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The Middle District of Florida in Gallant v. Ortho-McNeil-Jannsen Pharmaceuticals, Inc., 2014 U.S. Dist. LEXIS 131769 (M.D. Fla. Sept. 29, 2014), recently addressed a plaintiff’s negligence per se and fraud claims in the Risperdal litigation.  It dismissed the negligence per se claim, a claim that is a bit unusual for a drug case.  While device plaintiffs often use such claims to try to avoid preemption, plaintiffs in drug cases ordinarily don’t have that concern. But, ordinary or not, the claim remains improper.

Negligence per se claims generally seek to treat statutory requirements as standards of care that, if violated, create a private cause of action for someone injured thereby.  But that can’t and shouldn’t work when FDA regulations are involved.  Section 337(a) of the FDCA reserves to only the government the authority to bring an action for violations of the FDCA and FDA regulations.  And the Supreme Court in Buckman clarified that only the FDA is authorized to police violations of its own regulations.

Against this background, it’s clear why violations of FDA regulations (including those that may or may not address off-label promotion) cannot support a state-law negligence per se claim.  To allow such a claim would be to allow an improper circumvention of Section 337(a) and Buckman.  And so Florida courts do not recognize such claims:

Gallant argues that Defendant’s failure to abide by the FDCA demonstrates a deviation from the standard of care owed to Gallant and, therefore, demonstrates that Defendants were per se negligent or reckless.  However, district courts in this Circuit have consistently held that negligence per se claims premised on violations of the FDCA and/or FDA regulations are barred because Florida does not recognize such causes of action.

Id. at *4-5 (citing Small v. Amgen, Inc., No. 12-CV-476, 2014 U.S. Dist. LEXIS 28904, 2014 WL 897033, at *6 (M.D. Fla. Mar. 6, 2014); Kaiser v. Depuy Spine, Inc., 944 F. Supp. 2d 1187, 1192 (M.D. Fla. 2013); Cook v. MillerCoors, LLC, 872 F. Supp. 2d 1346, 1351 (M.D. Fla. 2012)).

And so this particular foray into negligence per se claims in drug cases ended quickly, with a dismissal, as it should have.

The Court also dismissed plaintiff’s fraud claims.  Plaintiff, as plaintiffs often do, provided a laundry list of alleged misrepresentations and omissions:

[T]he Complaint alleges a series of misrepresentations and omissions committed by Defendants, including “[f]ailing to publish or report negative studies about Risperdal;” “[p]resenting false and misleading studies and reports concerning Risperdal;” “[f]ailing to file accurate and timely reports of post marketing adverse events;” and “[d]istributing promotional materials . . . which were false, misleading and/or lacking in fair balance.”  The Complaint also alleges that Defendants sent healthcare professionals a false and misleading letter that minimized Risperdal’s risks and that Defendants “knew or should have known about articles written by independent researches . . . that demonstrated an association between atypical antipsychotics, including Risperdal, and serious and life threatening adverse effects . . . .”

But these are fraud claims, and that means that plaintiff must satisfy FRCP 9(b)’s particularity pleading requirements.  And plaintiff’s broad allegations didn’t even identify the misstatements:

[O]ther than the conclusory allegations set out above, Gallant does not identify with particularity any allegedly false statements.  As such, the Complaint lacks any facts concerning the substance and details of Defendants’ allegedly fraudulent conduct and, accordingly, Defendants have not been alerted to the precise misconduct with which they are charged.

Id. at *6-7.  And so these claims were also dismissed.

Now, plaintiff did bring failure to warn and warranty claims, which we are more accustomed to seeing in drug cases,  And, for now, those are essentially the only claims that the plaintiff has left.

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Our first post of the fall (and new year, according the Hebrew calendar), concerns something we do not usually post about – the adequacy of allegations in a criminal indictment.  Much like we feel about seasonal changes, we have mixed views about the opinion in United States v. Kaplan, No. 2:13-CR-00377-PMP-CWH, 2014 U.S. Dist. LEXIS 124174 (D. Nev. Sept. 5, 2014), a review of a Magistrate’s Report and Recommendation (R&R) found at 2014 U.S. Dist. LEXIS 124176.  The case involves allegations that a urologist, as part of his scheme to increase profits, re-used needle guides that were indicated as single-use devices.  He was investigated by FDA and charged with conspiracy to adulterate medical devices and false statements to a federal official, the latter based on alleged misrepresentations to FDA investigators about when he stopped re-using needle guides.

We should state up front that we do not advocate unsafe medical practices.  (An extreme stance for us to take, we know.)  We would hope that procedures like those at issue here, prostate biopsies with an accompanying transrectal ultrasound, are performed with maximal sterility—maybe the not word when discussing this anatomical region—and professionalism.  Jokes about prostate and rectal exams have been a comedy staple for years (e.g., “Mr. Babar” singing “Moon River” in Fletch), but medical practices that would entail the use of less than sanitary devices or instruments in such exams are not funny.  We should also state that we do not know what it is about Nevada medical practice and alleged re-use of single-use devices.  There have well publicized trials (and a few decisions) in cases against drug manufacturers predicated on the idea that the approved size of the vials of medications encouraged a Nevada clinic to engage in colonoscopy practices that allegedly resulted in a hepatitis outbreak.  We do not practice criminal law, so we can only guess whether some part of all of this is trying to deter dangerous medical practices in a place where they may not be sufficiently rare.

The allegations being tested in Kaplan did not include, from what we can tell, that anybody had been physically injured as a result of re-using needle guides. There was not even an allegation of economic injury to a patient or payor, because there was no suggestion that the defendant charged the new needle guide price for re-used needle guides or even that he charged for the needle guides at all, as opposed to just charging for the diagnostic procedure.  Whether such a re-use practice was actually dangerous or in violation of standards of care for urologists was not was not spelled out in the decision, which focused instead on the straight legal issue of whether using a single use device more than once constituted adulteration under the FDCA. (We would say “approved as single use,” but the regulatory status of the devices that the defendant used is not discussed.  We can quickly see that needle guides, whether “reusable or disposable,” are Class I devices under 21 CFR § 878.4800, so they do not get approved or cleared.)

Many times in the course of arguments on preemption and primary jurisdiction and testimony on company conduct, we have taken the position that the FDA’s charge to police compliance with the FDCA and its regulations is real and meaningful.  While the plaintiffs’ bar may contend that FDA is the puppet of industry and needs its help in punishing bad conduct—for a slight fee, of course—examples where FDA investigates, shuts down operations, and tries to put people in jail go some way to giving judges and juries the confidence to keep enforcement of FDA laws and regulations out of the hands of private litigants.  While the Kaplan defendant was not a user-fee-paying manufacturer, his prosecution is an example of FDA enforcement.  Similarly, tacking on an indictment for allegedly lying to an investigator from the FDA’s Office of Criminal Investigations shows a little more of FDA’s teeth.  Evidence about FDA inspections of manufacturers, whether routine or “for cause,” are standard fodder in drug and device cases.  The same statute, 18 USC §1001, used here also can be used to criminalize a materially false statement (with requisite mens rea) to an inspector.  The court’s decision to not dismiss the false statement count also helps, in this sense, as it affirms FDA’s “jurisdiction to investigate violations of the FFDCA, including the adulteration of medical devices”–§1001 requires the false statement be made to a federal agency acting within its jurisdiction—and that adequate pleading of a false statement involves allegations of “the date of the alleged false statement, the content thereof, and to whom the statement was made”—allegations often lacking in consumer fraud and similar claims against manufacturers.  2014 U.S. Dist. LEXIS 124174, **12-15.

