Using pharmaceuticals, drugs, vaccines, and medication involves introducing outside materials into the body. This can cause anxiety in some people who may not be clear about exactly what is going into their body. Patients have to rely on the medical advice of their doctors to be comfortable taking a certain medication or vaccine.
Even with the assurance of your doctor, most drugs carry some risk of side effects. Many people may suffer no negative side effects or even have positive side effects. However, negative side effects can range from minor effects like nausea or fatigue to more serious side effects, like liver problems and brain infections.
Unfortunately, if you were injured because of a COVID-19 vaccine side effect, you may be limited in your legal options to file a claim. Lawmakers built-in extra protections for doctors, hospitals, and drug companies for injuries related to the coronavirus pandemic. This may include any side effects of the COVID vaccine. However, if you suffered a serious injury, you may still be able to recover damages for medical malpractice.
If you or a loved one was injured because of a medication side effect, contact our office today online or by phone at 800-529-6162.
The SARS-CoV-2 virus spread quickly across the world in early 2019 causing coronavirus, also known as COVID-19. The coronavirus is from a group of RNA viruses that cause diseases in humans and other animals. These viruses generally involve some respiratory tract infections. The common cold can be caused by coronavirus, as well as much more severe varieties, like SARS, MERS, and COVID-19.
Governments, researchers, and drug makers acted quickly to try and develop a vaccine to reduce the risk of serious injury caused by COVID-19. Various groups worked together to share information about the virus, including the genetic sequence. This information was used to develop various vaccine types, including mRNA vaccines, adenovirus vector vaccines, and inactivated virus vaccines.
In the United States, there were 3 approved vaccines used for COVID, generally referred to as:
- Pfizer-BioNTech vaccine
- Moderna vaccine
- Johnson & Johnson (or Janssen) vaccine
Both the Pfizer and Moderna vaccines were mRNA vaccines. According to the Centers for Disease Control and Prevention (CDC), “Messenger RNA (mRNA) vaccines teach our cells how to make a protein that will trigger an immune response inside our bodies.”
mRNA vaccines teach the body how to make a protein that triggers an immune response. The immune system can then produce antibodies to reduce the risk of infection if the real virus enters the body. The mRNA vaccines do not use a live virus or inactivated virus. Although the widespread use of mRNA was new, the science has been studied for decades.
Some of the side effects of the mRNA vaccines were known through initial testing and before it was provided to the general public. Other side effects have become known since the widespread use of the vaccines. Side effects of a Pfizer or Moderna vaccine can include:
- Pain, redness, and swelling at the area of the shot
- Muscle pain
In some cases, the vaccine can cause severe allergic reactions. According to Moderna, severe allergic reactions generally occur within a few minutes up to an hour after the dose. Other rare but serious side effects that were reported during post-authorization include myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the lining outside the heart). Myocarditis and pericarditis can occur within a few days of the second dose and symptoms include:
- Chest pain
- Shortness of breath
- Fast-beating, fluttering, or pounding heart
Viral Vector Vaccine
The other widely administered type of vaccine in the U.S. was the Janssen or Johnson & Johnson vaccine. Instead of using mRNA, the viral vector vaccine uses a harmless version of a virus that is unrelated to the COVID-19 virus. This helps the body build proteins to protect against the COVID-19 disease.
Many people were waiting for the J&J vaccine as an alternative to the mRNA vaccines because it only required one shot. However, since they were introduced, the mRNA vaccines are preferred by the CDC because of some of the risks associated with serious adverse events. The minor side effects of the J&J COVID vaccine include:
- Soreness at the site
- Fever and chills
- Muscle pain
However, there were some more serious side-effects that were reported in rare cases involving the Janssen vaccine, including:
- Severe allergic reactions
- Thrombosis with thrombocytopenia syndrome (TTS)
- Guillain-Barré Syndrome (GBS)
TTS can cause blood clots and low platelet counts. GBS is an immune system disorder that damages the body’s nerve cells, which can cause muscle weakness and paralysis. GBS was more common in men ages 50 years and older.
Lawsuits for Defective Drug Injuries
Drug manufacturers can be liable for injuries caused by dangerous side effects of medication, especially when the drug companies knew about the risks but failed to disclose the dangers. Drug approval by the Food and Drug Administration (FDA) goes through a lengthy testing and review process. Drug companies have to put out warnings about known risks and side effects but there may be unknown risks that develop over time.
Negligence Claim Against Drug Makers
To file a claim against a drug company for damages, the injury victim generally needs to prove a product liability claim or negligence. Negligence is the failure to exercise due care that causes an injury. In order to prove a negligence claim, the injury victim needs to prove 4 elements:
- The defendant owed the plaintiff a duty of care;
- The defendant breached the duty of care;
- The breach caused the plaintiff’s injury; and
- The plaintiff suffered harm or damage as a result.
However, proving negligence can be difficult against large companies. Instead, most drug defect claims involve a product liability claim. With a product liability claim, the injury victim does not need to show negligence but only that the product was unreasonably dangerous.
