Court Opinion

ID: 173952
Source: CourtListenerOpinion
Date Created: 2010-08-24 16:45:33+00
Date Added: 2024-06-11T17:25:27.994774
License: Public Domain

NOT PRECEDENTIAL

                   UNITED STATES COURT OF APPEALS
                        FOR THE THIRD CIRCUIT

                      Nos. 09-1426, 09-3598 and 09-4120

                                      M.G.
                by and through her parents and natural guardians,
                                  K. and J.G.,

                Appellant/Cross Appellee in 09-1426 and 09-3598

                                       v.

   A. I. DUPONT HOSPITAL FOR CHILDREN; NEMOURS FOUNDATION;
NEMOURS CARDIAC CENTER; WILLIAM I. NORWOOD,M.D.,PH.D; NUMED,INC.;
   ALLEN J. TOWER; NEMOURS DE INSTITUTIONAL REVIEW BOARD;
                            JOHN MURPHY
                  Appellants/Cross Appellees in 09-4120

                  Appeals from the United States District Court
                    for the Eastern District of Pennsylvania
                         (D.C. Civil No. 2:08-cv-00228)
                  District Judge: Honorable R. Barclay Surrick

                              Argued July 12, 2010

       Before: RENDELL, JORDAN and GREENAWAY, JR., Circuit Judges.

                            (Filed: August 24, 2010)

Barbara R. Axelrod, Esq. [ARGUED]
James E. Beasley, Jr., Esq.
Catherine A. Rothenberger, Esq.
The Beasley Firm
1125 Walnut Street
Philadelphia, PA 19107
  Counsel for Appellant/Cross-Appellee

David J. Creagan, Esq. [ARGUED]
David E. Edwards, Esq.
White & Williams
1650 Market Street
One Liberty Place, Suite 1800
Philadelphia, PA 19103
  Counsel for Appellees/Cross-Appellants
  A.I. Dupont Hospital for Children, Nemours Foundation Inc.,
  Nemours Cardiac Center, William I. Norwood, Numed Inc.,
  Allen J. Towers, Nemours De Institutional Review Board
  and John Murphy

R. Nicholas Gimbel, Esq.
McCarter & English
1735 Market Street, Suite 700
Philadelphia, PA 19103

Sara L. Petrosky, Esq. [ARGUED]
Suzanne Pritchard, Esq.
McCann & Geschke
1800 John F. Kennedy Boulevard
Suite 801
Philadelphia, PA 19103
  Counsel for Appellees/Cross-Appellants A.I. Dupont Hospital for Children,
  Nemours Foundation Inc., Nemours Cardiac Center, William I. Norwood,
  Numed Inc., Allen J. Towers, Nemours De Institutional Review Board
  and John Murphy

John M. Hudgins, IV, Esq.
Weinberg, Wheeler, Hudgins, Gunn & Dial
950 East Paces Ferry Road
Atlanta, GA 20236

Christopher E. Appel, Esq.
Mark A. Behrens, Esq.
Shook, Hardy & Bacon
1155 F. Street, N.W.
Suite 200

                                          2
Washington, DC 20004
 Counsel for Amicus Appellees
 American Coatings Assn, American Ins. Assn.
 American Petro Institute, American Tort Reform Assn.,
 American Chemistry Council, Coalition for Litigation Justice, Inc.
 NFIB Small Business Legal Center, Nat'l Association of Manufacturers,
 Pharmaceutical Research and Manufacturers,
 Product Liability Advisory Council, Property Casualty Insurers Assn.
 of America, and United States Chamber of Commerce

James M. Beck, Esq.
Dechert
2929 Arch Street
18 th Floor, Cira Centre
Philadelphia PA 19104
     Counsel for Amicus Appellee
      Product Liability Advisory Council

                               OPINION OF THE COURT

RENDELL, Circuit Judge.

