Failure to Warn
The plaintiff says in her petition that the Zostavax vaccine’s patient information sheet and label and prescribing information failed to warn of the risk of viral infection. Her complaint referenced several reports that followed the vaccine’s introduction in 2006. The reports linked Zostavax to viral infections leading to disease of the central nervous system.
Shingles Warning Label Added
Merck added a warning to Zostavax’ label in August 2014, which said the vaccine could raise one’s risk of getting shingles, but that warning never reached the plaintiff, according to her petition. There can typically be lag time between the announcement of a label change and any label changes actually taking effect; so legal arguments in the case will at least partly concern whether that label change ever reached the Plaintiff.
The plaintiff said in her petition: “Despite this information and the potential correlation between being administered the Zostavax vaccine and developing an infection within a relatively short period of time, leading to the development of shingles or varicella-zoster virus pneumonia, Merck failed to properly address and provide this information both to patients and the medical providers prescribing the vaccine.”
Shingles Vaccine approved by FDA
The shingles vaccination is approved by the U.S. Food and Drug Administration for the prevention of shingles in people 60 and older. The plaintiff received the shot in November 2014, according to her petition. Shortly afterwards, she said she developed a headache, dizziness, blurred vision. Her complaint said she continues to suffer from injuries to her right eye, elevated blood pressure, headaches, and dizziness. She said the only warnings she received with documentation that accompanied the vaccine indicated the possibility of rash and itching at the injection site.
Vaccine Safety Questioned in Scientific, Medical Journals
The plaintiff in her petition blames Merck & Co. for making and marketing the vaccine when it was aware of the infection risks. She referenced several scientific and medical journals that have questioned the vaccine’s safety.
Merck Shingles Vaccine Lawsuit Filed
The complaint includes claims for negligence, design defect, failure to warn, breaches of express and implied warranties, fraudulent and negligent misrepresentation, unjust enrichment. The plaintiff also seeks punitive damages.
Shingles Vaccine Attorney
The plaintiff’s attorney said, “We’ve been looking at this potential case for sometime, and we believe it is highly meritorious. (We) believe the vaccine is at best 50 percent effective. Either it is not effective, or it has caused shingles and other issues, like in this case, where it has caused a serious opthamological complication.”
Shingles Vaccine from Jacked-up Chickenpox Vaccine
The shingles vaccine shot for artificial immunity is primarily a more potent version of Merck’s chickenpox vaccine, Varivax. Zostavax came from Merck’s European joint vaccine venture with Sanofi. Merck and Sanofi disbanded in 2016.
The case is Bentley v. Merck & Co. Inc. et al, case number 161004102 in the Philadelphia County Court of Common Pleas.