Thomas v. Hoffman-LaRoche, Inc.
| Decision Date | 03 January 1992 |
| Docket Number | HOFFMAN-L,No. 89-4908,89-4908 |
| Citation | 949 F.2d 806 |
| Parties | Prod.Liab.Rep. (CCH) P 13,013 Mary Kathryn THOMAS, Plaintiff-Appellant, v.aROCHE, INC., Defendant-Appellee. |
| Court | U.S. Court of Appeals — Fifth Circuit |
John A. Owens, Susie T. Carver, Phelps, Owens, Jenkins, Gibson & Fowler, Tuscaloosa, Ala., for plaintiff-appellant.
Amy Johnson, Henry & Kelly, Austin, Tex., for amicus curiae, Public Citizen.
Earl Keyes, Keyes, Moss, Piazza & Woods, Jackson, Miss., Frederick T. Davis, John D. Winter, Karl E. Seib, Jr., Patterson, Belknap, Webb & Tyler, New York City, for defendant-appellee.
Appeal from the United States District Court for the Northern District of Mississippi.
Before WISDOM, KING and BARKSDALE, Circuit Judges.
Mary Kathryn Thomas sued Hoffman-LaRoche, Inc., the manufacturer of a prescription acne medication called Accutane, under a failure to warn theory 1 for injuries she sustained allegedly as a result of taking Accutane. The district court granted Hoffman-LaRoche's post-trial motion for judgment notwithstanding the verdict, setting aside a jury award of one million dollars. The district court held that Thomas had failed to introduce sufficient evidence to show that the allegedly inadequate warning caused her injury. 731 F.Supp. 224. We AFFIRM.
In late January 1984, the plaintiff had an appointment with her dermatologist, Dr. Robert P. Myers. She had been under Dr. Myers's treatment since 1979 for acne rosacea. When she met with Dr. Myers, Dr. Myers diagnosed Thomas as having developed a more serious form of acne, cystic acne. The cystic acne had proved resistant to the antibiotic treatment that Dr. Myers had prescribed for Thomas's acne rosacea, so Dr. Myers decided to prescribe Accutane for Thomas. At a monthly check-up on February 23rd, Thomas reported experiencing dry skin and headaches as side effects of the Accutane. Dr. Myers prescribed a skin cream for the dry skin, but, because of success in treating Thomas's acne, maintained Thomas's Accutane treatment.
Several days later Dr. Myers received a telephone call from Thomas's daughter who told Dr. Myers that her mother was disoriented and confused. Dr. Myers met with Thomas the following day, took her off Accutane, and referred her to a local internist, Dr. Dill. Dr. Dill, in turn, referred Thomas to Dr. Lawrence Mahalak, a neurologist. Thomas was hospitalized on February 29, 1984, suffering from a fever and disorientation.
On March 6th, Thomas was transferred to the Mayo Clinic in Rochester, Minnesota. While at the Mayo Clinic, March 12th, Thomas suffered her first seizure. She recovered from her fever and was discharged on March 23rd. On discharge, Dr. William Swanson, the treating physician at the Mayo Clinic during her March stay, wrote that the cause of her illness was "uncertain although the course [of her illness] would be most compatible with some type of infectious etiology, most likely viral."
On May 16th, Thomas was again admitted to a local hospital, under the care of Dr. Mahalak, suffering from a fever and disorientation. She was diagnosed as having pneumonia. While in the hospital, Thomas suffered her second seizure. She was transferred to the Mayo Clinic on May 22nd. At the time of her transfer, Dr. Mahalak, in consultation with Dr. William Causey, an infectious disease expert, attributed the seizures to a recurrent central nervous system infection. Thomas recovered and was released from the Mayo Clinic on May 26th. At the time of her discharge from the Mayo Clinic, the neurologist in charge of her treatment, Dr. J.D Bartleson, stated that he was unable to reach a diagnosis.
In early June 1984, Thomas, again suffering from fever and disorientation, was admitted to the University of Southern Alabama Hospital under the care of Dr. William Kase, a board certified neurologist. She recovered from her symptoms and was released within four days.
In February of 1989, Thomas, again suffering from fever and disorientation, was admitted to a local hospital under the care of Dr. Mahalak. While in the hospital, she suffered a third seizure. Every expert who testified as to the cause of the 1989 seizure agreed that it was most likely caused by a virus, though a specific virus was neither isolated nor identified. The experts who expressed an opinion on the issue agreed that this third seizure was not related to the taking of Accutane in 1984. 2
At trial, Thomas introduced the testimony of three experts to establish that her use of Accutane had caused her 1984 seizures. Dr. O'Donnell, 3 an expert with a Ph.D. in Pharmacy, testified that he believed that Accutane did cause seizures in some patients, though he was not permitted to express his opinion as to whether the use of Accutane caused Thomas's seizures. Two physicians, Dr. Mahalak and Dr. William J. Riley, 4 testified that, to a reasonable degree of medical certainty, Accutane had caused Thomas's two 1984 seizures.
