Generic Drug Consumers Lack Important Legal Protections July 1, 2015
Many times, people take generic drugs because they are more cost effective and included in insurance plans. However, these consumers may not have the same legal protections taking a generic drug as a brand name drug. Despite generics being copies of existing drugs, legal protections for consumers of generic drugs may not apply.
Because of legal rulings, two different standards apply to generic and brand name drugs.
Here is a bit of the history that led to this gap in consumer protections. In an important Supreme Court case, Wyeth vs. Levine, the court decided that manufacturers of branded drugs are liable if they do not update their labeling to reflect newly found dangers. The manufacturers must warn of risks even before getting approval from the FDA for label changes.
In contrast, generic manufacturers need only comply with current FDA labeling requirements, even if newly found risks apply to them. The Supreme Court, in PLIVA vs. Mensing, decided that consumers could not sue generic manufacturers for failing to update labels to include potential dangers. The Court reasoned that generics were required by regulatory law to keep current FDA labeling and could not change their label to reflect newly found dangers.
Because of these rulings, thousands of products liability suits have been dismissed against generic manufacturers, despite the drugs essentially being copies of brand name drugs. A consumer could find they are unable to seek compensation for an injury or illness caused by a generic drug, even though consumers of the brand-name drugs do have such protection!
Fortunately, a proposed FDA rule could eliminate this double standard. The rule would require both generic and brand name manufacturers to alter their labeling to warn of newly discovered risks. The FDA first proposed the rule in November of 2013. Due to pharmaceutical industry opposition, it does not look like the FDA will implement this rule change until later this year!
Philadelphia Products Liability Lawyers at Galfand Berger Advocate for Consumers’ Rights
If you suspect that you may have been injured by a defective or mislabeled product, call the experienced Philadelphia products liability lawyers at Galfand Berger. You may be able to file a products liability action and recover damages to compensate you for any harm you have suffered. Call 800-222-8792 or submit an online contact form to schedule a free consultation.