Call Moll Law Group About Your Preterm Infant Formula Claim
In Gill v. Abbott Laboratories, the plaintiff sued Abbott Laboratories on behalf of her preterm infant, claiming that the company’s cow’s milk-based preterm infant formula caused the infant’s necrotizing enterocolitis (“NEC”), an intestinal disease that often affects preterm infants. The science can be a little difficult to understand since the studies say that preterm infants exclusively fed the cow’s milk-based formula are at a higher risk of developing NEC than those fed only human milk, but studies have not firmly concluded that there is a direct causal link between NEC and cow’s milk-based formula.
During Gill v. Abbott Laboratories’ pre-trial motions and pleadings, the manufacturer defended itself under the learned intermediary doctrine, an affirmative defense. This is a doctrine that applies in some states to remove responsibility from manufacturers of prescription drugs and medical devices of the duty to provide direct warnings to patients or consumers of the risks associated with those drugs and medical devices, so long as the manufacturer gives appropriate information to the physician prescribing the medication or device. The physician then bears the responsibility of letting patients know what the pros and cons are, and what would be the most prudent course of treatment. In Gill, the plaintiff moved for summary judgment and asked the court to determine that the manufacturer wasn’t entitled to use the learned intermediary doctrine and other similar affirmative defenses.
The manufacturer argued otherwise, claiming that the preterm infant formula was provided only at the direction of the doctor in the course of a preterm baby’s medical care in the hospital NICU, and that therefore the learned intermediary doctrine applied to prevent the manufacturer from being held responsible for the baby’s death. The court found that this doctrine didn’t apply because preterm infant formula is neither a recognized prescription drug nor a medical device, even though a physician and a care team of medical providers do help with the care plan that’s administered while a baby is in the NICU. The jurors returned with a verdict for the plaintiff against the manufacturer with regard to claims of negligent failure to warn, strict liability for failure to warn and negligent design. The plaintiff was awarded $95 million in compensatory damages and $400 million in punitive damages.
As preterm infant formula cases continue to go to trial, the questions of whether product liability theories or medical malpractice theories apply to them are likely to keep cropping up. In states where the courts determine that the learned intermediary doctrine applies, doctors may find themselves saddled with medical malpractice liability for failing to accurately assess the risks of feeding cow’s milk formula to a preterm baby. However, courts that find, as with the aforementioned case, the learned intermediary doctrine does not apply, since the formula is not a prescription drug or device, will likely require plaintiffs to establish that product liability theories like strict liability or negligence apply to the conduct of formula manufacturers. Only two companies in the country produce formula for preterm infants, and these rulings may have big consequences for them.
Whether you believe you were injured as a result of a manufacturer’s misconduct or medical malpractice by a healthcare provider, or both, please call our knowledgeable Chicago-based trial attorneys about your legal options. Please complete our online form or call us at 312.462.1700.