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Safe harbor.  We like the sound of that.  The term connotes a level of calmness and predictability that we find appealing in the regulation of drugs and medical devices, and we find ourselves writing about safe harbors a lot lately.  Bexis recently gave us his survey of safe harbors against state consumer fraud claims, and we commented just the other day that perhaps a safe harbor should apply in a class action alleging California consumer fraud claims based on purported overrepresentation of an antidepressant’s efficacy.  We doubted a safe harbor actually would apply in that case, but maybe we spoke too soon.

In Marcus v. Forest Laboratories, Inc., No. 13-11343-NMG, 2014 WL 866571 (D. Mass. Mar. 5, 2014), the District of Massachusetts applying California law found that California’s safe harbor applied to—wait for it—a class action alleging California consumer fraud claims based on purported overrepresentation of an antidepressant’s efficacy.  The plaintiffs in Marcus alleged that the FDA approved an antidepressant for adolescent use based on two studies showing statistically significant improvements compared against placebo.  Id. at *2.  Placebo-controlled studies are the gold standard, but according to the plaintiffs, the FDA set the bar too low.  It instead should have required a showing of “clinically significant” improvement over placebo, which would “examine whether the observed benefit of a drug outweighs the risks associated with the drug when compared to alternative, less risky treatments.”  Id. at *1.

In other words, the plaintiffs proposed a new, hypothetical standard under which the sale of the drug for adolescent use amounted to consumer fraud, even though the FDA had approved the drug for sale under the very real FDCA.  That sounds to us like plaintiffs attempting to apply California’s consumer statutes to condemn conduct that another law clearly permits.

It must have sounded that way to the district court too, because the count dismissed the complaint. As the court explained, the California safe harbor doctrine bars certain claims brought under California’s consumer statutes, and for the doctrine to apply,

another provision must actually “bar” the action or clearly permit the conduct. . . .  In other words, courts may not use the unfair competition law to condemn actions the legislature permits.

Id. at *3 (emphasis added) (quoting Cel-Tech Communications v. L.A. Cellular Tel. Co., 20 Cal. 4th 163 (1999)).  If the light is green, it cannot be consumer fraud to drive through the intersection. You get the idea.  In Marcus, the district court reasoned that Congress had entrusted the FDA to determine whether there is substantial evidence of efficacy for a particular purpose and whether a proposed label is false or misleading in any way.  Because the FDA had approved the antidepressant and its labeling, the safe harbor applied to bar claims that the labeling was false or misleading under California’s consumer laws.  Id. at *4.

It seems California’s safe harbor is more vital than we originally thought.  The court distinguished the case from cases involving food and homeopathic remedies, where the safe harbor did not apply, because prescription drugs are subject to greater and comprehensive federal regulation.  Id. at *4.  The court also distinguished cases involving alleged violations of federal law.  Id. at *5.  That seems obvious to us:  If federal law prohibited the conduct, it would not “clearly permit” the conduct and the safe harbor, by its own terms, would not be of any use.

Finally, the court rejected the novel argument that Wyeth v. Levine “calls into doubt” the viability of safe harbor provisions in state consumer protection statutes.  Id. at *5.  Plaintiffs sometimes treat Levine like is it some sort of all-purpose antidote to all they think is wrong with the law, but this argument can be seen only as a gargantuan stretch. The Supreme Court held in  Levine that FDA approval of prescription drug labeling does not necessarily result in implied federal preemption of state law failure-to-warn claims.  555 U.S. 555, 570 (2009).  Levine was about implied preemption, under which state-law gives way to federal law where it is impossible to comply with both.  (There are other forms of implied preemption, but “impossibility” preemption is the form most germane to prescription drugs.)  Implied preemption cannot be relevant where there is no state-law claim to begin with—for example, when a state-law creates a safe harbor into which the defendant can take refuge.  Kudos, we suppose, to the plaintiffs for thinking creatively, but we side the district court, which recognized that “Plaintiffs provide no justification to extend [Levine] to preclude state safe harbor defenses to claims arising under state consumer protection law and this Court has found no authority permitting it to do so.” Id. at *5.

So there you have it. The Marcus order is short and sweet, but it sure grabbed our attention. The present and future of drug and medical device class actions (to the extent there is any) will revolve around consumer protection statutes.  And while we will not shy away from opposing class certification in any class action, we should not forget that defenses may apply before a class certification motion is even a glimmer in counsel’s eye.  The defendants in Marcus did not forget, and they won.

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Howard v. Zimmer is an old case. It was filed in the Northern District of Oklahoma in 2002 and got transferred to the Northern District of Ohio for the Sulzer Hip and Knee MDL. In 2010, after not participating in a class action settlement in 2003 and having plaintiff’s claims carved up on summary judgment in 2006, Howard went up the Sixth Circuit, which held in 2010 that a claim for negligence per se—if Oklahoma law recognized it—would not be preempted.

Then the case was remanded back the original Oklahoma federal court, which referred to the Oklahoma Supreme Court the question of whether Oklahoma recognized negligence per se based on an alleged violation of the FDCA. The resulting “yes” to that question in March 2013 made #3 on our list of the worst decisions of 2013.  At that point, the case went back the Northern District of Oklahoma to see if plaintiff could actually offer admissible evidence to prove his remaining claim for negligence per se based on a violation of the FDCA. Howard surfaced again last week with Daubert challenge to a fair amount of plaintiff’s expert evidence. Somewhere in the interim, plaintiff had focused his negligence per se claim on the allegation that the Defendant’s manufacturing process allowed for some residue to remain on some portion of the particular knee implant used in plaintiff’s knee replacement surgery back in 2000. Howard v. Zimmer, Inc., No. 02-CV-0564-CVE-FHM, 2014 U.S. Dist. LEXIS 28758, ** 1-2 (N.D. Okla. Mar. 6, 2014). This claim sounds an awfully lot like manufacturing defect or negligent manufacturing and not really at like negligence per se based on a violation of the FDCA, but maybe a plaintiff in a case old enough to be reserving space for its bar mitzvah party should finally be showing whether he has any admissible evidence to support any claim linked to his injury.

Compared to what we have posted on in this case before, the Daubert decision was sound and not results-driven. The weakness of plaintiff’s experts could be viewed either as a shame given the judicial resources spent on the case or as a product of the particular non-preempted claim that plaintiff was left trying to prove. Either way, with plaintiff’s experts hamstrung, we expect Howard is nearing its end, especially if Defendant gets another shot at summary judgment.

The major part of the decision focused on the reliability of gas chromatography/mass spectrometry testing of the explanted device conducted by plaintiff’s expert to show residue—basically oil—was on the device when it was implanted. We know that our readers would appreciate an explanation of how gas chromatography and mass spectrometry work. Luckily, the internet is really cool, so we are not providing the explanation ourselves. Because the challenge here was to how the testing here was performed, as opposed to whether properly performed testing can ever be a reliable basis for expert opinions, the science behind the tests does not matter too much. Id. at **7-8. Also, the alleged methodologic failures were fairly basic when cast in laymen’s terms.

First, chain of custody for the implant was only established starting when the expert’s outfit got it, leaving open questions of what might have happened to it before then, innocently or otherwise. If what got tested was not what got explanted, then the testing can hardly be said to be useful to a jury. Second, part of the testing may have involved pouring a solvent into a plastic container, which itself could have produced some or all of the chemicals (hydrocarbons) that allegedly indicated possible residue oil from manufacturing the device. It was fairly obvious that some additional testing of the container should have been done to rule it out as a source of the chemicals. Third, although plaintiff contended only one part of the device had some post-manufacturing residue on it—and instructed the expert to only test it—the testing was done on the whole device together, including a plastic part that arguably could have produced the chemicals at issue when put in contact with the solvent. Following steps to avoid false results is fairly typical of good science. Fourth, the plaintiff’s expert never tested for the specific lubricants used in manufacturing the device, but only tested some generic mineral oil, which may or may not have the same mix of hydrocarbons.

Rather than resolving these questions or determining that success on any one challenge would have been sufficient to knock out the testing, the court held that “it is clear that the combination of the four errors is sufficient” to find the testing unreliable. Id. at ** 13-14. We might have preferred if the court had stated this as a failure of plaintiff to establish the reliability of the testing, as it was clearly plaintiff’s burden to do. The court had indirectly quoted Paoli for “any step that renders the analysis unreliable . . . renders the expert’s testimony inadmissible. This is true whether the step completely changes a reliable methodology or merely misapplies that methodology.” Id. at * 13 (quoting Mitchell v. Gencorp Inc., 165 F.3d 778, 783 (10th Cir. 1999)). Then the court found it “unclear” if the hydrocarbons found in the testing could have come from the lubricants used to manufacture the part at issue, as opposed to from the container, another part, or some post-explant contamination. Id. at * 14. So, this really does sound like the plaintiff not carrying his burden and we are content.

We were also pleased that all opinions based on the unreliable testing were excluded without any particular analysis. The tidy decision to exclude regulatory opinions from the expert who did the testing was also good. He denied expertise in FDA’s regulation of medical devices, but got a “general idea of what needs to be done” from internet research. Not enough. Id. at ** 16-17. Just like conducting the internet research we advocated above would not confer expertise in gas chromatography. Unfortunately, this expert did offer some opinions based neither on the testing or his non-existent regulatory expertise, so he was not excluded entirely.