       M.G. (“Plaintiff”) appeals the District Court’s grant of summary judgment on her

claim of negligence in favor of defendants A.I. duPont Hospital for Children, the

Nemours Foundation, the Nemours Cardiac Center, Nemours Delaware Institutional

Review Board (collectively, the “Institutional Defendants”); Dr. William Norwood and

Dr. John Murphy (the “Medical Defendants”); and NuMed, Inc. The Institutional

Defendants, Medical Defendants, and NuMed (collectively, “Defendants”), cross appeal

the District Court’s denial of summary judgement on Plaintiff’s medical monitoring

claim. For the following reasons we will affirm the District Court’s grant of summary

                                            3
judgment as to the negligence claim and reverse the District Court’s denial of summary

judgment as to the medical monitoring claim.1

                                                I.

       Plaintiff was born with Down Syndrome and a combination of three heart defects

that are uncommon but well-known congenital cardiac malformations that accompany

Down Syndrome. As a result of her condition, Plaintiff underwent treatment at the A.I.

duPont Hospital for Children in Wilmington, Delaware, where it was determined that a

shunting procedure known as the Fontan procedure was the most appropriate treatment

for Plaintiff’s condition. The Fontan procedure modifies the physiology of the heart to

deal with the primary effect of Plaintiff’s heart defects—the inability of her heart to

adequately pump blood to her lungs to be oxygenated. A Fontan physiology is typically

created in a two-step process, a Hemi-Fontan followed by a surgical Fontan Completion,

each of which traditionally requires open heart surgery. Here, the Medical Defendants

achieved the Fontan Completion not through surgery, but through a relatively new

catherization procedure (“Catherization Fontan”) that included the implantation of a

Cheatham Platinum Stent (“CP Stent”). The CP Stent had not been approved by the Food

and Drug Administration, a fact unknown to Plaintiff’s parents at the time of the

procedure.

       1
          Initially, the parents of three children, including Plaintiff, brought a class action.
In April 2007, the parties stipulated to convert the action from a class action to separate
civil actions. Only Plaintiff’s case is before us.

                                                4
       Following implantation of the CP Stent and the creation of the Fontan physiology,

Plaintiff began to develop protein losing enteropathy (“PLE”) and plastic bronchitis

(“PB”). PLE and PB are rare and life-threatening conditions, but are known

complications of a Fontan physiology. Although initially under the care of the Medical

and Institutional Defendants for treatment of her PLE and PB, Plaintiff’s parents became

dissatisfied with the care Plaintiff was receiving, and transferred her to the Children’s

Hospital of Pennsylvania (“CHOP”). While Plaintiff’s PLE dissipated, her PB remained

persistent, leading Plaintiff’s physicians at CHOP to conclude that the best course of

treatment would be to fenestrate, or put a hole in, the CP Stent. Eventually, Plaintiff’s PB

necessitated multiple fenestration procedures and the implantation of two additional

stents. Plaintiff’s physiological condition, underlying developmental issues, and

continuing struggle with PB, necessitate ongoing medical care and surveillance.

       Plaintiff’s original complaint contained six distinct counts: (I) Negligence: Lack of

Informed Consent, (II) Fraud and Intentional Misrepresentation, (III) Assault and Battery,

(IV) Strict Products Liability, (V) Breach of Express and Implied Warranties, and (VI)

Medical Monitoring. Plaintiff’s complaint asserts that her “exposure to the NuMED CP

Stent and Implantation Procedure . . . caused and will continue to cause [her] to suffer

physical pain, mental anguish, medical and other related personal injuries and/or

expenses.” App. 149. Specifically, Plaintiff contended that “as a direct result of the stent

placement and its resulting physiologic effects” she developed “at least two serious

                                              5
medical conditions . . . Protein Losing Enteropathy (PLE) and plastic bronchitis [PB].”

App. 158.

                                             II.

       On February 6, 2009, the District Court issued two memoranda and accompanying

orders, one resolving the claims against the Medical and Institutional Defendants

(hereinafter, “First Memorandum”), the other resolving the claims against NuMED, Inc.

and its CEO Allen Tower (hereinafter, “Second Memorandum”).

