Not too long ago we were asked what we thought about warning claims involving medication guides. Our off-the-cuff reaction was that such suits have been occasionally filed over the years, but were largely unsuccessful in achieving the plaintiffs’ primary goal, which almost always was to avoid the learned intermediary rule.  

That was our gut reaction, but since we also have to feed the blog, we decided that the question warranted a closer look.

First, a little on the current regulatory status of medication guides, which are also sometimes referred to as “patient package inserts,” or “patient brochures.” They are “FDA-approved patient labeling conforming to the [Agency’s] specifications.” 21 C.F.R. §208.3(h). Such guides were authorized by the FDA in 1998 under 21 C.F.R. §208.1, which states:

  1. This part sets forth requirements for patient labeling for human prescription drug products, including biological products, that the Food and Drug Administration (FDA) determines pose a serious and significant public health concern requiring distribution of FDA-approved patient information. . .
  2. The purpose of patient labeling for human prescription drug products required under this part is to provide information when the FDA determines in writing that it is necessary to patients’ safe and effective use of drug products.
  3. Patient labeling will be required if the FDA determines that one or more of the following circumstances exists:
  1. The drug product is one for which patient labeling could help prevent serious adverse effects.
  2. The drug product is one that has serious risk(s) (relative to benefits) of which patients should be made aware because information concerning the risk(s) could affect patients’ decision to use, or to continue to use, the product.
  3. The drug product is important to health and patient adherence to directions for use is crucial to the drug’s effectiveness.

Emphasis added. See also 21 C.F.R. §208.24(a) (“The manufacturer of a drug product for which a Medication Guide is required under this part shall obtain FDA approval of the Medication Guide before the Medication Guide may be distributed”) (emphasis added); 21 C.F.R. § 201.57(c)(18) (requiring all “FDA-approved patient labeling”to appear in the “Patient counseling information” section of drug labeling).

We added all this emphasis to underscore the point that requiring a medication guide – as distinguished from what it might say − is another of those decisions that requires FDA pre-approval. See Bartlett v. Mutual Pharmaceutical Co., 2010 WL 3659789, at *5 (D.N.H. Sept. 14, 2010) (“FDA may require that a drug be accompanied by a medication guide”) (citing §208.1). As we’ve explainedelsewhere, a mandate for FDA pre-approval such as this calls into play the Mensing/Bartlettimpossibility preemption rationale, since a hypothetical state immediate tort duty to include a medication guide would conflict with the federal agency preapproval requirement. Bowdrie v. Sun Pharmaceutical Industries Ltd., 909 F. Supp. 2d 179, 186 (E.D.N.Y. 2012) (finding preemption because “a specific FDA directive, is a necessary predicate to . . . any medication guide”).

In any event, there’s probably not much state law to be preempted, since every court to consider a hypothetical common-law duty to create a medication guide has rejected it. Hatfield v. Sandoz-Wander, Inc., 464 N.E.2d 1105, 1111 (Ill. App. 1984) (such a duty “would not only negate the role of prescribing physician as ‘learned intermediaries’. . ., but would also circumvent the exclusive power of the Federal government to determine the contents of prescriptive information”); Frazier v. Mylan, Inc., 911 F. Supp.2d 1285, 1289-90 (N.D. Ga. 2012) (no common-law duty where FDA had not required a medication guide); Bartlett, 2010 WL 3659789, at *5 (rejecting on common-law grounds a negligence claim concerning medication guides resembling the “take steps” argument held preempted in Mensing); Polley v. Ciba-Geigy Corp., 658 F. Supp. 420, 423 (D. Alaska 1987) (since “[t]he learned intermediary doctrine applies,” “the defendant drug manufacturers had no duty to advise patients directly or to provide patient brochures to physicians for distribution to patients”); cf. Ramirez v. Plough, Inc., 863 P.2d 167, 175 (Cal. 1993) (relying on FDA’s refusal to require foreign language patient package inserts as reason for rejecting similar common-law requirement).

The key point, though, is not preemption, but that medication guides don’t trump the learned intermediary rule. Such a guide, contained in a “blister pack,” was held irrelevant (“not properly in this case”) and inadmissible for this reason: “[t]he information that defendant communicated to Plaintiff is irrelevant under New York’'s ‘learned intermediary doctrine’.” In re Fosamax Products Liability Litigation, 2013 WL 174416, at *1 (S.D.N.Y. Jan. 15, 2013). An expert opinion from the ubiquitous Suzanne Parisian was excluded as in conflict with the learned intermediary rule:

Dr. Parisian’s supplemental report states that [defendant] should have done more to notify patients of the . . . change to the patient package insert. . . . [T]he issue of how [defendant] notified its patients of a label change is irrelevant. The “learned intermediary” doctrine, which applies to both design defect and failure to warn claims, focuses on the scope of a drug manufacturer’s duty to warn of the dangers of using the drug in question. That duty is fulfilled by giving adequate warning to the prescribing physician. Whether [defendant] communicated with its patients would have no effect on Plaintiffs’ claims. Accordingly, this motion is granted.

