ELDON E. FALLON, District Judge.
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
(Rec. Doc. 100 at 14).
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
Thoratec describes the LVAS as follows:
(J. Ex. 1 at 8).
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,
(Id. at 119).
Although Ms. Martin also provided Mr. and Mrs. Bush with a copy of the 2008 Patient Handbook and an instructional video, she told them that they did not need to review those independently because she had covered the same material with them in person. Mrs. Bush testified that, as a result, she never read the 2008 Patient Handbook all the way through nor watched the video.
(Id. at 111).
In her next note, dated October 21, 2008,
(Id. at 109).
With regard to the alarms, Ms. Martin testified that she instructed Mr. and Mrs. Bush that the system controller would indicate any problem with the pump or the power supply. Ms. Martin further emphasized that they should contact the local emergency medical services ("EMS") if the system controller emitted a continuous alarm and should contact Ms. Martin if the system controller emitted an intermittent alarm. Ms. Martin explained that continuous alarms are emergent or life threatening and that intermittent alarms are not. As Barbara Elias, an LVAD coordinator who testified as a qualified expert witness, explained, "[t]he patient ... needs to know what's emergent and what is non-emergent." (Tr. at 320).
On October 24, 2008, nearly a month after the implantation, Thoratec sent a correction letter to providers, including Dr. Katlaps. It noted:
(J. Ex. 2-B at 1-2 (emphasis added)).
On October 28, 2008, Dr. Katlaps signed and returned the acknowledgment form that was attached to the correction letter. The acknowledgment form provided:
(J. Ex. 2-C at 1). The letter also contained an enclosure intended for patients.
Between October 24, 2008, and October 28, 2008, none of Dr. Katlaps' notes reference the letter, nor do they indicate that he provided any new information to Mr. and Mrs. Bush. Ms. Martin's only note during this period, dated October 28, 2008,
(J. Ex. 15 at 103). Likewise, it did not indicate that she or Dr. Katlaps relayed the new information regarding the potential of a new alarm, namely a transient alarm.
In contrast, Mrs. Bush asserts that she and Mr. Bush were never made aware of the correction letter or the information it contained. This appears to be the credible account. First, Dr. Katlaps Ms. Martin have made it abundantly clear that Mrs. Bush was incredibly attentive to her husband's treatment and receptive to the information they had provided. Second, Mr. Bush's medical records, which are often incredibly detailed, do not reference the letter or indicate that its contents were communicated to Mr. and Mrs. Bush. Last, even if the records had referenced it, all of Ms. Martin's notes regarding the instruction she provided to Mr. and Mrs. Bush were entered months after the fact, raising questions as to their accuracy. Nor is it believable that Dr. Katlaps or Ms. Martin provided the information at a later date. It is the Court's impression, from the testimony, that both Dr. Katlaps and Ms. Martin concluded that the correction letter added nothing new to the information they had already provided to Mr. and Mrs. Bush and that their only obligation was to re-emphasize the information they had previously imparted, including advising of them of the significance of the continuous and intermittent alarms and what to do when each type of alarm occurred. The credible testimony and evidence supports the conclusion that Mr. and Mrs. Bush were never made aware that the LVAS was capable of emitting an additional alarm, namely a transient alarm, which required immediate action. This is significant because a transient alarm is a non-continuous alarm but nevertheless emergent, life threatening, and requires immediate action — characteristics Mr. and Mrs. Bush were told only attached to continuous alarms.
On the night of May 3, 2010, Mr. and Mrs. Bush were asleep when they heard the LVAS emit a sound, which Mrs. Bush described as "a little beep, light beep." (Tr. at 176). Mr. and Mrs. Bush then checked "everything," but were unable to find any malfunction. Mr. Bush, who felt fine, returned to sleep. The following morning they heard the same sound and, again, they checked everything and, once again, found nothing. Mr. Bush continued to feel fine. Mr. and Mrs. Bush then changed the controller, and heard another noise. However, the LVAS was not displaying any visual or auditory alarms. Mr. Bush then switched to battery power. Although everything appeared to be normal, the alarms concerned Mrs. Bush enough that at approximately 8:00 a.m. on May 4, 2010, she called Ms. Martin in Virginia from her home in Louisiana. She was unable to reach Ms. Martin, who was assisting with a surgery, and instead spoke with Mary Compton, Ms. Martin's administrative assistant. According to Ms. Compton, Mrs. Bush expressly stated that she had heard a noise coming from the LVAS which she had never heard before and that Mr. Bush was experiencing intermittent alarms or beeps." (Rec. Doc. 173). Mrs. Bush explained that she wanted to speak with Ms. Martin about the noise and alarms, but noted that Mr. Bush was doing well and it was not an emergency. Ms. Compton informed Mrs. Bush that Ms. Martin was in surgery and was not available.
