               NOT RECOMMENDED FOR FULL-TEXT PUBLICATION
                          File Name: 06a0287n.06
                           Filed: April 27, 2006

                                         No. 05-3704

                           UNITED STATES COURT OF APPEALS
                                FOR THE SIXTH CIRCUIT


       MOHAMED HISAM NAJIB,                        )
                                                   )
            Plaintiff-Appellant,                   )   ON APPEAL FROM THE UNITED
                                                   )   STATES DISTRICT COURT FOR
                      v.                           )   THE SOUTHERN DISTRICT OF
                                                   )   OHIO
                                                   )
       MERIDIAN MEDICAL                            )   OPINION
    TECHNOLOGIES, INC., ET AL.,                    )
                                                   )
           Defendants-Appellees.                   )
                                                   )
                                                   )
_____________________________________



       Before: DAUGHTREY and GILMAN, Circuit Judges; RUSSELL, District Judge*

       RUSSELL, District Judge. Plaintiff Mohamed Najib appeals the district court’s grant

of summary judgment on his negligence and products liability claims regarding performance of

an “EpiPen” which he used to treat acute asthma attacks. For the following reasons, we

AFFIRM the judgment of the district court with regard to Najib’s supplier-liability and

negligence claims but REVERSE the judgment with respect to Najib’s other claims.

                                     I. BACKGROUND


       *
       Honorable Thomas B. Russell, United States District Judge for the Western District of
Kentucky, sitting by designation.

                                               1
         An EpiPen is a product that contains a dose of the drug epinephrine, which is used to

treat anaphylactic shock. Najib’s physician had prescribed the drug for him to use when he

suffered an acute asthma attack. On or about April 19, 1997, he suffered such an attack, but

when he opened the EpiPen, he discovered that it had prematurely ejected. He apparently

suffered no injury as a result of this attack. Shortly thereafter, on or about April 26, 1997, Najib

suffered another acute asthma attack and his fiancee, Julie Campbell, attempted to assist him by

unboxing a new EpiPen and removing it from its outer tube. However, Ms. Campbell was

unable to remove the gray safety cap, and while Najib was attempting to remove it, the Epipen

“fell apart” (Deposition of Julie Campbell, J.A. 598) and became unusable. As a result, Ms.

Campbell and Najib were unable to administer the shot and Najib lost consciousness while

waiting for an ambulance. (Id. at 603). Ms. Campbell was able to resuscitate him, and he was

taken to the emergency room for treatment. (Id. at 609-612). Dr. Kenneth Bain, a

neuropsychologist, opined that the second incident caused hypoxic brain damage. (Deposition of

Kenneth Bain, J.A. 526-528).

         Najib’s Complaint alleged the following: in Counts One and Two, negligence in design,

manufacture, and failure to warn; in Count Three, failure to conform to representation; in Count

Four, supplier liability; and in Count Five, breach of implied warranty of merchantability. (J.A.

15-22). Counts Two, Three and Four included violations of Ohio’s products liability statute.

(Id.).

         The district court granted summary judgment on all of Najib’s claims. In so doing, the

district court held that the testimony of Jack Raber, a pharmacist, was irrelevant. The district

court also held that the testimony of Najib’s expert, Dr. Reese, was inadmissible because it


                                                 2
would not help the trier of fact and further held that this failure to produce admissible expert

testimony was fatal to his claims.

                                  II. STANDARD OF REVIEW

          This court reviews de novo a district court’s award of summary judgment. Barrett v.

Harrington, 130 F.3d 246, 251 (6th Cir. 1997). Summary judgment is proper if the evidence

submitted shows that there is no genuine issue of material fact and that the moving party is

entitled to judgment as a matter of law. Celotex Corp. v. Catrett, 477 U.S. 317, 322-23 (1986).

This Court must view the entire record in the light most favorable to the non-moving party.

Smith v. Chrysler Corp., 155 F. 3d 799, 804 (6th Cir. 1998). This court reviews the district

court’s decisions to exclude the testimony of Dr. Reese and Mr. Raber for abuse of discretion.

See, e.g., General Electric Co. v. Joiner, 522 U.S. 136, 141, 118 S.Ct. 512, 517, 139 L.Ed.2d 508

(1997).

                                         III. ANALYSIS

          A. Admissibility of Dr. Reese’s testimony

          The district court’s Opinion and Order (J.A. 473) indicates that, although it found Dr.

Reese to be qualified to receive an expert designation, it did not find that his testimony would be

helpful to a jury in “determin[ing] whether and how the EpiPens were defective.” (J.A. at 480-

81). With regard to Najib’s claims of negligent design and manufacture, the district court listed

three ways in which a product’s design could be defective. One is where the product “is more

dangerous than an ordinary consumer would expect ... or ... the benefits of the challenged design

do not outweigh the risk inherent in such design.” (J.A. at 481, quoting City of Cincinnati v.

