Good-Bye Colacicco
Remember Colacicco v. Apotex? At one point it was all the rage – indeed the surge in interest about the original 2006 district court opinion, Colacicco v. Apotex, Inc., 432 F. Supp.2d 514 (E.D. Pa. 2006), in which Bexis was involved as local counsel, was onefactor that motivated creation of this blog. For a while we thought that Colacicco would be the case the Supreme Court would take to decide prescription drug preemption. But for a bunch of reasons, not the least of which was consolidation with another case, the wheels of appellate practice ground exceedingly slowly in Colacicco, and it got overtaken by Wyeth v. Levine. The rest, as they say, was history.

We still thought that we might at least get another crack at preemption post-Levine back in the district court in Colacicco. The plaintiff in the case did too, and didn’t like that prospect one bit. So really late in the game, he tried to be slick, sever some claims, and get out of Dodge (or at least Judge Baylson’s courtroom). No such luck. SeeColacicco v. Apotex, Inc., 2009 WL 4729883 (E.D. Pa. Dec. 10, 2009) (denying transfer).

Well, Colacicco’s now gone bye-bye. On March 8, Judge Baylsonapproved a stipulation of dismissal entered into by the parties. So that long-running show is over. Too bad. With a few more breaks – and a speedier appellate process – the case coulda been a contender. Thanks to Dave Alden at Jones Day for the heads up.

Now Bruesewitz is a contender.

A Timely Reminder Why We Need The Vaccine Act
Bruesewitz, of course, involves the Vaccine Act, which was passed in 1986, to address a liability crisis that had developed in the vaccine sector and that was threatening the nation’s vaccine supply. The biggest problem was that vaccines were the sort of public good that most companies did as much out of public service as to make money. A lot of vaccines were sold to the government and other public or quasi-public entities for not much profit margin.

But the explosive growth of product liability threatened all that. Vaccines, like every other kind of prescription medication, have risks. Some of those risks, though rare, are quite grave. Beyond that, a lot of vaccines are routinely given to children at young ages to prevent childhood diseases that used to kill many thousands of babies annually. Vaccines are a major reason why life expectancy in this country increased by over 20 years in the 20th Century.

But age of innoculation is a problem, too. Vaccines are given at the same time that a variety of developmental disorders – these days, most notoriously autism – begin to manifest themselves in very young children. Thus, a lot of vaccine manufacturers got sued simply because they were in the neighborhood, temporally, when the diagnosis was made.

One seven-figure verdict could wipe out a the profit, such as it was, from a great deal of vaccine. The litigation expense was as bad or worse. Hence, the country was down to about two manufacturers of vaccines by the time Congress acted.

That’s more than 20 years in the past, and people tend to forget how messed up things were, and why Congress was willing to expressly preempt personal injury litigation. A very recent case, however, serves as a stark reminder of what that pre-preemption regime was like. Last month, a trial court in New York denied post-trial motions and let stand a verdict of more than 20 million dollars for a single vaccine-related injury.Tenuto v. Lederle Laboratories, 2010 WL 625223 (N.Y. Sup. Feb. 17, 2010). Amazingly, Tenuto was a pre-Vaccine Act case – and not by a little bit – involving the consequences of a polio vaccination given in May, 1979 – more than thirty years ago. Suit was timely filed in 1981.

This real life version of Jarndyce and Jarndyce is at least partially testament to the willingness of the New York Court system to allow unlimited interlocutory appeals, as the trial court felt the need to explain up front the “long and contentious history” of the case. 2010 WL 625223, at *1.

Be that as it may, Tenuto is a stark reminder of the “bad old days” before the Vaccine Act, and why unchecked litigation would have destroyed the country’s ability to prevent childhood (and other) diseases. Had the litigation industry succeeded in taking down the vaccine manufacturers, the upsurge in morbidity and mortality would have dwarfed the current increase in teen suicide caused by the more recent misguided suicide warnings that have deterred use of anti-depressants in that population.

The most troubling thing about Tenuto – beyond the jaw-dropping size of the verdict – is the imposition of a duty to warn about an exceedingly rare risk. Even the opinion justifying the verdict, which must resolve disputes in favor of the plaintiff as the winner, estimates the risk of an adult catching contact polio (here, resulting in paraplegia) from a vaccinated child at literally one in a million. 2010 WL 625223, at *3 (quoting defendant’s warning). In other words, the vaccine maker was held liable in Tenuto for a one-in-a-million risk. And as will become clear, liability was imposed even though it had warned about the risk.

Another medical source at the time estimated the risk as one in ten million. Id. (quoting the “Red Book”guide for pediatricians).

We find liability for this type of remote risk alone shocking. Yet it used to happen with unnerving frequency in vaccine cases.

