Perspectives: Meridia Multidistrict Litigation
By: Michael O'Meara, Esq.
COLUMNS Drugs & Supplements
October, 2002
On Aug.13, the federal Judicial Panel on Multidistrict Litigation (JPML) ordered the transfer and coordination of the federal actions entitled "In re: Meridia Products Liability Litigation", MDL No. 1481. The cases were centralized to the United States District Court for the Northern District of Ohio, Eastern Division in Akron, Ohio, before U.S. District Judge James Gwin. The consolidation and coordination of the above mentioned federal actions into a single district is the most efficient way to help resolve numerous cases nationwide.
Meridia, also known as sibutramine, is an anti-obesity medication that was originally tested, designed, manufactured, marketed and sold by Defendant Knoll Pharmaceuticals prior to its acquisition by Abbott Laboratories in 2001. Meridian is one of few remaining diet drugs still on the market. Unlike the combination of Pondimin (fenfluramine) or Redux (dexfenfluramine) and phentermine (fen-phen), which created a feeling of satiety by boosting production of a brain chemical called serotonin, Meridia works by slowing the body's dissipation of the serotonin that it produces naturally. Meridia is described as a Serotonin and Norepinephrine Re-uptake Inhibitor (SNRI) because it inhibits the reuptake of both chemicals in the brain that have been associated with satiety. Meridia is still on the market and available in three strength capsules: 5 mg, 10 mg, and 15 mg. The drug is classified as a Schedule IV controlled substance.
Today sibutramine is marketed in seventy (70) countries and sold as Reductil in Europe. It is estimated that 8.5 million people worldwide have take sibutramine since its approval in November 1997.
An estimated 2 million people in the United States currently take the medication. Meridia is one of the nation's most widely advertised prescription drugs with Abbott spending over $60 million on direct-to-consumer advertising in 2000. In 201, the sale of sibutramine helped Abbott earn global revenue of $200 million. Already in the first quarter of 2002, Abbott has seen 212 percent growth in sales compared to the first quarter of 2001.
Meridia has been strongly associated with serious cardiovascular injuries and death as a result of substantial increases in blood pressure, heart rate, and arrhythmia. Studies have shown that sibutramine has amphetamine-like effects including nervousness, hyperactivity, increased energy, anxiety, increased insomnia, tremor and dry mouth.
The British Department of Health has reported 20 adverse reactions and two deaths associated with the use of Reductil. In France, drug regulators have reported 100 adverse events. To date, at least 34 deaths worldwide have been associated with sibutramine. Between the period of November 22, 1997 and September 30, 2001, the FDA received the following reports regarding Meridia: 397 reports of people with serious adverse reactions, including 152 hospitalized patients and 29 deaths (19 deaths ere the result of cardiovascular causes such as heart attacks). Included in the 19 cardiac deaths were 10 people 50 years of age or younger, including three women under the age of 30. Furthermore, 143 patients reported arrhythmia.
On March 15, 2002, the FDA announced that it was monitoring overseas reports of death and adverse events associated with sibutramine, the active ingredient found in Meridia. The FDA said that since sibutramine's U.S. launch as Meridia in 1997, the agency has received a total of 5,000 adverse reaction reports, with 306 being cardiac events. The total includes domestic and foreign reports.
On March 19, 2002, Public Citizen, a consumer watchdog group, petitioned the FDA to remove Meridia from the market.
'Not only does this drug contribute to major cardiovascular problems, but its effectiveness in lowering obesity is meager,' said Dr. Sidney Wolfe, director of Public Citizen's Health Research Group.
Data from Public Citizen's petition showed that the average yearly weight loss for patients taking a standard 10 mg dose was only six and a half pounds more than those taking a placebo. According to the FDA, the agency is examining Public Citizen's petition as well as the death and illnesses linked to the drug.
The Benefits of a Meridia Multidistrict Litigation
As a result of Meridia's troubled history, many consumers have suffered tremendous economic and non-economic injury. Many legal issues have arisen in the multitude of individual and class action suits that have been filed against Abbott Laboratories, Knoll Pharmaceutical Co., BASF Corp., GlaxoSmithKline, Knoll AG, and BASF AG. Currently there are more than 20 federally filed complaints against the makers of Meridia.
