Brochu v. Ortho Pharmaceutical Corp.

• Decision Date: 07 April 1981
• Docket Number: No. 80-1077,80-1077
• Citation: 642 F.2d 652
• Parties: Judith BROCHU and Emmanuel T. Brochu, Plaintiffs-Appellees, v. ORTHO PHARMACEUTICAL CORPORATION, Defendant-Appellant. . Re
• Court: U.S. Court of Appeals — First Circuit

Page 652

642 F.2d 652

Judith BROCHU and Emmanuel T. Brochu, Plaintiffs-Appellees, v. ORTHO PHARMACEUTICAL CORPORATION, Defendant-Appellant.

No. 80-1077.

United States Court of Appeals First Circuit.

Reargued Jan. 5, 1981.

Decided March 3, 1981.

On Motion For Certification Or Petition For Rehearing and

Rehearing En Banc

Denied April 7, 1981.

David F. Dobbins, New York City, with whom George S. Frazza, New Brunswick, N. J., Karl E. Seib, Jr., Theodore B. Van Itallie, Jr., Robert W. Sparks, Patterson, Belknap, Webb & Tyler, New York City, and Sulloway, Hollis & Soden, Concord, N. H., were on brief, for defendant-appellant.

Ronald L. Snow, Concord, N. H., with whom Mary Susan Leahy and Orr & Reno, P.A., Concord, N. H., were on brief, for plaintiffs-appellees.

Before ALDRICH, BOWNES, and BREYER, Circuit Judges.

BOWNES, Circuit Judge.

This is a civil action based on diversity of citizenship brought in the United States District Court for the District of New Hampshire by Judith Brochu and her husband Emmanuel, residents of the state of New Hampshire, against the Ortho Pharmaceutical Corporation (Ortho), a New Jersey corporation. In their complaint the Brochus alleged that Mrs. Brochu sustained serious bodily injury as a result of taking a type of oral contraceptive, Ortho-Novum 2 mg., manufactured by Ortho. Mr. Brochu also claimed damages for loss of consortium and past and future expenses resulting from his wife's injuries. Their suit was based on four separate theories: Negligence, strict liability, fraudulent misrepresentation, and negligent misrepresentation. The Brochus withdrew both negligence claims before the case reached the jury. Ortho appeals the jury verdict of $600,000 for Mrs. Brochu and $100,000 for her husband on the following grounds: that the case was tried on an erroneous theory of strict liability; that the warnings given were adequate as a matter of law; that submission of the fraudulent misrepresentation claim to the jury was prejudicial because there was no evidence to support it; that the jury charge improperly intermingled concepts of strict liability and negligence; and that the judge did not give proper guidance to the jury on the question of discounting of damages.

FACTS

Judith Brochu first started using an oral contraceptive on August 29, 1967. The birth control pill prescribed by her physician, Dr. A. Craig Campbell, was the Ortho-Novum 2 mg. tablet, which is composed of 2 mg. of a synthetic progestogen and 100 mcg. of a synthetic estrogen. ¹ Mrs. Brochu used this brand of oral contraceptive until November 14, 1971; the next day she suffered a cerebral thrombosis that initially left her totally paralyzed on her left side. Before her stroke, Mrs. Brochu, who was twenty-seven years old and the mother of a young child, was employed as a hairdresser. According to her testimony at trial, she enjoyed an active family and social life. Expert testimony established that, as a result of the cerebral thrombosis, Mrs. Brochu, who is left-handed, does not have functional use of her left hand or arm and suffers from a lesion of the right ulna nerve and a carpal tunnel syndrome on the right side. Other direct or indirect effects of the stroke include epileptic-like seizures, depression, and difficult breathing and swallowing.

STRICT LIABILITY IN TORT

The Brochus have alleged two claims under the doctrine of strict liability:

1. By 1971 Ortho was marketing other oral contraceptives containing less estrogen, which, like the Ortho-Novum 2 mg. pill, were 99% effective, but presented much less risk to the user than the Ortho-Novum 2 mg. pill. Therefore the 2 mg. oral contraceptive with its higher estrogen level was defectively designed and unreasonably dangerous.

2. Because it did not withdraw the 2 mg. pill from the market, Ortho should have warned physicians that this product posed a much higher risk of cerebral thrombosis than other lower-estrogen-dosage products. The failure to do so made the product defective and unreasonably dangerous.

New Hampshire has adopted the doctrine of strict liability. Buttrick v. Arthur Lessard & Sons, Inc., 110 N.H. 36, 38, 260 A.2d 111, 113 (1969); Elliott v. Lachance, 109 N.H. 481, 484, 256 A.2d 153, 155-56 (1969). In allowing a cause of action under strict liability in Buttrick, the New Hampshire Supreme Court quoted section 402A of the Restatement (Second) of Torts, which provides:

(1) One who sells any product in a defective condition unreasonably dangerous to the user or consumer or to his property is subject to liability for physical harm thereby caused to the ultimate user or consumer, or to his property, if

(a) the seller is engaged in the business of selling such a product, and

(b) it is expected to and does reach the user or consumer without substantial change in the condition in which it is sold.

