According to the Centers for Disease Control and Prevention (CDC), more than 30 million people in the U.S. wear contact lenses. Contact lenses are classified as medical devices that are regulated by the FDA. Serious eye infections from contact lens use can lead to blindness, and affect up to one out of every 500 contact lens users per year. Other complications that are commonly linked to contact lenses usually cause milder symptoms, or no symptoms at all.
A recent case out of the Seventh Circuit addressed a product liability claim related to complications caused by contact lenses. A week after a man started using a particular type of contact lenses, he experienced sharp pain in his eyes. He did not immediately discontinue use of the lenses. He previously had eye problems with other contacts. He limited his use of the contacts to times when he exercised, and continued to wear the lenses off and on for a few months. He stopped using this particular type of contact lenses after five months.
More than two years later, the man sought treatment for severe eye inflammation. His ophthalmologist determined that he had chronic ocular surface inflammation; mixed papillary and follicular conjunctivitis, a non-specific inflammation of the mucous membrane of the eyes; and punctuate corneal erosions, very fine areas of eroded corneal epithelium, on the surface of his corneas. The ophthalmologist believed the man’s symptoms were probably related to contact lens wear and that his contact lenses could have started a cycle of inflammation. Specifically, the ophthalmologist stated that the man’s symptoms were consistent with oxygen deprivation to his eyes, secondary to contact lens use, as well as limited motility, or movement, of the contact lenses.
The man sued the manufacturer of the last contact lenses he wore. The complaint claimed the manufacturer was liable for negligence, strict product liability, and breach of implied warranty. After discovery and various motions to dismiss, the man had only one legal theory left for why the contact lens manufacturer would be liable for his eye pain: that he used lenses that were subject to the contact lens manufacturer’s recall.
The contact lens manufacturer moved for summary judgment on the ground that the man never used the recalled lenses. It relied on evidence showing that none of the lenses shipped to and later recalled from the store where the man purchased his contact lenses were in his prescription strength. The United States District Court for the Northern District of Illinois, Eastern Division, entered summary judgment in favor of the contact lens manufacturer. The Seventh Circuit United States Court of Appeals affirmed.
What was particularly interesting about this case was that the man’s theory of liability turned on the contacts he used being subject to a recall. The same month the man began to wear this manufacturer’s contact lenses, after discovering that many of the contact lenses manufactured in a particular facility had ion permeability levels below 1.0, the manufacturer conducted a medical assessment that concluded the low permeability levels created a negligible risk to consumers. Nevertheless, the manufacturer instituted a voluntary recall of 11 million contact lenses. The man’s contact lenses were manufactured in the same plant as the recalled lenses and the manufacturer shipped recalled lenses to the optical store where the man purchased his lenses. However, the manufacturer’s documentation established that none of the recalled contact lenses shipped to the optical store where the man purchased his lenses matched his prescription. The man argued that even if his contacts were not subject to that exact recall, because they were manufactured in the same facility, they probably suffered from the same defects. The district court and the circuit court found this theory was unsupported by the evidence.
The FDA’s premarket approval process for contact lenses did not address ion permeability, the basis for the recall. The Seventh Circuit did not reach the question of whether the man’s state law claims were preempted by the Medical Device Amendments (MDA) to the Food, Drug, and Cosmetic Act. However, in reviewing the district court’s decision, the Seventh Circuit did note that the manufacturer’s contact lenses were Class III devices within the meaning of the MDA and such devices must be approved by the FDA pursuant to the agency’s pre-market approval process. The man argued that his suit was not preempted by the MDA because the manufacturer failed to list ion permeability as a “material characteristic” in its premarket approval list. The manufacturer responded that the FDA did not require it to meet any ion permeability threshold. The district court, in dicta, concluded that the man could not establish that the manufacturer violated federal standards with respect to ion permeability.
By Sarah Kelman, JD, and the experts and editors at Medical Law Perspectives.
For more details, see the Scalpel Weekly News, March 9, 2015.
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See also Medical Law Perspectives, July 2014: Injuries Resulting From Laser Procedures: Risks for Physicians, Technicians, and Manufacturers
See also Medical Law Perspectives, March 2013: When Cataract Treatment Creates More Harm Than Cure: Malpractice Liability Issues