Congress enacted 28 U.S.C. 1407 to allow for the consolidation of federal cases, 'when civil actions involving one or more common questions of fact are pending in different districts...[and it has been determined] that transfers for such proceedings will be for the convenience of parties and witnesses and will promote the just and efficient conduct of such actions.
The Meridia lawsuits filed in different districts warrant consolidation since there are many common questions of fact such as whether Meridia was and is toxic and safe; whether persons who took Meridia are at an increased risk of developing serious injuries, including, but not limited to arrhythmia, increased heart rate and increased blood pressure; and whether the Defendant's adequately tested Meridia prior to distribution and sales in the marketplace. In addition, consolidation to one centralized location will allow for a level of convenience for those parties and witnesses involved in this litigation.
In order for the plaintiffs to efficiently manage mass tort litigation in a MDL setting, committees are formed. Typically, a Plaintiffs' steering Committee (PSC) is formed that involves attorneys who contribute their legal services to the litigation. Lead counsel is appointed to oversee the management of the litigation process. An executive committee is established to assist the lead counsel in over-seeing subcommittees that are formed to specifically focus on certain areas of the litigation process. Some examples of subcommittees include the Settlement Committee, Science Committee, Discovery Committee, and Law and Briefing Committee. The Science Committee, for example, would focus on understanding how the drug works and how it affects the human body. The Science Committee would also retain experts to educate and demonstrate why the drug may or may not be harmful. One of the responsibilities of the discovery Committee would be to ensure that the necessary documents are obtained and produced. These sub-committees are the driving force that moves this complex litigation toward a resolution.
In cases involving mass torts such as in Meridia, there can be millions of pages of documents to obtain and analyze. To ensure that this is accomplished, a document depository is established. This is a centralized location where attorneys analyze the documents to determine which ones are relevant to the litigation. The team of attorneys from several different law firms analyze the documents produced. This team effort allows for an efficient, cost effective way to advance the litigation.
State attorneys involved in the Meridia litigation may also benefit from the MDL process. Attorneys who have filed their claims in state courts may have access to deposition transcripts and documents obtained by the MDL. This is yet another reason how an MDL setting can promote an efficient resolution to claims.
In the Meridia MDL, a Case Management Conference has been scheduled for Friday, Sept. 20, before U.S. District Judge James S. Gwin in Akron, Ohio. The Court has provisionally appointed Stanley M. Chesley of Waite, Schneider, Bayless & Chesley in Cincinnati and John R. Climaco of Climaco, Lefkowitz, Peca, Wilcox & Garofoli in Cleveland to serve as co-lead counsel for the Plaintiffs. In addition, the Court has provisionally appointed the following attorneys to the Plaintiff's Steering Committee: Richard Arsenault of Neblett, Beard & Arsenault in Alexandria, La., Daniel E. Becnel, Jr. of the Law Offices of Daniel E. Becnel, Jr., in Reserve, La., Turner Branch, Elizabeth J. Cabraser of Lieff, Cabraser, Heimann & Bernstein, in San Francisco, Carl Franklovitch of Franklovitch, Anetakis, Colantonio & Simon in Wheeling, W.Va., Paul Gellar of Cauley Geller Bowman & Coates in Boca Raton, Fla., don Hildre of Dougherty, Hildre, Dudek & Haklar in San Diego, Will Kemp of Harrison, Kemp & Jones in Las Vegas, Richard A. Lockridge of Lockridge, Grindal & Nauen in Minneapolis, Kenneth B Moll of Kenneth B Moll & Associates in Chicago, Stephen B Murray, Jr. of the Murray Law Firm in New Orleans, Diane Nast of Roda & Nast in Lancaster, Pa., and Richard Schiffrin of Schiffrin & Baroway in Bala Cynwyd, Pa.
Pursuant to LR 16.3(a), and subject to further discussion at the Case Management Conference, the Court has recommended that the Meridia MDL be assigned to the Mass Torts track.
In conclusion, when involved in litigation such as Meridia, it is imperative that there be a mechanism through which cases get resolved in an efficient, organized and cost effective manner. The consolidation and coordination of the Meridia federal cases into a single district for pre-trial discovery and proceedings is clearly the best mechanism to achieve that goal.