In re TEMPOROMANDIBULAR JOINT (TMJ) IMPLANTS PRODUCTS
LIABILITY LITIGATION
TEMPOROMANDIBULAR JOINT (TMJ) IMPLANT RECIPIENTS, Aрpellants,
v.
THE DOW CHEMICAL COMPANY, Appellees.
No. 95-2886.
United States Court of Appeals,
Eighth Circuit.
Submitted June 14, 1996.
Decided May 16, 1997.
Robert J. LaRocca, Lancaster, PA, argued (Joseph C. Kohn, Douglas A. Abrahams, Philadelphia, PA, on the brief), for Appellants.
Michele Odorizzi, Chicago, IL, argued (Herbert L. Zarov, on the brief), for Appellee.
Before BOWMAN, JOHN R. GIBSON, and BEAM, Circuit Judges.
BOWMAN, Circuit Judge.
This is a products liability matter. Plaintiffs, who are the recipients of temporomandibular joint (TMJ) implants, prosthetic devices used to correct TMJ disorders, seek to impose liability upon The Dow Chemical Company (Dow Chemical) for injuries alleged to have been caused by the implants. The pretrial proceedings in these various personal injury actions were consolidated in the District of Minnesota by the Judicial Panel on Multidistrict Litigation pursuant to 28 U.S.C. § 1407 (1994). See In re Temporomandibular Joint (TMJ) Implants Prods. Liab. Litig.,
I.
The TMJ connects the upper and lower jaw. A TMJ implant is a device that is surgically inserted to replace an improperly functioning TMJ. Plaintiffs allege that their implants deteriorated after implantation, causing, inter alia, surrounding jaw bone disintegration, serious autoimmune responses, and severe head and neck pain.
Dow Corning Corporation (Dow Corning), together with its subsidiary, Dow Corning Wright, manufactured and sold TMJ implants containing silicone.2 Dow Chemical and Corning, Incorporated (Corning), each fifty percent owners of Dow Corning's stock, formed Dow Corning in 1943 to participate in the organosilicon compound industry. Plaintiffs do not allege that Dow Chemical ever manufactured, sold, or tested TMJ implants or supplied any component parts of or substances used in such implants. Instead, plaintiffs assert that Dow Chemical is liable because of its alleged involvement in the research, testing, and development of silicone used in the TMJ implants.
Since Dow Corning's inception, Dow Chemical has performed a number of services for Dow Corning. Among Dow Chemical's services were approximately a dozen limited toxicology tests performed on a variety of silicone compounds from 1943 through the early 1970s. None of the tests was conducted to determine whether the specific compound tested could be used safely as a medical implant.3
Three Dow Chemical scientists, including Dr. V.K. Rowe, published two articles, one in 1948 and one in 1950, describing toxicological research performed on various silicones (none of which are alleged to be present in any TMJ implant). The 1948 article concluded that silicones as a group have a very low order of toxicity. However, the article warned of dangers associated with certain silicone compounds. Specific harmful effects included irritation, inflammation, edema, and necrosis. The 1950 article concluded that no adverse effects were found in rats administered certain commercial silicones in their diets.
In 1967, Dr. Rowe attended a mеeting at Dow Corning discussing the toxicology of various Dow Corning products, including Silastic TM rubber dental liner and dental impression material. The concept of a permanent tooth implant was discussed. Before any long-term studies were to be carried out, preliminary studies on animals were to be performed. There is no indication that Dr. Rowe participated in this discussion or that TMJ implants ever were discussed.
Dow Corning established its own toxicology department within Dow Chemical's facilities in 1968, hiring a former Dow Chemical employee to head the department. In 1971, Dow Corning's toxicology laboratory moved into its own space in a Dow Corning building. Four years later, the two companies signed an agreement giving Dow Corning the use of various Dow Chemical trademarks and trade names. In return, Dow Chemical retained the right to inspect Dow Corning's products to protect the integrity of its trademarks and trade names.
Plaintiffs sued both Dow Chemical and Corning for damаges resulting from implant-related injuries. The District Court granted summary judgment in favor of both defendants in all of the consolidated cases, rejecting plaintiffs' theories of corporate control and direct liability. In re TMJ Implants Prods. Liab. Litig.,
In this appeal, plaintiffs argue that the District Court prematurely granted summary judgment. Plaintiffs' contentions primarily concern the relationship between this litigation and the consolidated breast implants litigation in Alabama. In re Silicone Gel Breast Implants Prods. Liab. Litig.,
II.
