Manufacturers and Sellers Are Often a Misunderstood Source of Medical Liability

man getting eye exam

When you hear the words “medical liability”, the picture that comes to mind most often is one involving a malpractice lawsuit against a doctor, hospital or other healthcare providers. Truth be known, over the past five years regulators, lawmakers, and consumers have continued to pressure product manufacturers in the pharmaceutical, medical device, food, and consumer product industries over a legitimate concern about the safety of products and how effectively recalls and notifications are being managed.

Stericycle Expert Solutions is an Indianapolis-based company that offers comprehensive services to help protect consumers and enhance companies' brands by guiding swift action for a successful resolution when a medical device, drug, or food product recall puts consumers' lives in danger. For the past five years, the global B-to-B services company has released a quarterly Recall Index to forewarn consumers of product and drug recalls that could threaten their well-being.

According to the Q2 2018 Index, pharmaceutical recalls declined 27%, and recalled units dropped 95% to just under 16 million, which is in line with the average for 2016. Medical device recalls, on the other hand, increased by 5% making it the largest quarter since 2005. Recalled medical devices did decrease to just over 42 million units, which was lower than eight of the previous thirteen quarters. Sixteen companies reported at least five recalls, which was the largest increase since Q3 of 2013.

This month, the Recall Index posted the most recent FDA Medical Device Warning for the Raindrop corneal inlay developed by the now defunct ReVision Optics. The California-based manufacturer won approval from the Federal Drug Administration in June of 2016 for the optical device intended to treat presbyopia, which is the loss of near focusing abilities. With the popularity of smart phones, a hydrogel inlay placed on the patient's cornea of his or her non-dominant eye could reshape the curvature and allow them to read the fine print on their phone. After the premarket study, the FDA's ongoing collection of patient data confirmed that 16-plus percent of patients had experienced central corneal hazing, a cloudy layer that can develop following an eye infection, trauma or surgery.

When manufacturers rush to be first to market with the latest technological advances or medical device innovations, mistakes can happen and consumers pay an unexpected price. The purpose of Florida's product liability laws is to ensure that the cost of injuries and damages resulting from defective products are borne by the manufacturers, distributors, and sellers who fail to thoroughly test and warn the public about a product's potential dangers. Unlike other areas of personal injury, proving someone was negligent is not usually required in a strict liability claim. If you or a loved one has been injured or permanently damaged due to another company's failure to provide a safe product or service, contact an attorney at Schackow & Mercadante.