Meningitis outbreak sheds light on lack of pharmacy regulation

The deadly meningitis outbreak that has affected hundreds of patients nationwide and led to 28 deaths has raised some alarming issues for many patients. In addition to the present problem of finding and recalling contaminated medications from that particular facility, investigations into the root cause of the outbreak has led to the revelation that compounding pharmacies are not effectively regulated by the government.

Over the past two decades, the Food and Drug Administration has documented about 200 “adverse events” connected to 71 different compounding facilities.

In a large number of the cases that reporters reviewed in which patients were injured by contaminated drugs from compounding pharmacies, it wasn’t FDA regulators that ultimately shut the unsafe facilities down. Instead, it was large settlements or judgments against the pharmacies from products liability lawsuits brought by the patients themselves.

This situation shows that while many consumers rely on government regulators to protect them from unsafe products, particularly when it comes to medications, injured patients must often take their own action to help protect others from similar harm. This is one reason why punitive damages, which are meant to compensate victims for harm that cannot truly be measured, are so effective and important. With punitive damages, juries can choose award amounts that are truly meaningful deterrents to negligent drug companies.

Meanwhile, state boards governing these pharmacies can only suspend licenses and levy small fines in set amounts. Legal experts agree that civil suits are one of the most effective methods for change in this industry. The executive director at the Center for Justice & Democracy told reporters that “the entire regulatory system lacks teeth” in this area.

Source: USA Today, “Harsh punishments rare for drug compounding mistakes” Peter Eisler, Nov. 1, 2012