                                  A. First Memorandum

       In the First Memorandum, the District Court applied Delaware law 2 and noted that

the Delaware Health Care Malpractice Insurance and Litigation Act (the “Health Care

Act”), 18 Del. C. §§ 6801 et seq., governed the claims at issue, since it defines medical

negligence in an all-encompassing manner as “any tort or breach of contract based on

health care or professional services rendered, or which should have been rendered, by a

health care provider to a patient.” App. 23 (citing 18 Del. C. § 6801(7)). The District

Court continued:

              A cornerstone of the Health Care Act is the requirement that
              plaintiffs asserting claims against healthcare providers must

       2
        The District Court conducted a choice of law analysis that is uncontested on
appeal. The District Court found Delaware law applicable because, although Plaintiff is
from New Jersey and Pennsylvania is the forum state, the complained-of conduct
occurred in Delaware, Plaintiff intentionally traveled to Delaware to receive treatment,
and Delaware has an interest in regulating activity within its borders and maintaining the
predictability of its health care regulations.

                                             6
              support those claims with expert testimony regarding the
              healthcare provider’s deviation from the standard of care and
              the causal connection between the healthcare provider’s
              deviation and plaintiff’s injury. See 18 Del. C. § 6853(e)
              (“No liability shall be based upon asserted negligence unless
              expert medical testimony is presented as to the alleged
              deviation from the applicable standard of care in the specific
              circumstances of the case and as to the causation of the
              alleged personal injury or death . . . .”). Indeed, the testimony
              of a competent medical expert is an essential element of any
              medical negligence claim, including informed consent claims,
              in Delaware.

App. 24. The District Court found that Plaintiff’s medical negligence, lack of informed

consent, and fraud claims all failed because Plaintiff did not satisfy her burden of

producing medical expert testimony that established causation.3 Accordingly, the District

Court granted the motions for summary judgment with respect to these claims.

       The District Court allowed Plaintiff’s “Medical Monitoring” claim to proceed,

denying the motion for summary judgment with respect to this count. The District Court

acknowledged that, although Pennsylvania and New Jersey recognize medical monitoring

as a cause of action, in Delaware, “it is not clear whether medical monitoring is an

independent tort or whether medical monitoring is simply a remedy, as it is in many other

jurisdictions.” App. 22. The District Court noted that the “Delaware Supreme Court has

       3
          The District Court had previously dismissed Plaintiff’s assault and battery claim,
strict liability claim, and breach of express and implied warranties claim against Dr.
Norwood and Dr. Murphy, and extended that conclusion to the Institutional Defendants in
this decision. Plaintiff does not address this issue or these claims in her opening brief,
and so these claims have been waived.

                                              7
acknowledged medical monitoring but has never explicitly recognized medical

monitoring as a legally cognizable cause of action,” and that, as a result, the District

Court sitting in diversity “must predict how the state’s supreme court would resolve the

issue, giving consideration to the decisions of intermediate state courts.” App. 39. The

District Court then predicted that the Delaware Supreme Court would permit a claim for

medical monitoring on this record. The District Court suggested that because Defendants

caused Plaintiff to come into contact with an adulterated medical device and this contact

(and the continued presence of the device in Plaintiff’s body) will require Plaintiff to

receive continued medical monitoring specifically with respect to the effects of the CP

Stent, Plaintiff might be able to sustain a medical monitoring claim.

                                B. Second Memorandum

       In the Second Memorandum, which dealt with the claims against NuMED, Inc.

(the manufacturer of the CP Stent), and Allen Tower (the sole shareholder and CEO of

NuMED, Inc.), the District Court again found that Delaware law applied with respect to

the various tort claims in Counts I through V, and that, again, Plaintiff’s claims were

blocked due to her inability to demonstrate causation.4 Plaintiff does not argue for

reversal of summary judgment on any of these five counts with respect to either NuMED

or Tower, including the lack of informed consent claim, and so these issues have been

       4
        The District Court dismissed Plaintiff’s strict liability claim on the grounds that
Delaware law bars strict product liability claims, and the breach of express and implied
warranties claims failed for a variety of non-causation related reasons.

                                              8
waived.

       The District Court denied NuMED’s motion for summary judgment as to Count VI

(the medical monitoring claim) with respect to NuMED, for the same reasons that it

denied the motion for summary judgment in the other decision. The District Court

granted the motion for summary judgment with respect to Allen Tower, on the grounds

that, applying New York law (through a new choice of law analysis), Plaintiff failed to

prove “complete domination” and to pierce the corporate veil. Again, Plaintiff does not

argue for reversal of the entry of judgment in favor of Allen Tower in her opening brief,

and so that issue is waived.

