In Law360, Andrew Campbell Weighs in on Top Life Sciences Cases to Watch in 2014

The year 2014 is sure to be transformative in the life science industry as courts around the country will decide cases on False Claims Act issues, disputes stemming from off-label drug promotion, as well as a challenge to the Federal Trade Commission's power to penalize pay-for-delay deals.

Andy Campbell of Faegre Baker Daniels, who has national experience representing pharmaceutical and medical device manufacturers, told Law360 that a case recently decided in the Ninth Circuit that created an exception to the pre-emption doctrine in medical device injury lawsuits will be one to watch at the federal level. At issue in Stengel v. Medtronic, Inc. is whether medical device amendments to the Food, Drug, and Cosmetic Act preempt a state law alleging that a medical device manufacturer violated an obligation under federal law to report adverse event information to the Food and Drug Administration.

"The question in Stengel is whether failure to report adverse information is something a private plaintiff can assert," Campbell said in Law360. "If the Ninth Circuit ruling is upheld, you could assert a claim for failure to warn based on a failure to report. If that happens, the FDA could find itself drawn into discovery proceedings in countless personal injury suits," Campbell added.