Shapria, M.D.

IN THE SUPREME COURT OF THE STATE OF DELAWARE
NADIV SHAPIRA, M.D., and §
NADIV SHAPIRA, M.D., LLC, §
§
Defendants Below, §
Cross Appellants, §
§ No. 392, 2013
v. §
§
CHRISTIANA CARE HEALTH § Court Below:
SERVICES, INC., §
§ Superior Court of the
Defendant Below, § State of Delaware, in and for
Appellant/Cross Appellee, § New Castle County
§
and § C.A. No. N11C-06-092 MJB
§
JOHN HOUGHTON and §
EVELYN HOUGHTON, his wife, §
§
Plaintiffs Below, §
Cross Appellees. §
Submitted: June 4, 2014
Decided: August 7, 2014
Before STRINE, Chief Justice, HOLLAND, BERGER, and RIDGELY, Justices
and LASTER, Vice Chancellor,* constituting the Court en Banc.
Upon appeal from the Superior Court. AFFIRMED and REMANDED.
John A. Elzufon, Esquire (argued) and Gary W. Alderson, Esquire, Elzufon Austin
Tarlov & Mondell, P.A., Wilmington, Delaware for Cross Appellants, Nadiv
Shapira, M.D. and Nadiv Shapira, M.D., LLC.;
*
Sitting by designation pursuant to art. IV, § 12 of the Delaware Constitution and Supreme Court
Rules 2 and 4 (a) to fill up the quorum as required.
Dennis D. Ferri, Esquire (argued) and Allyson Britton DiRocco, Esquire, Morris,
James LLP, Wilmington, Delaware, for Appellant, Cross Appellee, Christiana Care
Health Services, Inc.
Randall E. Robbins, Esquire (argued) and Carolyn S. Hake, Esquire, Ashby &
Geddes, Wilmington, Delaware, for Appellees, Cross-Appellees, John Houghton
and Evelyn Houghton.
BERGER, Justice:
2
This is an appeal from a jury verdict in favor of the patient in a medical
malpractice action. The patient alleged that his physician negligently performed a
surgical procedure and breached his duty to obtain informed consent. The patient
also sued the supervising health services corporation based on vicarious liability
and independent negligence. The jury found both the physician and the
corporation negligent and apportioned liability between them. On appeal, the
physician and corporation assert that the trial court erred in several evidentiary
rulings, incorrectly instructed the jury on proximate cause, and wrongly awarded
pre- and post-judgment interest. In cross appeals, the physician and corporation
seek review of the trial court’s decision to submit a supplemental question to the
jury, as well as its failure to alter the damages award based on the jury’s response
to that supplemental question.
We affirm the judgment in favor of the patient. The trial court should not
have requested supplemental information from the jury after the verdict. Although
the trial court decided not to modify the verdict, the jury’s response to the
supplemental question arguably could affect other proceedings between the
physician and corporation. As a result, the judgment below is AFFIRMED and the
case is REMANDED with instructions to the Superior Court to vacate the
supplemental verdict.
3
FACTUAL AND PROCEDURAL BACKGROUND
In December 2009, John Houghton1 fell from a ladder and suffered multiple
non-displaced rib fractures, among other injuries. He was admitted to Christiana
Hospital,2 where he experienced severe chest pain despite receiving oral pain
medication. Because of his persistent chest pain, Houghton’s physicians requested
a consult with Dr. Nadiv Shapira, a thoracic surgeon affiliated with Christiana
Hospital who performs the “On-Q procedure.” The procedure, intended to treat
pain caused by rib fractures, involves the insertion of a catheter, known as the “On-
Q,” under the patient’s skin and over the ribs using a metal tunneling device.
The catheter is approximately five inches long and contains several holes. When
liquid analgesic is infused through the catheter, it soaks the surrounding tissue.
The goal is to place the catheter in such a way that it can be used to continuously
soak the nerves around the ribs with analgesic in order to relieve the pain
associated with the rib fracture. The On-Q procedure has not been approved by the
FDA and is thus an “off-label” use of the On-Q catheter.
Shapira evaluated Houghton and determined that he was a candidate for the
On-Q procedure because of his high level of chest pain, his inability to breathe
deeply, and his poor response to the oral pain medication. Shapira discussed the
1
His wife, Evelyn Houghton, joined in this action, but there are no issues on appeal related to her
claims. Accordingly, we will refer only to John Houghton unless the context requires otherwise.
