Reed v. St. Jude Medical
- John Tunheim
- 0:17-cv-05560
- U.S. District Court · District of Minnesota
- 6
In Reed v. St. Jude Medical, Judge Tunheim granted dismissal, dismissed the complaint with prejudice, and denied a motion to add evidence.
David A. Reed and Georgia Gerard-Reed’s claims against St. Jude Medical were dismissed with prejudice; their motion to add Exhibit K was denied.
What happened
David A. Reed and Georgia Gerard-Reed sued St. Jude Medical, claiming that a mechanical heart valve implanted in 2011 was defective and caused David Reed’s later heart problems. Reed also raised allegations concerning an off-the-record heart examination and sought to add an unsigned exhibit.
The court concluded that the defective-valve claims were barred by federal law because the valve had received federal safety approval. It also found that any medical-fraud claim was not described with enough detail. The court treated Reed’s attempted appeal of the magistrate judge’s recommendation as an objection and reviewed the recommendation.
Judge John R. Tunheim adopted the recommendation, granted St. Jude Medical’s motion to dismiss, dismissed the complaint with prejudice, and denied the plaintiffs’ motion to add Exhibit K.
The detailed version
- Reed v. St. Jude Medical · No. 0:17-cv-05560
- John Tunheim
- Sept. 6, 2018
Background
David Reed received a mechanical heart valve from St. Jude Medical on December 13, 2011. He alleged that the valve was defective, leaked, and caused heart and lung complications, including a heart attack on December 9, 2016. The valve was removed on December 22, 2017.
The valve had received approval from the Food and Drug Administration through its Premarket Approval process. After St. Jude Medical removed the case to federal court, it moved to dismiss. The plaintiffs, who were representing themselves, filed several motions concerning exhibits and appeared to raise additional allegations of medical fraud related to an off-the-record heart examination. Reed also argued that the federal approval should be invalidated and sought to add Exhibit K, an unsigned and unsworn document.
Magistrate Judge’s Recommendation and Objections
Magistrate Judge Hildy Bowbeer recommended granting the motion to dismiss and dismissing Reed’s claim with prejudice. She also recommended denying the outstanding motions, treating them as proposed amendments, because they would not help state a valid claim.
Reed attempted to appeal the recommendation directly to the Court of Appeals. The district court treated that filing as an objection instead. Although the court found that most of the objections were general and procedurally inadequate, it reviewed the recommendation independently because Reed was representing himself. The court specifically considered Reed’s objection concerning Exhibit K.
Court’s Analysis
Under Rule 12(b)(6), a court may dismiss a complaint for failure to state a claim on which relief can be granted. The court accepts well-pleaded factual allegations as true but requires enough factual content to make the claim legally plausible.
The court held that the claims concerning the alleged heart-valve defect were expressly preempted. Federal preemption means that federal law displaces certain state-law claims. Relying on the federal medical-device statute and the Supreme Court’s decision in Riegel v. Medtronic, Inc., the court agreed that Reed could not proceed with the defective-valve claims.
The court also agreed that any potential medical-fraud claim concerning the heart examination was not adequately pleaded. It further concluded that adding Exhibit K or otherwise amending the complaint would not allow the plaintiffs to state a valid claim.
Disposition
The court adopted Magistrate Judge Bowbeer’s Report and Recommendation dated July 24, 2018. It granted St. Jude Medical’s Motion to Dismiss, dismissed the plaintiffs’ complaint with prejudice, and denied the plaintiffs’ Motion to Add Exhibit K. The court directed that judgment be entered accordingly.
Read the full 6-page opinion on CourtListener, the free public archive maintained by the Free Law Project.