Source: https://diethylstilbestrol.co.uk/the-des-manufacturer-identification-problem-a-florida-public-policy-approach/
Timestamp: 2019-04-21 09:09:09+00:00

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Terri Lynn Conley suffered from cervical adenosis. She underwent surgery for removal of most of her cervix, as well as removal of other precancerous and cancerous tumors. Conley’s mother ingested the drug diethylstilbestrol (DES) twenty years before while Conley was present in utero. Doctors commonly prescribed DES as a miscarriage preventative around the time period that Conley’s mother was pregnant, but subsequent research linked in utero exposure to DES to the kind of cancer that Conley developed.
The trial court granted motions to dismiss and judgments on the pleadings for the defendants because of Conley’s inability to identify the specific manufacturer. On appeal, the Fourth District Court of Appeal affirmed, held: failure to allege legal causation by identifying the specific tortfeasors precludes recovery. The district court recognized, however, the compelling argument in favor of relaxing the identification requirement in DES-like situations, and considered various theories fashioned by courts of other jurisdictions. The court proposed its own theory of liability for adoption in Florida, and urged its serious consideration by the supreme court. The court concluded, however, that it lacked authority to approve a new theory of liability before the Supreme Court of Florida had done so. It certified the following question to the supreme court as an issue of great public concern: “Does Florida recognize a cause of action against a defendant for marketing defective DES when the plaintiff admittedly cannot establish that a particular defendant was responsible for the injury?” Conley v. Boyle Drug Co.
and two major policies for the imposition of liability on manufacturers of defective products in products liability cases.
These policy considerations will have a major effect on a DES case. Various courts have recognized them as appropriate guideposts when trying to accommodate the “competing demands for change and stability. The Supreme Court of Florida must consider these policy considerations in the DES context because it presents the court with a factual circumstance that strains the current boundaries of accepted tort doctrine. Because these general tort law and products liability policies are the reasons behind the doctrines that courts accept now, it necessarily follows that the court must use them to guide its analysis of this DES products liability case. Application of these policies may lead to recovery for a DES plaintiff.
Unfortunately, courts often face factual circumstances where justice and equity compel the resolution of a dispute in favor of one party, but established tort law doctrines are inadequate to effect such a resolution. These situations are products of an ever-changing society; therefore, the court must use policy considerations when deciding whether or not to create a new doctrine of liability, or to modify an existing one, in order to meet the needs of a changing society.
In our contemporary complex industrialized society, advances in science and technology create fungible goods which may harm consumers and which cannot be traced to any specific producer. The response of the courts can be either to adhere rigidly to prior doctrine, denying recovery to those injured by such products, or to fashion remedies to meet these changing needs. Just as Justice Traynor… in Escola v. Coca Cola Bottling Co …. recognized that in an era of mass production and complex marketing methods the traditional standard of negligence was insufficient to govern the obligations of manufacturer to consumer, so should we acknowledge that some adaptation of the rules of causation and liability may be appropriate in these recurring circumstances.
The court’s willingness to adapt the law to new circumstances is indicative of a judicial philosophy that sees the law as a servant of society, not as its master. Law remains useful only so long as it undergoes a metamorphosis that parallels that of society. “Any legal system, to remain viable over a span of time, must have the flexibility to admit change.” The Sindell court used policy considerations to reach its result. Although many may disagree with the method chosen by the Sindell court to resolve the defendant-identification issue, the importance of Sindell is that a court, to responsibly fulfill its obligations, must see the scope of its role in society as encompassing the power to modify existing legal doctrines to meet the needs of the society it serves.
When fashioning a new remedy, or modifying an existing one to meet the needs of society, a court will look to general policies to guide it in its task. One such policy courts recognize is that the purpose of tort law is to compensate an injured plaintiff for wrongs others commit.
It found that their application would be appropriate in the DES context because Michigan courts already had adopted the policies underlying these theories. One of the underlying policy reasons the court identified was that the purpose of tort law is to compensate injured persons.