That was not the case for Dr. Fred Hetzel, whom we have mentioned before. In addition to opinions based on the unreliable testing, he tried to offer legal conclusions about the meaning of FDA regulations on Good Manufacturing Practice regulations and speculation that metallic residue also could have been on the device when it was implanted. As to the first part, it was apparently “law of the case” from way back when the case was back in the MDL that Hetzel was “not competent to testify to legal conclusions about what the GMPs require.” Id. at * 18. This is an interesting limit to have in a case where the plaintiff was trying to proceed on the theory that the violation of those regulations constituted negligence per se. As to the second part, Hetzel basically admitted that he had no evidence of any metallic residue on plaintiff’s device, in part because relevant evaluating and testing was not performed. Id. at ** 18-19. This made it easy for the court to find opinions on metallic particulates unreliable—and obviously irrelevant.

The last part of the decision concerned the attempt of a treating opinion to ascribe the failure of plaintiff’s knee replacement surgery to an issue with the manufacture of the device based on his experience that he saw a similar course with another patient with the same device. Opinions based on “clinical experience” often get offered by plaintiff and defense experts, particularly surgeons, and it can be hard to sort out when an opinion is simply based on what amounts to a comparison to the expert’s own unpublished case report or on something more substantial. The court’s analysis was direct and logical, so we will just insert it:

There is no evidence that any further scientific inquiry was conducted to determine the extent of the similarities between [plaintiff’s] experiences and those of the other patient. The sole basis for Dr. Robertson[‘s] opinion appears to be that both [plaintiff] and the other patient had aseptic loosening and that both patients’ implants were easier to remove than anticipated. Plaintiffs have failed to establish that this comparison is reliable. Plaintiffs have not provided evidence that this comparison has been subject to peer review and publication, that there is an established rate of error for this comparison, or that this comparison has general acceptance. See Bitler v. A.O. Smith Corp., 400 F.3d 1227, 1233 (10th Cir. 2005). Dr. Robertson’s methodology for reaching the conclusion that [plaintiff] and his other patient’s experiences were substantially identical is insufficiently rigorous, and, as a result, his opinion should be excluded. See Kumho Tire Co., Ltd. v. Carmichael, 526 U.S. 137 (1999) (“[The objective of Daubert’s gatekeeping requirement] is to make certain that an expert, whether basing testimony upon professional studies or personal experience, employs in the courtroom the same level of intellectual rigor that characterizes the practice of an expert in the relevant field.

Id. at * 22-23 (record cite omitted). That is dead on and even introduced the burden issue we harped about above. As its parting shot, the court dismissed the argument that cases providing for the admissibility of prior accidents (or ADEs or MDRs for our typical cases) do not support an expert’s reliance on a single prior patient for a causation opinion. Id. at ** 23-24.

We hope that we are nearing the end of Howard, as it seems to have been a long and expensive exposition of a principle we find self-evident: not every failed surgery with a medical device gives rise to a viable cause of action against the device’s manufacturer. With close to twelve years of litigating, including a bad preemption decision by the Sixth Circuit and a really bad negligence per se decision by the Oklahoma Supreme Court, it may be that the case was an exercise in futility from the start, because there was never anything wrong with the device. (And, much like Howards End, movies where Antony Hopkins does not play a psychopath can run a little long.)

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We will not be the first to comment on the Eighth Circuit’s affirmance earlier this week of summary judgment in Boehm v. Eli Lilly & Co., 2014 WL 904202 (8th Cir. March 10, 2014), nor will we be the last.  The case is that good and that important. (And, unlike some of the recent cases we’ve dithered over, it is published!  It is precedential!  We are excited!)  The court combined a nice learned intermediary analysis with an even nicer Daubert analysis.  The virtues of the Eighth Circuit’s decision are obvious enough, but there are a couple of wrinkles in it that caught our eye.

The first wrinkle is a reminder of how creative plaintiff lawyers can be and how they will do just about anything to try to evade the learned intermediary doctrine.  (Arkansas law supplied the learned intermediary rule in this case.)  In Boehm, the plaintiff alleged that he suffered from a movement disorder called tardive dyskinesia (TD) as a result of taking Zyprexa for his bipolar disorder. His legal claim was for failure to warn.  But this claim suffered from many problems.  Let’s count them:  First, the Zyprexa label expressly warned about TD as a possible side effect.  Second, the treating/prescribing doctors were aware that atypical antipsychotics such as Zyprexa could cause TD.  Third, those doctors still prescribe Zyprexa. Fourth, the doctors testified that an alternative warning about the risk of movement disorders would not have changed their decisions to prescribe Zyprexa to treat Boehm’s bipolar disorder.

Faced with that sort of overwhelming record, what’s a clever plaintiff lawyer to do?  No matter how clear and comprehensive the warning, a plaintiff lawyer will extract some detail that is absent from the label, and then try to inflate that into some potentially changed behavior on the part of the doctor.  What if that detail is hokum?  Keep reading.

The Boehm court helpfully reproduced the pertinent part of the doctor depositions.  Here is the deposition of one of the treaters:

[Boehm’s counsel]:  I’m going to ask you about something that – a figure that I have seen here, that 15 percent – and I will ask you if you are aware of this.  But 15 percent of those who have taken neuroleptics, such as Zyprexa, for three years, develop tardive dyskinesia?

[Dr. Kaczenski]:  Yes, that’s a number I have known for a long time.

Plaintiff’s counsel then exploited that answer during the deposition of another treater:

[Boehm’s Counsel]:  Did you receive any information that once a patient is prescribed Zyprexa for three years, one in six patients will develop tardive dyskinesia?  Were you told that?

[Dr. Miller]:  No.

Q.  All right.  If you had known that, and that is an established fact in this case pursuant to Doctor Kaczenski’s deposition testimony *** — that the inciden[ce] of tardive dyskinesia increases to one in six patients after three years of use, would you still have prescribed that to Tim Boehm?

A.  Not for that long.

Voilà!  Or, maybe, abra cadabra!  Has the plaintiff successfully made the learned intermediary doctrine disappear?  Not quite.  At least, not for a court that is really paying attention. The district court was aware that “Dr. Kaczenski did not offer the 15% risk figure on his own; the percentage was part of a leading question.”  Boehm, 2014 WL 904202 at *3.  It was hardly, as the question suggested, “an established fact in this case.” (But you’ve got to admire the chutzpah.)  Accordingly, the court requested briefing on whether the alleged 15% risk was supported by scientific evidence that would be admissible under Daubert.

Naturally, the plaintiff obliged by proffering the opinion of one of his paid experts, a psychiatrist who opined that “Zyprexa is capable of a high rate of incident tardive dyskinesia/dystonia after three years of use, affecting between 15-20% of those prescribed the drug.”  Id.  That is a classic ipse dixit.  (That is, it’s just a guy with credentials saying ‘I’m smart and I say so.’)  When the defendant challenged that opinion as lacking scientific support, the expert submitted two supplements to his report.  It reminds us of those late night commercials that keep saying, “Wait, there’s more.”  First, there was an article on the National Empowerment Center website stating that  “Different studies quote different rates of tardive dyskinesia ranging from 15%-20% for people using [antipsychotics] for more than three years.”  It also stated that Zyprexa “has been found to cause TD,” but it listed no sources for its information.  Second, an expert witness hawked his plaintiff-TD-testifying wares on a webpage and bloviated, without citing a source, that the cumulative rates of TD are in the range “of at least 15%-20% for the first three years.”  Id.  Not very impressive stuff, as far as scientific evidence is concerned, is it?

But wait, there’s more.

The plaintiff expert  again supplemented his report with a 2010 peer-reviewed study comparing TD incidence rates for users of first-generation and second-generation antipsychotic drugs.  The study did not appear to substantiate the 15% assertion, and, in fact, showed that bipolar patients taking Zyprexa can expect better results than other patients.

None of this impressed the court very much, and it had little difficulty concluding that the plaintiff and its expert and the 15% allegation flunked Daubert.  Indeed, some of the materials relied upon by the plaintiff’s expert undermined the 15% figure.  And now we come to the second wrinkle in the case.  The district court concluded that the materials in the expert’s first supplement  – “a blog post and website advertising” – were a “deficient foundation” to support the 15% risk figure.  Id. at *4.

(Awkward pause.)  Well. Harrrrumph.

While we have no doubt that the blog post relied upon by the plaintiff expert was insufficiently reliable, we do think it is possible that some blog posts can be utterly reliable — authoritative, even. Maybe you’re reading one right now.  At least we occasionally cite things.

Anyway, the Eighth Circuit ends up rejecting the plaintiff’s imaginative and energetic sidestep of the learned intermediary doctrine: “On appeal, Boehm places great emphasis on the testimony in which Dr. Miller agreed that prescribing Zyprexa for three years was ‘too long’ given the 15% risk of developing TD.  But that testimony was based on Boehm’s counsel instructing Dr. Miller that a 15% risk factor for Zyprexa users has been established by Dr. Kaczenski’s testimony, which was untrue.”  Id. at *5.  Just so.