In re Fosamax Products Liability Litigation, 924 F. Supp. 2d 477, 496-97 (S.D.N.Y. 2013) (citations and quotation marks omitted).

The same result also occurred in an aspect of the Bartlett litigation that did not get appealed to the Supreme Court. The learned intermediary rule precluded a medication-guide-based claim:

Starting with the patient medication guide, it is well established that a manufacturer’s duty to warn of a drug’s safety risks requires that the physician, not the patient, be warned. Since [defendant] had no duty to warn [plaintiff] directly, its failure to issue such a warning (in the form of a medication guide or otherwise) cannot serve as the basis for a finding of causation.

Bartlett v. Mutual Pharmaceutical Co., 731 F. Supp.2d 135, 148 (D.N.H. 2010), aff’d on other grounds, 678 F.3d 30 (1st Cir. 20120, rev’d on other grounds, 133 S. Ct. 2466 (2013). Accord Bartlett, 2010 WL 3659789, at *6 (rejecting medication guide“exception” from the learned intermediary rule); Bartlett v. Mutual Pharmaceutical Co., Inc., 2010 WL 3092649, at *7 (D.N.H. Aug. 2, 2010) (“[r]eferences to a patient medication guide, because they would imply a duty to warn the patient, would be confusing to the jury and unfairly prejudicial”).

Older cases also considered and rejected the same arguments when couched in terms of a “voluntarily assumed” duty:

Informational pamphlets, such as provided [the prescriber] by [defendant] for distribution to his patients in the exercise of the doctor’s discretion, can aid in expanding the range of communication between doctor and patient. . . . Nevertheless, a direct relationship between the manufacturer and the patient does not arise as a result of the provision of such brochures. . . . Although we recognize that the intent of such brochures is to ultimately benefit the user, we do not believe that by preparing such brochures and distributing them to physicians, a prescription drug manufacturer undertakes to render a voluntary service so as to invoke the “voluntary duty” rule.

Seley v. G. D. Searle & Co., 423 N.E.2d 831, 840 (Ohio 1981). See id.at 839 (“voluntary duty” doctrine “has no application to cases based on failure to provide adequate warnings with prescription drugs” because “[i]t has become a well established rule in such cases that the manufacturer satisfies his duty to warn of dangers associated with use of the product by providing adequate warnings to the medical profession”).

Patient brochures provided by the manufacturer to physicians for distribution to the consumer may aid the physician in communicating with his patient but do not establish the undertaking by the drug manufacturer of a voluntary duty to warn the patient directly.

Spychala v. G.D. Searle & Co., 705 F. Supp. 1024, 1033 (D.N.J. 1988).

The Kansas Supreme Court later expressly adopted the Spychala holding as part and parcel of the learned intermediary rule:

[W]e adopt the ruling of Spychala and other similar cases. The majority viewpoint is that under the learned intermediary rule drug manufacturers are not liable for failure to directly warn patients of risks and side effects. . . . [Defendant] provided [the prescriber] with physician and patient information sheets, thereby satisfying its duty to warn mandated by federal regulations. Thus, under the learned intermediary rule, [defendant] is not liable for failure to warn [plaintiff] directly.

Humes v. Clinton, 792 P.2d 1032, 1042-43 (Kan. 1990) (citations omitted).

In Frazier, the court likewise dismissed the plaintiff’s allegations about a medication guide because “[t]he learned intermediary doctrine would still bar plaintiff's claim because it only requires a duty to warn the physician.” 911 F. Supp.2d at 1290. See Ellis v. C.R. Bard, Inc., 311 F.3d 1272, 1280-81 (11th Cir. 2002) (learned intermediary rule controlled; alleged deficiencies in patient brochure did not create any broader duty) (applying Georgia law); In re Accutane Products Liability Litigation, 2012 WL 3194954, at *4-5 (M.D. Fla. July 24, 2012) (citing medication guide language in support of adequacy as a matter of law under learned intermediary rule) (applying New York law); Snyder v. Hoffman-LaRoche, Inc., 2008 WL 4790666, at *6 (M.D. Fla. Oct. 30, 2008) (labeling as a matter of law under learned intermediary rule despite prescriber’s decision not to provide patient with medication guide); Lorenzi v. Pfizer Inc., 519 F. Supp. 2d 742, 750 (N.D. Ohio 2007) (citing medication guide language in support of adequacy as a matter of law); cf. Taurino v. Ellen, 579 A.2d 925, 929-30 (Pa. Super. 1990) (similar reaffirmance of learned intermediary rule in pre-1998 oral contraceptive case).

