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It’s a short week, so we are going to do a short post about a short decision on a product that lasted a long time. 

An inferior vena cava (“IVC”) filter was implanted in plaintiff in 2004.  Some years later she experienced a complication, not identified in the decision, which led her to file a products liability suit against the manufacturer in June 2022 – over 18 years later.  In re Cook Medical, Inc., 2023 U.S. Dist. LEXIS 205990, at *1 (S.D. Ind. Sep. 27, 2023).  Plaintiff is a resident of Texas and had her 2004 surgery in Texas, so the court applied Texas law which has a 15-year statue of repose. 

A statute of repose sets a definitive date beyond which an action cannot be filed.  It does not matter that plaintiff’s cause of action has not yet accrued.  A statute of repose is triggered by an event like the sale of the product and establishes a bright line cutoff that extinguishes liability.  For that reason, statutes of repose are considered defense friendly.  But they typically require a significant period of time to pass.  The standard is around 10-15 years from sale or manufacturer. (Note Montana’s is only 3 years). 

And while they are usually hard and fast rules, some statutes of repose, like Texas’s, have exceptions.  Texas law provides that the 15-year statute of repose does not apply if the product is accompanied by an express warranty “that the product has a useful safe life of longer than 15 years.”  Id. at *2.  In this case, plaintiff tried to rely on language in the IVC filter’s Patient Guide that said the product was safe effective as a temporary or permanent device.  Id. at *3.  However, the Patient Guide also lists possible adverse effects such as migration of the device or perforation of the vena cava.  Read together, the Patient Guide did “not guarantee the [filter] would conform to a particular standard for the duration of [plaintiff’s] life.”  Id. at *4.  Any “warranty” that the product could remain permanently implanted was qualified by the identification of possible adverse events.  Since the manufacturer did not warrant the IVC filter had a “useful safe life” of more than 15 years, this exception did not apply.  While this may seem case-specific, it is hard to imagine any manufacturer of an implantable medical device warranting the life span of its product given all of the variables of the human body, a person’s healing capacity, a person’s compliance with medical advice, etc. 

Plaintiff next argued she qualified for the “latent disease” exception.  This exception provides that if a plaintiff is exposed to a product before the end of 15 years, that exposure caused plaintiff’s disease, but the symptoms of the disease did not manifest in a reasonably noticeable way until after 15 years had passed, the statute of repose does not apply.  Notice the word “disease.”  Plaintiff tried to argue that “disease” should be broadly interpreted to include “medical device failures.”  Id. at *5.  Not only did plaintiff have no case law to support her interpretation, but the statute also establishing the exception does not mention medical devices or the types of injuries that arise from them.  The plain language of the statue applies to “diseases resulting from exposure to a product.”  Id.  Think asbestos, lead, Agent Orange.  Not a medical device that works as intended for more than 15 years. 

Defendants’ motion for judgment on the pleadings was granted in its entirety.

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In stark contrast to the “MDL treatment” that the Valsartan plaintiffs received earlier this year, the decision in Post v. Amerisourcebergen Corp., 2023 WL 5602084 (N.D.W. Va. Aug. 29, 2023), was more mainstream.  Class certification was denied for a variety of good reasons.

Unlike the result, the Post class action allegations, were relatively unusual.  The members of the class were all patients of the same physician.  Plaintiffs alleged that “defendants” “unlawfully made payments to [the physician] to induce him to misdiagnose” them so that they were eligible for the product at issue.  Id. at *1 We’re not 100% sure, but only one of these “defendants” apparently was the product’s manufacturer.  Plaintiffs sought “the return of every payment made from every source” for this treatment – essentially, they wanted after-the-fact (Post-hoc?) free medical care.  Id.  In addition, they demanded various damages for “invasion of privacy” and “negligence,” as well as punitive damages.  Id.

And they wanted this all as a class action.

The Post reaction?  No way.

Continue Reading Post-Out Sticky Notes
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Several of your Reed Smith bloggers are making plans to be in New York on December 5 – 6 to attend ACI’s annual Drug and Medical Device Litigation conference. We’re looking forward to great content and numerous networking opportunities – and maybe even the chance to catch up with some of our loyal readers.

