Attorney Jim Love explains
how the amalgam MSDS applies to
mixed amalgam in the Barnes V Kerr ruling.
The District Court dismissed Dr. Barnes's claims on the ground that Kerr's warnings were adequate as a matter of law. The Sixth Circuit Court of Appeals affirmed the lower court ruling, finding that "Kerr's warnings [did not state] that mercury would be any less toxic when mixed with the other constituents of dental amalgam."
Ideally, the ostensible adequacy of Kerr's warnings should protect dental patients from any health risks posed by dental amalgam. The "learned intermediary" doctrine requires dentists to communicate manufacturer warnings to patients who are treated with dental amalgam. As learned intermediaries, dentists are expected -- indeed required-- to pass along manufacturers' warnings.
See e.g., McNeil v. Wyeth American Home Products Corp., Slip Copy, 2005 WL 544222 (N.D. Tex. 2005) ("It is reasonable for the manufacturer to rely on a physician to pass on its warnings to the ultimate consumer....")
See also, McKee v. Moore, 648 P.2d 21 (Okla. 1982). ("The manufacturer's duty to warn the ultimate consumer of prescription drugs, or devices, as distinguished from those sold directly to the consumer, is limited to advising the prescribing or treating physician of the drug's or device's potential dangers in the absence of contrary FDA regulations. Once the physician is warned, the choice of treatment and the duty to explain the risk is incumbent on the physician.")
Koury v. Follo, 272 N.C. 366, 158 S.E.2d 548 (1968). ("A manufacturer's label] is evidence of a warning which the physician disregards at his peril, and his disregard of it is relevant upon the issue of his use of reasonable care....")
Unfortunately, dentists are prohibited by their state dental boards from passing along manufacturer warnings to their patients. In response to a recent request for a declaratory ruling, the North Carolina Dental Board determined that North Carolina dentists were not free to communicate manufacturer warnings to their dental patients. Indeed, they are required to contradict the warnings by informing their patients that FDA and ADA have approved the use of dental amalgam in non-allergic patients. Failing to abide by the Board's prohibitions may result in disciplinary action.
Obviously, the FDA position on amalgam has contributed to a bizarre set of circumstances in which a manufacturer, through its warnings, can escape liability for injuries caused by dental amalgam while those warnings are suppressed, or at best, substantially diluted by the mandates of the various dental boards. In this Alice in Wonderland scenario, the losers are all the dental patients of this country. While the FDA cannot mandate "informed consent", proof of safety should be and has not been required by the FDA.
Dr. David E. BARNES, Plaintiff-Appellant/Cross-Appellee,
THE KERR CORPORATION, Defendant-Appellee/Cross-Appellant.
No. 04-5546. No. 04-5663.
United States Court of Appeals, Sixth Circuit.
Argued: July 20, 2005.
Decided and Filed: August 11, 2005.
ARGUED: James M. Love, Gassaway & Love, Tulsa, Oklahoma, for Appellant. Michael Zaleski, Quarles & Brady, Madison, Wisconsin, for Appellee. ON BRIEF: James M. Love, Gassaway & Love, Tulsa, Oklahoma, Robert E. Reeves, Law Offices of Robert E. Reeves, Lexington, Kentucky, for Appellant. Michael Zaleski, Quarles & Brady, Madison, Wisconsin, David B. Bartel, Patrick S. Nolan, Quarles & Brady, Milwaukee, Wisconsin, J. Stanley Rogers, Rogers & Duncan, Manchester, Tennessee, for Appellee.
Before: CLAY, GILMAN, and COOK, Circuit Judges.
GILMAN, Circuit Judge.
- This is a products liability case brought by David E. Barnes, a practicing dentist, against the Kerr Corporation, a provider of dental amalgams (commonly known as "silver fillings") that contain mercury, copper, tin, and silver. Barnes claims that, during a 13-year period ending in June or July of 1999, he and his staff were exposed to toxic mercury vapors when removing old fillings and inserting new ones, and that Kerr's amalgams are the major source of his alleged mercury poisoning.
