In the case of Donna S. Riegel v. Medtronic, Inc., 2007, the U.S Supreme Court ruled in favor of Medtronic, a medical device manufacturer. The lawsuit was initiated by Donna S. Riegel after her husband Charles died due to complications from a balloon catheter made by Medtronic that burst during his angioplasty procedure. She claimed that the company had failed to warn about potential risks associated with their product and sought damages under New York state law for negligence and strict liability. However, the court held that federal law preempts state laws on matters concerning medical devices approved by Food and Drug Administration (FDA). Since FDA had already approved this particular device after rigorous testing and review process under Medical Device Amendments (MDA) of 1976 - which requires manufacturers to demonstrate safety and effectiveness before marketing any new device – it was deemed as meeting all necessary standards set forth at federal level thus preempting any additional requirements or liabilities imposed at state level. This ruling affirmed legal protection for medical device manufacturers against lawsuits challenging safety or efficacy of their products once they have received pre-market approval from FDA.

In the case of Donna S. Riegel v. Medtronic, Inc., the dissenting opinion argued that federal law should not preempt state tort claims against medical device manufacturers because it undermines patient safety and public health interests. The dissenters believed that Congress did not intend to shield manufacturers from liability when they passed the Medical Device Amendments (MDA) in 1976, which was designed to protect consumers by ensuring devices are safe and effective before entering the market. They contended that allowing patients to sue for damages under state law would provide an additional layer of protection by holding companies accountable for faulty products or negligence in design, manufacturing or labeling processes. Furthermore, they pointed out potential conflicts with other Supreme Court precedents regarding preemption issues and expressed concerns about leaving injured parties without any legal recourse if their rights were stripped away at both federal and state levels.