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Supreme Court: Generic drug companies are legally immune from lawsuits

Posted: July 31, 2013 |   Comments

( Generic drug companies can no longer be legally held responsible for the harm that their products cause. A U.S. Supreme Court ruling gives these companies immunity from lawsuits brought to them by consumers suffering from side-effects, whether they were warned about them or not.

As per "In 2004, Karen Bartlett took sulindac, a generic, prescription-only non-steroidal anti-inflammatory drug manufactured by Mutual Pharmaceutical, for her painful shoulder. A few weeks after Bartlett took the drug, she developed an acute case of toxic epidermal necrolysis, which left her extremely disfigured, disabled, and almost blind. Sulindac's label did not warn about toxic epidermal necrolysis as a possible side effect because the brand name drug, Clinoril, did not warn about it. Under federal law, generic manufacturers are prohibited from making unilateral changes to a drug's composition and labeling, including warnings; a generic drug's composition and labeling must be consistent with the brand name drug. In 2005, however, FDA recommended changing all non-steroidal anti-inflammatory labeling to contain a more explicit toxic epidermal necrolysis warning.

"Bartlett sued Mutual Pharmaceutical under a state law requiring manufacturers to ensure that their products are not unreasonably dangerous, and a jury awarded her $21 million for her design-defect claim. The Fifth Circuit affirmed, but the U.S. Supreme Court reversed that decision. In Mutual Pharmaceutical Co., Inc. v. Bartlett, the Court held that state law design-defect claims based upon the adequacy of a drug's warnings are preempted by federal law. The Court reasoned that it was impossible for Mutual Pharmaceutical to comply with state law requiring it to strengthen its warnings or change sulindac's composition and federal law requiring it to not alter sulindac's warnings and composition. Thus, the Court concluded that the state law is 'without effect.'"

Although the Supreme Court ruled in favor of the generic drug company, some sympathy was shown for Bartlett's horrific situation. Justice Samuel A. Alito, Jr. states in his opinion following the trial: "This case arises out of tragic circumstances. A combination of factors combined to produce the rare and devastating injuries that respondent suffered: the FDA's decision to approve the sale of sulindac and the warnings that accompanied the drug at the time it was prescribed, the decision by respondent's physician to prescribe sulindac despite its known risks, and Congress' decision to regulate the manufacture and sale of generic drugs in a way that reduces their cost to patients but leaves generic drug manufacturers incapable of modifying either the drugs' compositions or their warnings. Respondent's situation is tragic and evokes deep sympathy, but a straightforward application of pre-emption law requires that the judgment below be reversed."

Bartlett and many others who have been injured by FDA approved generic drugs now have no way to seek recourse or fair compensation. As one barrier after another is set up by the government to protect the drug industry, we must ask, what rights, if any, do consumers really have and how can a government that takes such actions claim to protect the health and safety of its citizens?

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