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Mass Tort Update
THOMAS vs. HOFFMAN LA ROCHE
Verdict Date: June, 1989;
Result: $ 1,000,000 verdict
State: Mississippi
Facts: This was a pharmaceutical products liability action brought by a 59-year-old female plaintiff who allegedly suffered severe drug- induced encephalopathy after she was prescribed Accutane by her treating dermatologist for treatment of an acne rosacea condition. The plaintiff became severely disoriented after taking the drug for approximately 30 days and although the drug was stopped, her condition continued to deteriorate, whereupon she suffered multiple seizures and lapsed into a temporary coma. The plaintiff suffered two more similar episodes in the months following, but eventually recovered, although she continues to suffer from a permanent pre-disposition to experiencing seizures allegedly stemming from the accutane-induced encephalopathy. The plaintiff's cause of action against the defendant pharmaceutical company proceeded on a products liability failure to warn theory. The plaintiff contended that the defendant pharmaceutical company failed to provide adequate instructions and warnings in its product literature and information to physicians prescribing the drug Accutane. Specifically, the plaintiff alleged that the defendant's informational literature failed to include seizures as a potential risk associated with the use of Accutane, and failed to specifically advise physicians that the drug was approved and intended for use only in the treatment of severe cystic acne and was contraindicated for use in the treatment of relatively minor skin conditions such as acne rosacea. The plaintiff claimed damages for three episodes of drug-induced encephalopathy and a permanent residual seizure disorder. The plaintiff further alleged economic loss based upon the testimony establishing that she was forced to give up her lucrative tupperware distributorship during the time period she was incapacitated due to the subject illness. The plaintiff had originally brought suit against the defendant treating dermatologist on the basis that he negligently prescribed Accutane to treat acne rosacea, a relatively minor condition for which this very Dangerous Drug is contraindicated. This defendant settled out of the case prior to trial for $ 75,000. In January of 1984, the plaintiff, then 54 years old, was prescribed the drug Accutane by her treating dermatologist. At the time, she was suffering from a recurring acne rosacea which her treating dermatologist had treated with tetracycline from time to time. The plaintiff testified that the doctor recommended Accutane, advising that it could possibly cure her condition. After 30 days on the drug, the plaintiff began to become severely disoriented. The plaintiff's daughter took the plaintiff back to the treating dermatologist, who advised her to stop taking the drug and referred her to a neurologist, who immediately hospitalized her. While hospitalized in Jackson, Miss., the plaintiff's condition deteriorated, she experienced multiple seizures and became mute. The plaintiff was transferred to the Mayo Clinic where she was diagnosed as suffering from viral encephalitis. At the Mayo Clinic, the plaintiff lapsed into a coma from which she eventually recovered, following which she experienced a rapid improvement. Two months later, the plaintiff experienced a recurrence of the previous neurologic symptomatology, including multiple seizures.
The episode subsided and the plaintiff's condition again stabilized for approximately one month, whereupon she again experienced a recurrence of the same neurologic symptomalogic pattern. After sorting through all the plaintiff's test results, the plaintiff's treating neurologist linked the plaintiff's symptoms to Accutane and determined that she had suffered an accutane-induced encephalopathy. The encephalopathy has not recurred, but the plaintiff suffers from a permanent seizure disorder requiring that she be maintained on anti-seizure medication indefinitely. The plaintiff contended, through expert testimony offered by the plaintiff's treating neurologist, that Accutane was the cause of the plaintiff's episodes of encephalopathy and residual seizure disorder. The plaintiff additionally presented a neurologist who had previously treated a patient who suffered neurological complications after ingesting Accutane, who opined that the plaintiff's problems were caused by Accutane. The plaintiff's expert pharmacologist testified that the drug has been known to cause seizures in certain individuals. The defendant's medical experts, one of whom had treated the plaintiff, asserted that the cause of the plaintiff's condition was viral in nature and that the symptoms exhibited by the plaintiff was most consistent with viral encephalitis. These experts admitted, however, that viral encephalitis is usually not a recurring condition and one of the expert's conceded that he had never himself seen a patient suffering from viral encephalitis where the condition recurred at a later point in time. The defendant, however, offered evidence indicating that Accutane has a relatively short half-life and argued that the recurring nature of the plaintiff's problems was not consistent with the type of reaction one would expect. The plaintiff further contended that the warnings and advisements set forth in the product informational literature in 1984 were inadequate in that they failed to make mention of the risk of seizures associated with the drug of which they knew or should have known based upon the available medical information at the time. In this regard, the plaintiff pointed to the defendant's own adverse experience reports which the plaintiff contended established that the defendant was aware of a possible link between Accutane and seizures. The defendant countered that the information contained in the adverse experience reports cited by the plaintiff was inconclusive and that in 1984, the defendant had received only ten adverse experience reports concerning Accutane, which the defendant argued was an insufficient number to prompt a modification of its literature. The plaintiff further maintained that the 1984 product literature failed to specifically advise physicians that this potentially Dangerous Drug was contraindicated for use in treatment of relatively minor skin conditions and indicated for use only in severe cases of cystic acne, a condition for which there is no other known cure. The plaintiff maintained that the treating dermatologist was unaware, through his own educational sources, of the potential link between Accutane and seizures and that had he been made aware of this risk, he would not have prescribed the drug.
The defendant pharmaceutical company elicited testimony from the treating dermatologist to the effect that he subscribed to the Dermatological Journal, which published an article prior to 1984 of which Accutane was the subject matter and which mentioned seizures as possibly linked to the use of the drug. The physician testified that he read the Dermatological Journal regularly and would have read the article in question. On cross-examination by plaintiff's counsel, the physician could not recall any of the other articles which appeared in the particular issue cited by the defendant. The treating neurologist testified as to the adverse reaction suffered by the plaintiff involving severe neurologic symptoms including disorientation, inability to speak, multiple seizures, followed by a coma from which she eventually recovered. The reaction recurred in a substantially similar manner on two subsequent occasions and the plaintiff has since recovered, although she suffers from a permanent predisposition to seizures requiring that she be maintained on anti-seizure medication indefinitely. The evidence indicated that the plaintiff condition improved and remained normal for five years following the third episode and that after a bout of the flu, she again experienced a seizure. The plaintiff testified that she was forced to sell her lucrative tupperware distributorship due to the fact that she was unable to work for six months while she was ill, and the plaintiff claimed damages for income lost as a result of having to give up the business. The plaintiff's expert economist calculated a lost income figure reduced to present value of $ 500,000 if the plaintiff had worked until age 60 and $ 750,000 if the plaintiff had worked until age 65.
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