The good people at ACI asked the blog to be a media sponsor this year – and are offering a special registration discount for the conference for the blog’s readers. Make sure to use the code D10-999-DDLB24 when you register. You’ll save 10 percent off your conference registration.

If you want to register, you can do so here. We look forward to seeing you in New York!

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As we emerge from our fourth month-long trial in a little over two years, we are sure that we have missed some recent legal developments.  As good as this Blog is as a source for what is going on in drug and device product liability litigation, you do actually need to read it to absorb information.  With all due concern for Bexis’s feelings on the matter, reading the Blog every day can end up being a lower trial priority than witness prep sessions, sleep, and daily hygiene.  Whatever developments we missed, though, we do not think that Bartlett or Mensing are no longer good law or that the Yates decision has been consigned to the scrap heap of preemption history.  We also expect that Twombly and Iqbal, entwined as TwIqbal on these virtual pages, still apply to 12(b)(6) motions in federal court.  The decision in In re Tepezza Mkt’g, Sales Pracs., & Prod. Liab. Litig., MDL No. 3079, 2023 WL 7281665 (N.D. Ill. Nov. 3, 2023), gave us a moment of pause about these assumptions.  Then we realized it was just a bad decision about a common issue in an MDL.

We have been discussing the issues of what a design defect claim with a prescription drug looks like and whether it can survive preemption for a very long time.  When the Sixth Circuit issued the Yates decision that affirmed the dismissal of design defect claims as to the prescription contraceptive Ortho Evra, we took a fairly deep dive into the subject.  It was obvious to us that the teachings of Bartlett and Mensing, along with the interplay of state design defect law and the regulatory requirements for prescription drugs, dictate that a non-preempted design defect claim for a prescription drug is a nearly mythical beast.  In general, a design defect claim for a prescription drug requires proof that the design of the drug—essentially, its chemical composition—presented an unacceptable risk of injury, that plaintiff suffered that injury due to the design of the drug, and that plaintiff would not have been injured if she had used the properly designed version of the same drug instead.  Changing the chemical composition of a drug makes it a different chemical entity, which in turn changes its properties, risks, and benefits.  FDA approval of a different chemical entity to treat the same condition as the original drug cannot be assumed.  Adding on TwIqbal, the plaintiff has to plead sufficient facts to support a design issue with the drug—not merely the existence of some risk—that could have been fixed without sacrificing efficacy or approval (among other things).  Good luck with that.

Courts have sometimes divided the design defect preemption analysis into pre- and post-approval design claims.  The latter are clearly preempted—even the plaintiff in Tepezza conceded that.  Some pre-approval claims have been found to sidestep preemption, although we find the logic lacking.  In Tepezza, the plaintiff brought design defect and negligent design claims under the law of an unspecified state (Virginia or Illinois) for alleged “hearing loss and/or tinnitus”—yes, boilerplate on the case-specific injury—from the use (over one of two inconsistent alleged time periods) of an FDA-approved prescription biologic for an eye disease.  The alleged design defect was that the medication posed a risk of “hearing loss and/or tinnitus.”  And, no, we do not think that the allegation of a risk is the same thing as alleging facts that, if true, would establish the existence of a design defect, but that is the only allegation discussed in the Tepezza decision.  When the manufacturer moved to dismiss for failure to state a claim, the court proceeded without mentioning TwIqbal, any state law, or any FDA requirement.  The fuzziness of a preemption analysis untethered to actual factual allegations or state or federal requirements tends to favor the plaintiff.  And so it did in Tepezza.

Rather than looking at plaintiff’s factual allegations to see if they were sufficient to establish a design defect claim under the applicable state law and then comparing that to the federal requirements to see if it would be impossible for the defendant to comply with both independent of action from FDA, the Tepezza MDL court engaged in a more abstract analysis.  Although it started with a recitation of the Mensing principle that requires preemption unless the defendant manufacturer “could independently do under federal law what state law requires of it,” the decision quickly detoured to the much derided reasoning of the Holley case that a manufacturer was not “required to use the allegedly defective design in the first place.”  2023 WL 7281665, *2 (citations omitted).  By “derided,” we mean Holley netted seventh worst in 2019 and Gaetano, which followed it, nabbed fifth worst in 2021.  Based principally on Holley and Gaetano, the court held “to the extent that Horizon had a duty under state law to create a safer alternative design, Horizon could have satisfied that duty without coming into conflict with any federal requirement.”  Id.