- In July of 1999, Barnes brought an action against Kerr for negligence, the manufacture and sale of a defectively designed product, the failure to warn, intentional concealment, the failure to disclose a known defective condition, and breach of implied warranty. This action, which was initially brought in a Tennessee trial court, was removed to federal court by Kerr on the basis of diversity of citizenship. Despite holding that the expert testimony offered by Barnes was admissible, the district court granted summary judgment to Kerr, concluding that Barnes had not established that Kerr was responsible for the vast majority of his exposure to mercury and that, in any event, the numerous warnings provided by Kerr were adequate as a matter of law. For the reasons set forth below, we AFFIRM the judgment of the district court.
A. Factual background
3. Barnes's alleged exposure to mercury
B. Procedural background
A. Standard of review
Neither party disputes that Tennessee law is controlling in the present case. Under Tennessee law, "no negligence claim can succeed unless the plaintiff can first prove that the defendant's conduct was the cause in fact of the plaintiff's loss." Waste Mgmt., Inc. of Tenn. v. S. Cent. Bell Tel. Co., 15 S.W.3d 425, 430 (Tenn.Ct.App.1997); see also Lindsey v. Miami Dev. Corp., 689 S.W.2d 856, 861-62 (Tenn.1985) (concluding that, although the plaintiff "is not . . . required to prove the case beyond a reasonable doubt, [he must] . . . introduce evidence from which reasonable persons may conclude that it is more probable that the event was caused by the defendant than that it was not") (citation and quotation marks omitted);Shouse v. Otis, 224 Tenn. 1, 448 S.W.2d 673, 676 (1969) (holding that, for a defendant to be held liable, its "omission must be such that[,] had it not happened[,] the injury would not have been inflicted").
Barnes claims in his brief that, even if the alleged harm from his exposure to mercury was not due entirely to Kerr products, Kerr "is jointly and severally liable for Dr. Barnes's injuries." A plaintiff whose injuries have multiple causes, however, can recover against a defendant only where the defendant's conduct was "a `substantial factor' in bringing about the harm being complained of." McClenahan v. Cooley, 806 S.W.2d 767, 775 (Tenn.1991). Although the doctrine of joint and several liability was once applicable in Tennessee, see Velsicol Chem. Corp. v. Rowe, 543 S.W.2d 337, 343 (Tenn.1976) (applying joint and several liability where "an indivisible injury has been caused by the concurrent, but independent, wrongful acts or omissions of two or more wrongdoers"), the rule has since been rejected in all but a few circumstances. See McIntyre v. Balentine, 833 S.W.2d 52, 58 (Tenn.1992) (adopting the doctrine of comparative negligence, and stating that "today's holding renders the doctrine of joint and several liability obsolete," because "[h]aving . . . adopted a rule more closely linking liability and fault, it would be inconsistent to simultaneously retain a rule, joint and several liability, which may fortuitously impose a degree of liability that is out of all proportion to fault").
The doctrine of comparative negligence, in turn, is relevant to the present case only insofar as Barnes has shown that Kerr's conduct was "a substantial factor" in causing Barnes's alleged mercury poisoning. McClenahan, 806 S.W.2d at 775. For this reason, the district court correctly held that, in order to survive summary judgment, "[i]t is essential that Dr. Barnes prove . . . that the product manufactured and sold by Kerr or the warnings provided by Kerr proximately caused the injuries [Barnes] alleges to have sustained."
Barnes points out that Kerr's website "admit[ted] that it has 46% of the national market share" in dental amalgam production. The Tennessee Supreme Court, however, has not yet adopted the doctrine of market-share liability. See Phillips v. R.J. Reynolds Indus., Inc., 769 S.W.2d 488, 489 (Tenn.Ct.App.1988) (affirming the trial court's grant of summary judgment against a plaintiff who pursued "industry wide/market share liability" in suing a tobacco company, but not discussing in detail whether market-share liability is a valid basis for recovery in Tennessee). Nor have we found a case analogous to the present one in which the theory has been applied in Tennessee, and the theory is not mentioned in Tennessee's Products Liability Act. See Tenn.Code Ann. § 29-28-101 to 108 (defining and limiting products liability actions in Tennessee courts, but not discussing market-share liability).
