Author Contributions: Dr Psaty had full access
to all of the data in the study and takes responsibility for the integrity
of the data and the accuracy of the data analysis.
Study concept and design: Psaty, Furberg, Ray,
Acquisition of data: Psaty, Ray.
Analysis and interpretation of data: Psaty,
Drafting of the manuscript: Psaty, Ray, Weiss.
Critical revision of the manuscript for important
intellectual content: Psaty, Furberg, Ray.
Statistical analysis: Psaty.
Study supervision: Weiss.
Financial Disclosures, and Disclaimer: In 2002
to 2003, each of the authors was retained by plaintiffs’ attorneys as
experts in cases related to cerivastatin and rhabdomyolysis or myopathy. In
that capacity, they were compensated for reviewing this issue and providing
expert opinions for use in litigation. Plaintiffs’ attorneys reviewed
and commented on written expert reports resulting from this work. These expert
reports were disclosed to the defendants in the cases, including Bayer Corporation,
and the authors have been questioned in deposition regarding the reports.
This article is based solely on published literature and public record documents;
none of the confidential information reviewed in the authors’ capacity
as experts during the litigation has been used in this article. Like this
article, the litigation expert reports also included
information from the published literature about drug safety and HMG Co-A reductase
inhibitors. Much of the review for the plaintiffs’ attorneys was conducted
with confidential company documents under court protective orders. The present
article was developed after some, but not all, of these documents became publicly
available during the trial of the Haltom case in Nueces County, Texas. Information
that is not publicly available has been excluded from this article.
The initial review of these now public documents was supported in the authors’
capacity as plaintiff experts. The costs of obtaining trial exhibits from
the Nueces County Clerk were paid by the authors, and the time and effort
expended on this project by the authors have been in their capacity as professors
at their universities. Although as described above plaintiffs’ attorneys
commented on the expert reports, this manuscript reflects the views of the
authors, and multiple drafts were written and revised without the participation
of the attorneys representing plaintiffs in the cases related to cerivastatin.
The authors were not compensated by plaintiffs’ attorneys for the time
spent in preparation of this article.
As of September 2004, Bayer AG
had agreed to settle 2861 cerivastatin lawsuits out of court.
There continues to be litigation related to cerivastatin and rhabdomyolysis or myopathy.
The majority of cases that the authors were involved with have been settled
by the manufacturer. Specifically, Dr Psaty is not involved in any ongoing
cases. On January 14, 2003, Dr Weiss received a letter that confirmed his
agreement to serve as an expert for plaintiffs in the Baycol Products Liability
Litigation, MDL No. 1431, in the US District Court in Minnesota, and that
retention is still active. Several of the cases for which Dr Furberg has served
as an expert remain to be settled, and some may go to trial. Dr Ray is still
involved in one case. In 2001, Dr Psaty served as a consulting expert in epidemiology
on behalf of Bayer Corporation to review reports on another medication that
had become the subject of lawsuits.