Mutual Pharmaceutical Co. Vs. V. Karen Bartlett

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Issue In the case of Mutual Pharmaceutical Co., Inc v. Bartlett 133 S. Ct. 2466 (2013), the plaintiff Karen Bartlett was prescribed a medication named Clinoril for shoulder pain. Mutual Pharmaceutical dispensed the prescription in the generic form. The drug caused Karen Bartlett to develop toxic epidermal necrolysis. At the time of the incident, the label of the drug did not specify development of toxic epidermal necrolysis as a possible side-effect. For Karen Bartlett not adequately labeling the medication caused her medical damages. Was Mutual Pharmaceutical Co guilty of noncompliance with consumer protection and product safety laws? Rule “The Federal Food, Drug and Cosmetic Act (FDCA) establishes standards to prohibit misleading labeling.” (Gresham, 2013) “The FDCA also requires that manufacturers of drugs gain approval from the Food and Drug Administration (FDA) prior to engaging in interstate commerce.” (Gresham, 2013) Any new drug is submitted under a New-Drug Application (NDA) for approval. The Hatch-Waxman Act was created for generic drugs. In addition, under the Hatch-Waxman Act …show more content…

v. Barlett, 133 S. Ct. 2466 (2013). The Supreme Court based its decision in part on PLIVA, Inc. v. Mensing, 131 S. Ct. 2567 (2011), believed federal law prohibited generic manufacturers from implementing unilateral label changes and that a drug company strengthen its warnings. State law secured U.S. Supreme Court decision assuring that the Hatch-Waxman Act preempts state-law tort claims pointing to the design/composition of generic drug products. Of particular relevance, the Supreme Court also stated that the drug in question was “chemically incapable of being redesigned.” (133 S. Ct. at 2475) The Supreme Court fell short of holding that design defect claims against brand manufacturers were

In this essay, the author

  • Explains that mutual pharmaceutical co., inc. dispensed clinoril for shoulder pain, which caused karen bartlett to develop toxic epidermal necrolysis. the label of the drug did not specify this as a possible side-effect.
  • Explains that the federal food, drug and cosmetic act (fdca) establishes standards to prohibit misleading labeling. manufacturers of generic drugs are prohibited from making changes to a drug or the already approved label.
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