Mass Tort Defense : Mass Tort Defense Lawyer & Attorney : Sean P. Wajert : Dechert Law Firm : Products Liability, Class Actions, Pharmaceutical Litigation

California's high court is preparing to address a split among the state's lower courts on what seems to be a straightforward issue of product liability law governing component parts.

The Restatement of Torts (Third): Products Liability says that in the context of a final, finished product that injures a user and which is made up of components from different manufacturers, if a given component is itself defective and the defect causes the harm, then the supplier of that component is of course liable. In addition, the supplier can be liable even if the component by itself is not defective, but only if the seller substantially participates in the integration of the component into the design of the product (and the defect causes the harm). Restatement 3d, Section 5.

In essence, the doctrine holds that an entity supplying a non-defective raw material or a non-defective component part is not strictly liable for defects in the final product over which it had no control.  In this respect the Third Restatement of Torts simply codified the doctrine of various states’ common law. E.g., TMJ Implants Products Liability Litigation, 872 F. Supp. 1019 (D. Minn. 1995), aff’d, 97 F.3d 1050 (8th Cir. 1996) (applying Minnesota law)); Kealoha v. E.I. Du Pont de Nemours & Co., 844 F. Supp. 590 (D. Hawaii 1994), aff’d, Kealoha v. E.I. Du Pont de Nemours & Co., et al., 82 F.3d 894 (9th Cir. 1996) (applying Hawaii law); Jacobs v. E.I. Du Pont de Nemours & Co., 67 F.3d 1219 (6th Cir. 1995) (applying Ohio law); Apperson v. E.I. Du Pont de Nemours & Co., 41 F.3d 1103 (7th Cir. 1994) (applying Illinois law); Crossfield v. Quality Control Equip. Co., Inc., 1 F.3d 701 (8th Cir. 1993) (applying Missouri law); Childress v. Gresen Mfg. Co., 888 F.2d 45 (6th Cir. 1989) (applying Michigan law); In Re: Silicone Gel Breast Implants Products, 996 F. Supp. 1110 (N.D. Ala. 1997); Travelers Ins. Co. v. Chrysler Corp., 845 F. Supp. 1122 (M.D.N.C. 1994); Sperry v. Bauermeister, 786 F. Supp. 1512 (E.D. Mo.1992); Estate of Carey v. Hy-Temp Mfg., Inc., 702 F. Supp. 666 (N.D. Ill. 1988); Orion Ins. Co., Ltd. v. United Tech. Corp., 502 F. Supp. 173 (E.D. Pa. 1980); Mayberry v. Akron Rubber Machinery Corp., 483 F. Supp. 407 (N.D. Okla. 1979); Artiglio v. General Electric Co., 61 Cal.App.4th 830 (Cal. Ct. App. 1998); Bond v. E.I. Du Pont de Nemours & Co., 868 P.2d 1114 (Colo. Ct. App. 1993); Shaw v. General Motors Corp., 727 P.2d 387 (Colo. Ct. App. 1986); Castaldo v. Pittsburgh-Des Moines Steel Co., Inc., 376 A.2d 88 (Del. 1977); Depre v. Power Climber, Inc., 263 Ill.App.3d 116 (Ill. App. Ct. 1994); Curry v. Louis Allis Co.,
Inc., 100 Ill.App.3d 910 (Ill. App. Ct. 1981); Murray v. Goodrich Eng’g Corp., 30 Mass. App. Ct. 918 (Mass. App. Ct. 1991); Welsh v. Bowling Electric Machinery, Inc., 875 S.W.2d 569 (Mo. Ct. App. 1994); Zaza v. Marquess & Nell, Inc., 144 N.J. 34 (N.J. 1996); Parker v. E.I. Du Pont de Nemours & Co., Inc., 121 N.M. 120 (N.M. Ct. App. 1995); Munger v. Heider Mfg. Corp., 90 A.D.2d 645 (N.Y. App.
Div. 1982); Hoyt v. Vitek, Inc., 134 Ore. App. 271 (Or. Ct. App. 1995); Moor v. Iowa Mfg. Co., 320 N.W.2d 927 (S.D. 1982); Davis v. Dresser Indus., Inc., 800 S.W.2d 369 (Tex. App. 1990); Bennett v. Span Indus., Inc., 628 S.W.2d 470 (Tex. App. 1982); Westphal v. E.I. Du Pont de Nemours & Co., 192 Wis. 2d 347 (Wis. Ct. App. 1995); Noonan v. Texaco, Inc., 713 P.2d 160 (Wyo. 1986).