In its analysis, the Abel court referred to Holloway v. General Motors Corp. , in which the question arose whether the plaintiff had the burden of proving the specific cause of a defect when alternative causes were possible. In Holloway, a woman was injured and her father killed when the vehicle in which they were riding left the road and struck a utility pole. The plaintiffs alleged that a defective ball joint assembly broke, causing the driver to lose control of the car. This all occurred while the plaintiffs drove the car across chuckholes in the road. The court, in response to a policy argument advanced by General Motors, stated that “it is the injury inflicted on the plaintiff that entitles him to a remedy, not his skill in discovering precisely where defendant’s manufacturing process went wrong.” The court held that as long as the plaintiffs presented evidence from which a jury could reasonably infer that some defect in the manufacturing process caused the accident, their burden of proof had been met even though they were unable to isolate the specific cause. The court also noted that an alternative liability situation presented a “somewhat analogous situation” in which the “rule is that a plaintiff need not prove which person among alternative negligent tortfeasors caused his injury.” The implication of this discussion by the court is that in order to give meaning to the policy that tort law should compensate injured plaintiffs, it is reasonable to shift burdens of proof in unusual factual circumstances where failure to do so would preclude recovery. If there is a proof problem that is difficult to resolve, the law should stand ready to compensate the injured plaintiff unless the defendant can exonerate himself.
The Holloway decision was an easy one because the question on rehearing was premised on the fact that some defect in the defendant’s product caused the accident. The only issue in that case was whether the plaintiff must prove which one. The Abel case presented a more difficult question because the problem involved proving which defendant manufactured the DES that harmed the plaintiffs. The Abel court recognized that the proof problem in this DES case was “substantially and significantly distinguishable” from the classic alternative liability case. The court also recognized that the same policy consideration which compels it to use this theory in the classic case also compels it to adapt the theory to variations of the original fact pattern, such as the DES cases, which present similar, but not identical, problems of proof.
The law should show a preference for an innocent plaintiff over a possibly culpable defendant. The policy presented by this statement is a corollary of the policy that tort law should compensate the injured plaintiff. These two policies are entirely intertwined. If the purpose of tort law is to compensate the injured plaintiff, then the effect is a legal preference for an innocent plaintiff over a possibly culpable defendant in an appropriate circumstance. Likewise, if the law shows a preference for innocent plaintiffs, then the end result will be a judicial tendency to compensate injured plaintiffs rather than to deny recovery. Each policy seems to be the natural consequence of the other.
When we consider the relative position of the parties and the results that would flow if the plaintiff was required to pin the injury on one of the defendants only, a requirement that the burden of proof on that subject be shifted to defendants becomes manifest. They are both wrongdoers-both negligent toward plaintiff. They brought about a situation where the negligence of one of them injured the plaintiff, hence it should rest with them each to absolve himself if he can. The injured party has been placed by defendants in the unfair position of pointing to which defendant caused the harm. If one can escape the other may also and plaintiff is remediless.
In the Sindell case, the same court adapted the Summers alternative liability framework to fashion what is popularly known as the market share liability theory. The court stated that “[t]he most persuasive reason for finding plaintiff states a cause of action is that advanced in Summers: as between an innocent plaintiff and negligent defendants, the latter should bear the cost of the injury. The court added that failure to provide evidence of causation was not the fault of either the plaintiff or defendants, but that the defendants’ conduct in marketing a drug the effects of which are delayed for many years played a significant role in creating the unavailability of proof.
We are faced with a choice of either fashioning a method of recovery for the DES case which will deviate from traditional notions of tort law, or permitting possibly negligent defendants to escape liability to an innocent, injured plaintiff. In the interests of justice and fundamental fairness, we choose to follow the former alternative.
The court considered the various theories submitted by the plaintiff, and then rejected all of them. The court found the defendants liable on its own theory which it based on the notion that each defendant contributed to the risk of injury to the public and, consequently, the risk of injury to individual plaintiffs.