The Eighth Circuit also wasted little time in disposing of the plaintiff’s overpromotion theory.   It was by no means clear that Arkansas law would countenance such a theory, but even if it did, the case was bereft of the requisite “individualized proof” that a drug manufacturer’s excessive promotion of its product caused the plaintiff’s physician to initiate or maintain the prescription at issue.  The court allowed that there was evidence in the record of aggressive marketing that stressed the medicine’s “safety”, “efficacy,” and “ease of use” for treating bipolar patients, but there was no evidence that any company representative made statements to the treating doctors “that negated the package insert warning, and there is no evidence their prescribing decisions were affected.”  Id. at *6.

We are impressed by the Eight Circuit’s reasoning … even if that court is less than impressed by the force of blog posts.

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This guest post is from Reed Smith’s Lindsey Harteis, who as always gets all the credit and shoulders all the blame for what follows.  Her post is about the First Amendment implications of the FDA’s recent draft guidance on manufacturer distribution of scientific articles and textbooks, a proposal that alters, but does not fundamentally change the FDA’s previous guidance on this subject that we discussed back in 2009.

Take it away Lindsey:

********************

Last week, the FDA released new draft guidelines that represent its latest recommendations for what drug and device manufacturers should do when they wish to distribute information on unapproved or “off-label” (this FDA prefers the more pejorative term “unapproved”) uses of their drugs and devices via scientific articles, scientific or medical reference texts and clinical practice guidelines (CPGs) to any health care entity.  See Guidance for Industry Distributing Scientific and Medical Publications on Unapproved New Uses – Recommended Practices, 79 Fed. Reg. 11793-796 (FDA March 3, 2014) (“Draft Guidance”).  The draft guidance itself is available online here.

It’s an interesting coincidence, but doubtless no more than a coincidence, that the FDA’s timing comes close to landing  on the anniversary of the first First Amendment ruling in a torts case in New York Times v. Sullivan, 376 U.S. 254 (1964), which was decided 50 years ago on March 9, 1964.  Indeed, the FDA still seems willfully oblivious to the revolution in First Amendment jurisprudence that has since occurred.

We’re most concerned with the guidance as it applies to clinical and scientific articles and reprints.  For more comprehensive coverage of the guidance as it applies to medical reference texts and clinical practice guidelines CPGs, check out what the FDA law blog has to say.

While members of Congress still are mum on the issue of yet another case of the FDA testing (“breaching”) the bounds of the First Amendment, it doesn’t sit well with us.  We at DDLaw have a storied romance with off-label use itself.  Notwithstanding the risks of using medical drugs and devices that have not cleared the hurdles of the FDA’s approval process, off-label uses offer substantial benefits to many patients, which is why the practice is so common. In still others, such uses can offer acute conveniences that might not justify additional testing, but sure as heck improve a patient’s quality of life and care.  For example, this guest author routinely uses a continuous blood glucose monitor in areas of the body where the FDA has yet to OK marketing for use in adults. Why?  Because doctors know the device was extensively studied (and is approved) for use in locations other than the abdomen for children, but has not yet undergone the expense of the required separate testing before approving alternate sites in adults.  Rather than accumulate scar tissue by using the device in a very small area, engaging in off-label use allows me to preserve and maintain healthy tissue and use the device in a way that’s significantly more comfortable, day in and day out, without compromising the accuracy of the blood glucose readings themselves.

As we’ve discussed before, drug and device manufacturers can’t always justify the expenses associated with having a product FDA- approved for additional uses.  To obtain FDA approval for a new use, manufacturers are required to demonstrate, through clinical trials, the safety and efficacy of a new drug for each intended use or indication.  21 U.S.C. §355(d).   Manufacturers have reduced incentive to pursue having additional uses printed on their labels where drugs are soon to be off-patent and where the population who could benefit from the now off-label use is not large enough to justify the expense of studies, to name a few examples.

Let’s be clear: if you engage in off-label promotion, the government (or some plaintiff) may bring an action against you.  But there is a fine line between off-label promotion of a drug and allowing manufacturers to communicate dosing or other important information on off-label uses to practitioners in cases where they already plan (as is their right) to invoke off-label use in a treatment plan.  Just see Wells v. Allergan, 2013 WL 389147 (W.D. Okla. 2013), where the trial court denied summary judgment on a failure to warn claim where the FDA had rejected proposed warning language speaking to dosage for off-label use of Botox in pediatric patients with cerebral palsy. Id. at *1.  There, although the FDA prohibited the manufacturer from warning about dosage limitations and lack of studies of Botox in pediatric patients, the court was not willing to grant the defense summary judgment on the failure to warn claim.  Id. at *7.  In fact, the court seemed appalled that when the plaintiff’s physician specifically asked the manufacturer for dosing information for the off-label use, the manufacturer did not produce all of the relevant studies in its possession (presumably for fear of an FDA action based on off-label promotion). In that case, the plaintiff’s injuries may have been avoided altogether if the manufacturer had felt comfortable sharing all of its known dosing information for the off-label use.  Wells demonstrates that physicians often decide to pursue off-label use with or without the benefit of the most up to-date dosing information – because the FDA actively inhibits such dissemination.  It certainly would have been better for that plaintiff’s physician to have as much information about dosing as possible, as the manufacturer had dosing information that likely could have prevented his injuries.  Instead, Wells makes manufacturers feel as though they are damned if they do issue warnings on off-label uses (when it’s misconstrued as off-label promotion) and damned if they don’t (by a viable failure to warn claim).

[Editor’s Note:  Bexis would argue that after Bartlett the claim in Wells is preempted because the FDA requires by regulation (and here rejected) all warnings about the risks of off-label use have prior agency approval before they may be included in the labeling.  That’s impossible to square with a tort duty to do so immediately.]

Even the FDA recognizes the longstanding right of physicians to prescribe drugs beyond the uses and populations included in their label.  The agency says so in its 2009 Guidance on this subject:

Once a drug or medical device has been approved or cleared by FDA, generally, healthcare professionals may lawfully use or prescribe that product for uses or treatment regimens that are not included in the product’s approved labeling (or, in the case of a medical device cleared under the 510(k) process, in the product’s statement of intended uses). These off-label uses or treatment regimens may be important and may even constitute a medically recognized standard of care. Accordingly, the public health may be advanced by healthcare professionals’ receipt of medical journal articles and medical or scientific reference publications on unapproved new uses of approved or cleared medical products that are truthful and not misleading.

FDA , Guidance for Industry – Good Reprint Practices for the Distribution of Medical Journal Articles and Medical or Scientific Reference Publications on Unapproved New Uses of Approved Drugs and Approved or Cleared Medical Devices (January 2009), available here.

Doctors engage in these uses where they find the benefits of the particular use outweigh the risk for the individual patient.  And the most valuable tools for helping a physician make this risk-benefit analysis are often the very clinical studies the new Guidance seeks to make more cumbersome for physicians to obtain from the most likely source – whoever is the manufacturer of that particular drug or device.

So long as we are talking about truthful (and not misleading) information on off-label uses, it’s hard to see how limiting the informational environment on off-label use helps anyone – it certainly doesn’t help physicians trying to determine dosing for an off-label use and least of all the patient for whom an off-label use represents a last resort.  Manufacturers are the logical source (and sometimes the only source) for the most robust and up-to-date compliment of information outside of a drug’s label itself.  They are, after all, chiefly responsible for monitoring post-market results of their own products.

The authors of the FDA Guidance certainly are aiming to make it less likely that physicians can get information on off-label use from the hand of a manufacturer, even where that manufacturer had nothing to do with the act of publishing itself.  But before we get into the Draft Guidance itself, it’s worth emphasizing – it is just that,(1) a draft subject to a notice and comment period that ends May 2, 2014 and (2) guidance: it doesn’t have the effect of binding anyone:

“If a manufacturer who chooses to distribute scientific of medical journal articles that include information on unapproved or uncleared uses of its product(s) does so in accordance with the recommendations of this guidance, the FDA does not intend to use that distribution as evidence of the manufacturer’s intent that the product(s) be used for an unapproved new use.” (Draft Guidance).

The agency itself characterizes the Draft Guidance as recommendations, and states the word “should” as used in the document means that something is suggested or recommended, but not required.  (Draft Guidance).

Now that we’ve clarified these housekeeping issues, this is how the Draft Guidance applies to scientific or medical journal articles that a manufacturer wishes to distribute and which contain information on off-label use.

The organization that publishes the articles:

  • Should have an editorial board that uses experts who have demonstrated expertise in the article’s subject matter.
  • Should review and objectively select, reject or provide comments on articles considered for publication.
  • Should follow a publicly stated disclosure policy including any conflict of interests or biases of the article’s authors, contributors, or editors.

The article itself should:

  • Be peer reviewed
  • Be an unabridged reprint or copy (no excerpts)
  • Contain information addressing “well-controlled” clinical studies that are considered scientifically sound .  There’s a an exception for devices allowing for “significant investigations” that aren’t other “well-controlled,” including proof-of-hypothesis, animal and bench testing.
  • Be accompanied by the FDA-approved labeling for the product it pertains to.
  • Also be accompanied by a comprehensive bibliography, when such a thing exists, of all other published “well-controlled” studies that concern this particular off-label use.
  • Also be accompanied by “representative” publications reaching contrary or different conclusions about the particular off-label use (again, if they exist).
  • Not be accompanied by promotional materials.  Indeed, the FDA doesn’t even want the same sales reps distributing the material.  Talk about throwing up roadblocks.

