People For the American Way

Trump Judge Tries to Uphold Dismissal of Woman’s Claim that Medical Product Defects Led to Husband’s Death: Confirmed Judges, Confirmed Fears

News and Analysis
Trump Judge Tries to Uphold Dismissal of Woman’s Claim that Medical Product Defects Led to Husband’s Death: Confirmed Judges, Confirmed Fears

Confirmed Judges, Confirmed Fears” is a blog series documenting the harmful impact of President Trump’s judges on Americans’ rights and liberties. Cases in the series can be found by issue and by judge at this link.

Trump Eleventh Circuit judge Kevin Newsom argued in dissent that the court should affirm a lower court’s dismissal, without trial or even pre-trial discovery, of a woman’s complaint that defects in a company’s cardiac defibrillator resulted in her husband’s death. The majority rejected Newsom’s view and reversed the lower court, giving the woman a chance to prove her claims, in its December 2020 decision in Sharp v St. Jude Medical Inc.

 Milton Sharp had a heart condition involving an irregular heartbeat and relied on an implantable cardiac defibrillator (ICD) manufactured by St. Jude to both monitor and regulate his heartrate. Despite the ICD, Mr. Sharp died after suffering a ventricular fibrillation in his heart.

Wendy Sharp filed a wrongful death claim in federal court, contending that defects in the ICD resulted in her husband’s death. Specifically, the complaint alleged that defects in the ICD caused important insulation to erode, which caused short-circuiting and failure to deliver the high voltage therapy that someone like Mr. Sharp needs when he suffers a heart attack. The complaint contended that the claim arose out of St. Jude’s violation of FDA policies and regulations concerning the manufacture and sale of such ICDs. The lower court proceeded to throw out the case as a matter of law, without any discovery, claiming that the complaint failed to state a valid claim. Ms. Sharp appealed.

A 2-1 panel of the Eleventh Circuit reversed. Using proper legal standards, the majority explained, the lower court was wrong in ruling that Ms. Sharp’s complaint failed to contain sufficiently specific allegations to state a claim for relief that is “plausible on its face.” The majority recounted how the complaint stated in detail ways in which the manufacture of the ICD was defective, including violating federal regulations, failing to follow specific commitments to the FDA in premarket approval (PMA) documents, failing to use the right amount of insulation resulting in short-circuits and other problems, and violating accepted manufacturing standards. The complaint also pointed to evidence of the defects in the ICD, including an FDA recall of the type of leads used in the ICD due to an insulation defect  and a postmortem inspection of Mr. Sharp’s ICD that showed that his “particular device suffered from this same insulation abrasion defect.”

Trump judge Newsom dissented, and tried to defend the lower court’s decision by claiming that Ms. Sharp’s complaint had not “sufficiently alleged claims for a manufacturing defect.” In accord with the general principle of drawing “all reasonable inferences in favor” of a plaintiff, which Newsom failed to do, the majority refuted Newsom’s arguments. For example, although Newsom asserted there was a “timing issue’ because some of Sharp’s claims appeared to relate to a PMA  representation after Mr. Sharp’s ICD was installed, the majority specifically noted that the complaint did contain allegations concerning the right period, and that Newsom had failed to “make all reasonable inferences in favor of Ms. Sharp” at this stage as required by law.

As a result of the majority’s decision, therefore, Wendy Sharp will get a chance to prove that defects in the medical device manufactured by St. Jude wrongfully caused her husband’s death. If it had been up to Trump judge Newsom, she and possibly others in the Eleventh Circuit claiming such defects would never have that opportunity.


Confirmed Judges Confirmed Fears, Eleventh Circuit Court of Appeals, Kevin Newsom