One in a million (let alone one in ten million) is considered a trivial risk – even by notoriously cautious governmental regulators. “EPA is generally not concerned about cancer risks at or below the range of 1 x 10-6, or 1 in a million.” 73 Fed. Reg. 64229, 64237 (EPA Oct. 29, 2009). If everybody in this country has a one-in-a-million chance of dying in an automobile accident, the number of fatalities in a year would be a little over 300. In reality,the traffic fatality rate is 100 times greater than that – even with seatbelts and airbags.

In fact, in Tenuto, the doctor who administered the vaccine – and who didn’t pass along the manufacturer’s warning – escaped liability because the risk was “too remote”:

Notwithstanding the duty to warn the parents of [the vaccinated child] of the risks of incurring contact polio recognized by the New York Court of Appeals, the defendant [prescriber] maintained in the medical malpractice and negligence causes of action against him that the standard of care was not to warn parents of the risks because they were too remote. . . . The jury apparently adopted [the prescriber's] argument because it did not find [him] liable for his failure to warn the parents of the risks of contact polio.2010 WL 625223, at *3.

It is a measure of the extent to which the product liability system gets out of control in vaccine cases, that while one jury let the prescribing doctor skate for not warning at all of a one-in-a-million risk, another jury tagged the vaccine manufacturer – which did warn – for over $20 million on the same facts. Why? Because the warnings could have been “more expansive.” 2010 WL 625223, at *3. How? According to the opinion, the manufacturer could have “disseminating a warning . . . through drug sales representatives . . . as well as through written warning notices that are occasionally sent to doctors and hospitals known as ‘Dear Doctor letters.’” Id. at *7.

This is a one-in-a-million – at best – risk we’re talking about here. What the court holds was “reasonably necessary,” id. at 14, if anybody ever did it, would deluge doctors in letters about trivial risks and would have sales reps doing nothing but talking about risks that the average doctor would likely never see an entire lifetime of practice.

If a doctor saw 50 patients a day (that’s less than 10 minutes each for an 8 hour day), five days a week, with no vacations, that doctor would need 2000 weeks, or more than 77 years, to see a million patients. Doesn’t happen.

Then the doctor would have to – as the doctor in Tenuto did not – think that the one-in-a-million warning was important enough to bring up during the less than ten minutes s/he saw the hypothetical patient.

The court held that this utterly impractical warning duty was not preempted – because the defendant in fact did revise its warnings (after the fact, of course) to include the information. Unfortunately, Vaccine Act preemption had not kicked in yet. 2010 WL 625223, at *7-8.

Tenuto is an excellent reminder why we needed the Vaccine Act. With a severely injured (we do not in the least question the plaintiff’s injuries), one-in-a-million plaintiff before them, neither the court nor the jury was capable of keeping liability within sensible bounds.

Another inherent problem with vaccine litigation, present in Tenuto in spades, is letting the jury decide whether the defendant complied with notoriously complex and arcane FDA regulations about vaccine manufacture. The court in Tenuto allowed several experts to testify at some length about this sort of regulatory gobbledygook – such as “monkey neurovalence” – even though it recognized that New York does not allow common-law standards of care to be dictated by mere regulations. E.g., Elliott v. City of New York, 747 N.E.2d 760, 763-64 (N.Y. 2001); Long v. Forest-Fehlhaber, 433 N.E.2d 115, 117 (N.Y. 1982). SeeTenuto, 2010 WL 625223, at *8-14.

Amazingly, in this whole long discussion, the only case that the court substantively discussed wasn’t even from New York. Instead, it was the Strong case from Missouri (a state apparently with no compunction to allowing negligence per se on mere regulations) – a case that the FDA felt strongly enough was wrongly decided to intervene as amicus precisely against the admission of this sort of testimony, as we discussed earlier.

Finally, in the discussion of the warning claim in Tenuto, there’s notably nothing at all about warning causation (medical causation was not contested), despite this being a one-in-a-million risk. Who’s to say that the prescriber would have done anything different with the supposedly better warning? No evidence mentioned in the opinion supports the proposition that the doctor would either have given the warning or would have otherwise changed his practice. No evidence suggests that the plaintiff would have done anything different either. The opinion simply ignores causation.

