The multi-district lawsuit over the diabetes drug saxagliptin is a compilation of more than 80 lawsuits from around the country, but the lawsuit was lost because the plaintiff’s only expert witness was unreliable and failed to show a causal relationship between the drug and heart failure. federal authorities announced. The Court of Appeal said this week.
Jury panel consisting of 3 out of 6 judgesth The U.S. Circuit Court of Appeals upholds a U.S. District Court for the Eastern District of Kentucky’s decision to dismiss a 2022 lawsuit filed by Leesa Taylor and dozens of others against Bristol-Myers Squibb, AstraZeneca Pharmaceuticals and two more companies. did.
The decision could have long-term implications for cases that rely on expert witnesses, such as medical malpractice and product liability claims. This reinforces years of court decisions that have made it clear that juries cannot determine causation in complex medical matters without expert testimony.
After the Daubert hearings (established by a 1993 federal court ruling evaluating the credibility of expert witnesses), lower courts excluded the opinion of Dr. Parag Goyal, a professor of cardiology at Weill Cornell Medical College. did. Goyal said saxagliptin, which is sold under the brand name Onglyza, “possibly…could cause heart failure.”
However, Professor Goyal based his findings on a single study commissioned by the US Food and Drug Administration, a 2013 study known as SAVOR, “Saxagliptin Assessment of Recorded Vascular Outcomes in Patients with Diabetes.” The analysis found no statistical differences between patients who took the drug and those who did not in terms of cardiovascular death or morbidity, stroke mortality, or hospitalization rates for related heart problems. It wasn’t served.
However, patients with saxagliptin were found to have a 27% increase in hospitalizations for heart failure compared to those taking a placebo. However, the study cautioned that this increase should be considered in the context of other tests that may have resulted in false positives. The court called for further investigation, citing published research and explaining that “class effects should not be presumed.”
Still, the SAVOR study prompted a warning from the FDA and a number of class-action lawsuits against drug companies across the United States. Most of these cases were consolidated and assigned to the Eastern District of Kentucky in 2018.
“Dr. Goyal’s reliance on SAVOR was unreliable, apart from all other studies involving human data.”th Circuit Court Judge John Nalbandian wrote in a Feb. 13 opinion. “As Dr. Goyal acknowledged, no statistically significant association between saxagliptin and heart failure has been found in clinical studies beyond SAVOR.”
The Court of Appeal proceeded to dismantle Mr. Goyal’s expert report.
“Despite acknowledging that it was inappropriate to make a finding of causation based on a single study, Dr. Goyal still made a finding of causation based solely on SAVOR,” the court noted. “SAVOR is not definitive. This study only observed ‘higher hospitalization rates in patients treated with saxagliptin’ and did not observe a causal relationship between the two.”
The judges said Goyal’s testimony reversed the normal burden of proof and cited no other evidence required by long-established court rules. He “selected data to support his claims” and applied the so-called Bradford Hill standard unreliably. Epidemiologist Bradford Hill established in 1965 he nine factors to include when examining causal relationships. In Goyal’s report, he claimed that two of the factors were met: specificity and biological gradient. However, he later testified that this was not the case.
“These changes in Dr. Goyal’s Bradford Hill analysis, which are neither explained nor justified, cast doubt on the reliability of his testimony,” the appellate judges wrote.
Lower Court Judge Karen Caldwell correctly dismissed the case and did not err in refusing to give the plaintiffs time to find a second expert. That would prejudice and burden the drug company defendants, requiring new discovery, depositions, motions, hearings and years of delays, the opinion said.
The plaintiffs, led by Kentucky personal injury attorney Ashton Rose Smith, also argued that the case should be allowed to proceed, allowing a jury to decide the issue without expert testimony. But an appeals court investigation found that no state court had previously recognized it.
“Other district courts in all jurisdictions require expert testimony to show general causation, “at least when the issue is medically complex and beyond common knowledge or lay experience.” ” the Sixth Circuit said.th The circuit judges wrote, citing federal court decisions from 2017 and 2019.
The drug companies, represented in the appeal by Paul Schmidt of the New York and Washington, D.C.-based Covington & Burling law firm, could not be reached for comment Wednesday.
Bristol-Myers Squibb officials referred inquiries to AstraZeneca, which currently owns Onglyza. AstraZeneca representatives could not be reached Wednesday.
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