Supreme Court Affirms FDA Approved Drug Labels Do Not Shield Brand Name Drug Makers from Liability

In 2009, the United States Supreme Court handed down a seminal decision regarding the liability of drug manufacturers for failure to adequately warn of the risks associated with using a particular drug. The Court examined the argument of a drug manufacturer that it could not be held liable for a failure to warn, eventhough it would have been possible to issue a more updated warning label, because the FDA had already approved the drug, and its manner of uses, as safe. hand.jpg

The case, Wyeth v. Levine, 129 S. Ct. 1187 (2009), arose out of an incident whereby the injection of a drug caused a woman to suffer gangrene from a known side effect, which ultimately resulted in the amputation of her arm.

The drug at issue, Phenergan, is an antihistamine used to treat nausea. The injectible form of the drug can be administered two different ways. One way is through a traditional IV, and the other is more akin to a shot. If the drug accidentally enters an artery, it causes immediate and irrevercible gangrene. When the patient was given the drug, she was given it in the shot manner, and it somehow entered an artery, causing gangrene, which ultimately resulted in the amputation of her forearm.

The evidence presented at trial demonstrated that the risk of the type of injury suffered by the plaintiff can be almost entirely eliminated through the use of the traditional IV method. That method is safer because the fluid will not begin to flow unless the needle is inserted properly. Despite this, the labeling did not contain any warnings about the risks of the method of injecting the medication that the plaintiff received. As a result, the jury found that manufacturer was negligent, that the drug was a defective as a result of inadequate warnings and instructions, and it awarded total damages of $7,400,000 to the plaintiff.

As discussed by the Court, FDA regulations “permit a drug manufacturer to change a product label to add or strengthen a warning about its product without prior FDA approval so long as it later submits the revised warning for review and approval.” However, the drug manufacturer, Wyeth, argued that it could not be held liable for inadequate label warnings, because the FDA had approved the drug as safe, and that including additional warnings on the label was preempted by the federal laws.

The Court rejected the drug manufacturer’s claims that issuing more up to date warning labels, considering that it had received evidence of at least 20 reports of amputations similar to the plaintiff’s since the 1960s, was preempted due to the FDA’s position as the sole arbiter of approval and gatekeeping for all drug labels.

The Court stated the reasoning behind allowing state laws to favor more stringent warnings, in that the FDA has limited resources to monitor all drugs on the market, and that manufacturers have the most information regarding the safety of their products.

Specifically, the Court said, “State tort suits uncover unknown drug hazards and provide incentives for drug manufacturers to disclose safety risks promptly. They also serve a distinct compensatory function that may motivate injured persons to come forward with information.” For these, and other reasons thoroughly discussed in the opinion, the Court rejected the manufacturer’s arguments, and upheld the decision finding a failure to warn.

In fact, in accordance with the logic outlayed in this case, the FDA has proposed changes, which would allow generic drugmakers to make changes to the labels. They have previously been unable to do so, as they must adopt labels that are identical to the previously approved medications. This proposal is incredibly significant, because the Supreme Court more recently held that generic drugmakers could not be held liable for failure to warn claims, even though the brand name manufacturers can be.

If you or a loved one has been injured or died as a result of a medication or pharmacy dispensing error, contact the experienced Maryland prescription error attorneys at Lebowitz & Mzhen, LLC. Our lawyers have extensive experience in handling medication and prescription error cases, and we will advocating to for your rights to the fullest extent of the law. Whether you or a loved one were harmed by medications that were improperly prescribed, dispensed, or administered, or you suffered as a result of medication side effects, contact us today by calling us at (800) 654-1949 or through our website, in order to schedule your complimentary initial consultation.

More Blog Posts:

Massachusetts Senate Passes Bill Regulating Compounding Pharmacies, Pharmacy Error Injury Lawyer Blog, published November 13, 2013
Four Doctors Potentially Tied to 27 Prescription Medication Related Deaths, Pharmacy Error Injury Lawyer Blog, published November 6, 2013

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