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Young v. Key Pharmaceuticals Inc.

September 12, 1996


Appeal from Superior Court, King (86-2-10641-3) County; Honorable Charles W. Mertel, Judge.

Guy, J. WE Concur: Durham, C.j., Dolliver, J., Smith, J. Madsen, J. (dissenting). Johnson, Alexander, Sanders, J.j., concur with Dissent.

The opinion of the court was delivered by: Guy


GUY, J. -- This is a products liability action against the manufacturer of a prescription drug (theophylline) which is used to alleviate symptoms of asthma. In 1979, Plaintiff suffered permanent brain damage as a result of seizures allegedly caused by toxic levels of theophylline in his bloodstream. Plaintiff claims his injuries resulted from the manufacturer's failure to provide adequate information and warnings to prescribing physicians about the effect of viral illnesses on the body's ability to metabolize the drug. Plaintiff appeals the trial court's summary dismissal of his strict liability claim. The manufacturer appeals the Court of Appeals' reversal of a jury verdict in its favor on Plaintiff's negligence claim. The Court of Appeals held that the trial court committed reversible error when it excluded an exhibit offered by Plaintiff and when it refused to give two of Plaintiff's proposed jury instructions. We affirm the trial court in all respects.


Plaintiff Devan Young *fn1 will be 21 years old on May 19, 1996. The injuries complained of in this lawsuit occurred more than 17 years ago, on the morning of February 1, 1979, when Devan was three years old.

Prior to that date, Devan Young had had a history of severe asthma, a respiratory disease. He had been hospitalized four times and had been seen at the emergency room more than 80 times. The severity of his asthmatic condition posed a significant threat to his life.

In order to alleviate the symptoms of his asthma, doctors prescribed theophylline for Devan. Theophylline is an effective bronchodilator that has been used to treat the symptoms of asthma for many years. Theo-Dur, manufactured by Defendant Key Pharmaceuticals, Inc., is theophylline in a sustained-release preparation. Theo-Dur is designed to slowly release theophylline into the blood stream over a 12-hour period so as to be effective 24 hours a day when taken twice a day. Theo-Dur was the drug prescribed for Devan Young.

In the late 1970s, theophylline's use in asthmatic children was known to pose a risk primarily for two reasons. The first was that theophylline has a "narrow therapeutic range," in that serum concentrations have to be between 10 and 20 micrograms per milliliter (mcg/ml) to be effective. Below that level the drug is ineffective; above that level there is a risk of adverse reactions, including the risk of seizures. The second was that children metabolize and eliminate theophylline rapidly. In order to maintain the therapeutic level in children, doctors had to prescribe dosages and schedules that often were difficult to maintain, and children tended to suffer from "peaks and valleys" in theophylline treatment because their serum levels would drop below the therapeutic range before they received their next scheduled dosage. Theo-Dur was designed to reduce the "peaks and valleys" experienced by children, thus increasing the effectiveness of theophylline as a treatment for asthmatic children.

Devan Young's physician prescribed Theo-Dur beginning in September 1978. His blood was tested on January 26, 1979, and the theophylline level was within the therapeutic range. At that time, doctors believed they could safely rely on the results of blood tests showing the theophylline level for six months.

On January 31, 1979, Devan Young's mother brought him to the allergy medical clinic at Children's Orthopedic Hospital for his regularly scheduled allergy shot. The shot was not given because the clinic nurse thought the child looked sick that day. Devan was then seen by his doctor at the clinic. There was no notation in the doctor's records that the child had either a viral illness or a fever. He had a "barking cough" that was attributed to his asthmatic condition.

In the early morning hours of February 1, 1979, Devan began to have seizures and was rushed to the hospital. He had been experiencing flu symptoms the previous evening and had a fever when he was admitted to the hospital. His seizure persisted and doctors speculated at that time that the seizure was fever-induced. Later that day doctors drew blood from Devan and discovered that his serum theophylline level had reached 68 mcg/ml. The viral illness and fever from which Devan suffered on that day purportedly caused the theophylline elimination in his system to slow. The theophylline levels thus became elevated to a point of toxicity, causing seizure. *fn2

The seizures suffered by Devan Young on the morning of February 1, 1979, caused permanent and severe brain damage.

Plaintiff Young, through his guardian ad litem E. Rosa Young, brought suit against the hospital, the treating physicians and Key Pharmaceuticals. Plaintiff claimed Key was liable under both strict liability and negligence theories. The hospital and physicians were dismissed on summary judgment, and that dismissal was upheld by this court in Young v. Key Pharmaceuticals, Inc., 112 Wash. 2d 216, 770 P.2d 182 (1989). The case was remanded for trial against Key Pharmaceuticals, the only remaining defendant.

In July 1991, Key's motion for summary judgment of dismissal on the strict liability claim was granted. The case then proceeded to trial on the negligence theory. The evidence at trial showed that Key Pharmaceuticals was aware of reports, studies and articles prior to February 1, 1979, which suggested that prolonged fever and certain viral illnesses, including flu, might impair the body's ability to eliminate theophylline and that the relationship between the drug and viral illness or fever could result in the accumulation of toxic levels of theophylline in the body, even when administered in normal doses. By the time of trial there was no dispute as to the validity of these studies. The question at trial was whether Key should have warned prescribing physicians of this "possible" risk based on the information it had available to it prior to February 1, 1979. Plaintiff argued that Key knew or should have known of the dangers the drug presented and should have warned doctors of the risks involved in prescribing the drug. Key defended against the claim that it failed to adequately warn against the dangers involved in using the drug by arguing that, in late 1978 and early 1979, the state of knowledge about the relationship between fevers or viral illnesses and theophylline was not yet clinically reliable and that it would have been irresponsible for the drug company to warn of risks that were not yet proven to be legitimate risks. At the end of a five-week trial, the jury returned a defense verdict, finding that Key was not negligent.