Beretta U.S.A. Corp., 768 N.E.2d 1136, 1146 (Ohio 2002)). A second is “where the


                                                   3
manufacturer fails to incorporate feasible safety features to prevent injuries.” (J.A. at 482, citing

Perkins v. Wilkinson Sword, Inc., 700 N.E.2d 1247 (Ohio 1998)). The third such situation

occurs when “a product ... differs in a material way from its design specifications or from

otherwise identical units.” (J.A. at 482, citing Kemp v. Medtronic, Inc., 1999 U.S. Dist. LEXIS

22470, at * 24 (S.D. Ohio 1999)).

       In light of these possibilities, the district court examined Dr. Reese’s testimony and

determined that it amounted to his “opinion ... that something malfunctioned, but he did not

know what.” (J.A. at 482-3). The district court noted that Dr. Reese “did not even review the

EpiPen’s design specifications or manufacturing procedures,” which it said “prevented him from

addressing whether and how the EpiPen differed in a material way from its design specifications

or from otherwise identical units.” (J.A. at 483). It also said that Dr. Reese’s testimony did not

address the first or third possible bases for a finding of negligence in design or manufacture

listed above. (Id.). As to the failure to warn, the district court said that because Dr. Reese was

“unable to identify the alleged defect,” Najib had “failed to prove that Defendants knew or

should have known about a defect” and granted summary judgment on that claim. (J.A. at 484).

Similarly, with respect to the claim of failure to provide usable instructions, the district court

said that “[b]ecause [Dr. Reese’s] report fails to detail how the instructions were unclear, his

conclusion [that they were inadequate] is irrelevant.” (Id.).

       Addressing the claim of a defect in manufacture or construction, the district court found

that Najib could not satisfy the first prong of the test set forth in the statute (which requires him

to establish by a preponderance of the evidence that there was a defect in the product) because

“[Dr.] Reese cannot state what the alleged defect was.” (J.A. at 485). The district court granted


                                                  4
summary judgment on that claim, as well as the claims for failure to conform to representations

and the breach of implied warranty of merchantability, on essentially the same grounds.

Examination of Dr. Reese’s report (J.A. 348) and deposition testimony (J.A. 762) indicates that

the district court correctly interpreted Dr. Reese’s testimony. Although Dr. Reese did discuss

possible alternate designs and alternate labeling/packaging possibilities in his report, such

discussion amounts essentially to speculation where the actual defect in a product is not

identified. Therefore, it appears that the district court did not abuse its discretion in excluding

Dr. Reese’s testimony.

       B. Sufficiency of Najib’s admissible evidence

       A separate issue, addressed although not so delineated by the parties, is whether, even

exclusive of Dr. Reese’s testimony, summary judgment on Najib’s claims was appropriate.

Najib argues that the circumstantial evidence of a defect in the case (i.e., the evidence that the

gray cap became stuck and the EpiPen fell apart) is sufficient to create an issue for the jury. In

response, Meridian argues only that “Plaintiff is not qualified to testify regarding the technical

aspects of the Epi-pen’s design or components, its manufacture ...” and that “Plaintiff’s

testimony by itself is insufficient, as a matter of law, to sustain his claim for design or

manufacturing defect.” (Defendant-Appellant’s Brief, at 15).

       A careful reading of the district court’s opinion indicates that it did not consider the

possibility that the circumstantial evidence could be sufficient to withstand the summary

judgment motion. As Plaintiff correctly asserts, Ohio law provides for this possibility. In State

Farm Fire & Cas. Co. v. Chrysler Corp., the Supreme Court of Ohio said that

       [w]here direct evidence [of a product defect] is unavailable, a defect in a
       manufactured product existing at the time the product left the manufacturer may

                                                  5
       be proven by circumstantial evidence where a preponderance of that evidence
       establishes that the loss was caused by a defect and not other possibilities,
       although not all other possibilities need be eliminated.

