Opinion ID: 606706
Heading Depth: 2
Heading Rank: 2

Heading: Strict Liability-Defective Design

Text: 40 Under Kentucky law, the test for whether a product is in a defective condition and unreasonably dangerous to the user is whether an ordinarily prudent manufacturer, being fully aware of the risks, would have placed the product on the market. Nichols v. Union Underwear Co., 602 S.W.2d 429, 433 (Ky.1980). Plaintiff argues that the only way to decide whether an ordinarily prudent manufacturer would place a product on the market is to balance the product's risks, its harmful side effects, against its benefits. Defendant argues that Kentucky has never adopted the risk/benefit analysis proffered by plaintiff. To support its position, defendant cites Ingersoll-Rand, 775 S.W.2d at 932, where the Kentucky Court of Appeals stated it was disturbed by the risk/benefit analysis provided in a jury instruction. Defendant fails to note two critical points. 41 First, the Ingersoll-Rand court specifically stated that it was not expressing an opinion on the appropriateness of the risk/benefit analysis instruction in future cases, but that in the case before it such an instruction was not appropriate because [t]here was simply no evidence before the jury in this case which would allow the jury to evaluate the risks and benefits associated with the design and manufacture of [the product] in order for them to use this instruction in any meaningful way. Id. at 933. In the case at bar, evidence of the risks and benefits associated with ritodrine were a main focus of the case. Second, the jury in this case was not given a risk/benefit analysis instruction; it was given the standard strict liability instruction, approved in Kentucky. Thus, Ingersoll-Rand is inapplicable. 42 As summarized by the Kentucky Supreme Court, the standard for strict liability is formulated: 43 The manufacturer is presumed to know the qualities and characteristics, and the actual condition, of his product at the time he sells it, and the question is whether the product creates such a risk of an accident of the general nature of the one in question that an ordinarily prudent company engaged in the manufacture of such a product would not have put it on the market. 44 Montgomery Elevator, 676 S.W.2d at 780 (quoting Nichols, 602 S.W.2d at 433). In the context of her defective design claim, plaintiff's arguments regarding the weighing of the risks against the benefits of ritodrine were not improper, given the evidence presented in this case. The district judge did not instruct the jury to weigh the risks against the benefits, but only instructed them that ritodrine was in a defective condition unreasonably dangerous to the user if an ordinarily prudent manufacturer of such a drug, being fully aware of the risks associated with the use of ritodrine, would not have put the drug on the market. The instruction that was given is consistent with Kentucky law. 45 In a nutshell, plaintiff claims that oral ritodrine is bereft of benefits as far as improving neonatal outcome. 8 Weighing no benefits against the serious risks posed by the drug and suffered by the plaintiff, it is clear, plaintiff asserts, that the risks outweigh the benefits and thus no ordinarily prudent manufacturer would put the drug on the market. Astra maintains that oral ritodrine is effective in prolonging pregnancy, and therefore in improving neonatal outcome, and that the risks to maternal and fetal health associated with oral ritodrine are outweighed by the benefits of reducing neonatal morbidity and mortality. Astra also maintains that, because of FDA approval, ritodrine's effectiveness is not open to question. 46 Plaintiff's expert in this area was Dr. Mortensen. Dr. Mortensen, a pediatrician with a master's degree in pharmacology and trained in toxicology, reviewed the test results that were submitted to the FDA with the New Drug Application in 1974. Dr. Mortensen also reviewed several articles discussing betamimetic drugs in general and ritodrine in specific. Defendant objected to Dr. Mortensen being allowed to testify as an expert on these issues, but that objection was overruled. Defendant argues that Dr. Mortensen did not possess sufficient qualifications to testify regarding the efficacy of ritodrine. However, the two cases defendant cites in this regard are not helpful. Sterling v. Velsicol Chemical Corp., 855 F.2d at 1208, concerns the criterion for admission of expert testimony that it be in conformity to a generally accepted explanatory theory, not the required qualifications of an expert. Rohrbough v. Wyeth Laboratories, Inc., 916 F.2d 970, 975 (4th Cir.1990), also does not address the qualifications a person should possess to qualify as an expert. Dr. Mortensen has experience in clinical studies on the efficacy of drugs. Her testimony centered on the testing procedures used in various studies of the efficacy of ritodrine and the interpretation of the test results. Her testimony on the clinical studies investigating ritodrine was properly allowed. 47 Before addressing the arguments concerning efficacy, we must first address whether plaintiff should have been allowed to litigate the efficacy issue at all. Defendant argues that [p]laintiff should not have been permitted to litigate this issue, because it is a mockery of the scientific analysis employed by the FDA and the Advisory Committee which conclusively found that ritodrine was efficacious. We reject the argument that FDA approval preempts state product liability claims based on design defect. While this circuit has not directly ruled on whether a plaintiff in a product liability action may litigate an FDA finding that a drug is efficacious, the Fifth Circuit has ruled that the Food, Drug and Cosmetic Act, 21 U.S.C. § 301 et seq., does not preempt state law claims based on defective design. Hurley v. Lederle Lab. Div. of Am. Cyanamid Co., 863 F.2d 1173, 1176-77 (5th Cir.1989). In so holding, the Fifth Circuit reversed the district court's finding of preemption, noting that the great majority of United States district courts which have addressed this issue have ruled against preemption. Id. at 1176 (footnote omitted). 