A transferee court in federal multidistrict proceedings has the authority to enter dispositive orders terminating cases consolidated under 28 U.S.C. § 1407 (1994). See Temporomandibular Joint (TMJ) Implant Recipients v. E.I. Du Pont De Nemours (In re Temporomandibular Joint (TMJ) Implants Prods. Liab. Litig.),
Federal law governs our review of whether the District Court prematurely granted summary judgment. See, e.g., Wallace v. Dorsey Trailers Southeast, Inc.,
III.
We first address plaintiffs' concerns about the timing of the summary judgment. These concerns center around Dow Chemical's use of In re Breast Implants. In 1993, the district court in In re Breast Implants granted an interlocutory summary judgment to Dow Chemical in a suit brought by the recipients of silicone gel breast implants.
The District Court issued its order in the present consolidated TMJ implants cases granting summary judgment to Dow Chemical on March 31, 1995, but final judgment was not entered at that time. See In re TMJ Implants,
Plaintiffs contend that the District Court abused its discretion in declining to vacate its order granting summary judgment in this case. Plaintiffs argue that before the court in In re Breast Implants vacated summary judgment, Dow Chemical asserted that the factual and legal issues surrounding Dow Chemical's summary judgment motion in this case were identical to those already adjudicated in its favor in the breast implants litigation. Plaintiffs further argue that after summary judgment in the breast implants litigation was vacated, Dow Chemical reversed direction, claiming that In re Breast Implants should not affect the TMJ litigation because breast implant silicone and TMJ implant silicone are different. Moreover, plaintiffs contend that because of Dow Chemical's reliance on the breast implants litigation, Dow Chemical was able to avoid discovery in the present case concerning its role in the research and development of silicone, and it avoided discovery on the differences, if any, that exist between breast implant silicone and TMJ implant silicone. Without this discovery, plaintiffs argue, the grant of summary judgment was premature.
A trial court's determination that a claim is ripe for summary judgment is reviewed for abuse of discretion. See, e.g., Humphreys v. Roche Biomedical Labs., Inc.,
In addressing plaintiffs' contentions that the timing of the grant of summary judgment was unfair, we note that plaintiffs mischaracterize Dow Chemical's position in the District Court and unduly minimize the role of the District Court. In referring to the breast implants litigation, Dow Chemical argued that the court should not discount the analysis in In re Breast Implants merely because that case involved breast implants and this case involved TMJ implants. Plaintiffs have turned this valid contention on its head, reworking Dow Chemical's argument to be that because this toо is a silicone implant case, the results must be the same. However, neither plaintiffs nor Dow Chemical elected to rely solely on the decision in In re Breast Implants; both parties marshalled evidence to support their positions regarding Dow Chemical's motion for summary judgment. Dow Chemical simply analogized the breast implants litigation to the TMJ implants litigation in support of its motion. This does not estop Dow Chemical from pointing out distinctions between the breast implants case and the present case.
Furthermore, the District Court did not rely on the opinion in In re Breast Implants as heavily as plaintiffs contend. The District Court expressly relied on reasoning in In re Breast Implants only when discussing the corporate control claims, see In re TMJ Implants,
Moreover, neither before nor after the Alabama district court's reversal of field in the breast implants litigation did plaintiffs make use of Federal Rule of Civil Procedure 56(f), which allows a party to request a delay in granting summary judgment until completion of further discovery. Not only did plaintiffs never file an affidavit pursuant to Rule 56(f),7 but also they never filed a motion for a continuance or to compel discovery.8 Because plaintiffs failed to take appropriate action to delay the entry of summary judgment and obtain additional discovery, the entry of summary judgment was not premature and did not constitute an abuse of the District Court's discretion. See Humphreys,
Finally, the only discovery plaintiffs explicitly sought before the District Court was to rule on Dow Chemical's motion for final judgment--FDA documents pertaining to Dow Corning's attempt to gain FDA approval for its TMJ implant--is irrelevant to the direct liability claims against Dow Chemical.9 In its May 25, 1995 letter to the District Court, plaintiffs asserted that the FDA documents would demonstrate that the silicone in TMJ implants is equivalent to that contained in previously-marketed silicone products. Even if this contention were correct, plaintiffs never have asserted that the documents would show any contacts between Dow Chemical and Dow Corning sufficient to justify finding Dow Chemical directly liable to plaintiffs; thus, based on plaintiffs own assertions, these documents would not raise a genuine issue of material fact to create a jury question on any of plaintiffs' claims, and the District Court did not abuse its discretion in granting summary judgment without waiting for discovery of these documents.10 See Anderson,
We conclude plaintiffs have failed to show that the District Court abused its discretion regarding the timing of its entry of summary judgment for Dow Chemical.
IV.
