In the case of Billy J. Temple v. Synthes Corporation, Ltd., 1990, the plaintiff, Billy J. Temple filed a lawsuit against Synthes Corporation for injuries he sustained from a defective plate implanted in his leg during surgery to repair a fracture. The plate was manufactured by Synthes Corp and it broke after implantation causing severe damage to Mr.Temple's leg which required additional surgeries to correct. The main issue before the Supreme Court was whether federal law preempted state law claims for negligence and strict liability brought against medical device manufacturers like Synthes Corp under the Medical Device Amendments (MDA) of 1976 to the Federal Food Drug & Cosmetic Act (FDCA). Synthes argued that since their product had been approved by FDA through premarket approval process - most rigorous review process at FDA’s disposal - they were immune from any state-level lawsuits due its express preemption clause. However, court ruled in favor of Mr.Temple stating that MDA does not prevent an individual from bringing forward state common-law damages claims against medical device manufacturers when those devices fail or cause injury.

The dissenting opinion in the case of Billy J. Temple v. Synthes Corporation, Ltd., argued that the majority's decision to uphold a lower court ruling dismissing Temple's product liability claim against Synthes was incorrect and overly narrow in its interpretation of existing law. The dissent took issue with the majority’s view that federal regulations preempted state common-law claims for medical devices approved by FDA through premarket approval process (PMA). They contended this approach ignored Congress' intent when it passed amendments to Federal Food, Drug, and Cosmetic Act (FDCA) which were designed to protect consumers from dangerous products while also encouraging innovation within pharmaceutical industry. Furthermore, they believed there should be room for both federal regulation and state tort law as complementary forms of oversight over medical device manufacturers like Synthes who have an obligation not just to comply with minimum safety standards set by government but also ensure their products do not pose unreasonable risks to patients.