Opinion ID: 1613536
Heading Depth: 1
Heading Rank: 6

Heading: adverse reactions

Text: ... Drowsiness, ataxia and confusion have been reported in some patients particularly the elderly and debilitated.... Other adverse reactions reported during therapy include isolated instances of skin eruptions, edema, minor menstrual irregularities, nausea and constipation, extrapyramidal symptoms as well as increased as increased and decreased libido. ¶ 39. The Librax package insert listing, also manufactured by Hoffmann-LaRoche, is nearly identical to that for Librium. Klonopin, the third prescription drug manufactured by Hoffmann-LaRoche, was prescribed for myoclonic jerks, and informs that it should not be used by patients with a history of sensitivity to benzodiazepines, or by patients with clinical or biochemical evidence of significant liver disease. It warns that Klonopin produces CNS depression and side effects in pregnancy and should not be used when engaging in hazardous occupations requiring mental alertness. Lastly, the package insert for Prozac, manufactured by Eli Lilly, which is barely legible in the record, cautions that it causes anxiety, insomnia, seizures, weight loss, etc., and warns of rashes and possible allergic events. ¶ 40. Bennett submitted adverse drug printouts generated by the United States Food and Drug Administration concerning Prozac, Prozac and Klonopin, and Prozac and Librium. Reactions include dementia, paranoid psychosis, manic reaction, restlessness, hallucinations, hostility, schizophrenic effect, suicide attempts, and injury intent. Bennett contends that, because the FDA reports detailed adverse drug reactions and indicated adverse reactions, individually and in combination, prior to Jake's killing his wife, there is evidence of design defect and failure to warn. ¶ 41. Eli Lilly and Hoffmann-LaRoche argue that Bennett's strict liability/negligence claims must fail because Dr. Ali testified that he would not have done anything differently had different warnings been given. Specifically, when asked whether he had any criticism of the companies or of the drugs, whether he was familiar with the package inserts, whether he had any criticisms of the warnings contained in the package inserts, and whether there was anything either company could have said or done that would have changed his decision at that time, Dr. Ali responded no, yes, no, and no, respectively. In granting summary judgment in favor of Eli Lilly, the circuit court's only finding as to the adequacy of the warning was as follows: Dr. Ali testified in his deposition that he was familiar with the Prozac package insert in effect at the time he prescribed Prozac for Jake Bennett and that he has no criticism of the warnings and instructions it contains. Lilly's warning to Dr. Ali is adequate as a matter of law, and Lilly is entitled to summary judgment on plaintiff's negligent failure to warn claim. ¶ 42. The United States Court of Appeals for the Fifth Circuit, however, has held that, although a doctor testifies that he considers a warning to be adequate, this testimony does not dispose of the question. Hurley v. Lederle Labs. Div. of Am. Cyanamid Co., 863 F.2d 1173, 1178 (5th Cir.1988). Although his testimony is competent on the issue, the adequacy of the warning is not a matter that can be conclusively resolved solely on the basis of the administering physician's opinion. Id. ¶ 43. Eli Lilly and Hoffmann-LaRoche make much of the fact that Bennett had been prescribed, without adverse effects, Klonopin, Librium and Librax for several years prior to being treated by Dr. Ali. This argument ignores Bennett's claim that it was the combination of these drugs with Prozac that caused Bennett's violent outburst. Bennett submitted affidavits from two doctors asserting that to a reasonable degree of medical certainty Prozac, in combination with Librium, Librax and Klonopin, produced a loss of impulse control, rage, with delusions and psychosis leading to the killing of his wife. Dr. Cole testified: A minimally competent physician would not have prescribed only Prozac or Prozac and Benszodiazopines (such as Klonopin, Librium, and Librax) together if the drug manufacturers Eli Lilly and company and/or Hoffmann-LaRoche, Inc., had medically warned of side effects of uncontrollable anger, violent behavior, delusions, and psychosis. Prozac was and is an extremely dangerous drug and Prozac taken together with Bezodiaphines (such as Klonopin, Librium and Librax) causes patients aggravation and side effects of uncontrollable anger, rage, violent behavior, delusions and psychosis. Eli Lilly and Co. Inc., and Hoffmann-LaRoche, Inc., respectively failed to conduct adequate human studies concerning Prozac only and Prozac and Benzodiazepines taken together (such as Klonopin, Librium and Librax) and their interactions and side effects. ¶ 44. Similarly, Dr. Sarah Deland testified by affidavit that Eli Lilly and Hoffmann-LaRoche, failed to adequately disclose in 1994 the side effects of Prozac; and Librium, Librax