Moreover, even if market-share liability were a valid basis for recovery in Tennessee, Barnes failed to provide any proof as to the percentage of the market that Kerr controlled between 1986 and 1999. Beyond pointing out that Kerr's website claimed — in 2003 — to have a 46% market share, and alluding to this fact in a footnote on page 48 of his second brief, Barnes has presented no argument, and no evidence, to support a theory of market-share liability.
According to Barnes's own expert, Dr. Richardson, at least 81% of Barnes's exposure to mercury came from removing existing amalgam from the teeth of patients. So even if Barnes's claim that Kerr controls 46% of the market in alloy amalgams is correct, and has been correct since 1986, this still means that over half of the dental amalgams in use have been manufactured by businesses other than Kerr. The difficulty of attributing Barnes's alleged mercury poisoning to Kerr is further emphasized by Barnes's admission that, when removing a dental amalgam, he is unable to tell who manufactured it.
Barnes also failed to present sufficient evidence that Kerr was responsible for his exposure to mercury-contaminated office air and the release of mercury particulate during the placement of new amalgams. As the district court correctly noted, Barnes has not produced any evidence establishing what percentage of the mercury in the air of his office came from Kerr's products. Moreover, according to Dr. Richardson, mercury particulate would be released only during the placement of new amalgams if Barnes used a drill. Barnes's admission that he usually did not use a drill when placing new amalgam fillings therefore effectively excludes the placement of new amalgam fillings as a significant source of mercury exposure.
Barnes has thus failed to present evidence that would permit a "reasonable person . . . [to] conclude that it is more probable that [Barnes's alleged mercury poisoning] was caused by [Kerr] than that it was not." Lindsey, 689 S.W.2d at 861-62 (citation and quotation marks omitted). We therefore affirm the district court's holding that Barnes failed to show causation.
Barnes also alleges that Kerr failed to include warnings about the dangers of exposure to mercury. As Kerr correctly notes, the adequacy of a product warning can be decided as a matter of law where reasonable minds cannot differ as to its sufficiency. See Jacobs v. E.I. du Pont de Nemours & Co., 67 F.3d 1219, 1245 (6th Cir.1995) (interpreting Tennessee law and holding that a warning about the use of Teflon products in medical applications was adequate as a matter of law). In a case involving prescription drug warnings, the Tennessee Supreme Court set out five general criteria to determine the adequacy of product warnings:
1. the warning must adequately indicate the scope of the danger; 2. the warning must reasonably communicate the extent or seriousness of the harm that could result from misuse of the [product]; 3. the physical aspects of the warning must be adequate to alert a reasonably prudent person to the danger; 4. a simple directive warning may be inadequate when it fails to indicate the consequences that might result from failure to follow it and, . . . 5. the means to convey the warning must be adequate.
Pittman v. Upjohn Co., 890 S.W.2d 425, 429 (Tenn.1994) (citation omitted); see also Evridge v. Am. Honda Motor Co., 685 S.W.2d 632, 636 (Tenn.1985) (holding that a warning is adequate under Tennessee law if it is "one calculated to bring home to a reasonably prudent user of the product the nature and the extent of the danger involved in using the product") (citation omitted). An action based on an inadequate warning requires not only that the warning itself be defective, but that the plaintiff "establish [that] the product is unreasonably dangerous by reason of defective warning and . . . that the inadequate labelling proximately caused the claimed injury." Hurt v. Coyne Cylinder Co., 956 F.2d 1319, 1329 (6th Cir.1992) (interpreting Tennessee law).