523 N.E.2d 489, 493-94, 37 Ohio St. 3d 1, 5 (Ohio 1988). In that case, which involved a fire of

unknown origin that broke out in the plaintiff’s vehicle while it was parked, the Supreme Court

of Ohio affirmed a directed verdict in favor of the car’s manufacturer because the circumstantial

evidence that did exist failed to rule out a number of causes (maintenance, etc.) and therefore

could not causally link the fire to a defect in the car’s manufacture. Id. at 495. In this case, the

destruction of the EpiPen as a result of its failure rendered direct evidence unavailable, meaning

circumstantial evidence may be used to establish that the EpiPen was defective. The district

court’s opinion, however, does not address this possibility. Rather, it examines only the expert

testimony offered by Plaintiffs and grants summary judgment on the basis of its exclusion of that

testimony. This is understandable in light of the fact that the arguments before the district judge

concerned primarily the admissibility of the expert testimony. However, Najib did raise the

circumstantial evidence argument. The district court said:

       ...the Court holds that [Dr. Reese’s] testimony and report will not help the trier of
       fact determine whether the EpiPen was negligently designed or manufactured.
       Accordingly, the Court grants the Defendants’ motion for summary judgment on
       these claims.

(J.A. at 483). The district court made similar statements in its analysis of several of Najib’s

other claims. (J.A. at 484, 485, 487).

       We believe, however, that the circumstantial evidence in Najib’s case is significantly

different from that presented in State Farm because he presented testimony that excludes other

possible causes for the EpiPen’s malfunction. He and his fiancee both testified that the EpiPen

in question was new, had not previously been removed from its box, and that they knew how to

                                                  6
remove the cap. Therefore, we believe that Najib’s case is more similar to the situation

described by the Ohio Court of Appeals in Hickey v. Otis Elevator Co. in which proof of

causation by circumstantial evidence was held to be appropriate for jury determination. 840

N.E.2d 637, 641-42, 163 Ohio App.3d 765, 770-71 (Ohio Ct. App. 2005). In that case, the Court

of Appeals distinguished between cases in which the issue of causation is complicated by virtue

of the nature of the product at issue (Hickey dealt with a malfunctioning elevator) and those in

which a jury could reasonably infer causation from the circumstantial evidence because the

product itself was relatively simple (citing Porter v. Gibson Greetings, Inc., 1997 WL 761851

(Ohio App. 2 Dist. 1997), which dealt with an ordinary balloon). Id. Therefore, we believe that

the district court’s opinion inappropriately granted summary judgment on the issue of defect

where an issue of material fact exists. We note that we express no opinion on the issue of

causation, as that issue is not before us at this time.

        We note, however, that, under Ohio law, the use of circumstantial evidence to prove the

element of defect is allowable in the context of products liability claims, but is insufficient to

prove negligence. Gast v. Sears Roebuck & Co., 313 N.E.2d 831, 39 Ohio St.2d 29 (Ohio 1974).

Therefore, as to Najib’s negligence claims, the district court’s grant of summary judgment for

failure to introduce evidence of breach was appropriate in light of its evidentiary rulings.

        C. Admissibility of Mr. Raber’s testimony

        Plaintiff offered the testimony of Jack Raber, a pharmacist. As to the admissibility of

Mr. Raber’s testimony, the district court’s opinion says:

        Plaintiff offers the deposition testimony of Raber, a pharmacist, to establish that
        the EpiPen could be used to treat asthma attacks. Thus, Raber did not testify to
        Plaintiff’s manufacturing or design defect claims, nor did his testimony address
        Plaintiff’s inadequate warning and instruction claims. Because the Court

                                                   7
       excluded [Dr. Reese’s] report and testimony above, Plaintiff is unable to establish
       that the EpiPen malfunctioned. Consequently, [Mr. Raber’s] testimony becomes
       irrelevant and the Court grants the Defendants’ motion for summary judgment for
       lack of evidence.

(J.A. 488). The district court based its evaluation of Mr. Raber’s testimony’s relevance on its

conclusion that Plaintiff had failed to survive summary judgment due to the shortcomings of Dr.

Reese’s testimony. However, as discussed in Section B, supra, the district court erroneously

failed to consider circumstantial evidence in making this determination. Therefore, the relevance

of Mr. Raber’s testimony may also need to be reconsidered in light of the district court’s

consideration of that evidence.

       D. Supplier-liability claim

       As noted above, count four of Najib’s complaint alleged supplier-liability against

Meridian. Under Ohio law, Meridian cannot be considered both the EpiPen’s manufacturer and

its supplier. Ohio’s products liability statute specifically provides, in its definition of “supplier,”

that the term “does not include ... a manufacturer.” Ohio Rev. Code Ann. § 2307.71(15)(b).

Therefore, the district court’s grant of summary judgment on this claim was proper.

                                       III. CONCLUSION

       For the foregoing reasons, we AFFIRM the district court’s order granting summary

judgment to the Defendants on Najib’s supplier-liability claim and negligence claims, and

REVERSE the grant of summary judgment on the issue of defect as to the remaining claims.

We therefore REMAND the case for further proceedings consistent with this opinion.




                                                   8
