Court Dismisses Claim Against Drug Manufacturer for Failure to Provide Medication Guide with Prescription

Plaintiffs have to be careful when it comes to filing a Maryland pharmacy error claim. A recent case shows how asserting the wrong claim in a case can result in the case’s dismissal.

In that case, the plaintiff brought a claim against a drug manufacturer for allegedly causing her husband’s death due to the manufacturer’s failure to provide a medication guide with her husband’s prescription. The manufacturer made a generic form of amiodarone hydrochloride, a drug used for certain life-threatening heartbeat irregularities. As a generic drug, it is required to have the same labeling as its approved brand-name counterpart. One of the labeling requirements is making medication guides available for distribution to each patient who is prescribed the drug. The medication guides explain the approved uses of the drug and also explain the drug’s side effects “in nontechnical, understandable language.” In amiodarone’s medication guide, it states that the drug should be used only to treat “life-threatening heartbeat problems.”The plaintiff’s husband died after taking amiodarone to treat his non-life threatening atrial fibrillation. The plaintiff alleged that her husband died because he had been taking amiodarone, which he had been prescribed. The manufacturer allegedly failed to provide the medication guide for distribution, which her husband did not receive when he filled his prescriptions in May and June 2015. The plaintiff claimed that her husband was not aware that only those with life-threatening heartbeat irregularities should take the drug, due to its serious side effects. She argued that the manufacturer failed to warn her husband by failing to provide the medication guide, as required under federal law.

However, under the Federal Food, Drug, and Cosmetic Act (“FDCA”), only the federal government is permitted to file suit for a failure to comply with the Act’s requirements. Since the plaintiff’s claim was based only on the manufacturer’s failure to comply with the FDCA by failing to provide the medication guide, the court dismissed her claim.

Failure to Warn Claims

In “failure to warn” claims, a defendant may be liable for failing to warn consumers about the risks involved in using a product. As a general rule, a product must adequately warn consumers of the dangers of using the product, unless the product’s dangers are obvious. This means that a defendant, such as a drug manufacturer, may be liable if it fails to disclose an unreasonably dangerous condition, fails to adequately disclose the risks, or fails to instruct consumers on the correct use of the product. These claims can be complicated, however, and should be handled by attorneys who are experienced in this particular area of law.

Contact a Prescription Error Lawyer

If you or a loved one has suffered an injury that you believe may be a result of a medical error, you may have grounds to pursue a claim for compensation. At Lebowitz & Mzhen, LLC, our Maryland pharmacy error attorneys have decades of experience representing victims of prescription errors, medical malpractice, and other negligent conduct. Our attorneys work closely with medical experts to assess your claim and aggressively pursue the compensation you deserve. Contact us at 800-654-1949 or 410-654-3600 to schedule a free consultation.

More Blog Posts:

Steps That All Pharmacists Can Take to Reduce Dispensing Errors, Pharmacy Error Injury Lawyer Blog, July 16, 2018.

Study Notes an Increase in Accidental Overdoses from Cancer Drug, Pharmacy Error Injury Lawyer Blog, July 2, 2018.


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