                               C. Remaining Issues on Appeal

       Although Plaintiff’s Notice of Appeal indicated that she was appealing the

dismissal of Counts I through V, the only one of these five counts she addressed in her

Opening Brief is her negligence-based lack of informed consent claim set forth in Count I

of her Complaint against the Medical Defendants and the Institutional Defendants.

Accordingly, the other issues have been waived. See Tracinda Corp. v. DaimlerChrysler

AG, 502 F.3d 212, 236 n.18 (3d Cir. 2007) (“[I]t is well-settled in this court that an

appellant’s failure to identify or argue an issue in his opening brief constitutes waiver of

that issue on appeal.” (internal quotation marks and citations omitted)); United States v.

Pelullo, 399 F.3d 197, 201 n.2 (3d Cir. 2005) (“Where, as here, an appellant fails to raise

an issue in an appellate brief, even if it was listed in the Notice of Appeal, it is deemed

                                              9
waived.”), cert denied, 546 U.S. 1137 (2006).

       NuMED, the Medical Defendants, and the Institutional Defendants all cross appeal

the denial of summary judgment on the medical monitoring claim.

                                             III.

       The District Court had jurisdiction pursuant to 28 U.S.C. § 1332. We have

jurisdiction over Plaintiff’s appeal pursuant to 28 U.S.C. § 1291, and over the

Defendants’ cross-appeal pursuant to 28 U.S.C. § 1292(b). We exercise plenary review

over a grant or denial of summary judgement and apply the same standard used by the

District Court. Giles v. Kearney, 571 F.3d 318, 322 (3d Cir. 2009). A grant of summary

judgment “should be rendered if the pleadings, the discovery and disclosure materials on

file, and any affidavits show that there is no genuine issue as to any material fact and that

the movant is entitled to judgment as a matter of law.” Fed. R. Civ. P. 56(c). We view

the facts in the light most favorable to the nonmoving party, drawing all reasonable

inferences in the non-movant’s favor. However, “[t]he mere existence of a scintilla of

evidence in support of the plaintiff’s position will be insufficient; there must be evidence

on which the jury could reasonablely find for the plaintiff.” Anderson v. Liberty Lobby,

Inc., 477 U.S. 242, 252 (1986).

                         A. Negligence: Lack of Informed Consent

       As the District Court noted, medical negligence actions brought under Delaware

law are governed by the Health Care Act. The Health Care Act defines medical

                                             10
negligence as “any tort or breach of contract based on health care or professional services

rendered, or which should have been rendered, by a health care provider to a patient.” 18

Del. C. § 6801(7). Under section 6853, titled “Affidavit of Merit, expert medical

testimony,” the Health Care Act explicitly states:

              No liability shall be based upon asserted negligence unless
              expert medical testimony is presented as to the alleged
              deviation from the applicable standard of care in the specific
              circumstances of the case and as to the causation of the
              alleged personal injury or death . . .

18 Del. C. § 6853(e). Thus, under the Health Care Act, a claimant must show, by expert

medical testimony, (1) the applicable standard of care, (2) the deviation from that

standard, and (3) that this deviation caused the alleged personal injury or death. Delaware

law requires that causation meet the “but for” causation standard, see Edwards v. Family

Practice Associates, Inc., 798 A.2d 1059, 1066 (Del. Super. Ct. 2002) (“Plaintiffs must

show such negligence was a proximate cause of injury; that is, but for the negligence, the

injury would not have happened.”), which means that the claimant must show that the

harm would not have occurred if not for the defendant’s deviation from the standard of

care. See Burkhart v. Davies, 602 A.2d 56, 59 (Del. 1991).

       The Informed Consent Statute of the Health Care Act, 18 Del. C. § 6852, is

contained within, and governed by, the “Medical Negligence” chapter of the Delaware

Code. See Brzoska v. Olson, 668 A.2d 1355, 1366 (Del. 1995) (“If a health care provider

violates his or her duty of care in obtaining the consent of the patient by failing to disclose

                                              11
all relevant information (risks) that a reasonable person would deem significant in making

a decision to have the procedure, the action should be pleaded in negligence—not

battery.”). The Health Care Act 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.

