The spate of lawsuits continues against Merck & Co. related to its shingles vaccine called “Zostavax.” Zostavax was approved by the U.S. Food & Drug Administration (FDA) in May 2006 as a shingles vaccine and was specifically designed and marketed for use by patients over the age of 50. However, the complaints about Zostavax began almost immediately with thousands of reports that, after use of Zostavax, patients actually developed shingles and other serious complications.

Over 36 million patients have been injected with Zostavax since it was approved. Merck has earned on average $685 million a year on sales of the vaccine. However, it is unclear if the vaccine is actually effective. According to reports, in clinical trials, shingles occurred in 1.7 percent of Zostavax patients, vs. 3.3 percent of unvaccinated adults over 60. So, essentially Zostavax is effective about 50 percent of the time.

Further, although supposedly marketed and approved for patients over 50 years of age, the vaccine appears to be most dangerous for just those patients since older patients tend to have weaker immune systems than younger patients. Use of Zostavax has shown to cause complications in patients who have compromised immune systems.

In this article, we provide a discussion of some Zostavax litigation around the country. There are hundreds of cases. Procedurally, Merck is defending many cases on statute of limitations grounds — two years here in Georgia (and in many jurisdictions). In general, there are circumstances where a patient can extend the statute of limitations and some plaintiffs are having success in making those factual arguments. Merck is also defending the cases on all other legal grounds.

Survey of Cases and Consolidation In Pennsylvania Federal Court

Cases against Merck with respect to Zostavax date to at least 2011. The first case might be a case filed in federal court in New York by Elizabeth Ohuche in 2011. She claimed that in 2009, she was given the Zostavax vaccine by her doctor. She claimed that a few days after the injection, she developed severe headaches, a fever and, thereafter, developed excruciating pains followed by mumps, boils and eruptions all over her face followed by clustered and very painful rashes. (As an aside, these symptoms are consistent with Ohuche contracting shingles.) Plaintiff further claimed that, over the next couple of years, she lost partial sight in her right eye and that she continued to be “very ill and confined in bed.” See Ohuche v. Merck & Co., 903 F. Supp. 2d 143 (S.D.N.Y. 2012).

Ohuche filed suit against Merck without an attorney. As such, she had difficulty presenting the correct kind of evidence and presenting enough evidence to satisfy the federal court’s standards. Her case was eventually dismissed because her doctor testified that she knew the risks of receiving the vaccine. Consequently, the court held that she had a better case of medical malpractice against her physician than a case of product liability against Merck.

More recently, a case was filed against Merck in February 2017 in Philadelphia. In that case, the plaintiff, Jorja Bentley alleged claims similar to Ohuche. According to reports, within 24 hours of receiving the Zostavax vaccine, Bentley began experiencing headaches, dizziness, and blurred vision. She claims that she eventually suffered loss of vision — which continues — and from high blood pressure which she attributes to the injection of Zostavax. See Bentley v. Merck & Co., Inc., Case No. 161004102. Ms. Bentley’s case was eventually removed to federal court. See here.

As noted, Ms. Bentley’s case is just one of hundreds now pending across the country. Indeed, there are so many cases in federal court that Merck asked to have the cases consolidated into multi-district litigation. That was approved on August 2, 2018.

Bentley’s case was among those consolidated. In addition, the Order consolidated cases and transferred them to the Eastern District of Pennsylvania from district courts in Florida, Massachusetts, New Jersey, New York, Pennsylvania, and Wisconsin. There were 57 cases consolidated via the Order with another 41 pending cases likely to be added to the list from other federal district courts. In all cases, the various plaintiffs asserted that medical complications resulted shortly after they received the Zostavax vaccine. The various complications alleged include:

• Shingles
• Herpes encephalitis — brain damage
• Optical nerve damage — damage to the eyes
• Kidney damage
• Liver damage
• Bell’s palsy — damage to facial muscles causing half the face to appear to droop
• Guillain Barre Syndrome — a neurological disorder where the body’s immune system attacks the peripheral nervous system causing tingling and pain, and eventual paralysis
• Viral-related illnesses and injuries

The above list is not inclusive. The causes of action all involved claims with respect to insufficient warning of risks and known complications, improper design, inadequate testing, failures in the manufacturing and regulatory processes, improper and/or inadequate labeling and/or instructions and deceptive marketing.

To date, no cases have gone to trial.

Prescription Drug Liability Attorneys: Zostavax and the Statute of Limitations

As noted above, Merck is defending all of the cases and one main argument being used is the statute of limitations. In general, the law gives various persons who are injured only a limited amount of time to file their lawsuits. With products liability cases, the most common statute of limitations is two years. That is the statute in Georgia. As a consequence, if an injured person was injected with Zostavax more than two years ago, the person will have some difficulty with their lawsuit. This was the result in one recent case, for example. See Juday v. Merck & Co, Case No. 17-2081 (US 3rd Cir. April 4, 2018) (non-precedential). In that case, the plaintiff was injected in 2014, but did not file her lawsuit until 25 months later. The applicable statute of limitations was 24 months from the date of harm. The trial court dismissed the case because of the breach of the time limitation. The plaintiff had no evidence to suggest that he was entitled to more time. The plaintiff received his injection on March 2, 2014 and began suffering complications — coughs, bumps, and rashes — by March 13, 2014. The plaintiff called his employer on the 13th to say he was sick because of the vaccine injection. Taken as a whole, the court held the plaintiff to have known about the cause of his complications — the Zostavax injection — at least as late as March 13, 2014. The case was not filed until April 2016. The dismissal was affirmed by the Court of Appeals. 