These cases embody the important concept that the policy considerations of meeting the changing needs of society, plaintiff compensation, and plaintiff preference, compelled the courts first to make the decision as to whether the plaintiff was entitled to a remedy. The courts did not consider the difficulty of constructing a remedy. If the plaintiff was entitled to recover, then the courts, guided by these policy considerations, were obligated to find a theory which would afford an appropriate remedy. If one did not exist among traditional tort theories, then the courts fashioned a new theory. The fact that this task was difficult was no excuse for not fulfilling this duty.
Courts must not restrain themselves within the confines of existing tort doctrines, thereby sacrificing legitimate claims to stare decisis. The driving force behind any decision should be applicable public policy, not simply fitting a set of facts to the template of an existing doctrine.
The law of products liability has changed dramatically over the last century. The changes are the result of a major philosophical upheaval in the courts in response to the industrialization of America. The strict rules, which courts designed to protect industry from destruction by numerous lawsuits, have given way to strict liability, which courts designed to protect the consumer from the excesses of industry. There are several policy reasons behind this shift. One major consideration is that imposing liability on a manufacturer for injuries caused by defects in its products will be an incentive to adequately test its products to ensure they are safe before marketing them. Several courts considered this policy in their deliberations in DES and DES-like cases.
The manufacturer is in the best position to discover and guard against defects in its products and to warn of harmful effects; thus, holding it liable for defects and failure to warn of harmful effects will provide an incentive to product safety …. These considerations are particularly significant where medication is involved, for the consumer is virtually helpless to protect himself from serious, sometimes permanent, sometimes fatal, injuries caused by deleterious drugs.
A manufacturer is in the best position to discover defects or dangers in his product and to guard against them through appropriate design, manufacturing and distribution safeguards, inspection and warnings…. A rigorous rule of liability with enhanced possibilities of large recoveries is an “incentive” to maximize safe design or a “deterrence” to dangerous design, manufacture, and distribution.
By imposing joint liability on each member of the blasting cap industry, the court shifted the burden of proof to each manufacturer-each manufacturer had to exonerate itself to escape liability. This burden acts as an incentive for manufacturers to take necessary precautions to ensure the safety of persons who might foreseeably come into contact with their products.
The cost of damages [sic] awards will act as an incentive for drug companies to test adequately the drugs they place on the market for general medical use. This incentive is especially important in the case of mass-marketed drugs because the consumers and their physicians in most instances rely upon advice given by the supplier and the scientific community and, consequently, are virtually helpless to protect themselves from serious injuries caused by deleterious drugs.
All of these courts found that imposing liability on manufacturers was a legitimate vehicle for giving them incentive to ensure the safety of the consuming public. These courts also recognized that consumers have an inherent difficulty in protecting themselves from defective products. In light of these factors, all of these courts have reasoned that it was appropriate to impose liability in these cases because the manufacturers were in a better position than the consumer to take necessary safety precautions.
Another major consideration in products liability law when a court must decide whether or not to impose liability on manufacturers is that the manufacturers are better able to spread the risk of loss by passing on the cost to consumers. This consideration is often accompanied by the safety incentive consideration, and the courts have used them together to justify a relaxation of the traditional element of defendant identification.
As between the injured plaintiff and the possibly responsible drug company, the drug company is in a better position to absorb the cost of the injury. The drug company can either insure itself against liability, absorb the damage award, or pass the cost along to the consuming public as a cost of doing business. We conclude that it is better to have drug companies or consumers share the cost of the injury than to place the burden solely on the innocent plaintiff.
The Sindell court stated the policy in much the same way, and pointed out that 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. The Hall court pointed out that loss distribution is a reasonable policy because accidents and injuries are seen as an inevitable, and therefore foreseeable, cost of consumers using a product.
Manufacturers are aware that injuries to consumers caused by their products are an inevitable consequence of placing products into the stream of commerce. For this reason, they take into account their foreseeable liability for injuries when they price their products for sale. They pass the cost of insuring themselves against this liability on to their consumers-the cost is reflected in the prices consumers pay. This is a legitimate cost of putting a product on the market. Consumers, on the other hand, are not in a position to insure themselves against the potential catastrophic consequences of using presumably safe products. Their insurance is often inadequate to compensate them for the total amount of their loss. Because manufacturers are in a better position to insure themselves for these losses, it is appropriate that they bear this burden.
