Court Discusses Potential Scope of Liability Against Brand-Name Drug Manufacturer in Case Involving Generic Medication

Under Maryland product liability law, the manufacturer of a product has a duty to ensure that the product does not present any unreasonable risk of harm to the consumer when the product is used for its intended purpose. Additionally, product liability law also generally applies a blanket of strict liability over all parties in the product’s chain of distribution. This means that any party in the chain of distribution may be liable for a plaintiff’s injuries caused by the product without a showing that the party was negligent.

DNA ChainWhen discussing the liability of a pharmaceutical manufacturer that allegedly created a dangerous drug, some specific rules apply. For example, in a recent case, the court discusses whether a brand-name manufacturer can be potentially liable in a case involving a plaintiff’s injuries that arose after consumption of a bioequivalent generic medication. Ultimately, the court concluded that the brand-name manufacturer could be held liable under the state’s product liability laws, and it dismissed the defendant manufacturer’s motion for summary judgment.

The Facts of the Case

The plaintiffs were two children born with serious developmental delays by the time they turned three, and they were later diagnosed with autism by the age of five. During delivery, the plaintiffs’ mother was given the generic equivalent of the medication Brethine to suppress premature delivery. The plaintiffs were born full-term but later experienced what they claim to be the side effects of the medication.

The plaintiffs filed a product liability lawsuit against the manufacturer of the brand-name drug, as well as the company that bought the rights to the drug after it went to market. The plaintiffs claimed that there was some evidence that the drug had adverse effects on lab rats, yet the drug’s warning did not disclose the risk. Under federal law, the brand-name manufacturer is responsible to create the warning label for both brand-name and generic products.

The defendants argued that they did not owe the plaintiffs a duty of care because the plaintiffs’ mother did not take a drug that was manufactured by either defendant. Additionally, the original manufacturer argued that, since it sold the rights to the drug prior to the plaintiffs’ mother taking the generic version, the case against it should be dismissed.

The court resolved both of the defendants’ claims in favor of the plaintiff, holding that the brand-name manufacturer could be liable even in a situation in which the company sold the rights to the drug before the plaintiffs’’ injuries. The court explained that the fact that a brand-name manufacturer is required under federal law to create a warning label creates a duty that extends to anyone who takes that medication, as well as any bioequivalent generic versions of the drug. The court acknowledged that the original manufacturer of the medication that had sold the rights prior to any injury made a good argument in favor of finding that it could not be held liable, but it ultimately concluded that selling the rights did not terminate the duty that was owed to patients who consumed the medication.

Have You Been Injured by a Dangerous Medication?

If you or a loved one has recently been injured after consuming a dangerous medication, you may be entitled to monetary compensation through a Maryland product liability or pharmacy error lawsuit. The dedicated personal injury attorneys at the law firm of Lebowitz & Mzhen, LLC have extensive experience handling pharmacy error claims as well as product liability cases involving dangerous pharmaceutical drugs. Call 410-654-3600 to schedule a free consultation to discuss your case with an attorney today.

More Blog Posts:

Experts Hope a Bottle’s Label Design Can Decrease Prescription Errors, Pharmacy Error Injury Lawyer Blog, January 2, 2018.

Court Finds Evidence Insufficient in Recent Pharmacy Error Case, Pharmacy Error Injury Lawyer Blog, December 15, 2017.

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