Again without considering actual allegations about how the drug’s design could have been changed to make it non-defective, the Tepezza court buttressed its conclusion with three things.  First, without much of a survey, it concluded “[n]umerous district courts presented with this precise question have reached the same conclusion,” noting only two contrary decisions, Yates and another case within the sixth circuit, Fleming.  As can be seen from our prior posts, such as here, here, here, here, here, and here, the majority position actually favors preemption.  Second, the court looked to the Seventh Circuit’s decision in Kaiser, which we bashed here and here.  Kaiser concerned a class II medical device.  Since Lohr in 1996, design claims about such devices have not been preempted.  The facile conclusion that, “[e]ven though Kaiser involved a federal regulatory scheme for a medical device, its reasoning applies with equal force in this context” and that this reasoning supported the non-preemption of an ill-defined pre-approval design defect claim leaves us stunned.  We cannot recall seeing Lohr applied to a drug approved under an NDA or a biologic approved under a BLA.  We have seen pre-approval design claims against a biologic held to be preempted, though. 

Third, the court distinguished the treatment of the “stop selling rationale” in Bartlett with its application in Yates to pre-approval design defect claims.  In the Tepezza court’s view, there was a gap in the holding that “an actor seeking to satisfy both federal- and state-law obligations is not required to cease acting altogether in order to avoid liability” that allowed liability to be imposed on a failure to “have acted differently” rather than a failure to “have stopped acting.”  Id. at *3 (citations omitted; emphasis in original).  As we explained here, there is no duty to a user/consumer until the product is marketed or otherwise made available for use.  Indeed, whether a product is defective is typically measured at the time it leaves the defendant’s hands, not at some point during its development.  To sell the drug at issue in this case or its hypothetical non-defective variant, the manufacturer needed to obtain a BLA from FDA.  It cannot do that “independently” (see Mensing), so it would have to “cease acting altogether” in terms of trying to manufacture and sell the drug to avoid liability under state law (see Bartlett).  The only other option would be to sell the variant without a BLA, which would subject the manufacturer to all sorts of federal liability.  So, concluding plaintiff’s “claim is that Horizon should have submitted to the FDA a formulation that did not cause permanent hearing loss and tinnitus” and that claim was not preempted skips a few necessary steps.  Id.

The court punted on the issue of whether the drug, “as a biologic, is scientifically incapable of being redesigned,” noting it as a state law issue to be tested after discovery.  Of course, this is why we said above that the proper preemption analysis would have “look[ed] at plaintiff’s factual allegations to see if they were sufficient to establish a design defect claim under the applicable state law and then compar[ed] that to the federal requirements to see if it would be impossible for the defendant to comply with both independent of action from FDA.”  You do not need to wait for costly discovery to do that analysis.

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The legal doctrine we discuss today, the reporter’s privilege, lies outside our traditional bailiwick but is worth a quick visit. Recognized in most states, the reporter’s privilege—also known as the journalist’s or newsman’s privilege—is an absolute or conditional “protection, under constitutional or statutory law, from being compelled to testify about confidential information or sources.” Black’s Law Dictionary (11th ed. 2019). Although rarely relevant in product-liability litigation, the doctrine was recently applied in the Zantac litigation to protect JAMA peer review documents from discovery by a plaintiff.

The plaintiffs allege that ranitidine, which had been sold under the brand name Zantac before it was removed from the market, caused them or their decedents to develop cancer. In 2020, the Journal of the American Medical Association (JAMA) announced that it was going to publish a peer-reviewed article linking Zantac to cancer and sent embargoed copies of the article to various entities. But JAMA pulled the article at the last moment after receiving criticism of the article’s underlying methodology. A revised version of the article was ultimately published after the authors reran their analysis using a different methodology.

