Thursday, May 24, 2012

Actos Lawsuits Part Two: Multidistrict Litigation Details



Continuing from part one which details the particulars of the pending Actos lawsuits, part two will talk about the MDL case as well as case law which may pertain to Actos suits. The discussion at a recent attorney’s conference regarding Actos litigation discussed the highlights of the MDL Actos case. When lawsuits involve potentially dangerous drugs, medical devices or other types of extremely complex issues which affect large numbers of people, federal courts may choose to use multidistrict litigation or MDL to ensure the cases are more properly managed. MDL places civil cases with common issues in a single district court which then handles discovery and pretrial procedures. The MDL goal is essentially to conserve resources and expedite the entire process. One judge is charged with management of the pretrial and discovery litigation, and should the cases not settle during the course of the MDL they will be returned to the original court to await trial.

Actos MDL and the Judge Assigned

The Actos lawsuit which was pending in a Texas district court will now be sent to an MDL in the Western District of Louisiana. The federal MDL regarding Actos in this Louisiana districts has been assigned to Judge Rebecca F. Dougherty who was nominated by George H.W. Bush in 1991.  Judge Dougherty was an English teacher prior to attending law school, then after graduating from Louisiana State University Law Center in 1981 she went on to a career as a private practice attorney for the next decade. Judge Dougherty has been featured in women’s business articles and the attorneys involved believe she is a judge who is very much focused on both technology and practicality and will handle the Actos MDL in a skillful and experienced  manner which will benefit the victims of Actos.

Selection of Special Masters

Judge Dougherty has chosen special masters, which is normal in such a case however she has chosen various tiers of special masters. The attorneys involved believe this is a good sign that Judge Dougherty wants to press on discovery and really get it going. Judge Dougherty has chosen an overall special master as well as two deputy special masters who will handle ex-parte conversations as well as keep track of billing and time. The theory is that this step was taken as a response to the Vioxx trials in order to avoid fighting over fees—in other words the billing and time will be monitored from the very beginning. Attorneys feel that having these deputy special masters will be extremely helpful in terms of getting what is needed through discovery.

Details of the MDL Litigation

The defendants in the Actos MDL have waived service of process for Japanese companies, and direct filing can be done electronically. The same company which was used in the Toyota cases has provided some real substance very quickly in terms of discovery. They are using a newer type of searching known as concept searching which not only uses keywords but adds related keyword terms to the search. Negotiations are currently underway regarding protective orders and plaintiff fact sheets, and because there is a “whistleblower” in this case there are lots of interesting details. In fact, Helen Ge, the so-called whistleblower who was hired by Takeda as a “rubber-stamping” medical reviewer, has been served with a subpoena in order to preserve her testimony in the MDL which is considered the primary jurisdiction.

The Subject of Epidemiology

Epidemiology will be an important aspect of the Actos litigation, just as it is in virtually any cancer case. The study of the determinants of health-related issues is known as epidemiology with various methods available such as descriptive studies or surveillance. Case law will show that the science behind epidemiology studies must be specific to the chemical as well as to the disease. Plaintiffs who have been exposed to one chemical and developed a type of cancer then presented evidence based on another tumor have ended up as trial court exclusions. The exposure level in the Actos cases will be key information—it is extremely important that you have accurate information regarding how many pills your client took on a daily basis. 

Actos Litigation in Good Position Regarding Epidemiology

The Actos cases are actually in a better position than many past cases. For instance in Allen vs. Pennsylvania Engineering, the plaintiff was exposed to ethylene oxide at his workplace—a hospital—and subsequently died of brain cancer. Walter Allen worked in the maintenance department of Baton Rouge General Hospital for over two decades during which time he changed out cylinders containing ethylene oxide. Unfortunately there were no epidemiology studies which linked brain cancer with the chemical despite years of occupational studies. Two of the expert witnesses in Allen’s case were deemed unqualified to render their opinions regarding the link to chemical exposure due to lack of adequate science. When no epidemiological study has discovered statistically significant links between exposure and cancer, expert testimony simply doesn’t carry the measure of dependability required to proceed. The Actos cases thankfully are not laboring under the lack of epidemiological studies and further pharmaceutical cases are much easier to prove since knowing the dosage can prove the exposure.

Burleson v. Texas Department of Criminal Justice

The dosage of a potentially carcinogenic substance is extremely important in litigation. A prison inmate in Texas brought a civil rights action alleging that prison officials showed indifference to his health when allowing him to weld with thorium tungsten electrodes during his two years as a welder in the prison. The appeals court found that the inmate’s expert witness presented no reliable evidence regarding the precise level of harmful exposure even though the U.S. Department of Health had previously determined that thorium dioxide was in fact a carcinogen. Thankfully, the Actos cases are significantly different from these cases and Judge Dougherty has made the comment that we are dealing with people’s lives and while we have all heard the expression “don’t make a federal case out of it,” if it is coming to federal court, it’s serious business.
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