The shingles vaccine marketed under the trade name “Zostavax” was approved by the U.S. Food & Drug Administration (FDA) in May 2006. However, since its approval and widespread use, there have been more than 42,000 reports of complications from use of shingles vaccines including 128 related deaths, 850 hospitalizations, and 660 related disabilities. See report here. Not all of those reports are related to Zostavax, but based on the medical evidence, it is clear that use of Zostavax can be dangerous, even deadly, particularly for those with compromised immune systems. Examples would include those with HIV, cancer, those needing blood thinners, and others
Here in Georgia, if you or a loved one has been injured by the use of dangerous drugs or defective medications or medical devices, you — the innocent victim(s) — are entitled to sue under Georgia products liability law. Thousands of Georgia citizens are injured every year by defective products including medical-related products. In this article, we discuss general principles of George products liability laws and how they apply to those injured by use of Zostavax. In two companion articles, we provide detailed information about Zostavax, about shingles and the current status of Zostavax litigation around the country.
Principles of Product Liability
Georgia products liability laws are intended to protect consumers from potential dangers that result from defective and dangerous products. If a product, device, or medication causes injury, Georgia courts apply the laws of products liability to ensure that the businesses or manufacturers bear the burden of paying for the injuries or damages that their products cause. Products liability is a subset of the law of negligence. Georgia law imposes a general duty on all persons to use “ordinary care” to protect others against unreasonable risks of harm or injury. See the Georgia tort statute at O.C.G.A. § 51-1-2.
As an example, you have to use “ordinary care” when driving your car or another vehicle on the roads and highways of Cobb County and the rest of Georgia. Failure to use “ordinary care” will result in your being held liable if there is an accident.
This bedrock principle applies to products that are manufactured and placed into the “stream of commerce.” The manufacturers and sellers must exercise ordinary care to make sure that their products do not cause injury. In general, there are four ways that products can be considered dangerous giving rise to a products liability lawsuit:
- Design defects – the product is designed wrong; is inherently unsafe
- Manufacturing defects – the product was properly designed, but some defects occurred in the manufacture; defective tires are a good example here
- Warning defects – many products are dangerous if not used properly or if used by the wrong individuals; insufficient safety warnings, inadequate or faulty labeling, or incorrect/inadequate instructions can give rise to products liability claims
- Advertising defects — the product was advertised/marketed in a false or fraudulent manner
Product liability cases are complex; dangerous pharmaceutical product liability cases are even more complex. It generally requires the testimony of experts to establish one or more of the above failures. As a reminder, there are two types of witnesses: eyewitnesses and expert witnesses. The former testify with respect to matters that they personally witnessed or experienced. The latter testify with respect to technical matters with respect to which they have knowledge because of their training, education or long experience.
Experts are needed for product liability and dangerous drug cases because most folks do not have the necessary training and education to be able to say whether Zostavax was designed defectively, whether it was manufactured incorrectly, whether the warnings on the label were inadequate, or whether the marketing of Zostavax was false and/or deceptive. As such, experts are needed to provide the evidence necessary to establish any of these facts at trial.
To give just one example with respect to Zostavax, one common method of proving a “design defect” is to compare the “target” product — here Zostavax — to other similar products on the market. In this regard, an expert would be retained for the litigation to compare Zostavax to a new shingles vaccine called Shingrix. Shingrix was approved by the FDA in 2018. Shingrix was developed and is manufactured by GlaxoSmithKline. According to most medical and news reports, Shingrix is more effective and safer than Zostavax. Indeed, the US Centers for Disease Control and Prevention now recommend that Shingrix be used for patients over the age of 50. See the Business Insider news article here. By comparing Zostavax to Shingrix, the expert might be able to show how Zostavax was defectively designed.
As another example related to labeling and failure to warn, if the warning given is adequate or if the patient took the vaccine with full knowledge and understanding of the potential side effects, then that will defeat the liability. This is what happened in the case of Ohuche v. Merck & Co., 903 F. Supp. 2d 143 (S.D.N.Y. 2012). In that case, Merck was held not liable on summary judgment for alleged complications caused by Zostavax because the patient knew about the risks.
Aside from proving the defect or failure to warn, as with negligence cases generally, there must be proof of causation. That is, the victim of a dangerous prescription drug must show a causal link between use of the medication to the complication, injury or death that resulted. Causation is also something that must generally be shown through the use of expert medical testimony.
Georgia Prescription Drug Liability Attorneys: Zostavax as a Dangerous Drug
From the foregoing, if you have been injured from the use of Zostavax, your skilled and experienced attorneys will likely sue for products liability on all theories including:
- Design defect
- Manufacturer defect
- Failure to warn
- Negligence per se
- Fraudulent concealment
- Consumer fraud and unfair trade/advertising practices
The failure to warn cause of action is particularly viable since it became clear early on that Zostavax was dangerous. With a proper warning label and/or adequate instructions to physicians and others prescribing Zostavax, complications for patients might have been avoided. Further, Merck & Co. actually changed the labeling for Zostavax in 2014, adding language that cases of shingles had been reported after use of Zostavax. Then, in 2016, the labeling was changed again, this time adding language that cases of necrotizing retinitis had been reported after use of Zostavax. See report here. However, the additional language — even if deemed legally adequate — came too late for any patient suffering those complications prior to the labeling changes.
Contact the Roger Ghai Law Offices
If you have been injured or have suffered complications from use of Zostavax, call an experienced personal injury attorney like the ones at the Roger Ghai Law Offices. We here at the Roger Ghai Law Offices are proven and have years of experience recovering compensation on behalf of clients who have been injured by defective products and medications. We have a proven track record with other dangerous prescription drugs such as the blood thinner Xarelto. We provide legal services for the residents of Cobb County including the communities of Kennesaw, Acworth, Marietta, and the surrounding areas. Click here to schedule your consultation.