Insinuating that JAMA’s decision to pull the original article reflected nefarious efforts “to suppress science critical of Zantac,” one plaintiff subpoenaed JAMA demanding that it produce all documents relating to its decision to withhold the article. JAMA resisted, arguing that its peer review process, which involves the confidential review and criticism of draft articles, is protected by the reporter’s privilege, which Illinois has codified at 735 ILCS 5/8-901 to -909.

The trial court ordered JAMA to produce a privilege log and copies of the documents for in camera review. After the court concluded that the documents were covered by the privilege, the plaintiff filed a motion to divest JAMA of the privilege, which is conditional under Illinois law. The court granted the motion and JAMA appealed.

The appellate court reversed in Gibbons v. GlaxoSmithKline, 2023 IL App (1st) 221666 (2003).

Before concluding that the statutory privilege protects JAMA peer review communications, the court rejected JAMA’s contention that the communications were protected under common law. While recognizing that the common law peer-review privilege protects communications involving assessments of a practitioner’s professional competence, the court refused “to extend that privilege” to “professional publications.” 2023 IL App (1st) 221666 ¶ 32.

Although it rejected JAMA’s common-law claim, it held that JAMA’s communications were protected from disclosure, finding that the plaintiff had failed to establish the prerequisites that must be satisfied before the statutorily enshrined reporter’s privilege may be lifted.

Under Illinois law, the reporter’s privilege “is qualified, not absolute.” To overcome the privilege, the party seeking disclosure must show that the information sought is relevant, that other sources of the information have been exhausted, and that the public interest favors disclosure. The Gibbons court found that the Zantac plaintiff satisfied neither the relevance nor the exhaustion requirement.

Information disclosed in JAMA’s privilege log revealed that JAMA had communicated with an unidentified government official in connection with its decision to drop the original version of the article at issue. The plaintiff seeking JAMA’s communications suspected that the official was someone at FDA given the article’s subject matter and the agency’s known critique of the original version’s underlying methodology.

According to the plaintiff, the possible intervention of an FDA official was relevant to causation because it called the article’s methodology into question and raised the specter of “government misfeasance.” The appellate court found no merit to either assertion. Based on its own in camera review of the documents, the court “fail[ed] to see” how “what JAMA editors or government regulators thought about [the article] is relevant to the causation question” in the plaintiff’s “underlying lawsuit.” 2023 IL App (1st) 221666 ¶ 42. And alleged governmental misfeasance, said the court, was “a ‘collateral matter’ that is not directly relevant to [the plaintiff’s] claims that the pharmaceutical company defendants intentionally or negligently marketed a drug that caused cancer.” Id. ¶ 43.

That finding alone was sufficient to defeat the plaintiff’s subpoena but the court went on to also conclude that the plaintiff had failed to exhaust other means to obtain JAMA’s communications with the presumed-FDA official. In particular, the court faulted the plaintiff for having failed to submit a Freedom of Information Act (FOIA) requesting the communications from the FDA. According to the court, the plaintiff “was required” by Illinois statute “to attempt to obtain the information from that agency before seeking divestiture” of JAMA’s reportorial privilege. 2023 IL App (1st) 221666 ¶ 50.

So, only tangentially related to our daily work, but an interesting decision nonetheless.

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In 1972, Neil Young wrote his great song, “Alabama,” the lyrics of which included the following: “Alabama, you’ve got the rest of the union, to help you along; what’s going wrong?”  Those lyrics occurred to us in 2013, when we read the Weeks decision, in which the Alabama Supreme Court endorsed innovator liability. We get how crazy California would embrace such nonsense, but how could Alabama, home of Huntsville rocket scientists and inspiration for To Kill a Mockingbird, arrive at such an error? We called the Weeks decision “execrable” when we wrote about it here.  Two years later, we were humming along to a greater song, Lynyrd Skynyrd’s “Sweet Home Alabama,” when the Alabama legislature abolished the innovator liability doctrine in that great state.  (We discussed that solonic reversal here.)

Today’s case, Watkins v. Pfizer, Inc., 2023 WL 7308325 (S.D. Alabama Nov. 6, 2023), furnishes fresh proof that the product liability element of product identification is alive and well in Alabama, thanks to the legislature’s restoration of sanity. Watkins involves a very popular over the counter (OTC) medicine.  The pro se plaintiff sued a couple of manufacturers, alleging that the OTC pain reliever caused him to suffer from Stevens Johnson Syndrome (SJS).  If you’ve read this blog for any length of time, you know that while SJS is a very rare disease, it is not so rare in the area of OTC litigation.  SJS can be a terrible disease, and SJS plaintiffs can be terribly sympathetic.  Even so, there are legal and medical defenses in SJS cases.  

