Errors Noted in “Probable” Case Report
(September 18, 2006) — The U.S. District Court for Nebraska on September 8, 2006, dismissed a lawsuit that had been filed against two manufacturers of black cohosh (Actaea racemosa, syn. Cimicifuga racemosa) products. The suit had been filed by a woman who had required a liver transplant five months after starting to use these products, and by her husband. The Court also ruled to exclude the testimony of both of the plaintiffs’ experts, and stated that the plaintiffs “have no evidence to establish either general or specific causation.”
In coming to this decision, the Court considered testimony obtained from both the patient and her physician, who had been retained as one of her two experts, which contradicted a published case report of this event.1 As originally published, the authors, who included the expert physician, reported that the patient “did not drink alcohol or use illicit drugs, and was not taking any medications, including other herbal medications, acetaminophen, or nonsteroidal anti-inflammatory drugs” [emphasis added]. In fact, the testimony revealed that the woman regularly consumed wine, used Advil® (ibuprofen, a non-steroidal anti-inflammatory drug) on a regular basis, and had been prescribed Valtrex®, a drug which lists “liver enzyme abnormalities; hepatitis” as a reported adverse reaction.
Importantly, this case was one of only two that some health authorities have identified as presenting a “probable” causal relationship between black cohosh and liver damage. But their analysis was based only on the published case report, which had inexplicably misreported an absence of drug and alcohol use by the patient. This U.S. District Court ruling is therefore significant in the ongoing international attention to black cohosh, which has resulted in label requirements and/or consumer advisories in Australia, the European Union, the United Kingdom, and Canada for products that contain the herb.2,3 AHPA has initiated communications with each of these international health agencies to suggest reconsideration of the relevance of this case.
The case discussed above is Grant and Beck v. Pharmavite, LLC and Nutraceutical Corp. The September 8 decision is posted at AHPA’s website at http://www.ahpa.org/Portals/0/pdfs/06_0908_BlackCohosh_NebraskaDistrictCt.pdf.
References:
1. Levitsky J, Alli TA, Wisecarver J, Sorrell MF. March, 2005. Fulminant Liver Failure Associated with the Use of Black Cohosh. Digestive Diseases and Sciences 50(3):538-539.
2. AHPA Update, February 14, 2006: Australian TGA Requires Liver Warning on Black Cohosh (http://www.ahpa.org/Default.aspx?tabid=69&aId=259&zId=16).
3. AHPA Update, July 18, 2006: UK’s MHRA to Require Label Warning on Black Cohosh (http://www.ahpa.org/Default.aspx?tabid=69&aId=304&zId=16).