2
Appellant and cross-appellee, Christiana Care Health Services, Inc. (“CCHS”), owns and operates
Christiana Hospital.
4
On-Q procedure with Houghton. Although he did not have an “exact recollection”
of the conversation at trial, Shapira testified that he would always talk to patients
about the “aims, risks and alternatives” of the On-Q procedure.3 Shapira would
explain that the purpose of the procedure was to provide pain relief in order to
prevent “further deterioration” and to ameliorate the risks associated with
continued reliance on a breathing tube and respirator.4 Shapira would also mention
the risks of bleeding, infection, injury to adjacent organs or tissues, and side effects
of the medication being transmitted through the catheter.
Finally, Shapira would explain that oral and intravenous pain medications
are alternatives to the On-Q procedure. Shapira testified that he normally would
tell patients that epidural anesthesia, while a “very effective” treatment for rib
fracture pain, is “not an option” because it carries a “very significant risk” and “has
its limitations.”5 According to Shapira, epidural anesthesia is not an alternative
often used at Christiana Hospital, and he did not present epidural anesthesia as a
treatment option to Houghton.
Shapira also failed to advise Houghton that Shapira had an independent
interest in the On-Q procedure. In 2007, Shapira entered into a contract with the
On-Q’s manufacturer, I-Flow Corporation, under which Shapira became a member
3
App. to CCHS’s Opening Br. at A-539.
4
App. to CCHS’s Opening Br. at A-539.
5
App. to CCHS’s Opening Br. at A-542-43.
5
of I-Flow’s speaker’s bureau. I-Flow paid Shapira to give presentations to other
physicians about the On-Q procedure, and Shapira created a promotional pamphlet
about the procedure. Also in 2007, Shapira created a database at Christiana
Hospital to collect information about his patients’ responses to the On-Q
procedure. Around that time, the number of patients on whom Shapira performed
the On-Q procedure began to increase significantly. In 2009, Shapira requested
and received approval from CCHS’s Institutional Review Board (“IRB”) to study
the effectiveness of the On-Q procedure using the patient data he was collecting.
By mid-2009, Shapira had labeled himself, in addition to a thoracic surgeon, an
“interventional pain management physician” based on his frequent performance of
the On-Q procedure at Christiana Hospital.6
Houghton agreed to the On-Q procedure, and Shapira inserted two On-Q
catheters into Houghton’s rib fracture area on December 8, 2009. The next day,
Houghton inadvertently removed the catheters. Shapira then performed another
surgery to insert two new On-Q catheters. One of those catheters became
displaced and perforated some of Houghton’s internal organs. As a result,
Houghton spent significant additional time in the hospital and underwent several
surgeries to remove the catheter and repair the organ damage.
6
App. to the Houghtons’ Answering Br. at B-393-94.
6
Houghton’s action alleges that Shapira negligently failed to obtain informed
consent before performing the On-Q procedure, and negligently performed the
procedure. Houghton also alleges that CCHS is liable for Shapira’s negligence
because Shapira was CCHS’s agent. Finally, Houghton claims that CCHS
negligently failed to properly manage Shapira’s On-Q study, and negligently
granted “expedited review” of Shapira’s application to conduct the study.
After an eight day trial, the jury returned a verdict finding both Shapira and
CCHS liable in negligence. The verdict sheet did not ask the jury to address
Houghton’s medical negligence and informed consent claims against Shapira
separately. It asked only whether Shapira was negligent. The jury awarded $3.75
million in damages to Houghton and $650,000 to Evelyn Houghton for loss of
consortium. The jury apportioned 65% of the total liability to Shapira, and 35% to
CCHS.
After the verdict, CCHS requested that the jury be asked to apportion
CCHS’s 35% liability. CCHS argued that it needed to know how much of the 35%
liability was attributed to CCHS in its capacity as Shapira’s employer, and how
much was attributed to CCHS’s independent failure to adequately manage
Shapira’s data collection and study. The Superior Court granted the request for the
supplemental question but refused to reform the original verdict based on the jury’s
7
answer. The Superior Court also awarded the Houghtons costs, pre-judgment
interest, and post-judgment interest. This appeal and cross-appeal followed.