(2) The rule stated in Subsection (1) applies although

(a) the seller has exercised all possible care in preparation and sale of his product, and

(b) the user or consumer has not bought the product from or entered into any contractual relation with the seller.

110 N.H. at 38; 260 A.2d at 38-39.

A. Design Defect

New Hampshire recognizes defective design as a basis for a strict liability claim. Thibault v. Sears, Roebuck & Co., 118 N.H. 802, 807, 395 A.2d 843, 846 (1978). In Thibault the New Hampshire Supreme Court stated that "(a) design defect occurs when the product is manufactured in conformity with the intended design but the design itself poses unreasonable dangers to consumers." Id. New Hampshire, however, has never considered the design defect theory in the context of an ethical drug case. In determining the result we believe the New Hampshire court would reach if presented with that issue, we consider the decisions of other state and federal courts and the general weight of the authority. Rigby v. Beech Aircraft Co., 548 F.2d 288, 291 (10th Cir. 1977); Julander v. Ford Motor Co., 488 F.2d 839, 844 (10th Cir. 1973).

In Thibault the New Hampshire Supreme Court outlined what the plaintiff in a defective design strict liability case must prove to prevail. Initially, the plaintiff must demonstrate "the existence of a 'defective condition unreasonably dangerous to the user.' " 118 N.H. at 807, 395 A.2d at 846; accord, Restatement (Second) of Torts § 402A(1). Courts are to consider the social utility and desirability of the product as well as its danger in determining if it is unreasonably dangerous. Thibault noted that "(s)ome products are so important that a manufacturer may avoid liability as a matter of law if he has given proper warnings." 118 N.H. at 807, 395 A.2d at 846.

In its brief, Ortho strenuously objects to the Brochus' theory that a drug, specifically Ortho-Novum 2 mg., might be unreasonably dangerous, with or without warnings. ² It calls their design defect argument a "semantic ploy." We disagree. We are unwilling to say that under New Hampshire's balancing test no drug can ever be classified as unreasonably dangerous. We do not believe, as Ortho contends, that the New Hampshire Supreme Court would necessarily limit the application of Thibault to mass-produced items sold over the counter.

In Thibault the New Hampshire court listed several factors to consider in balancing product utility and danger. One consideration is whether the risk could have been lessened without significantly affecting effectiveness or cost. The court noted that "liability may attach if the manufacturer did not take available and reasonable steps to lessen or eliminate the danger of even a significantly useful and desirable product." Id. Under New Hampshire law, "when an unreasonable danger could have been eliminated without excessive cost or loss of product efficiency, liability may attach even though the danger was obvious or there was adequate warning." Id. 118 N.H. at 808, 395 A.2d at 847. We think that plaintiffs' first claim based on a design defect inherent in the high content of estrogen and the danger resulting from it states cause of action in strict liability under New Hampshire law. ³ Ortho has limited its challenge on this claim to its legal basis. We, therefore, note only that there were evidentiary grounds to support a jury finding of liability on this claim. ⁴

B. Warning

Another consideration specified by Thibault is the presence or absence of warnings: when the risk is not apparent, "the user must be adequately and understandably warned of concealed dangers." Id. 118 N.H. at 808; 395 A.2d at 846. In cases involving ethical drugs, the manufacturer must warn the physician, not the patient. E. g., Reyes v. Wyeth Laboratories, 498 F.2d 1264, 1276 (5th Cir.), cert. denied, 419 U.S. 1096, 95 S.Ct. 687, 42 L.Ed.2d 688 (1974); Basko v. Sterling Drug Co., 416 F.2d 417, 426 (2d Cir. 1969); Ortho Pharmaceutical Corp. v. Chapman, 388 N.E.2d 541, 548 (Ind.App.1979).

As noted, Thibault also pointed out that some products are so important that liability may be avoided as a matter of law if adequate warnings are given. Plaintiffs claim that Ortho's warnings were inadequate because, although the company knew that there was a significantly higher risk of cerebral thrombosis from ingesting Ortho-Novum 2 mg. than from ingesting lower-dosage oral contraceptives, it did not so inform physicians. We have previously held that "having embraced strict liability, the New Hampshire court would ... (impose) upon a drug manufacturer an affirmative duty to warn the medical profession of ... dangerous side effects." McCue v. Norwich Pharmacal Co., 453 F.2d 1033, 1035 (1st Cir. 1972).

Although not specifically cited in Thibault, the New Hampshire Supreme Court presumably based this duty to warn on Comment k to the Restatement (Second) of Torts, section 402A, ⁵ which provides:

k. Unavoidably unsafe products. There are some products which, in the present state of human knowledge, are quite incapable of being made safe for their intended and ordinary use. These are...