Tenuto is a timely reminder why we need Vaccine Act preemption in the first place. Most courts and most juries are simply not capable of dealing with remote risks in a rational fashion when faced with a victim of such a risk. Tenuto’s straight-faced suggestion that Dear Doctor letters be required for one-in-a-million risks is proof enough of that. This is an opinion that would make perfect sense if the risk were one in a thousand or perhaps even one in ten thousand. But it’s a result that’s perfectly absurd when the risk is one in a million.

druganddevicelaw.blogspot.com

Well, to quote early SNL character Emily Littella, “Never mind.” (At least for the moment.) In re Yasmin and Yaz, 2010 U.S. Dist. LEXIS 17567 (S.D. Ill. February 26, 2010) offers a ray of hope in S.D. Ill. Maybe a corner has been turned. Common sense and fairness have descended upon the heartland. We could keep throwing in happy metaphors and phrases all day, we’re so giddy.

Here’s what happened: Plaintiffs had sued the Bayer defendants for alleged injuries arising from oral contraceptive medicine. If they had sued only the Bayer defendants, the case would satisfy diversity jurisdiction. But plaintiffs usually don’t want to be in federal court, especially if the option is to be in an ultra-plaintiff friendly state court like Madison County, Illinois. So plaintiffs also sued Niemann Foods, the local pharmacy that sold the product. Now with Illinois residents on both sides of the “v,” there seemed to be no diversity jurisdiction.

But there is a well-established doctrine of “fraudulent joinder,” which provides that a nominally in-state defendant can be ignored for removal/diversity jurisdiction purposes when plaintiffs cannot possibly assert a valid claim. Despite the use of the word “fraudulent,” the courts don’t actually inquire into whether the plaintiff is somehow lying by joining the local defendant. The issue is whether the claim against the local defendant is objectively viable. It is therefore not surprising that the Bayer defendants removed the case to federal court and argued that Niemann Foods had been fraudulently joined. It is also not surprising that plaintiffs swiftly filed a motion to remand the case back to Madison County. What is surprising is that Chief Judge Herndon of S.D. Ill. found that plaintiffs had fraudulently joined Niemann Foods.

Plaintiffs argued that fraudulent joinder occurs only if there is “no possibility” that plaintiff could prevail against the nondiverse defendant. Now that’s a tough test. But the court agreed with Bayer that the true test is whether there is “any reasonable possibility” of success in state court against the nondiverse defendant. Still a tough test, but at least sane. And in this case, Bayer convinced the court that there was no no reasonable possibility of prevailing against the store on theories of strict liability, negligence, failure to warn, breach of implied warranty, and fraudulent misrepresentation. (The complaint simply hurled all these theories against all defendants, without distinction or much explanation.)

Fundamental to the court’s decision was that under the law of Illinois (as in most places), pharmacists have no duty to provide customers with a warning regarding a drug’s potential risks or side effects. Such a duty would be burdensome on pharmacists, would interfere with the patient-physician relationship, and would be inconsistent with the learned intermediary doctrine (it would be strange to impose a warning duty on pharmacists that is not imposed on the manufacturer).

So far so good. But now the court starts talking about the “common defense rule,” which provides that “where there are colorable claims or defenses asserted against or by diverse and non-diverse defendants alike, the court may not find that the non-diverse parties were fraudulently joined based on its view of the merits of those claims or defenses.” Huh? This is the type of bizarre obstacle that SD Ill. courts have employed in the past to remand tort cases. Basically, even if the claim against the in-state defendant is bogus, “fraudulent joinder” doesn’t work, and the case therefore cannot be kept in federal court, if the claim against the diverse defendant is similarly bogus. Is there anybody reading this post who does not think the “common defense rule” is uncommonly weird?

In any event, the court declined plaintiffs’ invitation to invoke the “common defense rule,” because there is a key distinction between the diverse manufacturer defendants and the non-diverse pharmacy defendant. Plaintiffs alleged that the manufacturers had concealed the dangers of the product. If that’s true, then there’s no reason to think that the pharmacy knew the dangers. And if the pharmacy didn’t know, it had no duty to warn. That’s a nice, elegant formulation. It gets rid of most of the claims against the pharmacy, including strict liability, negligence, failure to warn, and the Illinois Consumer Fraud Act claim. We like it. We also think it could have swooped in to rescue diversity jurisdiction in earlier SD Ill. cases, but, like Mark McGwire, we’d rather talk about the future than the past.

The implied breach of warranty claim also had no “reasonable possibility” of success against the pharmacy, because such a claim applies to a sale of goods, not services, and the court concluded that a pharmacist mostly transacts in services, not goods.

The last potential hurdle to federal diversity jurisdiction is whether the amount in controversy exceeds $75,000. Plaintiffs’ complaint cleverly sought damages “in excess of $50,000.” Why, it’s almost as if plaintiffs were deliberately trying to avoid federal jurisdiction. Would one be cynical to suspect that plaintiffs cheerfully planted a low number in their complaint, but were planning on arguing for a high, high number once trial commenced in the delightful confines of the Madison County courthouse?

