Product Liability

Lesser expensive generic drugs soon available, but are they safe?

The patents for several of the best-selling prescription medications will be expiring over the next two years, paving the way for drug companies to manufacture and sell less expensive generic versions of the drugs. Among the medications that will likely be matched by a generic competitor are the cholesterol-lowering Lipitor and the blood thinner Plavix. On average, generic drugs cost as much as 20 to 80 percent less than their brand-name equivalents.

Generic drugs are what the Food and Drug Administration calls “copies of brand name drugs that have exactly the same dose, intended use, side effects, route of administration, risks, safety, and strength as the original drug.” However, the generic version, by law, is not entirely the same. It may have different colors or inactive ingredients. About half of all generic drugs are produced in the same plants used to manufacture the brand name drugs.

These subtle differences, however, can have a huge impact on patients. Though rare, some patients can experience reactions, or side effects, caused by dyes or fillers in the drugs. Additionally, side effects from the active ingredient used in both the brand name and the generic drug often are not fully recognized until years after the patent for the brand name medication has expired.

One such example is with the heartburn drug Reglan (metoclopramide). The drug was on the market for yeas before it was found that long-term use (12 weeks or longer) of the drug put users at risk for a neurological disorder known as tardive dyskinesia.

Despite these concerns, the Supreme Court ruled last month that makers of generic drugs are not required to warn patients if they receive reports of new side effects from their drugs. This decision was based on the notion that because the FDA must approve changes on each drug’s warning label, generic makers are not liable for failing to warn patients. This new ruling further protects generic drug makers from being sued under state liability laws for failing to warn patients of these new dangers.

Which begs the question, is it worth the savings in money to switch to generic brands when the companies may be keeping life-threatening information from patients?

Beasley Allen Reglan Lawyer