Oakland Office Wins Summary Adjudication on Failure to Warn Claims About Benzene on Preemption Grounds

Gordon & Rees client Radiator Specialty Co. won summary adjudication extinguishing any failure to warn claims, on the ground that the product containers had warning labels in compliance with Federal Hazardous Substances Act (FHSA) labeling requirements.

Radiator’s national counsel Jim Riley and Stacy Yates of Coats Rose in Houston led the charge, capitalizing on similar successes they have obtained in other jurisdictions. The case is venued in Alameda County, and Jeff Coons of the brand-new Oakland office of Gordon & Rees provided the local expertise so the client could obtain what we understand to be the first ruling of its kind in California.

In Johnson v. Armored Autogroup, Inc., plaintiff claims to have developed leukemia from occupational exposure to benzene from various products, including Radiator Specialty’s Liquid Wrench, while working as an auto mechanic in the 1960s and 1970s.  Radiator moved for summary judgment arguing that the FHSA preempted plaintiffs’ failure to warn and design defect claims, and that Radiator’s labels complied with the FHSA.

Riley argued the motion in front of Alameda Superior Court Judge Wynne Carvill on March 21, 2014, and the court issued its ruling on March 27, 2014, granting summary adjudication on plaintiffs’ failure to warn claims. Judge Carvill allowed, however, plaintiffs’ design defect cause of action to go forward.

Riley, Yates and Gordon & Rees’s Oakland office continue to defend the matter and hope to report further successes soon as plaintiffs potentially most appealing causes of action have now been dismissed.

Physician’s Failure To Read Trumps Drug Company’s Failure To Warn

When the prescribing physician in a pharmaceutical product liability case admits that at her deposition that she never reviewed the manufacturer’s label before treating her patient and that the label played no role in her decision to prescribe the drug, plaintiff’s claim that the label should have contained a stronger warning is rendered moot.

Often the physician, a trained clinician, will testify that she was familiar with the risks in question and did not need to be provided a warning. Alternatively, the physician may testify that a stronger warning would not have influenced her decision to prescribe the drug and that she still prescribes the drug. Under either scenario, it may be argued on summary judgment that the learned intermediary did not rely on the allegedly inadequate warning and that, therefore, the plaintiff cannot establish that the alleged failure to warn was a proximate cause of plaintiff’s injury.

In an article on his Drug and Device Law blog on October 17, 2013 titled, “Don’t Forget About a Prescribing Physician’s Failure to Read Warnings,” James M. Beck, Counsel resident in the Philadelphia office of Reed Smith, provides an exhaustive survey of cases dismissing claims where the learned intermediary physician failed to read the warnings. Beck reports on and provides summaries of decisions from 42 jurisdictions.

As Beck observed in another blog post on October 28, 2011, “After all, there is a causation element to every warning claim – the defect (whatever is allegedly wrong with the warning) has to cause the injury. If the prescribing physician never even read the purportedly inadequate warning, none of those inadequacies could have affected his/her treatment of the patient.”
 

No FIFRA Preemption, No Problem!

In Gresser v. Dow Chemical Co., Ind. Ct. App., No 79A02-1111-CT-1014, 4/30/13, the plaintiffs in this toxic tort case alleged that their children developed a variety of illnesses after a purported exposure to Dursban TC in their home following a pesticide application by the co-defendant pesticide applicator.

Plaintiffs alleged that defendants Dow Chemical Company and Dow Agrosciences (collectively, “Dow”) failed to use reasonable care to instruct about the use of the product; warn about its danger; and appropriately test the design of the product. Following discovery, both plaintiffs and Dow filed motions for summary judgment.

On April 13, 2013, the Indiana Court of Appeals reversed a trial court order granting Dow summary judgment on FIFRA preemption grounds, but granted Dow summary judgment on the basis of the rebuttable presumption in Indiana’s product liability statute (the “IPLA”) that a product is not defective if it complies with federal or Indiana standards or regulations. Thus, Dow obtained from the IPLA presumption relief that it could not obtain by preemption.

Ind. Code § 34-20-5-1  provides a rebuttable presumption that a product which caused physical harm is not defective, and the manufacturer or seller of the product is not negligent, if before the sale by the manufacturer, the product “complied with applicable codes, standards, regulations, or specifications established, promulgated, or approved by the United States or by Indiana, or by an agency of the United States or Indiana.”

In determining that Dow was entitled to the statutory presumption, the court held that Dursban TC’s compliance with both FIFRA and Indiana law had a significant impact under IPLA’s consumer expectation-based product liability regime because the risk of harm had been evaluated by agencies with the duty of monitoring the effects of Dursban TC. Furthermore, Dursban TC’s labeling and warnings had been approved by experts.

On the basis of this ruling, the appellate court determined that the trial court correctly granted Dow summary judgment motion on plaintiffs’ failure to warn claims
 

This decision is significant because Dow was able to obtain through the use of the statutory presumption the same end result that it would have obtained had the appellate court found that the plaintiff’s claims were subject to preemption. Other states, including New Jersey, have similar provisions in their statutes in varying contexts.  In New Jersey, the New Jersey Product Liability Act, N.J.S.A. 2A:58C-1 et seq., specifically provides an evidentiary presumption in the favor of drug manufacturers against failure-to-warn claims:

"If the warning or instruction given in connection with a drug or device or food additive has been approved or prescribed by the federal Food and Drug Administration under the Federal Food, Drug and Cosmetic Act, 52 Stat. 1040, 21 U.S.C. Sec. 301 et seq., … rebuttable presumption shall arise that the warning or instruction is adequate."