The article must not:

  • Be false or misleading (however the FDA chooses to define that term).
  • Recommend any use of the product that would be dangerous.

The article should not:

  • Be in a special supplement or some other one-shot publication funded by the product’s manufacturer.
  • Have any markings, highlighting, summary or other description added by the manufacturer that emphasizes the off-label use.
  • Only be available through the product’s manufacturer.  It should be available through other, independent distribution channels.
  • “Be written, edited, excerpted, or published specifically for, or at the request of, a drug or device manufacturer.”
  • Be attached to information specifically about the product (except for FDA-approved labeling).

Required disclosures

  • “[A] prominently displayed and permanently affixed statement disclosing” that the information discusses an off-label use.
  • The financial interest of the authors, including compensation amount received by the author from the manufacturer.
  • Anybody that has provided funding for the study discussed in the article.
  • Any significant risks or safety concerns associated with the off-label use, both those discussed in the article and not.

Our reaction to the Draft Guidance is simply, “the more things change, the more they stay the same.”  The FDA is still trying to test the bounds of the First Amendment, but its Draft Guidance isn’t imposing any new source of liability.  And even if it were, it’s been this blog’s longstanding position that off-label promotion is constitutionally protected speech, where it is (1) truthful and (2) involves scientific information about off-label use.

For just a few of our favorite First Amendment decisions that you won’t find cited in the FDA’s latest draft, see Thompson v. Western States Medical Center, 535 U.S. 357 (2002) (holding a FDA provision that a compound drug prescription must be unsolicited and that pharmacists cannot advertise or promote compounding any drug is unconstitutional restriction of commercial speech under the Central Hudson test); United States v. Caronia, 703 F.3d 149, 169 (2d Cir. 2012) (holding that the government cannot prosecute pharmaceutical manufacturers under the FDCA for speech promoting the lawful, off-label use of an FDA-approved drug); Sorrell v. IMS Health Inc., 131 S.Ct. 2653, 2659 (2011) (“Speech in aid of pharmaceutical marketing…is a form of expression protected by the Free Speech Clause of the First Amendment.”).

All of these cases are more recent (and thus supersede) all of the cases that the FDA decides to cite in the Draft Guidance.  Rather than confront its more recent losses, the FDA has chosen to stick its head in the sand.  Because the FDA appears to have no answer, we still think the First Amendment has enough mojo to defeat any FDA legal challenge that might invoke the Draft Guidance.

If you haven’t yet seen the finale episode of True Detective, this is where this blog post should end for you.  Throughout the episode, we could see that the more things changed, the more they stayed the same — Rust and Marty’s relationship, the shots of the bayou, and the winding roads we saw in previous episodes.  At the end, Rust and Marty gaze up at the stars, and Rust says “Once there was only dark, if you ask me the light is winning.”  And so it is here at the Drug and Device Law Blog.  Once there were only a few cases giving our clients the right to communicate about off-label uses with physicians per the First Amendment.  With time, and possibly additional legal challenges to whatever final form the Draft Guidance takes, maybe we can have a few more stars to cite in briefs, and maybe enough light will be shed on off-label uses for the people who need it most, the patients.

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Here’s another “little list” that came about because of Bexis updating chapter two (information-based claims) of his book.  This one includes all cases where, due to the ordinary burden of proof, warning claims were dismissed on causation grounds where there was simply no evidence in the record about the prescribing physician’s actions.  The reasons for the prescriber’s unavailability differ.  S/he could be dead, disappeared, or for whatever reason never deposed.

Obviously, the rationale of these cases doesn’t fly in jurisdictions where a “heeding presumption” puts the onus on the defendant to come up with affirmative proof of lack of causation.

First, some cases from Texas, one of a few states that has addressed this issue repeatedly.  In Centocor, Inc. v. Hamilton, 372 S.W.3d 140 (Tex. 2012), the Texas Supreme Court pointed out that the plaintiff’s questioning of the prescriber was simply inadequate.  “Instead of proving that greater risk of [the condition would have changed [the prescriber’s] decision to prescribe [the drug], [plaintiffs] elicited no evidence to that effect.”  Id. at 172.  Also under Texas law, the Fifth Circuit in Pustejovsky v. PLIVA, Inc., made clear that the party with the burden of proof loses when the prescriber simply doesn’t remember anything:

[Plaintiff] has not carried her burden. As [plaintiff] admits, [the prescriber] did not recall ever reading the package insert for the drug or consulting the Physician’s Desk Reference.  Her lack of memory, of course, does not preclude the possibility that she had read these materials, but neither can it sustain [plaintiff’s] burden.

Lacking any evidence that [the prescriber] was aware of [defendant’s] warnings, [plaintiff] instead speculates about other ways an adequate warning might have reached [the prescriber] and altered her decision. . . . Certainly, these scenarios are possible. Ultimately, however, without any summary-judgment evidence to support them, they remain nothing more than possibilities. . . .  While [plaintiff] can imagine any number of scenarios to fill the gaps in [the prescriber’s] memory, she has provided evidentiary support for none of them.  Accordingly, [plaintiff] fails to demonstrate a genuine issue of material fact regarding causation.

Continue Reading Little Lists 2 – Warning Causation Dismissal Where Prescriber Not Deposed

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One of the best developments in drug and device law over the last 15 years has been the demise of the class action. Although seen by plaintiffs and some commentators as convenient devices that can be used to resolve large numbers of claims in bunches, courts have generally come to understand that class actions just don’t work in cases involving drugs and medical devices.  The differences among the claims and the claimants are just too numerous, making class actions all but uncertifiable outside of the settlement context.  (See our class certification denial cheat sheets here and here.)

When class actions are filed against drug and medical device manufacturer these days, they usually look like Plumlee v. Pfizer, Inc., No. 13-CV-00414-LHK, 2014 LEXIS 23172 (N.D. Cal. Feb. 21, 2014).  A patient who had used both branded and generic Zoloft filed a class action against the innovator manufacturer, but not because there was anything allegedly wrong with the product or because she had experienced any alleged side effect.  The plaintiff does not even appear to have alleged that the product failed to work as well as it was supposed to.  She allegedly took the medicine for more than three years, which suggests to us that she was benefiting from the therapy.  Id. at **9-10.

So what was the plaintiff’s beef?  Well, she alleged that the innovator manufacturer made numerous misrepresentations, basically by allegedly overstating the effectiveness of the drug in the label and in marketing.  Our favorite allegation is that the manufacturer marketed the product to doctors through sales representatives who were “typically young attractive people.” Id. at **8-9.  Perhaps the plaintiff is referring to the 2010 motion picture Love & Other Drugs, which starred Hollywood hunk Jake Gyllenhaal as a sales rep for the drug company that also happens to be the defendant in this case.  (The movie also presented a cavalier and horribly insensitive portrayal of patients with Parkinson’s disease, but that’s a topic for another day.)  We don’t know what movies the plaintiff has seen, but we do know that her objective was to recover the purchase price of the drug for herself and other patients under California’s Consumer Legal Remedies Act, Unfair Competition Law, and False Advertising Law.  Id. at *17.

There are so many things wrong with this lawsuit, we hardly know where to start.  For one thing, we emphasize again that this plaintiff did not allege any injury.  For all we know, she got exactly what she paid for, which makes us (and the defendant) wonder how she had standing to sue at all.  In addition, having just read yesterday’s post on statutory safe harbors for consumer claims, we wonder whether this action falls into California’s safe harbor for “business practices which the Legislature has expressly declared to be lawful in other legislation,” see Cel-Tech Communications, Inc. v. Los Angeles Cellular Telephone Co., 973 P.2d 527, 542 (Cal. 1999).  Plaintiff was complaining about FDA-approved labeling, and although we doubt that any safe harbor applies, maybe one should.  We also wonder how the plaintiff ever hoped to get a class certified.  Claims based on alleged misrepresentations, whether in the drug and device context or not, present myriad individual issues, including and particularly on causation.  Did the prescriber review the label or see any marketing?  Would different information on the drug’s efficacy have made any impact?  If the sales representative was actually as young and attractive as Jake Gyllenhaal (or his beautiful co-star Anne Hathaway), would the physician have been more or less influenced by the purported sales pitch?  Good luck attempting to adjudicate these individual issues and countless others on a classwide basis.

Thankfully, it looks like we may never know the answers to these questions, because in the end, the undoing of the plaintiff’s complaint was the statute of limitations.  The plaintiffs’ claims were subject to three-year and four-year statutes of limitations, and the most interesting part of the order is the part addressing when the plaintiff’s claim accrued. This, again, was a consumer action seeking a refund of the purchase price, so the claim accrued when the plaintiff last purchased the product.  Plumlee, at **22-24.  This makes sense to us and apparently also to the plaintiff, who conceded that “her injury was deception at the point of sale.”  Id. at *24 n.5.

