used as an engine of an industry’s destruction.

In re Zyprexa Products Liability Litigation, ___ F. Supp.2d ___, 2009 WL 4260857, at *65-66 (E.D.N.Y. Dec. 1, 2009).

So thanks to whoever you are for sending us the email that brought this situation to our attention, even though the result wasn’t exactly what you wanted.  We’re always looking for ideas with which to “feed the blog.”

Wednesday, February 24, 2010

Weasels and weeds

We read lots of cases. A few are flawless and a few have no redeeming features, but most have a little bad mixed with the good, or vice versa. We tend to be curmudgeonly, even though we are down a curmudgeon, and we will fuss about a flaw in a opinion that rules in favor of a drug or device maker. Aaron v. Wyeth, No. 2:07cv927, slip op. (W.D. Pa. Feb. 19, 2010), is such a case.

The facts are unfortunate: Randy Aaron was diagnosed by his psychologist as having serious psychological problems, including major depressive disorder and delusional disorder. The psychologist told Aaron’s primary care physician’s office that Aaron should be evaluated for antidepressants. For some reason, Aaron’s case ended up with another doctor who wasn’t Aaron’s regular physician, just part of the same practice group. This other doctor prescribed Effexor for Aaron without talking to the regular physician or the psychologist. Slip op. at 3. Over the next 11 days, Aaron continued to have problems, told his psychologist that he stopped and started taking his medication, and eventually committed suicide. Id.

Instead of suing the doctors (we’ve blogged before about how a lot of the cases we see are really malpractice cases in disguise) Aaron’s estate representative sued Wyeth, the maker of Effexor. The claims were mostly the usual thing – supposedly inadequate warnings about the risk of suicide in adults and that those supposedly inadequate warnings rather than serious mental illness caused Aaron’s suicide. After discovery, Wyeth moved for summary judgment, arguing that the warnings adequately told the prescriber of the risk at issue and that the failure to warn claims were preempted.

We’ll start with the good news: the court granted summary judgment and found that the warnings were adequate and non-causal despite some weaselly testimony from the prescribing doctor about whether the labeling warned about the risk of suicide in adults. The court first recited familiar principles of Pennsylvania law that the only possible claims against a prescription drug maker are manufacturing defect (not alleged) and negligent failure to warn and that the manufacturer’s only obligation under the learned intermediary doctrine was to warn the prescriber. Slip op. at 9-12. The court then looked at the labeling and found that the labeling appeared to advise the prescriber about the specific risk at issue in the case, the risk of suicide in adult patients. Id. at 12-13.

Plaintiff had tried to challenge the labeling with an expert report saying the label was inadequate. The court rejected the report because it was unsworn, and plaintiff had not made the expert available for deposition. Such unsworn testimony isn’t competent evidence on summary judgment because Rule 56(e) requires an affidavits, not unsworn documents. Slip op. at 13-14. We are cheered to see the court enforcing the express requirements of the rules, as courts too often consider unsworn stuff, especially from experts. We’re pleased – but perplexed. This is the kind of thing that’s usually easily fixable by plaintiff’s counsel. There’s something going on that didn’t make it’s way into the opinion; we suspect any fix would not have made a difference, so counsel decided not to bother.

But what cheered us even more was the court’s handling of the prescriber’s deposition testimony. For some reason, the prescriber testified that he “recalled” that the labeling’s suicide warnings applied only to pediatric and adolescent patients, not adult patients, and he persisted in this testimony even after he was shown the actual warnings at his deposition. Slip op. at 14. Basically he “recalled” something that was demonstrably false. We can only speculate why the prescriber gave this testimony. Perhaps he was trying to help the estate of his former patient because the plaintiff was pointing the finger at him (funny things happen when plaintiffs, but not defendants, can have informal chats with prescribers) for writing a script without investigating the facts. Perhaps the prescriber was not so good at reading drug labels, although we thought that would be required to get through medical school and licensing.

Now many judges would have thrown up their hands at this point, figuring that the prescriber’s mushy testimony created a factual issue, and denied summary judgment. To his great credit, the judge did not do that. He first recited several admissions by the prescriber that he was aware of the suicide risks regarding depressed patients and antidepressants. Slip op. at 14-15. The court then found that the prescriber had “read the appropriate literature regarding Effexor, and was therefore warned of the relevant risks.” Id. at 15. His demonstrably incorrect belief that the warning did not apply to adults was “of no moment.” Id. That is as it should be. Drug makers have a duty to put appropriate warnings in their labeling. They do not have a duty to ensure that a learned intermediary understands information written to be read by the medical community, and they cannot be held responsible if the prescriber falls below the reading comprehension expected of a professional.

The bad news is at once familiar, novel, and ambiguous, if that’s possible: The court rejected preemption as an alternative ground for summary judgment. That isn’t newsworthy, you might say; courts have been rejecting preemption defenses with depressing regularity since Wyeth v. Levine, including a decision in an SSRI/suicide case that we reported yesterday. A drug maker still should be able to establish a preemption defense consistent with Wyeth v. Levine if the FDA rejected the additional warning that the plaintiff claims should have been used, as we have discussed before.

Here’s the troubling part of Aaron: Wyeth tried to follow this path by arguing that the FDA repeatedly rejected different or additional warnings. Courts that reject this argument usually say that the FDA did not consider or reject the exact warnings at issue in the case. The Aaron court, however, appeared to fault Wyeth for failing to push harder for approval after the FDA had rejected proposed warnings. The court said: “Though the FDA disagreed with certain changes to the Effexor labeling proposed by Wyeth, Wyeth did not press its position, it instead acquiesced to the requests made by the FDA. . . . . Such evidence does not definitively show it was impossible for Wyeth to enhance its safety warnings in place at the time of Aaron’s suicide.” Slip op. at 9.

Whazzat you say?

This suggestion that a drug maker can refuse to “acquiesce[] to the requests made by the FDA” and must “press its position” even after the FDA has rejected a proposed warning strikes us as, to use a term not found in the Diagnostic and Statistical Manual of Mental Disorders, crazy. Surely a drug maker need not have a record of begging for reconsideration, appealing to higher authorities, disobeying requests from the FDA, and holding its breath until it turns blue in order to show that it was impossible to use a warning rejected by the FDA. And the FDA would not like a legal standard that requires drug makers to plead their cases again and again after rejection by the FDA in order to establish preemption. That makes unnecessary (not to mention annoying) extra work for the Agency.

Now the Aaron opinion is ambiguous about exactly what happened in Wyeth’s interactions with the FDA. Maybe FDA personnel merely made discouraging comments about proposed labeling in informal discussions, and Wyeth never asked for an agency decision on proposed labeling (but we doubt it). We don’t know, and the opinion doesn’t clearly tell us. So Weyth has to take the good, with the bad, with the ugly.

Because the opinion is ambiguous about exactly what happened and because the court granted summary judgment on another ground, the opinion’s comments about Wyeth not pressing its position harder are (thankfully) mere dictum. We could ignore such little bits of dictum, but they are like weeds that can grow when fed the noxious fertilizer that comes from plaintiffs’ counsel. This weed should be yanked out before it spreads.

Tuesday, February 23, 2010

Well ... Hell....

We've always thought that the FDA's close regulation of SSRI's (selective serotonin reuptake inhibitors) and the issue of suicide was among the best fact patterns for preemption.  So did the FDA - it entered the preemption field to preserve its control over the labeling of these drugs.

If our side can't win the preemption fight after Levine with this fact pattern, then it's going to be difficult for us to do so anywhere.  Today, we lost the first post-Levine appellate decision in this area, Mason v. SmithKline Beecham Corp., slip op. (7th Cir. Feb. 23, 2010).  It's not our best facts, as the suicide was a young adult (23 years old), and subject to an eventual FDA label change, but it's not good either.

