Walls v. Alpharma: is the learned intermediary doctrine the right cure for pharmacists in Alabama?

• Author: Doughty, Julie L.

INTRODUCTION

Imagine that you are a pharmacist. A male customer walks into your pharmacy to get his and his wife's prescriptions filled. You notice that the husband's prescription is classified as a pregnancy category C drug. (1) His wife's prescription is for a different drug, but treats the same condition--scabies. You fill the prescriptions, but do not warn the consumer about the risks associated with his prescription. Later, the doctor directs the customer's pregnant wife to take her husband's medication because her prescribed treatment was ineffective. Months later, you learn your pharmacy is being sued for not warning the wife that her husband's medication may be harmful to an unborn child. The wife now alleges that the medication caused her child's birth defects. This situation recently occurred in Alabama. (2) Many pharmacists are probably confused by this lawsuit and even more confused about what, if any, duty they have to warn consumers of potential risks of taking prescribed drugs.

This Note addresses Walls v. Alpharma, a recent case of first impression, which expanded the application of the learned intermediary doctrine (LID) to pharmacists. (3) Under the LID, a drug manufacturer is required to provide adequate warnings only to the prescribing physician. (4) In 1984, Alabama adopted the LID in order to shield drug manufacturers from liability for failure to warn consumers. (5) In Walls, the Alabama Supreme Court expanded the scope of the LID to shield pharmacists. (6) Walls is significant because, with this ruling, Alabama has joined other states in applying the LID to protect pharmacists. (7) According to Walls, this protection applies when a pharmacist fills a prescription that is "valid and regular on its face," and no relevant statute or regulation applies. (8)

The Walls decision limits pharmacists' liability to consumers, yet it also creates unclear exceptions. Pharmacists are simply not given clear guidelines on what, if any, duty they have to warn consumers. Part I of this Note briefly outlines the background of liability for failure to warn, the LID and its application to drug manufacturers and pharmacists, relevant Alabama case law, and pharmacy regulations. Part II examines the factual and procedural history of Walls and analyzes the court's opinion. Finally, part III examines the potential effects of current regulations and invalid prescriptions on future Alabama litigation and briefly discusses some advantages and disadvantages of imposing a duty on pharmacists to warn of potential drug risks.

LEGAL BACKGROUND

1. Failure to Warn

   Traditional tort law generally requires a manufacturer to provide adequate warnings when the manufacturer is aware or should be aware that the product might be dangerous when used in a reasonably foreseeable manner. (9) This duty to warn is set out in the Restatement (Second) of Torts, [section] 402A. (10)

   Some products, such as prescription drugs, are incapable of being made safe but benefit the public, and, thus, Comment k to [section] 402A grants an exception. (11) Some courts have interpreted Comment k as granting blanket immunity for strict liability to prescription drug manufacturers. (12) Alabama, along with a majority of other jurisdictions, has adopted a case-by-case approach instead of granting blanket immunity. (13)

   To establish a failure-to-warn claim under the Alabama Extended Manufacturer's Liability Doctrine, (AEMLD), the plaintiff must show that the defendant had a duty to warn the plaintiff of the product's danger when used in its intended manner, that the defendant's warning was inadequate thereby breaching that duty, and that this breach proximately caused the injuries. (14) Compliance with FDA regulations is not conclusive evidence of an adequate warning. (15)

2. The LID

   1. Application of the LID to Drug Manufacturers

      The Supreme Court of New York County in New York first developed the LID as an affirmative defense for "failure to warn" cases. (16) The Third Circuit Court of Appeals later modified the doctrine to require drug manufacturers to adequately warn the prescribing physician. (17) This doctrine provides that prescription drug manufacturers discharge their duty to warn patients by providing the warning to the prescribing physician. (18) Generally, when a drug manufacturer warns the prescribing physician of potential dangers, the manufacturer cannot be held liable to a consumer in a failure-to-warn case under AEMLD. (19)

      The rationale behind the LID includes the following four considerations: a court's reluctance to interfere with the doctor-patient relationship, physicians' superior position to convey the warning to their patients, the inability of drug manufacturers to communicate effectively with patients, and the complications of translating the risk information for lay patients. (20) A plaintiff who addresses this defense is required to prove that the drug manufacturer gave inadequate warnings to the prescribing physician and that these inadequate warnings proximately caused the plaintiff's injuries. (21)

