William C. McBride v. Merrell Dow and Pharmaceuticals Inc., an Ohio Corporation

Citations: 717 F.2d 1460; 230 U.S. App. D.C. 403; 9 Media L. Rep. (BNA) 2225; 1983 U.S. App. LEXIS 16533Docket: 82-1786

Court: Court of Appeals for the D.C. Circuit; September 27, 1983; Federal Appellate Court

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William C. McBride, an Australian teratology expert, appeals the dismissal of his defamation claim against Merrell Dow Pharmaceuticals and others, stemming from an article in Science magazine titled "How Safe Is Bendectin." The Circuit Court reviews the case under District of Columbia defamation law, concluding that McBride's complaint sufficiently states a claim for relief. The court references Herbert v. Lando, emphasizing that First Amendment concerns do not warrant heightened pleading standards in defamation cases. While affirming most of the lower court's ruling, the appellate court reverses part of the dismissal, noting the potential for meritless claims to burden journalism. The article in question purportedly undermined McBride's credibility by suggesting that expert testimony against Bendectin was unconvincing, echoing sentiments from an FDA panel member. The court underscores the need for the district court to manage the remand carefully to protect against frivolous litigation while preserving journalistic freedoms.

William McBride, an expert witness from Sydney's Women's Hospital, was compensated at $5,000 per day to testify in Orlando, contrasting with Richardson-Merrell's payment of $250 to $500, with a maximum of $1,000 per day. McBride was among the first to link thalidomide to birth defects and claimed that Bendectin caused malformations in David Mekdeci. His focus on thalidomide at an FDA meeting led to comments from Avery, who acknowledged McBride's stance while stressing the need to focus on Bendectin. Beverly Paigen from Roswell Park Memorial Institute also testified for Belli. The complaint alleges that McBride's reputation and standing as a medical scientist were harmed by three types of false and defamatory statements: linking him to attorney Melvin Belli, contrasting his pay with that of Richardson-Merrell's witnesses, and suggesting he lacked knowledge during FDA testimony. It further claims defendant Irvine acted as a paid public relations agent for Merrell Dow, spreading misinformation to undermine McBride and influence public perception. The complaint asserts that defendants acted with "actual malice" and without a genuine belief in the truth of their publication. Although Science magazine published a correction, it was deemed insufficient by the plaintiff. The complaint seeks significant damages. The district court dismissed the case with prejudice, ruling that the article could not be interpreted as defamatory, according to legal standards that define defamation based on the potential to harm one's professional standing. An identical lawsuit was also dismissed in D.C. Superior Court prior to this case, with that court indicating it would have dismissed on the merits had the earlier opinion not been issued.

The district court evaluated three alleged defamatory aspects of an article concerning Dr. McBride. It accepted Dr. McBride's assertion that he had never met Melvin Belli and acknowledged that the article incorrectly implied Dr. McBride was a witness for Belli in a Florida trial. However, the court found no implication of Belli engaging in any improper conduct, ruling that mere association with a controversial figure like Belli does not constitute defamation. 

Regarding the claim about Dr. McBride's $5,000 daily fee for testimony, the court concluded that the fee itself was not defamatory, suggesting it indicated professional success rather than a lack of integrity. The court highlighted that Dr. McBride's own admission of earning $1,116 per day—higher than other experts—contradicted any implication of impropriety.

For the third allegation, which suggested Dr. McBride lacked knowledge, the court determined that Avery's comments indicated McBride's analysis was unconvincing rather than implying ignorance. Even if Avery had asserted Dr. McBride was ignorant, the court stated such a claim would be a non-defamatory opinion. Ultimately, the court found that none of the article's statements could reasonably be construed as disgraceful or subjecting Dr. McBride to public ridicule, agreeing that two of the three defamation claims were without merit.

Dr. McBride was considered a witness for litigants represented by Belli, despite Belli not appearing at the trial and the two never having met. Thus, it is accurate to state that McBride was one of Belli's witnesses, but even if this were incorrect, it would not be defamatory. Remarks made by Dr. Avery at an FDA panel hearing are not actionable since McBride did not claim they were reported inaccurately. The comments suggested that McBride was unnecessarily lengthy in discussing thalidomide's dangers, which is not a defamatory conclusion. Furthermore, these remarks may be protected under D.C. law as reports of official proceedings. 