We also liked some language, more in the R&R than in the opinion, about how states regulate the practice of medicine and FDA does not.  In concluding that FDA gets to prosecute adulteration even when done by an individual in connection with practicing medicine, because it regulates the distribution of drugs and medical devices, the opinion has an unexplained cite to 21 USC § 396.  Id. at *10.  That provision, without much more analysis, seems hard to reconcile with the indictment, as the FDCA is not to be “construed to limit or interfere with the authority of a health care practitioner to prescribe or administer any legally marketed device to a patient for any condition or disease within a legitimate health care practitioner-patient relationship.” While we are fine with the idea that parties other than the FDA are not allowed to enforce the FDCA’s prohibitions against adulteration or misbranding, we would think that there needs to be some act by the physician that is more than just “prescrib[ing] or administer[ing a] legally marketed device to a patient,” on-label or off-label, to allow prosecution for misbranding.

Given § 396, the evaluation of whether the alleged conduct here meets the requirements of adulteration is lacking. 21 USC § 331(k) prohibits:

The adulteration, mutilation, destruction, obliteration, or removal of the whole or any part of the labeling of, or the doing of any other act with respect to, a food, drug, devise, tobacco product, or cosmetic, if such act is done while such article is held for sale (whether or not the first sale) after shipment in interstate commerce and results in such article being adulterated or misbranded.

In the criminal context—again, not our area—statutes can be too vague to impose liability in some or all situations.  The term “held for sale” is not defined in the FDCA and the Ninth Circuit has prohibited using § 331(k) to impose liability for distributing homemade GHB for free. (GHB is not to be confused with the “roofies,” or, rather, “floories” featured in The Hangover.)  By contrast, because the Kaplan defendant charged for his services (although not necessarily for the needle guides themselves), there was a “commercial component” to defendant’s actions with regard to the needle guides and that was enough.  Id. at **7-10.  Such an interpretation of “held for sale” was “consistent with the FFDCA’s overall structure and purpose of ‘protect[ing] consumers from dangerous products . . . from the moment of their introduction into interstate commerce all the way to the moment of their delivery to the ultimate consumer.’”  Id. at *8 (quoting Unites States v. Sullivan, 332 U.S. 689, 696 (1948)).

The ultimate consumer here was the patient, not the physician who had bought the needle guides for use in his practice. This is a necessary conclusion for the needle guides to still be “held for sale” when the alleged adulteration takes place.  But this is where we think the logic breaks down.  Quoting from the R&R, the opinion stated that the “patients’ payment for medical services undoubtedly reflects the costs of materials used to provide the unique medical service.  When the single use needle guide is used for a patient’s biopsy, its value and usefulness as a medical device is transferred to the patient in exchange for payment.”  Id at *9 (internal quotations omitted).  The next sentence from the R&R stated “It has no residual value, at least as a needle guide, because it can only be used once.”  2014 U.S. Dist. LEXIS 124176, *15.  Defendant’s alleged adulteration, however, was not with regard to the first patient on whom a new needle guide was used—the patient who paid for its complete value—but any patient on whom a needle guide was re-used.  What constituted adulteration beyond simply prescribing or administering the device, as reading § 331(k) with § 396 would require, is not specified. Whether re-sterilizing the device, simply re-using it, or doing something else changed the device enough to adulterate it,  the acts must have occurred after the care of the first patient for each needle guide. If the first patient bought the needle guide and used up all of its value, then how was the needle guide still held for sale for the unwitting second and third patients?  We do not know, but we also do not see how this logic could be used to impose liability on the manufacturers of drugs or devices, which is always our primary concern.  Should the new year bring new cases with allegations that manufacturers are liable for adulteration because doctors re-used products contrary to labeling, we promise to think about it harder.

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Those of you who dialed into yesterday’s teleseminar given by the Reed Smith side of the blog saw an image of a leaking tube of toothpaste on one slide and a poster for the Orson Wells motion picture The Third Man on another.  For those who dialed in, thank you.  To those who couldn’t make it, we will probably do another one next year, so stay tuned.

As for pictures of toothpaste and old movies, they are not as random as you might think.  Our point about the toothpaste was that as the law squeezes down on traditional avenues of product liability—such as through applications of the learned intermediary doctrine and/or defenses based on federal preemption—plaintiffs are squeezing around the obstacles to find alternate paths. The Third Man poster was an introduction to our segment on attempts to recover for alleged product defects from parties other than product manufacturers, i.e., third parties.  That could include doctors, pharmacists, monograph publishers, pretty much anyone who touched the process with any perceived capacity to pay a judgment.

It is somewhat poetic then that we bring you today another “third man” and another novel theory of liability, and the case even involves teeth.  The case is Tavilla v. Blue Cross, No. 1 CA-CV 12-0843, 2014 Ariz. App. Unpub. LEXIS 1093 (Ariz. App. Sept. 11, 2014), and the dispute was over the plaintiff’s health insurer’s refusal to cover injuries allegedly caused by off-label use of pain medication.  In Tavilla, the plaintiff had a history of chronic pain, and his pain management doctor prescribed a form of fentanyl that is delivered on a plastic stick that dissolves in the patient’s mouth, like a lozenge.  Id. at *2.  The product, however, was indicated only for cancer patients, which the plaintiff was not.  Id. at **2-3.  That made the use “off label,” which is perfectly legal and sometimes is the standard of care, which we have explained countless times.

Now, the key fact is that the plaintiff’s health insurer paid for the drug, even though the plaintiff’s policy excluded coverage for drugs prescribed off label.  That is to say, the insurer paid for the plaintiff’s pain medicine gratuitously and without any contractual duty to do so.  Id. at **2-3.

The plaintiff later developed severe tooth decay that his dentist said was typical of decay seen in people who use sugar-containing lozenges.  Id. at *3.  The plaintiff therefore sued the doctor who prescribed the lozenge-like fentanyl drug for medical malpractice and the drug’s manufacturer for product liability.  Id. at *4 n.4.  We don’t know how that litigation came out, but we suspect it was not so promising for the plaintiff because he also sued his health insurer to pay for his extensive dental work.  Id. **3-4.

As you read the remainder of this story, bear in mind the old saying “no good deed goes unpunished.” That is because the plaintiff’s theory against the insurer was that the insurer acted in bad faith by paying for the pain medicine even though it did not have to, but then denying coverage for his extensive dental work, which was also excluded under the policy.  Id. at **13-20.  This is the Drug and Device Law Blog, not a health insurance blog, so we will not delve into the intricacies of health insurance contracts and the implied covenant of good faith and fair dealing.  Suffice it to say that the Arizona courts found no breach of contract in the insurer’s overpayment of policy benefits.  They also found no bad faith in the insurer’s alleged failure to investigate the physician’s prescribing practices, prevent the prescription of the drug, or deny coverage for use that was off label.  Id.

We write about this case because it is an example of a plaintiff attempt to recover for injuries allegedly caused by a prescription drug by pursuing novel claims against someone other than the drug manufacturer.  But we also think the result is correct because finding potential liability in this situation would lead to numerous perverse incentives.  Insurance companies already have a business incentive to pay no more than what they owe under their contracts because every dollar overpaid is a dollar off the bottom line.  It would not help their policyholders (i.e., patients requiring medical treatment) to create additional incentives to deny payment by opening insurers to extracontractual damages as a penalty for funding treatment that they technical have no duty to cover.

More apropos to the drug and device practice, it also would not help patients to impose extracontractual duties on insurers to protect patients from the complications of medical treatment, including off-label use of prescription drugs.  The plaintiffs in Tavilla argued that the insurance company should have investigated the physician’s off-label use of the product and prevented the physician from doing alleged harm, including by refusing to pay for the treatment or making it a drug that required “precertification” for coverage.  Id. at **16-18.  But as the Arizona courts observed, “To impose such a duty would put [the insurer] squarely between the insured and the insured’s own physician.”  Id. at 17.

We subscribe to that mantra.  Physicians practice medicine, and they make treating decisions based on their assessment of the risks and benefits as they apply to each individual patient.  Absent from Tavilla is any discussion of the severity of the plaintiff’s pain, the other options considered and/or tried, what the doctor knew and/or considered vis-à-vis potential complications and risks, what the manufacturer warned about, and whether the treatment promised or resulted in substantial benefit to the patient.  These are the factors that product liability and medical malpractice claims take into account, and rejecting liability in cases like Tavilla channels the inquiry onto those more traditional paths. That seems to us the correct way to go.

