Wagner v. Roche Laboratories

• Decision Date: 13 November 1996
• Docket Number: No. 95-1209,95-1209
• Citation: 671 N.E.2d 252,77 Ohio St.3d 116
• Parties: , 65 USLW 2363, Prod.Liab.Rep. (CCH) P 14,789 WAGNER, Appellant, v. ROCHE LABORATORIES et al., Appellees.
• Court: Ohio Supreme Court

Page 116

77 Ohio St.3d 116

671 N.E.2d 252, 65 USLW 2363, Prod.Liab.Rep. (CCH) P 14,789

WAGNER, Appellant, v. ROCHE LABORATORIES et al., Appellees.

No. 95-1209.

Supreme Court of Ohio.

Submitted May 22, 1996.

Decided Nov. 13, 1996.

On November 8, 1982, plaintiff-appellant, Josephine Wagner, was prescribed the drug Accutane (isotretinoin) for treatment of cystic acne on her face by her dermatologist, Dr. Craig Burkhart. Dr. Burkhart had previously prescribed the antibiotic Minocin (minocycline), a tetracycline derivative, for appellant's acne problem, and continued appellant on the Minocin prescription in addition to the newly prescribed Accutane.

On December 30, 1982, appellant reported vision problems and headaches to Dr. Burkhart, who immediately discontinued the prescriptions and referred appellant to an ophthalmologist. The ophthalmologist diagnosed appellant with papilledema (swelling of the optic nerve caused by increased pressure on the brain) and referred appellant to a neurologist. The neurologist diagnosed appellant with pseudotumor cerebri ("PTC"), also called benign intracranial hypertension, a serious condition involving swelling of the brain. PTC is accompanied by effects often associated with a brain tumor (such as papilledema, vision problems, nausea, and severe headaches), but no tumor is actually present.

Steroids were prescribed to treat the PTC effects. As a result of the steroid therapy, appellant experienced avascular necrosis, which involves diminished blood flow to the heads of bones, eventually leading to destruction of the bone ends. Appellant underwent several surgeries to replace both hip joints and a shoulder joint.

According to the court of appeals' opinion, appellant filed a medical malpractice suit against Dr. Burkhart on August 26, 1986. On August 23, 1988, Dr. Burkhart joined appellees Roche Laboratories and Hoffman-La Roche, Inc. ("Roche") as third-party defendants. Appellant amended her complaint to include a product liability claim against Roche, the developers of Accutane. On August 2, 1991, appellant settled her malpractice suit against Dr. Burkhart for $185,000 and soon after dismissed her complaint against Roche without prejudice pursuant to Civ.R. 41(A)(1)(a).

On February 24, 1992, appellant instituted the present action by refiling her complaint against Roche, reasserting the product liability claims. Appellant claimed that the Accutane and Minocin worked in combination to cause her PTC, which necessitated the steroid treatments, which ultimately resulted in the avascular necrosis, which necessitated the joint replacements. Appellant alleged that Roche had failed to provide warnings in the Accutane package insert that Accutane could cause PTC and also that Accutane should not be taken in combination with some drugs, such as Minocin. Appellant alleged that her PTC and associated problems were proximately caused by appellees' failure to provide the warnings.

The case proceeded to a jury trial. Testimony at trial established that Accutane was approved by the federal Food and Drug Administration for treatment of severe cystic acne in May 1982 and that Accutane was first marketed in September 1982, shortly before Accutane was prescribed for appellant by Dr. Burkhart.

Accutane is a synthetic derivative of Vitamin A, and both belong to the same family of drugs, called retinoids. Accutane is a very effective acne treatment, but its use is restricted to severe cases of cystic acne that are resistant to other standard methods of treatment due to concerns about Accutane's side effects and toxicity. The chemical structures of Accutane and Vitamin A are similar, and due to that similarity, the two produce some similar biological effects when ingested.

Hypervitaminosis A syndrome is a symptom complex associated with the ingestion of large dosages of Vitamin A often prescribed to treat acne. One of the symptoms of hypervitaminosis A is PTC. Appellant's theory of recovery at trial was premised on her presentation of expert testimony that Accutane is so similar chemically to Vitamin A that appellees either were aware, or should have been aware, that Accutane also had the potential to cause PTC, and that appellees should have included a warning of that potential effect in the Accutane package insert. Appellant further presented expert testimony questioning the testing process conducted by appellees prior to the FDA approval of Accutane, and alleged that deficiencies in the testing protocol had prevented appellees from gathering information on the connection between Accutane and PTC.