Plaintiffs argue that the record shows genuine issues of material fact with respect to several of their direct liability claims, and that summary judgment therefore should have been denied. This Court reviews de novo the decision to grant summary judgment. E.I. Du Pont,
Having reviewed carefully the parties' arguments and submissions, we conclude that no genuine issues of material fact exist as to any of plaintiffs' theories for holding Dow Chemical directly liable for plaintiffs' injuries.
A.
Plaintiffs assert that Dow Chemical is liable under section 324A of the Restatement (Second) of Torts for negligent performance of an undertaking. Section 324A provides:
One who undertakes, gratuitously or for consideration, to render services to another which he should recognize as necessary for the protection of a third person or his things, is subject to liability to the third person for physical harm resulting from his failure to exercise reasonable care to protect his undertaking, if
(a) his failure to exercise reasonable care increases the risk of such harm, or(b) he has undertaken to perform a duty owed by the other to the third person, or
(c) the harm is suffered because of reliance of the other or the third person upon the undertaking.
Restatement (Second) of Torts § 324A (1965). The District Court found that summary judgment should be granted on this claim because there is no evidence to show that Dow Chemical undertook to " 'render services to another' through its trademark agreements or through any other means." See In re TMJ Implants,
An actor's specific undertaking of the services allegedly performed without reasonable care is a threshold requirement to section 324A liability. See, e.g., Patentas v. United States,
The existence and nature of a legal duty are generally questions of law. See, e.g., Homer,
To establish liability under section 324A, plaintiffs must prove that Dow Chemical undertook a duty with respect to TMJ implants. Plaintiffs argue that Dow Chemical assumed such a duty by undertaking to render services to Dow Corning through its trademark agreements with Dow Corning and through its silicone research and testing performed for Dow Corning and that Dow Chemical should have recognized that these services were necessary for the protection of plaintiffs. Plaintiffs assert that the trademark agreements provided that Dow Chemical could examine the quality of Dow Corning's products as a condition for the use of Dow Chemical's trademarks and trade names. Also, plaintiffs contend that Dow Chemical performed substantial silicone research and testing, at Dow Corning's request, that Dow Corning did not and could not perform. Through these endeavors, plaintiffs argue, Dow Chemical undertook at least part of Dow Corning's duty to ensure the safety of Dow Corning's TMJ implants.
The record, however, contains no evidence to show that Dow Chemical undertook to render services to Dow Corning through its trademark agreements. A standard trademark agreement, in and of itself, does not establish an affirmative duty to inspect that could result in tort liability to third parties, see Mini Maid Servs. Co. v. Maid Brigade Sys., Inc.,
The silicone research allegedly performed by Dow Chemical at the request of Dow Corning also does not demonstrate an undertaking sufficient to impose liability on Dow Chemical under section 324A. For section 324A liability to attach, Dow Chemical must have specifically undertaken the task of ensuring the safety of Dow Corning's TMJ implants or of ensuring the safety of Dow Corning's entire array of silicone products. See Blessing,
Plaintiffs can point only to Dow Chemical's performance of approximately a dozen tests involving silicone (but not its use in medical implants) performed over four decades at the request of Dow Corning, a 1967 meeting attended by a Dow Chemical employee in which the idea of a tooth implant was discussed, a 1948 and a 1950 article published by three Dow Chemical scientists discussing toxicological research on various silicones,12 and a trademark agreement allowing Dow Chemical to inspect the quality of Dow Corning's products. However, these Dow Chemical actions and Dow Corning's purportedly inadequate laboratory facilities are insufficient to establish an undertaking of such breadth and magnitude as to create a duty on the part Dow Chemical to ensure the safety of all of Dow Corning's silicone products. See In re New York State Silicone Breast Implant Litig.,
Absent the threshold requirement of a specific undertaking of the services that form the basis for Dow Chemical's alleged duty under section 324A, plaintiffs' claim must fail, and we need not consider the remaining aspects of section 324A liability. The District Court did not err in granting summary judgment to Dow Chemical on plaintiffs' negligent undertaking claim.
B.
