There are a lot of people who take the generic version of a prescription drug. There are many reasons people take generics: the generic is much cheaper than name brand, insurance strongly suggests it, or it is believed that they have the same make-up as their more expensive counterparts are just some examples. Some examples of the generic vs. the name brand include: Acetaminophen and Tylenol, Ibuprofen and Advil, and Paxil and Paroxetine. People may believe that the difference in Acetaminophen and Tylenol is in name only, but the law looks at it much differently, at least at this point in time.
Prescription drugs can be dangerous and manufacturers are required to make sure that their drugs are designed relatively safely and adequately labeled. People who suffer injuries from taking medically prescribed drugs may have tort claims under state law against manufacturers for failure to label the drugs or for creating a defective drug. Some recent decisions by courts have highly impacted the rights of people to recover who suffer injuries based on whether that person took the name brand drug or the generic equivalent.
The U.S. Supreme Court decided in 2011 that there is a big difference between generically labeled drugs and their name brand counterparts when it comes to state law tort cases. In Pliva v. Mensing, 131 S.Ct. 2567 (2011), the United States Supreme Court found that a generic manufacturer of a drug cannot be sued under state law for failure to adequately and safely label their products. Justice Thomas’ reason behind this decision was that the generic manufacturers had to follow the federal law that required them to label their drugs exactly like the name brand equivalent and thus were pre-empted from following state law to adequately and safely label their products.
What is really fascinating and bizarre is that name brand companies are liable under state law for failure to adequately and safely label their products. See Wyeth v. Levine, 129 S.Ct. 1187 (2009). Justice Thomas even acknowledged this peculiar situation where a plaintiff can recover only if he or she takes the name brand drug:
“We recognize that from the perspective of [the plaintiffs], finding pre-emption here but not in Wyeth makes little sense. Had [the plaintiffs] taken Reglan, the brand-name drug prescribed by their doctors, Wyeth would control and their lawsuits would not be pre-empted. But because pharmacists, acting in full accord with state law, substituted generic metoclopramide instead, federal law pre-empts these lawsuits.”(Pliva at 2581.)
The next question the U.S. Supreme Court will tackle is whether generic manufacturers can be liable for design defects of drugs under state law. This spring the High Court will hear and decide a case from New Hampshire where a jury recently awarded a plaintiff $21 million for design defects in the drug sulindac (brand name Clinoril) when she was left blind and covered in lesions after she took the generic drug. Mutual Pharmaceutical Co v. Bartlett 731 F.Supp.2d 135. The plaintiff was successful in arguing a state law tort claim that the generic sulindac had a design defect and thus was not safe for market consumption.
This case is extremely similar to Pliva because the manufacturer argues that federal law requires them to mimic the name brand drug and thus pre-empts any state law tort claims. The U.S. Supreme Court will be deciding whether state law design defects claims are pre-empted by federal law for generic manufacturers. If the court agrees with the manufacturers, it will mean one less avenue for individuals to recover who suffer real injuries from generic prescription drugs.
Injuries from taking prescription drugs can be substantial and dangerous. While the general public thinks there is not a difference between generic and name brand drugs the law looks at the two very differently. It is best to consult with your doctor and insurance provider on the best course of action regarding your prescriptions. If you believe you have suffered an injury because of a prescription drug please contact our office immediately for a consultation.