What’s the problem?
May 21, 2018 – Severe cases of neural tube birth defects involving the brain, spine, and spinal cord have been reported in children born to women who took dolutegravir — the active ingredient in Juluca — at the time of pregnancy or during the first trimester, according to an FDA Safety Alert issued on Friday. The announcement followed preliminary results of an ongoing observational study in Botswana, the agency said.
Neural tube defects (NTDs) are birth defects of the brain and spinal cord that can cause severe, life-threatening health problems for babies, including death. A baby’s neural tube normally starts out as a small, flat ribbon that develops into a tube by the end of the first month of pregnancy. If the tube fails to close all the way, a neural tube defect can occur.
Approved by the FDA in Nov. 2017, Juluca is the first complete HIV-1 treatment regimen that contains only two drugs, dolutegravir (integrase inhibitor) and rilpivirine (non-nucleoside reverse transcriptase inhibitor, or NNRTI) which are combined into one pill. Juluca is manufactured by ViiV Healthcare, and is intended to treat HIV-1 patients whose virus has been suppressed for at least 6 months, and who have no history of treatment failure and no known substitutions associated with resistance to the ingredients in Juluca.
If You are Taking Juluca
If you are currently on a regimen of Juluca, you should not stop taking it without talking to your doctor first, FDA cautions, as doing so could worsen your HIV infection.
If you are pregnant or planning on becoming pregnant, discontinuing treatment with Juluca without switching to an alternative HIV medicine could cause your viral load to increase, which could allow the virus to spread to the baby.
If you take Juluca at the time of becoming pregnant and during the 1st trimester of pregnancy, there is a risk that your baby may be born with neural tube defects. These defects are first seen very early on in pregnancy, before many women even know they are pregnant. For this reason, women of childbearing age should consult their physician about alternative HIV medicines, FDA said.
About Class Action Lawsuits
Although we are a nationally recognized class action firm, the Products Liability Litigation Group at our law firm has decided against the filing of a Juluca class action suit and is currently filing individual claims on behalf of families whose children were born with neural tube defects after the mother took Juluca during pregnancy.
A class action is a type of lawsuit filed with the court on behalf of large group of people or “class” of individuals that have been injured or wronged. The class is represented by the law firm and the case is generally decided upon a single member of the class who is sometimes referred to as the “class representative or class rep.”
Why Our Law Firm Is Filing Individual Lawsuits Opposed To a Class Action
In some instances, a class action may offer some advantages, as they aggregate a large number of individualized claims into one representational lawsuit. The aggregation can increase the efficiency of the legal process, lower the costs of litigation and in some cases offer the solution to a common problem wherein small recoveries do not provide the incentive for any individual or law firm to file an individual lawsuit.
However, a class action suit can also be a detriment to many class members, as they are often forced into a blanket “low ball settlement” and higher attorney fees. At Schmidt & Clark, LLP we understand that our clients are suffering emotionally and economically due to loss of wages and/or high medical bills and we plan to maximize each client’s recovery by filing individual Juluca lawsuits on their behalf.
Do I Have a Juluca Class Action Lawsuit?
The Class Action Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in Juluca lawsuits. We are handling individual litigation nationwide and currently accepting new neural tube birth defect cases in all 50 states.
Free Case Evaluation: Again, if your child was harmed by Juluca side effects, you should contact our law firm immediately. You may be entitled to a settlement by filing a suit and we can help.