Skotak v. Tenneco Resins, Inc.

The widow and children of George Sko-tak (the Skotaks), appeal the summary judgment awarded Tenneco Resins, Inc. (TRI). Because the Skotaks did not produce sufficient evidence to create a genuine issue of material fact concerning the adequacy of the warning in issue, the judgment is AFFIRMED.

I.

George Skotak died as a result of liver cancer in 1986. The Skotaks sued TRI in district court under theories of strict liability, negligence, and breach of an implied warranty, alleging that the cancer was caused by Thorotrast, a drug manufactured between 1943 and 1953 by TRI’s predecessor, Heyden Chemical Corporation, and used as a contrast medium in radiology; that Mr. Skotak underwent surgery in 1947 to have a blood vessel removed from his neck; that Dr. Albert D’Errico performed the operations; and that he either administered the Thorotrast, or ordered it to be administered. Dr. D’Errico died before this action was filed.

TRI moved for summary judgment, including on the grounds that: (1) the Sko-taks could not prove the essential elements of their strict liability and negligence claims; and (2) as a matter of law, TRI was not liable as the corporate successor to Heyden. TRI claimed, among other things, that the Skotaks could not establish: (1) that Mr. Skotak received an injection of Thorotrast during the period 1943 to 1953, when it was manufactured by Hey-den; or (2) that the warning given by Hey-den was not adequate.

In response, the Skotaks submitted a brief (included in the record) and the following evidentiary materials: (1) affidavits by Mr. Skotak’s sister and cousin, which stated that Dr. D’Errico performed surgery on Mr. Skotak in either 1946 or 1948 at Baylor Hospital; (2) some of Mr. Skotak’s medical records, from another facility, prepared prior to the surgery; (3) excerpts from the deposition of Dr. Block, Mr. Sko-tak’s subsequent physician, in which he testified that a 1958 x-ray report showed the presence of Thorotrast in Mr. Skotak’s body; (4) excerpts from the deposition of plaintiff Mary Skotak, who married Mr. Skotak in 1953, in which she testified both (a) that Mr. Skotak told her that he received Thorotrast in 1947 and (b) that Dr. Groman, who treated Mr. Skotak at the time of his death, told her, based upon reading medical articles, that Thorotrast caused cancer; and (5) TRI’s answers to interrogatories in this ease and an earlier case, concerning the warnings that accompanied Thorotrast.

The district court held that TRI was not liable as the corporate successor of Hey-den, because TRI had not expressly assumed liability for injuries caused by Tho-rotrast. The district court also held:

Assuming, arguendo, that Tenneco assumed the liabilities of its predecessor, the Skotaks’ case fails under the “learned intermediary” doctrine. Under that doctrine, a manufacturer discharges its duty to warn by adequately warning the prescribing physician. Koonce v. Quaker Safety Products & Manufacturing Company, 798 F.2d 700, 717 (5th Cir.1986); Alm v. Aluminum Company of America, 717 S.W.2d 588, 591-92 (Tex.1986). A plaintiff must prove that an inadequate warning was given and that the inadequate warning was the cause of the injury. That is, it must be shown that an adequate warning would have caused the physician to act differently. See Stanback v. Parke, Davis and Company, 657 F.2d 642, 645 (4th Cir.1981) (Virginia law); Dunn v. Cederle Laboratories, [121 Mich.App. 73] 328 N.W.2d 576, 582 (Mich.App.1982).

The Skotaks cannot meet their burden on this issue. They have not identified with any certainty the doctor who administered Thorotrast to Mr. Skotak. The one physician who they have identified is deceased. There is no one who can testify as to the identity of the physician, whether any warning was received by him, whether such a warning was adequate, and whether an adequate warning would have changed the actions of the physician. The Skotaks have the burden of proving inadequacy of warning and cause of the injury. Since they have produced no evidence in this regard, summary judgment must be granted on the theory of inadequate warnings.

The Skotaks timely appealed.

II.

On appeal, the Skotaks contend that there are genuine issues of material fact, including with respect to (1) the adequacy of the warning; and (2) TRI’s liability as the successor to Heyden. It is not necessary *o address either successor liability or causation; the judgment is affirmed solely on the Skotaks’ failure to show a genuine issue of material fact concerning the adequacy of the warning.