Sometimes the issue is analyzed as one of no duty on the part of the component seller; other courts view it as an absence if causation.  The policy reasons behind the component parts doctrine are well established. Multi-use component and raw material suppliers should not have to assure the safety of their materials as used in other companies' finished products. That would require suppliers to retain experts in a huge variety of areas in order to determine the possible risks associated with each potential use. And finished product manufacturers know exactly what they intend to do with a component or raw material and therefore are in a better position to guarantee that the component or raw material is suitable for their particular applications.  In the drug and device area, liability is inconsistent with the FDA regulatory scheme because suppliers cannot warn consumers of dangers created by the design of the finished product; the FDA controls who warns and what the warning says.

But when a component manufacturer sufficiently participates in designing a defective and unreasonably dangerous final product, the component manufacturer may be held liable for injuries caused by the final product even though the component itself was not defective or unreasonably  dangerous.  Which raises the question what is ‘‘substantial participation.’’ The Restatement suggests the courts look at whether: (1) the manufacturer or assembler of the integrated product invited the component manufacturer to design a component that would perform specifically as a part of the integrated product;  (2) the component part manufacturer assisted the seller in modifying the design of the integrated product so that it would accept the component part, or (3) the component part manufacturer played a substantial role in deciding which component best serves the requirements of the seller’s integrated product.

A common mass tort battleground for these issues is asbestos.  In O'Neil v. Crane Co., 177 Cal.App.4th 1019, 99 Cal.Rptr.3d 533 (2009)(review granted 12/23/09), the plaintiffs, the widow and children of a naval officer who died of mesothelioma, sued the manufacturers of shipboard pumps and valves, alleging that asbestos insulation used with those components caused the injury.  The trial court dismissed the claims under the component part make doctrine, but last Fall, a panel of the Second Appellate District overturned the trial court's dismissal and said the pump and valve makers could be liable for the officer's death.

The court found that the defendants did not supply a “building block” material, dangerous only when incorporated into a final product over which they had no control. Rather, they sold finished valves and pumps, which needed insulation of some kind. That analysis did not give sufficient attention to the notion that the steam system of the ship ought to be viewed as the finished product, as that term is used in the context of the component parts defense. And it gave insufficient weight to the basic policy underlying the compnent part doctrine.

The panel disagreed with the trial court and with two other appellate decisions going the other way. The state's First Appellate District in Taylor v. Elliott Turbomachinery Co., 171 Cal. App. 4th 564 (2009), found  that pump and valve manufacturers were not liable —as manufacturers of non-defective component parts of a greater whole, and as manufacturers of separate products from those (asbestos) that actually caused the alleged harm. And a different panel of the Second District, Merrill v. Leslie Controls Inc. (Cal. Ct. App., 2d App. Dist., No. B200006, 11/17/09), had also declined to find liability in similar circumstances. See generally Lindstrom v. A-C Product Liability Trust, 424 F.3d 488 (6th Cir.2005)(no liability; causation focus). 

That a component seller knew or should have known that the product maker might use potentially hazardous materials in its design should never be sufficient to impose liability for the design that is the responsibility of the finished product seller.  It makes no sense to have suppliers act as "design police" for every possible item their non-defective part could possibly be combined with in a finished product. 

Under a proper analysis, a warning claim should fare no differently. See Braaten v. Saberhagen Holdings, 198 P.3d 493 (Wash. 2008); Simonetta v. Viad Corp., 197 P.3d 127 (Wash. 2008)(no liability for failure to warn of the hazards of exposure to another manufacturer's asbestos insulation).  The Washington court found the duty to warn under common law negligence was limited to those in the chain of distribution of the hazardous product. Because the defendants did not manufacture, sell, or supply the asbestos insulation, the defendants could not be found liable for breaching a duty to warn. The defendants were not strictly liable because only a product's manufacturer, seller, or marketer is in the position of knowing its dangerous aspects.  To hold a defendant strictly liable for another party's product would be manifestly unfair.

The California Supreme Court has recently agreed to review the issue. O'Neil v. Crane Co., Cal., No. S177401, (petition for review granted 12/23/09).  Here's hoping the doctrine is applied correctly, and this does not become another "asbestos" law exception to common sense rules.

