The Metzger Law Group supports the Leukemia & Lymphoma Society and the International Myeloma Foundation


Does the Sophisticated Intermediary Defense Apply in Toxic Tort Cases? - Part I of IV

by Raphael Metzger, Esq.



Among the defenses asserted by defendants in toxic tort cases is the so-called sophisticated intermediary defense. See, generally, Centola, G., “Manufacturers Often Are Able To Rely On The ‘Sophisticated Intermediary Doctrine to Defend Against Plaintiffs’ Failure-To-Warn Claims.”  Mealey’s Emerging Toxic Torts Vol. 7, No. 21, pp. 27-35 (February 5, 1999).

Five years ago, one state supreme court observed that “judicially created doctrines such as the ‘sophisticated purchaser’ and ‘bulk supplier’ defenses have become familiar maxims of product liability law.”  Macias v. State of California (1995) 10 Cal.4th 844, 42 Cal.Rptr.2d 592.  While it is true that the “sophisticated intermediary” defense is often bandied about, the fact remains that it has not been accepted in most jurisdictions and that it has little, if any, application in toxic tort cases.

This is the first of a four-part series which explains why the defense should not apply in toxic tort cases.  This commentary will show that the defense is contrary to federal and state statutory and regulatory law.  The second part in the series will show that the defense has not been adopted in the Restatement Second of Torts.  The third part in the series will delineate the limited scope of the defense in those jurisdictions that have adopted it.  The last installment will explain why the defense should not succeed on summary judgment against a properly drafted toxic tort complaint.

1. What is the Sophisticated Intermediary Defense?

The sophisticated intermediary defense is a common law defense to certain tort claims.  The defense was first recognized for prescription drugs.  Because a physician owes a duty of care in the treatment of his patient, certain courts reasoned that when a physician orders a prescription drug for his patient, the manufacturer of the drug should not be liable to the patient for adverse reactions if the manufacturer adequately warned the physician of the hazards.  Because the physician is a knowledgeable professional, owes a duty of care directly to his patient, and typically has a close relationship with his patient, the physician was deemed to be a “sophisticated intermediary.”   Courts reasoned that when adequately informed by the manufacturer of the hazards of its drugs, the physician should be expected to inform his patient of such hazards, in lieu of the manufacturer.  Accordingly, courts have held that a prescription drug manufacturer owes no duty to warn a patient of adverse drug reactions if it adequately warns the physician, because the drug is prescribed for the patient by the physician.  See, e.g., Carmichael v. Reitz (1971) 17 Cal.App.3d 958, 95 Cal.Rptr. 381.

2.         Application of the Sophisticated Intermediary Defense to Toxic Tort Cases

The sophisticated intermediary defense is not easily transposed to products liability cases, because important differences exist between physician-patient and employer-employee relationships.   A physician is a highly trained professional, who is compensated to care for the health of his patient and who owes the duty of a licensed medical professional to his patient.  An employer or other intermediary in the chain of distribution of an industrial chemical is often not a trained professional and owes no special duty of care to the employee or other user.  Unlike a physician, whose primary purpose in selecting a drug is to promote the well-being of the patient, the primary interest of a chemical manufacturer in selecting its product is the efficacy of the product in its customer’s applications.  While selecting and manufacturing a chemical product to avoid health risks to exposed workers is a factor that a chemical manufacturer may consider, it is not the manufacturer’s primary consideration.  Thus, it is questionable whether the sophisticated intermediary doctrine should apply in any toxic tort cases involving chemical products other than prescription drugs, and some courts have rejected its application as to chemical products other than prescription drugs.

3.         With Respect to Industrial Chemicals, the Sophisticated Intermediary
Defense is Contrary to the Federal Hazard Communication Standard

About 32 million workers are potentially exposed to one or more chemical hazards.  There are an estimated 575,000 existing chemical products, and hundreds of new ones are being introduced annually.  This poses a serious problem for exposed workers and their employers. 
Chemical exposure may cause or contribute to many serious health effects such as heart ailments, kidney and lung damage, sterility, cancer, burns, and rashes. . . .
Because of the seriousness of these safety and health problems, and because many employers and employees know little or nothing about them, the Occupational Safety and Health Administration (OSHA) has issued a rule called "Hazard Communication."  The basic goal of the standard is to be sure employers and employees know about work hazards and how to protect themselves; this should help to reduce the incidence of chemical source illness and injuries.  
The Hazard Communication Standard establishes uniform requirements to make sure that the hazards of all chemicals imported into, produced, or used in U.S. workplaces are evaluated, and that this hazard information is transmitted to affected employers and exposed employees. 
Chemical manufacturers and importers must convey the hazard information they learn from their evaluations to downstream employers by means of labels on containers and material safety data sheets (MSDS's).  In addition, all covered employers must have a hazard communication program to get this information to their employees through labels on containers, MSDS's, and training.

This program ensures that all employers receive the information they need to inform and train their employees properly and to design and put in place employee protection programs.  It also provides necessary hazard information to employees, so they can participate in, and support, the protective measures in place at their workplaces.

U.S. Dept. of Labor, Occupational Safety and Health Administration, "Chemical Hazard Communication," OSHA Publ. No. 3084 (1989), p. 2.

The Hazard Communication Standard is found at 29 C.F.R. § 1910.1200.   It has an express statement of purpose:

The purpose of this section is to ensure that the hazards of all chemicals produced or imported are evaluated, and that information concerning their hazards is transmitted to employers and employees.  This transmittal of information is to be accomplished by means of comprehensive hazard communication programs, which are to include container labeling and other forms of warning, material safety data sheets and employee training.