We haven't had a chance to read it yet, but since it's going to be published anyway, we thought we'd get it out there for our readers to know about it.

Monday, February 22, 2010

Canadian Court Blocks Innovator Liability for Generics

We're feeling uncharacteristically magnanimous after last night's USA Olympic hockey victory, so we'll cheerfully report on a recent pharma innovator-liability case from the True North. In Goodridge v Pfizer Canada Inc., 2010 ONSC 1095 (Feb. 18, 2010), the plaintiffs claimed injuries from off-label use of Neurontin and its generic version. We tip the cyber hat to Nick Mizell at Shook Hardy for bringing the case to our attention.
Most of the Canadian opinion is as tasty as a maple glazed donut from Tim Horton's. The court believed it was writing the first Canadian opinion on innovator liability for generic products, and as far as we can tell that's true. One of the first things the court decided was that American precedents were interesting but useless. (Perhaps that's how Canadian hockey fans felt about Rafalski and Miller -- until last night. But we digress.) At first we thought that's too bad, because, as the court observes, most American decisions "favoured the Defendants' arguments." (We admit it - we love the "ou" in "favour" and "colour."  Why not "doctour"?) But the Canadian court goes on to reach the right result, holding that Pfizer Canada owes no duty to consumers of generic gabapentin.

Applying the first part of the duty test, the court acknowledged it was foreseeable to an innovator that people might be injured by the generic. But the rest of the test goes against the plaintiffs. The connection between the innovator -- which simply "releas[ed] an idea that is copied" -- is remote from the consumer of the generic. More important, the court thought it simply unfair to impose liability on an innovator that "cannot control, qualify, or stop" the conduct in question -- off-label use of the generic.

Further, the Canadian court identified two policy reasons for not imposing a duty on the innovator: (1) such a duty would essentially impose strict liability for defective products, which would be "a radical change in Canadian law" (the court quotes from an earlier Canadian's court's observation that while many American courts imposed strict liability, it wasn't necessary "in the Canadian context, where there is much greater social assistance available for those who are hurt" -- ouch!); and (2) innovator liability would stifle -- you guessed it -- innovation. We uttered similar comments about innovator liability cases in the United States here. Interesting and useful -- at least we think so.

The court addressed other issues, mostly in a sensible way. For example, the court refused to certify an off-label promotion class action. The plaintiffs tried to exploit the allegations of off-label promotion of Neurontin in the US, but the court saw no "basis in fact for the allegations about wrongful marketing activities in Canada." The court also declined to accept the plaintiffs' argument that Canadian doctors were necessarily "influenced by any promotional activities emanating from the United States." The court did certify some common issues for class treatment, but ordered individual trials for individual issues (specific causation and injury, anyone?). It also deleted the question of punitive damages as a common issue.

We're not yet ready to issue a gold medal, but the judge did a better than average job -- certainly better than what we've seen in the figure-skating competition.

Friday, February 19, 2010


Back in April we posted about the "funky" non-manufacturer claims in Timberlake v. Synthes Spine Co., 2009 U.S. Dist. Lexis 29074 (S.D. Tex. Mar. 31, 2009).  Those claims - trying to hold people who conducted clinical trials liable in a post-approval case for alleged misconduct in how the trials were conducted - were dismissed, but with leave to replead.  You can read all about that in the prior post.

We promised then that we would "watch those later proceedings with interest," given the unprecedented nature of the non-manufacturer claims.  Well, in Timberlake v. Synthes Spine, Inc., 2010 U.S. Dist. Lexis 11967 (S.D. Tex. Feb. 10, 2010) - an otherwise uninteresting decision letting the plaintiff get away with a belated expert designation (has a case ever gone to trial without the plaintiff trying to slip in a new last-minute expert report?), we noticed this:  "Plaintiff points out that his recent motion to dismiss the Viscogliosi Brothers group of defendants greatly streamlines this case."  Id. at *5.

That means that Timberlake's lost its funk.  The bizarre claims have been voluntarily dropped.

Since we promised, we thought we'd let you know.

9th Cir - No Negligence Per Se Claim for Off-Label Promotion

In an (unfortunately) not-for-publication opinion, the 9th Circuit affirmed a defense summary judgment in Carson v. Depuy Spine, Inc., No. 08-56698, slip op. (9th Cir. Feb. 16, 2010).  There's nothing particularly interesting about the affirmance as to the manufacturing defect claim.  But what the court had to say about plaintiff's allegations concerning off-label promotion is music to our ears.  First, there's nothing improper about off-label use:
The FDCA expressly protects off-label use: “Nothing in this chapter shall be construed to limit or interfere with the authority of a health care practitioner to prescribe or administer any legally marketed device to a patient for any condition or disease within a legitimate health care practitioner-patient relationship.” 21 U.S.C. § 396. In addition, the Supreme Court has emphasized that off-label use by medical professionals is not merely legitimate but important in the practice of medicine.
Slip op. at 5 (citing, you guessed it, Buckman).

Beyond that, plaintiff couldn't prove either a violation or causation with respect to her claim of supposedly illegal off-label promotion:
Because the FDCA prohibits private enforcement, 21 U.S.C. § 337, [plaintiff] asserts a state law negligence per se theory predicated on violation of federal law. . . .  In California, there are four elements required to establish a viable negligence per se theory: (1) the defendant violated a statute or regulation; (2) the violation caused the plaintiff's injury; (3) the injury resulted from the kind of occurrence the statute or regulation was designed to prevent; and (4) the plaintiff was a member of the class of persons the statute or regulation was intended to protect. . . .

The district court correctly concluded that [plaintiff] had failed to present sufficient evidence to create a genuine issue as to two of the elements: violation of federal law and causation. . . .  There is no evidence in the record to support [plaintiff's] claim that [defendant] illegally promoted an off-label use of the [device], that [the prescriber] was influenced by such promotion, or that the off-label use of the disk caused [plaintiff's] injury.
Slip op. at 6-7.

OK, we would have preferred a holding that because the federal statute prohibits private enforcement, you negligence per se is unavailable to make an end run around congressional intent, but you can't have everything.  Two other important principles were upheld:

(1) an illegal off-label promotion claim fails absent evidence that the prescriber was influenced by the off-label promotion.  That means no fraud on the market-type theories.

(2) there must be something about the off-label use - not just the use - of the product that actually caused injury.  The mere fact of an off-label use is not tortious.

Thursday, February 18, 2010

What To Do With Un-Preempted Fraud On The FDA Claims

This post is about un-preempted fraud on the FDA claims and how to approach them….

"Heresy!" We hear you shout. "There’s no such thing as an unpreempted fraud on the FDA claim – at least one not brought by DoJ on behalf of the FDA itself. You guys have said so yourselves, in your discussion of preemption and “embedded” fraud on the FDA allegations."

Yes we did.

We continue to believe every word of what we said about fraud on the FDA claims being preempted whether or not they constitute “causes of action” or something less than that. Substance should win out over form.

But some fraud on the FDA claims can’t be “preempted” because they’re not subject to the Supremacy Clause from which the preemption doctrine flows. We’re talking about fraud on the FDA claims that plaintiffs purport to bring under other federal statutes – chiefly the Lanham Act, RICO, and more recently, the False Claims Act. Because those are federal statutes, they can’t be “preempted” the way state-law claims were in Buckman Co. v. Plaintiffs’ Legal Committee, 531 U.S. 341 (2001).

That doesn’t mean that federal plaintiff's skate, though.  Buckman bars fraud on the FDA claims, no matter what their purported statutory basis.  We just can't call it “preemption” that's the basis for dismissal.

