Generic Drugs

Generic Drug Companies Insulated From Lawsuits

While most people would consider it more difficult to bring a lawsuit against a major drug manufacturer than a generic company, this is not the case. Due to a variety of federal laws, combined with the concept of federal law pre-emption over state law, generic drug companies enjoy a strong insulation against liability for the damages caused by their products and their failure to warn.

However, at Galligan Reid PC, we have more than 25 years of litigation history. Our Iowa generic drug labeling attorneys have a thorough understanding of your legal rights and options. If there is any way to obtain for you the compensation you deserve, our lawyers will do everything possible to find it. Contact us to learn more.

Generic Drug Approval Process

The Hatch-Waxman Act of 1984 altered the federal Food, Drug and Cosmetic Act by allowing generic drug manufacturers to gain approval of a drug similar to one made by a major manufacturer without having to go through the complex, time-consuming approval process. This leaves users of these drugs without adequate warning of their potential dangers.

Failure to Warn

Another major roadblock for victims of dangerous generic drugs involves the Hatch-Waxman Act not allowing generic drug companies to change their safety warnings unilaterally. Because of this, patients do not receive timely warnings when generic drug manufacturers discover new dangers associated with their products.

Federal Pre-Emption

The linchpin of these limitations comes from the concept of federal pre-emption, a legal concept meaning that when federal law and state law contradict each other, the federal law takes precedent.

Although the issue of pre-emption can be complicated, in generic drug litigation, it boils down to:

  • State laws: Many state laws require generic drug companies to update their warning labels as soon as they receive new information about potentially dangerous side effects.
  • Failure to warn claims: The Hatch-Waxman Act (which is considered federal law) has the effect of prohibiting manufacturers of generic drugs from unilaterally changing the safety warnings on their products' labeling.
  • Federal pre-emption: The United States Supreme Court has determined that the federal laws pre-empt the state laws requiring these safety warnings, thus limiting claims of injured parties against generic drug companies.

Although it might look impossible to bring a successful claim against a generic drug company for damages, this is not always the case. It is important to talk with an attorney who has experience in these matters. We offer free initial consultations so you can learn about your rights and options from a Galligan Reid PC lawyer, without cost or obligation.

Contact Our Generic Drug Product Liability Attorneys

To schedule your free initial consultation with a lawyer from our firm, call 515-282-3333 (800-217-9312 toll free) or contact us online.