In 2004, the respondent (Bartlett) was prescribed Clinoril - a nonsteroidal anti-inflammatory drug (NSAID) by her doctor for shoulder pain. Her pharmacist filled the prescription with a generic form of the NSAID manufactured by the petitioner, Mutual Pharmaceutical. Shortly thereafter, the respondent developed severe toxic epidermal necrolysis. As a result, she is severely disfigured, physically disabled and almost blind (Mutual Pharmaceutical Co., Inc. v. Bartlett, 2013).
In 2005, the respondent sued the petitioner in New Hampshire state court shortly after the FDA recommended a warning label change on NSAIDs to indicate toxic epidermal necrolysis as a possible side effect. The petitioner, Mutual Pharmaceutical, had the case removed to federal court based on the supremacy of federal law in FDA matters. In essence, federal law is superior to state law where the federal and state governments have competing statutes (Mutual Pharmaceutical Co., Inc. v. Bartlett, 2013).
The federal court ruled in favor of the respondent on her claim that Mutual was liable for a design-defect claim. The federal jury awarded the respondent $21 million. Mutual appealed to the United States Supreme Court citing the supremacy clause
(Mutual Pharmaceutical Co., Inc. v. Bartlett, 2013).
Mutual's appeal argued that they could not be expected to comply with New Hampshire's law and a conflicting federal law. New Hampshire's law prohibits the manufacture and distribution of drugs where the manufacturer can reasonably ascertain that the drugs are unsafe for public consumption. However, the petitioner prevailed by asserting that they had met the burden of FDA requirements and that the FDA requirements - as compared to the New Hampshire statute - rendered the state law as "without effect" due to the Supremacy Clause (Mutual Pharmaceutical Co., Inc. v. Bartlett, 2013).
Was the United States Supreme Court correct in overturning the lower federal court's decision to rule in favor of the plaintiff (Bartlett) and rule that the defendant (Mutual Pharmaceutical) pay $21 million to the plaintiff?
Further, was the Supreme Court correct in dismissing this case based on the Supremacy Clause?
Rules for case #1- Mutual Pharmaceutical Co. v. Bartlett
The Federal Food, Drug, and Cosmetic Act (FDCA): Manufacturers must obtain Food and Drug Administration approval before marketing any brand-name or generic drug in interstate commerce. (Mutual Pharmaceutical Co. v. Bartlett)
Supremacy Clause: State laws that conflict with federal laws are "without effect". Know as the supreme law of the land. (Mutual Pharmaceutical Co. v. Bartlett)
Design-Defect: Imposes affirmative duties on manufacturers that include a duty to design their specific products in a safe manner for their specific use. (Mutual Pharmaceutical Co. v. Bartlett)
Hatch-Waxman Act of 1984: Generic drugs may be approved without the same level of clinical testing that is so required fr approval of a new brand-name drug. The generic drug must be identical to the already approved brand name as far as chemical equivalence and rate and extent of absorption. (Mutual Pharmaceutical Co. v. Bartlett)
Food and Drug Administration: Responsible for protecting the publics health, safety and security of human as well as veterinary drugs, bio chemicals, medical devices, Unites States food supply, cosmetics and radiation emitting products. (www.fda.gov)
Failure To Warn Claim. In accordance with the United States Food and Drug Administration (2010), when a drug manufacturer formulates a new medication for market consideration, the Federal Food, Drug, and Cosmetic Act or FDCA requires it to submit a New-Drug Application or NDA. Next, the FDA reviews supporting studies, clinical investigations, and trials to ensure the medication is safe for consumer use and that its therapeutic benefits outweigh its potential harmful…