The Supreme Court of Florida has not yet passed on the issue of whether a plaintiff must identify the specific manufacturer in a DES-like case to maintain a cause of action. The policy considerations previously discussed, however, have been expressed in Florida case law. The Florida courts, in particular the supreme court, have relied on these considerations to justify fashioning new remedies or to reconsider the usefulness of accepted doctrines.
The supreme court faces a major policy decision in the Conley v. Boyle Drug Co. case. Existing tort doctrines will not afford Terri Lynn Conley a remedy. If the court, however, applies the policy considerations identified in the DES and DES-like decisions, which are part of Florida common law, then the court can and should find that she is entitled to a remedy. This section will discuss Florida’s application of the identified policies in various settings, and show how their application to a DES case may permit recovery for DES plaintiffs.
The rational study of law is still to a large extent the study of history. History must be a part of the study, because without it we cannot know the precise scope of rules which it is our business to know. It is a part of the rational study, because it is the first step toward an enlightened scepticism [sic], that is, towards a deliberate reconsideration of the worth of those rules…. For the rational study of the law the black-letter man may be the man of the present, but the man of the future is the man of statistics and the master of economics. It is revolting to have no better reason for a rule of law than that so it was laid down in the time of Henry IV. It is still more revolting if the grounds upon which it was laid down have vanished long since, and the rule simply persists from blind imitation of the past.
It does not necessarily follow that when this court has before it a case on writ of error from a judgment, the affirmance of which will crystallize into a precedent for the future an unrighteous rule of decision which is shocking to every conception of justice and fairness, that this court is thereby precluded from re-examining the law which may be applicable to this case, even to the extent of re-examining the correctness of the conclusions announced in previous cases, for the purpose of determining whether or not the rule previously announced is sound, or if sound as a general principle, whether its application to a case like the one before the court is not subject to modification in the light of demonstrably unequitable consequences which have never before been considered or taken into account.
DES manufacturer identification presents the kind of problem that the flexibility of the common law was designed to meet. If the supreme court accepts review of the Conley case, it would have to modify the traditional tort law requirement of specific tortfeasor identification in “light of the demonstrably unequitable consequences which have never before been considered or taken into account.” Widespread use of generic drugs creates numerous identification problems, and these problems are examples of those contemporary conditions that must be met with contemporary standards which are better calculated to obtain justice among all of the parties involved, based upon the circumstances applying between them at the time in question.
One force behind modifying existing law is a court’s recognition that it should focus on finding a way to compensate the injured plaintiff in a fashion which is equitable to all parties. This represents a shift from the early common law when courts focused on punishing the tortfeasor. Using the “compensation” model rather than the “punishment” model, the Waller court abrogated the common law rule that tort actions did not survive the death of the tortfeasor. The court recognized that the only reason for disallowing such an action at common law was that the punishment effect had been lost because of the tortfeasor’s death. If the court was no longer motivated by punishing the tortfeasor and was, in fact, motivated by compensating the injured plaintiff, then the reason for the rule no longer existed.
In the recent case of Champion v. Gray, the supreme court considered whether to modify or abrogate the “impact rule” with regard to negligent infliction of emotional distress. Joyce Champion heard the impact of a drunken driver’s car hitting her daughter and rushed to the accident scene. She collapsed and died after becoming overcome with shock and grief at the sight of her daughter’s dead body. The trial court, relying on precedent, dismissed the complaint, and the Fifth District Court of Appeal affirmed. Guided by the perception that “the public policy of this state is to compensate physical injuries …and physical and mental suffering which flow from the consequences of the physical injuries,” the Supreme Court of Florida modified the “impact rule” to recognize a cause of action for emotional distress when discernible physical injuries had resulted from it. These Florida cases illustrate the influence which the policy to compensate injured plaintiffs has on the shaping of the law. The Conley DES case presents another situation where this policy should exert its influence. If the court’s focus is on punishing the appropriate defendant, then it will deny recovery because the punishment purpose would not be served if the truly culpable defendant escaped liability. This possibility is the essence of the difficulty in the DES cases. If the court’s focus is on providing compensation to an injured plaintiff, however, then relaxation of the identification requirement is appropriate. It would allow compensation to a plaintiff with a legitimate claim from defendants who were definitely responsible for creating the harmful risk and possibly responsible for the plaintiff’s specific injury.
