Merck & Co. could have a growing Zostavax problem on its hands. After several plaintiffs filed lawsuits claiming the drugmaker’s shingles vaccine caused serious injury and death, attorneys say more cases are on the way.
Plaintiffs have sued in state and federal courts in Pennsylvania alleging that Merck’s Zostavax—used to prevent shingles, the painful complication of varicella infection—caused serious side effects, including death.
“I think Merck has failed terribly … to warn about the very serious side effects and the failure of the vaccine to do what they claim it does,” attorney Marc Bern told FiercePharma.
Bern, founding partner at Marc J. Bern & Partners, said his firm has “thousands of complaints” yet to be filed in Philadelphia, with the injuries running “the gamut from contracting shingles as a result of the vaccine all the way to serious personal injuries such as blindness in one eye, individuals who have serious paralysis in their extremities, brain damage, all the way to death.”
In a statement, Merck said it “stands behind the demonstrated safety and efficacy” of the shot, which is licensed in 50 countries.
“Nothing is more important to Merck than the safety of our medicines and vaccines,” a spokesperson told FiercePharma. She said the company has distributed more than 36 million doses of the shot since its 2006 approval. Before winning a FDA nod, Zostavax’s safety and effectiveness were studied in more than 30,000 patients, and a CDC committee continues to recommend its use, she pointed out.
“The company has continuously provided appropriate and timely information about Zostavax to consumers and to the medical, scientific and regulatory communities,” according to Merck’s statement.
Bern said he believes the cases should be grouped for mass tort status. Speaking with the New Jersey Law Journal, Lopez McHugh attorney Michael Katz, who filed several Zostavax injury cases in federal court, said he believes hundreds more are yet to come. Katz also believes the cases should be grouped together.
Zostavax pulled in $749 million in sales last year for Merck.
Meanwhile, Merck’s vaccines rival GlaxoSmithKline has filed for FDA approval for its challenger to Zostavax, Shingrix, which is expected to significantly shake up the market upon launch.