In addition to presenting testimony on the association of Vitamin A and PTC, appellant also presented expert testimony that Minocin, the antibiotic appellant was receiving at the time the Accutane was prescribed, also is associated with an increased risk of PTC. Appellant's experts testified that when two drugs each tend to cause a particular effect when taken separately, the threat of that effect will predictably be magnified if the two drugs are taken concomitantly. Appellant alleged that in her case the Minocin and Accutane had a synergistic effect, greatly increasing her risk of PTC, and that appellees knew of, or should have known of, that increase in risk, and should have included a warning on the Accutane package insert to discontinue certain other drugs, such as Minocin, when Accutane was prescribed.

Appellees argued throughout the trial that the warnings provided on the Accutane package insert were adequate, and presented expert testimony to support the sufficiency of the protocol behind the Accutane trials which led up to FDA approval.

The trial court having denied appellees' motion for a directed verdict, the jury returned a verdict for appellant and awarded $350,000 in damages. The trial court granted appellees' motion to set off the earlier $185,000 settlement amount appellant received from Dr. Burkhart against the damage award, denied appellant's motion for prejudgment interest, and entered judgment in favor of appellant for $165,000. The trial court later denied appellees' motions for judgment notwithstanding the verdict and for a new trial.

Appellees appealed to the Court of Appeals for Lucas County, contending that the trial court erred by denying their motion for a directed verdict, by denying their motion for judgment notwithstanding the verdict, and by denying their motion for a new trial. Appellant cross-appealed, urging that the trial court erred in several of its rulings, including granting the setoff and denying prejudgment interest.

The court of appeals, in a split decision, reversed the jury verdict in favor of appellant and determined that the trial court erred by not entering a directed verdict for appellees. The court of appeals found that the evidence revealed "no case reports, no medical literature, and no scientific studies associating Accutane with PTC or associating the concomitant use of Accutane and Minocin with PTC." The court of appeals went on to state that "[r]easonable minds could only conclude the warning provided by Roche for Accutane was adequate, and, therefore, the issue should not have been submitted to the jury."

In light of its holding that the trial court should have directed a verdict for Roche, the court of appeals found the remainder of Roche's appeal and Wagner's entire cross-appeal moot and did not address them.

The cause is now before this court upon the allowance of a discretionary appeal.

Don C. Iler Co., L.P.A., Don C. Iler and Nancy C. Iler, Cleveland, for appellant.

Arter & Hadden, Irene C. Keyse-Walker and George Gore; Patterson, Belknap, Webb & Tyler, L.L.P., and John Winter, Cleveland, for appellees.

ALICE ROBIE RESNICK, Justice.

This case requires us to interpret Civ.R. 50(A)(4) and to apply the standards contained in that rule to appellant's claims of failure to warn, in order to determine whether appellant created a jury question sufficient to overcome appellees' motion for a directed verdict. For the reasons which follow, we conclude that the trial court properly applied Civ.R. 50(A)(4) and correctly denied appellees' motion for a directed verdict. We reverse the judgment of the court of appeals, and remand this cause to the court of appeals for further proceedings.

Civ.R. 50(A)(4) provides:

"When a motion for a directed verdict has been properly made, and the trial court, after construing the evidence most strongly in favor of the party against whom the motion is directed, finds that upon any determinative issue reasonable minds could come to but one conclusion upon the evidence submitted and that conclusion is adverse to such party, the court shall sustain the motion and direct a verdict for the moving party as to that issue."

In Strother v. Hutchinson (1981), 67 Ohio St.2d 282, 284-285, 21 O.O.3d 177, 178-179, 423 N.E.2d 467, 469, this court observed:

"The law in Ohio regarding directed verdicts is well formulated. In addition to Civ.R. 50(A), it is well established that the court must neither consider the weight of the evidence nor the credibility of the witnesses in disposing of a directed verdict motion. * * * Thus, 'if there is substantial competent evidence to support the party against whom the motion is made, upon which evidence reasonable minds might reach different conclusions, the motion must be denied. Kellerman v. J.S. Durig Co. (1964), 176 Ohio St. 320 [27 O.O.2d 241, 199 N.E.2d 562] * * *.' Hawkins v. Ivy (1977), 50 Ohio St.2d 114, 115 [4 O.O.3d 243, 244, 363 N.E.2d 367, 368]." See, also, Ramage v. Cent. Ohio Emergency Serv., Inc. (1992), 64 Ohio St.3d 97, 109, 592 N.E.2d 828, 837.

"A motion for directed verdict * * * does not present factual issues, but a question of law, even though in deciding such a motion, it is necessary to review and consider the evidence." O'Day v. Webb (1972), 29 Ohio St.2d 215, 58 O.O.2d 424, 280 N.E.2d 896, paragraph three of the syllabus.

"When a motion for a...