Assurance of Care Legal Nurse Consultants

June 18, 2007

Merck & Co. Ordered to Pay Attorneys’ Fees, Costs Following VIOXX(R) Consumer Fraud Finding

Filed under: MEDICAL NEWS YOU CAN USE, VIOXX NEWS — aofcarec @ 11:04 am

Posted : Mon, 18 Jun 2007 16:56:00 GMT

Author : The Lanier Law Firm Category : PressRelease News Alerts by Email click here ) Create your own RSS PressRelease News | Create your own RSS | Home ATLANTIC CITY, N.J., June 18 /PRNewswire/ — New Jersey Superior Court judge Carol E. Higbee has ordered pharmaceutical giant Merck & Co. to pay fees and costs to a group of attorneys who proved in court that Merck committed fraud by deceiving doctors about the cardiovascular risks of the popular painkiller VIOXX(R) and deliberately hiding information about those risks from physicians. Merck could have settled both consumer fraud claims for less than $5,000, but fought the allegations in an April 2006 trial. Similar consumer fraud claims are pending in thousands of additional cases against Merck. Following the trial, jurors awarded $13.5 million in compensatory and punitive damages to 77-year-old John McDarby, who suffered a heart attack after taking VIOXX(R) for four years. Jurors also agreed that Merck committed consumer fraud and awarded an additional $4,013.36 to Mr. McDarby and $45 to second victim Thomas Cona based on the cost of their prescriptions. The order signed June 15 awards approximately $4 million in fees and costs for the attorneys who represented Mr. McDarby and Mr. Cona. “It is a pity that Merck is forcing our nation’s court system to waste thousands of hours of time and millions of dollars to hear these fraud claims after a jury has already said the company committed fraud,” says lead attorney Mark Lanier of The Lanier Law Firm. “This is lawsuit abuse by Merck, plain and simple.” The New Jersey Consumer Fraud Act provides for “reasonable attorneys’ fees, filing fees and reasonable costs of suit” to plaintiffs who prove a consumer fraud claim. The New Jersey statute does not limit counsel fees according to the amount of the original claim. According to the court, the law “provides an incentive to competent counsel to undertake high-risk cases and to represent victims of fraud who suffer relatively minor losses.” The ruling notes that Merck spent $500 million defending VIOXX(R) cases in 2006, and the company has reserved more than $850 million to defend future cases. Prior to the ruling, Merck withdrew any objection to the amount of time expended by attorneys for the plaintiffs or the hourly rate charged by plaintiffs’ counsel. The company acknowledged in a court filing that Merck’s overall fees and costs “were at least as high as plaintiffs corresponding fees and costs.” For more information, contact Mike Androvett at 800-550-4534 or mike@legalpr.com. The Lanier Law Firm CONTACT: Mike Androvett, 1-800-550-4534, mike@legalpr.com, for The Lanier Law Firm


June 12, 2007

Association of Avastin With Tracheoesophageal Fistula

Filed under: FDA WARNINGS, MEDICAL NEWS YOU CAN USE — aofcarec @ 10:35 am

DGNews

    OTTAWA, CANADA — June 12, 2007 — Hoffmann-La Roche Limited, in consultation with Health Canada, would like to inform health professionals of important new safety information regarding the use of Avastin (bevacizumab). 

    Avastin is a recombinant humanized monoclonal antibody that is directed against the vascular endothelial growth factor (VEGF). It is authorized for the first-line treatment of patients with metastatic carcinoma of the colon or rectum in combination with fluoropyrimidine based chemotherapy.

    Based on review of post market and clinical trial reports:

    · Serious adverse events, including fatal events, of tracheoesophageal (TE) fistula have been reported in association with use of Avastin clinical trials of small cell lung cancer (SCLC), non small cell lung cancer (NSCLC) and esophageal cancer.
    · Avastin should be permanently discontinued in patients with TE fistula or any gastrointestinal fistula. There is limited information on the continued use of Avastin in patients with other fistulas.
    · In cases of internal fistula not arising in the GI tract, discontinuation of Avastin should be considered.    There have been two confirmed serious adverse events of TE fistula (one fatal) reported in the first 29 patients enrolled in a U.S. investigator-sponsored multicentre, single-arm phase II trial, in patients with limited-stage small cell lung cancer (SCLC) treated with four cycles of concurrent irinotecan, carboplatin, radiotherapy, and Avastin followed by maintenance Avastin for up to 6 months. A third, fatal event (upper aerodigestive tract hemorrhage and death of unknown cause), was also reported, in which TE fistula was suspected but not confirmed.

    All three events occurred during the Avastin maintenance phase (during continued treatment with Avastin monotherapy) of the study in the presence of persistent (≥ 4 weeks) esophagitis. This study was closed for further recruitment as of March 12, 2007. No Canadian patients were enrolled in this study.

    Avastin is not indicated for use in SCLC or for use in combination with concurrent radiotherapy and chemotherapy for any cancer indication. To date, no cases of TE fistula have been reported in Canada.

    As of March 22, 2007, six additional cases of TE fistula have also been reported world wide in other lung and esophageal cancer studies involving the use of Avastin and chemotherapy alone or with concurrent radiation treatment. A review of all available data from Avastin clinical trials and spontaneous reports revealed that the events of TE fistulas observed to date with Avastin were reported in patients with SCLC, non-small cell lung cancer and esophageal cancer.

    In SCLC patients, it remains unknown if this cluster of events was influenced by the concurrent use of radiotherapy. TE fistulas have not to date been reported in patients with metastatic colorectal cancer, but the possibility that this is a rare adverse drug reaction associated with Avastin in indications other than lung or esophageal cancer cannot be excluded.

    There is limited information in the published literature on the background rate of TE fistula in patients with limited-stage SCLC, but it is estimated to be <1%1. The incidence of TE fistula observed in the U.S. investigator-sponsored trial to date exceeds this rate. Due to the small number of patients treated in the setting of limited-stage SCLC and the non-randomized nature of this trial, it is not possible to distinguish the toxicity observed in this trial from other risk factors for the development of TE fistula, such as intra-thoracic organ sensitivity from chemotherapy and radiotherapy alone.

    In Avastin clinical trials, gastrointestinal fistulas have been reported with the highest incidence of around 2% in patients with metastatic colorectal cancer, but were also reported less commonly in patients with other types of cancers (e.g. breast cancer, lung cancer and others). Uncommon (≥ 0.1% to < 1%) reports of other types of fistulas (e.g. bronchopleural, urogenital and biliary fistulas) were observed across various indications. Fistulas have also been reported in post-marketing experience. Although other risk factors (e.g. diagnosis of cancer, cancer progression, cancer treatments) are known to be associated with an increased risk of development of fistulas, a role for Avastin in increasing this risk cannot be excluded.

    Events were reported at various time points during treatment ranging from one week to greater than 1 year from initiation of Avastin, with most events occurring within the first 6 months of therapy.

    A description of cases of gastrointestinal fistula formation in patients treated with Avastin in clinical studies and post-marketing reports is included in the current Canadian Product Monograph (CPM, see Warnings and Precautions, Gastrointestinal Perforation). Roche intends to revise the Avastin prescribing information to include more detailed information regarding the incidence of all cases of fistula in patients treated with Avastin.

    Managing marketed health product related adverse reactions depends on health care professionals and consumers reporting them. Reporting rates determined on the basis of spontaneously reported post marketing adverse reactions are generally presumed to underestimate the risks associated with health product treatments. Any occurrence of serious and/or unexpected adverse reactions in patients receiving Avastin should be reported to Hoffmann-La Roche Limited, or Health Canada.

    SOURCE: Health Canada


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