It also makes sense that the district court rejected the plaintiff’s attempt to invoke the discovery rule to delay accrual.  California’s discovery rule “postpones accrual of a claim until ‘the plaintiff discovers or has reason to discovery the cause of action.’”  Id. at *26 (citations omitted).  Under this rule, the plaintiff bears the burden of proving not only delayed discovery, but also that he or she could not have discovery the claim with reasonable diligence.  As the district court held,

“A plaintiff whose complaint shows on its face that his claim would be barred without the benefit of the discovery rule must specifically plead facts to show (1) the time and manner of discovery and (2) the inability to have made earlier discovery despite reasonable diligence.  The burden is on the plaintiff to show diligence, and conclusory allegations will not withstand” a motion to dismiss.

Id. at *26 (citations omitted).  We are not completely convinced that discovery rules should exist at all.  But if we must have discovery rules, this formulation is as good as any, particularly its allocation of a burden to specifically plead reasonable diligence.

The district court’s application of the discovery rule was as good as it gets, too.  The plaintiff claimed that she did not discover the alleged untruthfulness of the defendant’s statements until years after she last purchased the drug.  Id. at *28.  But this is the age of TwIqbal plausibility, id., at *4, and that bare allegation did not meet the plaintiff’s burden because she did not allege specifically the time and manner of her discovery.  In other words, she failed to allege when and how she “learned” that clinical trials allegedly undermined the defendant’s representations.  Id.  Plaintiff’s allegations also did not meet her burden of reasonable diligence, and although the quote below is kind of long, it is worth reading because it provides a roadmap to responding to plaintiffs like this one:

Plaintiff pleads absolutely no facts that would support a finding that she was “not negligent in failing to make the discovery sooner and that [s]he had no actual or presumptive knowledge of facts sufficient to put [her] on inquiry.” . . .  To the contrary, the Complaint identifies and relies upon several published articles regarding the efficacy of [the drug] and other related drugs that were published many years before Plaintiff filed suit. . . .  Plaintiff does not explain why she was unaware of these publications before “early 2012” when she allegedly discovered the misrepresentation for the first time, nor explains why these publications did not serve to put her on notice that Defendant may have made misrepresentations about [the drug’s] efficacy. Furthermore, nothing in the Complaint provides the Court a basis to conclude that Plaintiff was unable to learn of [the defendant’s] alleged misrepresentations and omissions until 2012 despite reasonable diligence.  Plaintiff does not allege that she took any steps towards discovery.

Id. at **29-30 (emphasis in original, citations omitted). So, yes, the same tougher pleading rules can be used against plaintiffs trying to plead into discovery rules.  This is about as direct a holding as you are ever going to see.  It also correctly describes the standard of reasonable diligence, correctly assigns the burden to the plaintiff to plead specific facts, and correctly calls the plaintiff out for failing to meet that burden.  Onto our TwIqbal cheat sheet this one goes.

The only problem we have with the order is that the court granted leave to amend.  This class action has no legs, and hopefully the next motion to dismiss will put an end to the case for good.  Plaintiff surely is between a rock and a hard place: She kept her allegations general and vague with the hope that omitting her specific facts would help her on class certification.  But now the court has called her hand, and even if she is able to plead the specifics required for delayed discovery, the statute of limitations is the least of her problems.  We don’t know how this thriller ends, but we know how we would write the script if it were up to us.  The End.

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Because Bexis is updating chapter two (information-based claims) of his book, he has some ideas for some shorter lists of interesting cases.   Here’s one.  What follows are all the cases Bexis knows about that have dismissed consumer fraud/protection claims because the conduct under attack fit within the language of the statute’s “safe harbor” for government regulated activity.

We use “regulated” advisedly. State consumer protection statutes vary widely on just how these safe harbors (and not every state has one) are phrased, and the statutory terminology makes a difference – as it should.   Some state’s statutes exempt conduct in “compliance” with relevant governmental oversight, which we’re taking to mean “FDA,” regulations (Alabama, Colorado, Delaware, Georgia, Hawaii, Illinois, Maine, Minnesota, Nebraska, Nevada, Ohio, Oregon).   Other states exempt anything “permitted” by the relevant regulatory body (Arkansas, Connecticut, Indiana, Maine, Massachusetts, Montana, Nebraska, New Mexico, Ohio, Rhode Island, South Carolina, South Dakota, Utah, Wyoming).   Some states qualify their safe harbors with modifying adverbs, such as “specifically,” “expressly,” or “affirmatively” (Florida, Georgia, Idaho, Illinois, Indiana, Michigan, New Mexico, Ohio, Tennessee, Utah).  A broader formulation exempts anything that is government “regulated” (Alaska, Nebraska, Oklahoma).  A narrower formulation exempts only conduct “required” by the regulator (Florida, Idaho, Indiana, Ohio, Utah, Wyoming). Another variant is “authorized (with or without adjectives) (Illinois, Michigan, Tennessee, Virginia), or alternatively “authorized or approved” (Kentucky).  Then there are New York (“subject to and complies with”), Washington (“permitted, prohibited or regulated”) and California (a common-law carve out for “business practices which the Legislature has expressly declared to be lawful in other legislation,” see Cel-Tech Communications, Inc. v. Los Angeles Cellular Telephone Co., 973 P.2d 527, 542 (Cal. 1999)), which don’t follow anybody else’s pattern.  Finally, we have West Virginia, which didn’t need no stinkin’ safe harbors to exempt all FDA-approved products from its state’s consumer protection statutes.   White v. Wyeth, 705 S.E.2d 828 (W. Va. 2010).

To the extent that states show up more than once on these lists, they have either more than one statutory safe harbor or more than one definition for the safe harbor– see Bexis’ book for details (and all statutory citations).

Since we first mentioned the statutory safe harbor defense back May, 2007, the number of cases relying on these provisions to dismiss consumer fraud claims has burgeoned.   The earliest was American Home Products Corp. v. Johnson & Johnson, 672 F. Supp. 135 (S.D.N.Y. 1987) (applying New York law), which held that FDA approval of labels fit within the definition used in New York:

The rationale underlying the exemptive provisions of all of these [state consumer protection] statutes is the need for uniformity in the regulation of advertising and labeling and a deference to the expertise of the responsible regulatory agency.　.　.　.   Where the FDA has explicitly endorsed the particular facet of the labeling which is claimed to be inadequate, there is presented a clear conflict between federal law pertaining to the marketing of drugs in interstate commerce as directed by the FDA and the local law.

Id. at 144-145.   Accord In re Fosamax Alendronate Sodium Products Liability Litigation, 2013 WL 1558697, at *7-8 (D.N.J. April 11, 2013) (“[the drug] is approved by the FDA, and therefore, this approval is a complete defense to a [New York law] claim”); Cytyc Corp. v. Neuromedical Systems, Inc., 12 F. Supp.2d 296, 301 (S.D.N.Y. 1998) (“representations .　.　. that comport substantively with statements approved as accurate by the FDA cannot supply the basis for [plaintiff’s NY General Business Law] claims”).

It took fifteen years for another jurisdiction to follow suit, that being Illinois.   The Seventh Circuit applied the state’s safe harbor to a drug-related consumer fraud claim in Bober v. Glaxo Wellcome PLC, 246 F.3d 934 (7th Cir. 2001).  Thus FDA-approved statements have been exempted from consumer protection/fraud liability:

The pharmaceutical industry is highly regulated, both at the federal level and internationally.  Technical requirements abound, and it is not only possible but likely that ordinary consumers will find some of them confusing, or possibly misleading as the term is used in statutes like Illinois’s CFA.   But, recognizing the primacy of federal law in this field, the Illinois statute itself protects companies from liability if their actions are authorized by federal law.

Id. at 941.  Since Bober, there have been several such rulings under Illinois consumer protection statutes.   In Turek v. General Mills, Inc., 662 F.3d 423, 427 (7th Cir. 2011), the plaintiff’s allegations failed to state a claim because the “representations on the packaging of the defendants’ [product] are specifically authorized by the federal statutes and regulations [all FDA] that we’ve discussed.”   In Newman v. McNeil Consumer Healthcare, 2013 WL 7217197 (N.D. Ill. March 29, 2013), the plaintiffs’ “slight” evidence of noncompliance nonetheless failed:

[E]ven if a jury could so find, Plaintiffs have offered no evidence that the noncompliance at issue affected the FDA’s determinations and “specific authorization.”   Plaintiffs’ theory − as it has been generously interpreted − is that the FDA’s specific authorization is inconsequential because the agency lacked or lacks vital information due to Defendants’ noncompliance.  Therefore, Plaintiffs are obligated to provide evidence of noncompliance and explain how such noncompliance affected or is currently affecting the FDA’s decision making .　.　.　. Plaintiffs have failed to do so.

Id. at *8. Finally, while the plaintiff’s Illinois consumer fraud claim survived for other reasons in Scott v. Glaxo Smith Kline Healthcare, 2006 WL 952032 (N.D. Ill. April 12, 2006), the court noted that plaintiff would have a “very difficult burden to show that the statements were not specifically authorized” because industry was “highly regulated” by FDA.   Id. at *2 n.1.

