The legal landscape is littered with charges of negligence and misconduct by compounding pharmacies such as the one implicated in the nation's ongoing meningitis outbreak, but they rarely result in tough punishments, an examination of legal records shows.
In some cases, there's almost no penalty for pharmacies that break the rules, and the people who run them simply continue with business as usual, sometimes with tragic results.
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Through them all, there's a pattern: When a compounding pharmacy commits serious transgressions -- wrongs that endanger lives or involve large-scale criminal conspiracies -- the regulatory sanctions often are minimal. Tougher punishments frequently come in the form of personal injury lawsuits, which can elicit court-ordered penalties far more potent than, say, the suspension of a pharmacy's license.
Civil lawsuits are a powerful tool "to make sure the most dangerous compounding pharmacies are forced out of business," says Joanne Doroshow, executive director of the Center for Justice & Democracy at New York Law School. "Nothing else seems to be doing it … because the entire regulatory system lacks teeth."
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