DISCUSSION
1. Informed Consent Claim
Houghton’s informed consent claim against Shapira has two main
components. First, he alleges that Shapira breached the standard of care for
informed consent by failing to adequately disclose the risks and alternatives of the
On-Q procedure, including the fact that the On-Q procedure was “experimental”
and that an epidural was a viable alternative. Second, Houghton alleges that
Shapira breached the standard of care by failing to disclose significant personal
conflicts of interest regarding the On-Q procedure, including his business
relationship with I-Flow.
Although Shapira’s appeal focuses on Houghton’s second claim, Shapira
conceded at trial that he never presented Houghton with the option to receive an
epidural rather than undergo the On-Q procedure.7 Delaware’s informed consent
statute expressly requires a physician to disclose “alternatives to treatment . . .
which a reasonable patient would consider material to the decision whether or not
to undergo the treatment . . . .”8 Shapira, himself, acknowledged that epidural
7
App. to the Houghtons’ Answering Br. at B-410.
8
18 Del. C. § 6801(6).
8
anesthesia can be a “very effective” treatment method for rib fracture pain.9
Because receiving an epidural was a viable alternative to the On-Q procedure, and
Shapira did not tell Houghton about it, the jury could have found that Shapira
breached the standard of care on that basis.
As to the I-Flow/conflict evidence, Shapira mischaracterizes the Superior
Court’s ruling. The Superior Court did not hold that Shapira was required to
disclose that information as a matter of law. Rather, it held that Shapira’s
relationship with I-Flow (and his failure to disclose that relationship) was relevant
to the jury’s determination of whether Shapira met the standard of care for
informed consent. The Superior Court relied primarily on this Court’s decision in
Barriocanal v. Gibbs,10 in which we construed Delaware’s informed consent
statute. We agree with the Superior Court’s application of Barriocanal.
Delaware’s informed consent statute defines informed consent as:
. . . the consent of a patient to the performance of health care services
by a health care provider given after the health care provider has
informed the patient, to an extent reasonably comprehensible to
general lay understanding, of the nature of the proposed procedure or
treatment and of the risks and alternatives to treatment or diagnosis
which a reasonable patient would consider material to the decision
whether or not to undergo the treatment or diagnosis.11
9
App. to CCHS’s Opening Br. at A-542.
10
697 A.2d 1169 (Del. 1997).
11
18 Del. C. § 6801(6).
9
In short, a physician must provide the patient with information necessary to
understand (1) the nature of the proposed procedure, and (2) the material risks and
alternatives to the procedure. The physician must supply such information “to the
extent [that it is] customarily given to patients . . . by other licensed health care
providers in the same or similar field of medicine as the defendant.”12 Under
Barriocanal, whether the physician has met the standard of care required by the
informed consent statute is a question of fact for the jury.
In Barriocanal, this Court interpreted “material risks and alternatives” to
include information about a doctor’s inexperience with a procedure, a hospital’s
being understaffed on the day of the procedure, and the existence of a nearby
hospital in which the procedure also could be performed.13 While the Court did not
hold that such information was necessarily required to be disclosed under the
statute, the Court found that it was relevant.14 Shapira argues that Barriocanal
should not be read broadly to apply here. He points out that all of the undisclosed
information in that case directly addressed medical risks and alternatives.
By contrast, the undisclosed information at issue relates only to Shapira’s alleged
conflict of interest. Moreover, if doctors are required to disclose their potential
conflicts, Shapira claims that no one will know how much personal financial
12
18 Del. C. § 6852(a)(2).
13
Barriocanal, 697 A.2d at 1171-72.
14
Id. at 1173 (“We find that the type of ‘qualification’ information at issue in this case was relevant
to the issue of informed consent.”).
10
information must be included.
Shapira’s argument fails because his relationship to I-Flow directly relates to
the procedure he performed. The conflict information is relevant because it bears
on “risks and alternatives.” The conflict created a risk that Shapira wanted to
perform the procedure because it would benefit him personally, and not because it
was the most appropriate procedure. Likewise, the conflict created a risk that
Shapira did not disclose or consider all reasonable alternatives.