Summary judgment is proper “if the pleadings, depositions, answers to interrogatories, and admissions on file, together with the affidavits, if any, show that there is no genuine issue as to any material fact and that the moving party is entitled to a judgment as a matter of law.” Fed. R.Civ.P. 56(c). A “dispute about a material fact is ‘genuine’ ... if the evidence is such that a reasonable jury could return a verdict for the nonmoving party.” Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 248, 106 S.Ct. 2505, 2510, 91 L.Ed.2d 202 (1986). In reviewing a summary judgment, this court applies, de novo, the same test employed by the district court. Netto v. Amtrak, 863 F.2d 1210, 1212 (5th Cir.1989). And, contrary to the position urged by TRI, the district court’s determination of state law is likewise reviewed de novo. Salve Regina College v. Russell, — U.S. -, 111 S.Ct. 1217, 1221, 113 L.Ed.2d 190 (1991).

In this diversity case, Texas law, of course, applies to the Skotaks’ negligence and strict liability claims. For cases involving a drug manufacturer’s duty to warn, Texas courts apply the “learned intermediary” doctrine. See Alm v. Aluminum Co. of America, 717 S.W.2d 588, 591-92 (Tex.1986). Under that doctrine, that duty is satisfied by warning the physician of the dangers of the drug. Id. at 591. “[Ojnce the physician is warned, the choice of which drugs to use and the duty to explain the risks become that of the physician.” Stewart v. Janssen Pharmaceutica, Inc., 780 S.W.2d 910, 911 (Tex.Ct.App. — El Paso 1989, writ denied). Therefore, in order to prevail under Texas law on their negligence and strict liability claims, the Skotaks had the burden of proving, among other things, that the warning accompanying Thorotrast was (1) inadequate; and (2) a “producing cause” of Mr. Skotak’s death. Stewart, 780 S.W.2d at 911 (citing Technical Chemical Co. v. Jacobs, 480 S.W.2d 602 (Tex.1972)).

A.

In order to satisfy its initial burden under Rule 56(c), TRI bore “the initial responsibility of informing the district court of the basis for its motion, and identifying those portions of ‘the pleadings, depositions, answers to interrogatories, and admissions on file, together with the affidavits, if any,’ which it believe[d] demonstrate[d] the absence of a genuine issue of material fact.” Celotex Corp. v. Catrett, 477 U.S. 317, 323, 106 S.Ct. 2548, 2553, 91 L.Ed.2d 265 (1986); see also Russ v. International Paper Co.,. 943 F.2d 589, 592 (5th Cir.1991). Because the Skotaks bore the burden of proof at trial on the issues of adequacy of the warning and causation, TRI was not required to “produce evidence negating the existence of a material fact”; rather, TRI’s burden was “only [to] point out the absence of evidence supporting the nonmoving party’s case.” Latimer v. Smithkline & French Laboratories, 919 F.2d 301, 303 (5th Cir.1990).

TRI satisfied its burden. In its motion, it pointed out that the record contained no evidence on whether the Thorotrast administered to Mr. Skotak was accompanied by a warning and, if so, whether the warning would have added to the administering physician’s knowledge of the risks of using Thorotrast. TRI also pointed to the absence of evidence in the record regarding, among other things: when and where the Thorotrast administration occurred; the identity of the prescribing physician; and whether Mr. Skotak would have received Thorotrast even if the physician had full knowledge of the risks.

TRI failed, in its motion, to identify two articles from medical journals which were in the record as exhibits to the Skotaks’ opposition to TRI’s motion to dismiss for lack of personal jurisdiction, filed more than a year before TRI filed its summary judgment motion. The articles were presented then by the Skotaks in support of their description of the “background” of their lawsuit; they were not relevant to the issues raised in TRI’s motion to dismiss for lack of personal jurisdiction. Prior to TRI’s moving for summary judgment, the Skotaks never suggested that the articles were relevant to the issues of warning and causation. (In fact, as discussed infra, the Skotaks did not assert until their reply brief in this court that the articles create a genuine issue of material fact regarding inadequate warnings.) Therefore, the fact that TRI failed to identify those articles in its summary judgment motion does not establish a failure by TRI to meet its initial burden under Rule 56(c).