and Klonopin when taken together with Prozac. That within a reasonable degree of medical certainty, that in this case, Prozac did cause or contributed to causing psychosis, paranoid ideation, confusion, akathisia agitation, suicidal ideation, antisocial behavior, and violent reactions in Jake Bennett resulting in the death of his wife Jo Bennett.... The warnings in the 1994 Physicians Desk Reference were inadequate because medical articles prior to 1994 showed violent reactions and suicide tendencies in some patients to Prozac. ¶ 45. The only evidence supporting the drug companies' contentions to the contrary are the package inserts in the record, which have no accompanying explanations. ¶ 46. Because Dr. Ali's testimony regarding the adequacy of the warnings was, as a matter of law, not conclusive of the issue, and because Bennett produced evidence that the warnings were not adequate, we find that the circuit court erred in granting summary judgment on the adequacy of the warnings issue. 3. Causation ¶ 47. The Fifth Circuit, applying Mississippi law, has said plaintiffs must establish, by the preponderance of the evidence, both: (1) that an adequate warning would have prevented the treating physician from administering the drug; and (2) that the injury would not have occurred had the drug not been administered. Thomas, 949 F.2d at 814. To satisfy this burden of proving causation, a plaintiff may introduce either objective evidence of how a reasonable physician would have responded to an adequate warning, or subjective evidence to establish how the treating physician would have responded. Id. ¶ 48. Again, Eli Lilly and Hoffmann-LaRoche argue that Bennett fails to show that Dr. Ali would have acted differently. This is a compelling argument because it suggests no proximate cause exists between the manufacturers' failure to warn and Bennett's reactions to the prescription drugs. Odom v. G.D. Searle & Co., 979 F.2d 1001, 1003-04 (4th Cir.1992) (summary judgment appropriate where physician testified a different warning, one advising physicians not to prescribe an intrauterine device to women who might later want children, would not have changed his decision to prescribe the device); Willett v. Baxter Intern., Inc., 929 F.2d 1094, 1098-99 (5th Cir.1991) (alleged failure to warn of less than one percent increase in the risks associated with heart valve replacement was not the proximate cause of plaintiff's fear of future heart valve failure where the only reasonable conclusion is that an adequate warning would not have affected the physician's decision to proceed with the surgery); Kirsch v. Picker Intern., Inc., 753 F.2d 670, 671-73 (8th Cir.1985) (manufacturer's failure to warn of potential risks associated with radiation therapy for the treatment of acne was not the proximate cause of plaintiff's injuries where treating physician was aware of the risks). ¶ 49. The weight to be afforded such affidavit or testimony, however, depends on the substance of the evidence as well as the credibility and reliability of the treating physician himself. Woulfe v. Eli Lilly & Co., 965 F.Supp. 1478 (E.D.Okla.1997). Though Eli Lilly and Hoffmann-LaRoche contend the affidavits from Bennett's experts cannot create a genuine issue of material fact in the face of Dr. Ali's undisputed and unequivocal testimony, Bennett, relying upon the objective standard for proving warning causation, directs the court to his expert doctors' testimony that a minimally competent physician would have acted differently towards an adequate warning. Grenier v. Medical Eng'g Corp., 243 F.3d 200 (5th Cir.2001) (citing Thomas ) (applying Louisiana law) (the evidence of what the affiant personally would have done cannot suffice to prove causation under the learned intermediary doctrine, as a plaintiff, in order to show causation, may introduce either objective evidence of how a reasonable physician would have responded to an adequate warning, or subjective evidence of how the treating physician would have responded). ¶ 50. Because Dr. Ali's testimony that he would not have done anything differently had other warnings been given is subject to a credibility determination, we find that the circuit court erred in granting summary judgment on causation. B. Breach of Implied Warranty of Merchantability and Implied Warranty of Fitness for a Particular Purpose. ¶ 51. The Mississippi Products Liability Act (the MPLA) provides that a manufacturer may be held liable when the product breaches an express warranty or fails to conform to other express factual representations upon which the claimant justifiably relied in electing to use the product. Miss.Code Ann. § 11-1-63(a)(i)(4) (Supp. 2001). Bennett argues that Eli Lilly and Hoffmann-LaRoche both breached implied warranties of merchantability and fitness for a particular purpose. Eli Lilly and Hoffmann-LaRoche insist, however, that Bennett's implied warranties claims are without merit because the MPLA contains no provision for recovery based on breach of an implied