Product Liability Claim Against Drug Makers
Under product liability claims, manufacturers, suppliers, and distributors may be held liable for any injuries caused by their dangerous products. Showing product defects generally involves showing there was a defect, the defective product was used as intended, and the injury victim suffered damage caused by the defect. Product defect claims generally fall into one of the following 3 categories:
- Manufacturing defects
- Design defects
- Failure to warn defects
For example, manufacturing defects can involve problems with producing the drug or in the way the drug is packaged or handled. Improper handling of the drug and drug ingredients can be dangerous. The FDA regularly recalls dangerous drugs because of dangerous manufacturing practices, including:
- Unsterile packaging
- Potency higher or lower than labeled
- Contamination with microbes or fungus
- Particulate matter
- Improper seal on the packaging
- Undisclosed ingredients
- Failure to maintain the proper storage conditions
If a contaminated drug is administered to a patient, it can cause a serious or life-threatening infection. A few years ago, there was a meningitis outbreak that was traced back to tainted steroid injections. The drugs were contaminated with a fungus that caused fungal meningitis. These steroids had been injected in the areas around the spinal cord for back pain relief. However, the tainted drugs spread fungus to the spinal fluid, causing many patients to suffer meningitis, killing dozens of patients.
Liability of the Pharmaceutical Companies for Dangerous Drugs
Pharmaceutical companies are generally liable for dangerous drugs that cause serious injury or harm. However, injury victims may be limited in their recovery, depending on the situation. If the side effect was known and included on the label, the drug companies may not be liable because the risk was identified.
Medications approved by the FDA have strict labeling requirements. This generally includes providing important information laid out clearly on the product labeling, including:
- Indications and usage
- Dosage and administration
- Warnings and precautions
- Adverse reactions
- Drug interactions
When the drug company is aware of contraindications, warnings, precautions, dangerous interactions, and adverse reactions, they should be labeled on the packaging. This is a continuing obligation of the drug company that continues after the medications are initially released. If the drug company learns of additional risks of the drugs, they should communicate these warnings to doctors, so they can re-evaluate these drugs with their patients, in light of the additional risks.
Black box warnings communicate the most serious drug risks. This includes risks of a serious adverse reaction that may be potentially fatal, life-threatening, or permanently disabling. If the drug companies are aware of known risks and fail to properly label the drugs or mislead doctors about their safety, the drug company may be liable for damages.
Lawsuit Exceptions for COVID-Related Injuries
Unfortunately, many of the laws and rules that apply to other drugs do not apply to the COVID-19 vaccine. States and the federal government passed broad liability protections for “covered persons” for claims related to COVID-19. The Public Readiness and Emergency Preparedness Act (PREP Act) allows the Department of Health and Human Services (HHS) to immunize doctors, hospitals, drug companies, and healthcare providers during a declared public health emergency.
With liability immunity, drug companies, including Pfizer, Moderna, and Janssen are immune from many claims related to alleged injuries caused by the vaccines, which includes protection from ordinary negligence. However, there are limited exceptions.
Willful Misconduct Exception to Civil Lawsuits
According to Congress, “The sole exception to PREP Act immunity is for death or serious physical injury caused by ‘willful misconduct.’” The willful misconduct exception is very limited and is a difficult standard to meet.
A “serious physical injury” must be “life threatening, permanently impair a body function, permanently damage a body structure, or require medical intervention to avoid such permanent impairment or damage.” The standard for “willful misconduct” requires showing that the entity acted:
- Intentionally to achieve a wrongful purpose;
- Knowingly without legal or factual justification; and
- In disregard of a known or obvious risk that is so great as to make it highly probable that the harm will outweigh the benefit.
Other Options to Recover Damages After Improper Medical Care
If you were injured because of a COVID-19 side effect, you may be able to recover compensation from the government as part of the Countermeasures Injury Compensation Program (CICP). However, damages under the CICP are limited. Compensation for a successful CICP claim may include medical expenses and loss of income.
You may also be able to recover damages for improper medical care and treatment that was not directly related to COVID-19. There are many types of medical malpractice cases, including injuries caused by surgical errors, prescription errors, and hospital-acquired infections. A medical malpractice claim can be used to hold the doctors and hospitals liable for medical mistakes. A medical malpractice claim can help the injury victim recover damages for medical expenses, loss of income, future medical care, and pain and suffering.
If a patient died because of a medical error, the surviving family members may be able to file a wrongful death claim against the healthcare providers to recover compensation. If you want to know more about filing a wrongful death claim in your state, contact medical error attorneys who understand how to handle these complex cases and can answer all your questions.
How Do I Find Out If I Can Sue for Vaccine Side Effects?
The first step to finding out about your claim options after a medical injury caused by malpractice or defective medication is to talk to an experienced medical malpractice team. You may have a claim based on negligence, product liability, or medical malpractice. Even if your injury was not directly related to the vaccine, other medical care received may have fallen below the standards of care.
A medical malpractice attorney can talk to you about your case, review your medical records, and identify who might be responsible for your injuries. If the doctors or hospitals don’t want to turn over records your lawyer can compel disclosure of relevant medical records through the courts. Having an experienced attorney on your side can help you recover the maximum damages for your losses.
If you suspect your injury was caused by a problem with medication, the wrong medication, or your doctor did not warn you about the side effects, you may have a claim for damages. Contact a law firm that handles medication defects and medical malpractice cases like yours. Contact Gilman & Bedigian online or at 800-529-6162 for a free consultation