As is well established, “[w]hen a motion for summary judgment demonstrates the absence of evidence as to a material fact on which the nonmovant will bear the burden of proof at trial, the nonmovant must come forward with evidence which would be sufficient to enable it to survive a motion for directed verdict at trial.” Transco Leasing Corp. v. United States, 896 F.2d 1435, 1444 (5th Cir.1990). “The test is identical to that used for a directed verdict: ‘whether the evidence presents a sufficient disagreement to require submission to a jury or whether it is so one-sided that one party must prevail as a matter of law.’ ” Chiari v. City of League City, 920 F.2d 311, 314-15 (5th Cir.1991) (quoting Anderson, 477 U.S. at 251-52, 106 S.Ct. at 2512).

1.

The evidentiary materials submitted by the Skotaks in response to TRI’s summary judgment motion were insufficient to demonstrate the existence of a genuine issue of material fact. For example, no contemporaneous medical records were introduced to establish who administered the Thorotrast to Mr. Skotak, or when, or even whether it was administered in the late 1940s. Moreover, the Skotaks did not introduce expert witness affidavits or deposition testimony concerning the adequacy of the warning, even though they designated expert witnesses before responding to the motion and provided a supplemental designation, following their response.

Concerning the warning, the Skotaks attempted to demonstrate a genuine issue of material fact, by introducing a certified copy of a 1975 TRI response to an interrogatory in a similar case involving Thoro-trast. In that response, TRI stated:

Although the records indicate that Heyden did not regard Thorotrast as having harmful side effects, the records do indicate that one of two versions of the warning set forth below accompanied each box or package of Thorotrast.

[ 1 ]

The clinical evidence to date indicates that THOROTRAST is a valuable contribution to roentgenography, and that no harmful effects may be expected following its use.

We wish, however, to point out that the question as to the elimination of THOROTRAST from the body, following intravenous injection and subsequent storage in the reticulo-endothelial system, is still under investigation; and no definite and reliable evidence that could be accepted as conclusive has been published.

Therefore, in accordance with our established conservative policy, we recommend to the profession further study on the ultimate fate of the intravenously injected THOROTRAST before such injection is accepted as routine practice in the X-ray visualization of the liver and spleen, etc.

[ 2 ]

Clinical evidence indicates that THO-ROTRAST is a valuable contribution to roentgenography, particularly in arter-iography and hepatosplenography.

It should be pointed out, however, that the elimination of THOROTRAST from the body, following intravenous injection and subsequent storage in the reticuloendothelial system, is still under investigation. No definite reliable evidence that may be accepted as conclusive has been published.

Therefore, it is recommended that the medical profession should conduct further studies on the ultimate fate of the intravenously injected THORO-TRAST before its use is accepted as routine practice in the X-ray visualization of the arteries, liver, and spleen.

The [first] insert ... may have been an earlier version of the [second] one.... Additional information as to possible side effects may have been set forth in various articles appearing from time to time in medical journals. The records indicate that these articles or a bibliography of such articles were supplied to doctors and medical institutions who made inquiries of Heyden or otherwise expressed an interest in Thorotrast. The records also indicate that at least one x-ray supply company, General Electric X-Ray Corporation, carried Thorotrast as part of their x-ray supplies and in that cat-alogue (copyrighted 1935) stated:

“At the present time there is some controversy regarding the radioactivity of this material when used intravenously.”

The 1975 interrogatory response, without more, is insufficient to demonstrate the requisite fact issue. For example, the Sko-taks contend that a disputed fact is created by the statement in the first of the two warnings that “no harmful effects may be expected following [Thorotrast’s] use.” But, there is no evidence as to which of the two warnings accompanied the Thorotrast that Mr. Skotak allegedly received in the ' late 1940s. Moreover, the Skotaks failed totally to present any proof that the above warnings were inadequate.

2.

The Skotaks contend that other evidence before the district court on the summary judgment motion showed that Thorotrast injections are associated with a significant increase in liver cancer, and that the American Medical Association’s Council on Pharmacy and Chemistry disapproved of the use of Thorotrast as early as 1932. That evidence consists of the earlier discussed medical journal articles attached to the Skotaks’ earlier, separate, response to TRI’s motion to dismiss for lack of personal jurisdiction. That response was filed more than a year before TRI filed its summary judgment motion. Although these articles are part of the total record, the Skotaks never referred to them in their response in district court to TRI’s motion for summary judgment, nor did they argue in district court in their summary judgment response brief that such evidence created a genuine issue of fact concerning the adequacy of the warning. As stated, under Rule 56(e), the Skotaks were required to “set forth specific facts showing that there is a genuine issue for trial.” Fed.R.Civ.P. 56(e).

