Think twice the next time you accept a generic version of a brand-name drug. Americans are not protected by tort liability law if they become injured after taking a generic version of any drug. Though 84 percent of prescriptions written in the country are filled by a generic, the U.S. Supreme Court, in two hotly contested 5-4 votes, ruled to give international drug makers a free pass from liability whenever their generic drugs harm people. (See Pliva, Inc. v. Mensing and Mutual Pharmaceutical Co. v. Bartlett).
The makers of brand-name drugs, by contrast, can still be held accountable when the drugs they make harm people, that is, if those peoples’ attorneys can prove the drug maker failed to adequately warn of the potential harm, or else exaggerated the benefits, or perhaps simply committed negligence or fraud in getting the drug placed on the market in the first place.
Considering the millions of Americans this miscarriage of justice concerns daily, there has been almost a media blackout regarding the issue. Recent developments, however, show this may be changing. NBC’s Today Show on November 8 aired the story of Viola Purcell, a woman suffering from a permanent nerve disorder called tardive dyskinesia, which was caused by a generic version of Reglan that she took for five years. Ms. Purcell is not alone. Thousands of others were also hurt by generic versions of Reglan, and thousands more have been hurt by generic versions of other drugs. Many of these cases sit in legal limbo in state courts across the country, while lawyers attempt to navigate around the Supreme Court blockade against people hurt by generic drugs.
While plaintiffs lawyers from Matthews & Associates in Houston and a few other law firms continue trying to get around the blockade by bringing various state court actions to hold generic drug makers accountable, the FDA also seems to finally be ready to take action to give generic drug makers the incentive to report adverse events and to change their drug labels as needed.
It’s too little too late for Ms. Purcell and the thousands of other injured people the highest court hung out to dry; but it may someday help restore the discerning drug taker’s confidence in generic drugs and the FDA’s ability to work for the tax payers they’re entrusted to protect.