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Consolidation is governed by Fed. R. Civ. P. 42(a), which provides that: If actions before the court involve a common question of law or fact, the court may: 1) join for hearing or trial any or all matters at issue in the actions; 2) consolidate the actions; or 3) issue any other orders to avoid unnecessary cost or delay. Proper application of Rule 42(a) requires a district court to determine whether the specific risks of prejudice and possible confusion from consolidation were overborne by the risk of inconsistent adjudications, the burden on parties, witnesses, and available judicial resources posed by multiple lawsuits, the length of time required to conclude multiple suits as against a single one, and the relative expense to all concerned of the single-trial, multiple-trial alternatives.
Defendant Boston Scientific Corporation manufactured a transvaginal mesh prescription medical device called the Obtryx Transobturator Mid-Urethral Sling System. The Obtryx was designed to be permanently implanted as a treatment for severe stress urinary incontinence. The FDA approved the Obtryx in 2004 under the 510(k) process for medical device approval. The approval was premised that the device be substantially equivalent to a device already legally on the market, and thus did not require clinical trials before it was marketed. The Obtryx is made of Marlex polypropylene. The plaintiffs' experts Carol Sue Campbell and Chris Rene Wilson et al., testified at trial that Marlex can degrade when implanted transvaginally, and that it can elicit scar tissue that causes the mesh to shrink. Plaintiffs received Obtryx implants to treat their severe stress urinary incontinence and they alleged that they experienced severe complications from the implants. Each of them filed separate lawsuits against defendant. Prior to their individual cases being filed, the judicial panel on Multidistrict Litigation had created MDL 2326. The plaintiffs filed their separate cases directly in this MDL, with each seeking compensatory and punitive damages based on theories of negligence and strict liability for both design defects and failure to warn. The district court consolidated eleven cases for trial under Federal Rule of Civil Procedure 42. At the close of discovery, defendant moved to conduct separate trials for the remaining cases, arguing that the similarities did not predominate but this was denied. Prior to trial, the court also decided two evidentiary motions relevant to this appeal. Defendant moved to exclude evidence of the Marlex polypropylene's MSDS, but the district court denied this motion. However, the district court granted the plaintiffs' motion to exclude evidence concerning the FDA's 510(k) process and approval. Following the trial, the jury returned verdicts awarding past-compensatory damages and punitive damages to each plaintiff. Additionally, the jury awarded future-compensatory damages. Since trial, defendant has reached settlements with two of the plaintiffs, while defendant appealed the judgments in favor of the remaining two plaintiffs on the grounds that the district court abused its discretion by consolidating the four cases for trial, by permitting the MSDS evidence, and by excluding the FDA 510(k) evidence. Defendant also challenged the verdicts for lacking sufficient evidence. Finally, defendant challenged the punitive damages awards based on what it asserts was an erroneous jury instruction.
Was the trial unfair because of consolidating four independent cases?
The court affirmed the decision and held that in product liability litigation concerning a particular medical device, Fed. R. Civ. P. 42(a) consolidation of four cases was appropriate because common questions of law and fact formed a substantial part of each lawsuit. Therefore, there was lessened litigation costs and reduced need for expert testimony. The court also found that the district court took appropriate measures to ensure that distinct questions of fact and law could be developed at trial and distinguished by the jury. The court found that there was no showing of defendant’s prejudice, and it saved judicial resources. Likewise, the court ruled that defendant’s compliance with FDA regulatory approval process was properly excluded under Fed. R. Evid. 403 because it did not say much about product safety. Lastly, the court held that there was sufficient evidence to support the claims, and the district court correctly instructed the jury as to the standard for punitive damages as it existed at the time of trial.