Bush v. Thoratec Corp.
| Decision Date | 01 April 2014 |
| Docket Number | Civil Action No. 11–1654. |
| Citation | 13 F.Supp.3d 554 |
| Parties | Dina M. Robles BUSH v. THORATEC CORPORATION, et al. |
| Court | U.S. District Court — Eastern District of Louisiana |
Meyer H. Gertler, Helen Hairston Babin, Gertler Law Firm, New Orleans, LA, Louis L. Gertler, Gertler, Gertler, Vincent & Plotkin, LLP, New Orleans, LA, for Dina M. Robles Bush.
Sarah Elizabeth McMillan, McGlinchey Stafford, PLLC, New Orleans, LA, Shane V. Bohnen, Bowman & Brooke, LLP, Minneapolis, MN, Susan E. Henning, Michael M. Noonan, Curry & Friend, APLC, New Orleans, LA, Jason M. Bigelow, Peter M. Mansfield, U.S. Attorney's Office, New Orleans, LA, for Thoratec Corporation, et al.
FINDINGS OF FACT & CONCLUSIONS OF LAW
Plaintiff Diana Robles Bush (“Mrs. Bush”) brings this case on behalf of her deceased husband, Pete Bush (“Mr. Bush”). Mr. Bush was a recipient of the Thoratec HeartMate II left ventricular assist system (“LVAS”), a surgically implanted heart pump manufactured by now-dismissed Defendant Thoratec Corporation (“Thoratec”). It was implanted by the Hunter Holmes McGuire VA Medical Center (“McGuire”), a facility operated by Defendant United States, and Mr. Bush received follow-up care at both McGuire and at Tulane University Medical Center and Clinic (“Tulane”), a facility operated by Defendant University Healthcare System, L.L.C., which has also been dismissed.
Mrs. Bush originally filed suit in Civil District Court for the Parish of Orleans against Thoratec and Tulane. On July 14, 2011, Thoratec removed to this Court, and on October 24, 2011, 2011 WL 5038842, the Court denied Mrs. Bush's motion to remand and granted Tulane's motion to dismiss on the basis that Mrs. Bush had not proceeded through a medical review panel with respect to her claims against Tulane. (Rec. Doc. 40).
On November 29, 2011, 837 F.Supp.2d 603 (E.D.La.2011), the Court granted Thoratec's motion to dismiss Mrs. Bush's claims on the grounds of preemption pursuant to 21 U.S.C. § 360k(a) and Riegel v. Medtronic, Inc., 552 U.S. 312, 128 S.Ct. 999, 169 L.Ed.2d 892 (2008). (Rec. Doc. 41). However, the Court granted Mrs. Bush's motion for leave to amend her complaint so that she could attempt to state a nonpreempted claim. Mrs. Bush filed an amended complaint (Rec. Doc. 44) and then sought and received leave to file a second amended complaint (Rec. Doc. 68).
In her second amended complaint, Mrs. Bush articulated three potentially parallel state law claims. She argued that because the Food and Drug Administration (“FDA”) had no requirements for recall communications, warning requirements under state law were therefore consistent with federal law; or alternatively that Thoratec failed to comply with 21 C.F.R. § 7.49, which provides guidelines for recall notices; or alternatively that Thoratec violated federal regulations either by failing to include adequate notice and instructions in its correction letter, or by failing to identify the design defect in the percutaneous lead and by failing to take appropriate corrective action. However, Mrs. Bush later abandoned all but one theory: that Thoratec violated 21 C.F.R. § 7.49 by failing to include suggested content in its urgent medical device correction letter (the “correction letter”), and that a violation of federal law also violated Thoratec's duty to warn under Louisiana law.
Thoratec then moved to dismiss the second amended complaint because it was precluded by the express preemption clause of the Medical Device Amendments to the Food, Drug, and Cosmetics Act. 21 U.S.C. § 360k(a). (Rec. Doc. 74). In denying its motion, the Court reasoned that Thoratec's arguments were enshrouded in fact. (Rec. Doc. 89).
