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431:(FDA) before engaging in interstate commerce. When a new brand name drug is created, the drug must be submitted under a New-Drug Application (NDA). In the NDA is a compilation of materials that must include a full report of all clinical investigations and all relevant studies. The NDA may only be approved by the FDA if they find that the drug is safe for use and the therapeutic benefits outweigh the drug's harm.
24:
438:, known as the Hatch-Waxman Act. Under Hatch-Waxman a generic drug may be approved for use without the onerous provisions of an NDA provided the generic drug is identical to an already approved brand-name drug. Under Hatch-Waxman the generic drug manufacturer is prohibited from making any changes in the drug or from making any changes to the already approved label.
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The Court reversed the decision of the First
Circuit with Justice Alito writing for the majority. The Court centered its opinion around the impossibility of a generic drug manufacturer both meeting its obligations under State law and Federal Law. Where such conflict exists, the court writes, Federal
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In 2004 the respondent Karen
Bartlett was given Clinoril for shoulder pain. The pharmacist dispensed a generic form made by Mutual Pharmaceutical. Bartlett soon developed toxic epidermal necrolysis, with sixty percent of her skin destroyed. She underwent months in medically induced coma, twelve eye
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Justice Breyer, joined by
Justice Kagan dissented arguing that it was not totally impossible for the drug manufactures to comply with both State and Federal Law. He argued that the company could either choose not to do business in the State of New Hampshire or could accept that such damages are a
486:. The District Court dismissed her failure-to-warn claim on her doctor’s own testimony that she had not read the box nor label. On the claim of design-defect a jury found Mutual liable for over $ 21 million in damages. Mutual appealed.
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New
Hampshire State Law imposes a duty on drug manufactures that the drugs they produce are not unreasonably unsafe. The safety of drugs is to be judged by a combination of its chemical properties and its warning label.
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At the time of the incident the label did not specifically refer to developed toxic epidermal necrolysis but did warn of severe skin reactions, however toxic epidermal necrolysis was listed on the package insert
454:. When the patent expired the FDA approved several generic versions including one manufactured by Mutual Pharmaceutical. The drugs have serious side-effects including hypersensitivity skin reactions with
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manufactures cannot be held liable under state law for not adequately labeling medication when federal law prohibits them from changing the label from the original brand name drug.
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Because submitting an NDA is expensive and lengthy, the
Congress set out to create an easier path for generic drugs to be issued to the public. Congress passed the
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Bartlett sued in New
Hampshire State Court, however Mutual was able to remove the case to Federal District Court. Bartlett initially argued both
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liability. She also argued that
Federal drug law should be looked at as complementary to State laws, rather than in competition with them.
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Generic drug manufactures cannot be held liable for damages under state law when it conflicts with federal law.
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The Court of
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244:2010); motion for new trial denied, 760
713:Supreme Court (slip opinion) (archived)
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57:"Mutual Pharmaceutical Co. v. Bartlett"
741:United States Sixth Amendment case law
44:Please improve this article by adding
662:Mutual Pharmaceutical Co. v. Bartlett
636:Bartlett v. Mutual Pharmaceutical Co.
614:Bartlett v. Mutual Pharmaceutical Co.
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570:Bartlett v. Mutual Pharmaceutical Co.
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120:2013 United States Supreme Court case
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409:Supreme Court of the United States
229:Summary judgment granted in part,
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509:Law must take primacy under the
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251:(D.N.H. 2011); affirmed, 678
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145:Argued March 19, 2013
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266:. granted,
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193:U.S. LEXIS
191:607; 2013
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