At 4:00 p.m., Ms. Martin was out of surgery and Ms. Compton relayed the message. Several minutes later, Ms. Martin called Mrs. Bush back from her car. Their conversation lasted about 30 minutes. Mrs. Bush explained what had happened over the past day. Mrs. Bush wanted Ms. Martin to hear the noise, so she transferred Mr. Bush off of battery power and changed the controller to see if she could replicate it. When she changed the controller, the noise returned and Mr. Bush indicated that he was dizzy. Mrs. Bush told Ms. Martin that it was indicating a "low flow" alarm. Ms. Martin instructed Mrs. Bush to put Mr. Bush back onto battery power and, after doing so, Mr. Bush indicated that he began to feel fine once more. Ms. Martin told Mrs. Bush to keep him on battery power until she could determine the cause of the problem. Mrs. Bush testified that Mrs. Martin told her that they should only be concerned if the LVAS emitted an auditory and visual alarm, and if so, Mr. Bush should be taken to the hospital immediately.
Ms. Martin testified the alarms Mrs. Bush described "didn't make any sense":
(Tr. at 86). Even though the alarms were unusual and inconsistent with the designed alarms, she did not instruct Mrs. Bush to call EMS. Instead, Ms. Martin decided to contact Thoratec and get back to Mrs. Bush.
Less than 30 minutes after Ms. Martin and Mrs. Bush had spoken, and while Ms. Martin was on the telephone with a representative of Thoratec, Mr. Bush collapsed. Mrs. Bush testified that after he collapsed, she was unable to hear the sound of the LVAS functioning. She immediately called EMS, who transported Mr. Bush to a hospital, where he was pronounced dead at 6:58 p.m. According to his autopsy, he experienced "sudden cardiac death." (J. Ex. 4 at 1).
The LVAS components were analyzed by Thoratec after Mr. Bush's death. It was discovered that the implanted portion of the percutaneous lead had frayed interior wires, which likely made contact with one another. The system controller that Mr. Bush was using at the time of his death had shorted completely, and Ms. Martin was unable to retrieve any data from it. The other system controller, which Mr. Bush had recently used, did have salvageable data, although it has not been properly authenticated. Following Mr. Bush's death, Ms. Martin stated that Mrs. Bush had done everything exactly as she should have. However, Ms. Martin later testified that her opinion had changed when she learned that a Thoratec log indicated that there were multiple alarms, including a continuous "red heart" alarms, that "somebody should have told me about." (Tr. at 93). The testimony and evidence reveal that the log files, and other materials prepared as part of Thoratec's investigation, are not entirely reliable because there appears to have been confusion about which controller Mr. Bush was using at which times and also because the malfunction of the LVAS may have unpredictably altered its behavior. (See id.).
Mrs. Bush's complaint alleges tortious conduct by McGuire, which is owned, operated, and controlled by the United States, and is brought pursuant to the FTCA. As a general matter, the United States is immune to suits brought by individuals except where it has explicitly waived its immunity by statute. In re FEMA Trailer Formaldehyde Prods. Liab. Litig., 668 F.3d 281, 287 (5th Cir. 2012). The FTCA creates such a waiver, and "provides the sole basis of recovery for tort claims against the United States." Id. (citing 28 U.S.C. § 2671, § 1346). Specifically, the statute provides:
28 U.S.C. § 1346(b)(1) (emphasis added). As is the case with all waivers of sovereign immunity, the language of the FTCA is to be "narrowly construed in favor of the United States." In re FEMA Trailer Formaldehyde Prods. Liab. Litig., 668 F.3d at 287.
