Boston Scientific Loses Preemption Argument in Manufacturing Defect Case.

Generally, under the law of products liability, a manufacturing defect is an unintended defect in an otherwise safe product that occurs when the product departs from its intended design and is thus more dangerous than it should be. In Massachusetts, manufacturers are required to uphold a near-equivalent of strict liability called the implied warranty of merchantability.

In Dweyer v. Boston Scientific Corp., a man implanted with a cardiac resynchronization therapy defibrillator died from head trauma sustained after he lost consciousness and fell when the device malfunctioned.

Subsequently, the device was explanted from his body and returned to the manufacturer, Boston Scientific Corporation, for testing. The results confirmed that the wiring in the device transformer had failed. The decedent’s wife sued the manufacturer for negligence and breach of the implied warranty of merchantability. According to a Foley Hoag article, she alleged that the wrongful death had been caused by a defect resulting from the defendant’s violation of various federal Current Good Manufacturing Practices regulations applicable to all medical devices.

Boston Scientific moved to dismiss the case on the grounds that the 1976 Medical Device Amendments to the Federal Food, Drug and Cosmetic Act expressly preempted the wife’s claims because federal law occupied the field and thus supplanted state law.

The court noted the absence of Massachusetts authority on the specific issue, and thus deferred to the reasoning of the United States Court of Appeals for the Seventh Circuit. The court held that Current Good Manufacturing Practices regulations adopted by the Food and Drug Administration are legally binding requirements for the manufacturers of Class III medical devices.

Moreover, the court held that even in the absence of Current Good Manufacturing Practices regulations, the wife’s allegations would give rise to a right to recover under Massachusetts law, which imposes a duty of reasonable care on manufacturers and recognizes a breach of warranty where a manufacturing defect makes a product unreasonably dangerous. The wife’s state law claims paralleled federal requirements and thus were not preempted according to the court.

If you or a loved one has suffered an injury related to a defective product, please email us at or call 617-787-3700 now to speak with one of our Boston product liability lawyer experts.

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