Diana Levine sued Wyeth at the Vermont Supreme Court, seeking compensation from the defendant for improperly written instructions to Phenergan that resulted in the amputation of one of the plaintiff’s limbs; litigation continued in the Supreme Court. Levine was a professional string and keyboard player who suffered from migraines and nausea (Halbert and Ingulli 323). She regularly visited the local medical facility to receive Phenergan injections as part of her treatment. One day the migraine symptoms were so severe that she decided to go to the clinic for a second dose. The health care provider gave her a second dose via the IV-push method. It is unknown what went wrong, but Levine lost her right arm and forearm because of gangrene caused by incorrect injection.
Consequently, she filed lawsuits against the physician assistant, the local clinic, and Wyeth. It should be noted that Wyeth is the company that manufactures Phenergan. Levine claimed that “Wyeth should have instructed clinicians to use the IV-push method instead of the higher risk IV-push method” (Halbert and Ingulli 323). The jury ruled in Levine’s favor and demanded $ 7,400,000 in damages from Wyeth. However, dissatisfied with the jury’s verdict, the pharmaceutical company filed an appeal with the Supreme Court.
There, Wyeth argued that the two levels of law, state and federal, contradict each other to convince the Supreme Court that the U.S. Food and Drug Administration (FDA) is to blame. They stated that it was impossible to comply with state and federal laws regarding the labeling of their products simultaneously, but they did not provide any relevant evidence. It has also been shown that gangrene and subsequent amputation could have been avoided if Phenergan had included the IV-drip method instruction (Halbert and Ingulli 325). Moreover, the company did not warn Levine even though it should have. Based on these facts and the history of the law in the United States, the Supreme Court ruled in Levine’s favor.
There are several questions in the case of Levine v. Wyeth. One of them is whether the pharmaceutical company is the only one to blame for the improper Phenergan labeling (Halbert and Ingulli 324). Another one is whether the approvals from the FDA, especially those half a century old, are enough to give companies sufficient protection from such lawsuits.
As noted above, the Supreme Court sided with Levine. Wyeth was obliged to pay substantial compensation to the injured plaintiff. The verdict was “the judgment of the Vermont Supreme Court [in favor of the plaintiff] is affirmed” (Halbert and Ingulli 325). The court ruled that only a pharmaceutical company was at fault. It has also been proven that FDA approvals do not provide companies with absolute defense against lawsuits like Levine’s one.
- The judges began with the analysis of the history of Phenergan labeling by Wyeth and its approval from the FDA.
- They concluded that FDA approvals were not enough for the complete defense, and Levine has every right to sue them.
- They also clarified the IV-drip method could have saved Levine from injury.
- The judges then analyzed the nature of the purpose of the Congress to decide what comes first, state law or federal law.
- They concluded that one of the FDA’s claims that companies are responsible for the consequences of improper instructions is valid.
- Next, the judges analyzed the defendant’s two major arguments.
- A counterargument was given to one of Wyeth’s claims, and the other was not considered valid due to lack of evidence.
- The Supreme Court concluded that the pharmaceutical company was guilty and obliged to compensate Levine for the damage.
- Levine’s case made it possible that “manufacturers remain responsible for updating their labels” (Halbert and Ingulli 324).
Work Cited
Halbert, Terry, and Elaine Ingulli. Law and Ethics in the Business Environment. Cengage Learning, 2018.