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In a wrongful death suit brought by the family of a chemical plant employee, the U.S. District Court for the Southern District of West Virginia predicted last week that West Virginia would allow the application of the “sophisticated user” and “bulk supplier” defenses to the plaintiff's product liability claim. Roney, et al. v. Gencorp, et al., No. 3:05-cv-00788 (S.D. W.Va. Sept. 4, 2009).

From 1965 until 1982, Mr. Roney worked at the Pantasote Corporation/Gencorp Inc. Polyvinyl Chloride plant in Point Pleasant, West Virginia. There, he worked extensively with vinyl chloride monomer (“VCM”) – a major raw component of Polyvinyl Chloride (“PVC”). VCM is now associated in some scientific studies with the particular form of liver cancer – angiosarcoma – to which Mr. Roney succumbed. Mr. Roney’s estate filed suit against the defendants for failure to disclose their alleged full knowledge of the danger of VCM and for failing to warn Mr. Roney of its hazardous nature.

Such cases raise, as readers of MassTortDefense know, the related and difficult issues of the duty and ability of a remote supplier of a bulk product to warn downstream users, the customers or employees of their actual customers.  The issue is complicated by the duty of the supplier's immediate customer, in its own right, to warn its customers and to provide a safe workplace for its own workers.  When should that independent or separate duty, imposed on a party who is arguably in a more direct position to pass on effective warnings, cut off the chain of causation flowing up to the remote supplier?  And what about when the employer/intermediate customer is itself an expert in the potential hazards of the product?

Here, in defense of the failure to warn claim, the main product supplier asserted that it had no duty to warn because that duty was obviated by the employer’s own duty to warn its workers. Such a defense, commonly referred to as a “sophisticated user” defense, is available in many states but had not been explicitly adopted or rejected in the state courts of West Virginia. In some jurisdictions the stress is on the bulk supplier aspect and the practicability of warning downstream users; in others the emphasis is in the knowledge of the customer.  Here, the court addressed both aspects.

Section 388 of the Restatement (Second) of Torts addresses a supplier’s potential liability
for a “Chattel Known to Be Dangerous for Intended Use.” Comment n of this section is commonly cited as the basis for the sophisticated user defense: There is necessarily some chance that
information given to the customer will not be communicated by him to those who are to use the
chattel. This chance varies with the circumstances existing at the time the chattel is turned over to the person, including the known or knowable character of the third person and the purpose for which the chattel is given. "Modern life would be intolerable unless one were permitted to rely to a certain extent on others' doing what they normally do, particularly if it is their duty to do so."

Plaintiff relied on the fact that the West Virginia Supreme Court has rejected the learned intermediary doctrine, a defense plaintiff claimed was similar to the sophisticated user defense. See State ex Rel. Johnson & Johnson Corp. v. Karl, 647 S.E.2d 899 (W.Va. 2007). The reasoning of that decision, questionable in its own right, is not applicable to a scenario outside of the prescription pharmaceutical context and the rise of direct-to-consumer advertising. In deciding Karl, the court had recognized that through such DTC advertising pharmaceutical companies had arguably gained direct access to patients, a relationship starkly different than that which had existed when the learned intermediary doctrine was developed – when patients received drug information exclusively through their doctors. And starkly different from the industrial context. Chemical workers would typically have had little opportunity to influence the choice of products to which they would be exposed. Instead, they relied upon their employer to determine the scope of their duties and their role in the production process. They were insulated from the manufacturer of the chemicals they used, much as the patient used to be insulated from the drug manufacturer, observed the court.

The duty to warn, said the federal court, involved an analysis of the reliability of the third party as a conduit of necessary information about the product; the magnitude of the risk involved; and the burdens imposed on the supplier by requiring that it directly warn all users. That, in turn, included the degree to which the danger related to the particular product is clearly known to the  purchaser/employer. Thus, West Virginia would recognize a sophisticated user defense.

As with the sophisticated user defense, the bulk supplier notion is rooted in Restatement § 388
comment n. While the sophisticated user defense focuses on the reasonableness of reliance on the employer, the bulk user defense concerns the burden which would be imposed on the supplier if it were bound to directly warn all downstream users.  The impracticability of the manufacturer getting a warning for a chemical shipped in tank trucks or rail cars to the employees of the customer would also be recognized as a defense in the state, predicted the federal court.

The court rejected the defendant's third assertion that the dangers of vinyl chloride monomer are “open and obvious," as the connection between cancer and VCM is not readily known outside scientific, medical and industrial communities, said the court.

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