warranty, see Miss.Code Ann. § 11-1-63 (Supp.2001), only express warranties. ¶ 52. A United States District Court applying Mississippi law has held, however, that though the MPLA creates a cause of action in tort for breach of express warranty, it does not preclude the breach of implied warranty claims under the Mississippi Uniform Commercial Code in products liability actions. Miss.Code Ann. § 75-2-715. In re Rezulin Prods. Liab. Litig., 133 F.Supp.2d 272, 279 n. 3 (S.D.N.Y.2001) (citing Childs v. General Motors Corp., 73 F.Supp.2d 669 (N.D.Miss. 1999)). In other words, the MPLA does not abrogate a statutory cause of action for breach of implied warranty as grounds for recovery. Miss.Code Ann. §§ 11-1-63, 75-2-715. Generally speaking, a new statute will not be considered reversing long-established principles of law and equity unless the legislative intention to do so clearly appears. Thorp Comm. Corp. v. Miss. Road Supply Co., 348 So.2d 1016, 1018 (Miss.1977). Accord, Taylor v. General Motors Corp., 1996 WL 671648, at  (N.D.Miss.1996). In Taylor, as well as in the case at bar, the manufacturer relied only on the first sentence of the Act to support their argument that a breach of implied warranty claims are not recognized by the Act. If the Legislature had intended to restrict an implied warranty claim, it would have done so. Id. at 672. ¶ 53. We find, therefore, that the circuit court erred in finding Bennett was precluded from maintaining a breach of implied warranty cause of action. ¶ 54. Worth noting, however, is the fact that Bennett makes no supporting argument in support of his breach of implied warranty claims. One court has held, however, that inadequate warnings alone can constitute a product defect, whether the theory be implied warranty or strict liability in tort. Smith v. E.R. Squibb & Sons, Inc., 405 Mich. 79, 273 N.W.2d 476 (1979). Further, though we have held that a breach of warranty theory cannot be submitted to the jury without both proof of a defect and proof that such defect caused the injury, Crocker v. Sears, Roebuck & Co., 346 So.2d 921 (Miss.1977), we have previously found that a genuine issue of material fact exists as to causation. ¶ 55. Eli Lilly and Hoffmann-LaRoche argue that under the learned intermediary doctrine, Kevin cannot recover for any alleged implied representations purportedly relied on by Jake. They contend that their duty under the learned intermediary doctrine is based on the information they provide the prescribing physician, not the patient. They do not, however, cite any authority for this proposition. Though the learned intermediary doctrine has been applied to a breach of implied warranty case, Talley v. Danek Med., Inc., 7 F.Supp.2d 725 (E.D.Va.1998), aff'd, 179 F.3d 154 (4th Cir.1999), the learned intermediary doctrine relates only to the issue of whom the manufacturer warned. It does not govern the adequacy of the warning. Hurley, 863 F.2d at 1178. ¶ 56. Bennett alleged design defect claims and though he does not raise this as an issue on appeal, both Eli Lilly and Hoffmann-LaRoche address the issue. The circuit court dismissed this claim based on our adoption of Restatement (Second) of Torts, § 402, cmt. K. State Stove Mfg. Co. v. Hodges, 189 So.2d 113, 118 (Miss.1966). Comment K to § 402 A shields unavoidably unsafe products, such as prescription drugs, from strict liability and provides in pertinent part: 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 especially common in the field of drugs.... Such a product, properly prepared, and accompanied by proper directions and warning, is not defective, nor is it unreasonably dangerous.... The seller of such products ... is not to be held to strict liability for unfortunate consequences attending their use, merely because he has undertaken to supply the public with an apparently useful and desirable product, attending with a known but apparently reasonable risk. ¶ 57. The circuit court found that the drugs were unavoidably unsafe products within the meaning of Comment K, and that Comment K, as a matter of law, bars Bennett's strict liability design defect claim. The Fifth Circuit has stated, however, that, under Comment K, liability would be imposed only when the drug is not properly prepared, properly marketed, or accompanied by proper warnings. Swayze, 807 F.2d at 468 (applying Mississippi law) (emphasis added). Comment K, further, is an affirmative defense. Freeman v. Hoffman-LaRoche, Inc., 260 Neb. 552, 618 N.W.2d 827 (2000). It does not provide a blanket immunity from strict liability for prescription drugs, id., as not all prescription drugs are unavoidably unsafe. Feldman v. Lederle Labs., 97 N.J. 429, 479 A.2d 374 (1984). Though Comment K has been interpreted in a variety of ways in other jurisdictions, and there has been a wide range of disagreement regarding its application, id., we find that the circuit court erred in this finding. ¶ 58. We find that the circuit court erred in granting summary judgment on the issue of breach of implied warranties.