Thus, product liability practitioners, in both the FDA and FIFRA contexts, should be mindful of the importance of developing evidence in discovery and at trial concerning the regulatory approval process and the  evaluations performed by the agency of the appropriateness of the product warnings, directions for use, and of the product’s safety and efficacy.
 

The Role Of The Heeding Presumption In Failure To Warn Litigation

In many jurisdictions, a product liability plaintiff is not permitted to testify concerning what he or she would have done had there been an adequate warning on a product; such testimony is considered both self-serving and speculative. In the absence of such testimony, some states have adopted the Heeding Presumption.

This rebuttable presumption instructs the jury that had an adequate warning accompanied the product, they are to presume that plaintiff would have “heeded” or followed the warning. This presumption establishes causation by permitting the inference that an adequate warning would have altered plaintiff’s conduct.  

In a compelling article published in the Bloomberg BNA Prduct Safety & Liability Reporter on August 23, 2012, titled," ‘If Only I would Have Been Told…..’ A Failure to Warn Discussion: Causation, the Uncertainty Principle, the Benign Experience Principle", William O. ("Skip") Martin Jr., a partner at Haight Brown and Bonesteel in Los Angeles, discusses the Heeding Presumption and provides strategies for defense counsel to overcome the presumption at trial.

In Reyes v. Wyeth Laboratories, 498 F.2d 1264 (5th Cir. 1974), the Fifth Circuit adopted the Heeding Presumption and described it as follows:

Where a consumer, whose injury the manufacturers should have reasonably foreseen, is injured by a product sold without a required warning, a rebuttable presumption will arise if the consumer would have read any warning provided by the manufacturer, and acted so as to minimize the risks. In the absence of evidence rebutting the presumption, a jury finding that the defendant’s product was the producing cause of the plaintiff’s injury would be sufficient to hold him liable. 

Martin advises that the Heeding Presumption may be rebutted by demonstrating either that the plaintiff did not read or look for any warning, or that plaintiff failed to follow adequate warnings on the product. In the article, Martin provides good case law examples of both scenarios. If it can be demonstrated that the plaintiff would not have read the warning or, if he or she had read them, would not have heeded the warning, the Heeding Presumption is overcome. The key to a successful defense of a failure to warn claim is to require plaintiff to demonstrate that his or her failure to warn claim was a proximate cause of the injury. Often, trial judges overlook that it is plaintiff’s legal burden to establish that an allegedly inadequate or missing warning was a cause of the injury.

In addition to his discussion of the Heeding Presumption, Martin also provides a good outline for taking the deposition of an adversary human factors or warnings expert. Most plaintiff warnings experts fail to present any competent evidence as to whether a warning would have altered the plaintiff’s conduct. Human factors/warnings experts criticize the existing warning or lack of a warning on a product label, but often have done little or nothing to determine how a different warning would have altered the outcome. Again, by focusing on the causation element in plaintiff’s burden of proof, a defendant can reduce the “sting” of plaintiff’s failure to warn allegation.

 

A Primer On New York Product Liability Law

Michael Hoenig’s Product Liability column in The New York Law Journal, “Complexities Abound In Product Design Claims” (January 11, 2010), provides an excellent primer  on the law of product liability in New York state and a good discussion of the leading cases. (NYLJ.com requires a subscription to access. If you cannot download the article, Mr. Hoenig  will post the article within a couple of weeks on his law firm’s web site).   Mr. Hoenig devotes the body of his article to a recent Appellate Division, First Department decision, Chow v. Reckitt & Colman Inc., 2010 NY Slip Op 00013 (App. Div., 1st Dept., Jan. 5, 2010).  There, a split First Department upheld the trial court’s grant of summary judgment to the defendant manufacturer of of a drain cleaner called "Lewis Red Devil Lye", which blinded the plaintiff during an attempt to unclog a floor drain in the kitchen of the restaurant where he worked.  Applying the Court of Appeals standard in Voss v. Black & Decker Manufacturing Co, the court examined the ‘risk-utility balancing’ calculus, which often lies at the heart of a defective design product liability inquiry. In addition to Mr. Hoenig’s “refresher” survey of the law of product design liability, he directs his readers to the commentary issued by the Committee on Pattern Jury Instructions of the Association of Justices of the Supreme Court of the State of New York, particularly PJI 2:120. For further reading, a thoughtful discussion of PJI 2:120 appears in a 2008 article "New  Design-Defect Jury Instructions: Catching ‘Denny’ " by Stephen R. Blacklocks, a partner in Hunton & Wiliams’  New York office.  As Mr. Hoenig states in the conclusion of NYLJ article, “Mastery of the legal principles – our survey merely scratches the surface – is indispensable in perfecting one’s advocacy.”  When your client next assigns you a new case for  you to defend, take a few minutes to review Mr. Hoenig’s primer to remind yourself just how many hurdles plaintiff’s counsel needs to overcome to make out a prima facie case of design defect.