Ohio Unpublished Opinions

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KERPELIS v. PFIZER, INC., Unpublished Decision (6-7-2004)
2004-Ohio-3049
Maria Kerpelis, Plaintiff-Appellant, v. Pfizer, Inc., et al.,
Defendants-Appellees.
Case No. 03 MA 17.
Court of Appeals of Ohio, Seventh District, Mahoning County.
Dated: June 7, 2004.

Civil Appeal from Common Pleas Court, Case No. 01 CV 1310.

Affirmed.

Maria Kerpelis, Pro-se, 304 15th Street, Campbell, OH 44405,
for Plaintiff-Appellant.

Attorney Tracy L. Turnbull, Attorney Ralph Streza, Porter,
Wright, Morris & Arthur, 925 Euclid Avenue, Suite 1700,
Cleveland, OH 44115-1482, Attorney for Pfizer, Inc.

Attorney Barbara J. Arison, Attorney Greg R. Farkas, Frantz,
Ward, LLP, 55 Public Square, 19th Floor, Cleveland, OH 44113,
Attorney for Bristol-Myers Squibb Co.

Attorney Janet S. Gore, Tucker, Ellis & West LLP, 1150
Huntington Bldg., 925 Euclid Avenue, Cleveland, OH 44115,
Attorney for Janssen Pharmaceutica.

Attorney Philip A. Kuri, 200 Courtyard Square, 80 S. Summit
Street, Akron, OH 44308, Attorney Ying Amorn, M.D.

Attorney David Comstock, Comstock, Springer & Wilson, 100
Federal Plaza, East, Suite 926, Youngstown, OH 44503, Attorney
for St. Elizabeth Medical Ctr., for Defendants-Appellees.

JUDGES: Hon. Mary DeGenaro, Hon. Cheryl L. Waite, Hon. Joseph
J. Vukovich.

OPINION

DeGENARO, J.

{ 1} This timely appeal comes for consideration upon the
record in the trial court and the parties' briefs.
Plaintiff-Appellant, Maria Kerpelis, appeals the decision of the
Mahoning County Court of Common Pleas which granted summary
judgment to Defendants-Appellees, Pfizer, Inc., Janssen
Pharmaceutica, Inc., Bristol-Myers Squibb Company, St. Elizabeth
Medical Center, and Ying Amorn, M.D. Kerpelis argues that the
trial court erred when it granted summary judgment since her
affidavit and evidence she discovered after the trial court
granted summary judgment demonstrates that Appellees are liable
for her injuries. Kerpelis relied on her own lay opinion to
establish her medical malpractice and product liability claims
against Appellees rather than producing an expert witness who
could testify regarding causation. Since Kerpelis never produced
an expert witness in response to Appellees' motions for summary
judgment, the trial court's decision must be affirmed.

Facts

{ 2} Kerpelis underwent a colonoscopy performed by Dr. Amorn
at the St. Elizabeth Medical Center and was discharged the next
day. At that time, Dr. Amorn prescribed Populsid, a medication
manufactured by Janssen.

{ 3} Kerpelis claims that while she was in the hospital she
was infected due to unsanitary conditions. Shortly after leaving
the hospital Kerpelis visited another doctor, complaining of
fever, chills, muscle aches, fatigue, and abdominal pains. That
doctor prescribed Trimox, an antibiotic manufactured by
Bristol-Myers Squibb. Kerpelis still suffered from those symptoms
one week after her colonoscopy and she visited her doctor a
second time. That doctor then gave Kerpelis several one-dose
packets of Trovan, a medication manufactured by Pfizer.

{ 4} Kerpelis took each of these medications that day. At
around midnight Kerpelis had what she claims to be an acute
reaction to the medications. During that time, she suffered from
extreme respiratory distress and her symptoms included shortness
of breath, racing heart, severe abdominal pain, aching joints,
and fatigue. The symptoms lasted for hours that night and
Kerpelis claims she still suffers from them. Although Kerpelis
believes the medications she took caused the episode she never
asked a doctor to confirm her belief.