It's the other aspect of Buckman that requires dismissal of fraud on the FDA claims nominally brought under the auspices of a federal statute.  Buckman also makes absolutely clear that Congress did not intend that private individuals be permitted to enforce the FDCA, and thus did not intend that private persons raise fraud on the FDA allegations indirectly under the guise of other statutory claims. In short, private litigation of fraud on the FDA claims on any basis conflicts with the FDA’s exclusive administrative authority.

Actually, since drug and device companies have a long history of jockeying for commercial advantage under the Lanham Act, that statute produced a fair amount of law, even prior to Buckman as annoyed courts held that de facto private FDCA claims based upon another federal statute were precluded by the FDA's exclusive jurisdiction.  Those decisions were not dependent upon any preemption precedent.

First, the basic principles. As Buckman recognized, the FDCA explicitly precludes private litigants from seeking to prosecute any statutory or regulatory violation:
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). This is probably our favorite all-time statutory section on this blog.  It “leaves no doubt that it is the Federal Government rather than private litigants who are authorized to file suit for noncompliance.” Buckman, 531 U.S. at 349 n.4.

A lot of the justification for the preemption decision in Buckman is not preemption specific.  That means it's equally applicable to the misuse of other federal statutes to bring FDCA-based claims as it is to analogous state-law attempts. For instance, there is the Court’s recognition that the FDA has “a variety of enforcement options that allow it to make a measured response to suspected fraud.” 531 U.S. at 349. Prosecutorial “flexibility is a critical component of the statutory and regulatory framework under which the FDA pursues difficult (and often competing) objectives.” Id.; accord Heckler v. Chaney, 470 U.S. 821, 831 (1985) (FDCA frees the FDA to pursue whatever remedies the FDA thinks best fit the violation).  These propositions are not limited to arguments denominated "preemptive."

Internally, the FDA has a “fraud policy” for investigating “acts such as submitting fraudulent applications, [and] making untrue statements of material facts” that “may call into question the integrity of some or all of the applicant’s submissions.” 56 Fed. Reg. 46191, 46199 (1991). Fraud can be – but is not necessarily –a basis for withdrawal of prior Agency approval. Id. at 46200.

Buckman discussed a number of ways that private fraud on the FDA claims generally impinge upon the FDA’s statutory authority to administer the FDCA in both legal and practical ways.

• Private litigants challenge practices and product approvals the FDA might considers legal and beneficial. 531 U.S. at 349-50 (describing attacks upon products with “accepted and necessary” off-label uses).
  • Private litigants seek different and more drastic penalties – usually monetary – than the FDA considers wise. “[F]raud-on-the-FDA claims inevitably conflict with the FDA’s responsibility to police fraud consistently with the Administration’s judgment and objectives.” Id. at 350. 
  • Private FDA fraud litigants use “unpredictable civil liability” to create “burdens not contemplated by Congress in enacting the FDCA.” Those burdens “deter” and “discourage” manufacturers from seeking approval of “potentially beneficial” products. Id.
  • Private fraud-on-the-FDA litigation spills over into areas that “the FDCA expressly disclaims any intent to directly regulate.” Id. at 350-51.
  • Private litigants interpret the FDA’s disclosure regulations too rigorously, creating “an incentive to submit a deluge of information that the Administration neither wants nor needs, resulting in additional burdens on the FDA[].” Id. at 351.
For all of these reasons, the Court held that it was crucial to the FDA’s operation for the Agency to retain plenary authority over enforcement and product approval.

Thus, the numerous legal and policy reasons for rejecting private fraud-on-the-FDA claims are in no way unique to state-law – as opposed to federal-law – private actions:  (1) express statutory prohibition of private enforcement actions; (2) conflict with the FDA’s power to determine what products to approve for marketing; (3) inaccurate attacks upon legal conduct; (4) draconian damage demands; (5) deterrence of beneficial product submissions; (6) claims that exceed the scope of FDA regulatory authority; and (7) drowning the FDA in unwanted information.

We’ve never seen anything in the legislative history of these other federal statutes (Lanham Act, RICO, FCA) suggesting that Congress viewed them as a mechanism to allow private litigants to sue over alleged FDCA violations, contrary to §337(a). The legislative history should thus allow the normal canons of statutory construction to operate:  (1) that subsequent statutes/amendments are presumed harmonious with existing law; (2) that statutes capable of co-existence should be read to effectuate both; (3) disfavoring “absurd” results; and (4) disfavoring implied repeals.

That's the prologue.  Now to the directly applicable law.

Attempts by private federal plaintiffs to do indirectly what they are not allowed to do directly – bring private FDCA-based causes of action (especially particular fraud on the FDA claims) – have gone on almost since the FDCA was enacted.  Ostensible private actions under other federal statutes have frequently been rejected by other federal courts as end runs around the FDA’s exclusive enforcement authority. Most notably there’s Mylan Laboratories, Inc. v. Matkari, 7 F.3d 1130 (4th Cir. 1993), where the court considered fraud on the FDA claims dressed up both under the Lanham Act and as supposed “predicate acts” under RICO. The plaintiff in Mylan alleged that that FDA approval of several abbreviated new drug applications “had been obtained through ‘fraud’ and ultimately was withdrawn and that the data. . .had been ‘falsified.’” The claimed statutory wrong in Mylan was your typical broad fraud on the FDA attack – that the statute was violated simply from “the very act of placing a drug on the market.” Id. at 1139.

The Court in Mylan said “no way, José” to that attempt to allege fraud on the FDA under the Lanham Act and RICO – refusing to allow either of these federal statutes to be employed so as to reexamine whether FDA regulatory approval was fraudulently obtained:
Such a theory is, quite simply, too great a stretch under the Lanham Act. We agree with the defendants that permitting [plaintiff] to proceed on the theory that the defendants violated §43(a) 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. [Plaintiff], in short, is not empowered to enforce independently the FDCA.

7 F.3d at 1139 (citation omitted). The court likewise “affirm[ed] a ruling that precludes [plaintiff] from relying on, as its sole basis for the predicate acts in its RICO counts, the theory that the FDA was defrauded.” Id. at 1137.

Mylan followed Sandoz Pharmaceuticals Corp. v. Richardson-Vicks, Inc., 902 F.2d 222 (3d Cir. 1990), where the Third Circuit likewise refused to allow a plaintiff alleging an FDCA violation to hijack the Lanham Act. Any claim that would require a court “to determine preemptively how a federal administrative agency will interpret and enforce its own regulations" could not be brought under the Lanham Act. 902 F.2d at 231. Thus, a Lanham Act claim cannot turn on whether an FDA regulation was satisfied, because courts would be “usurp[ing]” the power of the FDA. The Sandoz court:
d[id] not believe that the district court had to find. . .that which the FDA, with all of its scientific expertise, has yet to determine. Because agency decisions are frequently of a discretionary nature or frequently require expertise, the agency should be given the first chance to exercise that discretion or to apply that expertise. . . . [Plaintiff’s] position would require us to usurp administrative agencies' responsibility for interpreting and enforcing potentially ambiguous regulations.

902 F.2d at 231 (various stuff omitted). A plaintiff who complains of an FDCA violation “is free to petition the FDA to investigate,” but dissatisfaction with the FDA’s response “does not create a claim. . .under the Lanham Act.” Id. at 231 n.10; see CIBA Corp. v. Weinberger, 412 U.S. 640, 644 (1973) (“petitioner, having an opportunity to litigate the ‘new drug’ issue before the FDA and to raise the issue on appeal to a Court of Appeals, may not relitigate the issue in another proceeding”). Where the FDCA did not “directly” create a private right of action, the Lanham Act could not create one “indirectly.” Sandoz, 902 F.2d at 231.

