Products Liability Expert Proofs, Medical Monitoring, and More By Michael Hoenig - New York Law Journal - June 16, 2008	Print article

In Wendler & Ezra PC v. American International Group Inc.,¹ the U.S. Court of Appeals for the Seventh Circuit reminds us that an expert's ipse dixit is inadmissible. Thus, an expert "who supplies nothing but a bottom line supplies nothing of value to the judicial process."²

In this nonproducts case a law firm specializing in tort suits on behalf of truck drivers sued for defamation claiming that the defendant insurer posted a message on an electronic bulletin board frequented by truck drivers. The posting suggested that the writer was an unhappy client but plaintiff claimed it was the insurer adversary attempting to steer potential clients away.

The district court granted summary judgment after concluding that the law firm could not establish the posting's origin. To show that the message came from someone at the insurance company, plaintiff offered the affidavit of expert Y who described himself as the Web master at teamster.net. According to the affidavit, software told Y that the posting originated from the IP address registered to defendant AIG. The affidavit did not state, however, what software had been employed, how it worked, what data had been provided to the program, and what, if anything, had been done to find out whether the poster had "spoofed" one of AIG's addresses. Spoofing means taking steps to make a message appear to originate from some address other than its original source.

The parties debated whether the information stored on the computer system at teamster.net is covered by the "business records" exception to the hearsay rule, Federal Evidence Rule 803(6). The Seventh Circuit found the answer to this question irrelevant, not only because the raw data was never offered as evidence but also because expert Y had specialized knowledge that allowed him to give an expert opinion and experts may rely on information that would not be admissible in evidence.

Nevertheless, since Y's affidavit "does not say what software he used, what data he fed it, what results it produced, and how alternative explanations (including spoofing) were ruled out," the opinion was a "bottom line" conclusion, an inadmissible ipse dixit. The district court was right to exclude the affidavit. This approach is germane to many situations where experts express opinions purporting to base their conclusions on software or computer programs but provide no foundational facts regarding the program, the data, the results and the alternative conclusions that could be drawn. Such "net" opinions are suspect and ripe for challenge.

Experts' use of inadmissible hearsay arose in Pineda v. Ford Motor Co.,³ a products case in which an automobile technician was injured when the rear lift-gate glass of a 2002 SUV shattered. Among plaintiff's theories was failure to warn and, to prove this allegation, plaintiff offered expert C, an engineer, to give an opinion that the pertinent service manual and bulletins did not provide adequate instructions and warnings, specifically, no step-by-step instructions for replacing the lift-gate brackets and hinges and reconnecting them to the lift-gate glass. Defendant moved to exclude the opinions or for a Daubert hearing. The court granted the reliability hearing.

Subsequent Instructions

At the hearing, C admitted he was not a warnings expert, except to the extent that "warning and instructions" are "solutions to an engineering problem." He testified about Ford's 2004 Safety Recall Instruction (SRI) which described the procedure for replacing the lift-gate brackets and hinges on the 2002 SUV. C claimed that the Recall Instruction, by contrast, provided adequate, proper and detailed instructions and was an appropriate alternative. The trial court, however, held that C could not compare the 2002 service manual to the 2004 Safety Recall Instruction because Federal Evidence Rule 407 renders inadmissible evidence of subsequent remedial measures.

Plaintiff argued on appeal that he only sought to admit evidence of the 2004 Recall Instruction as an example of effective language for an alternative instruction and warning and not to prove culpable conduct or the need for a warning. The Third Circuit, however, viewed the parties and the district court as conflating "separate issues of whether the SRI itself can be admitted into evidence and whether [C's] opinion can be admitted if based on a consideration of the SRI."

Thus, Federal Evidence Rule 703 "is clear that the SRI does not need to be admissible evidence" in order for C's opinion to be admissible. The rule's only requirement is that the data be "of a type reasonably relied on by experts in the field in forming opinions or inferences upon the subject." The Third Circuit found it to be reasonable for an engineer to rely upon a warning and an alternative safety instruction subsequently issued by a manufacturer in forming his opinion that an earlier service manual fails to provide adequate instructions and warnings to technicians. Thus, despite Rule 407's general exclusion of subsequent remedial measure evidence, Rule 703 permitted C to base his opinion on a consideration of the SRI.

Medical Monitoring

Recently, the Supreme Courts of New Jersey and Oregon rejected so-called "medical monitoring" claims. The New Jersey decision, Sinclair v. Merck & Co.,⁴ was issued on June 4 while the Oregon decision, Lowe v. Philip Morris USA Inc.,⁵ was published on May 1. Each case involved lawsuits by named plaintiffs suing as well on behalf of a class of other claimants. In New Jersey, the pharmaceutical product claimed to require that persons be monitored was Vioxx, a prescription drug approved for sale in May 1999 for the relief of acute pain and other conditions. In September 2004, Vioxx was voluntarily withdrawn from the market following the recommendation of a board overseeing a long-term study of the drug that the study be halted because of a risk of serious cardiovascular events such as heart attacks and strokes. In Oregon, the plaintiffs sought periodic medical screening because of the incidence of lung cancer attributable to smoking.

In Sinclair, the New Jersey case, the court held that the state's Product Liability Act does not include the remedy of medical monitoring when no manifest injury is alleged. The court also held that the Product Liability Act was the sole source of remedy for plaintiffs' defective product claim. Thus, the Consumer Fraud Act did not provide an alternative remedy. Plaintiffs had contended that, as a result of direct and prolonged consumption of Vioxx, they were at enhanced risk of "silent heart attacks" and other latent and unrecognized injuries. They wanted to have defendants fund a court-administered screening program to provide medical diagnostic tests for each class member and follow-up with an epidemiologist.