In Watkins, one of the defendants offered up the defense that it was not a manufacturer, designer, or seller of the product.  It filed a motion to dismiss the case under Fed. R. Civ. P. 12(b)(6).  The injury occurred in Alabama.  Therefore, Alabama substantive law governed the case.  Quoting the same 2015 statutory amendment that the Blog discussed (Ala. Code section 6-5-530(a) says that “Designers, manufacturers, sellers, or lessors of products not identified as having been used, ingested, or encountered by an allegedly injured party may not be held liable for any alleged injury”), the Watkins decision threw out the complaint because, no matter how liberally the pro se plaintiff’s complaint was construed —  which, in the Eleventh Circuit can be quite liberal indeed – it did not include the statutorily mandated element of identifying a product made/sold by the defendant. The court took judicial notice of publicly available materials, including the defendant’s annual report, that demonstrated who makes what. The plaintiff did not challenge the information showing that the movant did not make or sell the medicine. Accordingly, the court dismissed all of the plaintiff’s claims against the moving defendant because the plaintiff “failed to state a plausible claim for relief under Alabama law against” the moving defendant. 

As one of our esteemed defense-side colleagues (who played for and won a national championship under Bear Bryant) would say, Roll Tide.   

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We don’t have much patience for litigation attempting to seek damages for drug addicts who injured or killed themselves through their illegal use of drugs.  We’ve discussed several times how such plaintiffs (or their estates) should lose under the in pari delicto doctrine that prevents criminals from recovering damages for the consequences of their own criminal acts.  Lots of cases so hold.  See, e.g., Albert v. Sheeley’s Drug Store, Inc., 265 A.3d 442, 448 (Pa. 2021); Price v. Perdue Pharma Co., 920 So.2d 479, 486 (Miss. 2006); Orzel v. Scott Drug Co., 537 N.W.2d 208, 213 (Mich. 1995); Patten v. Raddatz, 895 P.2d 633, 637-38 (Mont. 1995); Lastrina v. Bettauer, 289 A.3d 1222, 1234 (Conn. App. 2023); Gentile v. Malenick, 112 N.Y.S.3d 364, 365 (N.Y.A.D. 2019); Kaminer v. Eckerd Corp., 966 So.2d 452, 454 (Fla. App. 2007); Pappas v. Clark, 494 N.W.2d 245, 247 (Iowa App. 1992); Inge v. McClelland, 725 F. Appx. 634, 638 (10th Cir. 2018) (applying New Mexico law); Romero v. United States, 658 F. Appx. 376, 380 (10th Cir. 2016) (applying New Mexico law); Messerli v. AW Distributing, Inc., 2023 WL 4295365, at *5 (D. Kan. June 30, 2023), certif. denied, 2023 WL 6961977 (D. Kan. Oct. 20, 2023); Alston v. Caraco Pharmaceutical, Inc., 670 F. Supp.2d 279, 287 (S.D.N.Y. 2009); Sorrentino v. Barr Laboratories, Inc., 397 F. Supp.2d 418, 422-23 (W.D.N.Y. 2005), aff’d, 218 Fed. Appx. 7 (2d Cir. 2007); Foister v. Purdue Pharma, L.P., 295 F. Supp.2d 693, 705 (E.D. Ky. 2003).

Continue Reading Another Opioid Addict Overdose Case Dismissed, Several Times Over
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California’s Proposition 65 has become a poster child for ineffective and counterproductive over-warning.  You know what we are talking about.  Prop 65 is the voter-enacted law that requires businesses to warn Californians about significant exposures to chemicals that allegedly cause cancer or birth defects.  See Cal. H&S Code § 25249.5 et seq.  A decent idea in concept, but California is now blanketed with boilerplate warnings of chemicals “known” to cause cancer, to which literally no one pays any attention.  No one.  We saw multiple such warnings while running errands just the other day, and the only people they are conceivable helping are attorneys who file lawsuits to recover generous statutory penalties and attorneys’ fees. 