Accordingly, it is necessary to determine where the alleged torts occurred in order to apply the appropriate choice of law provisions. In the context of claims brought under the FTCA, a tort occurs in the place of the act or omission, not the place of the resulting injury. Richards, 369 U.S. at 9-10, 82 S.Ct. 585. As the United States Supreme Court has noted:
Id.; see, e.g., Ins. Co. of Pa. v. United States, 590 F.Supp. 435, 442 (S.D.Miss. 1984) (holding that where acts or omissions of an out-of-state tortfeasor caused an in-state injury, the law of tortfeasor's state must be applied).
Here, it is apparent that the allegedly negligent acts or omissions occurred in Virginia. Mr. Bush's LVAS device was implanted in Virginia and much of his recovery occurred in Virginia. Dr. Katlaps received the correction letter and signed the acknowledgment in Virginia, and he and Ms. Martin allegedly failed to inform Mr. Bush of the new information contained in the correction letter during his recovery in Virginia. Although providers in Louisiana and Virginia shared the responsibility for Mr. Bush's care after he returned to Louisiana, Mrs. Bush has previously asserted that the Louisiana providers were never made aware of the correction letter. Further, Mrs. Bush indicates that Ms. Martin "continued to provide close and continuing care to [Mr.] Bush in Louisiana up to and including the day he died." (Rec. Doc. 127-11 at 2). The fact that Mrs. Bush only called Ms. Martin, and not the providers in Louisiana, on the day of Mr. Bush's death implies that she considered Ms. Martin primarily responsible for Mr. Bush's care. In sum, Mrs. Bush's understanding of the facts does not controvert McGuire's assertion that the alleged acts and omissions all occurred in Virginia, even though the resulting injury to Mr. Bush was in Louisiana.
Having concluded that the incident occurred in Virginia, it is necessary to apply that state's choice of law provisions to determine which substantive and procedural laws apply. The place-of-the-wrong standard is the "settled rule in Virginia" when resolving conflicts arising in multistate tort actions. Jones v. R.S. Jones & Assocs., Inc., 246 Va. 3, 431 S.E.2d 33, 34 (1993) (internal quotation marks omitted). Pursuant to this rule, the claims are governed by the substantive law of the forum where the torts occurred and the procedural law of the forum where the action was brought. Id. As discussed above, the acts or omissions here took place in Virginia, and accordingly, the substantive law of Virginia is applicable. Because this action was brought in federal court in Louisiana, federal procedural law governs.
The Virginia Medical Malpractice Act ("VMMA") provides relief for "any tort action or breach of contract action for personal injuries or wrongful death, based on health care or professional services rendered, or which should have been rendered, by a health care provider, to a patient." VA.CODE ANN. § 8.01-581.1. By its plain language, the statute broadly includes any claims sounding in tort or contract. Thus, all of Mrs. Bush's claims are within the substantive scope of the VMMA.
It is also necessary to determine whether the parties meet the VMMA's criteria. The statute states that any "person... licensed by [Virginia] to provide health care or professional services as a physician [or] registered nurse" is considered a health care provider, as is "any corporation... or other entity" if it "employs or engages" such a person and if the corporation or other entity also "engages in health care services." VA.CODE ANN. § 8.01-581.1. Here, evidence in the record indicates that Dr. Katlaps and Ms. Martin were licensed by Virginia to provide health care or professional services as a physician and as a registered nurse, respectively. (Rec. Docs. 165-1, 165-2). With regard to McGuire itself, Mrs. Bush specifically asserts that "as a federal facility, [it] is not licensed by the Commonwealth of Virginia" and it thus falls outside the VMMA's reach. (Rec. Doc. 160-2 at 1). However, the plain language of the VMMA states that "a corporation ... or any other entity, except a state-operated facility, which employs or engages a licensed health care provider and which primarily renders health care services" is itself a health care provider. VA.CODE ANN. § 8.01-581.1. Thus, McGuire, while not licensed by Virginia itself, is considered a health care provider under the VMMA both because it employs or engages health care providers licensed by Virginia, including Dr. Katlaps and Ms. Martin, and also because it primarily renders health care services.
The VMMA defines "malpractice" as "any tort action ... for personal injuries or wrongful death, based on health care or professional services rendered, or which should have been rendered, by a health care provider, to a patient." VA.
Under the VMMA, "expert testimony is ordinarily necessary to establish the appropriate standard of care, to establish a deviation from the standard, and to establish that such a deviation was the proximate cause of the claimed damages."