18 Del. C. § 6801(6). Consequently, as with other claims under the Health Care Act, to

succeed on a lack of informed consent claim such as this one, a plaintiff must show that

by failing to obtain informed consent, a defendant fell below the applicable standard of

care. In particular, the claimant must prove “by a preponderance of evidence that the

health care provider did not supply information regarding such treatment, procedure or

surgery to the extent customarily given to patients, or other persons authorized to give

consent for patients by other licensed health care providers in the same or similar field of

medicine as the defendant.” 18 Del. C. § 6852(a). The plaintiff must also show that the

deviation from the standard of care caused the harm, supporting this evidentiary burden

with the presentation of expert testimony. This requirement has been explicitly applied to

lack of informed consent claims. See Valentine v. Mark, 2004 WL 2419131, at *3 (Del.

Super. Ct. Oct. 20, 2004) (“More importantly, an informed consent action still requires

expert testimony as to causation. . . . Section 6853 makes it abundantly clear that . . . only

                                              12
expert testimony can prove the essential element of causation. Section 6852 [the

informed consent provision] cannot therefore be used as a backdoor around the

requirement that causation in medical negligence cases be supported by expert

testimony.”). Accordingly, in order to prevail on a cause of action for informed consent,

Delaware law requires a claimant to show not just a deviation from the standard of care,

but to show by expert testimony that the deviation complained of is the “but for” cause of

a legally cognizable harm.

       We agree with the District Court that Plaintiff has not presented the necessary

expert testimony to demonstrate that the deviation from the standard of care by the

Defendants was the “but for” cause of the harm she suffered. Plaintiff has demonstrated

that following the Catherization Fontan and the implantation of the CP Stent, she suffered

from PLE and continues to struggle with PB. However, the complications suffered by

Plaintiff are known complications of the Fontan physiology, and Plaintiff did not produce

expert medical testimony showing that these harms were caused by the Defendants’

failure to inform as to the use of the CP Stent or by the Catherization Fontan. The only

medical expert Plaintiff produced, Dr. Paul Grossfeld, testified that PLE and PB are both

known complications of the Fontan physiology that can and do develop even in the

absence of negligence by the treating physician. App. 242-44. In response to the direct

question of whether Plaintiff’s complications were due to the CP stent or the use of the

catherization procedure, Dr. Grossfeld replied “I don’t know,” and “I don’t know. I think

                                            13
that’s unlikely,” respectively. App. 243-44.

       The District Court’s conclusion seems inescapable. Plaintiff did not meet her

burden with respect to causation, and summary judgment was appropriately granted with

respect to this claim.5

                                  B. Medical Monitoring

       Plaintiff’s original sixth cause of action was a claim entitled “Medical

Monitoring.” She contended that “[a]s a direct result of defendants’ acts, omissions, and

conduct, plaintiffs . . . who have received NuMED CP stent have been exposed to a

       5
         Plaintiff urges on appeal that her harm is not limited to PLE and PB, but also
includes the harm of being required “to undergo multiple procedures to fenestrate [the CP
Stent],” Appellant’s Br. 48, and to undergo “additional procedures to expand the stent as
she grows” in the future. Appellant’s Resp. Br. 11. Plaintiff contends that her parents
would not have consented to the CP Stent implantation if they had been given all of the
information. Accordingly, Plaintiff urges that the multiple fenestration procedures she
had to undergo at CHOP, as a result of the CP Stent, and the created need to dilate or
expand the stent in the future, represent harm that but for Defendants’ actions (in
proceeding without informed consent) she would not have to endure.
       In response, Defendants urge that the treatment Plaintiff underwent at CHOP—the
fenestration procedures—are a result of known complications of Fontan physiology that
Plaintiff would have had to undergo regardless of whether the Fontan was completed by
surgery or catheter. Defendants’ position is that if surgical completion had taken place,
Plaintiff would have had a Gore-Tex tube implanted, which would have required
Plaintiff’s CHOP doctors to punch a hole or fenestrate the same Gore-Tex material that
was used for the CP Stent.
       We note, first, that Plaintiff did not specifically identify the need to undergo
multiple fenestration procedures as a harm in her initial complaint. Even leaving this
concern aside, Plaintiff’s argument is unavailing as she does not identify any expert
testimony in the record that establishes that Defendants’ actions were a “but for” cause of
the need for multiple fenestration procedures.