This is not a case where a doctor fails to disclose that she owns some stock
in a publicly-traded medical company. Shapira was making a name for himself,
and earning money, by promoting the On-Q procedure. In addition, he was
gathering data about the procedure’s efficacy. He had a strong incentive to play
down the risks of the On-Q procedure and play up the problems with alternative
treatments.
Under these circumstances, the conflict evidence was relevant to the
informed consent claim and admissible. The trial court properly permitted the jury
to consider this evidence when reaching its determination as to whether Shapira
met the standard of care under Delaware’s informed consent statute.
11
2. Evidence of the Procedure’s “Experimental” Nature
Shapira argues that the Superior Court erred by permitting Houghton’s
expert witnesses to testify at trial that the On-Q procedure was experimental while
prohibiting four defense witnesses from testifying that the procedure was not
experimental. This argument lacks merit because it ignores the fact that only
Houghton’s witnesses were qualified as experts. The witnesses who testified that
the On-Q procedure was experimental were giving expert opinions regarding the
standard of care for treating rib fracture pain. They possessed “specialized
knowledge” about what treatments for rib fracture pain were generally accepted in
the medical community and what treatments were not.15 The defense witnesses, on
the other hand, were presented as “fact witnesses,” not experts.16 They were bound
by Delaware Rule of Evidence 701, which states:
If [a] witness is not testifying as an expert, the witness’ testimony in
the form of opinions . . . is limited to those opinions . . . which are . . .
not based on scientific, technical or other specialized knowledge
within the scope of Rule 702.17
The Superior Court correctly ruled that the question of whether a procedure is
experimental is an opinion requiring specialized knowledge and cannot be given
15
See D.R.E. 702 (“If scientific, technical, or other specialized knowledge will assist the trier of fact
to understand the evidence or to determine a fact in issue, a witness qualified as an expert by
knowledge, skill, experience, training or education may testify thereto in the form of an opinion or
otherwise . . . .”).
16
App. to Shapira’s Opening Br. at AA-108.
17
D.R.E. 701.
12
unless the witness is qualified as an expert.18
3. Pre-judgment and Post-judgment Interest
The Superior Court awarded pre-judgment and post-judgment interest under
6 Del. C. § 2301(d). That provision entitles a plaintiff who has made a pre-trial
settlement demand on the defendant to recover pre-judgment and post-judgment
interest under certain circumstances. Section 2301(d) states:
In any tort action . . . in the Superior Court . . . for bodily injuries,
death or property damage, interest shall be added to any final
judgment . . . provided that prior to trial the plaintiff had extended to
defendant a written settlement demand valid for a minimum of 30
days in an amount less than the amount of damages upon which the
judgment was entered.
The statute is unambiguous. It plainly states that a plaintiff is entitled to interest if
(1) the plaintiff extended the defendant a written settlement demand before trial,
(2) the demand was valid for at least 30 days, and (3) the amount of damages
recovered in the judgment was greater than the amount the plaintiff had demanded.
Shapira does not dispute that those requirements were met. Instead, he advances
an interpretation of § 2301(d) that would require the settlement demand to be made
at least 30 days before trial. We decline to read such a requirement into the statute.
The statute requires only that the demand be “valid for a minimum of 30 days,” not
18
See App. to Shapira’s Opening Br. at AA-132-33. Shapira also argues that the Superior Court
abused its discretion by limiting him to four experts. But this is simply another version of the claim
that his fact witnesses should have been allowed to testify that the On-Q procedure is not
experimental.
13
that the 30 day period must elapse prior to the start of trial.
Shapira argues alternatively that 6 Del. C. § 2301(d) is unconstitutional
because it “unduly inhibits [the] exercise of [his] fundamental right to resort to the
courts in defense of claims made against [him and] creates an irrebuttable
presumption that [he is] responsible for causing delay . . . .”19 This argument lacks
merit. A legislative enactment is “presumed to be constitutional”20 and “should not
be declared invalid unless its invalidity is beyond doubt.”21 Shapira presents
nothing to rebut the presumption of § 2301(d)’s constitutionality other than
conclusory statements about the statute’s perceived one-sidedness. He ignores the
fact that § 2301(d) applies only when a plaintiff recovers more in a judgment than
it demanded in settlement negotiations. The statute incentivizes plaintiffs to make
less aggressive settlement demands, but it does nothing to restrict a defendant’s
right of access to the courts or its ability to present a defense. As the Superior
Court noted, we have interpreted § 2301(d) in the past without questioning its
constitutionality.22 We adhere to that view.