Plaintiffs also advance the theory that Dow Chemical is liable for aiding and abetting Dow Corning's tortious conduct under Restatement (Second) of Torts § 876(b) (1979). Secondary liability under section 876(b) attaches when one actor "knows that the other's conduct constitutes a breach of duty and gives substantial assistance or encouragement to the other so to conduct himself." Courts have recognized three basic requirements for aiding and abetting liability: (1) the primary actor must commit a wrongful act that causes an injury; (2) the aider and abettor must be generally aware of his role in the overall wrongful activity at the time assistance is provided; and (3) the aider and abettor must knowingly and substantially assist the wrongful act. See, e.g., Halberstam v. Welch,
In analyzing the present case under the standard outlined above, we assume, as the District Court did, that plaintiffs can establish a wrongful act on the part of Dow Corning. See In re TMJ Implants,
Applying the foregoing legal standards to this case, the second requirement of section 876(b) clearly is not satisfied. The record is silent as to Dow Chemical's general awareness of both the hazards associated with TMJ implants and its supposed role in assisting Dow Corning's tortious conduct at the times the alleged assistance was provided. Plaintiffs contend that the knowledge requirement is satisfied by the transfers of various employees between Dow Chemical and Dow Corning and by the sale of silicone products by Dow Chemical subsidiaries. However, there is no indication that any information regarding the dangers of TMJ implants or any silicone implants was ever disseminated to Dow Chemical. Thus, plaintiffs have not established a genuine issue of material fact regarding Dow Chemical's general awareness of the dangers of TMJ implants. Cf. Anguiano v. E.I. Du Pont de Nemours & Co.,
The third aiding and abetting requirement is also unsatisfied. The record does not indicate that Dow Chemical either knew of or substantially assisted Dow Corning's alleged tortious activity. See Ezzone v. Riccardi,
An analysis of the Restatement's substantial assistance factors supports this conclusion. First, we look at the nature of the act encouraged and analyze the import of Dow Chemical's aid. The record shows that Dow Corning designed, manufactured, and sold the TMJ implants on its own. Dow Corning was not "heavily dependent" on Dow Chemical in this endeavor. Cf. Halberstam,
Because there is no genuine issue of material fact to create a jury question on plaintiffs' aiding and abetting tortious conduct claim, plaintiffs' claim must fail. The District Court's grant of summary judgment on this claim must be sustained.
C.
Plaintiffs contend that Dow Chemical is liable for material misrepresentations and omissions concerning the safety of silicone. Plaintiffs assert two fraud-based claims: (1) fraudulent concealment, based upon Dow Chemical's alleged duty to plaintiffs to correct its prior representations concerning the safety of silicone after discovering that silicone presented a health risk; and (2) fraudulent misrepresentation, based upon Dow Chemical's representations concerning the appropriateness of silicone use in medical implants after learning of silicone's health risks.
A fraudulent concealment claim requires:
(1) Deliberate concealment by the defendant of a material past or present fact, or silence in the face of a duty to speak;
(2) That the defendant acted with scienter;
(3) An intent to induce plaintiff's reliance upon the concealment;
(4) Causation; and
(5) Damages resulting from the concealment.
Nicolet, Inc. v. Nutt,
Plaintiffs' fraudulеnt misrepresentation claim also must fail. A viable fraudulent misrepresentation claim requires showing that:
(1) [a] representation was made;
(2) the representation was false;
(3) when the representation was made, it was known to be false or made recklessly without knowledge of its truth and as a positive assertion;
(4) the representation was made with the intention that it would be relied upon;
(5) there was reliance upon the representation; and
(6) damage occurred as a result.
Citizens Nat'l Bank v. Kennedy and Coe,
Summary judgment was correctly granted on plaintiffs' fraud claims.
D.
Finally, plaintiffs allege that Dow Chemical conspired with Dow Corning to conceal and misrepresent the dangers of implanted silicone. To establish a civil conspiracy, plaintiffs must show five elements: (1) two or more persons; (2) an object to be accomplished; (3) a meeting of the minds on the object or course of action to be taken; (4) the commission of one or more unlawful overt acts; and (5) damages as the proximate result of the conspiracy. See, e.g., State ex rel. Mays v. Ridenhour,
Plaintiffs have not presented evidence sufficient to create a genuine issue of material fact on their civil conspiracy claim. As already detailed, there is no evidence that Dow Chemical knew what type of silicone was used in TMJ implants or the dangers associated with this silicone, much less that Dow Chemical agreed with Dow Corning to conceal the hazards of the silicone in TMJ implants. Similarly, plaintiffs offer only pure speculation, but no evidence, of a broader conspiracy encompassing all silicone products. See Anderson,
V.
The District Court's grant of summary judgment in favor of Dow Chemical is affirmed.