48 FDA approval is evidence which the jury may consider in reaching its verdict. The jury may weigh FDA approval as it sees fit, especially in a case where the plaintiff has presented evidence to support an articulable basis for disregarding an FDA finding--in this case the finding that ritodrine was effective. Tobin presented an articulable basis for disregarding the FDA's finding that ritodrine was effective in improving neonatal outcome: the individual studies relied on by the FDA were insufficient to support a finding of efficacy as found by the FDA Advisory Committee, and the pooled data requested by the Advisory Committee was statistically invalid. 49 To understand the arguments of the parties concerning ritodrine's effectiveness, it is necessary to review the New Drug Application that was submitted to the FDA and the results of the required clinical trials, along with subsequent articles that have been published discussing ritodrine. Approval of a new drug by the FDA requires a showing of substantial evidence of efficacy based upon adequate and well-controlled studies. The required clinical studies on ritodrine consisted of Phase I (16 studies in healthy patients to determine safety), Phase II (5 studies in preterm labor patients to determine efficacy), and Phase III (11 studies in preterm labor patients comparing ritodrine patients to non-ritodrine controls to determine safety and efficacy). 50 The clinical trials were designed to measure a gain in days in the length of pregnancy as a measure of efficacy under the assumption that any increase in the gestational period would reduce neonatal morbidity and mortality. The Phase III studies consisted of tests of oral ritodrine's effectiveness based on three separate testing procedures: a placebo series, in which oral ritodrine was compared to the use of a placebo; an ethanol series comparing ritodrine to the use of ethanol; and a series referred to as the Creasy studies, in which all patients were treated with injections of intramuscular ritodrine and then half received oral maintenance doses of ritodrine while the other half received placebos. In the Creasy studies, any recurrences of premature labor were treated with injections of intramuscular ritodrine. 51 After the data from these studies was submitted to the FDA, the FDA Advisory Committee on Fertility and Maternal Health Drugs found that the required clinical trials failed to demonstrate efficacy. Specifically, the tenor of the committee was that there was not substantial data to support the efficacy of ritodrine for the treatment of premature labor. The Advisory Committee found that three of the Phase III placebo-controlled studies were flawed because they included women who were not actually in preterm labor. Because the remaining individual studies did not have a sufficient number of patients to establish statistical significance regarding improvement in neonatal outcome, the Advisory Committee requested the data be pooled and resubmitted. The initial data was presented in terms of gain in days; it did not include statistics on neonatal outcome or mortality. The Advisory Committee requested that, when the data was resubmitted, it should include such information. The manufacturer was asked to pool the data from all the studies for an all-patient analysis; stratify all of the patients by gestational age; and analyze neonatal mortality, birth weight, and the incidence of respiratory distress syndrome. 52 Dr. Peter, who participated in the proceedings before the FDA, testified at trial that this pooled data does not represent statistically valid results. Dr. Barden, one of Astra's experts, said he was not surprised that one of the members of the Advisory Committee stated the pooled studies were not statistically valid, 53 [b]ecause the problem with the pooled studies, as you well know, were that some of the patients had rather than placebo, the treatment with ethanol or alcohol, which is another treatment of premature labor. So that tends to mean that by pooling the data, they were mixing apples and oranges in a sense. 54 Comments made by various members of the Advisory Committee recognized the inappropriateness of pooling data: So, strictly speaking, the statistical tests are not valid for the pooled studies. The statistical tests would presume that the groups randomized were similar in every respect but for the treatments received, and here we have a combination of different controls and different treatment regimens for ritodrine patients. Dr. Little of the committee commented that obviously, it is not reasonable to pool data. Yet, on the basis of the originally submitted data, which the Advisory Committee had found did not contain substantial evidence to support a finding of efficacy, and the newly reworked data, the committee recommended approval. 55 The FDA made its own determination regarding efficacy. FDA regulations require that efficacy be established by at least two 'adequate and well-controlled' studies. Warner-Lambert Co. v. Heckler, 787 F.2d 147, 151 (3d Cir.1986). The FDA determined that four studies of the Phase III studies met this test, and approved ritodrine in 1980. The four studies are referred to by the names of the project leaders: Fuchs, Barden, Creasy, and Sivasambo. Plaintiff introduced evidence regarding the methodology and conclusions of each study. 