As a general matter, "whether a witness is qualified to testify as an expert is largely within the sound discretion of the trial court." Lloyd v. Kime, 275 Va. 98, 654 S.E.2d 563, 569 (2008) (internal quotation marks omitted). However, for claims brought under the VMMA, "this determination must be made with reference to [the expert qualification requirement]," which establishes standards for experts testifying on the standard of care.
VA.CODE ANN. § 8.01-581.20.
While physicians are presumed to know the statewide standard of care in their particular specialties or fields of medicine if they are licensed in Virginia or are licensed in another state and also meet the educational and examination requirements in Virginia, "[i]f neither situation applies, a witness nonetheless may be qualified to testify as to the standard of care if the witness demonstrates sufficient knowledge, skill, or experience to make him competent to testify as an expert on the subject matter at issue." Lloyd, 654 S.E.2d at 569 (internal quotation marks omitted). However, "[i]n all cases, to qualify as an expert witness on the standard of care, the witness must have expert knowledge on the standard of care in the defendant's specialty and an active clinical practice in either the defendant's specialty or a related field of medicine within one year of the date of the alleged act or omission forming the basis of the action." Id. (internal quotation marks omitted); see VA.CODE ANN. § 8.01-581.20. Thus, in most instances, to
However, there are exceptions to this requirement "in those rare cases in which a health care provider's act or omission is clearly negligent within the common knowledge of laymen." Raines, 341 S.E.2d at 196 n. 2 (citing Easterling v. Walton, 208 Va. 214, 156 S.E.2d 787, 790-91 (1967)). The Virginia Supreme Court has been careful to note that "[t]he medical malpractice statutes did not supersede the jury system." Id. at 197 ("The determination of negligence, proximate cause, and damages remains within the jury's province.").
There are a number of instances where, pursuant to this exception, qualified expert testimony in medical malpractice cases has not been required. For example, in Jefferson Hospital, Inc. v. Van Lear, a patient fell and broke his hip while trying to locate a bathroom after the floor nurse failed to respond to a call light that had been plainly visible to her for 20 to 30 minutes. 186 Va. 74, 41 S.E.2d 441, 442-43 (1947). There, the Virginia Supreme Court recognized that expert testimony was not necessary because the hospital employees "were, of course, aware of the physical condition of [the patient, t]hey knew the nature of his operation and disabilities[, t]hey knew, or should have known, that a delay in answering his call for a nurse or an orderly ... might induce him to get out of bed and attempt to wait on himself." Id at 443.
In Beverly Enterprises-Virginia, Inc. v. Nichols, a patient choked after she attempted to eat food that a provider left without offering assistance. 441 S.E.2d at 3. There, the Virginia Supreme Court again concluded that it was possible to find "negligence without the necessity of expert testimony on the appropriate standard of care," because the provider "was aware of [the patient's] mental and physical condition [and] that she was unable to feed herself and had two prior serious choking incidents." Id. "Certainly, a jury does not need expert testimony to ascertain whether the defendant was negligent because its employees failed to assist [the patient] under these circumstances." Id.
Likewise, in Nichols v. Kaiser Found. Health Plan of Mid-Atlantic States, Inc., a patient became seriously ill after she was given the wrong medicine. The Virginia Supreme Court upheld the trial court's conclusion that "expert testimony was unnecessary because a jury could understand, without the aid of such testimony, that dispensing wrong medication is a breach of a pharmacist's standard of care." 257 Va. 491, 514 S.E.2d 608, 609 (1999). It reasoned:
Id. at 612.
In yet another case, Coston v. Bio-Medical Applications of Va., Inc., a patient was injured after she was placed in a defective chair by an employee who knew the chair was broken. 275 Va. 1, 654 S.E.2d 560, 563 (2008). The Virginia Supreme Court reasoned that "[c]ertainly, the issue whether the [employees] acts or
Because Mrs. Bush did not present the testimony of a qualified doctor or nurse with regard to the elements of medical malpractice — the applicable standard of care, whether that standard of care had been breached, and whether the alleged breach was the proximate cause of the alleged injury
It is necessary to determine whether the standard of care required that Dr. Katlaps and Ms. Martin relay the correction letter or its contents to Mr. and Mrs. Bush or required Ms. Martin to instruct Mr. and Mrs. Bush to seek immediate medical attention on May 4, 2010. As mentioned previously, the Virginia Supreme Court has held that "the standard of care in a medical malpractice action [is] that degree of skill and diligence exercised by a reasonably prudent practitioner in the same field of practice or specialty in Virginia." Tashman v. Gibbs, 263 Va. 65, 556 S.E.2d 772, 777 (2002). Likewise, the VMMA requires:
VA.CODE. ANN. § 8.01-581.20(a). A provider is not the "insurer of [a] diagnosis and treatment...." Brown, 331 S.E.2d at 445.