{ 5} After filing and dismissing complaints against each of
the defendants, Kerpelis filed a new complaint against all of the
defendants. That complaint alleged that the hospital and Dr.
Amorn committed medical malpractice and that the pharmaceutical
companies were liable under a theory of products liability.

{ 6} On December 5, 2001, the trial court entered a
pre-trial order. It ordered, among other things, that Kerpelis
provide the names and addresses of her prospective expert
witnesses to the defendants by August 1, 2002. On July 26, 2002,
Kerpelis moved for an extension of this deadline to September 15,
2002, which was granted by the trial court on August 19, 2002. On
September 16, 2002, Kerpelis filed a second motion to extend this
deadline to October 20, 2002. The trial court never specifically
ruled on this motion. Regardless, Kerpelis never notified the
defendants that she had found an expert witness to testify on her
behalf.

{ 7} Between October 15, 2002, and December 4, 2002, each of
the defendants filed a motion for summary judgment. In those
motions, the defendants argued that they were entitled to summary
judgment since Kerpelis did not have an expert witness to support
her claims. Kerpelis filed her brief in opposition on November
14, 2002. The only evidence Kerpelis could produce to establish
her claims was her affidavit describing her symptoms and beliefs
and printouts from the internet which showed that the FDA
restricted the use of Propulsid and Trovan after 1999. On January
7, 2003, the trial court granted the defendants' motions for
summary judgment, noting that Kerpelis had failed to present a
prima facie case of medical malpractice. On February 7, 2003, the
trial court modified its judgment to reflect that it was granting
summary judgment on Kerpelis' products liability and negligence
claims as well as her medical malpractice claims.

Summary Judgment Standard of Review

{ 8} In her sole assignment of error, Kerpelis' argues:

{ 9} "The trial court erred in sustaining
Defendants-Appellees' motion for summary judgment."

{ 10} Kerpelis argues that the trial court improperly
granted summary judgment to Appellees. When reviewing a trial
court's decision to grant summary judgment, an appellate court
applies the same standard used by the trial court and, therefore,
engages in a de novo review. Parenti v. Goodyear Tire & Rubber
Co. (1990), 66 Ohio App.3d 826, 829. Under Civ.R. 56, summary
judgment is only proper when the movant demonstrates that,
viewing the evidence most strongly in favor of the non-movant,
reasonable minds must conclude no genuine issue as to any
material fact remains to be litigated and the moving party is
entitled to judgment as a matter of law. Doe v. Shaffer (2000),
90 Ohio St.3d 388, 390. A fact is material when it affects the
outcome of the suit under the applicable substantive law.
Russell v. Interim Personnel, Inc. (1999), 135 Ohio App.3d 301,
304.

{ 11} When moving for summary judgment, a party must produce
some facts that suggest that a reasonable fact-finder could rule
in her favor. Brewer v. Cleveland Bd. of Edn. (1997),
122 Ohio App.3d 378, 386. "[T]he moving party bears the initial
responsibility of informing the trial court of the basis for the
motion, and identifying those portions of the record which
demonstrate the absence of a genuine issue of fact on a material
element of the nonmoving party's claim." Dresher v. Burt
(1996), 75 Ohio St.3d 280, 296. The nonmoving party has the
reciprocal burden of specificity and cannot rest on mere
allegations or denials in the pleadings. Id. at 293.

Newly Discovered Evidence

{ 12} Before this Court addresses the merits of Kerpelis'
argument, we must determine what evidence may be considered when
reviewing the trial court's decision. Kerpelis argues we can and
should consider the newly discovered evidence that she attached
to her appellate brief. In support of this argument, she cites
Domanski v. Woda (1937), 132 Ohio St. 208. But Domanski is
clearly distinguishable. In Domanski, the appellant asked the
trial court for a new trial based upon newly discovered evidence,
a motion which is now covered by Civ.R. 59(A)(8). Neither
Domanski nor Civ.R. 59(A)(8) allow an appellant to challenge a
trial court's decision to grant summary judgment by presenting
the appellate court with new evidence which was not submitted to
the trial court.

