December 2, 2016
Stryker Sales Corp. has denied a Rhode Island woman’s federal court allegations that the company knowingly sold her a defective prosthetic hip system that failed and required replacement after 10 years.
In a Nov. 14 answer filed in the U.S. District Court for the District of Rhode Island, Stryker says the injuries Janice Gulluscio attributes to the 2013 failure of her Trident Acetabular hip system may have been due to her own negligence or the acts of unrelated third parties.
Gulluscio sued Stryker, Stryker Sustainability Solutions Inc. and Stryker Orthopedics Corp. in January. She claims the Trident hip system implanted in her in 2003 failed due to manufacturing and design defects.
Gulluscio says the companies failed to adequately correct the defects and continued selling the device while never properly warning potential customers of the risks.
The suit alleges the defendants breached their express and implied warranties that the Trident was safe and fit for its intended purpose.
The plaintiff says that when her implant suddenly failed, it caused her to fall and suffer a broken wrist, a spinal fracture and broken tooth.
Stryker’s answer to Gulluscio’s suit was filed two weeks after Judge William E. Smith rejected the company’s motion to dismiss. Gulluscio v. Stryker Sales Corp. et al., No. 16-cv-293, 2016 WL 6459572 (D.R.I. Oct. 31, 2016).
The motion said Gulluscio had not offered sufficient evidence to back her claim that Stryker owed her a duty of care, that it knew of problems with the Trident but failed to warn consumers, or that it had breached any sort of warranty on the hip system.
Judge Smith denied the motion to dismiss and granted Gulluscio’s motion to file an amended complaint. He said that while her original complaint did not explicitly state how Stryker owed her a duty of care, it “nonetheless adequately establishes the elements of her negligence claim.”
While Stryker argued that Gulluscio’s failure-to-warn claim was “merely a legal conclusion,” the judge said it was “a factual statement alleging defendants’ failure to take a particular action.”
Judge Smith said the plaintiff had shown herself to be due relief under Rhode Island law for her breach of warranty claims.
He said that, according to the Rhode Island Supreme Court in Ritter v. Narragansett Electric Co., 283 A.2d 255 (R.I. 1971), “a manufacturer who sells a defective product unreasonably dangerous to the ultimate consumers may be strictly liable when the consumer of that product suffers any harm as a result of the defect.”
In its Nov. 14 answer, Stryker claims Gulluscio’s allegations may be preempted by federal law and may be barred by the “learned intermediary doctrine.” Under that theory, drug and medical device makers can avoid product liability claims if they can show they informed the plaintiff’s health care provider of the risks.
Gulluscio v. Stryker Sales Corp., et al., No. 16-cv-293, answer filed (D.R.I. Nov. 14, 2016).