The Ninth Circuit has now identified another problem with Prop 65:  The required warnings are government-compelled speech, which the First Amendment protects against.  In National Association of Wheat Grower v. Bonta, No. 20-16758, 2023 WL 7314307 (9th Cir. Nov. 7, 2023) (to be published in F.4th), a group of agricultural producers sued to enjoin California from requiring Prop 65 warnings in connection with glyphosate, the active ingredient in Roundup.  There were multiple versions of the warning that the state was trying to impose, but all would have compelled the plaintiffs to post statements that glyphosate was known to cause cancer or was “listed” or “classified” as causing cancer. 

The Ninth Circuit held that this violated their First Amendment right to be free from compelled speech.  The core issue is that there is no scientific consensus that glyphosate is a carcinogen.  The state relied on an International Agency for Research on Cancer (“IARC”) monograph classifying glyphosate as “probably carcinogenic to humans.”  Id. at *5.  But in this regard, IARC stands alone.  As the Ninth Circuit observed, “While IARC has concluded that glyphosate poses some carcinogenic hazard, federal regulators, California regulators, and several international regulators have all concluded that glyphosate does not pose a carcinogenic hazard.”  Id. at *4 (emphasis in original).  Thus, not only is there no scientific consensus, the evidence overwhelming shows that glyphosate does not pose a cancer risk in humans.  Even the IARC’s lonesome opinion is that glyphosate poses some “hazard,” which is theoretical and does not indicate a likelihood of cancer at real-world levels of exposure. 

Why does this matter?  It matters because compelled commercial speech is subject to intermediate scrutiny under the First Amendment, which requires the government to “directly advance” a “substantial” governmental interest, and the means chosen must not be “more extensive than necessary.”  Id. at *10 (citing Central Hudson).  There is, however, an exception for compelled commercial speech that is “purely factual and uncontroversial.”  Id. (citing Zauderer). 

Despite trying mightily, the state could not force its required warnings into the exception because none of the multiple proposed warnings was “purely factual and uncontroversial.”  The Prop 65 warning was not “purely factual” because the term “known carcinogen” carries a complex meaning, with considerable ambiguity on what an ordinary consumer would understand it to say.  Moreover, the warning was anything but “uncontroversial.”  It is obviously controversial to inform consumers that something is carcinogenic without a strong scientific consensus that it is.  On another level, it is likewise controversial to force these plaintiffs to convey a message fundamentally at odds with their businesses.  Id. at *12-*13. 

Intermediate scrutiny therefore applied, and the state’s proposed warnings failed.  California clearly has a substantial interest in protecting public health.  However, “compelling sellers to warn consumers of a potential ‘risk’ never confirmed by any regulatory body—or of a hazard not ‘known’ to more than a small subset of the scientific community—does not directly advance that interest.”  Id. at *16.  The means were also not narrowly tailored, since the state had “other means to promote its (minority) view that glyphosate puts humans at risk of cancer ‘without burdening [Plaintiffs] with unwanted speech.’”  Id.  The state could, for example, post information on its own website. 

Given the laundry list of chemicals on California’s Prop 65 list, we would not be surprised to see additional First Amendment challenges to Prop 65 warnings.  We also would not be surprised to see California’s AG continue to resist. 

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In 1919, J. Edgar Hoover described Communism as a “conspiracy so vast” that it was impossible for the populace to comprehend it.  The Palmer Raids and the first Red Scare soon followed.

That phrase echoed in our minds when we first read In re Valsartan, Losartan, & Irbesartan Products Liability Litigation, 2023 WL 1818922 (D.N.J. Feb. 8, 2023).  The Valsartan opinion was similarly mind-boggling in its scope.  It certified not one, not two − but four class actions:  one for economic loss, one for third-party payors (“TPPs”), and two for medical monitoring (“remedy” and “independent claim”).  Id. at *3.  Compare that to the state of class action precedent in product liability litigation not too long ago when we made this statement in 2007:

As far as we know, there has not been a single contested class action in product liability, personal injury litigation that’s been affirmed anywhere in the federal system in the decade since the Supreme Court put the kibosh on such things with its Ortiz and AmChem decisions.  That’s not limited to just pharmaceuticals, that’s every kind of product that’s made.