In determining the applicable standard of care, the testimony of a qualified expert witness may assist in the determination, but it is not itself dispositive. Despite the necessity of qualified expert testimony on the standard of care in most instances, "[t]he determination of negligence, proximate cause, and damages remains within the [fact finder]'s province."
T.J. Hooper, 60 F.2d 737, 740 (2d Cir. 1932).
With regard to the correction letter, it is necessary to determine whether the standard of care required that Dr. Katlaps and Ms. Bush relay its contents to Mr. and Mrs. Bush. Mrs. Bush has not offered the testimony of a qualified expert witness. Thus, as a threshold matter, it is necessary to decide whether the contents of the letter can be understood by a layperson.
In making this determination, it is useful to consider the letter itself. The letter, which was intended for healthcare providers, contains language that is not incomprehensible to a layperson (that is, someone other than a licensed doctor or nurse).
Dr. Matthias Loebe, McGuire's qualified expert witness, testified that "[t]he standard of care would require to alert the patient and his caregivers to seek support when they have recurrent alarms; and, in particular, seek — and if these alarms do not go away, to seek support in an institution that is close by." (Tr. at 360). He also indicated that it was incredibly important that patients had been properly educated on how to react to various alarms, but it was not necessary that they understand the underlying causes of those alarms. Of the alarms, Ms. Elias explained that it was necessary for both patients and healthcare providers to "know what's emergent and what is non-emergent." (Tr. at 320).
Prior to receiving the correction letter, doctors and nurses were only provided information about continuous and intermittent alarms. Within this context, the question is whether the so-called transient alarm, discussed by the correction letter, constituted a new type of alarm, separate and distinct from the continuous and intermittent alarms. As a preliminary matter, it is useful to consider the plain meaning of each of these terms. The term "continuous" means something that is uninterrupted.
As noted above, Dr. Loebe and Ms. Elias testified that the standard of care required a healthcare provider to supply information about the nature of each type of alarm. Despite this, they concluded that Dr. Katlaps and Ms. Martin did not breach the standard of care by not providing information about a new type of alarm. This is inconsistent with the requirement that the healthcare provider provide information about each alarm. Such an inconsistency defies logic and Dr. Loebe's and Ms. Martin's detailed testimony regarding the standard of care itself, and it hampers the credibility of their determination that the standard of care had not been breached by Dr. Katlaps and Ms. Martin. The credible testimony and evidence supports the conclusion that the standard of care in this case required that a doctor or nurse provide information about all alarms to their patients.
Had Dr. Katlaps and Ms. Martin provided the information contained within the correction letter, Mr. and Mrs. Bush would have been able to determine the meaning of the transient alarms they experienced and react themselves. However, this information was not communicated to them and they were not able to respond appropriately on their own. Instead, they were only able to describe the LVAS' behavior to Ms. Martin, forcing her to do what they might have done themselves had they been properly informed.
Having established that the standard of care required a doctor or nurse to educate the patient about all alarms and also that a nurse recognize and respond appropriately to those alarms, it is necessary to determine whether that standard was breached by either Dr. Katlaps or Ms. Martin. With regard to the correction letter, Mrs. Bush alleges that Dr. Katlaps and Ms. Martin did not provide the information it contained and thus breached the standard of care. Dr. Katlaps noted that he reviewed the symptoms of the percutaneous lead problem. He also conceded that the correction letter "did not tell us anything new [and] there was no new concept described in that notice and no new additional action necessary beyond what it describe[d]." (Katlaps Tr. at 59-60). He stated that he did speak with Mr. Bush about the correction letter, but he was vague regarding what he said, and there is nothing to indicate that he mentioned anything about a transient alarm:
(Katlaps Tr. at 62-63 (emphasis added)). It is apparent that Dr. Katlaps did not believe the correction letter contained information that would change the way Mr. and Mrs. Bush responded to certain alarms, nor is there any indication in the medical record that he discussed the existence or nature of transient alarms.
