Merck May Try to Share Vioxx Blame With Physicians
Law Feature -- February 2005
By Erin Prather
Google " Vioxx " plus "lawsuit" and you will be inundated with Internet sites offering litigation services regarding Merck's voluntary withdrawal of the drug. From Fen-Phen to breast implants, recalls have created mountains of litigation. Vioxx is no exception. And, Merck may claim that physicians who prescribed the drug also should be held accountable for any harm to patients.
Part of a new class of pain relievers (the COX-2 inhibitors), Vioxx was marketed as an arthritis, menstrual, and acute pain medication from 1999 until it was pulled off the market Sept. 30, 2004.
Sales of the drug had skyrocketed, partly due to pharmaceutical companies advertising their products directly to consumers, including an endorsement from Olympic figure skater Dorothy Hamill. At the time it was withdrawn, Vioxx was marketed in more than 80 countries. Worldwide sales in 2003 totaled $2.5 billion.
Racing to the Courthouse
Plaintiff's attorneys are scrambling to find potential clients to join lawsuits against Merck. Many are seeking clients through television and newspaper advertising.
In an article on Forbes magazine's Web site (www.forbes.com), Merck general counsel Kenneth Frazier outlined what Merck's investors should expect from the company's defense team.
First, Merck may argue that physicians are responsible for deciphering Vioxx's potential risks and benefits because they gauge risks and benefits of any treatment for their patients. This defense was used in the silicone breast implant lawsuits.
"Merck can argue that it notified physicians about the risks and that physicians should take into account those risks before prescribing Vioxx to a patient," said Lee Spangler, JD, assistant general counsel for the Texas Medical Association . "That doesn't necessarily mean that Merck is free from all responsibility. It only means that plaintiffs could argue that both physicians and Merck are responsible."
Also, Merck will try to defend each lawsuit individually so the cases will not be filed as a class action. For a class action lawsuit to be filed, it must be proved that a large group is "similarly situated."
Merck will argue that a class action suit cannot be filed because each person's health is different, and proving that Vioxx directly caused a heart attack or stroke would be difficult. That would benefit Merck, as economic damages likely would be enormous if it lost a class action suit. Merck is gambling it will win individual cases and discourage other lawsuits, as lawyers will be less inclined to accept new cases.
The company also may assert that the Adenomatous Polyp Prevention on Vioxx (APPROVe) study that led to the Vioxx withdrawal only showed an increased risk of cardiovascular problems after 18 months of continuous Vioxx use and that it is the first study to clearly demonstrate a Vioxx risk.
Merck also will contend it disclosed the risk of Vioxx to patients in a timely manner. Since the drug's approval in 1999, heart attack and stroke have been listed as potential adverse effects.
Seeking an Alternative
Following the Vioxx withdrawal, physicians were advised to contact patients to discuss discontinuing the drug and finding possible alternative treatments.
Mark Post, administrator for Dallas rheumatologist Leyka Medilia Barbosa, MD, says the staff immediately informed patients of the Vioxx withdrawal and the need for other options. "We called our patients, if they hadn't called us first. Due to how the withdrawal was handled, even though we knew Vioxx was safe and effective for particular patients, we told them to stop taking it," Mr. Post said.
Physicians are trying to determine which patients, if any, should be switched to another COX-2 inhibitor. Sales for the Pfizer painkillers Celebrex and Bextra jumped following the Vioxx withdrawal; however, studies soon suggested that those drugs may cause the same cardiovascular risks as Vioxx. Some physicians have stopped prescribing COX-2 inhibitors altogether. Others believe physicians should offer the medications to their patients as long as they are aware of the health risks and present all information to their patients.
"The most important thing is for physicians to keep the best interest of their patients in mind," Mr. Spangler said. "Physicians should continue to be informed of current studies about pharmaceuticals and how those studies affect the current standard of care. Through peer reviews, journal studies, and articles, physicians set the standard of care. As long as physicians are aware of those standards, practice in conformity with them, and inform patients of the risks and benefits associated with a particular treatment plan, that is probably the best they can do."
Erin Prather can be reached at (800) 880-1300, ext. 1385, or (512) 370-1385; by fax at (512) 370-1629; or by email at Erin Prather.
Vioxx Had Troubled Past
Questions surrounding Vioxx's safety emerged long before it was withdrawn from the market last September.
In June 2000, Merck submitted the Vioxx GI Outcomes Research (VIGOR) study to the U.S. Food and Drug Administration (FDA). The study examined the side effects of Vioxx, such as stomach ulcers and bleeding. It showed that patients taking Vioxx had fewer side effects than patients taking naproxen, but the patients had more heart attacks. The study led to a 2002 requirement for a warning of the increased heart attack risk.
Additionally, a study published in the Aug. 22, 2001, issue of the Journal of the American Medical Association that reanalyzed data from clinical trials of both Vioxx and Celebrex determined that a warning should be raised because of the risk of cardiovascular events with COX-2 inhibitors. Also, on Sept. 17, 2001, the FDA warned Merck about its promotional activities for Vioxx. The FDA charged that Merck was conducting a promotional campaign minimizing the VIGOR study findings and misrepresenting the drug's safety. The agency instructed Merck to cease the promotional activities and issue a "Dear health care provider" letter to correct false or misleading information.
Merck's eventual decision to withdraw Vioxx from the market was based on another study, the Adenomatous Polyp Prevention on Vioxx (APPROVe) study. It compared Vioxx to placebos to determine whether Vioxx (25 mg) prevented the recurrence of colon polyps. The trial was halted because of an increased risk of heart attack and stroke observed in patients after 18 months of continuous treatment with Vioxx.