As it should, the federal court looked past plaintiffs’ self-serving damages number. Plaintiffs claimed “severe and permanent injuries,” “past and future expenses for medical care, monitoring, and medications,” and “physical, emotional, and economic injuries.” The court had no problem concluding that “it is plausible and supported by the preponderance of the evidence that the amount in controversy has been established.”

And that’s it. To our amazement and delight, the SD Ill court reaches the right result and provides a handy precedent for future use when fraudulent joinder issues arise. To quote another Gilda Radner SNL character, “It’s always something.”

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The pumps (which are FDA approved) are machines, and of course machines don’t care what you put in them – they’ll infuse it. Thus, the most interesting aspect of pain pump cases we’d seen prior toMeharg had to do with product identification. That is, plaintiffs have been trying to sue various drug companies without even being able to allege the the defendant’s drug was actually used. That’s a no-no, and it’s produced some favorable decisions reaffirming the rule that a plaintiff can only sue the manufacturer of a product s/he actually used. Timmons v. Linvatec Corp., ___ F.R.D. ___, 2010 WL 476661, at *3-4 (C.D. Cal. Feb. 9, 2010); Haskins v. Zimmer Holdings Inc., 2010 WL 342552, at *2 (D. Vt. Jan. 29, 2010); Gilmore v. DJO Inc., 663 F. Supp.2d 856, 860-61 (D. Ariz. 2009); Combs v. Stryker Corp., 2009 WL 4929110, at *2-3 (E.D. Cal. Dec. 14, 2009); Dittman v. DJO, LLC, 2009 WL 3246128, at *3 (D. Colo. Oct. 5, 2009); Sherman v. Stryker Corp., 2009 WL 2241664 at *5 (C.D. Cal. March 30, 2009). These pain pump cases are yet another reason why we like Twombly/Iqbal.

We expect that the pain pump litigation will continue producing decisions on weird points, because the plaintiffs will be suing the wrong defendants, the manufacturers of the drugs used in the pumps, over injuries that were caused, not so much by the drugs, but by how the drugs were continuously infused by the pumps – if there’s any causation at all, that is. In fact, we can almost guarantee it.

Why?

Preemption.

These pain pumps (at least in cases where we’ve seen it discussed) are Class III devices. That means the cases against the manufacturers aren’t very likely to succeed under Riegel v. Medtronic, Inc., 552 U.S. 312 (2008), and the manufacturers will either get out on preemption, e.g., Wolicki-Gables v. Arrow International, Inc., 641 F. Supp.2d 1270 (M.D. Fla. 2009), or they’ll settle out cheap and take their chances with more attenuated – but at least not preempted – claims against the drug manufacturers. That’s what looks like happened in Meharg. The court mentions that the medical device claims had been settled. Slip op. at 3 n.4.

The claim in Meharg, which is essentially an attempt to blind-side a manufacturer with liability for an off-label use that it neither encouraged nor promoted, is one of those weird theories. But plaintiffs didn’t get very far.

Why?

The state of the art defense.

It appears from Meharg that the continuous infusion of these local anesthetics is a lot different than their occasional injection (or other application) on a one-shot (really bad pun) basis. Continuous infusion isn’t what these drugs were approved for, and since the off-label use wasn’t (even the plaintiffs agreed – which is saying something) anything the defendants made any attempt to encourage, the defendant didn’t know about side effects peculiar to off-label use.

Since it’s the state of the art defense, the key date is when the product was used. Here that’s technically the drug, not the device, but it doesn’t matter (it might in other cases).That date is February, 2006. Remember that fact.

We haven’t posted a lot about the state of the art defense on this blog, but when we did, we did so thoroughly. For a general discussion of why it’s not a good thing to hold drug/device manufacturers liable for not warning of risks that were unknown or undiscovered at the time of use, seehere.

In that post we included one of our 50-state surveys of the states that had adopted that state of the art defense in drug/device cases. We provided citations to cases from 42 states – check that – 40 states, Puerto Rico, and the District of Columbia. It so happens that Indiana was on that list:

Indiana: Ortho Pharmaceutical Corporation v. Chapman, 388 N.E.2d 541, 548 (Ind. App. 1979); Phelps v. Sherwood Medical Industries, 836 F.2d 296, 305-06 (7th Cir. 1987).Meharg is an Indiana law case. That’s why (one reason, anyway)the plaintiff in Meharg lost – umm … that is, because of the state of the art defense, not because we included Indiana in our blog post.