Contrarily, a statement that McBride was paid $5,000 a day to testify in a Florida trial could carry a defamatory implication, suggesting that his testimony was for sale due to the weakness of the plaintiffs' case. The standard for dismissing a complaint under Fed. R. Civ. P. 12(b)(6) is stringent; a complaint should not be dismissed unless it is clear that no facts could support the claim for relief. McBride asserts that the district court misapplied this standard by suggesting that an article could not be read as defamatory if it also had a non-defamatory interpretation. Under D.C. defamation law, a court's ability to rule a statement as non-defamatory is limited to cases where it cannot be reasonably understood in a defamatory sense. First Amendment considerations do not influence this determination at the pleading stage. Since there is a possibility that a reasonable person might interpret the article as conveying defamatory meanings, the decision is reversed. Establishing defamation does not require proof of prejudice among all community members; a publication can be defamatory if it lowers the plaintiff's standing among a substantial, respectable minority of their associates.

Dr. McBride is not definitively claimed to have been defamed, as the fee statement regarding the $5,000 payment for one day of testimony is partially accurate; however, McBride perceived this payment as compensation for five days away from his practice. The potential defamatory implications of the fee statement are acknowledged, but McBride's complaint may fail unless he demonstrates actual malice, which requires proof of knowledge of falsity or reckless disregard for the truth, as established in New York Times Co. v. Sullivan. It is probable that Dr. McBride is considered a public figure due to his international recognition in teratogenics and his active participation in controversial public debates, particularly regarding Bendectin and thalidomide. His involvement in these debates, including testifying before the FDA and in legal cases, indicates that he has thrust himself into public controversies, inviting both positive and negative commentary. The heated nature of the Bendectin discussion, which involved significant public interest and political implications, suggests that individuals in such roles should expect critical discourse. The only aspect that may prevent the dismissal of McBride's complaint is the allegation that the fee statement was a deliberate falsehood intended to harm his reputation. Although the credibility of this claim may be questioned, McBride is entitled to present evidence to support it.

Contemporary libel law poses significant challenges to journalistic independence, with potential libel suits leading to self-censorship among writers and publications due to the risks and costs of litigation. It is important to control frivolous suits to protect press freedom, advocating for limited discovery focused on questions relevant to sustaining summary judgment. Justice Powell's concurrence in Herbert v. Lando emphasizes the need for district courts to balance First Amendment interests with the plaintiff's private interests in libel cases involving public figures. District of Columbia law supports the use of summary procedures in libel actions, as established in Nader v. de Toledano, which highlights the efficiency of summary judgment in conserving resources and reducing misuse of the legal system. The court underscores that these considerations are particularly vital in cases involving public officials or figures due to the threat to First Amendment freedoms. The Washington Post Co. v. Keogh decision is cited to illustrate the necessity of summary procedures to prevent harassment that could inhibit free debate and lead to widespread self-censorship. The case's outcome may be influenced by a related lawsuit filed by Dr. McBride in the Superior Court. The district court's decision is partially affirmed and partially reversed, with the case remanded for further proceedings consistent with this opinion. 

Additionally, there is ongoing debate over the safety of Bendectin, a drug for morning sickness, with an FDA panel finding no evidence of birth defects, while lawyers continue to pursue lawsuits against its manufacturer, alleging harm to children born to mothers who took the drug.

Several scientists assert that there is no evidence indicating that the drug Bendectin is harmful to fetuses, suggesting that lawsuits against it are unfounded. The central issue revolves around the concept of safety; specifically, whether a lack of evidence demonstrating harm equates to an assurance of safety, and if a manufacturer can be held liable despite existing "residual uncertainty" regarding a product's safety. Bendectin is widely used during pregnancy, with an estimated 25% of pregnant women in the U.S. taking it, and it is commonly prescribed alongside prenatal vitamins. Concerns about its safety arose only recently, primarily following a study by Kenneth Rothman that suggested a weak link between Bendectin and congenital heart defects, which gained public attention due to a high-profile trial in Florida.

In response to growing public concern, the FDA expedited its safety hearings for Bendectin. An FDA panel convened on September 15 and 16, reviewing animal studies and 13 epidemiologic studies, ultimately concluding unanimously that there was no proven association between Bendectin and birth defects. However, they acknowledged an inherent "residual uncertainty" regarding the drug's effects on fetuses, noting that the studies varied significantly in design and reliability, with most suffering from a bias due to the recall method used to gather data from pregnant women post-delivery.