                                               14
hazardous procedure and product, and suffered a significantly increased risk of the side

effects caused by this device. This increased risk makes periodic diagnostic and medical

examinations reasonable and necessary.” App. 178. The complaint continued:

              “Medical monitoring is necessary because: (a) The NuMED
              CP Stent is a proven and admittedly hazardous product; (b)
              Plaintiffs’ exposure to the hazardous product and procedure
              was proximately caused by defendants’ tortious conduct; (c)
              Medical monitoring will detect injuries from the NuMED CP
              Stent and its implantation; (d) This monitoring will be
              different from what normally is recommended to individuals
              who did not receive a NuMED CP Stent; and (e) Medical
              monitoring will assist in preventing further injuries from or as
              a consequence of implantation of the NuMED CP Stent.”

App. 178-79. Plaintiff posed the medical monitoring claim as an independent cause of

action, not merely as a remedy for negligence or some other tortious conduct, despite

condition (b), which refers to “defendants’ tortious conduct.”

       As noted above, the District Court allowed Plaintiff’s “Medical Monitoring” claim

to proceed, denying the motion for summary judgment with respect to that count. The

District Court acknowledged that in Delaware, “it is not clear whether medical

monitoring is an independent tort or whether medical monitoring is simply a remedy, as it

is in many other jurisdictions.” App. 22. The District Court noted that the “Delaware

Supreme Court has acknowledged medical monitoring but has never explicitly recognized

medical monitoring as a legally cognizable cause of action,” and that, as a result, the

District Court sitting in diversity “must predict how the state’s supreme court would

resolve the issue, giving consideration to the decisions of intermediate state courts.” App.

                                             15
39. The District Court then predicted that the Delaware Supreme Court would permit a

claim for medical monitoring on this record.

       In an August 28, 2009 Order, the District Court certified the following three issues

for immediate interlocutory appeal to this Court:

       1) Would the Delaware Supreme Court recognize a medical monitoring cause of
       action if presented with the record in this case?

       2) If the appellate court answers the first certified question in the affirmative,
       would Plaintiff be able to state a claim for medical monitoring in Delaware?

       3) If the appellate court answers the first two certified questions in the affirmative,
       would Plaintiff meet her summary judgment burden of establishing a genuine issue
       of fact for trial regarding her medical monitoring claim?

App. 99-100.

       Because we find that Plaintiff is unable to establish the elements necessary to state

a claim for medical monitoring, we decline to reach the questions posed by the District

Court, and will, for the following reasons, reverse the denial of summary judgement.

       Defendants argue that the District Court erred in predicting that the Delaware

Supreme Court would adopt a stand-alone cause of action for medical monitoring. In

particular, Defendants contend that the District Court erred in extending Delaware law

beyond the bounds of the recognized medical monitoring claim in which a plaintiff

alleges long-term exposure to a proven toxic substance with known tendencies to produce

serious future medical injuries. We agree.

       Neither the District Court nor Plaintiff points to any case in this Circuit, let alone

                                              16
in Delaware, in which a free-standing medical monitoring claim has been allowed to

proceed although the plaintiff has not demonstrated significant exposure to a toxic

(poisonous) or proven hazardous substance.6 Medical monitoring was addressed by this

Court in litigation surrounding the plaintiffs’ exposure of polychlorinated biphenyls

(PCBs) from working in or living adjacent to a rail-yard. In re Paoli Railroad Yard PCB

Litigation, 916 F.2d 829 (3d Cir. 1990) (Paoli I); 35 F.3d 717 (3d Cir. 1994) (Paoli II);

113 F.3d 444 (3d Cir. 1997) (Paoli III). In Paoli II, this Court found that medical

monitoring is a viable claim under Pennsylvania law and re-articulated the following test

from Paoli I, concluding that these elements are necessary to make out a medical

monitoring claim in Pennsylvania:

              1. Plaintiff was significantly exposed to a proven hazardous
              substance through the negligent actions of the defendant.