Defective Drugs Attorneys — Contact the Roger Ghai Law Offices

If you have been injured or have suffered complications from use of Zostavax, call the experienced personal injury attorneys at the Roger Ghai Law Offices. Call now because deadlines must be met. As we saw from Elizabeth Ohuche’s case, products liability cases are complex and you need proven and experienced attorneys to help you. We here at the Roger Ghai Law Offices have years of experience recovering compensation on behalf of clients who have been injured by a defective products and medications.

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
• Misrepresentation
• 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.

Approved by the U.S. Food & Drug Administration (FDA) in 2006, the vaccine called Zostavax — made and marketed by Merck & Co. — was designed to be a vaccine against the shingles virus. However, since 2006, the medical evidence and reports suggest that use of Zostavax might be dangerous and has led to serious medical complications.

If  you have been injured or suffered medical complications or if a loved one has died from complications caused by use of the Zostavax shingles vaccine, then you are entitled to sue for compensation for your injuries or for the wrongful death. Since 2006, over 36 Million Americans were injected with Zostavax, and there have been thousands of reports about complications following injection. Merck earned as much as $685 million on sales of the vaccine, but safety and effectiveness are in clear doubt.

In this article, we discuss some of the known complications from use of the Zostavax vaccine. In two companion articles, we will detail how personal injury cases work here in Georgia and discuss the status of Zostavax litigation around the country.

Georgia Dangerous Medications Litigators — Background on Shingles 

Shingles is a painful rash caused by a virus — varicella zoster — that usually causes a “band” of infected tissue on the torso, legs, face or other parts of the body. Often — although not always — the infected skin blisters, and these blisters are contagious at that stage. The virus — the same virus that causes chickenpox — tends to lie dormant after infection, being held in check by the body’s immune system. But, if the immune system is compromised — by stress, medication, bodily trauma or disease — then varicella zoster can become active resulting in the rash and/or other conditions. The risk of contracting shingles rises as you age. It is reported that one-third of Americans eventually get shingles, and by age 85, half of adults will have had at least one outbreak of shingles. See a related article in the New York Times here.

Many have heard about shingles since, famously, David Letterman contracted the condition back in early 2003. He was unable to host his late night television show for nearly a month. See here. Shingles is quite painful and, as Letterman said: “I had the shingles really bad, and part of the concoction of drugs they give you to fight that pain are pretty serious.” See here. Eventually, after he stopped taking the pain medications, Letterman ended up with serious bouts of depression and nervous anxiety. As Letterman’s experience shows, shingles is serious painful condition and not one to be taken lightly.

In addition to the painful rash, the shingles virus can cause other medical conditions. About one in five of those infected with the virus contract post-herpetic neuralgia (PHN) which is the most common complication of shingles. PHN is a feeling — or phantom — of pain, tingling, itching or burning where the shingles appeared but after the rash itself has healed. Shingles that develops near the eyes can create a risk of vision loss or lessening, optic nerve damage and glaucoma. Similarly, shingles that develops in the ear canal or on the ears can cause tinnitus, hearing loss, ear pain, vertigo and loss of balance caused by damage to the interior of the ears.

Other conditions and risks include:

• Cardiovascular damage leading to possible heart attack and or stroke
• Meningitis — nerve and/or tissue damage or inflammation to spinal cord
• Encephalitis — the same as meningitis, but to the brain
• Disseminated varicella — infection of internal organs such as the lungs and liver
• Increased risk of secondary bacterial infections and attendant complications
• Death

Background on Merck & Co.’s Zostavax

Given the seriousness of shingles, pharmaceutical companies have engaged in the research to develop a vaccine for the virus. The process for creating vaccines is now very well-known and understood to medical science. In simple terms, a live version of the virus is mutated so that it is not dangerous to the body. That mutated version — the vaccine — is then injected into the body and it tricks the body into thinking there is an infection of the “real” virus. The body then produces antibodies which fight the infection and keep the body from succumbing to an outbreak of the “real” virus.

Zostavax was designed in just this manner. In the medical literature, it is called a “live attenuated vaccine.” In general, vaccines can be administered in one to several doses and can be placed under the skin or injected deeper into muscle tissue. Zostavax is administered in one dose and is placed under the skin. By comparison, a new vaccine — called Shingrix — is two-dose and is muscle-injected.

As noted, Zostavax was approved by the FDA in 2006 and was available on the market shortly thereafter. Almost immediately, patient complaints began. Since Zostavax is a weakened version of “live” varicella zoster virus, those with a weakened immune system ended up actually contracting shingles or experiencing the other serious complications associated with the virus. Zostavax was specifically approved for patients over the age of 50, but it was just this group of patients who were experiencing the complications.

Defective Drugs Attorneys — 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 can help you seek money damages to compensate you for your medical bills, pain and suffering. Proving liability and recovering damages in vaccine cases is complex and requires the most experienced and skilled lawyers to maximize your chances of success. 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.