A recent Supreme Court ruling is limiting court actions by injured patients who have filed claims against manufacturers of generic drugs.
The ruling was issued last year and said generic drugmakers do not have control over their labels and therefore cannot be sued for failing to alert the public. Under the 1984 Hatch-Waxman Act, generic drugmakers were not required to undergo the Food and Drug Administration’s (FDA) lengthy approval process if they could prove the generic drug was equivalent to the brand-name medicine.
In most cases, the Henry-Waxman Act requires generic manufacturers use the same labels as brand-name drugs, with dosing instructions and risks for injury. For this reason, judges have started to dismiss many product liability lawsuits against generic manufacturers while allowing those against brand-name drugs to move ahead.
In a March 20, 2012 article, The New York Times reported that a woman who had received the brand name for an anti-nausea medication had suffered gangrene – or a condition that results in dead or weakening body tissue. She sued the manufacturer Wyeth and won $6.8 million.
Another woman took the generic version of the defective drug, known as promethazine, and had to have her arm and forearm amputated because of complications from gangrene. Her case was dismissed last fall following the Supreme Court ruling.
The Supreme Court ruling comes as Americans are increasingly turning to generic medicines. As prices skyrocket and the economy struggles, many health insurance companies are requiring generics be filled before brand-name drugs. Doctors are required to show medical needs for the brand name over generic.
As a result, nearly 80 percent of prescriptions in the United States are filled generic and most states permit pharmacists to dispense a generic in place of a brand name.
What Can Consumers Do:
Support efforts to change the law. Public Citizen, a consumer advocacy group, has petitioned the FDA to give generic companies greater control over their labels. The move may allow generic drug users to sue. U.S. Rep. Henry A. Waxman, D-California, is also exploring ways to address the issue.
Talk to your doctor. Ask your doctor about the medicine being prescribed, the generic and potential side effects. If you are still concerned about potential injuries, ask your doctor to call your insurance company and request a brand-name.
Research any medication you use. Write down the name of the medicine you are prescribed, the medicine you receive at the pharmacy and research both drugs. Discuss any side effects with your physician.
Consider foregoing insurance. If you are really concerned and can afford the brand-name prescription, consider purchasing it. There are many discount drug programs which may help you reduce your costs. Check with any groups you are affiliated with, including AAA and AARP.
Contact your health insurance company. If the company has required you to use generic medications, ask if it has changed its policy and is now allowing use of brand-name medications.
Massachusetts Patients’ Bill of Rights and Preventing Medical Errors.