19
Shapira’s Opening Br. at 34.
20
Hoover v. State, 958 A.2d 816, 821 (Del. 2008).
21
Snell v. Engineered Sys. Designs, Inc., 669 A.2d 13, 17 (Del. 1995) (quoting Justice v. Gatchell,
325 A.2d 97, 102 (Del. 1974)).
22
See, e.g., Rapposelli v. State Farm Mut. Auto. Ins. Co., 988 A.2d 425, 427-29 (Del. 2010).
14
4. Supplemental Jury Question
In its original verdict sheet, the jury apportioned liability between Shapira
and CCHS, finding that Shapira was 65% at fault while CCHS was 35% at fault.
CCHS then requested that the jury provide a supplemental verdict explaining how
much of the 35% CCHS liability was attributable to CCHS’s agency relationship
with Shapira and how much was attributable to CCHS’s failure to properly manage
Shapira’s study. The Superior Court granted CCHS’s request but made clear that
apportionment of liability given in the original verdict sheet would not be
modified.23 The supplemental verdict apportioned 25% of CCHS’s liability to the
failure to properly oversee Shapira’s study and 75% to CCHS’s agency
relationship with Shapira. CCHS then moved to reform the original verdict based
on the jury’s supplemental verdict. The Superior Court denied that motion.
CCHS argues that the jury’s 75/25 sub-apportionment of CCHS’s liability is
inconsistent with the jury’s overall 65/35 apportionment between Shapira and
CCHS. We need not reach that argument because we find that there was no basis
for granting the request for a supplemental jury verdict in the first place. “Under
Delaware law, enormous deference is given to jury verdicts,”24 and they should not
be disturbed unless “the evidence preponderates so heavily against the jury verdict
23
App. to the Houghtons’ Answering Br. at B-574-75.
24
Young v. Frase, 702 A.2d 1234, 1236 (Del. 1997).
15
that a reasonable jury could not have reached the result.”25
Here, no one argues that the original verdict was unreasonable, let alone
against the great weight of the evidence. CCHS did not object to the form of the
original jury verdict sheet. Nor did CCHS object to the jury instructions, which
explained how the jury was to apportion liability. The Superior Court further
noted that the jury did not appear to be confused either by the original verdict sheet
or by the jury instructions. Quite simply, it was too late for CCHS to move to
supplement the jury’s verdict once the verdict had been returned. We find that the
supplemental verdict is invalid and instruct the Superior Court to strike that
verdict.
5. Jury Instruction on Proximate Cause
Shapira argues that the Superior Court’s jury instruction on proximate cause
contained an error of law. The Superior Court instructed the jury in relevant part
as follows:
Proximate cause is a cause that directly produces the harm, and but for
which the harm would not have occurred. A proximate cause brings
about, or helps to bring about, the plaintiff’s injuries, and it must have
been necessary to the result. There may be more than one proximate
cause of an injury.26
Shapira says that the inclusion of the phrase “or helps to bring about” renders the
instruction legally incorrect because it is “inconsistent with the ‘but for’ causation
25
Storey v. Camper, 401 A.2d 458, 465 (Del. 1979).
26
App. to CCHS’s Opening Br. at A-580 (emphasis added).
16
standard that the Delaware Courts have adopted.”27 Under settled law, this
argument fails. This Court repeatedly has found that the phrase “helps to bring
about” can be part of an accurate statement of the “but for” causation standard.28
Here, taking the jury instructions as a whole, we conclude that the Superior Court
properly instructed the jury on the standard for proximate cause.
CONCLUSION
The judgment of the Superior Court is AFFIRMED and the case is
REMANDED with instructions to the Superior Court to vacate the supplemental
verdict. Jurisdiction is not retained.
27
CCHS’s Opening Br. at 34.
28
See, e.g., Ireland v. Gemcraft Homes, Inc., 29 A.3d 246, 2011 WL 4553166, at *3 (Del. Oct. 3,
2011) (TABLE); Pesta v. Warren, 888 A.2d 232, 2005 WL 3453825, at *2 (Del. Dec. 14, 2005)
(TABLE).
17