On July 27, 2012, Mrs. Bush requested leave to further amend her complaint, this time adding claims against the United States. (Rec. Doc. 90). The Court granted Mrs. Bush's request (Rec. Doc. 91), and her third amended complaint was entered into the record. (Rec. Doc. 92). The third amended complaint was dismissed without prejudice shortly thereafter and immediately re-entered, following the presumed final denial of Mrs. Bush's administrative appeal in Virginia. (Rec. Docs. 98, 99, 100). All claims against Thoratec were then settled and dismissed on June 28, 2013. Currently, the only remaining claims are those against McGuire under the Federal Tort Claims Act (“FTCA”). Specifically, Mrs. Bush alleges:
Dr. Gundars Katlaps, Lisa Martin and other employees of McGuire failed to properly monitor [the] LVAS, failed to properly instruct the Bushes on how to monitor the percutaneous lead of [the] LVAS for damage, failed to provide proper notice to the Bushes regarding the defects of the ... LVAS, failed to render proper medical care to him at the time of his medical emergency on May 4, 2010, and committed other acts of negligence and medical malpractice....
On August 14, 2013, McGuire filed a motion for summary judgment (Rec. Doc. 120) and then on August 16, 2013, it filed motion in liminie to strike Mrs. Bush's expert witness (Rec. Doc. 121). Both were denied on September 30, 2013, 2013 WL 5507257. (Rec. Doc. 170).
This matter came on for trial before the Court without a jury. After considering the testimony of the witnesses, the exhibits admitted into evidence, and the memoranda submitted by the parties, the Court now makes the following findings of fact and conclusions of law, pursuant to Federal Rule of Civil Procedure 52. To the extent that a finding of fact constitutes a conclusion of law, the Court adopts it as such; to the extent that a conclusion of law constitutes a finding of fact, the Court also adopts that as such.
Mr. Bush was born on May 5, 1949. After enlisting in the United States Air Force, Mr. Bush served in Vietnam, where he sustained a service-related hearing loss, and appears to have had a difficult transition from military to civilian life. On July 26, 2001, he married Mrs. Bush. The couple resided in Slidell, Louisiana.
Mr. Bush began to experience cardiovascular difficulties and at some point, he began relying on a pacemaker. In mid–2008, his condition deteriorated and he was admitted for inpatient care. On July 29, 2008, he was transferred from a U.S. Department of Veterans Affairs (“VA”) facility in Louisiana to the VA's McGuire facility in Virginia. At the time he was admitted, his primary diagnosis was congestive heart failure and other diagnoses included hypertrophic cardiomyopathy, aortic valve stenosis, and chronic obstructive pulmonary disease. He reported shortness of breath even without physical exertion, which was associated with sharp, stabbing chest pain, which also prevented him from sleeping. According to his medical record, he felt as though “the air [was being] sucked out of him.” (J. Ex. 15 at 2). Mr. Bush was initially placed in the intensive care unit, but was later transferred to the cardiology unit.
In late-September, the healthcare providers at McGuire determined that, without further action, Mr. Bush would die within several months. They spoke with Mr. and Mrs. Bush about his options, and recommended that he receive a left ventricular assist system (“LVAS”), until he could undergo a heart transplant. The LVAS is equipment that consists of external and implanted components. The implanted portion, referred to as the left ventricular assist device (“LVAD”), includes both the heart pump itself and a percutaneous lead, which carries power and information to and from the pump. The external portion consists of a system controller and display. Ordinarily, the system receives power from an electrical outlet or a set of rechargeable batteries, but in emergencies, another battery could be used to provide power for up to 12 hours.
Thoratec describes the LVAS as follows:
On September 25, 2008, Dr. Katlaps implanted the LVAD in Mr. Bush. Prior to surgery, Mr. Bush signed a consent form acknowledging that the “[m]echanical failure of the [LVAD] device due to mechanical, electrical, or other intricate parts of the [LVAD] may lead to death.” (J. Ex. 15 at 170). Mr. Bush was the first patient at McGuire to begin using this particular LVAS model, and by all accounts, the surgery was a success.
Following the surgery, Dr. Katlaps and Ms. Martin, the LVAD coordinator, met with Mr. and Mrs. Bush almost every day they were in the hospital. Ms. Martin educated Mr. and Mrs. Bush on how to care for the LVAS components and how to recognize and respond to the various alarm lights and sounds.
In her October 1, 2008,1 note, Ms. Martin stated that she “[b]riefly reviewed” the LVAS with Mr. and Mrs. Bush” and that “[a]s patient progresses, will continue w[ith] daily education....” (Id. at 128). In her next note, dated October 9, 2008,2 she wrote:
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