Only two studies effectively avoided recall bias: one by Hershel Jick, which analyzed medical records of nearly 6,000 pregnant women and found no increase in birth defects among those who took Bendectin; and another by Richard W. Smithells, which compared women who took the drug to those who did not, also finding no evidence of increased birth defects. Nonetheless, Ralph D'Agostino, a statistician and FDA panel member, emphasized the importance of focusing studies on specific defects, as broader analyses tend to yield insufficient data on rare conditions.

Most studies investigating specific birth defects found no link to Bendectin, although two research teams reported a slight association. Rothman’s study revealed weak connections between heart defects and various substances, including Bendectin, but he cautioned that his findings were merely exploratory and affected by recall bias from open-ended questionnaires. Jean Golding's research indicated a slightly higher prescription rate of Bendectin among mothers of babies with cleft lips or palates, yet she expressed uncertainty due to biases in her methodology. 

The consensus at a subsequent FDA meeting highlighted that extensive research on Bendectin has not identified it as harmful, noting that known teratogens produce distinct syndromes, none of which have been linked to Bendectin. Jick emphasized the improbability of undiscovered issues, given the drug’s extensive use among 30 million pregnant women. Despite this, the FDA panel acknowledged concerns raised by Golding and Rothman’s studies, suggesting Bendectin may be overprescribed. Estimates indicated that fewer than 10 percent of pregnant women truly require the drug, contradicting its prevalent use among 25 to 40 percent of expectant mothers.

Attorney Belli remains undeterred by the FDA’s findings, pursuing lawsuits against Richardson-Merrell based on his list of women who took Bendectin and had children with limb defects. Epidemiologists counter that such lists do not constitute proof, highlighting the statistical likelihood of limb defects occurring independently of Bendectin use. Belli is involved in multiple lawsuits, claiming 75 cases, while Richardson-Merrell disputes this number. The meeting attracted numerous lawyers, whose aggressive questioning frustrated the company’s representatives. FDA panel chairman David Archer ultimately restricted further inquiries to written submissions only.

Belli and fellow attorneys involved in litigation against Richardson-Merrell are leveraging the company's troubled past, notably its involvement with thalidomide, which led to significant settlements in the 1960s for birth defects caused by the drug. In addition to thalidomide, Richardson-Merrell faced issues with Mer-29, a cholesterol drug that caused cataracts and resulted in an $80,000 fine for false statements to the FDA, followed by $200 million in damages from civil suits. Public concern over Bendectin, a drug marketed by Richardson-Merrell, was heightened by a National Enquirer article linking it to thalidomide and featuring David Mekdeci, a child with deformities. In January 1980, a jury awarded Mekdeci’s parents $20,000 for medical expenses but no damages for their son. A federal judge later deemed the verdict inconsistent, leading to a retrial in January 1981, which Belli opted out of, citing difficulties working with Mekdeci's mother and the availability of stronger cases. Expert testimony presented at the trial was criticized for lacking scientific rigor, particularly by FDA panel member Gordon Avery, who noted that the experts' presentations did not substantiate claims against Bendectin. Key witnesses included William McBride, who linked Bendectin to birth defects but primarily focused on thalidomide’s effects, and Beverly Paigen, who, despite not being a teratologist, claimed a connection between Bendectin and birth defects. However, her conclusions were challenged by other scientists.

The FDA panel's cautious stance on Bendectin may lead to increased litigation, influencing many women to believe the drug causes birth defects. Consequently, doctors might prescribe alternative medications for nausea and vomiting, despite limited knowledge about their safety. Bendectin remains the most researched drug for pregnant women, in contrast to the uncertainty surrounding other treatments. 

A correction regarding William McBride’s compensation for his testimony in the Mekdeci case clarifies that he was paid approximately $1,116 per day for his time away from practice, not the previously reported $5,000 per day. Additionally, he was reimbursed for travel expenses. The complaint includes several defendants associated with Merrell Dow. By 1982, over 52 lawsuits regarding Bendectin's safety were filed in federal courts. Melvin Belli was the attorney of record in the Mekdeci litigation, with McBride's involvement limited to co-counsel. The text also references statements by Belli regarding McBride's costs for participation in the trial. Lastly, a recent decision in Ollman v. Evans does not undermine the distinction between fact and opinion pertinent to Avery's comments.