Appellate Court Tosses Out 1,200 Shingles Vaccine Injury Lawsuits Against Merck
- by Carolyn Hendler, JD
- Published
- Risk & Failure Reports
The Third Circuit U.S. Court of Appeals dismissed approximately 1,200 lawsuits filed against Merck & Co. over its shingles vaccine, Zostavax. The Appellate Court upheld a U.S. District Court ruling that threw out the lawsuits for failing to abide by a court order requiring them to provide clinical test results.1
Zostavax, the first shingles vaccine on the market, was licensed in 2006 but was discontinued in the United States in 2020,2 while GlaxoSmithKline’s SHINGRIX was licensed in 2017 and is still in use in the U.S. today.3
The original Zostavax lawsuits were filed against the drug giant in 2020.4
District Court Requires Plaintiffs to Submit Threshold Evidence
The district court order issued by Judge Harvey Bartle in 2022 referred to as a Lone Pine order, required the plaintiffs to submit blood test results in the early stages of litigation as threshold evidence to prove their lawsuit had merit. The theory behind a Lone Pine order is that by requiring plaintiffs to submit certain threshold evidence, meritless cases will be dismissed early on in litigation.5 It is a method used in large tort cases, which forces the plaintiffs to show prima facie injury (a true or valid injury on its face6) and causation by a certain date or the case will be dismissed.7
District Court Sides with Merck, Throws Out Similar Cases
Prior to issuing the Lone Pine order, the same district court judge granted Merck summary judgment in five other similar cases.8 A summary judgment motion is brought when one party alleges that a trial is not necessary as the other side has no valid claims or defenses for the judge or jury to consider. The moving party argues that they are required a judgment as a matter of law due to there being “no genuine issues as to any material fact.”9
The motion for summary judgment was submitted by Merck when the bellwether plaintiffs failed to produce polymerase chain reaction (PCR) tests to show that they contracted shingles from the vaccine and not from past chicken pox infections. According to Judge Bartle, the PCR tests were necessary to prove specific causation and without it, the plaintiff’s expert witness was barred from testifying. In order to prevent a similar outcome in the almost 1,200 other lawsuits pending against Zostavax, the judge also ordered all other plaintiffs to submit PCR tests.10
When a person is infected with the varicella zoster (chickenpox) virus, it stays dormant in the body for years and be reactivated later in life causing a constellation of symptoms (painful blistering rash on the torso and sometimes the face) known as shingles (herpes zoster).11 Judge Bartle concluded that most people over the age of 30 have had the wild-type form of varicella-zoster from having chickenpox as a child.12
Judge Bartle said that Merck showed the court…
“uncontradicted medical authority” [that a the PCR test was] “the only way to tell whether the shingles was caused by the virus strain contained in Zostavax or by the wild-virus strain from chickenpox closeted in a person’s body.13
PCR Testing is Not Standard Treatment for Shingles
The issue with requiring PCR tests be submitted so long after the plaintiffs suffered from shingles, which they allege was caused by Zostavax, is that a PCR test can only be done when one is actively suffering from shingles. Requiring plaintiffs to perform the testing years after their shingles outbreak will not yield accurate results. It is not standard treatment to get a PCR test when suffering from shingles, so almost none of the plaintiffs had PCR tests available to meet Judge Bartle’s threshold requirement.14
Conceding that he had broad discretion as a trial judge overseeing thousands of lawsuits over multi-jurisdictions, the Third Circuit Court of Appeals found that Judge Bartle did not abuse his discretion when he ordered the plaintiff’s to meet the threshold requirement of providing PCR test results. The Appellate Court decided that the plaintiff’s had enough time to show how they would prove specific causation—that the vaccine gave them shingles—without PCR testing, but failed to do so.15
The Appellate Court stated:
To put it bluntly, if plaintiffs had a way to prove specific causation, ‘common sense dictates that it would have surfaced by now. We therefore conclude the district court did not abuse its discretion in dismissing the [cases] instead of allowing them to proceed to summary judgment.16
The court’s decision is unpublishable and may not be used as precedent in subsequent cases. According to plaintiff’s lawyer, Howard Bashman, this is a good thing as this case demonstrates how a Lone Pine order can deprive almost 1,200 plaintiffs of the procedural protections granted by the summary judgment process.
Bashman explained the court’s error was in requiring the plaintiffs to prove specific rather than general causation at this stage of litigation. Law professors, Nora Freeman Engstrom of Stanford Law School and Elizabeth Burch of the University of Georgia agreed with him, saying, “Numerous courts have recognized that Lone Pine orders can tempt courts to trammel on plaintiffs’ rights.”17
Bashman said:
We fundamentally disagree with the decision. [The ruling, would otherwise permit trial courts to use Lone Pine orders as] “an impermissible substitute for summary judgment without affording plaintiffs the protections of summary judgment.18
The plaintiffs have the option of appealing the decision to the U.S. Supreme Court.19
If you would like to receive an e-mail notice of the most recent articles published in The Vaccine Reaction each week, click here.
Click here to view References:
No comments:
Post a Comment