Swygert, Chief Judge, and Kiley and Fairchild, Circuit Judges.
Plaintiffs Anna and Leslie Singer, husband and wife, brought this diversity action to recover damages for personal injuries alleged to have been caused by Anna Singer's ingestion of Aralen, a drug product of defendant Sterling Drug, Inc. Verdict and judgment were for Sterling, and plaintiffs appeal. We reverse and remand.
Anna Sterling began taking Aralen for a facial rash under a written prescription from Dr. Hoit, a dermatologist, in 1957. He had diagnosed the rash as discoid lupus erythematosus.*fn1 Between 1957 and 1960 the doctor also gave oral prescriptions to pharmacists for Anna Singer's use. She continued taking Aralen until 1964, when she received notice from a pharmacist that the drug had a deleterious side effect. She again went to Dr. Hoit.
Thereafter, in 1964, Anna Singer was examined by Dr. Potts, an opthalmologist, who found her "visual field was constricted, that side vision had been lost, and that in addition central vision was diminished." Later examination by Dr. Potts disclosed extensive damage to the rod cells of Anna Singer's retina. The suit before us followed, alleging that the blindness, chloroquine retinopathy, was caused by the ingestion of Aralen.
The complaint was in four counts. In counts 1 and 2 Anna Singer claimed damages of $1,200,000 because of blindness proximately caused by Aralen.*fn2 In counts 3 and 4 Leslie Singer claimed damages of $35,000 for loss, among other things, of his wife's companionship and for deprival of her services during her blindness. Counts 1 and 3 were based on strict liability, and counts 2 and 4 on negligence. The jury returned verdicts against plaintiffs, and the judgments appealed from followed.
Plaintiffs contend that the district court's instructions rendered recovery impossible.
A. The district court erroneously instructed the jury on plaintiffs' strict liability counts in that the court used the term "wilfully and intentionally" in describing four allegations with respect to strict liability. The court also instructed the jury that plaintiffs had alleged in the strict liability counts that Sterling had not manufactured Aralen in accordance with its proper chemical formula. The court also stated that Sterling's answer framed the issue to be whether Sterling had been guilty of wilful and intentional misconduct.
The complaint alleged neither wilful and intentional misconduct on Sterling's part nor failure of Sterling to manufacture chemically pure Aralen. Under Indiana law the doctrine of strict liability does not require that Sterling be shown to have been guilty of wilful and intentional misconduct. Cornette v. Searjeant Metal Products, Inc., 147 Ind. App. 46, 258 N.E.2d 652 (Ind.App.Ct.1970); Perfection Paint & Color Co. v. Konduris, 147 Ind. App. 106, 258 N.E.2d 681 (Ind.App.Ct.1970). The instruction placed a heavier burden on plaintiffs than was justified. The instruction was also faulty in placing the burden on plaintiffs of proving that the drug was not "in accordance with its chemical formula." This was not a theory of plaintiffs at trial. The giving of the instruction is clearly reversible error.
Defendant argues that its duty to warn is the same under both strict liability and negligence counts and that accordingly the erroneous instruction was cured. We are not persuaded. The effect of the instruction was to impose on plaintiffs a heavier burden to prove that element under the strict liability count than under the negligence count.
Sterling argues that the Singers must prove a failure by Sterling to warn about a known risk in taking Aralen before the doctrine of strict liability applies. Sterling relies on Comment k of § 402A of the Restatement (Second) of Torts (1965) for its position that all prescription drugs are covered by this exception to the strict liability doctrine.
Comment k establishes two classifications of drugs which are exceptions to the strict liability doctrine:
1) Drugs in which there is a known but apparently reasonable risk of injury and the user has been warned of the risk, i. ...