Liability and evidentiary issues involving prescription production recalls.

• Author: Wood, James M.

LIABILITY lawsuits often follow a prescription product recall. To establish a manufacturer's liability, the patients' attorneys will often use evidence of a recall to attempt to prove:

1. The existence of a defect;

2. The cause of the injury;

3. The extent of the risk created by the product;

4. The manufacturer's notice or knowledge of the dangers of the product before the recall;

5. The foreseeability of the use to which the product was put at the time of the injury; or

6. The basis for an award of punitive damages. (1)

   However, courts and commentators alike recognize that evidence of a recall should be excluded at trial because of the policies that encourage recalls of defective products and because of the real prejudice such evidence might create for the jury. Thus, the company's lawyers should seek to exclude all evidence of the recall at trial. Federal Rule of Evidence 407 provides one way to exclude this evidence, urging that the recall is a "subsequent remedial measure" taken "after an injury or harm allegedly caused by an event." (2) Still, despite Rule 407's clear applicability to all product liability actions, evidence of a recall may be admissible if it falls within one of the Rule's limited exceptions. (3)

   This article first discusses the applicability of Rule 407 to the use of recall evidence in prescription product liability actions as well as other products. The article then analyzes the exceptions to Rule 407 that might allow evidence of those recall campaigns to be admitted at trial. The article explores ways such evidence can be excluded. However, in many instances, a company may offer such evidence to show the jury that it actively sought to remedy a problem in a responsible, timely, and responsive manner.

   1. The Admissibility of Recall Evidence--Federal Rule of Evidence 407

   The lawyer for a patient harmed by a recalled prescription product may attempt to offer evidence of a recall for a variety of reasons including an effort to prove the existence of a defect or to prove that the company negligently delayed the recall. However, there are a number of grounds by which a manufacturer can move to exclude evidence of a recall at trial: (4)

1. The recalled product is not the same model, product, or defect as the product at trial. (5)

2. The evidence of a recall is not relevant. (6) 3. The evidence is inadmissible hearsay.

4. Because the recall was involuntary or mandated by federal law it does not rise to the level of an admission. (7)

5. The relevance of the evidence of a recall is outweighed by plaintiff's prejudice to the jury. (8)

6. The recall constitutes a subsequent remedial measure that should be excluded as a matter of law. (9)

   The basis for many of these objections is Federal Rule of Evidence 407.

   1. Federal Rule of Evidence 407--Background

      A manufacturer of any recalled product sued in personal injury litigation should rely upon Federal Rule of Evidence 407 to limit evidence that the jury can hear and consider about the recall. Rule407 excludes evidence of remedial measures taken by a manufacturer, such as a recall, when offered to prove the defendant's liability. A remedial measure of the type described by Rule 407 is one taken by a company to remedy any type of defect such as one in its design, manufacture, or labeling. (10)

      Under the current rule, for a product recall campaign to constitute an inadmissible subsequent remedial measure, the defendant must commence the recall "after an injury or harm allegedly caused by an event." This temporal requirement is satisfied only where the company recalls the product "after the occurrence that produced the damages giving rise to the action." In the context of products liability, where the defendant's culpable conduct is often far removed from the resultant injury, courts interpret the Rule to exclude post-sale recalls that occur before the incident involved in a specific case. (11)

      Two policies justify the exclusion of these efforts. First, evidence of a recall has little relevance in assessing the manufacturer's liability. (12) Indeed, later improvements resulting from the knowledge gained from a recall might be based on factors completely unrelated to any problem with the product. (13) For example, a manufacturer may modify the design of a product to decrease costs, increase efficiency, or increase the marketability of a product. In addition, a company's repair may stem from its discovery that the product is capable of causing harm, rather than negligence in failing to foresee the harm. The second policy to exclude evidence of a recall is to encourage companies to remedy a risk without the very real concern that it might later be used against it in a courtroom. Finally evidence of recall measures should be excluded because of the potential prejudicial effect on the jury.

      Rule 407, incorporating Federal Rules of Evidence 401, 402, and 403, enunciates that whatever probative value a remedial measure might have, it should be excluded from evidence.

