Hahn v. Richter , 427 Pa. Super. 130 ( 1993 )

DEL SOLE, Judge,

dissenting.

Today the Majority has taken a giant step backward by reintroducing negligence principles in a product liability case. By holding that proof of negligence is necessary to recover from a prescription drug manufacturer, this court has, in essence, abolished strict liability as a theory of recovery available to those injured as the result of the consumption of an unreasonably dangerous product sold by a drug manufacturer in a defective condition. In arriving at this result, the Majority ignores almost thirty years of products liability jurisprudence in this Commonwealth, gives no reason for such a policy change, and fails to analyze how its decision would effect persons who have been injured by prescription drugs such as Thalidomide and DES. The Majority reaches its unprecedented decision by misapplying Comment k of the Restatement of Torts (Second) Section 402A to the facts of this case, and by misreading the comment itself and those eases which have in the past made reference to it.¹

Section 402A generally directs that “special” strict liability will be imposed on sellers of a product in instances where a consumer is harmed by the product which is sold “in a defective condition unreasonably dangerous” to the consumer. Comment j which follows Section 402, notes that some products which might otherwise be considered “unreasonably dangerous” can be prevented from being so, if proper directions or warnings are issued. In such a case, the properly labeled product will not be “defective,” nor unreasonably dangerous, and thus, the seller cannot be held strictly liable.

Comment k, which the Majority views as speaking to all prescription drug cases, is actually directed to all cases in which the product itself will always be unavoidably unsafe because it simply cannot be made safe for ordinary use. The comment advises that such products “are especially common in the field of drugs,” but nowhere does it read that all prescription drugs can be characterized as unavoidably unsafe.

Comment k describes two types of products which it views as incapable of being made safe with the scientific knowledge presently held. The first example presented is the vaccine for the Pasteur treatment of rabies. The Comment notes that the use of the product involves a very high degree of risk, but its use is justified since the disease itself leads to death. The Comment states that “[s]uch a product properly prepared, and accompanied by proper directions and warning is not defective, nor is it unreasonably dangerous.” Thus, where a consumer is advised of the danger of taking a drug such as the rabies vaccine which is known to be dangerous but has great utility since it is used to avoid certain death, the seller will not be held strictly liable for harm caused by the disclosed unavoidable risk because the risk was disclosed and the product can no longer be considered “defective” or “unreasonably dangerous”. Conversely, where an unavoidably unsafe product is not accompanied by a warning of its danger, the user will be uninformed, and the product will be considered defective and unreasonably dangerous exposing the seller to a strict liability claim.

Experimental drugs are given as the second example of an unavoidably unsafe product. Comment k recognized that with these drugs there is justification for their distribution, despite the fact that very often there can be no assurances of safety. The comment notes that strict liability should not apply to the seller of such products “with the qualification that they are properly prepared and marketed, and proper warning is given.”

In a situation where a new drug to combat the AIDS virus is created, this example would apply. Although such a drug may not be thoroughly tested at the time of distribution, and adverse side effects of its use may not yet be discovered, the need for it is great because of the deadly nature of the disease which it fights. Comment k instructs that the seller will not be strictly liable if a patient is harmed by the drug, provided it was properly prepared and the user has been warned of the drug’s experimental nature and the lack of knowledge of future side effects. A seller’s failure to abide by these duties owed to a user makes the drug defective even if experimental. Thus, its use is unreasonably dangerous and the seller would be strictly liable in the event of injury.

The protections offered by Comment k provide a haven for developers of new drugs which have great potential benefit, and protection to those marketing existing drugs that have a risk that cannot be eliminated. By advising the user of an experimental drug of its known risks, or that the risks are yet unknown, the seller has done all that can be expected and will not be held strictly liable for harm caused by the use of the product. Also, while there are commercial products that will remain “unavoidably unsafe,” they will not be deemed to be “defective” if the user of the product is properly warned. However, where a seller fails to disclose unavoidably known risks or the experimental nature of the product, Section 402A applies and the seller will remain strictly liable for harm caused by that risk. Just as the seller in Comment j will not be held strictly liable if proper warnings accompany a product, the seller of an unavoidably unsafe product will avoid strict liability if proper warnings of the product’s condition are given to the consumer. The absence of these warnings make the product “defective” and “unreasonably dangerous” and will cause the manufacture to be held strictly liable.

The Majority wrongly concludes that a manufacturer of a prescription drug cannot be strictly liable under 402A, and in support of its ruling relies upon language found in past cases. It begins with reference to our Supreme Court’s decision in Incollingo v. Ewing, 444 Pa. 263, 282 A.2d 206 (1971). The Majority interprets footnote nine in Incollingo v. Ewing, supra, as the basis for its statement “that the strict liability rule of Restatement 402(A) is not applicable in a case involving a prescription drug and that the standard of care required for a manufacturer of prescription drugs is set forth in § 388 of the Restatement (Second) which concerns the liability of a supplier of a chattel known to be dangerous for its intended use.” Majority Opinion at 865. The Majority, however, neglects to add that strict liability was not pled in Incollingo, rather the Supreme Court stated repeatedly throughout the opinion that that complaint against the drug manufacturer claimed that it “negligently and carelessly manufacture^] the said drug” Id. at 285, 282 A.2d at 218, and that the manufacturer of the drug “negligently failed to warn ... of the dangerous effects of the drug, failed to perform proper tests on the drug, and failed to take necessary precautions to avert the injuries complained of.” Id. at 269, 282 A.2d at 211. The Incollingo court’s notation in footnote nine advising that the strict liability rule of § 402A was not applicable to its decision, was necessary because the case was pled as a negligence case and recovery based upon strict liability was not sought.²

