Product liability lawsuits may be filed against manufacturers when their drug labels are inadequate. Sometimes the U.S. Food and Drug Administration catches the error and sends a warning letter, demands a label change, or mandates a recall. Federal action is not necessary to initiate a claim, however. One need only demonstrate that harm was caused after a particular drug was used as indicated. Defendants in product liability lawsuits may include manufacturers, corporate buyers, testing facilities, retailers, and pharmacies. Here we’ll highlight a few problems with drug labels, along with recent examples.
No Lot Number or NDC – Metformin
Actavis, Amneal, Apotex, Lupin, Markans, and Teva have been involved in metformin drug recalls due to the detection of unacceptable levels of a probable human carcinogen, Nitrosodimethylamine (NDMA). Typically, consumers can look at the National Drug Code and lot number to determine whether their drug was affected by a recall. However, pharmacies are not required to include this information on the amber bottles they dispense. Therefore, it could be challenging to know whether your drug was involved in a recall– unless a pharmacy representative notifies you.
Sometimes it takes weeks or months for the mandate to contact patients to come down from corporate. Other times, the product may “become unavailable,” without anyone telling you the reason why. Knowing the lot number and NDC is particularly crucial if you want to register a complaint in the FDA’s database.
Lack of Administering Instructions – Phenergan
Phenergan Manufacturer Wyeth lost a $6.7 million lawsuit after a judge agreed that the company had failed to provide adequate administering information. A clinician performed an IV push, failing to realize the drug could cause gangrene when exposed to arterial blood. The label should have made it abundantly clear that the medication needed to be administered via IV drip or intramuscular injection.
Patient Indications – SGLT-2 Inhibitors
A citizen’s petition begs the FDA to require stronger black box labels on SGLT-2 inhibitors, warning that the products may cause ketoacidosis in type 1 diabetics. Since 2013, the FDA has received at least 550 reports of low insulin and dangerously high levels of blood acids. According to Public Citizen, a consumer advocacy group, the current drug labels are “grossly inadequate” and should state that type 1 diabetics should not use it.
Dosage – Xeljanz
Patients taking the 10-mg twice-daily dosage of immunology drug Xeljanz for Ulcerative Colitis suffer an increased risk of blood clots and death, according to a 2019 black box label update. Similar results were observed in patients taking the 10-mg dose for Rheumatoid Arthritis in a trial. Currently, only the 5-mg dose is approved for arthritis patients, which explains the continued popularity of the drug. The European Medicines Agency placed a temporary restriction on the high dose for patients at risk of blood clots, including those with a history of heart failure.
Drug Interactions – Gabapentin and Pregabalin
Commonly prescribed pain and seizure medications Gabapentin and Pregabalin can severely weaken breathing and cause death in patients taking opioids or central nervous system depressants. Individuals with chronic obstructive pulmonary disease and the elderly are particularly vulnerable. The FDA required new warning labels in December 2019, even though the drugs had been on the market since 1993 and 2004.
Side Effects – Z-Drugs Containing Ambien
The risk of next-morning impairment after the use of zolpidem insomnia drugs containing Ambien was understated on the labels. In 2013, the FDA approved new dosing recommendations and label changes indicating patients should avoid driving the day after Ambien CR use. In April 2019, the FDA issued a black box warning about “complex sleep behavior,” where patients sleepwalk, sleep drive, sleep cook, shoot themselves, wander outside in the cold, fall, or take other medicines.
False Claims and Failure to Disclose Potential Allergens – CBD
The increasing popularity of cannabidiol concerns regulators, as many manufacturers make outlandish claims about their efficacy, causing patients to forego conventional medicines in favor of possible snake oil cures. Cannabis and Cannabinoid Research reports that “the actual contents of available products can vary considerably from what is disclosed on the label.” Sometimes there is no CBD in the product. Sometimes there is more CBD than what is labeled or contaminants like heavy metal toxins and pesticides.
Contact us today
If you or a loved one have been seriously injured after using a drug as indicated or prescribed, contact Showard Law Firm to see if you may have grounds for compensation through a product liability lawsuit.
- The New York Times, https://www.nytimes.com/2008/09/19/us/19scotus.html
- Medical Xpress, https://medicalxpress.com/news/2020-03-pill.html
- Fierce Pharma, https://www.fiercepharma.com/marketing/red-flag-upgrade-as-fda-slaps-boxed-warning-pfizer-s-xeljanz-over-cv-risks