Larkin v. Pfizer, Inc., No. 2002-SC-0746-CL.

Citation153 S.W.3d 758
Decision Date17 June 2004
Docket NumberNo. 2002-SC-0746-CL.
PartiesRobert I. LARKIN; and Barbara A. Larkin, Petitioners, v. PFIZER, INC.; and G.D. Searle & Co., Respondents.
CourtUnited States State Supreme Court (Kentucky)
Opinion of the Court by Justice COOPER.

This matter reaches us by a request for certification of a question of law from the United States Court of Appeals for the Sixth Circuit. CR 76.37. The operable facts as set forth in the request for certification are as follows:

"Robert Larkin is a 69-year-old resident of Indiana who has been a paraplegic since his involvement in an automobile accident in 1964. Dr. Jeffrey Reynolds has been Larkin's internist since 1988. Over the years, Dr. Reynolds has prescribed Larkin a variety of nonsteroidal anti-inflammatory drugs to alleviate the significant musculoskeletal pain Larkin suffers as a result of his paraplegia.

"In July 1988, Larkin visited Dr. Reynolds's Louisville office with complaints of a head cold. At the time, Larkin had blisters in his mouth and on his arms and legs. Dr. Reynolds prescribed one medication to treat Larkin's sinus infection and another to treat his blistering.

"Several weeks later, in August 1988, Larkin again visited Dr. Reynolds's office, complaining of sinusitis and shoulder pain. Dr. Reynolds gave Larkin a six-pill sample package of Zithromax, an antibiotic manufactured and distributed by Pfizer, Inc., to treat Larkin's sinusitis. Dr. Reynolds instructed Larkin to take two Zithromax pills the first day and one each day thereafter, until the pills were gone. The Zithromax sample package did not contain any written instructions or warning information, and Larkin does not recall any further discussion about the medication with Dr. Reynolds. In addition to providing him with the Zithromax, Dr. Reynolds also changed Larkin's prescribed anti-inflammatory medication to Daypro, a drug manufactured by G.D. Searle & Co. Larkin had the Daypro prescription filled at a drug store but testified that he does not remember receiving any literature containing instructions or warnings.

"In late September 1998, Larkin first noticed an itchy rash breaking out on his left arm and shoulder. As his condition worsened, Larkin developed large fluid-filled blisters over a large portion of his body. When the blisters drained, his skin sloughed off. In early October, Dr. Reynolds diagnosed Larkin's condition as toxic epidermal necrolysis and Stevens-Johnson syndrome. It was Dr. Reynolds's opinion that these conditions resulted from Larkin's taking either Daypro or Zithromax, or both.

"Larkin was admitted to a hospital burn unit for treatment of his wounds and was discharged some ten days later. Since then, Larkin — who previously had been able to move about with crutches — has been confined to a wheelchair, and his general strength has deteriorated.

"Toxic epidermal necrolysis (along with its milder form known as Stevens-Johnson syndrome) is a severe, sometimes life-threatening, skin condition that is often drug induced. More than 100 drugs have been implicated in cases of toxic epidermal necrolysis, including the antibiotic Zithromax and the non-steroidal anti-inflammatory Daypro."

"The physician package insert that accompanies Daypro (and is incorporated in the Physician's Desk Reference) provides that Stevens-Johnson syndrome and toxic epidermal necrolysis are `adverse reactions' experienced `at an incidence of less than 1%.' Dr. Reynolds was aware that these conditions were associated with Daypro — as well as `all' other non-steroidal anti-inflammatory drugs — at the time he prescribed the medication to Larkin." He did not, however, inform Larkin of this risk. Dr. Reynolds testified, `I wouldn't call it a common side effect that we would normally discuss.' When asked why it was not his practice to inform patients taking Daypro of the risk of Stevens-Johnson syndrome and toxic epidermal necrolysis, he stated:

Mostly it's the time element, to go over all possibilities of reactions, and there's other reactions that are as severe as Stevens-Johnson. I mean there's numerous possibilities, as you know, by just reading the [Physician's Desk Reference] and looking at the thickness of it, that, from a clinical standpoint, it's an impossibility to try to completely inform your patients of any medicine that they're being prescribed.