              2. As a proximate result of exposure, plaintiff suffers a
              significantly increased risk of contracting a serious latent
              disease.

              3. That increased risk makes periodic diagnostic medical
              examinations reasonably necessary.

       6
        The Delaware Supreme Court has not recognized a cause of action for medical
monitoring, a fact the District Court acknowledged. The District Court notes that courts
in Delaware have “acknowledged” medical monitoring tacitly without “expressly
addressing its viability as a cause of action.” App. 39 n.8 (citing Alderman v. Clean
Earth, Inc., No. 04C-06-181, 2007 Del. Super. LEXIS 191, at *8 (Del. Super. Ct. June 26,
2007); Brzoska v. Olsen, No. 92C-06-142, 1994 Del. Super. LEXIS 230, at *9 (Del.
Super. Ct. May 2, 1994), aff’d in part, rev’d on other grounds, 668 A.2d 1355 (Del.
1995); In re Asbestos Litig., No. 87C-09-24, 11994 Del. Super. LEXIS 685, at *5 (Del.
Super. Ct. Aug. 5, 1994)).

                                             17
              4. Monitoring and testing procedures exist which make the
              early detection and treatment of the disease possible and
              beneficial.

35 F.3d at 787. Plaintiff identifies a single case, Sutton v. St. Jude Med, S.C., Inc., 419

F.3d 568 (6th Cir. 2005), in which a court suggested that recovery of future medical costs

might be appropriate outside of the “toxic tort” context. In Sutton, the Sixth Circuit found

that Sutton had standing to seek medical testing and monitoring allegedly made necessary

by the implantation of a medical device that had not yet malfunctioned or caused Sutton

any physical injuries. Id. at 575. The Sutton Court only discussed basic standing

doctrine; it did not find that Sutton could recover for medical monitoring, nor did it find

that medical monitoring could be applied as a free-standing tort claim in a non-toxic tort

scenario.

       Thus, the District Court’s prediction that the Delaware Supreme Court would

permit a claim for medical monitoring on this record requires several “leaps” from the

current state of the law, generally, let alone Delaware law. Here, there is no toxic or

hazardous substance, as such. While unapproved devices are termed “adulterated”, they

are not necessarily harmful, and certainly not toxic. Moreover, the risk here is not a risk

of “contracting a serious latent disease.” Rather, it is a risk of the need for further care.

Further examinations are not to “monitor” the risk of disease, but to perform routine

oversight.

       In reaching this conclusion, we decline to predict whether the Delaware Supreme

                                              18
Court might acknowledge some variant of a medical monitoring claim. Even if the

Delaware Supreme Court would recognize a “standard” medical monitoring claim, such

as the one identified in Paoli, which requires a plaintiff to demonstrate that a defendant’s

negligence caused the plaintiff to be exposed to a proven hazardous substance that

resulted in a significantly increased risk of contracting a serious latent disease, the

plaintiff here cannot demonstrate that she has been exposed to a proven hazardous

substance, nor can she prove that such exposure resulted in a significantly increased risk

of contracting a serious latent disease.7 Accordingly, we find that Plaintiff is unable to

establish the elements necessary to make out a claim for medical monitoring. For the

foregoing reasons, we reverse the order of the District Court denying Defendants’

motions for summary judgment.

                                              IV.

       The District Court is hereby affirmed in part and reversed in part.

       7
         We also note the well-established principle that a federal court sitting in diversity,
when called upon to make a prediction of state law, should act conservatively. See, e.g.,
Day & Zimmerman, Inc. v. Challoner, 423 U.S. 3, 4 (1975) (per curiam) (“A federal court
in a diversity case is not free to engraft onto those state rules exceptions or modifications
which may commend themselves to the federal court, but which have not commended
themselves to the State in which the federal court sits.”); Travelers Indemnity Co. v.
Dammann & Co, Inc., 594 F.3d 238, 253 (3rd Cir. 2010) (“[I]n reaching our conclusion
we have exercised restraint in accordance with the well-established principle that where
‘two competing yet sensible interpretations’ of state law exist, ‘we should opt for the
interpretation that restricts liability, rather than expands it, until the Supreme Court of
[that state] decides differently’.” (internal citations omitted)).

                                              19