        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