Nor is it just federal courts that throw out consumer fraud cases based on FDA regulation placing a drug or device within a statutory safe harbor. In DePriest v. AstraZeneca Pharmaceuticals, L.P., 351 S.W.3d 168 (Ark. 2009), the Arkansas Supreme Court construed that state’s safe harbor – for “permitted” activity − as precluding consumer protection claims involving statements made in advertising for FDA-approved products:

Arkansas’s [statute] contains a safe harbor provision that specifically exempts conduct that is permitted under laws administered by a federal agency.　.　.　.   [T]the FDA-approved labeling did, in fact, indicate that the approved dose of [the drug] was superior.　.　.　. Therefore, because the advertising complied with the product’s labeling .　.　. the challenged conduct is advertising that is “permitted under laws administered by … [a] regulatory body … of … the United States”—in this case, the FDA.

The information included in the labeling of a new drug reflects a determination by the FDA that the information is not “false or misleading”.　.　.　.  By approving information to be included in the drug labeling, the FDA has determined that the information complies with its rules and regulations. Therefore, if the FDA labeling supports the statements made in advertising for an FDA-approved drug, the statements are not actionable under the [statute].

Id. at 176-77 (citations omitted).

A peculiar case is Prohias v. Pfizer, Inc., 490 F. Supp.2d 1228, 1233-1234 (S.D. Fla. 2007), involving claims made under Florida and Massachusetts consumer protection statutes.   The peculiarity is that in the midst of the period relevant to the purported class action, the defendant’s drug received FDA approval for marketing for the use in question. Before then, the use had been off label.   Id. at 1232. After (but not before) the FDA’s approval, the court held that the defendant’s drug marketing was protected by these statutes’ safe harbor provisions:

I conclude that the plaintiffs’ pre-July 2004 claims are not barred by the states’ respective safe harbor statutes. The safe harbor statutes of the consumer fraud acts of Florida and Massachusetts, which are applicable to [these] claims, respectively, only bar lawsuits challenging conduct which is specifically permitted by a federal or state regulatory scheme.

* * * *

In July of 2004, the FDA approved .　.　. [the drug for ] this indication. Accordingly, any advertisements .　.　. simply marketed an approved use for the drug.　.　.　.   [B]because the claims made by [defendant] in the post-July 2004 advertisements were implicitly authorized by the FDA, the claims in the advertisements fall within the safe harbor provisions of the Florida and Massachusetts consumer fraud acts.

Id. at 1233-34.   The same ruling was reached under the Florida statute in state court litigation brought by a plaintiff with the same unusual name – bet there’s a story there − against the marketing of another drug:

[The trial court ruled that] the conduct that Plaintiff challenges falls within the safe harbor of the Florida Deceptive and Unfair Trade Practices Act, because the promotional and advertising activity attacked in the Complaint is supported by the FDA-approved labeling .　.　. and thus is “specifically permitted” by federal law.　.　.　.   We entirely agree with this ruling.

Prohias v. AstraZeneca Pharmaceuticals, L.P., 958 So.2d 1054, 1056 (Fla. App. 2007).   Accord Berenguer v. Warner-Lambert Co., 2003 WL 24299241, at *3-4 (Fla. Cir. July 31, 2003) (“the Florida Act provides that any administrative rules adopted under the Act “must not be inconsistent with rules and regulations of federal agencies”; statements tracking FDA-approved OTC labels are “required or specifically permitted by Florida law, and [the statute], thus, does not apply”) (citation and quotation marks omitted).  Under these cases, once an indication has been subject to FDA approval, the product’s manufacturer is thereafter “specifically” allowed to market for that purpose, and its activities consistent with the approved labeling fall within a statutory safe harbor defined with this term.

Michigan’s safe harbor is likewise tied to conduct “specifically” authorized by a regulator.  A claim that a medical device (drugs are now immune in Michigan under other statutes) failed to provide its promised benefits fell within the safe harbor in Peter v. Stryker Orthopaedics, Inc., 581 F. Supp.2d 813 (E.D. Mich. 2008):

Here, the specific misconduct Plaintiff complains of is Defendant’s “failure to provide the promised benefits in connection with the transaction at issue.”  The general transaction, however, is the sale of the [device].  [These] are medical devices, which are heavily regulated by the FDA.  In fact, the FDA specifically authorized Defendant to market the [device] at issue in this litigation.  Because Defendant was specifically authorized to sell the [device] at issue, even though Plaintiff alleges that the device was defective, the [statute] does not apply. Defendant is, therefore, entitled to summary judgment.

Id. at 816.  The same result was reached in an unpublished decision of the Court of Appeals of Michigan in Duronio v. Merck & Co., 2006 WL 1628516 (Mich. App. June 13, 2006):

[The statute] provides that the [it] does not apply to “[a] transaction or conduct specifically authorized under laws administered by a regulatory board or officer acting under statutory authority of .　.　. the United States.”  The focus of this statutory provision is not the specific misconduct alleged by a plaintiff, but whether the general transaction is authorized by law.  The Food, Drug, and Cosmetic Act governs drug marketing, manufacturing, and distribution, and vests the FDA with powers to enforce regulations.  The regulations implementing the FDCA are extensive and detailed, and specifically regulate prescription drug advertising.  Because the general marketing and advertising activities underlying plaintiff’s [statutory] claim are authorized and regulated under laws administered by the FDA, the exemption .　.　. applies [and t]he trial court properly dismissed plaintiff’s [statutory] claim.

Id. at *6-7.  See Alexander v. Del Monte Corp., 2011 WL 87286, at *2 (E.D. Mich. Jan. 11, 2011) (“where the FDA specifically authorizes the conduct at issue, the [statute] is inapplicable”; food packaging).  Thus, the FDA’s “specific authorization” to market the device in question is sufficient, without more to preclude any consumer fraud claims in Michigan (and probably other state statutes using the same language) pertaining to representations concerning that product.

Virginia’s safe harbor is for “authorized” conduct.  Several cases have applied this safe harbor in drug/device litigation.  The first was Hart v. Savage, 2006 WL 3021110, at *1 (Va. Cir. Oct. 19, 2006), a trial court order holding that because “the device at issue is a prescription medical device regulated by the [FDA],” the “sale of such a device is authorized by federal regulation and exempt from the Virginia Consumer Protection Act.”   Id. at *1.   In Ball v. Takeda Pharmaceuticals America, Inc., ___ F. Supp.2d ___, 2013 WL 4040395, at *8-9 (E.D. Va. Aug. 8, 2013), reconsideration denied, 2013 WL 5503080 (E.D. Va. Oct. 1, 2013), the court similarly ruled:

The [statute], however, does not apply to federally regulated products.  The [statute] prohibits fraudulent practices in consumer transactions. But it does not apply to all transactions.  By its own terms, however, the [statute] does not apply to “[a]ny aspect of a consumer transaction which aspect is authorized under laws or regulations of .　.　. the United States, or the formal advisory opinions of any regulatory body or official of .　.　. the United States.”   .　.　.  Since federal law regulates the very matters the plaintiff says violate the [statute], the plaintiff’s [statutory] claim fails as a matter of law.

Id. at *8-9 (quoting Ali v. Allergan United States, 2012 WL 3692396 (E.D. Va. Aug. 23, 2012)).   Ali, of course, is the third Virginia case applying the safe harbor to allegations involving FDA-approved products, in this instance a device.   Ali held:

Plaintiffs’ [statutory] claim fails because it challenges conduct that is expressly excluded from the scope of the [statute].   Plaintiffs base their [statutory] cause of action on representations made by [defendant] about the [device] in advertisements and other marketing materials concerning the safety and effectiveness of the device.   Representations .　.　. in marketing materials for the device are authorized and regulated by the FDA under federal law.   The [statute], therefore, does not apply to it, and therefore no action challenging [defendant’s] marketing practices with respect to the [device] may be brought under the [statute].

Id. at *19.

In Arnett v. Mylan, Inc., 2010 WL 2035132 (S.D.W. Va. May 20, 2010), the court found an Oklahoma consumer fraud claim barred by that statute’s relatively capacious safe harbor for “regulated” activities:

A prescription pharmaceutical product may not be marketed in the United States unless and until the Food and Drug Administration (“FDA”) has approved the sale of that product pursuant to the FDCA.　.　.　.  [T]he simple language of section 754(2) focuses solely on whether there is regulation, not whether there is compliance.　.　.　.   Clearly, the defendants’ marketing and distribution of the patch constitutes a transaction that is regulated by federal law.  Therefore, the plaintiffs’ OCPA claim must fail in light of this statutory exception.

Id. at *3.  Obviously, if the statute’s safe harbor had specified “compliance,” as a number of them do, the result would have been different.  In each case the plaintiff’s allegations need to be matched against the scope of the safe harbor provided by the statute.

Finally, the California judicially implied safe harbor has also been applied to FDA-approved conduct in drug/device cases – most recently … yesterday.  In In re Celexa & Lexapro Marketing & Sales Practices Litigation, 2014 WL 866571, slip op. (D. Mass. March 5, 2014), the California safe harbor protected the defendant from claims that it misrepresented the efficacy of a drug that the FDA had found “safe and effective” for the indication in question:

Where, as here, Congress has entrusted the FDA to determine 1) whether there is a substantial evidence of efficacy for a particular indication and 2) whether a proposed label is false or misleading in any way, and the FDA approves a label for a certain indication, the safe harbor provision applies to bar a claim that the label was false or misleading.