It’s not just the Lanham Act and RICO. An ostensibly patent-related claim was dismissed on the same grounds in Mylan Pharmaceuticals, Inc. v. Thompson, 268 F.3d 1323 (Fed. Cir. 2001). The claim was that a patent was used to mislead the FDA to get a drug included in the Agency’s “Orange Book” (this is generic drug stuff). The court shot down the case, following “the long line of cases precluding private rights of action under the [FDCA].”  Id. at 1332.
[Plaintiff’s] action here. . .is in essence an attempt to assert a private right of action for “delisting” under the [FDCA]. We see nothing in the Hatch-Waxman Amendments to alter the statement in §337(a) of the [FDCA] that “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) (1994). In a case in which neither the statute nor the legislative history reveals a congressional intent to create a private right of action for the benefit of the plaintiff, the inquiry is at an end.

268 F.3d at 1332 (citation and quotation marks omitted).

Numerous other courts agree with the two Mylan cases and Sandoz. These courts have restricted the private rights of action conferred by various federal statutes to preclude litigants from using those statutes to evade the FDCA’s express prohibition against private enforcement. See Minnesota Mining & Manufacturing Co. v. Barr Laboratories, Inc., 289 F.3d 775, 782-83 (Fed. Cir. 2002) (patent statute cannot be used to circumvent prohibition upon private FDCA enforcement); PDK Labs, Inc. v. Friedlander, 103 F.3d 1105, 1113 (2d Cir. 1997) (Lanham Act claim that defendant’s “products [were] sold without proper FDA approval” dismissed as attempt “to privately enforce alleged violations of the FDCA”); In re Schering-Plough Corp. Intron/Temodar Consumer Class Action, 2009 WL 2043604, at *10 (D.N.J. July 10, 2009) (the “theory of injury is plainly an impermissible attempt by Plaintiffs to turn violations of the FDCA for off-label promotion into a private right of action under RICO”); In re Epogen & Aranesp Off-Label Marketing & Sales Practices Litigation, 590 F. Supp.2d 1282, 1289-90 (C.D. Cal. 2008) (“[a]llowing Plaintiffs to proceed on a theory that Defendants violated RICO by engaging in off-label promotion. . .would, in effect, permit Plaintiffs to use RICO as a vehicle to enforce the FDCA”); Schering-Plough Healthcare Products v. Schwarz Pharma, 547 F. Supp.2d 939, 943-44 (E.D. Wis. 2008) (FDA letters were not final; “ruling on the merits of [the] Lanham Act claim would require the court to usurp the FDA’s responsibility for interpreting and enforcing the agency’s regulations”); Photomedex, Inc. v. RA Medical Systems Inc., 2007 WL 3203039, at * 3 (S.D. Cal. Oct. 29, 2007) (“whether or not the regulatory agencies permitted Defendants to continue to manufacture and market their product, Plaintiff has no standing to assert its ‘fraud on the FDA claims” under the Lanham Act); Mylan Pharmaceuticals, Inc. v. Proctor & Gamble Co., 443 F.Supp.2d 453, 460 (S.D.N.Y. 2006) (“courts have rejected attempts, including under the Lanham Act, to create a private cause of action to challenge a manufacturer or distributor's sale of an FDA approved drug for off-label use”); Pediamed Pharmaceuticals, Inc. v. Breckenridge Pharmaceutical, Inc., 419 F. Supp.2d 715, 726-27 (D. Md. 2006) (Lanham Act allegations involving “adulteration, mislabeling, and new drug applications” “require[] direct application of the FDCA, which only the FDA is entitled to enforce”); Rita Medical Systems, Inc. v. Resect Medical, Inc., 2006 WL 2038328, at *3-4 (N.D. Cal. July 17, 2006) (“the Lanham Act cannot be used as a circuitous route to challenge determinations of the FDA”; “this Court would not be able to consider a claim as to the veracity of those [§510(k)] representations without unduly converting the Lanham Act claim into a review of an FDA [device approval] action”); Schwarz Pharma, Inc. v. Breckenridge Pharmaceutical, Inc., 388 F. Supp.2d 967, 974-75 (E.D. Wis. 2005) (refusing to determine that drug “has not been proven to be a therapeutic equivalent,” and thus could not be substituted by pharmacies); Ethex Corp. v. First Horizon Pharmaceutical Corp., 228 F. Supp. 2d 1048, 1055 (E.D. Mo. 2002) (whether drug was properly classified as “generic” is the “type of claim [] better left to the FDA who has the expertise in enforcing and interpreting its own complicated regulations”); Robertson v. McGee, 2002 WL 535045, at *3 (N.D. Okla. Jan. 28, 2002) (FDCA’s “comprehensive enforcement scheme” is “incompatible with individual enforcement under [42 U.S.C.] §1983; purported civil rights claim is “more appropriately addressed by the FDA”); Healthpoint, Ltd. v. Ethex Corp., 273 F. Supp. 2d 817, 839-40 (W.D. Tex. 2001) (“what federal law does or does not require for [drugs] to be marketed legally requires the direct application and interpretation of FDA regulations. . . . It is for the FDA to exercise its discretion to determine whether [the drugs] are on the market lawfully”); Healthpoint, Ltd. v. Stratus Pharmaceuticals, Inc., 273 F. Supp. 2d 769, 787-88 (W.D. Tex. 2001) (same); Hoffman-La Roche Inc. v. Medisca, Inc., 1999 WL 123578, at *5 (N.D.N.Y. Mar. 3, 1999) (plaintiff’s “attempt to bootstrap unrecognizable claims of defendants’ [FDCA] and FDA noncompliance into a basis for source confusion under the Lanham Act must fail”); Eli Lilly & Co. v. Roussel Corp., 23 F. Supp. 2d 460, 477-78 (D.N.J. 1998) (Lanham Act claims that “rely on interpretations of FDCA provisions and regulations promulgated thereunder” dismissed); Inmuno Vital, Inc. v. Golden Sun, Inc., 49 F. Supp. 2d 1344, 1359 (S.D. Fla. 1997) (Lanham Act claims “fail as a matter of law because no private right of action exists to redress alleged violations of the FDCA”); Avon Products, Inc. v. S.C. Johnson & Son, Inc., 984 F. Supp. 768, 797 (S.D.N.Y. 1997) (“a Lanham Act plaintiff must prove that the defendant’s efficacy claims are literally false, not simply that they fail to meet current [FDA] licensing standards”); Braintree Laboratories, Inc. v. Nephro-Tech, Inc., 1997 WL 94237, at *6-7 (D. Kan. Feb. 26, 1997) (“because no private right of action exists under the [FDCA], a plaintiff may not use the Lanham Act as an alternative vehicle by which to seek redress for an FDCA violation”; whether product properly classified as a “dietary supplement” is “reserved solely for resolution by the FDA”); Summit Technology, Inc. v. High-Line Medical Instruments Co., 933 F. Supp. 918, 933 (C.D. Cal. 1996) (Lanham Act unapproved product allegation “would allow a private litigant to interfere with the FDA’s own investigatory time-table and prosecutorial decision-making,” and “would force the Court to rule directly on the legality of Defendants’ conduct before the FDA has had a chance to do so”); Summit Technology, Inc. v. High-Line Medical Instruments Co., 922 F. Supp. 299, 305-06 (C.D. Cal. 1996) (same); Barr Laboratories, Inc. v. Quantum Mechanics, Inc., 1994 WL 1743983, at *10-11 (E.D.N.Y. Feb. 7, 1994) (claim that consumers were “falsely led to believe that the FDA had approved defendant’s drugs” dismissed); Grove Fresh Distributors, Inc. v. Everfresh Juice Co., 1989 WL 152670, at *3 (N.D. Ill. Nov. 29, 1989) (“[w]here Congress has precluded private causes of action under the FDCA, we find it difficult to justify the use of the FDCA to establish a crucial element of a private cause of action under the Lanham Act”).

