Opinion
CIVIL ACTION NO. 3:99CV-649-R
February 6, 2001
MEMORANDUM OPINION
This case is before the Court on separate motions for summary judgment by the defendants. (Dkt.#s 22-23). For the reasons that follow, this Court GRANTS Defendants' motions.
BACKGROUND
Plaintiffs originally filed this products liability action in Jefferson Circuit Court on August 30, 1999. In their Complaint, Plaintiffs asserted claims for negligence, breach of warranty and strict liability against G.D. Searle Co. ("Searle") and Pfizer Inc. ("Pfizer") arising from side effects Robert Larkin ("Larkin") allegedly suffered as a result of taking a prescription drug prescribed by his doctor and manufactured by one of the defendants.
Larkin is now 67 years old and has been paraplegic since a 1964 car accident. Due to his paraplegia, Larkin suffers from musculoskeletal type symptoms. Many of these conditions relate to the use of crutches to ambulate. Dr. Jeffrey Reynolds has been Larkin's treating physician since 1988 and has proscribed a number of nonsteroidal anti-inflammatory drugs to help Larkin with his condition.
In July 1998, Reynolds saw Larkin for complaints of a head cold. Larkin also had symptoms of mouth, arm and leg blisters. After examination, Reynolds concluded that Larkin had symptoms consistent with sinusitis and a reaction to medication. Reynolds prescribed Cefzil to treat Larkin's sinus infection. To relieve the blistering, Reynolds changed Larkin's nonsteroidal anti-inflammatory medication from Naprosyn to Voltaren.
On August 31, 1998, Reynolds saw Larkin again. Larkin complained of sinusitis and shoulder problems. During this visit Reynolds changed Larkin's nonsteroidal anti-inflammatory medication to Daypro and his antibiotic to Zithromax. Larkin had his prescription filled at Walgreen's in Clarksville, Indiana. He claims he did not receive a package insert with his prescription.
In late September 1998, Larkin noticed an itching rash on his left arm and upper shoulder. Two or three blotches the size of fingernails appeared on his shoulder. Larkin visited the Baptist East Hospital Emergency Room the next day, Saturday, September 26, 1998. He stayed in the hospital overnight. Larkin saw Reynolds at a scheduled appointment the following Tuesday. By this time his rash had spread to both arms and shoulders. Reynolds recommended hospitalization but Larkin declined.
Larkin's condition worsened. His skin began filling with fluid with blisters expanding to the size of footballs. The blisters eventually drained and the skin sloughed off. The rash caused pain and Larkin could not sleep. Reynolds saw Larkin on October 2, 1998, and diagnosed him with toxic epidermal necrolysis ("TEN") associated with Steven's-Johnson syndrome ("SJS"). These are rare and potentially life-threatening cutaneous (dermatologic) reactions thought to be associated with more than a hundred different prescription drugs. Both Daypro and Zithromax have caused such side effects in some patients in the past. Reynolds consulted with two specialists and admitted Larkin to the hospital. His prognosis was uncertain. Larkin remained in the hospital for about three weeks. The rash covered 70% of his body, leaving only his feet and forearms rash-free. While Larkin's rashes eventually healed, he lost stamina and doctors expect the loss to be permanent. He also lost the ability to ambulate with crutches and is confined to a wheelchair.
Both Daypro and Zithromax are prescription drugs with SJS and TEN as known potential side effects. These side effects have an incidence of less than 1%. A Physician Package Insert accompanies both drugs setting forth prescribing information, warnings and adverse event information for physicians. Both Daypro and Zithromax warn of SJS and TEN in these package inserts and Reynolds has stated that he was aware that the drugs can cause these disorders.
Plaintiffs do not fault Reynolds. Reynolds testified that he instructs patients on the most common side effects associated with the use of a particular medication. He claims, however, that it would be impossible for a physician to instruct a patient on the potential side effects of every drug because of time constraints. Plaintiffs state that SJS and TEN are rare side effects and that a physician's standard of care does not require a prescribing physician like Reynolds to warn or advise patients of such a rare side effect. Reynolds does not give patients a copy of the PDR and is aware of no physician who does.
Reynolds had no specific conversations with Larkin concerning the potential side effects of Zithromax or Daypro on August 31, 1998. Larkin remembers no warnings accompanying Zithromax or Daypro in either the samples or filled prescriptions he received. Larkin asserts that he knew nothing of the risk of SJS or TEN before his illness. Reynolds testified that in his medical opinion, Daypro and/or Zithromax caused Larkin's SJS and TEN, although he cannot pinpoint which was the cause.