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Some plaintiff lawyers seem horrified at the prospect of showing up in federal court.  How else to explain the machinations to prevent diversity jurisdiction?  What is it about federal courts that they dislike so much?  The assignment of one judge who will stick with the case and thereby come to learn its frailties?  The proclivity of federal judges to correct counsel who call the lectern a podium?  The Article III freedom from elections and political contributions?  Don’t ask us.  Log onto one of those plaintiff lawyer websites, and when a little bubble pops up where a sunny-faced minion volunteers to help you, ask said minion.

Meanwhile, we keep seeing cases where plaintiff lawyers sue local defendants to keep the case against the out-of-state company out of federal court.  Such cases do not come as solitary spies, but in battalions.  To keep a local defendant in the case, and the case out of federal court, the plaintiff needs to allege that the local defendant is culpable of something.  When there is fraudulent joinder, that something turns out to be nothing, or something dopey this way comes.  Nothing can come of nothing.  Take Martin v. DePuy Orthopaedics, Inc., 2014 U.S. Dist. LEXIS 130143 (D. Nevada September 16, 2014), for example.  The plaintiff, a Nevada citizen, sued several defendants, including Nevada corporation Precision Instruments in Nevada state court for products liability.  The plaintiff alleged that each of the defendants were involved in the stream of commerce as to the plaintiff’s allegedly defective artificial hip.  He lumped them together.  He did not bother to allege which defendants manufactured versus distributed or retailed the product at issue.  The defendants removed the case to federal court, and the plaintiff moved to remand for lack of complete diversity.  The defendants argued that the diversity-destroying defendant,  Precision, had been fraudulently joined and therefore should not count in the diversity analysis.

The plaintiff proudly pointed to his amended complaint, which alleged that Precision was engaged in the business of selling artificial hip/stems, including the one that was sold to the plaintiff.  But the same exact allegation was made against the eight other defendants, and the court could not see how it could be the case that all nine defendants sold the same hip/stem to the plaintiff.  Good point.  Moreover, the defendants tendered the declaration of the principal of Precision, who searched through a database and found no evidence that the company had supplied a product for the plaintiff’s surgery.  The best that the plaintiff could come up with in reply was a copy of a surgery record in which a nurse appears to have noted that the guy from Precision took extracted hardware.  But that document was hearsay; it was not made by the plaintiff for the purpose of medical treatment, nor was it established to be a business record.  Thus, there was no admissible evidence that the non-diverse defendant played any role in the surgery.  Rather, the plaintiff merely offered a boilerplate complaint that defied the rules of physics, commerce, and logic.  The court concluded that Precision had been fraudulently joined and kept the case on the federal side of the street.

The allegations in Sazy v. DePuy Spine, LLC, 2014 U.S. Dist. LEXIS 130789 (N.D. Texas September 18, 2014), aren’t much better, as fraudulent joinder cases go.  In fact, they are much worse.  The plaintiff brought suit in Texas state court against three out-of-state companies and one solitary individual, named Brownell, who had the good fortune of being a resident of Texas.  The defendants removed the case to federal court on the ground that Brownell’s joinder was fraudulent.  This argument was bolstered by the fact that the complaint’s reference to Brownell was brief and mysterious.  In fact, Brownell was mentioned by name in only two places in the complaint:

  1. “The Defendants and Defendant Brownell aided and abetted one another in committing torts against the Plaintiff.  The Defendants had specific intent and knowledge that their conduct constituted torts.”
  2. “Clearly, the Defendants and Defendant Brownell had the intent to assist one another in the torts.  The Defendants and Defendant Brownell gave one another assistance or encouragement and the Defendants’ assistance or encouragement was a substantial factor in causing the torts.”

Brevity is not always the soul of wit.  Sazy is hazy.  That “Clearly” is precious.  What’s that line about protesting too much?  And who tells the tale full of sound and fury?

As our eyes drifted across the pages of the Sazy case for the first time, we grew worried about the result when the federal court decided to apply the liberal Texas pleading standard in assessing whether Brownell had been fraudulently joined. We do not agree with applying state local rules to test fraudulent joinder.  It seems to reward mischief.  But we stopped worrying when we remembered how bare-bones the complaint was.  The court also remembered, deeming the complaint “devoid of any allegations as to how Brownell aided and abetted, assisted, encouraged, or participated in acts allegedly committed by the DePuy Defendants.”  The court confessed that it had “no inkling” of what Brownell allegedly did to injure the plaintiff.   The complaint contained “no allegations of specific acts committed by Brownell, no allegations that Brownell was a party to any agreement or contract with” the plaintiff, and no allegations that Brownell negotiated or administered any contact or agreement with the plaintiff.  In short, the complaint was awesome in its reticence, and not in a good way.  Aided and abetted by a complaint that signified nothing, the federal court had little difficulty retaining jurisdiction.  All’s well that ends well.

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Before Bryan Cranston was Walter White, terminally ill chemistry teacher turned murderous meth manufacturer; before he was Hal, the clumsy and loving husband on Malcolm in the Middle – he was Tim Whatley.  Jerry Seinfeld’s re-gifting dentist who converted to Judaism just “for the jokes.” So affronted is Jerry for his profession, that Kramer – as only he can – labels Jerry an anti-dentite.

We’ll admit to not delighting in trips to the dentist. The scraping, the drilling, the prodding.  Let’s face it, we’re litigators.   The not being able to talk alone is torture.  But, we wouldn’t normally call ourselves rabid anti-dentites.  That is until they try to sue dental product manufacturers.

Today’s case deals with a relatively rare (thankfully) instance of a prescriber suing for damages to his business caused by his prescribing of an allegedly defective device.  Prescott v. Argen Corp., No. 13-6147, slip op. (N.D. Ill. Sep. 17, 2014). Plaintiffs are dentists who alleged that the crowns they purchased and implanted in their patients were defective and that they therefore sustained economic injuries.  Id. at 1.  Plaintiffs brought claims for breach of implied warranty of merchantability, fraudulent misrepresentation, consumer fraud, negligence, and strict products liability.  Id. at 5.  Defendants moved to dismiss on several grounds.

First, plaintiffs’ breach of warranty claim failed for insufficient allegations of both notice and privity.  Plaintiffs argued that the notice requirement should be excused because defendants had actual knowledge of the defect.  But, that exception requires “actual knowledge of trouble with a particular product purchased by a particular buyer.”  Id. at 6.  Allegations of a defendant’s “general awareness” of issues with a product line aren’t enough.  Id.   As to privity, plaintiffs alleged only a “good faith belief” that privity existed, which the court found “stops short” of actually claiming privity.  Id. at 8.  They next tried to circumvent the requirement altogether relying on consumer personal injury cases.  But the same privity exception does not extend to economic loss cases.  Id. at 9.

Second, on their fraud claim plaintiffs had to satisfy Rule 9’s heightened pleading requirements — which they did not do because “they fail[ed] to identify any specific transaction that resulted from fraud.”

Id. at 10.  Here the court focused on a very common pleading crutch – the ambiguous “at all relevant times.”  “At all relevant times” defendant knew about the alleged defect.  “At all relevant times” defendant made “various false statements.”  In our opinion this is too vague to withstand TwIqbal, let alone Rule 9.

Third, plaintiffs’ consumer fraud claim failed for lack of specificity, id. at 15-16, but an even more fundamental flaw was that plaintiff-dentists are not consumers.  A consumer is someone who purchases a product “not for resale in the ordinary course of his trade or business.”  Id. at 13.  Plaintiffs tried unsuccessfully to argue that they did not purchase the crowns for re-sale, but all of the allegations regarding purchase for use in treating patients led the court to the rightful conclusion that the dentists were “business purchasers” and therefore fell outside the protections of Illinois consumer fraud statute.   Id. at 13.