There is an exception to the Buckman/Mylan/Sandoz rule, but it’s not one that is likely to affect a claim that actually raises fraud on the FDA issues. Cases hold that, even if a claim is somehow FDCA-related, it doesn’t run afoul of the FDA’s exclusive jurisdiction if the nature of the claim does not require the court to interpret any FDA regulation. The classic example of a case fitting into this exception is a false advertising claim that a product is FDA-approved when it actually isn’t.  Alpharma, Inc. v. Pennfield Oil Co., 411 F.3d 934, 938-39 (8th Cir. 2005); see Solvay Pharmaceuticals, Inc., v. Global Pharmaceuticals, 298 F. Supp.2d 880, 884 (D. Minn. 2004) (same result concerning falsity of statement that drug was “generic”). That’s all well and good – as long the claim is “yes/no” like that. But once the plaintiff shifts from alleging “did the FDA approve” to “should the FDA have approved,” Alpharma, 411 F.3d at 939, then we’re back into the thicket of FDA regulations and the exception goes bye-bye. That’s because allegations of fraud on the FDA raise a large number of difficult questions that intrude directly upon administrative decision-making, such as:
  • Did the FDA intend its regulations to mean what a plaintiff contends they mean?
  • Did the FDA actually require the information that the plaintiff contends was fraudulently withheld?
  • Did the FDA rely on the allegedly fraudulent submission?
  • Was the allegedly fraudulent information actually material to the FDA’s determinations?
  • What different action would the FDA have taken, had it received the information the plaintiff claims the agency should have received?

Given these questions, it would be difficult to mistake a fraud on the FDA allegation for the kind of “was it approved or not” questions that can slide by the FDA’s exclusive jurisdiction without doing the Agency’s discretionary functions any serious damage.

Thus, that plaintiffs proceed under federal, rather than state, law does not give them any sort of free pass to conceal an action for purported FDCA violations in the trappings of a different cause of action. The FDA has sole and exclusive authority to regulate and approve drugs and medical devices as against other federal statutory claims. That’s why the FDA was created in the first place.


Wednesday, February 17, 2010

Choice of law, punitive damages, and Harry Truman

Readers of this blog know that we have strong opinions about many issues. We like Twombly/Iqbal. We hate junk science. And we really, really like preemption.

On some issues, however, we don’t have strong views, such as most choice-of-law issues. There are some choice-of-law issues about which we care deeply – for example we heartily dislike principal place of business as a choice of law factor because it would facilitate class actions. We also don't like rote application of forum law to "procedural" statutes of limitations, because that creates too much of an opportunity for gamesmanship, even by our standards.

But most of the time, we don’t have strong opinions on choice-of-law questions because our main interest is having the court apply the law most favorable to our client. This isn’t some sneaky defense lawyer trick; plaintiffs’ lawyers follow the same approach. Any plaintiffs’ lawyer worth his or her salt will argue in one case to apply the law of the forum (which the plaintiff initially selects) and then argue in another to apply the law of the plaintiff’s residence, depending upon which state’s law is better for the plaintiff in each case. Non-lawyers might call that hypocrisy; we recognize that it is just zealously representing the client.

That roundabout introduction brings us to Meng v. Novartis Pharmaceuticals Corp., 2009 WL 4623715 (N.J. Super. L. Div. Nov. 23, 2009), an interesting mass tort choice-of-law case that has been stuck in our inbox for some time. The plaintiffs in Meng, citizens of Maine and Mississippi, were bellwether plaintiffs in mass tort litigation against Novartis, a company incorporated in Delaware and headquartered in New Jersey. Plaintiffs claimed they developed osteonecrosis of the jaw after taking Zometa.

Plaintiffs in Meng sought punitive damages. Thus the curtain was raised on a real choice-of-law opera. Novartis asked the court to decide which state’s punitive damages law would apply in these bellwether cases. Novartis wanted the law of New Jersey, where the bad conduct alleged by plaintiffs allegedly occurred – and where plaintiffs chose to file their suits; plaintiffs wanted the law of their home states, where they lived and were prescribed the drug.

The court first noted that the parties had agreed that the law of the state where each plaintiff received dental treatment would apply to their claims for compensatory damages. Fair enough. The court then said that New Jersey choice-of-law rules may dictate applying one state’s law to some issues in a case and another state’s law. This is the doctrine of depecage we told you about before, which may seem a little odd at first blush, but is followed by New Jersey and other states. We won’t give that one a “fair enough” – depecage is almost always invoked to try for a tactical litigation advantage.

The Meng court conducted the detailed, multi-factor analysis required by New Jersey’s choice-of-law rules, and we’ll give you the highlights rather than repeat each step (choice of law is one of those things that can get real boring real fast, even to us). Under the law of New Jersey and most states, there is a presumption that the law of the place of injury applies. This presumption was overcome, the court reasoned, because the location of the injury “bears almost no relationship to the issue of punitive damages.” 2009 WL 4623715 at 3. The court took particular note of the fact that over 150 plaintiffs from 41 states had filed Zometa suits against Novartis in New Jersey state court rather than in a pending federal MDL. As we said above, we’d usually expect plaintiffs to argue in favor of the law of their own chosen forum – they chose it after all – but that didn’t stop anyone here.

The court found “the place of plaintiffs’ alleged injuries ‘fortuitous’ because the place of injury bears little relation to Defendant’s alleged punitive conduct toward the parties,” conduct that allegedly occurred at Defendant’s headquarters in New Jersey. Id.
The court then considered the reasonable expectations of the parties and their need for a foreseeable result.

The imposition of punitive damages, generally, is not intended to address the expectations of a plaintiff. Instead, a plaintiff’s interest is addressed through the award of compensatory damages. Here, Plaintiffs’ interests and expectations in being adequately compensated for their alleged injuries will be served through compensatory damages awarded pursuant to Maine or Mississippi law. On the other hand, Defendant should reasonably expect to be governed by the punitive damages law of the state in which it maintains its principal place of business and be punished by New Jersey’s punitive damages law for any wrongdoing it may have committed at its corporate headquarters. In light of these reasonable expectations, this factor favors application of New Jersey law on punitive damages.
Id. at 4-5.

The court further reasoned that New Jersey had the greater interest in determining whether punitive damages should be awarded because the alleged unlawful conduct occurred in New Jersey. The court therefore concluded that New Jersey had the most significant relationship on the matter of punitive damages and held that New Jersey punitive damages law should apply.

We posted before on Depecage, Punitive Damages, and Mass Torts, and the court’s decision relies on many of the considerations we identified before: applying the defendant’s home state law may better serve parties’ expectations, and makes sense if the alleged misconduct allegedly occurred in the defendant’s home state. (We’d like to say that the court followed our analysis, but the decision came out before our post, although we learned about it afterwards.)

Because the defendant drug company won, we like the result, and we credit the court for hitting points we discussed in our prior post. Does that mean that there should be a bright-line rule that the punitive damages law of the defendant’s principal place of business should apply in every case? Not necessarily. One could imagine cases in which the right result would be to apply the punitive damages law of the plaintiff’s home state: for example, if that state had made a policy decision to cap punitive damages in order to encourage business in the state and keep medical costs down, particularly if the prescriber’s decision was heavily influenced by promotional activities limited to that state, then a good argument could be made for applying the punitive damages law of the plaintiff’s home state.

One may also argue that the Supreme Court’s punitive damages decisions in Philip Morris USA v. Williams, 549 U.S. 346 (2007), and State Farm Mutual Automobile Insurance Co. v. Campbell, 538 U.S. 408 (2003), require punitive damages analysis to focus on the harm to the plaintiff, which occurred in the plaintiff’s home state.