STANDARD
Summary Judgment is available under Fed.R.Civ.P. 56(c) if the moving party can establish that the "pleadings, depositions, answer to interrogatories, and admissions on file, together with the affidavits, if any, show that there is no genuine issue as to any material fact and that the moving party is entitled to a judgment as a matter of law." In determining whether summary judgment is appropriate, a court must resolve all ambiguities and draw all reasonable inferences against the moving party. See Matsushita Electrical Industrial Co. v. Zenith Radio Corp., 475 U.S. 574, 587, 106 S.Ct. 1348, 89 L.Ed.2d 538 (1986).
"[N]ot every issue of fact or conflicting inference presents a genuine issue of material fact." Street v. Bradford Co., 886 F.2d 1472, 1477 (6th Cir. 1989). The test is "whether the party bearing the burden of proof has presented a jury question as to each element in the case." Hartsel v. Keys, 87 F.3d 795, 799 (6th Cir. 1996). The plaintiff must present more than a mere scintilla of the evidence. To support his position, he must present evidence on which the trier of fact could find for the plaintiff. See id. (citing Anderson v. Liberty Lobby, 477 U.S. 242, 251-52, 106 S.Ct. 2505, 91 L.Ed.2d 202 (1986)).
DISCUSSION
Plaintiffs have brought product liability claims for strict liability, negligence, and breach of warranty. While Kentucky recognizes product liability claims under each theory, a common element of each is demonstration that a product was defective or unreasonably dangerous. Montgomery Elevator Co. v. McCullough, 676 S.w.2d 776, 780-82 (Ky. 1984). Accordingly, for the purposes of this motion for summary judgment, the primary question before the court is whether a question of fact exists as to whether either Zithromax or Dapro was defective or unreasonably dangerous. See Snawder v. Cohen, 749 F. Supp. 1473, 1476 (W.D.Ky. 1990).
Kentucky has adopted the Restatement (Second) of Torts. Zithromax and Daypro are the types of desirable but unavoidably unsafe products described by the Restatement (Second) of Torts, § 402A, comment k. The evidence demonstrates that Plaintiffs' claims are most appropriately considered in that context. Comment k provides:
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 for 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 . . . 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 comment k (1965) (emphasis in original).
"Under comment k, the crucial question raised by any unavoidably unsafe product is whether the manufacturer provided an adequate warning." Clark v. Danek Med., Inc., No. CIV.A. 3:94CV-634-H, 1999 WL 613316, at *4 (W.D.Ky. March 29, 1999). When accompanied by an adequate warning, a desirable but unsafe product is not unreasonably dangerous. Id. The parties here dispute whether the defendants provided an adequate warning.
A major point of argument among the parties is whether this Court should apply the "learned intermediary doctrine." Defendants argue that this Court should apply this doctrine. Plaintiffs argue that Kentucky does not and would not apply the learned intermediary doctrine. For the reasons that follow, this Court finds that Kentucky would apply the learned intermediary doctrine and grants summary judgment in favor of the defendants finding the application of this doctrine dispositive.
The learned intermediary doctrine has wide-acceptance in prescription drug cases. Lloyd C. Chatfield II, Medical Implant Litigation and Failure to Warn. A New Extension for the Learned Intermediary Rule?, 82 Ky.L.J. 575, 575 (1993). Kentucky courts have not yet applied the rule, and federal courts have not formally addressed this issue under Kentucky law. See Clark, No. CIV.A. 3:94CV-634-H, 1999 WL 613316, at *4 (concluding that Kentucky courts might apply the learned intermediary doctrine, but declining to so hold finding that the learned intermediary doctrine would not be dispositive because the medical company had failed to adequately warn the doctor of the disease at issue); Snawder v. Cohen, 749 F. Supp. 1473 (W.D.Ky. 1990) (declining to adopt the learned intermediary doctrine when its application would not be dispositive). This Court has stated in dicta, however, that "when a manufacturer provides medical equipment to a physician, it should be able to rely upon that physician to give the proper warnings and obtain proper informed consent." Clark, No. CIV.A. 3:94CV-634-H, 1999 WL 613316, at *4.