Celexa, slip op. at 9. “[T]he prescription drug industry is subject to comprehensive regulations promulgated by the FDA.” Id. at 10. “[W]here plaintiffs base their claims entirely on the marketing and sales of [the product] after the FDA approved [the defendant’s] application for an adolescent indication and a proposed label, the safe harbor applies to bar such claims.”   Id. at 11.

Also, in Pom Wonderful LLC v. Coca-Cola Co., 2013 WL 543361 (C.D. Cal. March 13, 2013) – a different piece of this litigation than is now before the Supreme Court – the district court (on remand from the Ninth Circuit) granted summary judgment under California’s unfair competition law:

Under this doctrine, “[i]f the Legislature has permitted certain conduct or considered a situation and concluded no action should lie, courts may not override that determination.”  This rule applies equally to actions by the California legislature and actions by the U.S. Congress.　.　.　.   Here, Congress has explicitly allowed labeling that is not misleading, and granted FDA the authority to make such a determination. Defendant has complied with the relevant FDA regulations, and so, per the discussion above, is also compliant by extension with the FDCA. The Court therefore finds that California’s Safe Harbor [doctrine] provides a separate and independent basis for granting the Motion.

Id. at *5.   See In re PPA Cases, 2002 WL 35071721, slip op.  at 15, 16, 17 (Cal. Super. Aug. 23, 2002) (“plaintiffs’ [statutory] claim is barred by the ‘safe harbor’ provision of the unfair competition law because [defendant] was permitted by state and federal law to sell its products without [the plaintiffs’] warning”; “[t]he very concept of a safe harbor requires that conduct undertaken pursuant to then-existing permission cannot later be subject to challenge”; “FDA approvals mean that defendants’ sales of [their] products were conducted within a ‘safe harbor’ that prevents retroactive condemnation of their conduct under [the statute]”).

Finally, there is even hope for a similar implied safe harbor in New Jersey.   See New Jersey Citizen Action v. Schering-Plough Corp., 842 A.2d 174, 177 (N.J. Super. App. Div. 2003) (holding “not actionable” under New Jersey statute “the wording of the ads, to the extent that it is subject to FDA oversight”).

Our thanks to Karin Kramer of Quinn Emanuel for the two California-law slip opinions.

We knew we hadn’t updated our safe harbor posts in quite some time, so we can check that one off the list.

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Over three years ago (an eon in blogging time) we urged our readers – particularly those of you who are in-house – to consider joining the Product Liability Advisory Council (“PLAC”).  We believed then, and continue to believe, that PLAC membership helps pharmaceutical and medical device defendants litigate complex matters smarter and more efficiently, because of the cutting edge legal information available through PLAC’s twice-yearly conferences, online knowledge base, and defense counsel network.

More importantly, PLAC consistently churns out superior amicus curiae (“friend of the court”) briefs in cases involving product liability and complex litigation-related issues that are critical to defense success in major matters.  PLAC’s amicus briefs are crafted, not to show the flag or to say “me too,” but to affect the outcome of genuinely important cases in ways that benefit all defendants.  We use “all” advisedly.  PLAC will not brief issues that could divide defendants.

For these reasons, and on general principles, we think that every drug/device company that faces significant product liability exposure – which, unfortunately, is just about everybody these days – should join PLAC.  PLAC’s annual dues for corporate membership are $7,500, a sum that pales in comparison to a single major verdict, or indeed a settlement in a significant mass-tort matter.  To think of this another way, it usually costs PLAC many multiples of a company’s dues to file a single amicus brief, and (as Bexis knows from long experience) PLAC gets cajoles its brief writers to work on bargain-basement rates, which multiplies the “bang” for PLAC’s buck still further.

A little about PLAC.  Although it was originally founded by the auto industry back in 1982, it’s not an industry-specific group.  It’s a subject matter group, and those subjects are product liability and complex product-related litigation.  PLAC’s primary role is and always has been the filing of amicus briefs in appellate cases with issues of significant import in this kind of litigation.  Obviously, such cases usually involve product liability, but not always.  Procedural issues, such as class actions, abound (PLAC briefed punitive damages issues in Dukes).  PLAC has even filed briefs in criminal cases (on Daubert issues).

Let’s consider that a bit.  We’ve said elsewhere that the three most important defenses in prescription medical product liability litigation are, in order of importance:  (1) preemption, because if it applies it eliminates cases wholesale without regard to their factual merit; (2) Daubert, because it can eliminate entire categories of claims on causation grounds; and (3) the learned intermediary rule, because it eliminates cases individually, but potentially for several different reasons.

Take preemption.  All preemption in personal injury cases traces its roots back to Cipollone v. Liggett Group, Inc., 505 U.S. 504, 530 (1992), where the Supreme Court first rejected notion that torts were somehow different from other forms of government regulation.  PLAC briefed Cipollone.  The drafter of PLAC’s brief in that case (Mayer Brown’s Ken Geller) sits with Bexis on PLAC’s nationwide case selection committee, and outranks Bexis in seniority).  Cipollone was the case that established express preemption.  The first major implied preemption product liability preemption case was Geier v. American Honda Motor Co., 529 U.S. 861 (2000), which PLAC not only briefed, but helped organize (defense counsel was simultaneously on PLAC’s case selection committee).  PLAC was of course involved in the ensuing major drug- and device-specific Supreme Court preemption cases – win or lose: Lohr, Buckman, Riegel, Kent, Levine, etc.

Take Daubert.  PLAC helped create Daubert.  Toughening the standards for expert testimony was a PLAC project before Daubert existed.  PLAC has been in every major Supreme Court Daubert case – Kumho Tire, Joiner, Weisman and in state supreme court cases around the country where similar issues arise under state law.  PLAC has briefed expert issues involving benzene in New York, Doritos in Pennsylvania, and asbestos in a lot of places.

Take the learned intermediary rule.  In recent years, PLAC has appeared in multiple state supreme court cases where adoption of the learned intermediary rule has been on the menu. These include Connecticut, Georgia, Kentucky, and most recently Texas.  If somebody had brought the West Virginia case to PLAC’s attention, who knows? Maybe the result could have been better. Couldn’t have been much worse.

PLAC keeps statistics on the kinds of issues it briefs.  Here they are, out of somewhat more than 1,000 total PLAC briefs (some briefs fit more than one category):

Preemption (including drug and medical device) = 172

Punitive Damages = 149

Class Action = 138

Experts (mostly Daubert and state-court analogies) = 113

Design Defect (including comment k) = 109

Compensatory Damages = 46

Warnings (including learned intermediary rule) = 39

Discovery of Trade Secrets = 38

Tort Reform (including compliance defense statutes) = 26

Similar incidents/adverse events = 19

Everyone of these issues – even design defect – is of importance to drug and device defendants.

We don’t want to rehash what we said in 2011, so here’s a list of most (we omitted some state court writs) of the drug/device cases that PLAC has briefed since then.  These include the good, the bad, the settled, and the petition denied, so they didn’t all produce opinions.  But every one of them raised serious issues that any drug/device company could find itself facing.  PLAC has demonstrably been on the front lines of prescription medical product liability litigation throughout this period:

  • Bartlett v. Mutual Pharmaceutical, U.S. Supreme Court & First Circuit  – implied preemption of design defect and “stop selling” claims against generic manufacturers
  • Hutto v. McNeil-PPC, Inc., U.S. Supreme Court & Louisiana Supreme Court – OTC drug preemption, Mary Carter settlement evidence
  • Matrixx Initiatives Inc. v. Siracusano, U.S. Supreme Court – materiality of non-statistically significant adverse drug reaction reports
  • Scofield v. Wyeth LLC, U.S. Supreme Court – constitutionality/remittitur of punitive damages in bifurcated action
  • Smith v. Bayer Corp., U.S. Supreme Court – collateral estoppel effect of denial of class certification on second identical class filed in different jurisdiction
  • Stengel v. Medtronic, Inc., U.S. Supreme Court & Ninth Circuit (x2) – PMA preemption and novel state parallel violation theories
  • Werner v. Novo Nordisk, U.S. Supreme Court – personal jurisdiction of non-U.S. parent based on activity of separate corporate subsidiary
  • Weeks v. Wyeth, Inc., Alabama Supreme Court (x2) – whether an innovator drug manufacturer can be liable for allegedly inadequate/fraudulent warnings where the plaintiff took only a generic drug (Conte issue)
  • State ex rel. McDaniel v. Janssen Pharmaceuticals, Arkansas Supreme Court – gigantic ($billion+) state AG action verdict on novel theory in statutory quasi-class action
  • Garrett v. Howmedica Osteonics Corp., California Supreme Court – state-court expert admission standards
  • Gaston v. Schering-Plough Corp., California Supreme Court – existence of “presumption of reliance” in consumer fraud class actions
  • Caldwell v. Janssen Pharmaceuticals, Louisiana Supreme Court – overturning huge state attorney general verdict in statutory quasi-class action
  • Graphic Communications Local v. CVS, Minnesota Supreme Court − third-party payer non-reliance consumer fraud action against pharmacists; no private right of action issues
  • Daniel v. Wyeth Pharmaceuticals, Inc., Pennsylvania Supreme Court – propriety of punitive damages where defendant complied with all FDA regulations
  • Lance v. Wyeth, Pennsylvania Supreme Court – existence of negligent design theories in prescription drug cases where no alternative design exists, comment k
  • Hamilton v. Centocor Corp., Texas Supreme Court – whether Texas should adopt the learned intermediary rule; whether a direct-to-consumer exception existed
  • West Virginia ex rel. McGraw v. Johnson & Johnson, West Virginia Supreme Court – state AG consumer fraud quasi-class action, res judicata finality of FDA warning letters
  • Wyeth v. White, West Virginia Supreme Court – availability of consumer fraud remedies in cases involving FDA-approved products, non-reliance causation
  • Romo v. Teva Pharmaceuticals, Ninth Circuit (en banc) – application of CAFA to mass actions
  • Carrera v. Bayer Corp., Third Circuit – propriety of class action certification of consumer fraud claims in OTC product case
  • Plubell v. Merck & Co., Fifth Circuit – All Writs Act prohibition of duplicative, successive class actions
  • In re Vioxx Products Liability Litigation, Fifth Circuit – secondary payer state AG, fraud on the market, non-reliance causation theories
  • Merck Corp. v. Conway, Sixth Circuit – constitutionality of state attorney general hiring private counsel to sue drug companies on contingent fee basis
  • Caplinger v. Medtronic, Tenth Circuit – PMA medical device preemption in context of off-label use and claimed off-label promotion
  • Dobbs v. Wyeth Pharmaceuticals, Tenth Circuit – implied preemption under Levine “clear evidence” standard for prescription drugs
  • Teague v. Johnson & Johnson, Tenth Circuit – fraudulent misjoinder to defeat diversity jurisdiction
  • In re Pelvic/Gynecare Litigation, New Jersey Superior Court, Appellate Division – defense ability to consult with plaintiffs’ treating physicians and use them as expert witnesses in mass tort context
  • Polett  v. Zimmer, Inc., Pennsylvania Superior Court (en banc) − excessive compensatory damages in medical device case

This three-year activity (28 cases. some with more than one PLAC brief) list shows PLAC being engaged on practically every major product liability/complex litigation issue that currently exists in prescription medical product liability litigation:  all three kinds of preemption (medical device, generic drug, and innovator drug); class actions; attorney general actions; punitive damages; expert testimony; Conte claims; the learned intermediary rule; consumer fraud; CAFA, contact with plaintiff’s prescribers.  Go back further, or look more broadly, and you’ll find PLAC’s name on a host of other issues – market share liability, public nuisance, successor liability, confidentiality in discovery – you name it, if it’s important to defending product liability and other complex product-related cases, you’ll find PLAC’s fingerprints.

And there’s something else of great practical value.  PLAC has a new and improved (and secured) interactive website with a knowledge base that includes all of its amicus briefs (and a bunch of other stuff).  That website also supports communication between hundreds of active PLAC “sustaining” members (individual product liability defense attorneys) at most of the nation’s most active product liability defense firms.  Need to know about an opposing expert?  Need to find an expert?  Need to know about a jurisdiction, or opposing counsel?  Want to run some peculiar issue past a bunch of really knowledgeable litigators (including Bexis) who share the same “rising tide” philosophy as this blog – that defense wins anywhere help defendants everywhere?  PLAC’s interactive website is the place to be.  Indeed, the sharing of information that had always gone on inside of PLAC was one of the major inspirations for the founding of this blog back in 2008 – we’ve tried to take some of what PLAC does and apply it to the defense community at large.

In sum, if you’re a pharmaceutical company, or a medical device manufacturer, PLAC has your back.  In fact, if you are any manufacturer, PLAC has your back.

Conversely, we think that pharma/medical device companies should also have PLAC’s back.  As many amicus briefs as PLAC writes, by the end of every year budgetary constraints prevent PLAC from doing even more.  PLAC and this blog share the same philosophy, but PLAC can only brief important cases, can only provide some of the most sophisticated CLE seminars anywhere, and can only run its members’ communication network, if supported by contributing members, especially corporate members.  The $7,500 annual dues are a bargain, and once a company really needs amicus help, downright trivial. Finally, while PLAC briefs important cases that don’t involve its members, it does help to be a PLAC member to get cases accepted for briefing, especially when the budget gets tight.

For the $7,500 annual PLAC corporate dues a PLAC corporate member gets sympathetic review (no guarantees) of requests for amicus support in major appellate cases, unlimited attendance at PLAC’s two annual meetings (enough CLE to satisfy any state’s requirements and interesting enough that you won’t be tempted to take a nap), the PLAC electronic knowledge base, and the PLACconnect member’s exchange.

So we encourage all of our in-house readers whose companies aren’t current PLAC members to join.  Any company interested in joining (for us out-house defense attorneys there’s a substantial queue) can call PLAC at (703) 264-5300, and ask for Hugh Young, PLAC’s President, or email him at hyoung@plac.net.  If you want to discuss PLAC with Bexis (Jim Beck), a 20-year PLAC veteran, feel free to contact him through the links on the blog.

Who knows, maybe the next eight, nine, or even ten-figure verdict that PLAC helps overturn, or the next litigation-changing summary judgment the PLAC helps get affirmed might have your name on it.

Photo of Bexis

This breaking news post is from the non-Dechert bloggers, because it discusses a metoclopramide case.

Like the Drager case we told you about earlier, another case has held that, in the context of generic drug preemption, labeling a design defect claim a “risk/utility” or “consumer expectations” is a distinction without a difference – and both are preempted.  This time it’s a federal court in Arkansas on remand from the Eighth Circuit’s Fullington decision.  See Fullington v. Pfizer, Inc., 720 F.3d 739 (8th Cir. 2013).  The new case is Fullington v. Pfizer, Inc., No. 4:10CV00236 JLH, slip op. (E.D. Ark. Feb. 28, 2014).  As you might expect Fullington relied heavily on the Fourth Circuit’s reasoning in Drager.  But more that, Fullington got it right because, right from the start, the court asked the right question:  “[T]he Court directed [plaintiff] to explain what the Generic Defendants could have done to comply with [state] law without violating federal law.”  Slip op. at 5.  The correct answer was – as we’ve been saying since our “bullseye” post – nothing.  Generic manufacturers cannot change their warnings without prior FDA approval.  No drug (or device) manufacturer can change its design without prior FDA approval. Finally, plaintiffs cannot avoid preemption by claiming that the manufacturer of an FDA-approved drug had some state-law duty to take it off the market.  Slip op. at 5.

The only other thing the plaintiff in Fullington could think of was “post-marketing surveillance.”  Id.

[Plaintiff] does not explain how a failure to conduct post-marketing surveillance constitutes a design defect or breaches one of the implied warranties, nor does she explain how the defendants could have avoided liability on her design defect and implied warranty claims by conducting post-marketing surveillance.

Id.

We’ve said it before, and we’ll say it again.  For preemption purposes there is no distinction between theories of design defect.  What must the defendant actually do?  As long as any theory would require a change in design, it’s preempted because that requires prior FDA approval.

Photo of Michelle Yeary

Don’t get too excited.  When we say a twitch, we mean it in its smallest sense.  A shudder, a tremor.  One blip followed by a long flat line.  We aren’t talking about resuscitation at this point.  But, just maybe West Virginia hasn’t signed a DNR order quite yet.

Ever since the West Virginia Supreme Court of Appeals refused to adopt the learned intermediary doctrine in State of West Virginia ex rel. Johnson & Johnson Corp. v. Hon. Mark A Karl, 220 W. Va. 463 (W. Va. 2007), we haven’t been shy about telling you all the ways that decision simply got it wrong (see here and here). But, ever the optimists, we sift and pan through West Virginia decisions like 19th century gold miners – looking for those little nuggets we can use to breathe life back into the learned intermediary doctrine.

We got one of those nuggets back in 2010 when the West Virginia Supreme Court of Appeals decided that there is no private cause of action under the West Virginia Consumer Credit and Protection Act (“CCPA”) for prescription drugs.  White v. Wyeth, 705 S.E. 2d 828 (W. Va. 2010). Nowhere in that decision will you find the words “learned intermediary.”  However, what that court did say was that when a plaintiff alleges affirmative misrepresentations, he must prove reliance and because for prescription drugs “the consumer cannot and does not decide what product to purchase”, id. at 838, plaintiffs can’t establish a causal connection.  If we were playing charades, we’d be making the “sounds like” gesture.  The court even went so far as to say that it is the physician who must “exercise[] judgment whether or not to prescribe a particular medication.”  Id.   So close.

Continue Reading A Twitch of Life for Learned Intermediary Doctrine in West Virginia

Drug & Device Resources

Bexis’ Book

FDA-regulated products now account for an estimated one-fifth of overall economic activity in the U.S. They have also been the focus of a litigation explosion. This timely guide covers all aspects of litigation involving drugs, medical devices, vaccines and other FDA-regulated prescription products.
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