Duty to Warn
Several decisions from courts around the country have addressed the extent of a manufacturer's duty to warn and the effect of a plaintiff's failure to read or heed warnings.
Insecticides. Chemical manufacturers have urged the California Supreme Court to reverse what they consider a dangerous and revolutionary decision by an intermediate appellate court holding that they had a duty to ensure that bystanders and downstream users were accurately warned about the dangers of malathion exposure.
In Macias v. California, 28 Cal.Rptr.2d 796 (Cal.App. 1994), Juan Macias developed serious and permanent eye injuries from exposure to malathion during aerial sprayings of the insecticide in the Los Angeles area. The California Court of Appeal overturned the trial court's grant of summary judgment to the defendants and rejected the trial court's findings of no duty to warn and pre-emption under the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA).
The court found that although the manufacturers had complied with federal labeling law, they had an independent duty under Section 388 of the Restatement (Second) of Torts to warn bystanders directly anytime they believed the public was receiving inadequate or inaccurate warnings regarding product safety. The court concluded that a manufacturer must warn all persons whom it is foreseeable will come in contact with, and consequently be endangered by, the product. A warning to the immediate purchaser will not, as a general matter, discharge this duty.
The court also found that the state causes of action were not preempted by FIFRA, since the plaintiffs did not allege that the products were mislabeled and therefore did not seek the imposition of labeling that would conflict with federal requirements.
Non-prescription drugs. In Ramirez v. Plough Inc., 863 P.2d 167 (Cal. 1993), the California Supreme Court was presented with the question whether non-prescription drug manufacturers whose product labels are in conformity with state and federal law may be held liable under California law for failure to warn in languages other than English. The plaintiff, the mother of a child who allegedly contracted Reye's syndrome and suffered permanent injuries after ingesting aspirin, spoke only Spanish and could read the bottle's warning label in English.
The court reviewed applicable sections of the federal Food, Drug and Cosmetic Act, as well as FDA regulations, neither of which explicitly require product labeling in languages other than English, and it ruled that a manufacturer would be required to use bilingual labels only if the California legislature enacted such a statute.
A contrary result was reached by a federal district court in Stanley Industries Inc. v. W.M. Barr & Co., 784 F.Supp. 1570 (S.D. Fla. 1992), in which a plaintiff brought claims of property damage against a linseed oil manufacturer based on failure to warn that the product was susceptible to spontaneous combustion. The defendant moved for summary judgment, arguing that proximate cause could not exist as a matter of law since the plaintiff, who did not speak English, had not read the label.
The court denied the motion, reasoning that strict liability and breach of warranty theories of recovery do not depend on conduct or failure of the parties to act. As for the negligent failure to warn claim, the court found that proximate cause was a question for the jury. The plaintiff's contention that the defendants inadequately conveyed warnings because they failed to attach bilingual instructions or universal cautionary symbols demonstrated the overlapping of adequacy and proximate cause.
Failure to read warnings. In Johnson v. Johnson Chemical Co., 588 N.Y.S.2d 607 (App.Div. 2d Dep't 1992), a New York court addressed a plaintiff's claims that warnings on a can of insect spray that exploded after being used near a kitchen stove pilot light were inadequate.
The court denied the defendants' motion for summary judgment, although the plaintiff admittedly failed to read the warning that advised users to extinguish all flames, pilot lights, burners and ovens before using the product. The court held that the reasonableness of the plaintiff's conduct and whether the warning was adequate were still questions for the jury.
Ignoring warnings. In an important decision, the Texas Supreme Court considered whether a manufacturer's failure to give adequate instructions for the safe use of its product can be the legal cause of an injury if instructions that would have prevented the accident were given but ignored.
In General Motors Corp. v. Saenz, 873 S.W.2d 353 (Texas 1993), the driver and passenger of an overloaded water tank truck were killed when a rear tire blew out, causing the truck to flip over at highway speeds. The truck was manufactured by General Motors, but it had been modified by three separate companies. The jury determined that the warning against overloading, placed on a small metal plate in the doorjamb and referencing the owner's manual, was inadequate. This decision was upheld by the intermediate appellate court.