The court in Meharg went right to Chapman, and stated:

In Ortho Pharmaceutical Corp. v. Chapman, 388 N.E.2d 541, 548 (Ind. App. 1979), the Indiana Court of Appeals held that in the context of a prescription drug manufacturer, “the duty to warn. . .does not arise until the manufacturer knows or should know of the risk” and that “the standard of constructive knowledge is that of an expert in that particular field.” In cases such as this one that involve an off-label use of a prescription drug that is not endorsed or promoted by the manufacturer, the requisite knowledge of the risk is two-fold: the manufacturer must know (or be charged with knowledge of) both that the off-label use is occurring and that the off-label use carries with it the risk of the harm at issue–in this case, damage to cartilage.Meharg, slip op.at 4.

By relying on Chapman, the court quite consciously avoided a legal thicket that exists with respect to the duty to warn in cases of off-label use. Meharg, slip op. at 4-5 n.6. The courts have never really settled on an approach to off-label use generally, and the rationales run the gamut from no duty at all (on the theory the off-label use is a form of misuse) to no discernable difference from warning about labeled uses. The various approaches are well summarized in Blain v. Smithkline Beecham Corp., 240 F.R.D. 179, 194-95 (E.D. Pa. 2007), and if you want all the gory details, they’re in Bexis’ book at the end of 2.20[1].

The plaintiffs, it turns out, didn’t have much to support the weird unpromoted off-label use cause of action. That’s not to say they didn’t try, but in the end their own expert – the ubiquitous Suzanne Parisian – slit their throat. She (or rather the plaintiffs’ lawyers who undoubtedly spoon feed their experts the only things they’re allowed to look at) was unable to find anything in the medical literature before the product use in this case.

There were some very generalized statements about infusions of other products. Meharg, slip op. at 5-6. Not helpful, with this defendant. As we pointed out earlier, liability must bedefendant (and thus drug) specific. There were two pre-use studies that also didn’t help, because neither study’s authors suspected that the drug was implicated in the injury. Id. at 6. One of those studies, we note, the manufacturer probably couldn’t even have been disseminated to doctors under 21 C.F.R. 99.101(b)(v), because it only involved “one case.” This is off-label use land, remember, and the rules are different (but more on that later). In short, both of the studies that Dr. Parisian’s Declaration brought to the court’s attention reinforced the defendant’s point that nobody suspected the risk in question at the relevant time.

But that pales to what else Dr. Parisian stated. She expressly said in her declaration that the defendant should have taken steps to warn after it received certain specific “spontaneous reports.” Slip op. at 7. However, as the court pointed out, that was “something that occurred on June 9, 2006, after Meharg’s surgery.” Id. at 8 (emphasis original).

Oops. Dr. Parisian (or maybe counsel) really walked into one there.

That something was the state of the art defense. It’s nice, in litigation to have a ruling early on that the state of the art defense applies as a matter of law on a date certain – if you’re a defendant, that is.

Dr. Parisian tried to salvage things by putting on her lawyer hat (which she shouldn’t be allowed to do at all, but that’s anotherstory), and concocting an even weirder theory. She claimed there should be a duty towarn about possible risks of possibleoff-label uses. So, even if you’re not promoting an off-label use, Parisian would impose a duty to research them. The number of possible off-label uses is nigh on infinite, but of course that doesn’t bother a plaintiffs’ expert. It did, however, bother the court. Thus, we have this nifty language in the closing footnote of the opinion:
This “duty” does not exist under Indiana law. . . . Dr. Parisian urges a far broader duty–a duty to warn physicians that there might be a risk, but we don’t know yet because we (and the scientific community at large) haven’t studied it yet. Requiring such warnings regarding an off-label use in the absence of a known risk would be highly inefficient: it would drain the resources of drug companies; it would cause physicians to be inundated with such pseudo-warnings and risk distracting them from heeding warnings of actual risk; and it would add very little to the fact that physicians already know that if a use is omitted from a prescription drug’s label that use has not been tested sufficiently to demonstrate that it is safe and effective. Further, the Court notes that [plaintiff] expressly disavows the position that “simply saying that the use was not approved satisfies [defendant]’s duty,” and argues instead that[defendant] was required to provide “[a] clear cautionary statement setting forth the exact nature of the dangers involved.” The problem with that argument is the fact that the “exact nature of the dangers involved” simply was not known prior to Meharg’s surgery.Slip op. at 8 n.9 (emphasis original) (various citations omitted). So if you need a ringing rejection of a duty-to research claim – here it is. A plaintiff should not be allowed to slip the bounds of the state of the art simply by arguing a duty to conduct research. At some point the real world is simply the real world.