The nonmoving party cannot discharge that burden by referring to the “mere allegations or denials” of the nonmoving party’s pleadings; rather, that party must, either by submitting opposing evi-dentiary documents or by referring to evidentiary documents already in the record, set out specific facts showing that a genuine issue exists.

Lavespere v. Niagara Mach. & Tool Works, Inc., 910 F.2d 167, 178 (5th Cir.1990) (emphasis added). See, e.g., Dorsett v. Board of Trustees for State Colleges & Universities, 940 F.2d 121, 123 (5th Cir.1991) (“an opposing party cannot establish a genuine issue of material fact by resting on the mere allegations of his pleadings”). Because the Skotaks failed to refer to these articles in district court in their summary judgment response, the articles were not properly before that court in deciding whether to grant the motion; therefore, they will not be considered here. Although on summary judgment the record is reviewed de novo, this court, for obvious reasons, will not consider evidence or arguments that were not presented to the district court for its consideration in ruling on the motion. See Nissho-Iwai American Corp. v. Kline, 845 F.2d 1300, 1307 (5th Cir.1988) (where nonmovant “failed to designate, or in any way refer to, the deposition as the source of factual support for her response to [the] motion [for summary judgment,] the deposition was never made part of the competent summary judgment record before the court”). See also Colony Creek, Ltd. v. Resolution Trust Corp., 941 F.2d 1323, 1326 (5th Cir.1991) (quoting John v. Louisiana, 757 F.2d 698, 710 (5th Cir.1985)) (The party opposing summary judgment “cannot attack summary judgment on appeal by raising distinct issues that were not before the district court”); Fields v. City of South Houston, 922 F.2d 1183, 1188 (5th Cir.1991) (quoting John v. Louisiana, 757 F.2d at 710) (“[Materials not presented to the district court for consideration of a motion for summary judgment are never properly before the reviewing court.”); Frank C. Bailey Enterprises, Inc. v. Cargill, Inc., 582 F.2d 333, 334 (5th Cir.1978) (in reviewing a summary judgment, we “can only consider those matters presented to the district court”).

As stated, because the Skotaks failed, in district court, to designate, or to, in any way, refer to the medical journal articles relied upon by them for the first time on appeal, those articles never became “part of the competent summary judgment record before the court.” Nissho-Iwai, 845 F.2d at 1307. Nissho-Iwai’s use of the term “competent summary judgment record” is particularly appropriate here; this rule is consistent with, for example, our rule that in reviewing summary judgments, we will not reverse an evidentiary ruling made by the district court, unless it was manifestly erroneous, even though we are making a de novo review of the record, as noted in our recent en banc decision in Christophersen v. Allied-Signal Corp., 939 F.2d 1106 (5th Cir.1991):

This is an appeal from a grant of summary judgment. Although we review grants of summary judgment de novo, that is, under the same Rule 56 standards as are used by the district court, in Rule 56 proceedings we still apply the manifest-error standard of review to the trial court’s evidentiary rulings. Thus an appeal of a summary judgment presenting evidentiary issues raises two levels of inquiry. At the first level, we review the trial court’s evidentiary rulings, which define the summary judgment record, and we give these rulings their due deference. At the second level, with the record defined, we review the trial court’s summary judgment decision de novo. When the contested evidence is essential to the cause of action and the trial court has excluded the evidence, we may decide the appeal at the first level solely on the basis of the soundness of the evidentiary ruling. For if we uphold the exclusion of essential evidence, the second-level inquiry becomes academic.

939 F.2d at 1109 (emphasis added; citations omitted).

Finally, the Skotaks did not refer to these articles in their opening brief on appeal; as noted, the first mention was in their reply brief. “In the absence of manifest injustice, this court will not consider arguments belatedly raised after appellees have filed their brief.” Najarro v. First Federal Savings & Loan Ass’n, 918 F.2d 513, 516 (5th Cir.1990).

B.

III.

Proof of an inadequate warning was an essential element of the Skotaks’ case. Because they failed to designate specific facts showing that there was a genuine issue for trial with respect to that element, TRI was entitled to summary judgment. Accordingly, the judgment of the district court is

AFFIRMED.