In Baldino v. Castagna, 505 Pa. 239, 478 A.2d 807 (1984), a like claim was made. In fact, the court stated that the “theory of liability against [the drug manufacturer] was primarily based on th[e] ... decision in Incollingo v. Ewing.” Id. 505 Pa. at 244, 478 A.2d at 810, citing Incollingo, supra. In both of these cases, the Supreme Court employed a negligence standard because the parties claimed a negligence failure to warn when adequate printed warnings provided by the manufacturer were nullified by the promotional claims made by the manufacturer’s salespersons. The cases apply a negligence standard because the plaintiffs’ complaints sought damages for negligent acts and not because a negligence standard overlaps, with or is equivalent to, a strict liability standard in a failure to warn case.

As further support for its position that Section 402A does not apply to prescription drug cases, the Majority cites Coyle v. Richardson-Merrell, Inc., 526 Pa. 208, 584 A.2d 1383 (1991). Nowhere in that opinion does the Supreme Court adopt the position suggested by the Majority. Actually, the case supports the application of strict seller liability for defective prescription drugs. It holds that the extent and adequacy of warnings sufficient to avoid Section 402A liability are measured by what information a prescribing physician needs. It further held that the purposes of 402A liability would not be served by extending sellers liability, under the circumstances there presented, to pharmacists. However, the Court did not eliminate 402A liability for manufactures of prescription drugs.

The cases relied on by the Majority do not differ with Comment k’s instruction that strict liability will not apply to an unavoidable unsafe product, assuming that there is proper preparation and warning. But it is the absence of proper warnings, not the failure to exercise reasonable care in providing such warnings, which causes the product to be defective and unreasonably dangerous, and therefore causes its seller to be strictly liable for harm caused by its use. Comment k teaches us that even those products which are unavoidably unsafe can be sold without subjecting its seller to strict liability if the product is accompanied by adequate warnings of its danger or its experimental nature. What is to be considered is whether the product was supplied with adequate warnings; negligence theories have no place in such an analysis. See Dambacher by Dambacher v. Mallis, 336 Pa.Super. 22, 485 A.2d 408 (1984).

In the instant case Appellant alleged and attempted to prove at trial, that the drug, Depo-Medrol, was defective when sold because it lacked adequate warning to the prescribing physician. It was never determined whether Depo-Medrol was a new or experimental drug, and the record does not disclose that proof of such was ever even offered. Because, in my view Comment k does not come into play in this case where the product is not shown to be “unavoidably unsafe” a requested instruction should have been given by the court. The jury should be advised:

A product otherwise properly made is defective if the supplier does not adequately warn of the dangers of the product. If you find that when the product left the supplier’s control, it lacked the warnings necessary to make it safe for its intended use, then the product was defective, and the supplier is liable for all harm caused by the defect.

Dambacher by Dambacher v. Mallis, supra, at 63, 485 A.2d at 429-30.

However, even if evidence was offered at trial to show that the prescription drug at issue was “unavoidably unsafe” as described in Comment k, such a determination should be for a jury to make and use when assessing the adequacy of the warnings provided. If a jury determined that a drug is experimental or that it is known to be unsafe but of great utility, the jury would then have to determine if such facts accompanied the product. Absence the inclusion of these warnings, strict liability would apply.

In either instance, application of negligence principles have no place in a Section 402A strict liability case.

For these reasons I dissent and would grant a new trial in which the jury would be charged on the principles of strict liability for failure to warn of the dangers of the prescription drug, Depo-Medrol.

McEWEN, J., joined DEL SOLE’S, J., dissenting opinion. FORD ELLIOTT, J., joined DEL SOLE’S, J., dissenting opinion.

1 . In his concurring Opinion, Judge Cavanaugh advances two policy considerations for his view that prescription drug manufacturers should not be burdened by compensating persons injured as a result of their defective products.

First, he suggests that while prescription drugs are inherently dangerous their beneficial effect to society as a whole outweighs the fact that they may harm particular individuals. Stated another way, he concludes that a person injured by a defective drug should not be compensated for the injury, but can take solace in the fact that, in general, drugs help society. I disagree. People injured by a defective product should be entitled to seek recovery from its manufacture whether it be drugs, food, autos, or any item placed in the stream of commerce. Since the seller is able to spread the loss over the entire product line, it is paid for by the society that benefits from the product. The drug industry is sufficiently protected since we have required that warnings of a drugs effects need only be provided to physicians and not the general public.

Second, Judge Cavanaugh suggests that FDA approval is sufficient to safeguard the public. I agree that the FDA goes a long way to eliminate risks associated with prescription drugs. However, there are at least two reasons for not exempting products subject to FDA preapproval from § 402A liability. First, Congress did not preempt the tort law of the states when creating the FDA. Second, much of the data relied on by the FDA is generated by the manufacturers. It is not independently produced. A continuing risk of liability will serve to enhance the proper development and description of drugs offered for commercial sale.

2 . The repeated reference by the Supreme Court to negligence being the basis of the claim in Incollingo, is readily explained by observing that the lawsuit was filed in 1961, five years before the adoption of Section 402A in Webb v. Zern, 422 Pa. 424, 220 A.2d 853 (1966). At the time suit was filed, negligence was the only available basis for recovery.