Plaintiffs also didn’t satisfy the consumer nexus test which requires the plaintiff demonstrate (1) a link between himself and the consumer,  (2) that the defendant’s representations concerned consumers other than the plaintiff, (3) that the defendant’s actions involved consumer protection concerns, and (4) that plaintiff’s requested relief would serve the interests of the consumers.  Id. at 14.  Even assuming the dentists could satisfy the first three prongs, an award of damages to the dentists would not “benefit the damaged patients in the least.”  Id. at 15.

Finally, plaintiff’s negligence and strict liability claims were dismissed in accordance with the economic loss doctrine. Plaintiffs yet again tried to fit within another exception – where the damages are the result of fraud.  But fraud was not a part of either their negligence or strict liability claim.  Negligence which is unintentional cannot constitute fraud, which by definition is intentional. Id. at 17.  Looking at the elements of strict liability, the court found “[n]one of these elements pertains in any way to intentional false representation.”  Id.

We don’t like pointing the finger at prescribers. They are our clients’ clients after all. But, when they point at us, we’re happy to see courts brush, rinse and floss those claims right down the drain.

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The overarching background of this case obviously involves highly complex medical issues as well as a real human tragedy.  Nevertheless, the outcome is ultimately determined by a relatively straightforward application of Virginia law.

That’s how the court in Higgins v. Forest Labs., 2014 U.S. Dist. LEXIS 124745 (W.D. Va. Sep. 8, 2014), concluded its opinion granting Forest Laboratories summary judgment.  There certainly were complex medical issues and terrible tragedy, as the case involved a patient who took an SSRI, Lexapro, for depression and other symptoms but who ultimately committed suicide.  But there also was a straightforward application of the law, as the testimony of the decedent’s prescribing psychiatrists obliterated plaintiff’s attempt to show proximate causation under the learned intermediary doctrine.

For those of us who take depositions of prescribing doctors, we know that what the doctor knew or didn’t know is the key testimony.  Defense and plaintiffs’ attorneys often have a back-and-forth in which the defense attorney attempts to show what the doctor knew about the drug’s risk and the plaintiffs’ attorney attempts to show what she didn’t know.  The outcome of that back-and-forth often doesn’t become clear until the deposition ends.  Sometimes, frankly, it never becomes clear.  Regardless, while that testimony is often important for trial, it also can be crucial for a summary judgment motion.  In Higgins it was.  It ultimately established, as the court put it, that the prescribers “were well aware of the risks of prescribing SSRIs such as Lexapro when they treated [the decedent] in 2004.”  Id. at *19.

In the Higgins depositions, the back-and-forth was fairly one-sided.  The defense attorney, through the use of open ended questions, established that the potential risk of suicide with the use of SSRIs was well known, there was a debate regarding it in the scientific community, and the prescriber knew the potential risk, considered it, discussed it regularly with his patients, and likely discussed it with the decedent and his family:

Q: Dr. Andres, going back to 2004, specifically the period of time when you treated Francis Krivicich, were you aware of a debate, a scientific debate or debate within the medical community, about the possible link between the use of SSRI medications and emerging suicidal thinking?

A: Yes.

Q: Can you tell me what you understood of that — that debate, that issue, in 2004?

A: Well, it became a — something of that was well known to the public. And the — debate was — among the psychiatrists was ongoing. And some people were saying that it was a major problem, other people were not, but it was an issue. It was in the minds of people.

These — in the department of psychiatry, we have case conference meetings and professional meetings that are held. And that — that was an issue that would come up at times. The — the end product of all of that was that it was — even today it would be considered an issue in the younger population. So you become a little more — in that group, a little more sensitive to the issue.

The latest kind of thinking is that the probability of suicide is less if you give the medication, because of the antidepressant effect. So it moves in the direction which is saying you should give the medications even to young people and then just be aware of the possibility.

With — in the specific case with Mr. Krivicich, the — I can’t remember exactly the context where that came up. But my hunch is — and I — and that the family was aware of the debate and that that ended — and that it influenced the conversation that he had with his family. So it — it was an issue. My hunch is — I can’t remember exactly what was said. My hunch is the issue came up in that context and then he decided to continue with it at least for a while.

Q: Doctor, the issue that we’re discussing, the ongoing debate about whether the SSRIs themselves could cause suicidal thinking or suicide, were you aware of that debate prior to 2004, prior to your treatment of Francis Krivicich?

A: I — I’m not sure of the — if it was in the — in the public arena; it was in the private arena I’m sure because we saw a ton of people who were depressed . . . . That was the main diagnosis. . . . I can’t imagine not having that kind of knowledge at issue.

Q: And to follow up on an answer you just provided, if I understand what you’re saying, if there was information in the media, information in the scientific community, about the possible link between these two, you would have been aware of it when that became public?

* * *

A: Yes.

Id. at *25-27.

This type of testimony blows a hole in a plaintiff’s case.  Regardless of whether the doctor was properly warned, she knew the risk.

But plaintiffs’ attorneys, who are good at what they do, try to minimize the importance of such testimony.  They seek to elicit from the prescriber testimony on other pieces of information or warnings that, had the prescriber known about it, might have made a difference. For instance, the current labels for SSRIs carry a black box warning on suicidality in young adults.  It wasn’t there when these doctors prescribed to the decedent. So, would that have made a difference? Well, while the plaintiffs’ attorney may have addressed this, the defense attorney attacked it head on and got testimony from the prescriber that was devastating to plaintiff’s case:

Q. Okay. So, again, would this have changed in any way — this warning, this black box warning, change in any way your decision to prescribe Lexapro to Mr. Krivicich, who was 60 at the time you treated him?

A. No. I mean I would feel free to use it.

Id. at *28.

Testimony from the second prescriber didn’t help either. He also recalled the debate in the scientific community on whether SSRIs increased the risk of suicide.  He testified that he was aware of the potential risk and took it into consideration when prescribing SSRIs:

Q. Okay. Now, if you can, during that period, the ’90s and early 2000s, what was your understanding of the debate at that time? And I appreciate you can’t identify it to a specific day.

A. The debate was whether the medications gave — caused patients to have de novo psychiatric ideation or worsened psychiatric ideation or whether this was simply suicidal ideation in a patient who is already severely depressed and might be having suicidal ideation anyway, regardless of whether or not he or she was taking medicine.

* * *

Q. Now, when you did become aware of the debate about the possible link between SSRI medications and depression — and if I understand, you were aware of that before you treated Mr. Krivicich?

A. Yes.

Q. Is that something that you took into consideration when you were treating patients that had depression or anxiety and for whom you may have considered prescribing antidepressants, SSRIs?

A. Yes.

Q. And how did you factor that — the debate, the discussion, into your treatment plan, if you will?

A. Again, it’s difficult to do it around a specific time, but I suspect by the time my clinical stance was that many more lives were saved by the antidepressants and their appropriate use than were lost as a result of using the SSRIs. So even if the assertions that these medications might lead to suicidal behavior or make it worse were true and that some patients were lost as a result of that, the overall benefit was massively on the side of using the antidepressants for patients who are depressed.

Id. at *29-30.  Moreover, his practice was to advise patients of the risk:  “I routinely told patients then, as now, that a worsening of depressive symptoms, including suicidal impulses, could occur and those should be reported to me immediately.”  Id. at *32.

This testimony left plaintiff’s case on the ropes. Plaintiffs’ attorney tried to fix it, but it only got worse, as the prescriber testified that the risk information was abundant in the literature.  In fact, he may have gotten it from a Dear Doctor letter from Forest Laboratories:

Q: Did — prior to treating Francis Krivicich —

A: Yes.

Q: — did either the literature or any sales representative or Dear Doctor letter from Forest Laboratories ever convey the message to you that the use of this medication can cause de novo suicidality or worsening of suicidality?

* * *

A: Yes.

Q: Okay. What conveyed that to you?

A: It’s hard for me to specify where that information came from, but my clinical literature from the journals and the newsletters was — was all congruent around this issue. So there was abundant information to me from more than one source.

.. . .

Q: And it’s your testimony that that article or something similar to that, prior to treating Francis, conveyed the message the medications do cause this, not can but do?

A: Yes.