      A majority of courts have applied the LID without any relevant exception. (22) Several jurisdictions, on the other hand, have recognized exceptions to this exception. At least two courts have held drug manufacturers liable when the patient played a substantial role in choosing the treatment. (23) At least one jurisdiction exempts oral contraceptives since the patient is more actively involved in the decision. (24) A final exception, mass immunizations, has been recognized when the patient does not have the benefit of a traditional physician-patient relationship. (25)

   2. Application of the LID to Pharmacists

      Several jurisdictions have extended the LID to lawsuits against pharmacists. (26) At least one court has rejected the LID as a defense for pharmacists. (27) Several jurisdictions recognize that a duty may still exist when the pharmacist is aware of contraindications or side effects. (28) Other courts have ruled that pharmacists may have a duty to warn the doctor or the patient when clear errors appear in a prescription. (29) Finally, others have recognized that pharmacists may voluntarily assume a duty. (30)

3. Alabama Cases

   The Alabama Supreme Court adopted the LID in Stone v. Smith, Kline & French Laboratories. (31) In that case, a psychiatric patient was placed on Thorazine and later diagnosed with "Thorazine-induced hepatitis." (32) The lower court certified the following question, among others, to the Alabama Supreme Court: "If the adequacy of the warning determines whether an unavoidably unsafe prescription drug is unreasonably dangerous, is an adequate warning to the prescribing physician, but not to the ultimate consumer, sufficient as a matter of law?" (33) The Alabama Supreme Court answered this question in the affirmative, stating that the manufacturer's duty is limited to advising the prescribing physician of potential risks. (34) The Alabama Supreme Court held that the plaintiffs claim, failure to warn, was insufficient since the manufacturer fulfilled its duty by warning the doctor. (35)

   The LID was recognized again in Stafford v. Nipp, which involved a patient whose prolonged use of birth control preceded the patient's stroke. (36) The patient sued the physician for malpractice and the pharmacist for breach of warranty. (37) The trial court relied on the LID in granting summary judgment on behalf of the pharmacist. (38) The Alabama Supreme Court held that a fact question existed as to whether the pharmacist dispensed the medication without a prescription. (39)

   In Toole v. McClintock, the U.S. Court of Appeals expanded the LID to include medical devices. (40) The patient in Toole argued that the manufacturer failed to adequately warn her physician of the risks of implant ruptures during breast implant surgery. (41) The patient suffered from oral ulcers, hair loss, fatigue, and pain. (42) The defendant manufacturer argued that jury instructions characterized relevant law, stating that the manufacturer's duty to warn depended on the patient's knowledge instead of on the physician's knowledge. (43) The court noted that the LID had been adopted by the Alabama Supreme Court and emphasized the policy behind its application. (44) The court held that the jury instructions correctly stated the issues and law since the plaintiff's claim involved warnings to her physicians.(45)

   Finally, in Morguson v. 3M Company, the Alabama Supreme Court briefly addressed the LID in relation to products liability4 actions brought against manufacturers of a heart-lung machine. (46) One of the plaintiffs claims was that warnings given by the manufacturer of the vent tubing to the physicians were inadequate. (47) That court noted that the LID only requires that warnings be provided to the physicians and not to the patient and that the manufacturer's warnings were adequate. (48)

4. Pharmacy Regulations

   The Omnibus Budget Reconciliation Act of 1990 (OBRA 90) required that all states enact regulations requiring pharmacists to screen for potential problems such as duplication, contraindications, interactions, wrong dosages, and drug abuse or misuse. (49) These state regulations should also require pharmacists to offer counsel to patients on matters they deem significant, which could include common severe side effects, interactions, and contraindications. (50) The pharmacist must make a reasonable effort to maintain a patient database that includes known allergies, drug reactions, and a list of medications. (51) The purpose of these state regulations should be to: "educate physicians and pharmacists to identify and reduce the frequency of patterns of fraud, abuse, gross overuse ... as well as ... adverse reactions to drugs...." (52)

   Alabama codified OBRA 90 in 1991. (53) Alabama's version emphasizes the pharmacist's role in counseling patients: "Pharmacists, because of their strategic position in the health care system, have...