{ 13} The Ohio Supreme Court clearly held a reviewing court
cannot add material to the record before it, which was not part
of the trial court proceedings, and then decide the appeal on the
basis of the new matter. See State v. Ishmail (1978),
54 Ohio St.2d 402, paragraph one of the syllabus. "Since a reviewing
court can only reverse the judgment of a trial court if it finds
error in the proceedings of such court, it follows that a
reviewing court should be limited to what transpired in the trial
court as reflected by the record made of the proceedings." Id. at
405-406.

{ 14} This Court has repeatedly and unconditionally followed
the Ohio Supreme Court's mandate on this issue in both criminal
and civil cases. See Hager v. Waste Technologies Industries,
7th Dist. No. 2000-CO-45, 2002-Ohio-3466; State v. Budrovic
(Oct. 31, 2001), 7th Dist. No. 00 CA 5. On December 12, 2003 this
Court struck Kerpelis' supplement to her brief, noting that
evidence not before the trial court may not be added to the
record. Accordingly, even though Kerpelis argues that we must
consider the evidence attached to her appellate brief, we cannot
do so.

Medical Malpractice

{ 15} Kerpelis next argues that the trial court erred when
it granted summary judgment to the hospital and Dr. Amorn since
the room where the colonoscopy was performed and the personnel
she dealt with were unsanitary. In response, both the hospital
and Dr. Amorn argue that Kerpelis' claim must fail since she did
not support her claim with expert testimony. In addition, Dr.
Amorn argues that Kerpelis did not specifically contest the trial
court's decision to grant summary judgment to him in her brief.
Accordingly, Dr. Amorn argues that this court does not need to
address whether the trial court's decision regarding his motion
for summary judgment was correct.

{ 16} Although Dr. Amorn is correct in a certain sense, we
will not disregard any error in the trial court's decision to
grant him summary judgment. Although Kerpelis was represented by
counsel in the trial court, she is acting pro se on appeal. And
it is clear that she intended to challenge the trial court's
decision to grant summary judgment to each of the defendants.
Furthermore, it is possible to interpret her argument as a
challenge to the trial court's decision to grant summary judgment
to him. She alleges that he performed the colonoscopy and that
the room she was in and the people she dealt with were
unsanitary. Clearly, this is an attack on Dr. Amorn's actions.
Kerpelis clearly challenges the trial court's decision in this
regard.

{ 17} However, the substance of Kerpelis' argument must
fail. The Ohio Supreme Court has long held that in order to
establish medical malpractice, the plaintiff must show: 1) the
standard of care recognized by the medical community; 2) the
failure of the defendant to meet the requisite standard of care;
and, 3) a direct causal connection between the medically
negligent act and the injury sustained. Bruni v. Tatsumi
(1976), 46 Ohio St.2d 127, paragraph one of the syllabus. And it
further held that expert testimony is generally required to
establish the standard of care and to establish whether the
defendant satisfied that standard in a medical malpractice case.
Id at 130. "Failure to establish the recognized standards of the
medical community has been fatal to the presentation of a prima
facie case of malpractice by the plaintiffs." Id. at 131.

{ 18} The exception to that rule is "in cases where the
nature of the case is such that the lack of skill or care of the
physician and surgeon is so apparent as to be within the
comprehension of laymen and requires only common knowledge and
experience to understand and judge it." Id. This exception has a
limited scope in a world of increasing medical complexity.
Buerger v. Ohio Dept. of Rehab. & Corr. (1989),
64 Ohio App.3d 394, 399. And the cases which apply this
exception generally deal with instances of gross inattention during
patient care or miscommunication with the patient, such as leaving a
medical instrument inside the body or operating on the right knee
versus the left knee. Lipp v. Kwyer, 6th Dist. No. L-02-1150,
2003-Ohio-3988, 14-15.

{ 19} In this case, Kerpelis does not have any expert
testimony supporting her claim that the hospital and Dr. Amorn
have violated the appropriate standard of care. Unless her case
is of such a kind that the lack of skill or care is so apparent
that it is within the comprehension of laymen, the trial court
properly granted summary judgment to the hospital and Dr. Amorn.
Kerpelis has not attempted to argue at any stage of the
proceedings that the common knowledge exception to the
requirement for an expert applies and a review of Kerpelis'
claims demonstrates that she would need expert testimony to
establish the standard of care and causation. Kerpelis' claim
cannot survive summary judgment merely because she believes that
the hospital and Dr. Amorn were negligent. Accordingly, the trial
court properly granted summary judgment to the hospital and Dr.
Amorn. Kerpelis' arguments to the contrary are meritless.

