Thursday, September 26, 2013
I write today to supplement Crane-Station’s excellent article yesterday, SCOTUS Shields Generic Drug Manufacturers From Liability.
The conservative majority of the Supreme Court of the United States (SCOTUS) recently denied a remedy to Karen Bartlett, a woman horrifically disfigured by the generic drug Sulindac by using a hackneyed interpretation of the Supremacy Clause, the doctrine of preemption from which it flows, and the Food and Drug Administration Act that was passed by Congress to provide protection to consumers, in addition to common law remedies, from injuries caused by drug manufacturers.
Time to take a quick tour of the legal doctrine of strict liability, which was the basis for liability imposed on Mutual Pharmaceutical Co., the manufacturer of Sulindac, the generic drug for Clinoril, in the Karen Bartlett case that Crane wrote about yesterday.
The origin of the idea for imposing strict liability (i.e., without the necessity of proving fault) on the manufacturer of a defective product that causes injury to a person can be traced back to Justice Roger Traynor’s concurring opinion in Escola v. Coca-Cola Bottling Co., 24 Cal.2d 453, 150 P.2d 436 (1944). He said,
Even if there is no negligence, however, public policy demands that responsibility be fixed wherever it will most effectively reduce the hazards to life and health inherent in defective products that reach the market. It is evident that the manufacturer can anticipate some hazards and guard against the recurrence of others, as the public cannot. Those who suffer injury from defective products are unprepared to meet its consequences. The cost of an injury and the loss of time or health may be an overwhelming misfortune to the person injured, and a needless one, for the risk of injury can be insured by the manufacturer and distributed among the public as a cost of doing business. It is to the public interest to discourage the marketing of products having defects that are a menace to the public. If such products nevertheless find their way into the market it is to the public interest to place the responsibility for whatever injury they may cause upon the manufacturer, who, even if he is not negligent in the manufacture of the product, is responsible for its reaching the market. However intermittently such injuries may occur and however haphazardly they may strike, the risk of their occurrence is a constant risk and a general one. Against such a risk there should be general and constant protection and the manufacturer is best situated to afford such protection.
The plaintiff in Escola was employed as a waitress in a restaurant when she was injured by an exploding bottle of Coca Cola that she was putting away. The exploding glass bottle severed the blood vessels, nerves, and muscles of the thumb and palm of her hand.
In an opinion written by Justice Traynor, a majority of the California Supreme Court formally adopted the doctrine of strict liability in tort in Greenman v. Yuba Power Products, Inc., 59 Cal. 2d 57 (1963). In this case,
Plaintiff brought this action for damages against the retailer and the manufacturer of a Shopsmith, a combination power tool that could be used as a saw, drill, and wood lathe. He saw a Shopsmith demonstrated by the retailer and studied a brochure prepared by the manufacturer. He decided he wanted a Shopsmith for his home workshop, and his wife bought and gave him one for Christmas in 1955. In 1957 he bought the necessary attachments to use the Shopsmith as a lathe for turning a large piece of wood he wished to make into a chalice. After he had worked on the piece of wood several times without difficulty, it suddenly flew out of the machine and struck him on the forehead, inflicting serious injuries.
Explaining the rationale for imposing liability on the manufacturer of Shopsmith, Justice Traynor reached back to his concurring opinion in Escola and said at page 64,
The purpose of such liability is to insure that the costs of injuries resulting from defective products are borne by the manufacturers that put such products on the market rather than by the injured persons who are powerless to protect themselves. Sales warranties serve this purpose fitfully at best. (See Prosser, Strict Liability to the Consumer, 69 Yale L.J. 1099, 1124-1134.) In the present case, for example, plaintiff was able to plead and prove an express warranty only because he read and relied on the representations of the Shopsmith’s ruggedness contained in the manufacturer’s brochure. Implicit in the machine’s presence on the market, however, was a representation that it would safely do the jobs for which it was built. Under these circumstances, it should not be controlling whether plaintiff selected the machine because of the statements in the brochure, or because of the machine’s own appearance of excellence that belied the defect lurking beneath the surface, or because he merely assumed that it would safely do the jobs it was built to do. It should not be controlling whether the details of the sales from manufacturer to retailer and from retailer to plaintiff’s wife were such that one or more of the implied warranties of the sales act arose. (Civ. Code, 1735.) “The remedies of injured consumers ought not to be made to depend upon the intricacies of the law of sales.” (Ketterer v. Armour & Co., 200 F. 322, 323; Klein v. Duchess Sandwich Co., Ltd., 14 Cal.2d 272, 282 [93 P.2d 799].) To establish the manufacturer’s liability it was sufficient that plaintiff proved that he was injured while using the Shopsmith in a way it was intended to be used as a result of a defect in design and manufacture of which plaintiff was not aware that made the Shopsmith unsafe for its intended use.
Ironically relying on a hackneyed interpretation of the Supremacy Clause of the U.S. Constitution and the doctrine of preemption that activists for state’s rights fiercely decry, Justice Alito and the four concurring conservative justices (Roberts, Scalia, Thomas and Kennedy) of the United States Supreme Court in Mutual Pharmaceutical v. Bartlett, basically ignored the merits of Justice Traynor’s sound reasoning and told Karen Bartlett to go pound sand despite her devastating injuries and a $21 million verdict against Mutual Pharmaceutical.
Despite congressional intent to provide protection to consumers, in addition to common law remedies, when Congress passed the Food and Drug Administration Act, the SCOTUS held that common law remedies were preempted by the Act thereby denying injured consumers like Karen Bartlett a remedy.
In a word, the decision is shameful.
Congress can fix the problem by amending the statute, but there is little chance that will happen with this deadlocked and useless Congress.
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Fred and Crane