Eighty percent of all prescriptions written in the U.S. are for generic drugs. Yet, if you are seriously injured by a generic drug that is not adequately labeled or is prescribed for an “off-label” use, you currently have no legal remedy.
Our highly qualified personal injury attorneys in Boston have won hundreds of millions of dollars in verdicts and settlements for patients and families who were victims of dangerous brand name drugs and medical products. These include Pradaxa, GranuFlo, Baycol, Rezulin, pain pumps, vaginal mesh products and more. This compensation has paid crushing medical bills, made up for lost income, and provided a measure of justice for lives permanently disabled or cut short.
But what about those who were seriously injured by their generic equivalents? Where is their justice?
Generic Drug Users Deserve Equal Justice
Currently, generic drug manufacturers enjoy legal immunity from lawsuits over labeling issues. This immunity stems from an FDA regulation that requires generic drugs to carry the exact same labeling information as its branded counterparts. Even if evidence comes to light that a brand name drug maker has failed to warn or down-played risks of serious side effects of a medicine, generic brands can’t update their labels to make consumers aware of this information. Courts have ruled this shields generic drug makers from injury lawsuits.
This glaring unfairness is a fundamental flaw in health care today, especially considering that eighty percent of all prescriptions written in the U.S. are now generic.
Zofran and Lipitor Generics Are Not Held Accountable
We see the travesty of this almost daily. Women are coming to us who took the drug when they were pregnant and gave birth to a child with a serious birth defect. We are suing GlaxoSmithKline on their behalf, based on evidence that the company, which originally developed the drug for chemotherapy and post-surgery patients, decided to market the drug for morning sickness without adequate safety testing.
Women who took ondansetron, the generic version of Zofran, and gave birth to a child with a serious birth defect, are contacting us. But we cannot file suit on their behalf against the generic manufacturers because, under the law, generic drug makers cannot be held liable for the injuries they cause.
We also represent many clients who took the cholesterol lowering drug Lipitor and developed type-2 diabetes. However, for every one patient injured by Lipitor, there are likely many more injured by atorvastatin, its generic equivalent. Patients seriously injured by the generic drug currently have no legal protection or recourse.
Victims of Generic Drugs Deserve Compensation
Our firm’s recent successes for victims of contaminated steroid injections; the settlement against Johns Hopkins Hospital on behalf of 9,000 women abused by a gynecologist; the $33 million verdict achieved on behalf of a child with cerebral palsy as the result of medical negligence; represent a measure of justice for people who suffered unimaginable losses.
We would like to be able to offer the same justice to people seriously injured by generic drugs. If generics are bioequivalent to their brand name counterparts, they should be treated as equivalent under the law.
Join the Fight for Legal Equivalency
Thanks largely to consumer outrage, the FDA has proposed a change to labeling regulations to allow generic drug makers to update their warning labels without having to wait for the brand name to do it first. This would make them just as accountable for letting consumers know as quickly as possible about evidence of new, dangerous risks. But generic drug manufacturers and other powerful interests are doing everything possible to delay or defeat this proposal.
The FDA needs to hear from those of us who think the generic drug loophole is unfair. You can do this by signing the petition sponsored by the American Association for Justice.