Merck Co., Inc. Faces Multiple Lawsuits for Prescription Drug Vioxx

It is estimated that over 80 million consumers worldwide had taken the prescription drug, Vioxx, before it was pulled from the market by its manufacturer, Merck Co., Inc. With Merck's annual sales from Vioxx peaking at approximately $2.5 billion in 2003, this marks the largest withdrawal of a drug from the market to date. Merck voluntarily pulled Vioxx from the market after it became increasingly linked to heart attacks, strokes and blood clotting.

It is being argued that Merck should be held liable for its decision to leave Vioxx on the market for five years despite the company's alleged knowledge of possible cardiovascular (CV) risks. Currently, Merck faces a magnitude of legal problems including criminal and financial federal investigations, shareholder actions and a multitude of individual plaintiff and class action suits in state and federal courts.

Prescription Drug Liability

In the U.S., drug manufacturers have a duty to adequately test drugs and medicines before releasing them to the market. The drug must be approved by the U.S. Food and Drug Administration (FDA) before becoming available for public consumption. However, FDA approval does not negate a drug manufacturer's liability for injuries caused by a defective drug.

Modern drugs provide patients with substantial health benefits, but, they may also pose several risks. Such drugs are "unavoidably unsafe." Provided that the drug is properly designed and prepared, placing a warning against all known risks and harmful side effects on the label may excuse a manufacturer from products liability. However, the manufacturer only has as duty to warn of all known risks, and is not expected to warn against any unknown dangers.

Lawsuits against Other Drug Manufacturers

In 1997, Wyeth Co. pulled its diet drug combination known as "fen-phen" from the market. Fen-phen was determined to cause severe heart-valve damage, and several lawsuits were filed against Wyeth. Cases against Wyeth are still pending, but the company continues to build its reserve for settlements and legal costs, having already paid out billions of dollars in settlements.

Similarly, the Bayer Company faced approximately 8,000 individual and class action lawsuits regarding its cholesterol drug, "Baycol," which was later associated with a serious muscle disorder. Bayer settled many of its lawsuits. One plaintiff suit, which went to trial in Texas, alleged that Baycol's design and marketing instructions were defective and that Bayer was negligent. However, the 2003 jury verdict was in favor of Bayer.

Coordination of Vioxx Federal Products Liability Suits

There are estimated to be more than 1,000 federal product liability actions filed against Merck as of March 2005. Many of these suits are national or worldwide class actions against the drug company giant. The amount of potential liability that Merck faces has led commentators to believe that Vioxx represents the largest risk of exposure to a drug company in a long time.

In January 2005, the Judicial Panel on Multidistrict Litigation (MDL) heard motions by 148 parties in 41 federal districts, including Merck, to coordinate or "centralize" proceedings into one district. The Panel held that centralization was necessary to avoid duplicative discovery, to avoid inconsistent pretrial rulings and to conserve party resources. The actions were consolidated and assigned to Judge Eldon E. Fallon of the U.S. District Court for the Eastern District of Louisiana. Judge Fallon is responsible for the coordination of all pretrial proceedings.

Pretrial Process for Vioxx Litigation

In March 2005, many attorneys entered Judge Fallon's Courthouse to be selected for the "plaintiff steering committee." Together with the judge and Merck, the committee will help shape the progress of the pretrial proceedings, such as information gathering and depositions. Once the pretrial activities are complete, the federal cases will all be returned to their individual districts to be tried. However, considering the sheer number of cases in addition to other complexities, the first federal case may not go to trial for a year or more.

Other Vioxx Cases

As opposed to federal cases, some state cases, including one in Alabama and another in Texas, are expected to begin by the summer of 2005. In addition, some shareholder actions against Merck are in a different federal court, being handled by District Judge Stanley Chesler in New Jersey.

"Arcoxia" Merck's Next Version of Vioxx

Vioxx is a non-steroidal anti-inflammatory drug (NSAID) which selectively inhibits the cyclo-oxygenase II (COX-2) enzyme in the body. Vioxx is related to traditional NSAIDs, such as ibuprofen and naproxen, which inhibit both COX-1 and COX-2 enzymes. Selectively blocking only COX-2 enzymes has been demonstrated to produce reduced gastrointestinal problems, such as ulcers and bleeding.

There are two other approved COX-2 selective NSAIDs on the market, Celebrex and Bextra, which are manufactured by Pfizer. Celebrex was a second-best seller to Vioxx. On April 7, 2005 Bextra was taken off the market due to concerns over serious, potentially fatal skin reactions to the drug, and the FDA announced that Celebrex and all other prescription NSAIDS must carry a black-box warning on the label, warning that users potentially face an increased risk of CV side effects.

Merck has indicated that it has plans to seek FDA approval for a drug in the same class as Vioxx, but with a different chemical structure, called "Arcoxia." Merck CEO Ray Gilmartin maintains that Arcoxia is currently undergoing testing to determine the CV effects of the drug.