Texas Sues Merck for Misleading Public About Vioxx® Safety
AUSTIN, TX -- July 8, 2005 -- The state of Texas has sued Merck for misrepresenting the safety of its arthritis drug Vioxx® (Petition, District Court of Travis County, State of Texas v. Merck & Co. Inc). Even before Vioxx® became available in 1999, Merck knew that the drug increased the risk of heart attacks and strokes, the lawsuit charges. Despite this knowledge, Merck aggressively promoted Vioxx® to doctors and patients in Texas, and pressured researchers who questioned its safety, the lawsuit further explains.
The Texas Medicaid program spent $56 million for more than 700,000 Vioxx® prescriptions over a 5-year period. Texas Attorney General Greg Abbott is asking Merck for triple that amount, or $168 million, to compensate the state for the drug company's alleged fraud, which would violate the Texas Medicaid Fraud Prevention Act.
"This is a prime example of a company's drive for profit steamrolling its duty to be safe," Attorney General Abbott said (Press Release, June 30, 2005 ). "Drug companies have an ethical, legal and professional responsibility to conduct meticulous clinical studies to ensure the safety and effectiveness of drugs for human consumption. Yet in this case, Merck took extreme measures to get this drug approved for widespread use, including for Medicaid patients, without the proper respect for good science and the concerns of peers."
Merck's History of Deception
Merck has been accused of using strong-arm tactics to promote Vioxx® before. At a Congressional hearing in May, documents suggested that in 2,000, company sales representatives were told to focus on Vioxx®'s benefits and to avoid discussing its link to heart problems whenever possible. If the issue did arise, they were instructed to minimize Vioxx® heart risks and to answer questions with pre-rehearsed "obstacle responses." At this time, Merck was aware of the Vioxx® Gastrointestinal Outcomes Research (VIGOR) study, which showed that Vioxx® users greatly increased their risk of heart attacks and strokes compared to patients taking naproxen, a traditional pain medication (N Engl J Med. 2000 Nov 23; 343(21): 1520-8). (See Vioxx® Risk Were Downplayed by Merck).
Last month, other damaging documents were handed to the press about Merck. One showed that in 2001, Merck applied for a patent to combine Vioxx® with another compound called "thromboxane synthase inhibitor," which is thought to protect the heart. Memos and documents, written in 2000, discussed a patent to reformulate Vioxx® to lower the risk of blood clots, heart attacks and strokes. When Merck made the patent request, it was also actively promoting Vioxx® and downplaying safety concerns. (See Merck Sought to Revise Vioxx® Formula, News Sources Say).
Merck finally withdrew Vioxx® from the market in September, 2004, in response to the APPROVe clinical trial, which treated colon cancer patients with the drug. The study showed that patients who took Vioxx® had a much greater chance of developing serious heart conditions compared with those who received a sugar pill or placebo.
Vioxx®, Bextra®, Celebrex®: Dangerous COX-2 Inhibitors
Also known as rofecoxib, Vioxx® is a nonsteroidal anti-inflammatory drug (NSAID) that blocks cyclooxygenase, an enzyme needed for the production of prostaglandins. Prostaglandins may cause inflammation and pain. Vioxx® interferes with the form of cyclooxygenase known as COX-2, and is therefore referred to as a COX-2 inhibitor. Before its recall, Vioxx® was approved to reduce the pain of osteoarthritis, rheumatoid arthritis, and migraine headaches. It was also used to relieve short-term pain and the discomfort of severe menstrual cramps.
Celebrex® (celecoxib) and Bextra® (valdecoxib) are two other COX-2 inhibitors, both manufactured by Pfizer. The company withdrew Bextra® from the market at the request of the Food and Drug Administration (FDA) in April of this year. Bextra® may increase the risk of heart attacks and strokes, especially among patients who have undergone coronary bypass surgery. It also has been linked to skin allergies and Stevens-Johnson syndrome, a painful blistering of the skin and mucous membranes that sometimes proves fatal. Although Celebrex® is still available, it has also been associated with heart problems.
COX-2 Medicines: Free Case Review
Brayton Purcell is evaluating cases of heart attacks, strokes, and blood clots that are linked to COX-2 arthritis drugs. If you or a loved one has had these conditions while taking Bextra® or Celebrex® or after discontinuing either medication, please feel free to contact us. We will review your case free of charge and let you know your legal options.