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The Baycol recall has lead to inquires as to when Bayer was first aware that fatal side effects were associated with Bacol , and whether Bayer failed to timely warn the public and health authorities of these side effects. The FDA is the organization that polices drug manufacturers. However, its authority is limited. It can order certain tests and reports be done to ensure product safety. It can order warnings accompany the product. I can order a recall of the product. However, it cannot order compensation to victims of a dangerous drug. That can only be done through the civil justice process. A number of lawsuits have been filed against Bayer alleging, among other things: strict product liability, failure to warn, negligence and wrongful death. One of the allegations is such lawsuits is that Bayer knew, by virtue of its own testing, that there was mounting clinical evidence and reports of physicians regarding serious side effects with Baycol. However, rather than tread softly and cautiously Bayer continued to market Baycol as safe and highly effective, will minimizing the associated risks. Despite findings that Baycol posed serious health risks, Bayer continued to seek FDA approval for higher dosages of the drug. As a result recommended dosages increased from .2 mg to .8 mg., even though Bayer had knowledge of Rhabdomyolysis causing death and kidney failure in Baycol users as early as January, 2000. The associated dangers of the drug increased as the dosage increased. After receiving reports of an increased number of serious Rhabdomyolysis cases, Bayer adjusted the recommended dosage level in May of 2001. On August 8, 2001 Bayer voluntarily recalled Baycol. This announcement came after numerous reports of sometimes fatal Rhabdomyolisis. At the time 31 deaths had been linked to the drug. In 12 of the 31 cases, the victims were taking Baycol in combination with gemfibrozil (Lopid), another lipid reducing medication. Since then, at least 100 deaths have been linked to the drug. Many Baycol victims have now brought claims or filed suit in state and federal courts. If you feel you have been harmed by use of Baycol, click here to have an attorney review your case for free, with no obligation. Or, call us toll free at 877.786.1LAW (1529). |