Notes
The Honorable Paul A. Magnuson, Chief Judge, United States District Court for the District of Minnesota
Because Dow Corning has filed a petition for reorganization under Chapter 11 of the Bankruptcy Code, it has not appeared in these proceedings. All nonbreast implant claims pending against Dow Corning have been transferred to the United States District Court for the Eastern District of Michigan, where Dow Corning filed its Chapter 11 petition. See Tort Claimants' Comm. v. Dow Corning Corp. (In re Dow Corning Corp.),
In fact, the only support found in the record for plaintiffs' assertion that Dow Chemical ever tested in any way any silicone compound actually used in any TMJ implant is a study published in 1972 by scientists at Dow Chemical. See Appellants' App. at 289-99. The study examined the effect of silicone injections on the reproductive systems of female rats and concluded that a number of the silicone compounds tested, including a low molecular weight silicone known as D4, were biologically active. Plaintiffs attempt to link D4 to silicone in TMJ implants by asserting that D4 serves as a basic building block in all silicone implants. However, even assuming the presence of D4 in TMJ implants, plaintiffs can point to no testing by Dow Chemical that could possibly form the basis for plaintiffs' tort claims. By publishing the study highlighting the dangers of D4, Dow Chemical obviously was not concealing the potential dangers of this compound, and absent evidence of further Dow Chemical studies concerning D4 or any other silicone compound allegedly contained in any TMJ implant, plaintiffs cannot establish an undertaking on the part of Dow Chemical to ensure the safety of any TMJ implant. Furthermore, plaintiffs have not shown that Dow Chemical knew that any of the specific silicone compounds tested would be contained in any TMJ implant, or any other medical implant for that matter
Plaintiffs do not appeal these corporate control rulings, and they asserted direct liability claims against only Dow Chemical; Corning thus is not a party to this appeal
The document depository was established by the court in the breast implants litigation for litigants in any federal or state case involving silicone implant product liability
After concluding that summary judgment was improper as to the negligent undertaking claim, the district court in In re Breast Implants found it unnecessary to address plaintiffs' other direct liability theories.
Plaintiffs' Reply Brief states that Dow Chemical's counsel indicated on August 18, 1994 that filing a Rule 56(f) affidavit was unnecessary. See Reply Br. at 5. Irrespective of this contention, in a September 2, 1994 letter to the District Court (a copy of which was sent tо plaintiffs' counsel), Dow Chemical unequivocally stressed its desire to have plaintiffs file a Rule 56(f) motion. See Reply App. at 8. Plaintiffs also contend that they did not know that discovery on the type of silicone contained in TMJ implants was necessary until Dow Chemical made this an issue in attempting to distinguish In re Breast Implants, well after the court's September 30, 1994 deadline for filing Rule 56(f) affidavits. However, as noted in the opening line of plaintiffs' brief, "This case concerns the role of Dow Chemical ... in the design and testing of the silicone used in [TMJ] implants." Appellants' Br. at 1. There being thousands of different silicone compounds, each with varying characteristics, plaintiffs should have known early in this litigation that it would be necessary to specifically identify the type of silicone in TMJ implants and to tie that type of silicone to testing performed by Dow Chemical and not simply rest on the notion that silicone is silicone
In a May 25, 1995 letter, plaintiffs asked the District Court to wait on issuing a final ruling until plaintiffs' counsel had obtained certain Food and Drug Administration (FDA) documents. Appellants' App. at 897. While United States v. Birchem,
While assertions in plaintiffs' May 25, 1995 letter concerning the existence of these FDA documents and their purported contents are relevant as to whether summary judgment was prematurely granted, the documents themselves were never before the District Court. As a result, plaintiffs' January 3, 1996 motion to supplement the record on appeal with these FDA documents and a Silastic TM Mammary Prosthesis informational brochure is denied, and these items will not be considered in addressing the merits of Dow Chemical's summary judgment motion. See Barry v. Barry,
Plaintiffs' February 12, 1996 motion to supplement the record on appeal with correspondence between the parties to this case and the District Court is granted. See United States v. Wilson,
Because the discovery sought in plaintiffs' May 25, 1995 letter did not demonstrate how postponement of the summary judgment ruling would enable plaintiffs to avoid summary judgment, the letter could not serve as the functional equivalent of a Rule 56(f) affidavit. See Humphreys,
We are aware of California Rules of Court 976(d) and 977(a), which limit the citation of opinions superseded by a grant of review by the California Supreme Court. However, because these rules are not binding on this Court, we cite to Artiglio but note its status in the California courts
Plaintiffs contend that the 1948 article spawned the medical implant industry through its assertion that silicones are inert. The article, however, did not make such a broad assertion. The article concluded that "silicones ... as a class are very low in toxicity," Appellants' App. at 428 (emphasis added), but specifically mentioned dangers associated with some of the silicones tested, Appellants' App. at 421-23. To find an undertaking based on this 1948 article would stretch the parameters of section 324A to impermissible bounds. Scientists engaged in preliminary research would be required to forever update their research, familiarize themselves with all the subsequent and previously inconceivable applications of their research, or face tort liability (here, almost fifty years after completion of the research). See Artiglio,