56 In the Fuchs study, the control group of mothers were treated with intravenous ethanol and no follow-up, while ritodrine patients were given initial intravenous doses of ritodrine and follow-up oral doses. The control group was further along in gestation based on each mother's last menstrual period, and the group was found to be in more advanced labor, in that they were more dilated, than the ritodrine group. The Sivasambo study compared ritodrine to librium, which according to recent studies actually increases uterine activity. The Creasy study, described above, did not have an adequate control group, in that all patients were given intramuscular injections of ritodrine at the onset of premature labor and again if contractions returned. In a later publication, Dr. Creasy stated that further studies have not proved that oral maintenance will decrease the incidence of preterm birth.... [T]hey do show that such an approach will decrease the need for repetitive hospitalization, thus improving the overall quality of life for the remainder of the pregnancy. The final study relied on by the FDA, the Barden study, involved a total of only 25 patients--some given oral ritodrine and others given a placebo. 57 Astra's evidence focused on the effect of oral ritodrine in prolonging the term of pregnancy, and then separately showed that extending the term of pregnancy improves neonatal outcome. Plaintiff refuted this claim with evidence that, while ritodrine may produce a short-term gain in prolonging pregnancy, there is no evidence of improved neonatal outcome. Plaintiff introduced articles written after the FDA approval. One of those articles concluded that the lack of any suggestion of an effect on [neonatal] mortality and respiratory morbidity remains noteworthy, particularly given the clear short-term effect of tocolytic treatment on duration of gestation. James F. King et al., Beta-mimetics in preterm labour--an overview of the randomized controlled trials, 95 British Journal of Obstetrics and Gynecology 211, 220 (1988). Other articles have come to similar conclusions: 58 Although ritodrine treatment delayed delivery for 24 hours, it did not significantly modify the ultimate perinatal outcomes after preterm labor. These observations may be explained by the recent reports that describe ... [beta]-agonist uterine-relaxant effects are too transient to impede preterm labor significantly; the national data on the incidence of LBW [low birth weight] infants provide further support for this observation. 59 Kenneth J. Leveno et al., The National Impact of Ritodrine Hydrochloride for Inhibition of Preterm Labor, 76 Obstetrics and Gynecology 12, 14 (1990). 60 The results with ritodrine are imprecise and uncertain and not worth the risk of a major reaction. 61 .... 62 Despite the use of betamimetics in Europe for about 20 years, there is no objective evidence that the incidence of prematurity has been reduced. The same statement holds in the United States after 8 years of use. 63 .... 64 Ritodrine is a very potent drug that has side effects that are extremely disturbing and may be lethal. 65 Edward A. Garber et al., Dilemmas in the Pharmacological Management of Preterm Labor, 44 Obstetrical and Gynecological Survey 512, 514-16 (1989). 66 In diversity actions, state law governs the grants and denials of motions for j.n.o.v. Bank of Cumberland v. Aetna Casualty & Surety Co., 956 F.2d 595, 597 (6th Cir.), cert. denied, --- U.S. ----, 113 S.Ct. 204, 121 L.Ed.2d 146 (1992). In evaluating a JNOV under Kentucky law a trial court is required to consider the evidence in the strongest possible light in favor of the party opposing the motion and must give the opposing party the advantage of every fair and reasonable inference that can be drawn from the evidence. Id. As a question of law, we review de novo the grant or denial of a motion for j.n.o.v. See Toth v. Yoder Co., 749 F.2d 1190, 1194 (6th Cir.1984). 67 We do not sit to review the findings of the FDA; our only role in this appeal is to decide if there was sufficient evidence on which the jury could base its verdict. Plaintiff introduced evidence, through the cross-examination of Astra officials, that a reasonably prudent manufacturer would not market ritodrine if the evidence of its efficacy was inconclusive. Plaintiff also introduced sufficient evidence regarding the various clinical studies concerning the efficacy of ritodrine. The jury found that ritodrine, as manufactured and marketed by Astra, was in a defective condition and unreasonably dangerous to plaintiff. We find that there was sufficient evidence before the jury to conclude that a prudent manufacturer knowing all the risks would not market ritodrine. 68 Defendant argues that if the warning accompanying ritodrine was adequate then it cannot be held strictly liable. The cases cited by defendant to support its position, that a drug manufacturer should be shielded from liability, so hold based on comment k of the Restatement (Second) of Torts § 402A. Comment k provides that the seller of unavoidably unsafe products is not to be held to strict liability for unfortunate consequences attending their use.... For comment k to apply, however, the product must be an apparently useful and desirable product. It is the useful or effective nature of ritodrine which plaintiff has called into question. Kentucky has ruled that comment k shields manufacturers from liability for highly useful and desirable product[s] attended with a known but reasonable risk. McMichael v. American Red Cross, 532 S.W.2d 7, 9 (Ky.1975) (citing comment k). A drug that prolongs pregnancy in order to reduce infant morbidity and mortality, if effective, is a highly useful and desirable product. 9 Plaintiff, however, has attacked the linchpin of this theory--effectiveness--with various evidence. The jury was instructed: 69 A product such as ritodrine is not in a defective condition unreasonably dangerous if it cannot be made completely safe for all users, but is nevertheless a useful and desirable product which is accompanied by proper directions and warnings. 70 The jury verdict rejecting this argument is supported by the evidence that was presented.