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Supreme Court will decide on generic drugmaker liability

This week the U.S. Supreme Court will take up the issue of whether generic drugmakers have any liability for selling unsafe medications.  The Court is likely to overturn the verdict awarded to Karen Bartlett, a New Hampshire woman who spent months in a burn ward and in a medically-induced coma, and ultimately was rendered legally blind, after taking an obscure anti-inflammatory for shoulder pain.  Bartlett's doctor prescribed sulindac for her shoulder pain, and her rare, severe reaction permanently damaged her skin, lungs and esophagus, in addition to rendering her blind. Her burn surgeon described her experience as "hell on earth."

Generic drugs account for 80% of all prescription medications. Two years ago, the Court held that since generic manufacturers aren't involved in drug approval and don't participate in composing drug labels or warnings, they cannot be held responsible for failing to give patients proper warnings and instructions. The argument in Bartlett's case is slightly different:  she argues the drug is unsafe under any conditions and production should have been discontinued.  The manufacturer says that since it did not design the drug, it cannot be held responsible for any unsafe characteristics. The drug manufacturer is Mutual Pharmaceutical Company, a subsidiary of Sun Pharmaceutical of India.

In Michigan, the issues are much simpler.  A decade ago, the Republican majority in  Michigan's Legislature adopted rules making Michigan the only state that grants complete immunity to any drug manufacturer, if the drug was once approved by the FDA.  Even if it is later proved that the drug is unsafe and that it was approved on the basis of faulty or fraudulent testing or lack of disclosure of data, the manufacturer retains its immunity in Michigan.  That was a special favor granted to pharmaceutical companies who donate heavily to politicians.

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