Every medication carries inherent risk.
No drug is completely free of side-effects, but patients rely on industry overseers to ensure that the benefits outweigh the negative consequences.
On Wednesday, March 5, 2009, the United States Supreme Court issued a ruling that will help protect consumers from potentially harmful products.
At stake in Wyeth v. Levine was whether drug manufacturers can be the target of tort suits after their product labeling has been approved by the Food and Drug Administration (FDA). In April 2004, guitarist Diana Levine sought medical attention for migraine headaches and nausea in her home state of Vermont.
Health-care providers administered one dose of anti-nausea medication Phenergan, which is produced by Wyeth, via intramuscular injection. Ms. Levine then received a second dose of the drug via intervenous injection, known as an "IV push," when the nausea failed to abate.
But the second dose led to gangrene in her right hand and forearm, forcing doctors to amputate. It was later discovered that the Phenergan was actually injected into an artery.
After successfully reaching a settlement with the clinic, Ms. Levine turned her attention to Wyeth with claims of insufficient labeling. Reportedly, the label mentioned the risk of gangrene, but failed to address the method of "IV push" administration.
Levine argued that the labeling for Phenergan should have been altered under the CBE ("Changes Being Effected") guidelines for updates safety information. The ruling could prove a landmark for patients looking to recover damages due to defective drugs or medical products.
Experts believe that this ruling will make drug companies increase safety measures in relation to their product, since they could still be held accountable if their defective medical products hurt consumers. Drug testing and drug research could increase outside of FDA testing, while some more experimental drug development could be halted.
At the same time, other drugs already on the market could be pulled off shelves because pharmaceutical companies are anticipating future lawsuits. Victims of improper use of medications should seek proper treatment immediately.
While such an incident can leave the patient distrustful of the health care establishment, getting well is of the utmost importance. Once treatment is complete, victims can seek civili action against a health-care provider or drug-maker with the help of a qualified plaintiff's attorney.
If you believe you have been injured or harmed by a defective drug, it is vital that you contact an experienced defective drug injury attorney immediately.