The Texas Supreme Court reversed, concluding that there is no presumption that a plaintiff who ignored instructions that would have kept him from injury would have followed better instructions. Even though GM's instructions were inadequate, if following the instructions would have prevented the accident, the plaintiffs could not recover because the inadequate warnings could not have been a legal cause of the accident.
Relying on the guidelines for evaluating scientific evidence established by the U.S. Supreme Court in Daubert v. Merrell Dow Pharmaceuticals Inc., 113 S.Ct. 2786 (1993), the Seventh Circuit has affirmed grants of summary judgment in two recent decisions, holding that the plaintiffs' causation evidence was insufficient.
In Porter v. Whitehall Laboratories Inc., 9 F.3d 607 (7th Cir. 1993), the plaintiff alleged that his kidney failure was caused by the painkiller ibuprofen. The trial court noted that, in determining admissibility of scientific expert testimony under the standards of Daubert, it should look at whether a scientific theory can be or has been tested, whether it has been subjected to peer review or publication, its known error rate, and whether it is generally accepted in the scientific community. Applying these standards, the court held that expert testimony that ibuprofen caused Porter's renal failure was inadmissible because the experts were not able to commit to causation within a reasonable degree of scientific certainty, and they did not conduct animal or clinical studies.
In Hayes v. Raytheon Co., No. 94-4004 (April 21, 1994), the Seventh Circuit upheld a summary judgment against plaintiffs who had alleged that video display terminals manufactured by Raytheon emanated "Hertzian radiation" that caused cervical cancer and cataracts. 808 F.Supp. 1326 (N.D. Ill. 1993).
The Seventh Circuit held that the district court had properly rejected the plaintiffs' causation proof. Applying the evidentiary analysis mandated by Daubert, the court said that gaps in the expert's reasoning led it to conclude that his expert opinion lacked the rigor and objective support required to distinguish admissible scientific opinion from impermissible speculation.
In a Texas case, a court of appeals reversed a multimillion dollar plaintiff's verdict and rendered judgment for the manufacturer in a Bendectin case. Merrell Dow Pharmaceuticals Inc. v. Havner, 1994 WL 86436 (Tex.App.--Corpus Christi, March 21, 1994).
A child was born with no fingers or thumb on her right hand, and her mother alleged that the birth defects were caused by her having taken Bendectin during her pregnancy. In an attempt to establish causation, the plaintiffs presented testimony from five expert witnesses, including a veterinarian who testified about animal studies; a chemist who testified about in vitro studies; statisticians who criticized the defendant's epidemiological studies; and an internist-pharmacologist who relied on a number of drug experience reports concerning birth defects among children.
The court carefully examined the testimony of each of these experts and determined that it amounted to nothing more than criticism of Merrell Dow's animal and human epidemiological studies. None of the experts' opinions was based on direct human scientific data. The court concluded that even if all the animal and human epidemiologic studies relied on by the defense were wrong, the most that could be concluded was that Merrell Dow had no conclusive evidence that Bendectin never causes birth defects in humans. Absence of evidence of a fact, standing alone, does not amount to some evidence of its converse. Since the plaintiffs had failed to bring forward anything more than suspicion on the essential element of causation, the court reversed the jury verdict and rendered judgment for Merrell Dow.
In Tidwell v. Upjohn Co., 626 So.2d 1297 (Ala. 1993), the Supreme Court of Alabama held that testimony by a pharmacist-pharmacologist and a psychiatrist that Halcion caused a man's suicide was sufficient to establish proximate cause.
Initially, the decedent's family physician had prescribed .25-milligram dosages of Halcion for sleep. After several days, the doctor determined that the decedent was suffering from depression and increased the dosage to .50-milligrams. The next morning the decedent shot himself. The plaintiff contended that the increased dosage of Halcion caused her husband's suicide and that Upjohn failed to warn physicians properly about the effects of a .50-milligram dosage of the drug. To prove causation, she offered the deposition testimony of a pharmacist-pharmacologist and a psychiatrist.
Reversing a summary judgment for Upjohn, the Court held that the pharmacist-pharmacologist had sufficient knowledge to testify as an expert on whether the Halcion ingestion had contributed to...