Plaintiff appealed. The Court of Appeals, in an unpublished opinion, affirmed the trial court's dismissal of the strict liability claim. It then reversed on the negligence claim, holding the trial court erred in excluding exhibit 19, an advertisement for another theophylline medication, and that it erred in refusing to give two of Plaintiff's proposed jury instructions relating to the duty to warn. Key Pharmaceuticals petitioned for review of the Court of Appeals' ruling on the evidentiary and jury instruction issues, and Plaintiff Young petitioned for review of the strict liability issue. We granted review on these issues. *fn3


1. Did the trial court err in dismissing Plaintiff's strict liability claim?

2. Did the trial court err in excluding a post-injury advertisement for a substantially identical theophylline drug, manufactured by a different drug company, which indicated that there may be a potential danger to theophylline users who have high fevers or certain viral illnesses?

3. Did the trial court's instruction to the jury on duty to warn misstate the law or prevent the parties from arguing their theories of the case?


Strict Liability

The Court of Appeals affirmed the trial court's summary dismissal of Plaintiff Young's strict liability claims in an unpublished opinion authored by Judge Agid. The Court of Appeals' opinion on this issue is succinct, well reasoned and carefully stated. Because we cannot improve upon it, we set it forth in full below and adopt it as our own.

The trial court dismissed Young's strict liability claim, ruling that the question whether Key had failed to provide adequate warning to physicians about Theo-Dur is governed by a negligence standard under the Restatement (Second) of Torts sec. 402A, comment k (1965).

Washington has adopted the strict liability formulation of the Restatement (Second) of Torts sec. 402A (1965) in a series of cases beginning with Ulmer v. Ford Motor Co., 75 Wash. 2d 522, 531-32, 452 P.2d 729 (1969). Comment k to section 402A adopted into Washington law in Terhune v. A. H. Robins Co., 90 Wash. 2d 9, 12-13, 577 P.2d 975 (1978), provides an exception to the strict liability doctrine under the following conditions:

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 recognizable 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.

In Terhune, the court applied comment k to the Dalkon Shield, holding that while a manufacturer has a duty to warn about unavoidably unsafe products, where the product can be sold only under prescription, the duty to warn runs only to the physician, not to the ultimate consumer. 90 Wash. 2d at 13, 17.

In Rogers v. Miles Laboratories, Inc., 116 Wash. 2d 195, 802 P.2d 1346 (1991), the court considered the question whether comment k should apply to shield a manufacturer from strict liability when it fails to adequately warn of the dangers of its product. Adopting the reasoning of the California Supreme Court in Brown v. Superior Court, 44 Cal. 3d 1049, 1059, 751 P.2d 470, 245 Cal. Rptr. 412 (1988), the Rogers court held that, when a manufacturer of an unavoidably unsafe product fails to adequately warn of its inherent dangers, comment k imposes liability only for negligence, not strict liability. 116 Wash. 2d at 207. The Rogers court reasoned:

As the California Supreme Court recently noted:

there is a general consensus that, although [comment k]

purports to explain the strict liability doctrine, in fact the principle it states is based on negligence. That is, comment k would impose liability on a drug manufacturer only if it failed to warn of a defect of which it either knew or should have known. This concept focuses not on a deficiency in the product--the hallmark of strict liability--but on the fault of the producer in failing to warn of dangers inherent in the use of its product that were either known or knowable--an idea which "rings of negligence[]" . . . .

(Footnote and citations omitted.) Brown, 44 Cal. 3d at 1059. We agree with this analysis. If the manufacturer of an unavoidably unsafe product fails to provide an adequate warning, it has been negligent--but it is liable in negligence and not in strict liability.

116 Wash. 2d at 207. The Rogers court thus rejected the argument that, where a manufacturer has not met its duty to warn, it would be strictly liable. 116 Wash. 2d at 207. As the Brown court explained in more detail:

The test stated in comment k is to be distinguished from strict liability for failure to warn. Although both concepts identify failure to warn as the basis of liability, comment k imposes liability only if the manufacturer knew or should have known of the defect at the time the product was sold or distributed. Under strict liability, the reason why the warning was not issued is irrelevant, and the manufacturer is liable even if it neither knew or could have known of the defect about which the warning was required. Thus, comment k, by focussing on the blameworthiness of the manufacturer, sets forth a test which sounds in negligence, while imposition of liability for failure to warn without regard to the reason for such failure is consistent with strict liability since it asks only whether the product that caused injury contained a defect. (See Little v. PPG Industries, Inc. (1978), 19 Wash. App. 812, 579 P.2d 940, 946.)

Brown, 751 P.2d at 476 n.4. The Rogers court explained the policy concerns underlying comment k as follows:

Comment k justifies an exception from strict liability by focusing on the product and its relative value to society, rather than on the manufacturer's position in the stream of commerce.

Some products are necessary regardless of the risks involved to the user. The alternative would be that a product, essential to sustain the life of some individuals, would not be available--thus resulting in a greater harm to ...

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