   2. Applicability of Rule 407 to Evidence of Recalls in Product Liability Actions

      Under Rule 407, evidence of a recall should be excluded whether the theory of liability is based on negligence or on strict liability either by the language of the Rule or by the fact that strict liability generally does not apply to prescription products in many jurisdictions. (14)

1. To Constitute an Inadmissible Subsequent "Remedial" Measure, the Product Recall Campaign Must "Have Made the Injury or Harm Less Likely To Occur"

   For a defendant's post-accident conduct to constitute an inadmissible subsequent remedial measure, it must, under Rule 407, be such that "if taken previously, [it] would have made the event less likely to occur." A claimed remedial measure is admissible if the measure would not have reduced the statistical occurrence of the injury-causing event. (15) Although a product recall campaign constitutes a subsequent remedial measure, Rule 407's exclusionary scope does not encompass every step in a product recall campaign.

   As a general matter, courts recognize that a defendant's general removal of its product from the marketplace constitutes an inadmissible subsequent remedial measure. However, a court in a prescription product case recently held that a defendant need not entirely remove its product from the marketplace to invoke the protection of Rule 407; the defendant's subsequent measure need only "have made the event less likely to occur."

   The defendant in the case entitled In re Propulsid Products Liability Litigation, (16) moved to exclude evidence of its Propulsid Limited Access Program ("LAP"), and the court granted the motion to exclude evidence of warning labels published after the death of the patient. After plaintiff's death and shortly before ceasing commercial distribution of Propulsid, the defendant created the LAP, which permitted patients with life-threatening diseases to continue using Propulsid. The LAP required patients to "meet certain health and safety criteria and be approved by the Food and Drug Administration before they can begin treating with Propulsid." (17) Defendant conceded that the LAP was feasible when the specific patient used Propulsid, but it argued that the program was not necessary based upon the then-existing knowledge about the defect. Plaintiffs' attorney opposed the motion arguing that "the LAP cannot be a subsequent remedial measure because Propulsid was not withdrawn from the market, and is still available, albeit on a restricted basis." (18)

   The Propulsid court began its analysis by reviewing Rule 407's text and its underlying policy of "'encouraging people to take, or at least not discourage them from taking, steps in furtherance of added safety.'" (19) The court noted that there was "no issue or dispute over ownership, control, or the feasibility of the precautionary measures." (20) The only issue was "whether the LAP adopted subsequent to [plaintiff's] death would have made his death less likely to occur." (21) The difference between the LAP and an inadmissible general recall is the extent to which the product is available. However, "Rule 407 does not exclude the evidence only if the claimant would have had no access to the product at the time of his injury; rather, Rule 407 excludes subsequent measures which would have made the harm less likely to occur." (22) The court concluded that restricted use would have reduced the likelihood that plaintiff would have had access to Propulsid; plaintiff's limited access to Propulsid would have reduced the likelihood that plaintiff would have suffered injury or harm.

   The Propulsid case suggests that Courts appear to be committed to a literal interpretation of Rule 407's text in determining whether a particular measure "would have made the injury or harm less likely to occur." In the context of a recall, the defendant need not entirely remove its product from the marketplace in order for conduct to constitute a Rule 407 subsequent remedial measure; it is sufficient that the conduct would have made the harm "less likely to occur."

   1. Post-Accident Tests and Reports Do Not Make the Injury or Harm Less Likely To Occur and Are Admissible

      Post-accident tests of an allegedly defective product are outside Rule 407's exclusionary scope, even if they are later used to plan the recall campaign. (23) Distinguishing between an admissible test and an inadmissible warning is difficult and often depends on the fact-intensive inquiry as to whether the test was conducted for the purpose of determining the product was defective. (24)

      The current trend is to further restrict Rule 407's exclusionary scope to actual physical repairs. This trend applies to tests and reports that are not only used in a subsequent recall but even those that are necessary to a successful recall. Thus, Rule 407 appears to be limited to the actual recall stage, rather than the investigation, communication, and preparation stages. Although the stated...