The courts often do not expressly state their policy of preferring an innocent plaintiff over possibly culpable defendants. Some court decisions imply the existence of just such a preference. Florida case law presents several examples of this policy.
An injury occurred in Groves v. Florida Coca-Cola Bottling Co. when a bottle exploded while in the plaintiff’s hand. The trial court granted a motion for a directed verdict for the defendant because the plaintiff failed to submit any direct evidence of negligence on the part of the defendant. The supreme court reversed and remanded. It reasoned that the doctrine of res ipsa loquitur did not require the plaintiff to eliminate every remote possibility of injury to the bottle after it left the defendant’s control and up to the time of the explosion. The court said that it was enough for the plaintiff to produce evidence that would permit a reasonable inference that the bottle was not subjected to “extraneous harmful influences” before it reached her. This reasonable inference created a prima facie case of negligence, and shifted the burden of proof to the defendant. By shifting this burden of proof to the defendant, the court implicitly showed a preference for the injured plaintiff over the possibly culpable defendant. By enhancing the possibility of recovery for the plaintiff, the court gave meaning to this policy consideration.
The First District Court of Appeal of Florida confronted the plaintiff preference issue in Skroh v. Newby, a classic “concert of action” case. The defendants were racing each other, and one of them struck and killed a man on a motorcycle. In this wrongful death case, the court held that even the defendant who did not actually collide with the motorcycle could be liable for the man’s death because his actions in racing constituted negligence proximately causing the accident. The effect of this decision was to assure compensation for the plaintiff in the event the “colliding” defendant was insolvent. By implication, the court was expressing its policy determination that it is better to prefer the innocent plaintiff over the negligent defendants.
Another example of the relaxation of a plaintiff’s burden of proof is Davis v. Sobik’s Sandwich Shops, Inc. In Davis, the plaintiff was injured in a three-vehicle rear-end collision. She “was an innocent passenger, free of any contributory negligence. She joined in the action everyone who could have caused the accident. The supreme court held that the plaintiff did not have to identify specifically the individual responsible for her injuries because the evidence showed that at least one of them must have been responsible. This decision relieved the plaintiff of the burden of proving which particular defendant (or defendants) caused her injuries. If the court had ruled otherwise, it would have left open the possibility that she would be uncompensated in a situation where she was entitled to a remedy. By ruling this way, the court implicitly recognized a policy of preferring innocent plaintiffs over possibly culpable defendants, thus extinguishing the possibility of nonrecovery for the plaintiff. The Conley case presents problems for both the plaintiff and the defendants. Neither can overcome the problem with more fact-finding. In this situation, guided by the policy of preferring innocent plaintiffs over possibly culpable defendants, the court should authorize recovery by relaxing the traditional requirement of specific tortfeasor identification so that the plaintiff can maintain a cause of action.
Strict liability should be imposed only when a product the manufacturer places on the market, knowing that it is to be used without inspection for defects, proves to have a defect that causes injury to a human being. The user should be protected from unreasonably dangerous products or from a product fraught with unexpected dangers.
By relieving the plaintiff of having to prove negligence on the part of the manufacturer, thus making the prosecution of a products liability case easier, the court gave manufacturers a greater incentive to ensure the safety of their products. The court noted that many products in the hands of the consumer are sophisticated and even mysterious articles …. In today’s world it is often only a manufacturer who can fairly be said to know and understand when an article is suitably designed and safely made for its intended purpose.
