Plavix

  • Plavix Medical Record Review & Outsourcing Services

The oral antiplatelet agent Clopidogrel was marketed jointly by Bristol-Myers Squibb Co. and Sanofi SA under the brand name Plavix. It is used to treat the formation of blood clots in peripheral vascular disease, cerebrovascular disease, and coronary artery disease. It belongs to the thienopyridine-class antiplatelet agent. Plavix works in an irreversible manner by blocking a receptor called P2Y12, adenosine diphosphate (ADP) chemoreceptor on platelet membranes. The U.S. Food and Drug Administration (FDA) approved the use of Plavix on November 17, 1997.

New England Journal of Medicine showed that patients who were on Plavix were 12 times more likely to experience gastrointestinal bleed, (GI bleed), and chronic ulcers than those taking Aspirin. The research revealed that Plavix and Aspirin if combined offered no benefit to the patients. Plavix increased the risk of moderate and serious bleeding. The study emphasized that the cost and risks of Plavix could not justify its use for the prevention of coronary artery disease and heart attack.

A study conducted by US Centers for Disease Control found that patients who used Prilosec, Nexium, and Prevacid before Plavix were more prone to get re-admitted to hospital thus making Plavix less effective.

    Serious Alleged Injuries may include:

    • Easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under skin
    • Bloody or tarry stools, blood in urine
    • Internal bleeding - gastrointestinal bleed, intracranial bleed
    • Ulcers
    • Heart attacks
    • Strokes
    • Thrombotic thrombocytopenic purpura (TTP)
    • Sudden numbness or weakness, especially on one side of the body
    • Bone marrow damage
    • Death

    FDA SAFETY WARNINGS:         

    • In 2009, the FDA added information to the drug label about poor metabolizers of Plavix. The same year, the FDA also released warnings against using Plavix when the patient was on omeprazole, a proton pump inhibitor antacid stating that taking the two together can significantly reduce the effectiveness of Plavix.
    • In March 2010, the FDA issued a Black box warning to highlight the reduced effectiveness of Plavix in patients who are poor metabolizers of Plavix and recommend to the medical community to consider using other anti-platelet medications or alternative dosing strategies for Plavix in patients identified as poor metabolizers.

    Lawsuit Allegations:

    As of September 2017, more than 5,000 cases were pending across the country against BMS that included cases from Delaware, New York, New Jersey, and California. In 2013, MDL No. 2418 was established in the U.S. District Court for the District of New Jersey under U.S. District Judge Joseph R. Goodwin. Amongst a list of allegations, the plaintiffs allege negligence, false or misleading advertising, and wrongful death.

    In June 2017, the U.S. Supreme Court announced a verdict in favor of BMS and dismissed 592 Plavix cases brought in California by people from other states. This left only 86 cases brought in California by Californians. The ruling limited cases to either the state where the company is located – in the case of BMS (New York) or where the plaintiffs reside. This left immediate and ongoing effects on other mass litigations across the country, involving other products and companies as well.

    Evidences:

    • Usage of Plavix in Pharmacy records
    • Duration of Plavix usage
    • Indication of Usage in Medical and Pharmacy Records
    • Complications and their treatment after intake

    Medical Record Review and claim validation of Plavix case should take approximately 3 hours in most instances; however, this approximation may vary in cases based on the volume of records.

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