Hoffman-LaRoche introduced Thomas's contemporaneous medical records, and the testimony of four other physicians, Dr. Causey, Dr. Kase, Dr. Swanson, and Dr. Elias Chalhub. 5 The records and the testimony introduced by Hoffman-LaRoche consistently pointed to an infectious process as the most likely cause of Thomas's fevers and seizures.
Despite the fact that over a million patients had used Accutane at the time of trial, no epidemiological study was presented that would suggest a causal connection between Accutane and seizures. One epidemiological study was completed and available at the time of trial, but neither party introduced the study.
Before Dr. Myers prescribed the drug, Hoffman-LaRoche had made available to him information that the product had been effective in treating patients with acne, but warned that a number of side effects were common. With respect to Accutane, the 1983 version of the Physician's Desk Reference ("PDR") stated:
Because of significant adverse effects associated with its use, Accutane should be reserved for patients with severe cystic acne who are unresponsive to conventional therapy, including systemic antibiotics.
In addition to this general warning, the PDR description also warned of a number of specific side effects that had been observed in Accutane patients: cheilitis, conjunctivitis, musculoskeletal symptoms, rash, temporary thinning of hair, skin peeling, skin infections, nonspecific urogenital findings, nonspecific gastrointestinal symptoms, fatigue, headache, and increased susceptibility to sunburn. The 1983 PDR description noted that use of Accutane was contraindicated for pregnant women and for patients who are sensitive to parabens. 6 By January 1984, Hoffman-LaRoche had also provided specific warnings by letter concerning three other side effects observed in Accutane patients: pseudotumor cerebri, corneal opacities, and skeletal hyperostosis. 7 The company provided the same information in inserts in the packages containing the product. The plaintiff seeks recovery arguing that Accutane was unreasonably dangerous despite these extensive warnings because Hoffman-LaRoche failed to list seizures as one of the potential side effects.
The testimony at trial established that, at the time Dr. Myers prescribed Accutane for the plaintiff's acne condition, doctors had prescribed Accutane to some four hundred thousand patients, of whom nine had reported "seizures" 8 after using Accutane. A tenth seizure was reported to Hoffman-LaRoche in late January of 1984, several days after the plaintiff began her Accutane treatment. The evidence further established that, by May of 1989, over a million patients had been treated with Accutane. Forty-nine seizures had been reported.
Hoffman-LaRoche received these reports and forwarded them to the Food and Drug Administration. Because it was unclear whether these seizures were caused by the use of Accutane, Hoffman-LaRoche did not specifically mention seizures in its warning at the time Dr. Myers prescribed Accutane for the plaintiff. Hoffman-LaRoche added a reference to seizures in the 1985 PDR, and sent a "Dear Doctor" letter 9 in the spring of 1984, notifying physicians of the change in the PDR description. Even in the spring of 1984, it remained unclear whether these incidents were caused by the use of Accutane; as a result, Hoffman-LaRoche's warning stated only that seizures "ha[d] been reported in less than one percent of patients and may bear no relation to treatment".
At trial, Thomas presented the testimony of Dr. O'Donnell to support her position that the warning accompanying Accutane was inadequate and that an adequate warning would have prevented her injury. Dr. O'Donnell testified that the warning given by Hoffman-LaRoche was inadequate for two reasons. First, Hoffman-LaRoche should have warned of the possibility of a slight risk of seizures associated with the use of Accutane in the fall of 1983, instead of in the spring of 1984. Second, because of the overall level of risk associated with Accutane, the warning should have stated that use of the product is contraindicated for all patients other than those with severe cystic acne. 10
With regard to whether an adequate warning would have changed Dr. Myers's decision to use Accutane, Dr. O'Donnell first testified:
In my opinion, if the warnings were complete as I described them and the use in less than severe conditions of acne was contraindicated, a reasonable physician would not have prescribed [Accutane] for Mrs. Thomas.
Counsel for Hoffman-LaRoche objected, on the basis that the opinion assumed a diagnosis of Thomas's condition that was not supported by any credible evidence. 11 The trial judge sustained the objection, but, after discussion, permitted Dr. O'Donnell to testify on the issue, provided that he not refer to a diagnosis unsupported by the evidence. Dr. O'Donnell did so:
Q. Doctor, do you have an opinion as...
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