And now the preemption point – it isn’t in the opinion, but it came to us while we were writing about it. It goes back to the off-label angle. It so happens that the FDA is notoriously picky about what it allows manufacturers to say about off-label uses. We’ve written lots of First Amendment posts on that. Ordinarily, a drug’s labeling is strictlylimited to statements about its labeled uses. There is, however, an equivalent to the CBE requirement for strengthening off-label warnings. It’s found in 21 C.F.R. 201.57(c)(6)(i):

In accordance with 314.70 and 601.12 of this chapter, the labeling must be revised to include a warning about a clinically significant hazard as soon as there is reasonable evidence of a causal association with a drug; a causal relationship need not have been definitely established. A specific warning relating to a use not provided for under the “Indications and Usage” section may be required by FDA in accordance with sections 201(n) and 502(a) of the act if the drug is commonly prescribed for a disease or condition and such usage is associated with a clinically significant risk or hazard.(Emphasis added). Note the specific “may be required by FDA” language where widespread off-label uses are discussed. Where off-label use is concerned, the FDA wants to keep tight control of the labeling. If it were possible to add or “strengthen” off-label warnings CBE-style – that is, without prior FDA approval, there would be no reason to include the highlighted sentence in 201.57 at all.

Further, aside from warnings, the FDA has a whole section, 21 C.F.R. Part 99, that severely limits what manufacturers can legally disseminate about off-label uses, and it expressly requires prior FDA approval of this type of material.

In light of the FDA’s promulgation of a slew of formal regulations restricting drug (and device) manufacturers’ off-label statements we think, with respect to off-label uses, the sort of warning claim seen in Meharg implicates Levine’s caveat, “we have no occasion in this case to consider the pre-emptive effect of a specific agency regulation bearing the force of law.” Wyeth v. Levine, 129 S. Ct. 1187, 1203 (2009). The “specific” FDA regulations governing what a manufacturer can say about off-label uses expressly require prior FDA approval in all circumstances, and under Levine, that’s enough to make a pretty good preemption argument.

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Here’s what we mean. For one thing, the court spends a page and a half criticizing the lawyers on both sides for being too argumentative in their statements of facts, 2010 WL 605922, at *1-2, which is about a page more than it spends on the law of preemption.

Mason involved a 23-year-old who committed suicide in 2003. That means that at the time, it was the FDA’s position that there was insufficient scientific data to support a warning of increased risk of suicide. The FDA had said so several times, rejecting various proposals to require such warnings over the years.

Eventually, after new SSRI studies were completed, the FDA authorized a warning for minors and young adults (that would have covered plaintiff) in 2007. Largely because of these warnings, SSRI prescriptions in this age group have declined and – since SSRI’s treat depression, which is far more suicide-provoking than the drugs – suicide rates have increased. We commented on this perverse (but predictable) effect here.

Rant aside, Mason states with zero reasoning that Levine “restored the preemption landscape to its pre-2001 form.” 2010 WL 605922, at *3. Levine didn’t say that at all. In 2001 there basically wasn’t any preemption precedent at all. What Levine said is that preemption requires “clear evidence” that the FDA wouldn’t have allowed the warning at issue (for impossibility preemption), and it recognized that there would be circumstances where preemption would frustrate what the FDA was trying to accomplish (obstacle preemption). Wyethv. Levine, 129 S.Ct. 1187, 1198 (for the clear evidence point), 1204 (”we recognize that some state-law claims might well frustrate the achievement of congressional objectives”) (2009).

We would have thought that demanding a warning where there was insufficient science to support it might have been one of these situations – or if it wasn’t, that the court would at least explain exactly why not.

No such luck in Mason. The court simply examines the facts of the case and endeavors to compare them to the “facts” in Levine.2010 WL 605922, at *4 (”if the evidence here is less compelling than it was in Levine, we will not find preemption”). That might have been OK if some sort of objective framework was used. But no, the analysis is as impressionistic as a Rorshch ink blot.
“the allegation is partially true,” 2010 WL 605922, at *5;this “does not provide much, if any, evidence,” id.;that “isn’t a great comfort,” id.;”[o]verall, we do not find the FDA’s rejection of the citizen petitions or its call to do more research very compelling for either side,” id. at *6;”[w]hile what [defendant] points out is true, it only tells one side of the story,” id, at *6;”[t]o the extent these subsequent events have any sway….” Id. at *7.This strikes us as more akin to guesstimating the volume of an irregular object before Archimedes had his original “eureka moment” over 2000 years ago, than to the kind of legal analysis we’ve come to expect from an appellate court. There’s no weighting, no test, no nothing – except the sort of “I’ll know it when I see it” subjectivity that courts use when they go for gut reactions over reproducibility of results.