That’s that, really.  Plaintiff has the burden to prove proximate causation.  In failure to warn cases, that means plaintiff must prove that the alleged failure of the drug company to warn the prescribing doctor had a causal relationship with decedent’s injury.  Yet, all that the back-and-forth questioning at the depositions established was that the prescribers knew the risk, took it into account, and prescribed anyway.

In other words, Plaintiff could not show proximate causation.  That means summary judgment for the defendant.  Straightforward.

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We missed a day this week, so here’s an extra post to make up for it.

This opinion, Redman v. RadioShack Corp., Nos. 14‐1470, et al., slip op. (7th Cir. Sept. 19, 2014), doesn’t even mention cy pres, but its rationale could be saying (like we have), “cy pres, no way.”

Redman was a coupon settlement with the usual pathetic – less than one half of one percent – response rate to the settlement notice (itself sent to only 5 million of the estimated 16 million class members).

Slip op. at 7.  It involved something called the Fair and Accurate Credit Transactions Act, but that doesn’t matter for present purposes.  The settling parties claimed that this pathetic response was the same as acquiescence in the settlement’s terms, but Judge Posner saw through that easily:

The fact that the vast majority of the recipients of notice did not submit claims hardly shows “acceptance” of the proposed settlement: rather it shows oversight, indifference, rejection, or transaction costs.  The bother of submitting a claim, receiving and safeguarding the coupon, and remembering to have it with you when shopping may exceed the value of a $10 coupon to many class members.

Slip op. at 7.

But even that (although interesting for other reasons) doesn’t matter for present purposes.

What’s interesting to us is the number that Judge Posner does on the attorney fee request made by class counsel.

Wisely, class counsel (unlike some other settlements we can recall) didn’t even attempt to use the value of theoretical, but unsought coupons.  Counsel did, however, use the full face value of the coupons ($830,000), even though various factors (again not relevant to our point, but including that no change was given for less-than-face-amount uses) made them worth less than face value to the class who filled out the forms to get them.  Slip op. at 11-12.  Judge Posner pointed out, id. at 12, that the restrictions “chipping away” at the value of these coupons were “even more egregious” than in Eubank v. Pella Corp., 753 F.3d 718 (7th Cir. 2014), a settlement he had famously denounced as “scandalous.”  The nominal face value of the coupons, therefore, could not be used as part of the denominator for determining the reasonableness of class counsel’s fee request.

[W]hile we don’t know how much $830,000 of coupons would be worth to the class, we can be confident that it would be less than that nominal amount, doubtless considerably so. And we note that were the value only $500,000 − and it may indeed be no greater – the agreed‐upon attorneys’ fee award would be the equivalent of a 67 percent contingency fee.

Redman, slip op. at 14.

Counsel also sought to inflate the denominator for purposes of their fee request by including “administrative costs.”  Id. at 10.  That wasn’t proper either, because those costs did not represent any “value received” by the class at all, since none of that sum went into the pockets of class members:

[T]he roughly $2.2 million in administrative costs should not have been included in calculating the division of the spoils between class counsel and class members.  Those costs are part of the settlement but not part of the value received from the settlement by the members of the class. The costs therefore shed no light on the fairness of the division of the settlement pie between class counsel and class members.

Id. (emphasis added).  To treat “every penny” of administrative costs as “value” to the class was “perverse”:

[It] eliminated the incentive of class counsel to economize on that expense − and indeed may have created a perverse incentive; for higher administrative expenses make class counsel’s proposed fee appear smaller in relation to the total settlement than if those costs were lower.

Id. at 10-11 (emphasis added).

The only sums properly included in the denominator for purposes of determining the reasonableness of a class action fee request are “benefit to the class,” meaning “what the class members received”:

The ratio that is relevant to assessing the reasonableness of the attorneys’ fee that the parties agreed to is the ratio of (1) the fee to (2) the fee plus what the class members received.  At most they received $830,000. That translates into a ratio of attorneys’ fees to the sum of those fees plus the face value of the coupons [case-specific calculation omitted].  Computed in a responsible fashion by substituting actual for face value, the ratio would have been even higher because 83,000 $10 coupons are not worth $830,000 to the recipients.

Slip op. at 11 (emphasis added).

Cy pres?  No way!

Cy pres awards, like the “administrative costs” excluded in Redman, do not go into the pockets of class members – not one cent.  Indeed, cy pres awards are even further removed from being “benefit to the class” because, as Judge Posner acknowledged (but found insufficient), some of the costs at least were to give “notice to the class.”  Id. at 10.  Cy pres distributions, which take money supposedly belonging to class members and give it to non-class members (such as organizations devoted to fomenting more litigation, or class counsel’s law school) are the antithesis of “benefit to the class.”  Far from being sums “received by class members,” cy pres distributions take money away from the class and give it to supposedly deserving bystanders.

Whether or not courts should ever have the power to redistribute money belonging (if at all) to a class to persons not even in the class, under Judge Posner’s reasoning in Redman, there’s no way cy pres distributions can properly be considered in evaluating the reasonableness of a fee request.  The same “perverse incentive” exists, maybe even more strongly, with cy pres.  It’s an easy way to inflate the denominator artificially with sums that do not benefit the class – particularly when actually distributing the same money to class members would give rise to additional “administrative costs” that are themselves improper to include in that same denominator.

Although we would prefer to abolish cy pres outright as an abuse of judicial power, removing cy pres sums from the denominator in fee calculation strikes us as the next best alternative, since we believe that without the “perverse incentive” so aptly identified by Judge Posner, cy pres distributions would be few and far between.

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We admit that we never gave much thought to denture adhesive, and until recently our knowledge of denture adhesive products was gained mainly from watching commercials that tend to run during daytime television or reruns of Murder, She Wrote.  But as Bexis says, useful precedent can come from unexpected places, and litigation over the denture adhesive known as Fixodent resulted in a good Daubert ruling in the district court that we reported on here more than three years ago.  The Eleventh Circuit has now affirmed the order in a published decision, so we will again wade into the sticky goo that was the plaintiffs’ experts’ opinions.

Numerous plaintiffs sued the manufacturer of Fixodent alleging that zinc in the product caused them neurological disorders.  One of the cases was Chapman v. Procter & Gamble Distributing, LLC, 2014 WL4454979 (11th Cir. Sept. 11, 2014), where the plaintiff alleged that she used Fixodent to place her dentures for eight years and experienced a neurological condition known as copper-deficiency myelopathy as a result.  Id. at *1.  The problem for the plaintiffs was that there was no reliable scientific evidence that use of zinc-containing denture adhesive caused the plaintiff’s condition, even assuming that “copper-deficiency myelopathy” even exists. Sure, the plaintiffs had experts who were willing to offer such opinions as “zinc containing Fixodent denture adhesives are a health hazard and capable of causing severe hematological and neurological injury” and “long-term use of Fixodent (containing 1.69% zinc) will result in . . . neurotoxic, neurologic, and hematologic consequences.”  Id. at *6.  But as we tend to say, just because an expert says something does not make it so.  The plaintiffs’ experts, it turns out, could not connect the dots, resulting in their opinions being excluded and summary judgment being granted for the defendants.  We described it all in some detail in our prior post, and the analysis in the Eleventh Circuit is similar.

So why then is the Eleventh Circuit’s opinion interesting?  Well, for a number of reasons.

First, the Eleventh Circuit (and the district court before it) applied the “McClain categories.”  Citing McClain v. Metabolife Int’l, Inc., 401 F.3d 1233 (11th Cir. 2005), the Eleventh Circuit stated that in cases where cause and effect has been proved and accepted by the medical community, federal judges “need not undertake an extensive Daubert analysis on the general toxicity question” for the sake of “judicial economy.”  Id. at *3.  In other cases—the “second category”—federal court must undertake a full Daubert analysis before admitting expert opinions into evidence.  Id. We understand that district judges sometimes express frustration with long and complicated Daubert motions.  We also believe generally that the Eleventh Circuit is about as good a place as any to challenge the admissibility of experts’ opinions, largely because of the McClain opinion.  We are uneasy, however, with dividing cases into categories that offer one side a potential pass when introducing expert opinions on causation.

