Rebecca Trela

About Rebecca Trela

Rebecca Trela represents major pharmaceutical and medical device companies in complex civil litigation, including mass tort and single-plaintiff actions. She defends against claims involving allegations of strict liability, negligence, failure-to-warn, and consumer protection act violations. Read Rebecca's full bio

FDA Gives Guidance on Reporting Medical Device Shortages

Last week, FDA released guidance for life sciences manufacturers that produce medical devices and components “critical to public health,” including materials that support or sustain life, or are used in emergency care or surgery.  If there is an anticipated (or actual) disruption that may result in a shortage based on increased demand or supply-side interruption, the FDA must be notified no later than seven calendar days from the onset.  The requirement to notify the Agency applies to a broad range of devices and equipment, and lasts for the duration of the COVID-19 emergency.

The FDA’s guidance on this topic arises out of the March 27, 2020, CARES Act amendments to the Food, Drug and Cosmetic Act.  Those updates, codified at 21 U.S.C. § 356j, mirror similar provisions for prescription drug shortages implemented in December 2016.  While the statutory provisions contemplate that a device manufacturer would provide notice to the FDA of an anticipated shortage or interruption at least six months in advance, or “as soon as is practicable,” the recent guidance recognizes that this may not be possible under current market conditions.

Continue reading

Dire Consequences: Avoiding Waiver in Pennsylvania Jury Selection

Practicing law at a socially appropriate distance has forced many litigators to broadly consider the value of face-to-face interaction—and what may be lost in its absence.  A recent Pennsylvania Supreme Court opinion highlights the importance of face-to-face interaction between a trial court judge and prospective jurors during voir dire.  It also unfolds a cautionary tale about waiver for counsel who would challenge a prospective juror based on actual bias.

In Trigg v. Children’s Hospital of Pittsburgh of UPMC, 2020 WL 1932639 (Pa. Apr. 22, 2020), the Court found a medical malpractice plaintiff waived her objection to the procedure by which the trial court had evaluated an objection to a juror’s actual bias.  The plaintiff challenged the juror for cause at trial, but argued for the first time in post-trial motions that the judge did not have the chance to observe the person’s “demeanor” because jury selection was overseen by the court clerk, with the challenge evaluated by the judge based only on the transcript record.

Due to its finding of waiver, the Court in its majority opinion “express[ed] no opinion” on the question weighed by the lower appellate court: whether a trial court judge could properly assess a prospective juror’s demeanor in post hoc fashion, or whether it is “essential” for a judge to observe the original voir dire in person.  One of the two concurring opinions, which was signed by five of the seven justices, was not so silent: “[I]t cannot be disputed by anyone who has ever picked a jury that [re-questioning] would have yielded responses that differed in demeanor.” (Donohue, J., Concurring).  The second concurring opinion also agreed: “I do not believe that calling the prospective juror in before the judge for a second round of questioning sufficed to replicate the opportunity for personal observation that the judge already missed.”  (Wecht, J., Concurring).

Underlying Proceedings in Trigg and Finding of Waiver

The Trigg trial commenced in the Allegheny County Court of Common Pleas in March 2017. Pursuant to local custom and consistent with the local rules, jury selection was managed by a court clerk, with a judge available to rule on objections.  The plaintiff did not raise any objection to the absence of a judge during voir dire.

Prospective juror 29 stated that two of her family members were doctors, raising a question about whether she would favor the medical malpractice defendants.  Upon further inquiry, the woman stated that she could follow the judge’s instructions and could decide the case based on the facts and the law.

The plaintiff challenged prospective juror 29 for cause at the conclusion of voir dire.  In presenting her argument, the plaintiff asked if the judge would like to read the individual voir dire transcripts, to which the judge responded, “Whatever you would want to do to make your record on your objection, go right ahead.”

The plaintiff replied: “I think it would be easier because some of them they talked about their biases and whether or not they could be fair. … [J]ust to read it would probably be quicker.”  The plaintiff did not ask the judge to question prospective juror 29 personally, nor did she object to the absence of the judge from the original voir dire.  After reading the transcript, the judge denied the plaintiff’s motion to strike prospective juror 29 for cause. The case proceeded to trial and the jury returned a verdict for the defense.