Products Liability

{ 20} Kerpelis finally argues that the trial court erred
when it granted the pharmaceutical companies' motions for summary
judgment since two of the medications she took, Propulsid and
Trovan, have been removed from the market by the Food and Drug
Administration. She argues that the fact that the FDA removed
these medications from the market demonstrates that they were
defective and were more dangerous than she could reasonably
foresee. In response, each of the pharmaceutical companies makes
a similar argument that Kerpelis failed to establish a cognizable
products liability claim since she did not produce any expert
testimony supporting her claim.

{ 21} In a products liability action, the plaintiff bears
the burden of proving: 1) there was, in fact, a defect in the
product manufactured and sold by the defendant; 2) the defect
existed at the time the product left the hands of the defendant;
and 3) the defect was the direct and proximate cause of the
plaintiff's injuries or loss. State Auto Mut. Ins. Co. v.
Chrysler Corp. (1973), 36 Ohio St.2d 151, paragraph two of the
syllabus; R.C. 2307.73(A). The pharmaceutical companies argue
Kerpelis' needs expert testimony to establish there was a defect
and the defect was the proximate cause of her injuries.

{ 22} Clearly, whether a prescription drug is defective and
whether it is the proximate cause of an injury are questions
which lie outside the knowledge of lay witnesses. Accordingly,
Kerpelis would have to introduce expert testimony to establish
these elements of her claim.

{ 23} "[W]here an issue in a case involves a question of
scientific inquiry which is not within the knowledge of lay
witnesses or members of the jury, expert testimony is required to
furnish the answers, and, if the issue relates to a causal
connection between an injury and a subsequent physical condition
which involves only a scientific inquiry, such causal connection
must be established by the testimony of medical witnesses
competent to testify on the subject, and the proof in such case
must establish a probability and not a mere possibility of such
causal connection." Stacey v. Carnegie-Illinois Steel Corp.
(1951), 156 Ohio St. 205, 210; see, also, Evid.R. 702.

{ 24} Kerpelis did not produce any expert testimony
supporting her claims that the medications were defective or that
they caused her injuries. The only evidence she introduced which
could demonstrate a defect is that the FDA took Propulsid off the
market and has ordered that Trovan be used only as a drug of last
resort.

{ 25} It is questionable whether the fact that the FDA took
action to restrict the use of Propulsid and Trovan creates a
genuine issue regarding whether these medications were defective.
But even if it does, Kerpelis has failed to introduce any
evidence that these medications proximately causes her injuries.
In her deposition, Kerpelis freely admitted that she never asked
a doctor or any other type of expert whether her medications
could have caused her symptoms. The only reason she thinks that
these medications injured her is because of the temporal
proximity between when she began taking these medications and the
onset of her symptoms. This belief establishes nothing more than
the mere possibility that these medications caused Kerpelis'
injuries. This is insufficient to survive summary judgment in
favor of Pfizer and Bristol-Myers Squibb.

{ 26} Further, this does not demonstrate that Trimox,
manufactured by Bristol-Myers Squibb, was defective in any way.
Without some evidence that Trimox was defective, Kerpelis' claim
against Bristol-Myers Squibb could not survive summary judgment.

{ 27} Kerpelis clearly has serious medical issues which were
caused by something. She believes those issues were caused by the
medications manufactured by these pharmaceutical companies. But
the manufacture and design of a prescription drug and how it acts
once it is ingested is clearly outside lay expertise. Since
Kerpelis did not produce an expert to testify on her behalf, the
trial court properly granted summary judgment to the
pharmaceutical companies. Kerpelis' arguments to the contrary are
meritless.

{ 28} Accordingly, Appellant's sole assignment of error is
meritless and the judgment of the trial court granting summary
judgment to Appellees is affirmed.

Waite, P.J., concurs.

Vukovich, J., concurs.



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