Fortunately, the Eleventh Circuit (and the district court before it) placed the expert opinions at issue into “category two” (noting that “[m]illions of consumers have regularly used Fixodent for decades without complaint”) and undertook a full Daubert analysis.

Which leads us to the second reason why we think this opinion is interesting:  In affirming the exclusion of the plaintiffs’ experts on general causation, i.e., whether the subject denture adhesive could cause copper-deficiency myelopathy, the Eleventh Circuit approved of the district court’s treatment of three concepts that we write on a lot—dose-response relationship, background rate of disease, and epidemiology.  The plaintiff alleged that she swallowed denture adhesive when she used the product to affix her dentures and that it caused an illness-inducing copper deficiency.  That argument begs the question of dose response—i.e., how much adhesive do you have to swallow to get sick?  The Eleventh Circuit put it this way:

Recognizing all substances potentially can be toxic, the judge noted “‘the relationship between the dose and effect (dose-response relationship) is the hallmark of basic toxicology’” and “‘is the single most important factor to consider in evaluating whether an alleged exposure caused a specific adverse effect.’”

Id. at *6.  The Eleventh Circuit agreed with the district court and its finding that the plaintiffs’ experts could not say (1) how much adhesive must be used for how long to increase the risk of copper deficiency or (2) for how long a person much experience copper deficiency before being at an increased risk of myelopathy.  Id. The lack of evidence on dose-response drove a truck-size hole through the experts’ opinions.

The Eleventh Circuit similarly approved of the district court’s handling of the background rate of disease and its observation that

[s]ome people use denture cream and some people have a myelopathy; it is possible (and depending on the incidence of myelopathies, likely) that some denture-cream users have an idiopathic myelopathy simply due to the background distribution of that disease. Without a baseline, any incidence may be coincidence.

Id. at *7 (emphasis added).  In other words, just because two events coincide does not mean that one caused the other because the other could have been caused by something else or by nothing at all.  The plaintiffs’ experts did not know the background rate of copper-deficiency myelopathy, which was another “serious methodological deficiency.”  Id.

So too was the lack of any epidemiological evidence, which is “the best evidence of causation in cases involving toxic substances.”  Id. at *6 (internal quotations omitted).  The plaintiffs’ experts offered lesser forms of evidence—case reports and animal studies—but such information cannot support a causation opinion.  Id.  Case reports are mere anecdotes, which can be useful in generating hypotheses for future study, but cannot prove a cause-and-effect relationship.  Animal studies can similarly provide useful research information, but their results cannot be validly extrapolated to prove causation in humans.  The experts also offered “hypotheses” and “plausible explanations,” which are not scientific data on any level.  Id.

Third, we found interesting the Eleventh Circuit’s treatment of specific causation—whether the product “actually caused injury in [the plaintiff’s] particular case.”  Id. As it turns out, no doctor ever diagnosed the plaintiff with copper-deficiency myelopathy or told her that denture adhesive was at fault, until her retained expert examined her in the course of litigation.  Id. at *8.  Prior to that litigation-driven point, who diagnosed the plaintiff?  Her husband diagnosed her, after conducting research on the Internet.  Id. at *8 n.13.  Hmm. Do you suppose his Internet search results included attorney advertising?  We don’t know.  Just saying.

In any event, the plaintiffs’ specific causation expert fell back on what we have called either the “real last refuge of a scoundrel” or “that most-abused method for determining medical causation,” depending on when you read and who was writing:  the differential diagnosis.  But the differential diagnosis that the plaintiffs’ expert performed was unreliable for the usual reasons—he could not “rule in” the denture cream because it had not been established that the product could cause the plaintiff’s alleged disease and there were numerous potential causes that he did not consider and could not reliably “rule out.”  Id. at **8-9.

We especially like that the Eleventh Circuit faulted the expert for failing to consider “the possibility of an idiopathic cause.”  Id. at *9.  Many diseases can occur spontaneously without any identifiable cause, and we agree that it is essential to take that into account when determining whether causation can be attributed to any particular factor.  As a practical matter, it is fair to ask whether a plaintiff could ever prove causation through a differential diagnosis when idiopathic disease is on the differential. After all, how can someone “rule out” a cause that cannot be identified in the first place?  Maybe it’s not possible, but if that reduces the reliance on differential diagnoses in litigation, that would be a change for the better.

Fourth, we like that the Eleventh Circuit affirmed the exclusion of the Plaintiffs’ final two experts, who intended to opine that the denture cream was toxic.  The Eleventh Circuit cited the following passage with approval:

In short, taking everything together, there is enough data in the scientific literature to hypothesize causation, but not to infer it.  Hypotheses are verified by testing, not by submitting them to lay juries for a vote.  It may very well be that Fixodent in extremely large doses over many years can cause copper deficiency and neurological problems, but the methodology [the plaintiffs’] experts have used in reaching that conclusion will not reliably produce correct determinations of causation.

Id. at *10 (emphasis added).  The law lags science; it does not lead it, and this is a quote that we can use in urging on district courts in their roles as gatekeepers for scientific opinion.

Without causation experts, summary judgment was a foregone conclusion.  The plaintiffs tried to argue that they could prove causation using their one remaining expert (a biochemist), treating physicians, and the defendants’ experts, but the Eleventh Circuit rejected those arguments, as had the district court, including on the basis that the defendants’ experts held the opinions that the denture adhesive did not cause copper deficiency myelopathy.  Id. at *12.

We like Chapman because it is a good example of a district court conducting a rigorous Daubert analysis and a Court of Appeals following and affirming that analysis to come to the correct result.  The opinion certainly puts a dent in that litigation, and so be it.

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This coming Wednesday, September 24th at 12:00 pm ET/9:00 am PT, three of your Reed Smith bloggers, Steve Boranian, Steve McConnell, and myself (Bexis) will be presenting a teleseminar that we’ve entitled, “And the Verdict Is…: Recent Trends in Drug and Device Litigation.”

What we’ll be talking about are some of the more notable trends that we have observed in drug and device litigation since the beginning of the year.  One of those topics is what the recent Supreme Court Bauman decision portends (and in some cases is already doing) to mass tort personal jurisdiction.  We’ll also discuss what types of claims plaintiffs seeking refuge from preemption are bringing and how those have fared.  These include innovator liability, driven by generic preemption, and a variety of claims driven by PMA medical device preemption.  Attendees will also hear about  recent developments in litigation involving off-label use, developments regarding the learned intermediary rule, and the “Third Man” – that is, claims brought by unusual plaintiffs or against unusual categories of defendants.  Join us for a one-hour presentation during which we will discuss these trends, their effects (or possible future effects) on litigation involving the pharmaceutical and medical device industries, and how these industries should prepare themselves for future litigation. To register for this free program, click here.

Talk to you then.

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Ever since the FDA decided that discretion was the better part of valor – or read the handwriting on the wall – and decided not to appeal United States v. Caronia, 703 F.3d 149 (2d Cir. 2012), to the United States Supreme Court, we’ve been wondering where the next First Amendment opportunity is going to come from.  We doubted that the government would ever again be so stupid as to prosecute off-label promotion without a large dollop of fraud and/or falsity thrown in.  Likewise, in private product liability actions, plaintiffs invariably allege (as opposed to prove) that any off-label promotion is false/fraudulent in one way or another.

The most promising spawning ground for future Caronias seems likely to be in False Claims Act (“FCA”) litigation.  While FCA claims are ostensibly brought in the name of the government, agencies like the FDA have relatively little control over the allegations that FCA plaintiffs (called “relators”) make.  Also, to increase their own take, such relators have the incentive to make the broadest allegations, which means they would like to avoid having to prove reliance on false information on a one-by-one basis.  In pursuit of that objective, FCA relators have been trying for years to bring FCA claims over activities that aren’t really “false” at all in the dictionary sense of the word – but rather are allegedly illegal.  Enter off-label promotion.