The reasoning of the learned intermediary doctrine is explained, supported and advocated by the Restatement (Third) of Torts § 6 (1998) (replacing Restatement (Second) of Torts § 420A). Although Kentucky courts have yet to adopt the Restatement (Third) of Torts, Kentucky courts have generally adopted the newer editions of the Restatement of Torts and this Court predicts it will do so here. James v. Meow Media, Inc., 90 F. Supp.2d 798, 811 (W.D.Ky. 2000). Given the wide acceptance of the learned intermediary doctrine and its place in the Restatement (Third) of Torts, this Court will apply this doctrine as Kentucky law.
Restatement (Third) of Torts § 6(b) provides in relevant part: "[A] prescription drug or medical device is defective if at the time of sale or other distribution the drug or medical device. . . . is not reasonably safe due to inadequate instructions or warnings as defined in Subsection (d)." Subsection (d) provides:
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 provided to:
(1) prescribing and other health-care providers who are in a position to reduce the risks of harm in accordance with the instructions or warnings; or
(2) the patient when the manufacturer knows or has reason to know that health-care providers will not be in a position to reduce the risks of harm in accordance with the instructions or warnings.
A prescription drug manufacturer has traditionally had a responsibility only to warn about the attendant risks of its drugs to health-care providers and not to patients. Restatement (Third) of Torts ("Restatment") § 6, cmt. b. The rationale behind this learned intermediary rule is that only health-care providers are in a position to understand the significance of the risks involved and to assess the relative advantages and disadvantages of a given form of medicine. Id. Through this rule, the duty to determine risks and notify the patient generally rests with his or her health-care provider. Id.
For a host of reasons courts have traditionally declined to impose liability on manufacturers of prescription drugs when adequate warning has been given to the treating physician. In part, this deference reflects concerns over the possible negative effects of judicially imposed liability on the cost and availability of needed drugs and medical technology. Id. This deference also rests on the presumptions that prescribing health-care providers, when adequately informed by drug manufacturers, can insure that the appropriate medication and treatment reaches the appropriate patients. Id.
"Failure to instruct or warn is the major basis of liability for manufacturers of prescription drugs and medical devices." Restatement § 6, cmt. d. When a manufacture adequately informs a prescribing health-care provider of the relevant risks and benefits associated with a prescription drug, that provider can reach appropriate decisions regarding which drug he or she should prescribe to a patient. Id. Sometimes a warning serves only to inform the health-care provider of an inherent and unavoidable risk. Id. While this information does not allow a provider to take precautions in administering the drug, it does allow the health-care provider, and through him the patient, to make an informed choice whether to utilize the medication. Id.
"Warnings and instructions with regard to drugs or medical devices that can be sold legally only pursuant to a prescription, are under the `learned intermediary' rule, directed to health-care providers." Restatement § 6, cmt. e. Subsection d(2) above recognizes that manufacturers may have a duty to notify patients directly in those situations where a prescription drug or device is administered without the personal intervention or evaluation of a health-care provider. Id. The administration of a vaccine in a clinic setting serves as an example. When manufacturers provide prescription drugs for distribution in this sort of unsupervised setting, a direct warning may be necessary. Id. That is not the case here.
Applying the Restatement § 6, this Court finds that both defendants are insulated from liability in this case by the learned intermediary doctrine. Plaintiffs meet no exceptions to the general rule. It is undisputed that Reynolds had been warned and knew of the risk of SJS and TEN associated with the use of both Daypro and Zithromax. By notifying Reynolds, the defendants satisfied their obligation to provide adequate warning.
The Court notes that this case presents a situation where any result seems unfair. Individuals across our country take medication on a daily basis to treat numerous ailments. These medications provide relief from both minor and life-threatening problems. At the same time, the nature of this medication is that it can never be safe for every user. Unlikely side effects accompany most medicines we as drug consumers take. While as users we rarely give a second-thought to these side effects, the reality is that when a medication causes a rare and serious side effect, the result is both frustrating and horrifying to the patient. Yet, from a public policy standpoint, our legal system has determined that so long as medical providers follow certain established precautions such as educating health-care providers, these calculated risks are acceptable given the tremendous benefits medicine can provide. As anyone who has had a family member's life saved or improved through medication knows, modern medicine can be truly astonishing. It is unfortunate that on a rare occasion it carries with it catastrophic results.
ORDER
Upon Defendants separate motions for summary judgment (Dkt.#s 22-23) and this Court being otherwise sufficiently advised,
This Court GRANTS Defendants' motions. this is final and appealable.