Merck Sued for Side Effects of ZOSTAVAX Shingles Vaccine

An individual filed suit on Wednesday in the Eastern District of Pennsylvania against defendant Merck & Co., Inc. (Merck) and Merck Sharp & Dohme Corp. (MSD), alleging that Merck and MSD engaged in the production and promotion of the ZOSTAVAX vaccine with full knowledge that the product had the capacity to be hazardous and dangerous. The plaintiff asserts that the defendants were negligent in the way they designed, manufactured and marketed the product.

According to the complaint, ZOSTAVAX is a shingles vaccine intended to provide “long-term prevention and protection against shingles and other zoster-related conditions and disease.” Shingles is a disease which can lead to serious complications, some of those including “scarring, bacterial superinfection, ocular and neurological injuries, allodynia, cranial and motor neuron palsies, pneumonia, encephalitis, hearing loss, and death.” As noted in the complaint, the FDA approved ZOSTAVAX in 2011 based on the results of the vaccine in a Shingles Prevention Study supported by Merck. Studies by Merck have revealed that ZOSTAVAX is initially 51% effective, but that percentage dramatically decreases over time.

The plaintiff claims that ZOSTAVAX is a live-attenuated vaccine, meaning it uses a weakened form of the disease it is intended to treat. Accordingly, these types of vaccines have specific shelf lives – the longer they go unused, the less potent they become. The plaintiff asserts that non-live zoster vaccines are just as effective as live-attenuated ones like ZOSTAVAX, and they maintain efficacy over time whereas live-attenuated ones do not. Merck has held the necessary patents to produce a non-live zoster vaccine for almost 40 years.

In early 2014, the plaintiff received ZOSTAVAX after relying on the warning label on the packaging, which specified that the vaccine was “effective in preventing shingles on a long-term or permanent basis, and that it did not carry any significant risks of adverse effects.” The plaintiff was later treated for shingles and other zoster-related conditions. The injuries she sustained from shingles are injuries that she claims were a direct and proximate result of her use of ZOSTAVAX.

The plaintiff contends that the defendants engaged in tortious and fraudulent conduct due to their “intentional concealment of material information from the public, and intentional misrepresentation of material information and/or downplay of the serious risks and dangerous defects.” These actions allegedly resulted in the misleading of the plaintiff, healthcare providers, the medical community, the general consuming public, and the FDA.

Although McKesson was the official distributor of ZOSTAVAX, the complaint explains that the defendants, Merck and MSD, used McKesson’s authority to create and publish a promotional campaign for ZOSTAVAX and to develop the vaccine information statement. Specifically, the document details that in terms of ZOSTAVAX, “Merck and McKesson have no separate minds,” meaning the actions that were taken by McKesson were also decided on by the defendants. Due to the collaboration between the defendants and McKesson, the complaint concludes that liability can be extended to the defendants regarding actions taken by McKesson.

The plaintiff’s complaint cites counts of negligence, product liability, design and manufacturing defect, failure to warn, breach of express and implied warranty, and unjust enrichment. The plaintiff seeks general, statutory, exemplary and punitive damages, pre and post-judgement interest, litigation fees, and any other relief deemed necessary by the court.

The plaintiff is represented by Marc J. Bern & Partners LLP.