The same policy consideration led the court to abrogate the “patent danger” doctrine in Auburn Machine Works Co., Inc. v. Jones. In that case, the plaintiff lost his balance when the side of a trench caved in and his foot became entangled in an exposed chain of a trench digging machine. The trencher possessed no shield and was obviously dangerous. The court reasoned that “the patent danger doctrine encourages manufacturers to be outrageous in their design, to eliminate safety devices, and to make hazards obvious.” By abrogating the “patent danger” doctrine, the court implicitly recognized its policy determination that manufacturers should make their products as safe as possible before putting them on the market.
Insurance Co. of North America v. Pasakarnis presents an interesting variation on the safety incentive theme. In Pasakarnis, the supreme court approved the seat belt defense as a means of mitigating damages in automobile accident cases. Although not a products liability case, this opinion illustrates how the safety incentive policy runs throughout all of tort law. The court noted that the “common thread running through [its] decisions has been that the law will step in to protect people against risks which they cannot adequately guard against themselves.” The law will step in to protect people, however, only to the extent that they cannot protect themselves. By making the seat belt defense available to defendants, the court has placed the burden of safety on those who are in the most reasonable position to take effective safety precautions. This is entirely consistent with the policy of imposing liability on manufacturers as an incentive for placing safe products on the market.
The manufacturers of DES were the only parties who could have taken precautions against its defectiveness. Neither the women who took the DES, nor their daughters were in a position to do so. If the court allows manufacturers to escape liability because of the identification problem, it will undercut the entire safety incentive policy. Such a result would encourage manufacturers to market their products in an untraceable generic form to avoid liability in the future, ultimately causing more DES-like situations where injured persons would be without a remedy. By imposing liability, the court will not only give manufacturers more incentive to produce safer products, but will also encourage them to devise methods of assuring that their products are traceable back to themselves. Traceability will help them avoid liability for the defects in some other manufacturer’s products.
To hold that prevailing industry standards supplant the ordinary standard of objective truth and proof, and should be conclusive on the issue of a product’s reasonable fitness for human use or consumption, would be to shift to the purchaser the risk of whatever latent defectiveness may ultimately be proven by experience and advancement of human knowledge, a risk we are convinced was from the inception of the implied warranty doctrine intended to be attached to the mercantile function.
The obligation of the manufacturer must become what in justice it ought to be-an enterprise liability …. The cost of injuries or damages, either to persons or property, resulting from defective products, should be borne by the makers of the products who put them into the channels of trade, rather than by the injured or damaged persons who are ordinarily powerless to protect themselves.
Theoretically, the DES manufacturers have prepared themselves, through insurance or other means, for the possibility of injuries arising from the use of DES when they placed it on the market. Therefore, if the court does not fashion some sort of recovery scheme for Terri Lynn Conley to take advantage of this preparation, the manufacturers will reap a windfall because they have already passed the cost of this preparation on to the consumers of DES. There can be no justice in denying Terri Lynn Conley and other DES plaintiffs recovery for their injuries when their mothers have already paid prices which included the cost of this insurance.
The Conley v. Boyle Drug Co. case will be a difficult decision for the Supreme Court of Florida. Only if the court relaxes the defendant identification requirement will Terri Lynn Conley have a remedy. Relaxation of the defendant identification requirement is consistent with the court’s policy of compensating injured plaintiffs for injuries caused by wrongs committed by others. It is also consistent with the policy of preferring innocent plaintiffs over possibly culpable defendants. Because the Conley case is a products liability action, the relaxation of the defendant identification requirement promotes the court’s policy of giving manufacturers the incentive to produce safe products. It is also consistent with the court’s recognition that manufacturers are better able than consumers to spread the risk of loss caused by defects in their products. The court must also recognize that the expanding use of generic drugs will inevitably cause the problem to occur again. The court must take some action that will encourage manufacturers to assure that their products are traceable back to themselves. To do otherwise will leave open a loophole through which manufacturers can escape liability for injuries sustained by their consumers. This result would be inconsistent with the court’s declared policy that “the law will step in to protect people against risks which they cannot adequately guard against themselves.” By recognizing that Terri Lynn Conley is entitled to a remedy at law, the court will protect Florida citizens from similar incidents in the future.

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