RotaShield is a vaccine that was administered orally to help in the prevention of rotavirus. It is no longer sold in the U.S.
Rotavirus is a very contagious and common viral illness. It causes diarrhea. Before the development of a vaccine, most children had had the illness at least once by age 5. Rotavirus infection is unpleasant, but it is usually treated at home with extra fluids to prevent dehydration and other remedies. On rare occasions, the patient becomes severely dehydrated and must be administered floods intravenously in the hospital. The patient is highly likely to recover with hospital treatment.
Symptoms of rotavirus infection usually start within two days of exposure to the virus. In children, there is first a fever and vomiting, then three days to a week of diarrhea. The infection can also cause abdominal pain.
In healthy adults, a rotavirus infection may cause only mild or no symptoms. Adults usually pick it up from their children, who catch it in a daycare facility or school.
What Went Wrong with Rotashield?
RotaShield was the first rotavirus vaccine approved in the U.S. in 1998. Soon after, in the U.S., some infants developed intussusception after receiving the RotaShield vaccine. At first, it was unclear whether this was directly attributable to the vaccine or if some other factor was involved.
Intussusception from all causes, not including Rotashield, is most common among infants in the first year of life. This can block food and fluid from moving through the intestine. In addition, the blood supply to the part of the intestine that has been affected is cut off. This, in turn, can lead to infection, the death of the intestinal tissue, or a tear in the intestine.
Intussusception from all causes not including Rotashield is most common among infants in the first year of life. One child in every 2,000 to 3,000 children is affected before their first birthday. Originally, based on the results of investigations of RotaShield, the Centers for Disease Control (CDC) estimated that only one or two additional cases of intussusception would be caused among every 10,000 infants vaccinated with RotaShield.
While evaluation of the investigations did not show a relationship between RotaShield and intussusception, intussusception was still listed in the labeling of the vaccine as a possible side effect. Doctors were also encouraged to report side effects of all kinds to the Vaccine Adverse Event Reporting System (VAERS).
After incidents of infants developing intussusception after vacation with Rotashield were reported to VAERS, the CDC recommended suspension of the vaccine while it conducted an emergency investigation into the vaccine and the causes of intussusception.
The investigations showed that RotaShield caused intussusception in some infants under 12 months old who were otherwise healthy. The risk of developing intussusception was higher after RotaShield was administered than the expected risk for children in this age group.
Further investigations were conducted by federal government agencies and state and local health departments throughout the U.S. The results indicated that the RotaShield vaccine increased the risk of intussusception by one or two cases for each group of 10,000 infants vaccinated.
The Advisory Committee on Immunization Practices (ACIP), American Academy of Pediatrics (AAP), and the American Academy of Family Physicians (AAFP) decided to stop recommending RotaShield because intussusception is a serious medical condition. However, the only severe complication of rotavirus can be prevented by rehydration. So, the risk of the rotavirus disease, which is not great, was not outweighed by the vaccine’s benefit.
In October 1999, manufacturers then voluntarily withdrew RotaShield from the market.
What Are the Side-Effects of Rotashield?
The most common adverse side effects of Rotashield reported were irritability, cough, runny nose, fever, loss of appetite, diarrhea, and vomiting. Other less common side effects were as follows:
- Difficulty breathing;
- Noisy breathing;
- Shortness of breath;
- Tightness in the chest;
- Wheezing.
There were many other similar side effects, but intussusception was the most significant.
What Are My Remedies If My Child Was Injured by Rotashield?
RotaShield was taken off the market in 1999. So no medical professional should present the RotaShield vaccine to anyone, adult or child.
If a person believes they were injured by the Rotashield vaccine or any other vaccine, they would want to consult a personal injury lawyer. Their lawyer would analyze the facts of their case to assess whether they would support a claim for medical malpractice, pharmacy malpractice, or strict product liability.
A case for medical malpractice would have to be based on a medical error by the doctor who prescribed the vaccine for a child. It would be challenging to succeed on a claim of medical negligence based on a doctor’s prescription of the Rotashield vaccine. That is because the packaged warnings initially warned about the risk of intussusception.
What Is a Statute of Limitations?
In addition, assuming a patient was injured by the RotaShield vaccine, the statute of limitations might defeat a civil lawsuit for damages. The statute of limitations is a time limit on civil claims. Statutes of limitations are set by state law, so the time limit that would apply to any particular case would depend on the state where the case is filed and its type.
Different states have different statutes of limitations for medical malpractice cases. The law in most states applies the discovery rule, which provides that a patient must have discovered the injury for the statute of limitations to begin to run.
Other states have a time limit that begins to run when the injured party receives a valid diagnosis from another licensed medical provider. The statute of limitations for malpractice or product liability would be one to three years after receiving a valid diagnosis.
Other states provide that the statute of limitations begins when the patient’s symptoms should have led them to seek medical attention.
An exception to the statute of limitations for minors might be helpful in a case involving RotaShield. The statute of limitations for the medical malpractice claim for malpractice experienced by a minor is three years following the minor’s 18th birthday. So, the statute does not begin to run until a minor reaches their 18th birthday. A civil lawsuit for medical malpractice must be filed by the person’s 21st birthday.
Still, RotaShield was in use more than 21 years ago, so if a person was injured as an infant by a Rotashield vaccine, this exception to the statute of limitations for medical malpractice might not be helpful to them. The statute of limitations may bar them from bringing a lawsuit for their injuries.
Can I Sue for Product Liability If I Was Injured by RotaShield?
Another option for the person injured by prescription medication or vaccines is a lawsuit for strict product liability. Under the law of strict product liability, a person who has been injured by a drug or vaccine must prove that the product was defective and that the defect caused them harm. Of course, every state also has a statute of limitations that applies to cases for strict product liability.
A person might claim that RotaShield had a warning defect; however, when it was initially introduced to the market, it came with a warning regarding the risk that an infant might develop intussusception. The history of RotaShield does not suggest that a manufacturing defect was involved in any injuries or side effects that it might have caused.
If a person were to overcome the statute of limitations problems and the fact that the RotaShield injury probably happened long ago, which would make proving any kind of case challenging, these lawsuits would result in an award of compensatory damages to cover the person’s economic and non-economic damages. These would include such losses as income loss, the cost of medical treatment, and pain and suffering.
Of course, a person who a prescription drug has injured should always report their experience to the FDA. If the case involves a vaccine, someone should report it to VAERS.
Do I Need a Lawyer for My RotaShield Issue?
If you believe that you or your child has been injured by RotaShield or any other medication or vaccine, you want to consult a class action lawyer. Your lawyer will review all the facts and determine if you have a case for malpractice or strict product liability.
Your lawyer can apply your state’s statute of limitations to see if it would bar your case and also evaluate the effect of the passage of time on your legal situation. Your lawyer can advise you of the next steps and help you protect your rights.