Ms. Martin had a similar mindset. Although she understood the difference between a transient alarm, which irregularly stops and starts, and an intermittent alarm, which has regular "short little inter-beeps every second or every four seconds," (Tr. at 56), she did not appear to have drawn this distinction for Mr. and Mrs. Bush after she received the correction letter:
(Tr. at 59-60).
As discussed in detail above, McGuire's qualified expert witnesses, Dr. Loebe and Ms. Elias, both testified that the standard of care would require a doctor or nurse to educate a patient on how to react to all alarms. The evidence and testimony demonstrates that Dr. Katlaps and Ms. Martin did not discuss with Mr. and Mrs. Bush potential of a transient alarm or that this new type of alarm required immediate action. Thus, they breached the standard of care.
Mrs. Bush has also alleged that Ms. Martin breached the standard of care by not recognizing and appropriately responding to the transient alarms described on the day of Mr. Bush's death. Ms. Martin's own testimony indicates that she did not recognize the existence of the transient alarms described by the correction letter, nor did she instruct Mr. and Mrs. Bush to seek immediate medical attention. Accordingly, she breached the standard of care in this instance, as well.
Before turning to the question of causation, it is necessary to address McGuire's assertion that Mr. and Mrs. Bush were contributory negligent because they did not timely and accurately describe the alarms Mr. Bush had experienced. "Contributory negligence is an affirmative defense that is based on the objective standard of whether a plaintiff failed to act as a reasonable person would have acted for his own safety under the circumstances." Sawyer v. Comerci, 264 Va. 68, 563 S.E.2d 748, 752 (2002). "[I]n order for contributory negligence to bar a plaintiff's recovery in a medical negligence action, the plaintiff's negligence must be concurrent with the defendant's negligence." Id. "A defendant who relies upon the defense of contributory negligence must prove that the plaintiff deviated from a standard of care and that the deviation was a proximate cause of damages." Id. at 753. The defendant has the burden of proving its existence by a preponderance of the evidence. Id. at 752. It is generally a question of fact, not law. Id. In this case, there are two areas where it is suggested that contributory negligence is present: first, in
As noted previously, Mrs. Bush's account of the alarms Mr. Bush experienced appears to be credible. Ms. Martin's account differs, but she bases that mainly on statements she received from Thoratec, not her own experience. Further, the results of Thoratec's investigation are not conclusive with regard to what alarms occurred and when they occurred, especially given the mechanical and electrical damage to the device. As Dr. Arslanoglu's testimony demonstrated, the transient alarms occurred as a result of a malfunction in the alarm mechanism itself; they were unplanned, unexpected, and unpredictable symptoms of underlying damage. Mr. and Mrs. Bush were observed by Dr. Katlaps and Ms. Martin to be incredibly vigilant with regard to Mr. Bush's care, and it defies logic to think that they would have purposefully neglected to inform Dr. Katlaps or Ms. Martin of any emergent alarm the device had issued. Even if McGuire had demonstrated that they were negligent by concealing these alarms, that negligence does not meet the concurrency requirement of Virginia law. Accordingly, the Court concludes that Mr. and Mrs. Bush were not negligent.
Next, it is necessary to determine whether Dr. Katlaps' or Ms. Martin's breach of the standard of care was the proximate cause of Mr. Bush's death. In Virginia, it is "simply [necessary] to prove that the particular time and manner of the patient's death resulted from the defendant's negligence," not "that the patient would have recovered perfect health, or survived indefinitely in the absence of the negligence." Blondel v. Hays, 241 Va. 467, 403 S.E.2d 340, 344 (1991).