In her motion for post-trial relief, the plaintiff challenged the judge’s basis for denying the objection to prospective juror 29 because ““[t]here was no opportunity for the trial court to observe the demeanor or tenor of the challenged venireman’s answers.”  The defendants asserted the plaintiff had waived this argument by failing to request that the judge personally question prospective juror 29, thus failing to give the court opportunity to correct the alleged error as required by Pa. R. Civ. P. 227.1(b)(1).

On appeal, the Pennsylvania Superior Court found no waiver because such a request would have been futile: “Re-questioning prospective jurors could never reproduce the authentic reactions that they displayed when the questions were originally asked . . . .  An absentee judge misses the crucial instant when would-be jurors reveal their most inmost selves by both words and actions.”

The Pennsylvania Supreme Court reversed and confined its analysis to the waiver issue.  The Court concluded that the plaintiff should have objected to the judge’s absence from the outset—even though the local rules actually provided for his absence.  The Court also credited the defendants’ argument that the plaintiff waived her arguments because her counsel “merely asked Judge Folino to read the transcript” to asses bias, and “declined to question the challenged juror before Judge Folino, even though they had the opportunity to do so.”

Potential Changing Role of Trial Courts

Both concurring opinions filed by Justice Donohue (joined by Justices Baer, Dougherty, Wecht and Mundy) and Justice Wecht (joined by Justice Dougherty) emphasized the right to a jury in civil jury trials provided by the Pennsylvania Constitution and the essential role the voir dire plays in preserving that right. They also explored Pennsylvania case law on actual bias challenges, focusing on the seminal opinion in Shinal v. Toms, 162 A.3d 429, 440 (Pa. 2017).  A venireperson may be challenged for bias that is either implied or actual. Actual bias arises when a juror’s prejudice “is revealed through his or her conduct or answers.”

As the Shinal court explained:

The juror appears before [the trial judge, who] sees him and hears what is said; and is able to form his opinion as much from the proposed juror’s conduct as from the words which he utters, printed in the record. Hesitation, doubt, and nervousness indicating an unsettled frame of mind, with other matters, within the judge’s view and hearing, but which it is impossible to place in the record, must be considered.

 In other words, Pennsylvania case law makes clear that actual bias is largely evaluated by observing the juror’s conduct face-to-face.

The concurring opinions expressed “reservations” and “deep misgivings” about a civil voir dire process conducted outside the presence of a judge.  Like the Superior Court, both concurrences determined that a second round of questioning would not yield adequate information for a judge to evaluate a prospective challenge based on actual bias.  Each called for the Civil Procedural Rules Committee to consider whether civil jury selection should mirror criminal jury selection, requiring the judge’s presence unless the parties agreed to waive.  Although not part of the holding, this strongly worded guidance leaves little doubt about the value Pennsylvania appellate courts place on a trial judge’s personal observation of jury selection.

Cautionary Tale for Pennsylvania Trial Lawyers

Pennsylvania trial lawyers familiar with the type of jury selection process utilized in Trigg may not be surprised that the plaintiff’s counsel did not object to the absence of the trial judge from the voir dire at the outset of trial.  This may no longer be an issue in Allegheny County: during the pendency of the appeal, Allegheny County amended its local rules, which now permit any party to request a judge preside over civil voir dire and the jury selection process. L. R. Civ. P. 212.2(d).  However, many other counties across Pennsylvania continue to conduct civil jury selection outside the presence of a judge.  Prudent counsel should consider objecting to this process both at the outset and when challenging a prospective juror based on actual bias—even if rules or local custom render the objection futile.

Does Pennsylvania Recognize Strict Liability Claims Against Medical Device Manufacturers? A Pennsylvania federal court calls the question.

For at least two decades, Pennsylvania law has recognized an exemption from strict liability for prescription drug manufacturers based on the state Supreme Court’s interpretation of the Restatement (Second) of Torts Sec. 402A cmt. k.  Comment k carves out an exception to traditional strict product liability claims for “unavoidably unsafe products,” or those which bear inherent risks—such as medicines which must be prescribed by a doctor.  A less settled question is whether that exemption extends to manufacturers of prescription medical devices, specifically regarding manufacturing defect claims.  On June 25, 2019, Judge Robreno of the U.S.D.C. Eastern District of Pennsylvania asked the Third Circuit to answer it.

Continue reading