Four in a single MDL order?  These class certifications glommed together no less than 111 consumer and TPP subclasses.  Valsartan, 2023 WL 1818922, at *24.  These class certifications combined 428 different pharmaceutical products, produced and marketed by 28 separate defendants, with claims governed by the laws of 52 separate jurisdictions.  There’s no way on earth that common issues could predominate over individual ones, or that this morass could possibly be tried to a jury.

Continue Reading An Abuse of Discretion So Vast….  Our Long-Delayed Critique of the Valsartan MDL Class Action Certifications
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In addition to its recent revamp of its “§510(k)” substantial equivalence clearance process for medical devices, (see our post here), the FDA has also been active with respect to off-label communications – another regulatory area of continuing interest to this Blog.  Our position has been clear, and the same from the Blog’s beginning more than 15 years ago:  Truthful medically related speech from any source, including FDA-regulated product manufacturers, is First Amendment-protected scientific speech, and thus the FDA cannot constitutionally ban it by calling it “off-label promotion” (“promotion” not even being an FDCA-defined term).

The FDA, of course, has long thought otherwise, but as we have discussed in the above prior posts, it has been piling up losses on this issue over the last couple of decades.  E.g., Sorrell v. IMS Health Inc., 564 U.S. 552 (2011); Thompson v. Western States Medical Center, 535 U.S. 357 (2002); United States v. Caronia, 703 F.3d 149 (2d Cir. 2012); Amarin Pharma, Inc. v. FDA, 119 F. Supp.3d 196 (S.D.N.Y. 2015).

The FDA’s chief concern about off-label communications from manufacturers has less to do with the safety of such uses − many of which are medical standard of care and Medicare reimbursable − than with the agency’s own bureaucratic imperative.  The FDA is concerned, probably with reason, about its own power.  If unfettered truthful off-label promotion is permissible, then the incentives for regulated entities to spend the large amounts of time and money now required to submit new uses of already approved FDA-regulated products for additional approvals would be reduced.  Historically, the FDA has taken the easy way out and simply targeted truthful speech about even the safest off-label uses as “illegal”

Of course, the FDA could do that using non-speech-related means – making add-on approvals less onerous to obtain and/or imposing either dollar-amount or percentage-based requirements that require submission to the agency of off-label uses above certain thresholds.  Unfortunately, the FDA has been stuck in the rut of criminalizing speech for so long that hasn’t wanted to change unless courts forced it to.

But in its latest “revised draft guidance” on off-label speech, released last month and entitled:  “Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products Questions and Answers,” the FDA seems to be getting – slowly but surely – around to coming to grips the legality of truthful off-label speech.

First, terminology.  What the FDA calls, rather ponderously, “unapproved uses of approved/cleared medical products,” everybody else in the world (including the Supreme Court in Buckman Co. v. Plaintiffs Legal Committee, 531 U.S. 341 (2001)), calls “off-label use,” so we go with the majority naming convention.  However, the FDA’s new Draft Guidance introduces another phrase, “scientific information on unapproved use(s)” (“SIUU”), that at least has a decent acronym, so we will use that.

We’re viewing the FDA’s action solely from a First Amendment/product liability litigation standpoint, so to us, the most significant change is the agency’s expansion of legal communications.  First, such communications may now be directed to any health care provider – not just health insurers seeking to determine whether an off-label use should be covered, as was previously the case.  Now:

The term health care providers (HCPs) refers to individuals such as physicians, veterinarians, dentists, physician assistants, nurse practitioners, pharmacists, or registered nurses who are licensed or otherwise authorized by law to prescribe, order, administer, or use medical products in a professional capacity.  The recommendations in this guidance are specific to communications by firms to HCPs engaged in making clinical practice decisions for the care of an individual patient.

Draft Guidance at 6.  So one major advance is that off-label communications, assuming they meet the FDA’s substantive standards, may be directed essentially to any treater who might find them useful.