And it gets worse. Even the gut reaction in Mason is intellectually dishonest. We discussed that a bit in the comments to our first post, and it occurs in the opinionat 2010 WL 605922, at *4. Note the transition. The court starts out its Levine comparison, logically enough (to the extent subjectivity can be logical) by looking at what the Levine majority had to say about the FDA’s review of the drug in that case. But incredibly, it then adds in the facts as portrayed by the Levine dissent: “While the opinion in Levine covers the administrative history and record, the dissent delves even deeper.” 2010 WL 605922, at *4.

Excuse us, but that’s neither logical nor honest. The “facts” that Mason goes on to recite from the Levine dissent were ignored altogether or pooh-poohed by the majority:
“For at least the last 34 years, the FDA has focused specifically on whether IV-push administration of Phenergan is ‘safe’ and ‘effective’…. And the record contains ample evidence that the FDA specifically considered and reconsidered the strength of Phenergan’s IV-push-related warnings in light of new scientific and medical data .” Levine, at 1222. The dissent then meticulously lists the various times the FDA considered a different warning label regarding the IV-push method. It begins in 1975 when several people from Wyeth and several members of the FDA met regarding Phenergan’s label and the FDA proposed that Phenergan should not be injected via Tubex, which is a syringe system used exclusively for IV push. Instead of banning the use of IV push altogether, both parties agreed that there was instead a need for better instruction regarding the problems of intra-arterial injection. A year later, an FDA committee recommended an additional IV-push-specific warning for Phenergan’s label but decided not to prohibit using the IV-push method. In its labeling order, the FDA cited numerous sources describing the costs and benefits of IV push including published case reports from 1960 about cases of gangrene caused by the intra-arterial injection of Phenergan.2010 WL 605922, at *4. But what did the Levine majority have to say about those selfsame facts? Not much. TheLevine majority held that FDA review of Phenergan was: “sparse,” 129 S. Ct. at1192;
“intermittent,”id.; its “retain verbiage verbatim” instruction occurred “without addressing [defendant’s] submission,”id.; after the FDA was finished, the warning, it“did not differ in any material respect,” id. at 1198; “FDA “paid no more than passing attention to the issue of IV-push,” id. at 1199; and
“the FDA did not consider and reject a stronger warning against IV-push,” id. at1203.

In short, in order to find no preemption in Mason, the court relied on facts from the dissent in favor of preemption in Levine – where the anti-preemption majority in Levine either denied, disregarded or downgraded those very facts. InMason the vampire “facts” from theLevine dissent,were disinterred, stood on their heads, and used to establish the polar opposite of what they were intended to establish.
If an expert witness offered an opinion like that, practically no court in the country (except possibly in New Jersey) would let it into evidence.

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For some reason, we think of Irwin Corey when we confront plaintiff expert witnesses in drug or device cases. Plaintiff lawyers are nothing if not cheap, so they like to use the same experts again and again to cover a broad swath of scientific and technical areas, even if those areas are far away from the witness’s training and practice. More often than not, they (the plaintiff lawyers and the instant “experts”) get away with it. We remember deposing a professor of marketing who not only uttered the most inane thoughts on how certain advertisements contained Freudian themes, but also took a few stray shots at cancer causation. Like any semi-awake lawyer, we asked the witness whether he considered himself an oncologist. The witness than said something like, “I’m not board-certified as a medical doctor, but I think that I have had education, experience, and training that would permit me to share a few things that would be helpful to the jury.” And then he grinned. He grinned because he knew he had played the game well.

Too many courts let plaintiff experts play the game. Courts are supposed to act as gate-keepers. Gate-keeping must be plenty hard, because more than a few judges seem inclined to let phony experts blather. The judges would rather have the jurors sort it all out. It’s possible that we are irretrievably scarred on this issue, since we practice in a jurisdiction where a witness is qualified to testify as an expert if the witness “has any reasonable pretension to specialized knowledge on the subject under investigation.” Miller v. Brass Rail Tavern, Inc., 541 Pa. 474, 480-81 (1995). That’s right, “pretension.”

It’s nice when we find the occasional case where judges put a halt to such drivel. Ranes v. Adams Laboratories, Inc., No. 06-1228 (Iowa Feb. 5. 2010) isn’t a perfect case on admissibility of expert testimony, but there’s way more good than bad in it. Ranes alleged that PPA caused him to sustain a stroke or something very like a stroke. But every treater in sight concluded that while Ranes suffered from some neurologically-related symptoms, those symptoms were not associated with a stroke and that PPA played no role. The defense expert, a neurologist, agreed with the treaters and believed that Ranes’s symptoms were consistent with a degenerative neurological condition — not a stroke.