United States ex rel. Solis v. Millennium Pharmaceuticals, Inc., No. 2:09-cv-03010 (E.D. Cal.), is such a case.  The allegations, as discussed in United States ex rel. Solis v. Millennium Pharmaceuticals, Inc., 2014 WL 1270581 (E.D. Cal. Mar. 26, 2014), are that the defendant drug manufacturer “caused” false claims to be submitted for federal reimbursement through off-label promotion that purportedly did not “properly disclose the dangers.”  Id. at *2.  The government declined to intervene, id. at *1, meaning:  (1) that it thought the suit not worth pursuing, and (2) the relator was free to pursue whatever allegations he wanted.  In Solis that turned out to be alleging promotion of off-label use through the dissemination of published articles in the medical literature.  That may be “illegal” under the FDA’s constitutionally-suspect interpretation of the FDCA to ban off-label promotion categorically, but it’s damn hard to conceive of the distribution of peer-reviewed scientific articles as “false” in any sense that the First Amendment would recognize.

We’re not the only ones with an eye open for promising First Amendment openings to challenge the FDA’s ban on truthful scientific speech whenever it happens to involve off-label uses of the speaker’s FDA-regulated product.  The Pharmaceutical Research & Manufacturers of America (“PhRMA”) is sick and tired of its members being shaken down for many millions of dollars by government “enforcement” actions seeking to monetize the FDA’s questionable interpretation.  The risks are so great, due to penalties like debarment and the specter of FDA regulatory retaliation, that individual manufacturers can’t go to the mat with the FDA on First Amendment issues in government enforcement actions, and are forced to settle for ridiculous sums.

That’s not true in a private FCA action – particularly one that the government doesn’t think is worth the time and effort to pursue.  Thus, on August 15, 2014, PhRMA filed an amicus curiae brief in Solis in support of the defendant’s motion to dismiss, arguing that the conduct in question was protected by the First Amendment, and therefore could not be the subject of an FCA (or any other type of) action.

PhRMA first placed Solis solely in the constitutional cross-hairs as a case alleging that the distribution of published, peer-reviewed scientific arguments could not possibly involve anything “false” under the First Amendment:

[N]either relator nor the government alleges that the speech at issue here − relaying reprinted articles about unapproved uses of the drug [in question] from peer-reviewed journals, and summarizing the results of clinical trials − was false or misleading.  Relator and the United States do not even agree on why the FCA proscribes this speech, or how this speech somehow causes others to submit false claims.  But their interpretations of the FCA share a critical flaw: both threaten core First Amendment rights and should be rejected under principles of constitutional avoidance.

PhRMA amicus br. at 2.

The relator was interpreting the FCA as deeming claims for reimbursement of off-label prescriptions “false” solely because the FDA interprets the FDCA as banning all off-label promotion.  That interpretation had several steps:  (1) truthful off-label promotion can “knowingly cause” submission of false claims, because (2) it is “reasonably foreseeable” that doctors would be influenced by such promotion to prescribe off-label; and (3) then submit claims for reimbursement of such off-label use to the government; therefore (4) the off-label promotion has “incited” the “illegal conduct” of submitting false claims.  Id. at 5.  Under this rationale it is “always foreseeable” that off-label promotion of any sort prompts “false” claims, because the whole point of promotion is to induce doctors to use drugs in the off-label manner being promoted.  Id.  PhRMA calls this approach unconstitutional.  We would add “Orwellian” to the description, since inherent in this reasoning is calling the truth “false.”

Caronia shows up, for the first of many citations, squarely for the proposition that the FDCA does not – and cannot – ban all off-label promotion, specifically not information that is objectively true.  PhRMA amicus br. at 3.  PhRMA makes the same argument accepted in Caronia, and that readers have seen on this blog for years – the First Amendment does not permit the criminalizing (here through the FCA) of truthful off-label promotion:

These constitutional concerns are well-founded: “Speech in aid of pharmaceutical marketing . . . is a form of expression protected by the Free Speech Clause of the First Amendment.” Sorrell [v. IMS Health Inc.], 131 S. Ct. [2653,] 2659 [(2011)].  Interpreting the FDCA to punish manufacturers for truthfully speaking about unapproved uses impermissibly restricts speech based on its content and the identity of the speaker, and thus triggers heightened scrutiny.  Caronia, 703 F.3d at 164-65.  The restriction is speaker-based because other individuals and entities − such as insurance companies, other doctors, and the government itself, among others − can and do speak to the same audiences about unapproved uses without running afoul of the law. Id. at 165 (“the FDCA permits physicians and academics, for example, to speak about off-label use without consequence”).  The restriction thus “has the effect of preventing [pharmaceutical manufacturers] − and only [pharmaceutical manufacturers] − from communicating with physicians in an effective and informative manner.” Id. (quoting Sorrell, 131 S. Ct. at 2663). And the restriction is content-based because it penalizes companies for disseminating information only about unapproved uses.

PhRMA amicus br. at 3 (footnotes omitted).

The particular speech involved in Solis, distribution of scientific articles and summarization of clinical trial results, is particularly protected as scientific speech.  Everyone involved in such research, except the manufacturer of the drug being studied, “can speak about the reprints and trial results as much as they wish.”  Id. at 4.  The government has had its biggest problems when it’s tried to ban this kind of scientific speech as “off-label promotion.”

If that is what the FDCA means, it is hard to imagine a more discriminatory restriction on speech that performs a vital role in the practice of medicine.  The government long ago “admit[ted] to the importance of ensuring the availability of [peer-reviewed medical journal articles discussing unapproved uses] to physicians and health care providers making prescription and treatment decisions.”   Washington Legal Foundation v. Henney, 56 F. Supp.2d 81, 85 (D.D.C. 1999), vacated as moot by 202 F.3d 331 (D.C. Cir. 2000).  And “the fear that people would make bad decisions if given truthful information cannot justify content-based burdens on speech.”  Sorrell, 131 S. Ct. at 2670-71 (internal quotation marks omitted).

PhRMA amicus br. at 4.

To avoid constitutional problems PhRMA advocates that the court emulate the judicial restraint taken in Caronia and take one of two steps to reconcile the FDCA with the constitution:

  • Construe the FDCA as prohibiting, at most, only false speech (that’s what Caronia did, as we discussed here).
  • Construe the meaning of “false” in the FCA as excluding off-label promotion.

PhRMA amicus br. at 4.

The “reasonably foreseeable” incitement rationale for truthful off-label promotion supposedly creating “false” claims can’t fly because foreseeability isn’t enough for “incitement” – the unlawful conduct must be “imminent.”  Id. at 5-6.  No way that happens where the speech identified the use as off-label and did not say “boo” about government reimbursement.  Id. at 6.  There is no “imminence” where scientific speech promotes an off-label use (which is itself legal and often the medical standard of care) to a doctor.  Rather any connection to submission of a “false” claim is “remote and attenuated”:

Physicians who received the reprints or other information from the manufacturer in this case received precisely the type of educational information that a trained physician would wish to receive about his patients.  Physicians were not only free to disregard these reprints; their Hippocratic Oath obligated them to use their own, independent medical judgment as to whether a given prescription was warranted.  And after those physicians prescribed the FDA-approved drug for an unapproved use, hospitals then made additional, independent determinations whether the prescriptions were reimbursable.

PhRMA amicus br. at 6.  “Foreseeability” is a tort concept, not a First Amendment concept.

PhRMA then addresses the “evidence” excuse that the government likes to trot out to argue that it’s ban isn’t really a ban because the government has discretion when to prosecute (and which Caronia rejected).  This “evidence” rationale is particularly inapposite to the FCA context because of the additional step of somebody else seeking federal reimbursement.  The relator “does not − and cannot − point to any act (other than truthful speech) by the manufacturer that allegedly ‘caused physicians to submit false claims.’  The only basis for liability identified in the Complaint is the manufacturer’s speech itself—as relator repeatedly acknowledges.”  Id. at 7.