One may also argue, as we have , especially after State Farm, that our federal system of government imposes territorial limits upon the power of states to punish activities that occur elsewhere.

Finally, one could make an argument that it simply makes more sense to look at the location where the alleged bad conduct had an effect rather that the place where it originated.

We’re lawyers. We have lots of arguments.

The point is that it is hard to make categorical statements on choice-of-law issues. The theoretical reason is that choice-of-law analysis is complex and depends upon analysis of the particular facts and policies of the states involved. The real reason is that we, like our opponents, may want to argue to apply the law of the forum or the plaintiff’s residence (or even some other place) depending upon the facts, the law, and (most importantly) our clients’ best interests.

If you paid attention to the title of this post, you probably are wondering what on earth this all has to do with Harry Truman. President Truman is said to have asked for a one-handed economist, because he was sick of economists who outlined the case for one course of action and then said, “On the other hand . . . .” On most issues we are the kind of one-handed lawyers Truman would have liked. But on choice-of-law questions, we freely admit to being two-handed lawyers because that is the kind of lawyer our clients like.

Tuesday, February 16, 2010

Weighing In On Citizens United

We have no intention of wading into the treacherous (and heated) debate about Citizens United v. Federal Election Com'n, ___ S. Ct. ___, 2010 WL 183856, slip op. (U.S. Jan. 21, 2010), an early frontrunner for hot-button Supreme Court decision of the year, especially after President Obama’s State of the Union speech. We leave it to the general constitutional law types to debate the pros and cons of the application of the First Amendment to campaign contributions.

But to our readers (some of whom are also clients):  Pssst - we have elected judges here in Pennsylvania, and we could do with more good ones.

But here at Drug And Device law, we are interested - very interested - in specific aspects of First Amendment jurisprudence. Just click on the First Amendment topic tab over on the right hand side of your screen, and you’ll see what we mean.

Thus we’ve studied the lengthy opinion in Citizens United to divine whether there are any usable soundbites that we could employ in support of a First Amendment challenge to FDA’s ability to regulate off-label promotion (previously blogged about here, here, here, and here - and elsewhere).

You’ve been paying attention if you ask, “What does regulation of core political speech have to do with regulation of commercial speech, which doesn’t get as much protection?” We’ve been paying attention too – so we're glad you asked.  Most important, there’s a lot of language in Citizens United that buttresses what FDA’s detractors have been saying for a while – you can’t cure unconstitutional bans on speech by enacting vague, overbroad, and slippery regulations that allow the speech to occur at the whim of FDA. For example:

“The Government may not render a ban on political speech constitutional by carving out a limited exemption through an amorphous regulatory interpretation.” Slip Op. at 7. The FDA has practically patented the amorphous regulatory interpretation.  In fact, the Agency rarely even bothers with regulations these days, instead it does "Guidance."


“[T]he FEC has created a regime that allows it to select what political speech is safe for public consumption by applying ambiguous tests….  This is an unprecedented governmental intervention into the realm of speech.” Id. at 19. Actually, with apologies to the Court, the FEC's actiona weren't all that unprecedented. The FDA’s been doing the same thing that for decades. Just try to figure out what its “intended use” regulations, 21 C.F.R. §§201.128, 801.4, mean. Is “guilty knowledge” of off-label use enough to violate these regulations?  Talk about a chilling effect.

For those of you who are fans of the blog – and we hope there are millions of you – you may recall the Government’s recent response to Allergan’s pending First Amendment challenge to FDA’s off-label regulations: “[i]n practice, FDA usually does not treat an unapproved use as an intended use solely because the manufacturer knows that the unapproved use is taking place.” We quoted it here (second bullet point).  Yup, it’s the good ole “trust us, we won’t infringe your free speech rights” argument. Hmm, sounds like this loosey-goosey approach to regulating around constitutional protections might run into problems after Citizens United. We’d call that “amorphous” and “ambiguous,” and we’d suspect that a fair number of courts would agree with that description.

But that’s not all:  the Citizens United Court also made clear that complex and murky regulatory schemes do give rise to a de facto prior restraint on speech:

“This regulatory scheme may not be a prior restraint on speech in the strictest sense of that term…. As a practical matter, however, given the complexity of the regulations and the deference courts show to administrative determinations, a speaker who wants to avoid threats of criminal liability and the heavy costs of defending against FEC enforcement must ask a governmental agency for prior permission to speak. These onerous restrictions thus function as the equivalent of prior restraint by giving the FEC power analogous to licensing laws implemented in 16th- and 17th-century England, laws and governmental practices of the sort that the First Amendment was drawn to prohibit.”
Slip Op. at 18.

This sure seems to undercut the Government’s argument in the Allergan case:  that FDA regulation of off-label promotion doesn't constitute a prior restraint because FDA isn’t technically prohibiting speech before it happens…  FDA’s just threatening to wallop you for saying something FDA thinks is off-label promotion – think Robert DeNiro with that baseball bat in the Untouchables (we could add a link, but we won't) and you'll get the idea.

And finally, of course, is this First Amendment chestnut:

“ Premised on mistrust of governmental power, the First Amendment stands against attempts to disfavor certain subjects or viewpoints. Prohibited, too, are restrictions distinguishing among different speakers, allowing speech by some but not by others.”
Slip Op. at 24. That’s an apt description of FDA’s (and the rest of the government’s) approach to speech advocating off-label uses. For details, Bexis laid all that out in his amicus brief in the Caputo case. See Brief  at 19-25.

We’ve just scratched the surface of Citizens United – it weighs in at over 150 pages of opinions, including a 90-page “vigorous” (to put it mildly) dissent, and there’s a lot of layers there – whether you think the result in Citizens United is parfait, an onion, or just an ogre.

But on our first pass, it strikes us that the case does have some relevance to what we do. If you buy the argument – as we do – that off-label promotion involves core scientific speech entitled to full First Amendment protection, the case has significant impact on attempts to regulate such speech in the ways FDA does. We expect the government will no doubt try to minimize the Citizens United case, and say that FDA’s regulatory scheme: (a) is targeted at “economic speech” and thus subject to lower scrutiny; and (b) is a permissible speech restriction “based on an interest in allowing governmental entities” – i.e., FDA – “to perform their functions.” Slip Op. at 24.

But they won’t be able to denigrate speech by “corporations” any longer, that’s for sure.

And no matter how much FDA and various other supporters of muzzling medical speech about off-label use try to spin Citizens United, it sure seems like many of the First Amendment themes that the decision explores are applicable whether the discussion concerns “core speech” or “economic speech.” It will be interesting to find out whethere Citizens United can be reconciled with FDA’s regulatory scheme, which on its face and as applied suffers from vagueness and overbreadth problems.

Monday, February 15, 2010

Sweet Ruling on Negligence Per Se

You might not want to read this post around mealtime. But it does offer food for thought on an old bete noire, negligence per se. Louie DePalma, a character in one of our all-time favorite sitcoms, Taxi, once hired a lawyer who advertised that if he lost a case, he'd "eat a bug". That's what happened in Gentry v The Hershey Co., et al., 2010 U.S. Dist. LEXIS 9278 (M.D. Tenn. Feb. 3, 2010). The Gentry case is a combination of CSI, Willy Wonka, and Animal Planet.

Ms Gentry was in the habit of picking up a York Peppermint Patty at the Petco while shopping for her pet. (Yes, we have the same reaction. Turns out there's a good reason for that reaction). She'd munch on the candy and then pay for it at the register. Only this time the texture of the Peppermint Patty was a bit ... off. That's because it came with something a little extra: moth larvae. She got sick and endured an "intensive regimen of psychological counseling." And then she sued every entity in the Peppermint Patty's chain of custody: manufacturer, distributor, and retailer.