Into the breach steps plaintiff’s expert, who was a toxicologist, not a neurologist. He primarily practiced as a pediatrician. Plaintiff’s expert, unlike every other doctor, diagnosed Ranes with vasculitis. He agreed that vasculitis was not shown by imaging or other medical tests. Plaintiff’s expert “diagnosed Ranes with vasculitis because he believed Ranes’s continual signs and symptoms are consistent with the toxic effects of PPA.”

Okay, at this point, if we’re wearing a black robe this case is a goner. The “expert” is in foreign waters, and the opinion sounds like circular, back-filling hogwash. The Iowa Supreme Court ultimately gets there, but it takes a while. As we read the opinion, we kept our fingers poised over the trap-door button. It felt swell at the end when we finally got to push it.

Iowa employs an ad hoc approach to decide expert admissibility. For complex scientific evidence, Iowa courts consider the Daubert factors. Because Ranes was a toxic-tort case with complex issues of differential diagnosis (or differential etiology), Daubert applied to Ranes. So far so good.

The court begins by holding that plaintiff’s expert is generally qualified to discuss the potential effects of PPA on the human body, and also how PPA potentailly affected the plaintiff. This despite the fact that the expert was not a neurologist and hadn’t really done much on the particular issue at hand besides read some studies. At this point, our hearts are sinking and are lips are saying “uh oh.”

But not to worry. The court observes that plaintiff’s expert relied on one case-control study and several case reports to support his general causation analysis. The expert reasoned that the case control study shows that PPA can cause strokes, and since Ranes likely suffered a “stroke-like event,” the study tended to show a relevant causal connection. But the case control study excluded men (the plaintiff was male) and there’s no support for the extrapolation from the study’s refernce to “stroke” to the so-called “stroke-like event” — whatever that is. The court holds that “a bare analogy from case reports to the injuries alleged in a particular case is unreliable.” Moreover, there were factual distinctions betweenRanesand the case reports. (That will almost always be the case with case reports.) The court makes a nice point when it says that if plaintiff’s expert “had taken his opinion in this case to a medical journal for publication, it would be in the form of another case report related to PPA, not a clinical trial or case-control study.” And “[r]easonable medical experts would not rely upon the presented anecdotal information.” Touche. Then the court seizes upon the fishy nature of the diagnosis and circular reasoning offered up by plaintiff’s expert, and points out that “a diagnosis of a disorder does not constitute additional evidence of causation of the disroder.”

Finally, finally — when we thought the court had been fooled by the pretense of expertise — the court comes back to the issue of qualifications and decides that the toxicologist is not qualified to make a diagnosis of vasculitis and that, in any event, the methodology was faulty because it was clear that the expert had cherry-picked the supporting evidence. He dismissed all the neurological tests performed over three years as faulty, and “relied only on symptoms Ranes reported to tie the case reports he located to Ranes’ case.” That cannot pass muster. No valid expert opinion, no evidence of causation — hello summary judgment.

Obviously, we approve of the Iowa court’s reasoning. (Though we don’t like the way it made us sweat for 30 pages. It was almost cruel the way the qualifications issue was hidden behind the back for a while.) We also think that the deficiencies the court identified with respect to the expert in Ranes will exist with the overwhelming majority of plaintiff experts.

Take it from us. We’re experts.

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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 think.

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 bloggersand other media types who aren’t really competent to make heads or tails of what they’re getting. In particular, the other side likes to throw adjectives like “illegal” and “fraudulent” around like they’re so much confetti – or a smokescreen, if (like us) you’re less inclined to be charitable. Throw in a few vague but dark hints about safety risks, and the other side hopes it can generate negative press. We know all 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 been likelyto bin 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 of those cases, so we took a look.

The plaintiffs’ publicist is trying to direct 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 – by hand-feeding them a “takeaway.” Being defense lawyers, you can’t expect us to take away the same thing. Here are the two takeaways we have fromthe 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 jurisdictionanalysis 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, 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 details 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 shouldwork for what they’re being used for, 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 a 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 21U.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 claim 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 Journas 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 contains a list of 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 at all. 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 happen 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, 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. The first 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 someof 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 ripoffof 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. MedtronicComplaint 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 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 thatthese stents aremore 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 isto be expected if more doctors believe the devices work and choose to use them more often. As we’ve discussed, among other places such as here, the FDA itself says that adverse event reports can’t establish causation. Jeez, we don’t think 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. SeeComplaint 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 indicative of a simple fact. The product in question works for the widely accepted use. It’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, seeHertz 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 on the basis of regulatory claims that conflict with how the Agency reads those same regulations. We think that’s a key takeaway.

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 hereand 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. If anything 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 that stem 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.”

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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.

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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.

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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.

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“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 Buckmanas annoyedcourts 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 themisuse 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.; accordHeckler 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; seeCIBA 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. SeeMinnesota 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); seeSolvay 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.

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