Generic drugs are often defined as medications that are comparable to or copies of brand name medications. They are released after a brand name drug’s patent (or exclusive right to the product) has expired. The generic medication has the exact same dose as the original drug, but has a different appearance and may have different inactive ingredients. Another key difference is the fact that generic medications are far cheaper than brand name drugs – 80 to 85% lower than the brand name product.
This cost differential often means that insurance companies, both private companies and Medicare, automatically switch their insureds to the generic version of a drug as soon as it becomes available – leaving consumers with little choice over their own drug consumption. Until recently, most people happily took the generic version of their drug without a second thought. However, last summer, the Supreme Court issued an opinion which has many consumers worried about their use of generics.
Pliva v. Mensing was a case which sought to determine the state law duties of generic medication manufacturers. The Court decided that generic manufacturers are not subject to “failure to warn” claims under state law, because generic manufacturers are required by federal law to have the exact same warning label as their brand name counterpart. Essentially, this ruling means generic companies have no duty to warn the consumers of their drugs. This is a bigger ruling that many of the other, more publicized, 2011 decisions issued by the Supreme Court. Why? Because the vast majority, up to 75%, of prescription medications consumed in America are generics. Justice Sotomayor, who issued the dissenting opinion, recognized the issue this decision made for every day consumers. “Today’s decision eliminates the traditional state-law incentives for generic manufacturers to monitor and disclose safety risks.”
State Courts are still grappling with the Mensing decision. Some have dismissed cases against generic drug manufacturers, while others have maintained the claims – agreeing that there were other actions that the generic company could have taken to protect their consumers, such as sending letters that warn of dangerous side effects to physicians and consumers.
While this issue develops, it is important for consumers to be aware of the risks associated with all medications – brand name and generic – and to consider requesting that your doctor issue your prescription as “brand name only” to protect your rights in the event that you suffer an injury caused by your medication.
For more info on generic drugs, check the FDA website: http://www.fda.gov/drugs/resourcesforyou/consumers/buyingusingmedicinesafely/understandinggenericdrugs/ucm167991.htm