At this point in the opinion, we are treated to a description of how a Peppermint Patty arrives in your hands. Unlike sausages, it's not a bad story. So much heat (between 700 and 900 degrees Fahrenheit) and then refrigeration are involved that it was exceedingly unlikely that the moths showed up in the patties before the patties showed up at Petco. Moreover, a swarm of expert entomologists had examined the larvae and, based on their (the moths', not the entomologists') numbers and maturity, all concluded that the moths didn't make their homes in the chocolate until Petco. This is gross and engrossing stuff. Moreover, the types of moths involved (Indian moths vs. Almond moths - we now know way more about this topic than we ever dreamed possible) often reside in grains and - ta da! - pet foods. So that proximity between the human food and pet food -- in this case, the patties were close to "dog treat island" -- which (ahem) bugged you about plaintiff's dining habits, was spot-on. Anyway, summary judgment for the manufacturer and distributor.

Interestingly, plaintiff did not oppose the summary judgment motions submitted by the manufacturer and the distributor, but Petco did. Sorry, says the court, but Petco was basically now crying for comparative fault, an affirmative defense it had never pled. Too late. Goodbye Hershey and distributor.

Now Petco is not without defenses. Some work, some don't. The sealed container doctrine does not work, because the boxes of patties were not sealed in the retail store. By the way, after the infestation was discovered, the store examined ten of the remaining patties and "observed larvae or webbing inside approximately four of those packages." As Homer Simpson would say, "I like those odds!" But the store didn't, so it discarded all remaining patties. The court seemed slightly annoyed by this, but didn't address spoliation.

Nor was Petco able to escape a breach of warranty claim on the ground that Ms Gentry had not actually paid for the patty. It was her custom and practice to pay at the register and Petco acted like that was hunky-dory. It's like restaurant patrons, where pay-when-served is the exception, not the rule. The restaurant cannot elude liability ("Waiter, there's a fly in my soup") because payment was not yet rendered.

But Petco did successfully fend off the claim of negligence per se, and that's why we are posting on this case. (Much as mint patties renew and embiggen us, we aren't calling them drugs or devices). Plaintiff argued that Petco was negligent per se because it violated both the FDCA and Tennessee's little FDCA. The court threw out the claim for two reasons, both near and dear to our defense lawyer hearts: (1) there is no private right of action under the FDCA (big or little), and application of negligence per se would be a clumsy way of circumventing that fact of life (citing Kemp v. Medtronic, Inc., 231 F.3d 216, 236 (6th Cir. 2000)), and (2) plaintiff generally asserted that Petco violated the FDCA, but never exactly said how. "Plaintiff does not point to the specific statutory provisions under the FFDCA or TDFCA which Petco is alleged to have violated. Thus, the Court cannot determine whether either statute sets forth a duty, the violation of which would constitute negligence per se." We've blogged in the past about how courts should not permit plaintiffs to make blanket assertions of FDCA violations in claims of negligence per se, especially in the wake of Twombly\Iqbal, and this time the court gets it right.

Petco still faces trial on other theories of liability, but negligence per se is gone. The court also precluded punitive damages because there was no evidence of recklessness. Plaintiff tried to show such recklessness by virtue of a supplemental expert affidavit in response to Petco's summary judgment motion. Plaintiff's expert discussed an FDA news release, Petco's training of its employees, and its track record in other stores. Petco cried foul because the expert had never uttered these opinions before and the discovery deadline had been passed a while ago. In an act almost as refreshing as a Peppermint Patty, the court actually enforced the discovery cut-off and excluded the supplemental affidavit. According to the court, "Plaintiff effectively tries to do indirectly that which she was being prohibited from doing directly -- supplement her expert's report."

Of course, plaintiffs do that all the time. They also all the time offer vague pleading to support claims of negligence per se or other theories. And they often get away with it. We've often found ourselves saying that if a judge ever did the right thing and enforced the rules against plaintiffs, we'd eat a bug. We won't be saying that anymore.

Friday, February 12, 2010

Us? Ethical?

Well we think so.  And apparently somebody else does so too.  The "Health Expert Blog" has listed us among its "Top 50 Medical Ethics Blogs" under the heading Medical Law Blogs.  We thank them for the recognition - deserved or not.

Another Pleading Idea

Twomby/Iqbal has (have?) a lot of us on the defense side looking more closely at pleadings.  Here's another idea to kick around - is it proper for an attorney simply to dump a slew of allegations from a document prepared by someone else - say, a complaint, consent decree, or other document filed by the government - into a civil complaint with no further investigation by the attorney operating the word processor?  Rule 11, after all, requires attorneys to conduct independent investigations of the pleadings they file.

But Rule 11 was defanged a long time ago, you say.  We thought so too.

But maybe there's something left.

360 reported today on a case indicating that Bayer's had some success getting consumer fraud actions in California pitched where attorneys did this.  We took a closer look, and there's actually more than one.  See Johns v. Bayer Corp., No. 09CV1935 DMS (JMA), slip op. (S.D. Cal. Feb. 9, 2010); Fraker v. Bayer Corp., CV F 08 – 1564 AWI GSA, slip op. (E.D. Cal. Oct. 6, 2009).  Johns and Fraker cite other cases that also support bringing Rule 11 motions against attorneys who simply parrot allegations they found elsewhere, and don't investigate them independently.

It's something to consider in an appropriate case when confronted with a complaint you know has been plagiarized from somewhere else - usually with typos included.

And kudos to Bayer for trying something that's so old, that it's new.

Thursday, February 11, 2010

Containing Conte

The aberrant Conte v. Wyeth, Inc., 85 Cal. Rptr.3d 299 (Cal. App. 2008), decision had its first birthday a couple of months ago – not that we’re celebrating, or anything.

It would be more accurate to say that we’re doing everything we can do to strangle Conte in its crib. If you’re new around here and don't know what we mean, you can click on “Conte” in the Topics list on the right hand side of your screen and you’ll get a complete list of our efforts.

Fortunately, it seems to be working. At age one, Conte is an only child. It has no siblings. By that we mean that no court anywhere has followed Conte. At worst we could say that it’s spawned one rather ugly cousin.

That cousin comes from, you guessed it, California. We blogged about that case, Dorsett v. Sandoz, Inc., 2009 WL 3633874 (C.D.Cal. Oct 28, 2009), here.  Even Dorsett isn’t 100% compatible with Conte. Remember how in the original Conte decision the court had the nerve to claim that imposing liability upon a name brand manufacturer for a purported “defect” in a generic drug’s labeling wasn’t a novel thing? We sure do. Conte stated:

Our decision today is rooted in common sense and California common law. We are not marking out new territory by recognizing that a defendant that authors and disseminates information about a product manufactured and sold by another may be liable for negligent misrepresentation.
Conte, 85 Cal. Rptr.3d at 311.  If one of our clients said something that contrafactual, it would get sued for violating California consumer fraud laws.

We’ve called that statement “hogwash.” We were being polite. When Conte first came down we also characterized it as “the very definition of ‘unprecedented.’”

So – what did the only court in the last year not to dismiss Conte out of hand have to say about Conte’s “no new territory” assertion? The Dorsett court didn’t believe a word of it. Instead, that court held that Conte’s liability theory was so completely novel and unprecedented that it related back to stop the statute of limitations from running under California’s liberal “John Doe” pleading policy:

Plaintiff was unaware that the law permitted her a cause of action against [the brand-name defendant] until the California Court of Appeal’s decision in Conte. . . . Prior to Conte, every single court to address the issue of brand-name-manufacturer liability for conduct leading to or arising out of the generic version of a drug had concluded that the brand-name manufacturer was not liable. The Conte court was the first to allow brand-name manufacturer liability for a generic drug. Because Plaintiff was unaware prior to Conte that a cause of action existed against [the brand-name defendant], the substitution of [it] relates back to the filing of the original complaint.
Dorsett, 2009 WL 3633874, at *2.

