Brand Name Drug Manufacturers Responsible for Generic Labels

Brand Name Drug Manufacturers are Responsible for Generic Labels

Dec 29,2017

Brand name drug manufacturers are now liable for defective labels on the generic versions of their drugs in California. Last week, the California Supreme Court ruled that brand-name drug manufacturers are responsible for the labels that end up on generic versions. According to the ruling, these manufacturers know that any deficiencies on their warning labels will also end up on the generic version. Moreover, the warning label on the generic version is legally required to be identical to that of the brand-name drug, according to FDA rules.

The ruling stems from a 2007 lawsuit against Novartis, the manufacturer of Brethine (terbutaline), a drug that suppresses premature labor. The mother of twin children born with autism claimed the generic version of the drug caused her children’s developmental delays.

Supreme Court Reverses Earlier Ruling

Novartis argued that it did not have control over the label in 2007, as it sold the rights to the drug in 2001. Initially a San Diego court found in the company’s favor, but that ruling was reversed last Thursday. According to the new verdict, brand-name drugmakers owe a duty in California “to warn of the risks about which it knew or reasonably should have known, regardless of whether the consumer is prescribed the brand-name drug or its generic ‘bioequivalent.’” Additionally, the court found \ Novartis could be sued if the harm caused by the defective label was “reasonably foreseeable.”

This decision is a game changer for victims who have been hurt by generic drugs. According to federal law, generic manufacturers are immune from lawsuits regarding injuries caused by their defective labels. Despite that, courts usually refuse to allow generic consumers to sue the brand name manufacturer for their injuries. This leaves victims with few options for recourse.

“We are glad that the California Supreme Court has found in favor of consumer rights in this case,” said Attorney Walter Clark, founder of Walter Clark Legal Group.

Our firm has been handling personal injury cases throughout the California Low Desert and High Desert communities for over 30 years. With a 95% success rate, the California personal injury attorneys at Walter Clark Legal Group will fight to hold those responsible for your loss accountable and win compensation to cover medical bills, lost wages, and pain and suffering. If you have been injured by a drug and want to discuss your legal options, contact us today for a free consultation with an experienced personal injury lawyer. We have offices in Indio, Rancho Mirage, Victorville, and Yucca Valley and represent clients through the entire California Low Desert and High Desert communities.

DISCLAIMER: The Walter Clark Legal Group blog is intended for general information purposes only and is not intended as legal or medical advice. References to laws are based on general legal practices and vary by location. Information reported comes from secondary news sources. We do handle these types of cases, but whether or not the individuals and/or loved ones involved in these accidents choose to be represented by a law firm is a personal choice we respect. Should you find any of the information incorrect, we welcome you to contact us with corrections.