Although a product manufacturer generally has a duty to warn of the dangers of its own products, it does not have a duty to warn of the dangers of another manufacturer's products.See Kellar v. Inductotherm Corp., 498 F.Supp. 172, 175 (E.D.Tenn.1978) (interpreting Tennessee law and noting that "[i]f a manufacturer could be held liable for injury merely because it foresaw a danger created by another party, there would literally be no end of potential liability. To sustain such a theory would be to cast manufacturers into the role of insurers of products manufactured by others"). This is true even where a manufacturer has sufficient expertise to foresee the dangers of another company's products. See id. In the present case, the warnings that Kerr gave to Barnes were sufficient as a matter of law. These warnings "adequately indicate the scope of the danger," Pittman, 890 S.W.2d at 429, by providing lists of serious medical ailments that can result from exposure to mercury. For example, the label on each jar of dental amalgam capsules featured not only a skull and crossbones next to the word "POISON," but also a list of illnesses, including "Bronchiolitis, Pneumonitis, Pulmonary Edema, [and] redness and irritation to [the] eyes and skin." Likewise, the MSDS warned that chronic mercury exposure could lead to "nervous irritability, weakness, tremors, gingivitis, erethism and greying of the lens of the eye."
The warnings also gave detailed advice on how to use the dental amalgam capsules in order to avoid mercury exposure. They "reasonably communicate the extent or seriousness of the harm that could result from misuse" of the capsules, Pittman, 890 S.W.2d at 429, by emphasizing that exposure to mercury can lead to the ailments described above. For this reason, the warnings are not "simple directive warning[s that] . . . fail to indicate the consequences that might result from failure to follow [them]." Id.
Finally, the physical aspect of the warning and the means used to convey the warning both favor Kerr. Kerr not only used a prominently displayed warning on the jar labels, with the skull and crossbones and a detailed list of serious medical ailments, but also included a warning in both the enclosed instructions and in the form of the MSDS periodic mailings. Far from being physically concealed, or presented in a manner not likely to alert a reasonable person, Kerr's warnings were openly displayed and repeatedly presented in three separate media. Indeed, as Kerr noted in its briefs, one has difficulty "imagin[ing] what more Kerr could have done to advise Barnes about the potential dangers . . . that can result from exposure to elemental mercury."
Barnes, however, contends that the warnings were inadequate because they stated the dangers of mercury alone, but not of mercury combined with the other ingredients of dental amalgams. We find this argument unpersuasive for two reasons. First, the admonitory power of the warning would not be increased by a statement that mercury is also dangerous when used in conjunction with the other ingredients in dental amalgams. The warnings already state that the dental amalgams contain mercury, enumerate the physical ailments that can result from mercury exposure, and provide a list of precautions for minimizing the danger of exposure. They do not claim that the other ingredients neutralize the danger while the dentist is working with the product.
The second reason that Barnes's argument is unpersuasive is that he has cited no Tennessee authority holding that a warning about a dangerous ingredient in a product must affirmatively state that the particular ingredient remains dangerous when it is combined or is being combined with the other ingredients. The fact that the warnings included such precautions as wearing glasses and gloves, using a facemask, and mixing the ingredient in an "amalgamator" clearly put Barnes on notice that the mercury was not simply dangerous in the abstract.
Reasonable minds therefore could not differ as to the sufficiency of the warnings given to Barnes. See Jacobs, 67 F.3d at 1245 (holding that, where reasonable persons cannot differ as to the adequacy of warnings, "there are no material issues of fact necessitating a trial"). For that reason, even if Barnes had established causation, we would affirm the district court's grant of summary judgment because the warnings provided by Kerr were adequate as a matter of law.
C. The admissibility of Barnes's expert witnesses
Kerr alleges in its cross-appeal that the district court erred in accepting the magistrate judge's recommendation to admit the testimony of the expert witnesses proffered by Barnes. Even with this expert testimony, however, Barnes failed to establish causation and failed to raise a genuine issue of material fact as to the adequacy of Kerr's warnings. We therefore conclude that no jurisprudential purpose would be served by reviewing the district court's ruling with regard to Barnes's expert witnesses.
For all of the reasons set forth above, we AFFIRM the judgment of the district court.