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Vioxx refunds revamped

By Anita Weier

December 23, 2004 - The Merck pharmaceutical company has agreed to alter and improve its consumer refund program for unused Vioxx, the popular prescription pain medication the company withdrew from markets earlier this year. Several state attorneys general asked for changes, Wisconsin Attorney General Peg Lautenschlager said today in a written statement. Though she was not one of the attorneys general who made the request, her office has been in contact with them and believes it is important to publicize the change, a spokesman said.

A major change is that consumers no longer have to submit unused Vioxx to get refunds. This is important because some may have already thrown the drug away on the advice of their doctors or because they did not want a potentially dangerous drug in the house. "It is crucial that Merck's refund program for Vioxx be as flexible as possible to ensure that refunds for all unused medication are available to Wisconsin consumers," Lautenschlager said. "It is my hope that the Vioxx refund program will be able to accomplish its goal of refunding the necessary money to every eligible consumer."

Vioxx belongs to a subgroup of nonsteroidal anti-inflammatory drugs known as COX-2 inhibitors. The U.S. Food and Drug Administration originally approved Vioxx in 1999 to treat arthritis pain, menstrual pain and other severe pain in adults, and subsequently approved Vioxx as a treatment for rheumatoid arthritis. Merck announced the immediate withdrawal of Vioxx on Sept. 30, due to reports that the drug substantially increased some users' risk of heart attack and stroke. At that time, about 1.6 million Americans were taking the drug.

Several state attorneys general became concerned that a refund program established by Merck contained too many hurdles for consumers. The attorneys general of Oregon, Illinois, Massachusetts, Michigan, Ohio, Texas, Vermont and Connecticut told Merck the refund program could unfairly exclude consumers who might have immediately destroyed Vioxx.

As a result, Merck agreed to significantly alter its refund program for unused Vioxx, effective Dec. 10. Specifically, Merck has agreed to do the following for former Vioxx users:

• Allow consumers who destroyed unused Vioxx to certify in writing that they had unused Vioxx on Sept. 30, but that they later destroyed the product.

• Allow consumers to file claims for a refund by March 31, 2005, instead of the former deadline of Dec. 31, 2004.

• Upon request, provide consumers who still have Vioxx with prepaid UPS mailers with pick up at consumers' homes to avoid the consumer having to take the mailer to a UPS facility or drop box.

• Contact consumers whose refund claims were rejected because the consumers did not return the product and inform them that they would be eligible to make a claim.

• Make a good-faith effort to notify consumers about the refund program in advertisements or print notices about Vioxx.

• Through Merck's sales staff, contact doctors who would have prescribed Vioxx and give them information about the modified refund program that the doctors can then distribute to patients.

• Work with HMOs and pharmacies to mail out updated refund notices to consumers who purchased Vioxx and who may be eligible for a product refund.

The successful efforts of the attorneys general to make these changes to the refund program do not in any way affect potential claims regarding marketing and promotion of Vioxx, Lautenschlager said.

Consumers seeking a refund for unused Vioxx should contact the Merck Refund Center (National Notification Center) at 1-800-805-9542. Additional information can be found at www.vioxx.com/rofecoxib/vioxx/consumer/patient_refund_information.jsp.


Wake County man files suit against Merck

A Wake County man has filed a lawsuit accusing the pharmaceutical company Merck & Co. of negligence in connection with its pain relief drug Vioxx.

May 24, 2005 - The lawsuit filed in Wake County Superior Court is believed to be one of the first of its kind in North Carolina.

The plaintiff, David Howard, alleges that Merck concealed the drug's cardiovascular risks, according to the lawsuit.

Howard, who is 48, claims that he took the prescription pain fighter in 2003 after injuring his ankle playing basketball. He suffered a heart attack less than one month after he began taking Vioxx, according to the lawsuit. Howard also was diagnosed with vascular disease and in September 2004 had his lower left leg amputated.

Howard names as defendants Merck and McKesson Corp., a San Francisco-based company that worked with Merck to market and distribute Vioxx.

Merck announced in September 2004 a voluntary worldwide withdrawal of Vioxx. The company said the decision was based on new, three-year data from a clinical trial.

The lawsuit filed on May 18 by the Raleigh law firm Lewis & Roberts also alleges that Merck violated North Carolina's unfair and deceptive trade practices act and products liability act.


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