. TRI also moved for summary judgment on the Skotaks’ claim for breach of implied warranty, and the district court held that the limitations period had run on that claim. The Skotaks do not appeal that ruling.

. TRI cross-appealed from the denial of its motion to dismiss for lack of personal jurisdiction. At oral argument, however, TRI’s counsel stated that, in the event this court affirmed the summary judgment, TRI would waive its objection to personal jurisdiction with respect to this case. Accordingly, it is not necessary to address it.

. Because causation is not addressed, it is not necessary to reach the subissue of whether, even if the warning was inadequate, the Skotaks were still required to prove that a different warning would have caused the physician to act differently, as held by the district court.

. Salve Regina College overrules this court's pri- or practice of "customarily deferring to the district judge in a diversity case involving interpretation of the law of the state in which the judge sits.” USX Corp. v. Tanenbaum, 868 F.2d 1455, 1457 (5th Cir.1989). See Allison v. ITE Imperial Corp., 928 F.2d 137, 139 (5th Cir.1991).

.Accordingly, the Skotaks’ negligence claims, such as the alleged failure to adequately test Thorotrast, are subsumed within this two-part standard. The district court held to this effect, by holding that the Skotaks were required to "prove that an inadequate warning was given and that the inadequate warning was the cause of the injury." The Skotaks do not argue otherwise, nor do they assert here an independent, or separate, negligence claim. See, e.g., Crocker v. Winthrop Laboratories, Div. of Sterling Drug, Inc., 514 S.W.2d 429, 432-33 (Tex.1974); Restatement (Second) of Torts, § 402A, comment k (1965).

. To assist in meeting their burden of proof, the Skotaks argue that TRTs response in this case to a similar interrogatory is inconsistent with the 1975 response. As TRI pointed out, however, its 1975 response was based upon information from Heyden’s records. Its response to the interrogatory in this case was based on its own actions; because TRI never manufactured Tho-rotrast, it never gave any warnings regarding it. Therefore, there is no inconsistency. In any event, if the Skotaks were dissatisfied with the answer filed in this case, they should have moved to compel a supplemental answer; they did not do so.

. The district court was not prohibited from considering the articles. However, Rule 56 does not impose upon the district court a duty to sift through the record in search of evidence to support a party’s opposition to summary judgment, especially where, as here, the nonmoving party is well aware of the existence of such evidence. Rule 56 allocates that duty to the opponent of the motion, who is required to point out the evidence, albeit evidence that is already in the record, that creates an issue of fact. See Nissho-Iwai American Corp. v. Kline, 845 F.2d 1300, 1307 (5th Cir.1988) (it is not necessary "that the entire record in the case must be searched and found bereft of a genuine issue of material fact before summary judgment may be properly entered”).

. In a 1979 case, this court held that evidence in the record must be considered by the reviewing court, even if not specifically brought to the attention of the district court. Higgenbotham v. Ochsner Foundation Hospital, 607 F.2d 653, 656-57 (5th Cir.1979). However, in Impossible Electronic Techniques, Inc. v. Wackenhut Protective Systems, Inc., 669 F.2d 1026 (5th Cir.1982), the court held that, "[a]bsent extraordinary circumstances, we should not reverse a grant of summary judgment based on the presence of a factual issue that was not in some way brought to the attention of the district court.” 669 F.2d at 1033 n. 7. In Nicholas Acoustics & Specialty Co. v. H & M Construction Co., 695 F.2d 839 (5th Cir.1983) and John v. Louisiana, 757 F.2d 698, 712-13, the court noted, but did not resolve, a possible conflict between Higgenbotham and Impossible Electronic. In the light of the Supreme Court’s 1986 summary judgment trilogy (Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 106 S.Ct. 2505, 91 L.Ed.2d 202 (1986); Celotex Corp. v. Catrett, 477 U.S. 317, 106 S.Ct. 2548, 91 L.Ed.2d 265 (1986); and Matsushita Elec. Indus. Co., Ltd. v. Zenith Radio Corp., 475 U.S. 574, 106 S.Ct. 1348, 89 L.Ed.2d 538 (1986)), Nissho-Iwai, Lavespere, and Fields reflect the current rule in this Circuit. Therefore, it is unnecessary to attempt to reconcile any conflict, if one exists, among those pre-trilogy cases.

Paragraph II.B. of original opinion is withdrawn.