Medical device safety issues could lead to future lawsuits

Inaccurate marketing information from medical devices companies like Pedinol Pharmacal could lead to future legal problems, based on federal Food and Drug Administration letters about drug side effects.

The company recently mailed out letters marketing its product Nalfon as a way to limit the pain associated with plantar fasciitis, a condition that affects the foot. The FDA has reported that not only is the new program inaccurate because it represents a use not in accordance with the intended use, but that drug side effects were not included.

Nalfon, a type of pain reliever, has been linked to stroke or heart attack in some situations, as well as gastrointestinal bleeding. The company included those risks in product packaging information, but not the new mailers, the FDA notes.

This lack of providing drug side effects information has led to several unrelated lawsuits, including a recent one alleging that pharmaceutical and medical device companies like Pfizer failed to report potentially serious adverse reactions. One lawsuit alleges that a man with no prior history of mental history who was taking Chantix, a smoking cessation drug produced by Pfizer, became aggressive before taking his own life.