According to Dr. Reynolds, when prescribing non-steroidal anti-inflammatory medications, he would typically discuss with patients the gastrointestinal side effects or `say if something . . . doesn't seem right, in particular, when starting a new medicine . . . then you need to let me know.'

"The package insert and Physician's Desk Reference entry for Zithromax provide under the heading `warnings' that `serious allergic reactions including . . . Stevens-Johnson syndrome and toxic epidermal necrolysis, have been reported rarely in patients on [Zithromax] therapy.' Under the heading `adverse reactions,' it indicates that Stevens-Johnson syndrome and toxic epidermal necrolysis are reported `rarely' by patients taking the drug. Dr. Reynolds testified that he was aware of the association between Zithromax (and many other antibiotics) and Stevens-Johnson syndrome and toxic epidermal necrolysis at the time he provided the drug to Larkin but that he did not discuss it with his patient."

* * * * * * Larkin and his wife sued Pfizer, Inc., and G.D. Searle & Co. for damages under theories of negligence, breach of warranty, and strict liability. They did not sue Dr. Reynolds. In his order granting summary judgment to Pfizer and Searle, United States District Court Judge Thomas B. Russell concluded that Zithromax and Daypro were both "the types of desirable but unavoidably unsafe products described by the Restatement (Second) of Torts, § 402(A), comment k," and, therefore, "the crucial question . . . is whether the manufacturer provided an adequate warning." Larkin v. Pfizer, Inc., No. 3:99CV-649-R, slip op. at 5, 2001 WL 34065029 (W.D.Ky. Feb. 8, 2001) (internal quotes omitted).

The question certified to us by the Sixth Circuit Court of Appeals is:

Whether the learned intermediary doctrine should apply in Kentucky to a case involving an allegation that a manufacturer of a prescription drug failed to warn the ultimate consumer of risks associated with that drug, even though the manufacturer informed the prescribing physician of those risks?

For the reasons explained in this opinion, our answer to the certified question is: "Yes."


In McMichael v. American Red Cross, Ky., 532 S.W.2d 7, 9-11 (1975), our predecessor court adopted comment k to the Restatement (Second) of Torts § 402A, which states an exception to the rule of strict liability:

k. Unavoidably unsafe products. There are some products which, in the present state of human knowledge, are quite incapable of being made safe for their intended and ordinary use. These are especially common in the field of drugs. An outstanding example is the vaccine for the Pasteur treatment of rabies, which not uncommonly leads to very serious and damaging consequences when it is injected. Since the disease itself invariably leads to a dreadful death, both the marketing and the use of the vaccine are fully justified, notwithstanding the unavoidable high degree of risk which they involve. Such a product, properly prepared, and accompanied by proper directions and warning, is not defective, nor is it unreasonably dangerous. The same is true of many other drugs, vaccines, and the like, many of which for this very reason cannot legally be sold except to physicians, or under the prescription of a physician. It is also true in particular of many new or experimental drugs as to which, because of lack of time and opportunity for sufficient medical experience, there can be no assurance of safety, or perhaps even of purity of ingredients, but such experience as there is justifies the marketing and use of the drug notwithstanding a medically recognized risk. The seller of such products, again with the qualification that they are properly prepared and marketed, and proper warning is given, where the situation calls for it, is not to be held to strict liability for unfortunate consequences attending their use, merely because he has undertaken to supply the public with an apparently useful and desirable product, attended with a known but apparently reasonable risk.

Restatement (Second) of Torts § 402A cmt. k (1965) (emphasis added). Thus, the fact that a particular drug might produce unfortunate side effects makes it "unavoidably unsafe" but not "unreasonably dangerous" (emphasis added), and strict liability will not obtain if "proper warning is given, where the situation calls for it." Id. The "learned intermediary" rule defines "proper warning" in the context of a prescription drug (or medical device). The American Law Institute (A.L.I.) has stated the rule as follows:

A prescription drug or medical device is not reasonably safe due to inadequate instructions or warnings if reasonable instructions or warnings regarding foreseeable risks of harm are not...

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