Betterton v. Evans

Citations: 351 F. Supp. 2d 529; 2004 U.S. Dist. LEXIS 26376; 2004 WL 3049372Docket: CIV.A.2:02 CV 318-P-

Court: District Court, N.D. Mississippi; December 10, 2004; Federal District Court

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Debbie Betterton, as the surviving spouse and representative of the wrongful death beneficiaries of David Lee Betterton, initiated a legal action against Edward Morgan Evans, M.D., Guidant Sales Corporation, and Cardiac Pacemaker, Inc. in the United States District Court for the Northern District of Mississippi. The case arises from the medical treatment of David Lee Betterton, who was admitted to Baptist Memorial Hospital on August 1, 2002, for chest and arm pain, where he was diagnosed with an enlarged heart and abnormal heart rhythm. Following a cardiac catheterization, a pacemaker system, including a Guidant pulse generator and two leads, was implanted by Dr. Evans on August 6, 2002.

Shortly after the procedure, a Guidant representative assessed the pacemaker and found inadequate voltage. Despite multiple attempts to reposition the leads, Dr. Evans ultimately removed them and noted issues with the lead insulation and indications of a defective pacemaker in medical records. Following these complications, a new pacemaker system was attempted by Dr. Bradley Wolf, but he was unable to implant it due to worsening conditions, including the presence of blood in the pericardial cavity, leading to Betterton’s deterioration and subsequent shock after resuscitation efforts. The case presents significant allegations of defective medical devices and negligence, as evidenced by the medical records and observations made by the physicians involved.

Dr. Wolf's attempts to insert a balloon pump into Betterton's artery failed, leading to the placement of a bypass system and a bypass assistant device. Mr. Betterton's condition worsened, resulting in his death on August 11, 2002. Following this, Debbie Betterton filed a wrongful-death lawsuit on December 31, 2002, alleging negligence, breach of contract, and res ipsa loquitur against the treating physicians, along with multiple claims against Guidant Sales Corporation and Cardiac Pacemaker, Inc. concerning the pacemaker system's failure. The claims against the pacemaker companies included product liability, failure to warn, negligence, and several breaches of warranty. On March 15, 2004, the pacemaker companies sought summary judgment, arguing that the Medical Device Amendments of 1976 preempted state-law tort claims related to Class III medical devices, effectively barring the plaintiff's claims. The standard for summary judgment requires no genuine issue of material fact and entitlement to judgment as a matter of law, with the moving party bearing the initial burden to show no dispute exists. The court must evaluate evidence favorably for the opposing party and cannot make credibility determinations or weigh evidence; if factual issues remain, the motion must be denied, and the case should proceed to trial.

Under Federal Rule of Civil Procedure 56(e), a party opposing a motion for summary judgment must provide specific facts through affidavits or other materials to demonstrate a genuine issue for trial, rather than relying solely on pleadings. Summary judgment is only appropriate if there is no genuine dispute about a material fact, meaning the evidence does not support the non-moving party's claim sufficiently for a jury to favor them. The determination hinges on whether the factual disagreements are substantial enough to warrant jury consideration or if the case is so one-sided that a legal ruling is justified. 

Class III medical devices, such as pacemaker systems, are defined under the Medical Device Amendments of 1976 as those posing potential unreasonable risks or vital for human health. Manufacturers must assure the FDA of a device's safety and effectiveness through a rigorous premarket approval (PMA) process, which involves extensive documentation and an average review time of 1,200 hours. In contrast, the '510(k)' process allows devices deemed 'substantially equivalent' to existing products to bypass extensive review, averaging only 20 hours, and does not qualify as official FDA approval. The Supreme Court in Medtronic, Inc. v. Lohr held that due to the less stringent nature of the '510(k)' process, state-law tort claims against manufacturers of Class III devices, like pacemakers, are not preempted by federal regulations under 360k.

The Product Development Protocol (PDP) process, through which the FDA approved the Model 1298 Insignia pulse generator by Cardiac Pacemaker, Inc. (CPI) on March 20, 2002, occupies a middle ground in the scrutiny spectrum of medical device approval, alongside the 510(k) process and the more rigorous Premarket Approval (PMA) process. The PDP process requires detailed submissions, including device descriptions, trial data, manufacturing methods, labeling, and progress reports. The plaintiff argues that the PDP is less stringent than the PMA, likening it more to the 510(k) process; however, the defendants contend that PDP and PMA processes are largely similar, with the key distinction being that PDP does not mandate clinical trials. While there is no binding case law directly equating PDP and PMA, statutory language supports their equivalence in terms of approval status. Specifically, Title 21 U.S.C. 360e(f)(1) indicates that a class III device approved through a PDP is equivalent to having PMA approval. Furthermore, FDA regulations explicitly state that a class III device with a completed PDP is considered to have an approved PMA. Therefore, within the regulatory framework, the PDP and PMA processes are positioned at the rigorous end of the approval spectrum, while the 510(k) process is recognized as the least rigorous. The Medical Device Amendments of 1976 establish that no state can impose additional requirements on devices that differ from federal standards regarding safety or effectiveness.

Guidant Sales Corporation and Cardiac Pacemaker, Inc. filed a motion for summary judgment, asserting that the plaintiff's state-law tort claims concerning a defective pulse generator and leads are preempted by 21 U.S.C. § 360k. The U.S. Supreme Court's decision in Medtronic v. Lohr established that such claims are not preempted when the medical device underwent only the '510(k)' process. However, the Fifth Circuit has clarified that the Lohr ruling applies solely to '510(k)' devices, affirming that claims against FDA-approved Class III devices through the PMA process are preempted. 

In this case, both the FINELINE II leads and the Model 1298 Insignia pulse generator were approved via the PMA process, leading to the conclusion that the plaintiff's claims against the manufacturers must be dismissed based on the precedent set in Martin v. Medtronic, Inc. Additionally, the court found that the PMA and PDP processes are treated similarly, further supporting the dismissal of claims against the pulse generator. 

Despite recognizing the troubling implications of this legal conclusion—especially considering the malfunctioning nature of the device and the hardships it caused the patient—the court concluded that existing law prohibits remedies for patients when a Class III medical device fails. Consequently, the court granted the motion for summary judgment, dismissing the plaintiff's claims against both companies with prejudice. An order to this effect will be issued promptly.

Rule 56 mandates that facts be interpreted in a manner favorable to the non-moving party, relying significantly on the Complaint for the factual background. Dr. Robert E. Turner, Dr. Todd D. Edwards, and Dr. Larry B. Spiotta were initially named as defendants but were voluntarily dismissed on August 18, 2004, and March 27, 2004, and March 27, 2002, respectively. Dr. Bradley Wolf was not included in the original 2002 action; instead, a separate suit was filed against him on August 6, 2004. This case was consolidated with the current action on November 3, 2004, but the plaintiff's claims against Dr. Wolf were dismissed on December 8, 2004, due to non-compliance with Mississippi Code Annotated, 15-1-36(15). Guidant Sales Corporation (GSC) and Cardiac Pacemakers, Inc. (CPI), both subsidiaries of Guidant Corp., stated in their motions that GSC is not a proper party to the suit as it did not design or manufacture the medical devices involved. The plaintiff has not responded to this argument. The two Guidant FINELINE II leads were approved via the PMA process.