The only cases advanced for the contrary proposition, involving an assault combined with racist speech and speech promoting an entirely unapproved drug, were just that – combination cases.  In both situations the speaker was also engaged in other criminal activity.  That’s not the case when the speech is solely off-label promotion.  Somebody else must make an independent medical judgment that the off-label use is therapeutically proper in a given patient.  Then another somebody else must come to an independent conclusion that the doctor’s use is also reimbursable under some relevant federal program.  That’s not “evidence” of action – or of anything.  It’s speech only, and at best an “incitement” of other persons that fails under the First Amendment’s “imminence” prong.  Beyond that, it’s truthful, and independently protected as scientific speech.

When PhRMA’s brief came in, the government went bonkers.  It filed a responsive brief on August 28, characterizing PhRMA’s relatively straightforward First Amendment argument as seeking “a constitutional right to knowingly cause other parties to submit false claims to the government, as long as a party does so by its speech.”  United States’ Statement Of Interest In Opposition To Amicus Curiae Brief Submitted By [PhRMA], copy here, at 2.  Yet it didn’t point to anything in the promotion that went beyond an off-label use (entirely legal) or that even mentioned reimbursement.

Interestingly the government made what – for it – is a huge concession right at the beginning:

[O]ff-label promotion by a manufacturer is not by itself a violation of federal law. The promotion of an approved drug for an unapproved use, without more, does not violate the False Claims Act, nor is it among the comprehensive list of prohibited acts in the Food, Drug, and Cosmetics Act (FDCA).

Government br. at 2 (emphasis added).  We’ve seen all too many courts make overbroad statements like “the FDCA prohibits off-label promotion.”  E.g., Mendez v. Shah, 2014 WL 2921023, at *6 (D.N.J. June 27, 2014); Blankenship v. Medtronic, Inc., 2014 WL 1226491, at *4-5 (E.D. Mo. March 25, 2014); Eidson v. Medtronic, Inc., 981 F. Supp.2d 868, 884 (N.D. Cal. 2013); Brady v. Medtronic, Inc., 2014 WL 1377830, at *6 (S.D. Fla. April 8, 2014) (taking one from each circuit).  Well, you know what?  So that it could make its “evidence” argument, the Department of Justice just agreed with us that every one of these cases is flat wrong.

After Caronia the government has been knocked off its prior absolutist rhetoric and now claims only that off-label promotion can be “evidence” of [fill in the blank of whatever illegal activity is at issue].  So the government stated in Solis that “promotional speech may be used as evidence to prove that a manufacturer knowingly caused the drug to be put to a certain use and billed to a Government health care program for such use, under circumstances in which the use is not covered and the claim is not eligible for reimbursement.”  Government br. at 2.

The rabbit goes into the hat with “knowingly causes.”  The promoter doesn’t do anything illegal.  It doesn’t tell anybody else to do anything illegal.  The government conveniently forgets that off-label use is legal.  The government cites (br. at 3) Wisconsin v. Mitchell, 508 U.S. 476, 489 (1993).  The speech in that case was racial epithets that increased an assault into a hate crime.  The government cites (br. at 4) United States v. Barnett, 667 F.2d 835 (9th Cir. 1982).  The speech at issue in Barnett was how to manufacture an illegal drug – an illegal act in and of itself.  The government also cites (br. at 4) Rice v. Paladin Enterprises, Inc., 128 F.3d 233 (4th Cir. 1997), often described as the “hitman case.”  The speech in Rice was advertisements soliciting murder for hire – another illegal act.

Repeat:  off-label use is legal.  Murder, assault, and making illegal drugs are not.

Based on this false analogy of speech about legal acts with speech about illegality, the government claims that the sky (or at least the Republic) will fall if it can’t use “foreseeability,” as opposed to the First Amendment’s incitement standard, as the test for “knowingly causes”:

If a course of conduct were constitutionally protected as long as it was effectuated through the use of speech, vast areas of federal and state law would be invalidated.  For example, the Sherman Act’s basic criminal prohibition against “contact[]s, combination[s] …, and conspirac[ies] in restraint of trade” (15 U.S.C. § 1) would become largely unenforceable [sic], because anti-competitive agreements are normally carried out through and embodied in speech among the participants.  Similarly, criminal conspiracy law would fall by the wayside, if statements by two parties agreeing to a criminal course of action were to be treated as protected speech.

Government br. at 3.  This would happen because, the government argues, “the types of statements that underlie anti-competitive agreements and criminal conspiracies may all be perfectly truthful.”  Id.  Wow.  That’s pretty scary.  But the analogy only works if the speech is about something illegal, which off-label promotion simply isn’t.

Repeat:  off-label use is legal.  Restraint of trade and whatever is the object of a “criminal” conspiracy are not – the former by statute and the latter by the definition of the offense.  The only way to make the huge logical leap from legality to illegality in Solis is by jumping to something that’s not mentioned in most (if not all) off-label promotion at all – reimbursement of the prescription sought by yet another person.  This Tinker-to-Evers-to-Chance form of “causation” requires use of foreseeability.  There’s no way that meets the imminence test.  It would be like banning advertisements for rifle ranges, karate, or maybe the movie Scarface, because someone might decide to do something illegal with the knowledge (truthful) so obtained.

PhRMA recently replied to the government’s brief in Solis, see here.  Not without reason it contends that the government “grossly misstated” its argument.  PhRMA Reply br. at 1.  Where speech is sought to be banned due to its effects (here “knowingly cause”) on the actions of third persons, “the First Amendment demands a direct causal nexus between the speech and the claim.”  Id.

Rather than respond to this argument, the government attacks a straw man: it accuses PhRMA of advocating a First Amendment right to shield all speech from sanction, no matter how closely connected to unlawful conduct.  But there is an obvious distinction between speech (even truthful speech) that incites illicit conduct − which is unprotected − and speech that encourages lawful conduct in the form of medically appropriate treatment − which the First Amendment plainly protects.

Id.

Thus, the government’s argument “is at least as radical as the position [it] invents for PhRMA.”  Id.  Why is that?  Because the scope of the government’s foreseeability-based causation test for a “false claim,” which ignores truthfulness, would turn anybody’s speech about off-label use into a FCA action:

[T]he government’s interpretation has no rational stopping point.  FCA liability would attach to any speech to doctors about any unapproved use of any FDA-approved medicine. Fellow doctors, patient advocacy groups, insurance companies, and the medical journals themselves all foreseeably distribute the same information to doctors as manufacturers do.  They all would be just as liable for inciting false claims under the government’s stated theory.

Id. at 1-2 (emphasis original).  Only the applicability of the First Amendment’s imminence test for incitement prevents the government (or FCA relators) from suing into silence anybody saying anything about off-label use.

PhRMA’s position in Solis thus came down to this:  all the defendant did was speak truthfully.  It didn’t break the law (the government having admitted that off-label promotion isn’t per se illegal).  It didn’t tell anybody else to break the law (off-label use being 100% legal).  Nothing was being prosecuted except the defendant’s speech.  Absent evidence satisfying the “imminence” standard for incitement, a truthful speaker cannot be punished for the illegal acts of others, even if those acts were “influenced” in some tort-foreseeable way by the speech.

If that isn’t the law, then free speech isn’t nearly as free as almost everybody in the country thinks it is.

Solis might well be the next Caronia.  Despite the government’s best efforts to avoid scrutiny, because it couldn’t control the FCA relator’s allegations in Solis, the question of liability for truthful off-label promotion is once again squarely presented.  PhRMA hopes, and the government fears, that the constitutional infirmities in the FDA’s ban on all off-label promotion will again be litigated and more importantly appealed.  We’re on the next bench behind.  We think that, under the Supreme Court’s decisions in Sorrell and Thompson v. Western States Medical Center, 535 U.S. 357 (2002), the FDA’s goose is already cooked, as Caronia demonstrates.  The First Amendment protection of truthful off-label promotion is bound to be recognized, sooner or later.  Once that is settled, assuming it ever is, then under New York Times Co. v. Sullivan, 376 U.S. 254 (1964), tort plaintiffs will have no more ability to predicate liability on such truthful speech than the government does.

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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