Here, had Mr. and Mrs. Bush been armed with the information contained in the correction letter, it is unlikely that Mr. Bush would have spent May 4, 2010, running errands or moving around his yard after experiencing irregular alarms the previous night and that morning. Instead, he and Mrs. Bush would have recognized the possibility that the alarms were caused by underlying damage to the percutaneous lead and understood that, if that was what was causing the alarms, the damage could be exacerbated by additional movement. As Dr. Katlaps and Ms. Martin testified, Mr. and Mrs. Bush were incredibly receptive to the information they had provided and attentive to Mr. Bush's care. Therefore, it is more likely than not that they would have recognized the alarms as a symptom of percutaneous lead damage and been proactive in their response. Ms. Martin testified that she had provided Mr. and Mrs. Bush with several methods of contacting her or, if she was unavailable, someone else at McGuire. She also instructed that they page — rather than call — her in an emergency. Had they been aware of the significance of the transient alarms, it is more likely than not that they would have followed her instructions and paged her. If she had not responded, they would have sought immediate medical attention. They also would have been able to limit Mr. Bush's movement and prevent any further damage. Likewise, had Ms. Martin recognized the alarms as a possible consequence of percutaneous lead damage, she could have instructed Mr. Bush to limit his movement and seek immediate medical attention.
Although it is impossible to predict exactly what would have occurred, Mr. Bush would more likely than not have been in a hospital — perhaps even one with a VAD
However, the conclusion that Mr. Bush would have lived longer depends on a finding that his death was the result of the LVAS' failure. This is a question of medical causation. As the Virginia Supreme Court has noted, "the question of causation of a human injury is a component part of a diagnosis, which in turn is part of the practice of medicine." Combs v. Norfolk & W. Ry. Co., 256 Va. 490, 507 S.E.2d 355, 358 (1998). There are instances where laypersons may be treated as qualified expert witnesses regarding causation, however in this instance causation is closely tied to a diagnosis. Here, both Dr. Loebe and Dr. Katlaps have addressed this issue.
Dr. Loebe testified that Mr. Bush's death was not a result of the LVAS' failure. Instead, he stated that the LVAS had not replaced the function of Mr. Bush's heart, that the malfunction of the LVAS "is usually not [a] fatal event for the patient," and that "patients do not die when the [LVAS] suddenly stops." (Tr. at 359, 367). Instead, he indicated that the proximate cause of Mr. Bush's death was his underlying heart disease, not any failure of the LVAS. Put differently, the progression of Mr. Bush's heart disease was an intervening event severing the causal relationship between the device's failure and Mr. Bush's death. However, his is not the only testimony on this point.
Despite its intended purpose of assisting his heart — not replacing it — Dr. Katlaps, Mr. Bush's treating physician, testified that the LVAS had been keeping Mr. Bush alive. He estimated that without it, he would only have remained alive for days or weeks, but that with it he would live at least a year. Unlike Dr. Loebe, he concluded that Mr. Bush's heart disease had progressed to the point where his heart was unable to function without the LVAS. Thus, any failure of the device would result in Mr. Bush's death. He discussed Mr. Bush's life expectancy with the device:
(Katlaps Tr. at 67-69).
Having weighed the testimony of Dr. Loebe and that of Dr. Katlaps, it appears
Having concluded that Mr. Bush's death would not have occurred but for Dr. Katlaps' and Ms. Martin's breach of the applicable standard of care, it is necessary to consider damages. Under Virginia law, a court "may award such damages as to it may seem fair and just." VA.CODE ANN. § 8.01-52. The following types of damages are permitted:
Id. Prior to reaching a determination as to damages, it is relevant to consider the awards made in other instances where medical malpractice has resulted in death. Of course, prior awards are not dispositive since each case is dependent on its own unique facts, but prior awards for similar damages are instructive. A survey of these awards demonstrates that general damages — that is, those for sorrow, mental anguish, and solace — are usually between $150,000.00 and $950,000.00 for each survivor and specific damages vary. See, e.g., Estate of Robertson v. Peery, 2013 WL 7139777 (Va.Cir.Ct.2013) (awarding $50.466.80 in medical expenses, $10,316.85 in funeral expenses, and $216,822.27 to each survivor of an 89-year-old patient); Estate of Willever v. Williams, 2012 WL 4503122 (Va.Cir.Ct.2012) (awarding $438,000.00 in medical expenses and $390,500.00 to each survivor of a 73-year-old patient); Estate of Madison v. Chesapeake Anesthesiologists, 2011 WL 7163456 (Va.Cir.Ct.2011) (awarding $425,000.00 to the spouse and $125,000.00 to each child of a patient); Estate of Lopez v. Galumbeck, 2010 WL 5517655 (Va.Cir.Ct.2010) (awarding $975,000.00 to the spouse and $243,750.00 to each child of a 36-year-old patient); Estate of Budnick v. Barry v. Walter, 2009 WL 5171892 (Va.Cir.Ct.2009) (awarding $46,997.56 for medical expenses, $2,675.00 for funeral expenses, and $2,200,000.00 to the survivor of a patient); Estate of Browder v. Gamache, 2009 WL 1912388 (Vir.Cir.Ct.2009) (awarding $211,953.29 for medical expenses, $785,000.00 for economic loss, and $6,500,000.00 to the survivor of a patient); Cumbee v. Nicholson, 2007 WL 4755239
Here, Mrs. Bush seeks $665,000.00 plus interest in general damages, $195,000.00 in punitive damages, and $184,307 in special damages. In support of her claim for sorrow, mental anguish, and solace, Mrs. Bush testified that, after Mr. Bush's death, she was hospitalized for depression and experienced weight loss, isolationism, and insomnia. She was treated for approximately four days. Her medical records indicate that she was billed $11,967.74 for that hospitalization. (J. Ex. 5 at 1-4). Mrs. Bush appears to have suffered significantly as a result of Mr. Bush's untimely death and the Court concludes that damages for sorrow, mental anguish, and solace of $200,000.00 are fair and just.