A few states (mostly in oral contraceptive cases) had recognized an FDA-required warning exception to the learned intermediary rule before medication guides existed. Section 2.03[3][c] of Bexis’ book counts three states (Massachusetts, Oklahoma, and Ohio (by statute)) as definitely in this category, and two more (Michigan and Wisconsin) as possible, with only federal district court authority. Other jurisdictions (Arkansas, Delaware, DC, Illinois, New Jersey, New York, Texas, Washington), have rejected this exception, and Michigan is split. See also Restatement (Third) of Torts, Products Liability §6, comment 3 (1998) (mentioning, but not adopting, this exception, leaving exceptions to “developing case law”); Kurer v. Parke, Davis & Co., 679 N.W.2d 867, 879-80 (Wis. App. 2004) (noting, but not reaching, exception). The advent of medication guides in 1998 has not caused greater acceptance of this exception – no state has adopted such an learned intermediary exception since the 1980s. In DiBartolo v. Abbott Laboratories, 914 F. Supp.2d 601 (S.D.N.Y. 2012), the court rejected an expansion of the government-mandated direct-to-patient exception to medication guides. Id. at 614 n.5 (“courts have consistently applied [learned intermediary rule] to failure-to-warn claims involving drugs for which patients were provided Medication Guides”). So did the court in Hanhan v. Johnson & Johnson, 2013 WL 5939720, at *3 (N.D. Ohio Nov. 5, 2013) (applying California law). In Wells v. Allergan, Inc., 2013 WL 389147 (W.D. Okla. Jan. 31, 2013), in a jurisdiction that already recognized that exception, the court held that the defendant’s full compliance with the FDA’s medication guide regulations justified application of the learned intermediary rule notwithstanding the exception. Id. at *5 n.6.

The plaintiff in Bartlett, being very creative in inventing novel theories, also attempted – unsuccessfully – to argue that medication guides, although directed to patients, could also serve as warnings to physicians. Bartlett, 2010 WL 3659789, at *7. Such claims, which questionably assume that there’s something in the medication guide portion of a package insert not present in more detailed parts directed to physicians, would be subject to the same warning causation defenses as any other literature – such as a physician’s failure to read that information:

[Plaintiff’s] doctor did not read or rely upon [the drug’s] label before prescribing the drug to her. So the medication guide, even if reprinted there, would not have affected the doctor's decision or prevented [plaintiff]s] injuries.

Id. Cf.Accutane, 2012 WL 3194954, at *5 (as to physicians, medication guide language supports adequacy as a matter of law). Indeed, as a practical matter, even doctors who do read drug labels are unlikely to seek information in a mere medication guide, so the failure-to-read causation defense looms even larger this sort of claim. In re Ethicon, Inc., Pelvic Repair Sytems Products Liability Litigation, 2014 WL 186869, at *4 (S.D.W. Va. Jan. 15, 2014) (“no evidence that [the prescriber] relied on the [product’s] patient brochure in deciding to prescribe”), rev’d in part on other grounds, 2014 WL 457551 (S.D.W. Va. Feb. 3, 2014) (applying Texas law).

As a matter of evidence, an FDA decision, following a plaintiff’s injury, to order a medication guide for a particular drug is a subsequent remedial measure that’s generally inadmissible under F.R. Evid. 407. In re Fosamax Products Liability Litigation, 2013 WL 174416, at *4 (S.D.N.Y. Jan. 15, 2013). A statement in a medication guide that an adverse reaction “can happen” was not sufficiently definitive to qualify as an admission in Rhodes v. Bayer Healthcare Pharmaceuticals, Inc., 2013 WL 1289050, at *6 n.3 (W.D. La. March 26, 2013).

The contents of medication guides, since they are available to plaintiffs, can play a role in determining when the discovery rule ceases to toll the statute of limitations, so counsel should pay close attention to such materials in any case filed beyond the statutory limit. Roth v. G.D. Searle& Co., 27 F.3d 1303, 1307 (8th Cir. 1994) (contents of patient brochures established that discovery rule was satisfied and action untimely filed) (applying Iowa law); Kendall v. Hoffman-La Roche, Inc., 36 A.3d 541, 556-57 (N.J. 2012) (information in medication guide “might have been sufficient” to satisfy discovery rule, but not on the peculiar facts of the case); Coleman v. Wyeth Pharmaceuticals, Inc., 6 A.3d 502, 515 (Pa. Super. 2010) (lack of information in patient package insert supported application of discovery rule).

Finally, since the FDA’s regulations require pharmacists to provide medication guides, and some pharmacies distribute their own patient information without any FDA requirement, pharmacy liability has been asserted on the basis that that independently prepared materials were inadequate. See Rite Aid Corp. v. Levy-Gray, 894 A.2d 563, 578-79 (Md. 2006) (independently created patient material created an express warranty); McNichols v. Johnson & Johnson, 461 F. Supp. 2d 736, 742-43 (S.D. Ill. 2006) (same). Cf. Rivera v. First DataBank, Inc., 115 Cal. Rptr. 3d 1, 8-9 (Cal. App. 2010) (publisher of non-FDA required medication guide owed no duty to plaintiff injured by drug). We haven't run across any failure-to-provide-FDA-approved-guides cases involving pharmadies.