Massachusetts Supreme Judicial Court Holds Failure-to-Warn Claim Against Drug Manufacturer Not Preempted Because There Was No “Clear Evidence” FDA Would Not Have Approved Plaintiffs’ Suggested Warning; Also Holds Non-Physician’s Causation Opinion Admissible and $63 Million Compensatory Award Not Excessive -
In Reckis v. Johnson & Johnson, 471 Mass. 272 (2015), a seven-year-old developed the severe dermatologic disease toxic epidermal necrolysis (TEN) after her parents gave her multiple doses of over-the-counter ibuprofen even after the girl began developing a rash. The child’s parents, for themselves and on her behalf, sued the drug’s manufacturers in Massachusetts Superior Court for negligence, breach of the implied warranty of merchantability (the Massachusetts near-equivalent of strict liability) and violation of Mass. Gen. L. ch. 93A (the Massachusetts unfair and deceptive practices statute), alleging the drug caused the TEN and defendant did not adequately warn consumers that redness, rash or blisters could be signs of a “life-threatening” disease, either with or without specific mention of TEN. A jury awarded the child $50 million and the parents $13 million.
Please see full publication below for more information.