With regard to damages for reasonably expected loss of income or services, the credible evidence indicates that Mr. Bush would have been able to live an additional two years had the LVAS continued to function properly. Accordingly, the Court adopts the conclusions of Mrs. Bush's expert witness, who calculates Mrs. Bush's damages for reasonably expected loss of income or services for that period as $23,535.00.
With regard to the expenses for care, treatment, and hospitalization as well as funeral expenses, the Court notes that the parties stipulated that Mrs. Bush is not entitled to any reimbursement because these expenses have been or will be paid by the United States.
With regard to punitive damages, the testimony and evidence do not justify or support an award. Under Virginia law, "negligence which is so willful or wanton as to evince a conscious disregard of the rights of others, as well as malicious conduct, will support an award of punitive damages in a personal injury case." Booth v. Robertson, 236 Va. 269, 374 S.E.2d 1, 3 (1988); see Doe v. Isaacs, 265 Va. 531, 579 S.E.2d 174, 176 (2003). Here, Dr. Katlaps and Ms. Martin were negligent in failing to provide information about the new type of alarm and Ms. Martin was negligent in failing to recognize the immediate nature of the situation on the day of Mr. Bush's death. The testimony and evidence clearly demonstrates that Dr. Katlaps and Ms. Martin did what they thought was best for Mr. Bush — that it did not coincide with what the standard of care required is unfortunate
Having determined the aggregate amount of damages, it is necessary to decide whether they must be reduced because of a prior settlement. With regard to FTCA claims, state law dictates how a settlement before trial will impact the distribution of damages after trial. See Gill v. United States, 429 F.2d 1072, 1078 (5th Cir.1970). Under Virginia law, "[w]hen a release ... is given in good faith to one of two or more persons liable for ... wrongful death," that release does not "discharge any other person from liability[,] but any amount recovered against the other person or any one of them shall be reduced ... in the amount of the consideration paid for [the release]." VA.CODE ANN. § 8.01-35.1(A); see Fairfax Hosp. Sys., Inc. v. Nevitt, 249 Va. 591, 457 S.E.2d 10, 14 (1995). Here, Mr. Bush suffered but one wrongful death, which Mrs. Bush alleges was caused by the United States and other now-dismissed parties, thus any damages will be reduced by the amount of consideration paid for the prior settlement. (See Rec. Doc. 188).
On the basis of the above findings of fact and conclusions of law, the Court finds that Mrs. Bush has not sustained any injury due to the negligence of the United States or its employees, Dr. Katlaps and Ms. Martin. Accordingly,
(J. Ex. 2-B at 5).
(Tr. at 303). As one text notes:
BARRY R. FURROW, ET AL., HEALTH LAW 295 (6th ed.2008).
VA.CODE. ANN. § 8.01-581.1. Further, Black's Law Dictionary defines "layman" as "[a] person who is not a member of a profession or an expert on a particular subject." Layman, BLACK'S LAW DICT. (9th ed.2009). Accordingly, under the specific circumstances here, a layperson is anyone who is not a doctor or a nurse.