We think that the result in Dorsett is crazy. We don’t think that the sheer unprecedented nature of a liability theory should be a basis to give statute-barred plaintiffs a new lease on life. Granted, Conte adopted a screwball pro-plaintiff theory of liability. Isn’t that enough? There’s something wrong with the law when the utter screwballiness (we just made up the word) of a novel theory is enough to confer upon plaintiffs not only a new theory, but also more time to pursue it than is available to plaintiffs who followed traditional law.

But it’s California – what’s that old joke about loose nuts rolling to the coast?

Outside, of California, however, we’re pleased to report that there has been no movement towards Conte. However, that’s probably an unintended favorable consequence of another really lousy decision,. The big picture changed with Wyeth v. Levine, 129 S. Ct. 1187 (2009), throwing a wet blanket over preemption in prescription drug cases. A lot of the incentive for courts to distort the law à la Conte came from the way that preemption was impacting upon cases involving generic drugs.

Preemption was a subtext in Conte itself. While the judges who dreamed up that case’s bizarre “misrepresentation” theory were able to dodge the preemption issue, the trial judge in Conte had also dismissed the plaintiff’s claims against the generic manufacturer on preemption grounds. See Conte v. Wyeth, Inc., 2006 WL 3939262 (Cal. Super. Sept. 26, 2006), aff’d in part and rev’d in part, 85 Cal.Rptr.3d 299 (Cal. App. 2008). And Conte wasn’t the only case. Check out our pre-Levine drug preemption scorecard. There were quite a few cases that bought generic preemption – that the FDCA (Hatch-Waxman division) mandated that generic labels be the “same” as brand name labels, so the common law couldn’t simultaneously demand that generic labels be different.

The prospect of widespread generic drug preemption created pressure to find another deep pocket for plaintiffs who took generic drugs to sue. The only deep pocket left was the brand name manufacturer. Conte was the weak link where the judiciary failed under the pressure.

Levine, however, seems to have put the kibosh on generic drug preemption arguments, even though it was not itself a generic drug case. Since Levine, most courts have held that there is no preemption in generic drug cases. See Demahy v. Actavis, Inc., ___ F.3d ___, 2010 WL 46513 (5th Cir. Jan. 8, 2010); Mensing v. Wyeth, Inc., 588 F.3d 603 (8th Cir. 2009); Bartlett v. Mutual Pharmaceutical Co., 659 F. Supp.2d 279 (D.N.H. 2009); Munroe v. Barr Laboratories, Inc., 2009 WL 4047949 (N.D. Fla. Oct. 15, 2009). So the stopcock’s been opened and the pressure has receded. Most courts, even those with a judicial activist bent, aren’t particularly inclined to seize upon bizarre and unprecedented liability theories when they don’t have to. With plaintiffs once again able to sue the actual manufacturers of generic drugs, Conte becomes a fifth wheel – and a square and clunky one at that.

Thus, the impact of Conte has been marginal outside of California because other judges throughout the country have been singularly unimpressed with its reasoning on the brand name liability question. Take Mensing, for example. To date, that’s the only appellate decision to consider Conte. Mensing gave Conte a dismissive brush off – even though both cases involved the same drug (Metoclopramide/Reglan) – holding that “[w]hatever the merits of Conte under California law,” it was contrary to the law of Minnesota, which required there to be a “duty of care.” 588 F.3d at 613. Conte’s pure foreseeability analysis did not impress the Mensing court:

[Plaintiff] focuses on the foreseeability of harm from the defendants’ action. . . . [W]e conclude that holding name brand manufacturers liable for harm caused by generic manufacturers stretches the concept of foreseeability too far. As for [plaintiff’s] negligent misrepresentation claim, the Minnesota Supreme Court has recognized negligent misrepresentation involving damages only for pecuniary loss.” We find it unlikely the Minnesota Supreme Court would extend the doctrine to misrepresentation involving the risk of physical harm in these circumstances.
588 F.3d at 613-14 (citations and quotation marks omitted).

Other courts considering Conte have been less diplomatic. Just the other day the court in Levine v. Wyeth, Inc., No. 8:09-cv-854-T-33AEP, order at 2 (M.D. Fla. Feb. 10, 2010) - no, not that Levine v. Wyeth - the court adopted a magistrate’s report recommending summary judgment for a brand name manufacturer named in a generic case. The magistrate blanched at the plaintiff’s Conte argument under Florida law:

The holding in Conte is not binding on this Court, and runs counter to the overwhelming majority of case law, including that of Florida. The Court cannot impose a duty of care on Defendants here where the generic manufacturers are responsible for the contents of their label, and where the Defendants lacked direct control as to the contents of that label.
Levine v. Wyeth, Inc., No. 8:09-cv-854-T-33AEP, magistrate’s report, at 7-8 (Mag. M.D. Fla. Jan. 13, 2010). Again, the same drug – different result. If you’re keeping score, Levine also rejected (in addition to Conte-style misrepresentation), claims for negligence (including negligence per se), strict liability, implied warranty, liability as a “component part” manufacturer, and fraud.

Thanks to Ed Gerecke and Dave Walz at Carlton Fields for sending along the Levine opinion – it was extremely timely.

The magistrate in Levine was positively restrained compared to Moretti v. Wyeth, Inc., 2009 WL 749532 (D. Nev. March 20, 2009).  Even though Nevada often looks to next-door California precedent in deciding product liability questions, Conte was caustically rejected:

Court rejects Plaintiff’s argument that this Court should create a duty in light of a recent California intermediate appellate decision. The Conte decision, including its foreseeability analysis, is contrary to well-established Nevada law. Moreover, with the exception of Conte, every other court that has considered this issue has rejected Plaintiff's arguments. Those courts have correctly held that brand name manufacturers do not have a legal duty to warn about the risks associated with their competitors' generic drugs. Simply put, Conte stands alone and is contrary to Nevada law and public policy.
Moretti, 2009 WL 749532, at *4 (citations and footnote omitted). Once again, Moretti involved the same drug as Conte.

The hits keep coming. In Burke v. Wyeth, Inc., another case involving Metoclopramide/Reglan (don't they all?), the court dismissed Conte as “anomalous” and declined to follow it. 2009 WL 3698480, at *3 (S.D. Tex. Oct. 29, 2009). Still another court correctly observed that Conte was “the only decision in several like actions that has allowed the plaintiff to proceed,” and disregarded that decision. Meade v. Parsley, 2009 WL 3806716, at *3 (S.D.W. Va. Nov. 13, 2009) . A Florida trial court also criticized Conte:

Plaintiffs rely upon a lone case from a California intermediate appellate court, as the only decision supporting their position. In fact, Conte is the lone outlier against the overwhelming weight of authority on this point. As of the date of the summary-judgment hearing here, thirty-four decisions had applied the laws of twenty different states to hold that name brand manufacturers are not liable for injuries caused by generic products. . . . No case before or after Conte has agreed with its reasoning. Of the cases after Conte to address this issue, all ten courts. . .have refused to follow Conte.
Dietrich v. Wyeth, Inc., 2009 WL 4924722 (Fla. Cir. Dec. 21, 2009).

Thus, even though California precedent has historically had considerable impact upon the development of product liability law, Conte seems to be an exception. No court outside California has shown the slightest inclination to follow Conte down the slippery slope to liability for other people’s products. With Levine - yes, that one - seeming to have removed the impetus for Conte-style disregard for traditional tort boundaries, we’re hoping that Conte goes the way of “enterprise liability” and other bad ideas whose time has passed.