The New Jersey Supreme Court examined prior precedents in which limited authority for medical monitoring was approved. But here, the action was not for personal injuries stemming from asbestos exposure nor for exposure to an environmental contaminate. Rather, it was brought under the products liability act for ingestion of a pharmaceutical product. The act allowed a claim "for harm caused by a product." "Harm" was defined, in part, as "personal physical illness, injury or death." Defendant argued that the word "physical" defined the words "illness" and "injury." Since plaintiffs had no injury the claim must fail. Plaintiffs contended the word "physical" modified only the word "illness" thereby not limiting the type of injury that may occur.

The court read the act to require a physical injury. Since plaintiffs did not have a physical injury the monitoring claim failed. The attempt to structure the action as a Consumer Fraud Act claim likewise was rejected. All product liability claims are included within the Product Liability Act. "The heart of plaintiffs' case is the potential for harm caused by Merck's drug. It is obviously a product liability claim." The consumer fraud claim "clearly falls" within the scope of the Products Liability Act.

Oregon Case

In Lowe, the Oregon case, plaintiff likewise did not allege that she suffered any present physical harm. She alleged only a "significantly increased risk of developing lung cancer" in the future. Thus, she claimed she needed periodic medical screening by CT scans which detect lung cancer early and thereby increase the probability of successful treatment, enhanced life expectancy and cure. The court-screened program for class members should also include smoke-cessation therapy and public education concerning the program, she claimed. The state's high court observed that this was not a case in which some present physical harm was caused as a result of defendant's negligence and plaintiff then sought damages for fear of developing cancer or the increased risk or the costs of medical care to determine the extent of her harm. Rather, plaintiff alleged only that the increased risk of lung cancer required periodic medical monitoring.

Plaintiff argued that a significant future risk of contracting lung cancer is, by itself, a sufficient harm to state a negligence claim. The need for medical monitoring costs was, she claimed, an additional present harm. The court examined whether a significantly increased risk of future injury is a sufficient harm to state a negligence claim. The court held "no." Although the question of when exposure to toxic substances causes a sufficient harm can present complex issues of science and law, the court here did not need to explore the outer reaches of these issues. Plaintiff's allegations only stated that her exposure significantly increased the risk of lung cancer sometime in the future. The threat of future physical harm is insufficient.

On the plaintiff's claim that the harm of having to undergo periodic medical monitoring is a "cost" which thereby states a sufficient injury, the court disagreed. A purely economic loss without injury to person or property is not actionable in negligence, according to established Oregon precedents. Accordingly, while the court reviewed case law pro and con on medical monitoring, it held that different decisions from other jurisdictions did not provide a basis for overruling Oregon's well-established negligence requirements.

Appellate Rulings

We now present a cluster of recent Appellate Division rulings worthy to note. We present them here in "bullet" format.

• In Bergin v. Town of Oyster Bay,⁶ an infant was injured when she fell from a horizontal ladder at a playground. Plaintiffs claimed the injury stemmed from inadequate ground cover beneath the ladder. Defendant town moved for summary judgment presenting evidence it maintained the playground in a reasonably safe condition. In opposition, plaintiff referred to U.S. Consumer Product Safety Commission guidelines as well as other proof. But the Second Department held that the "nonmandatory" CPSC guidelines were insufficient to raise a triable issue of fact.

• In Pareja v. City of New York,⁷ the First Department reiterated what should be known to litigators, that there was "nothing improper about admitting into evidence plaintiff's verified bill of particulars" to demonstrate her alleged failure to provide notice of prior injuries. As the court declared, "Statements and allegations in pleadings are always admissible as evidence, and may be used for any legitimate purpose at trial."

• In Steuhl v. Home Therapy Equip. Inc.,⁸ plaintiff was injured when, after she underwent back surgery, she was attempting to lower the head of a prescribed, motorized hospital bed. On the warnings claim, the defendant manufacturer showed that its beds are not sold directly to end users but to dealers who rely on trained technicians to assemble the beds. The assembler of the bed in plaintiff's home was aware of the functions of the clevis pin and hitch pin and that failing to ensure proper installation could cause the bed to fall apart. Since he "was thus aware of the specific danger at issue here, . . . any failure to warn did not proximately cause plaintiff's injury." As for plaintiff's claim that end users should in any event receive a warning, the court observed that the warning sticker recommended by plaintiff's expert would have been placed on the underside of the bed "rendering it unlikely that users would ever see it." Further, since the sticker was to warn and remind technicians, it was not intended to warn users of the bed.

• In Preston v. Peter Luger Enterprises Inc.,⁹ plaintiff was injured when the neck of a bottle of steak sauce broke. The strict products claim was based on both a design and manufacturing defect. Defendant obtained a partial summary judgment and this order was affirmed by the Third Department. The court's opinion provides a useful review of some of the factors litigants must contend with when contesting a summary judgment motion including the expert's showing. This should not consist of "bare conclusory assertions" not supported by "any empirical data or foundational facts."

 

Michael Hoenig is a member of Herzfeld & Rubin.

Endnotes:
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1. 521 F.3d 790 (7th Cir. 2008).
2. Id. at 791 (citing prior case law).
3. 520 F.3d 237 (3d Cir. 2008).
4. 2008 N.J. LEXIS 565 (Sup. Ct. June 4, 2008).
5. 2008 Ore. LEXIS 273 (Sup. Ct. May 1, 2008).
6. 2008 NY Slip Op 04452 (App. Div. 2d Dept., May 13, 2008).
7. 2008 NY Slip Op 02761 (App. Div. 1st Dept., March 27, 2008).
8. 2008 NY Slip Op 04023 (App. Div. 3d Dept., May 1, 2008).
9. 2008 NY Slip Op 04598 (App. Div. 3d Dept., May 22, 2008).