Search results for: ZOSTAVAX

It has been almost exactly one year since we brought you Part 2 of this Lone Pine story; so, like the court in its most recent decision, we’ll give you a little refresher.  The Zostavax MDL in its fifth year.  Plaintiffs allege that defendants’ anti-shingles vaccine caused them various injuries including shingles, hearing loss, and…

When we last visited the Zostavax MDL last December, over a thousand plaintiffs, all claiming shingles as an injury, had been dismissed because none of them could produce results from the only medical test that could establish causation.  We ended that post with:

The only claims left allege that Zostavax caused a hodge-podge of other injuries.  But it’s safe to say the nucleus of this MDL pretty much self-destructed.

Continue Reading Zostavax − Dredging the Dregs

Earlier this year we blogged about the Lone Pine order entered in the Zostavax MDL that required those plaintiffs alleging that the anti-shingles vaccine caused them to get shingles (1,189 of them) to produce evidence of specific causation by means of a PCR test.  The goal of the Lone Pine order was to winnow out non-meritorious claims.  That was Part 1.  Defendant’s motion to dismiss all 1,189 plaintiffs because not a single one produced the required test result or even asked for an extension – that was Part 2.  Without evidence of specific causation, the court dismissed about half the cases in the MDL. 

Shingles are caused by the same virus that also causes chicken pox, although the adult disease shingles is much more dangerous.  The virus remains in the body for life and can either lie dormant or reactivate and cause shingles.  Almost everyone over the age of 30 in the United States has had chicken pox and therefore carries the “wild-type virus” in their systems.  In re Zostavax Products Liability Litigation, 2022 WL 17477553, *2 (E.D. Pa. Dec. 6, 2022).  The vaccine consists of the Oka strain of the virus, a live-attenuated virus that is a weakened form of the wild-type.  Defendant presented “uncontradicted medical authority” that the only way to know whether a person’s shingles was caused by the wild-type virus or the Oka strain is through a PCR test.  In fact, plaintiffs’ own expert testified that specific causation could only be determined with a PCR test.  Id.  That is the same expert who failed to perform a differential diagnosis ruling out the wild-type virus in 5 bellwether cases that were therefore dismissed on summary judgment.  That is what led to the entry of the Lone Pine order.  If none of the bellwether plaintiffs had sufficient causation evidence, the court wanted to know which plaintiffs did.Continue Reading Lone Pine Stands Tall in Zostavax MDL — Part 2

One of the problems with so-called Lone Pine orders in MDLs is timing – they are usually entered way too late, more as vehicles to enforce settlements than as any genuine effort to weed out the large number of bogus cases that everyone, including plaintiffs, admits are present in MDLs.

We can’t say that the…

Lord knows, there are a lot of meritless MDLs.  Bexis’ and Michelle’s Bone Screw litigation, prompted by a televised CYA freak-out by then-FDA Commissioner David Kessler over an off-label use that had become the medical standard of care, was one, and it gave us Buckman.  Several MDLs against modern anticoagulants, such as Xarelto, are another example, since all of those second-generation drugs were safer than the older forms of blood thinners they superseded.  Currently, the Taxotere MDL – based on the dubious proposition that the plaintiffs cared more about hair loss than most effectively treating their breast cancer – and Zostavax – where not a single plaintiff can prove causation – come to mind.  Our colleagues defending other MDLS can also be excused for believing that their own litigation should be added to this list.

But for sheer factual baselessness, it would be hard to top the still-ongoing Avandia MDL, which somehow has managed to persist since 2007.  The Avandia litigation is infamously based on a purported increased risk that, over a decade ago, the FDA scientifically determined did not exist.  Briefly, a study erroneously found an increased risk of cardiovascular events with Avandia that led to both a boxed warning and additional studies.  The additional studies debunked that supposed increased risk and the FDA removed the boxed warning:Continue Reading Avandia Litigation – Is This Finally the End?

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FDA-regulated products now account for an estimated one-fifth of overall economic activity in the U.S. They have also been the focus of a litigation explosion. This timely guide covers all aspects of litigation involving drugs, medical devices, vaccines and other FDA-regulated prescription products.
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