29 C.F.R. § 1910.1200(a)(1).  See, also, Cal. Labor Code § 6360; 8 C.C.R. § 5194 et seq.

Labels and other forms of warning are addressed at 29 C.F.R. §1910.1200(f)(1) which states, in relevant part, as follows:

The chemical manufacturer, importer, or distributor shall ensure that each container of hazardous chemicals leaving the workplace is labeled, tagged or marked with . . . appropriate hazard warnings.

Chemical manufacturers and suppliers must “provide their customers with a material safety data sheet for each hazardous chemical they produce.”  29 C.F.R. § 1910.1200(g)(1).

With respect to each hazardous chemical, the manufacturer or supplier must list on the material safety data sheet “the health hazards of the hazardous chemical, including signs and symptoms of exposure, and any medical conditions which are generally recognized as being aggravated by exposure to the chemical.”  29 C.F.R. § 1910.1200(g)(2)(iv).

The material safety data sheets must disclose the identity of all hazardous ingredients which comprise 1% or greater of the composition, and all carcinogenic ingredients which comprise .1% or greater of the composition.  29 C.F.R. § 1910.1200(g)(2)(C).  The material safety data sheet must also state whether the hazardous chemical is listed in the National Toxicology Program (NTP) Annual Report on Carcinogens or has been found to be a potential carcinogen in the International Agency for Research on Cancer (IARC) Monographs or by OSHA. 29 C.F.R. §1910.1200(g)(2)(vii).

The employer must “maintain copies of the required material safety data sheets for each hazardous chemical in the workplace,” and “ensure that they are readily accessible during each work shift to employees when they are in their work areas.”  29 C.F.R. § 1910.1200(g)(8).

The premise of the Hazard Communication Standard is that by requiring chemical manufacturers and suppliers to provide toxicity hazard information to their customers, and requiring all employers to make the information available to their employees, workers will receive the information provided by the manufacturer.

While the Hazard Communication Standard does not expressly require chemical manufacturers to directly warn downstream workers of toxic or carcinogenic hazards, by requiring them to provide such warnings on material safety data sheets and product labels and to provide such material safety data sheets and labels to their customers, the hazard information should reach those employees who actually use and are occupationally exposed to the hazardous substances.

Since the sophisticated intermediary defense relieves a chemical manufacturer of its duty to warn downstream chemical users of the hazards of its product when there is a “sophisticated intermediary” in the chain of distribution (typically the user’s employer), it appears to contravene the duty imposed on chemical manufacturers by the Hazard Communication Standard.  Since no common law defense can negate duties established by statutes or regulations, it appears that the defense cannot apply in the context of occupational exposures, because such would contravene regulatory law.

4.         The Sophisticated Intermediary Defense Contravenes California’s
Safe Drinking Water and Toxic Enforcement Act of 1986

While the federal Hazard Communication Standard does not expressly require chemical manufacturers to directly warn customers’ employees who are exposed to their chemical products of cancer hazards, some state laws require such a warning.  For example, California law expressly requires direct warning to downstream users. In 1986 California Voters overwhelmingly adopted the Safe Drinking Water and Toxic Enforcement Act of 1986 (commonly known as "Proposition 65").  Its warning provision, found at Health & Safety Code § 25249.6, states:

No person in the course of doing any business shall knowingly and intentionally expose any individual to a chemical known to the state to cause cancer or reproductive toxicity without first giving clear and reasonable warning to such individual. Id.

"Proposition 65 requires that warnings be given to individuals."  California Labor Federation, AFL-CIO v. California Occupational Safety and Health Standards Board (1990) 221 Cal.App.3d 1547, 1556, 271 Cal.Rptr. 310.  (emphasis in original).  "All employees are individuals and thus are entitled to Proposition 65 warnings in the workplace absent an exemption in the law."

Regulations incorporating the cancer hazard warning requirements of Proposition 65 into California’s Occupational Safety and Health Plan are found at 8 C.C.R. § 5194(b)(6):

[A]n employer which is a person in the course of doing business within the meaning of Health and Safety Code Section 25249.11(a) and (b), is subject to the Safe Drinking Water and Toxic Enforcement Act of 1986 (Proposition 65 or the “Act”) (Health and Safety Code §25249.5 et seq.), and shall comply with the Act in the manner set forth in subsections (B) and (C).

8 C.C.R. § 5194(b)(6)(A) .

This language is clear and straightforward:  all employers doing business in California must provide mandated cancer hazard warnings to all exposed employees.  Similarly, section 5194(b)(6)(B) states:

Before exposing any employee to any hazardous substance that otherwise falls within the scope of this section and which requires a warning under this Act ... except as provided in subsection (D) below, any employer subject to the Act shall comply with the requirements set forth . . . .

Thus, under California law, any chemical manufacturer that manufactures its products in California and employs more than 10 employees, must provide carcinogenicity and reproductive toxicity warnings to all persons, including employees, exposed to such chemicals, prior to their exposure.  Since the duty to warn the exposed person is imposed by express law (the initiative), such duty cannot be negated by the assertion of a common law defense.  See, e.g., Edwards v. Basel Pharm., 933 P.2d 298 (Okla. 1997) [learned intermediary defense held inapplicable where FDA required drug manufacturers to provide direct warnings to consumers]

5.         Conclusion

A chemical manufacturer’s assertion of a common law sophisticated intermediary defense will often conflict with federal and state statutory or regulatory law.  When such a conflict arises, the defense is untenable, because a common law defense cannot contravene express statutory or regulatory law.


This article was published in Mealey’s Emerging Toxic Torts on April 21, 2000, as the first of a series of four articles regarding the sophisticated intermediary defense in toxic tort litigation.

The defense is sometimes also called the “sophisticated purchaser” defense, the “learned intermediary” defense and, where the intermediary is the plaintiff’s employer, the “sophisticated employer” defense.

Practice Concentrated