Another example of the Draft Guidance embracing more truthful off-label speech is the scope of permissible communications.  The FDA is no longer limiting permissible off-label communications to the results of expensive and lengthy randomized and controlled studies.  Beyond such gold-plated research:

[O]ther well-designed and well-conducted trials are also able to generate scientifically sound and clinically relevant information. . . .  [These] may include well-controlled investigations, partially controlled studies, studies and objective trials without matched controls, well-documented case histories conducted by qualified experts, and reports of significant human experience with a marketed device.

Id. at 10.  Moreover, the FDA finally recognizes that “[r]eal-world data and associated real-world evidence about medical products may be scientifically sound and clinically relevant.”  Id.

Thus, off-label communications to “health care providers” (no longer limited to health insurers) may discuss all types the FDA calls “[p]ublished clinical reference resources.”  See Id. at 20-26 (going into great detail about what such “references” may, or may not, contain).  This SIUU includes a much broader universe of materials – essentially any medical literature, provided that it is not “false, misleading, biased, or not based on studies and analyses that are scientifically sound and able to provide clinically relevant information.”  Id. at 9.

[T]he studies or analyses . . . should meet generally accepted  design and other methodological standards for the particular type of study or analysis performed, taking into account established scientific principles and existing scientific knowledge.

Id. at 10.  That’s a significant step forward, since it aligns the FDA’s view of permissible science more closely to what doctors (and Medicare) actually rely on in clinical situations.  We agree that material that “lack[s] enough detail to permit scientific evaluation” would generally not be scientifically sound.  Id. at 11.  Likewise, “communications that distort studies as well as communications based on publications that distort studies or include fraudulent data,” id., have no business being disseminated by anyone.  We’ve been fighting against similar junk science in litigation for many years.

As one would expect, the FDA requires a variety of disclosures and disclaimers – more than a dozen of them.  Id. at *12-13.  We won’t go into detail because we’re interested in the First Amendment and litigation aspects of this FDA’s relaxed restrictions, not its regulatory implications.  These details should not give rise to “parallel” claims, as they arise from FDA regulatory requirements, not the common law.  For instance, we’re not aware of any common-law requirement that promotional materials include “the most current FDA-required labeling,” to take one example.  Id. at 13.  Another long overdue FDA relaxation of restrictions on truthful off-label communications is that SIUU distributed by manufacturers may include “both audio and visual components.”  Id. at 15.  Off-label communications are no longer limited to the printed word.

Still off-limits, however, are so-called “persuasive marketing techniques” for off-label uses.

[T]hese marketing techniques influence use of the products based on elements other than the scientific content of the communication (as used herein, “persuasive marketing techniques”).  Examples of these persuasive marketing techniques include the use of celebrity endorsements, premium offers, and gifts.

Id. at 15 (footnote omitted).  We’re agnostic about these, but as the FDA points out such techniques aren’t based on science, and thus for First Amendment purposes would not fall within the category of protected scientific speech.

In another free speech advance, online off-label communications are now specifically allowable, subject to relatively minor restrictions to maintain separation between scientific off-label information and permissible promotion of on-label uses:

[F]irms may be interested in sharing information about both the approved and unapproved uses of their medical products online through websites. In these cases, FDA recommends that SIUU communications be on a separate web page from the web page that hosts promotional communications about the approved uses of the medical product.  FDA also recommends that firms not include direct links from web pages that host promotional communications about approved uses to webpages that host SIUU communications.  Similarly, FDA recommends that email messages used to share SIUU communications be separate and distinct from email messages used to share promotional communications about approved uses of the medical product.

Id. at 18.  Even “character-space limited platforms” may play a role, if only “to direct HCPs to an SIUU communication through a statement that does not mention the name of any specific medical product.”  Id. at 19.

In the past, we’ve been quite critical of the FDA for its unwillingness to grapple with the simple fact that truthful scientific speech – and thus First Amendment protection − can extend to off-label uses.  This Draft Guidance, however, seems to be different.  Were it to go into effect without being watered down, this regulatory regime could stand a prayer of being upheld against the most common First Amendment challenges that we’ve seen (and advocated) in the “off-label promotion” context.  Finally, the FDA seems on course to bring its off-label promotion restrictions into a closer relationship with the truth, and thus with the First Amendment.

Drug & Device Resources

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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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