Juluca Neural Tube Birth Defects Lawsuit Attorneys
The nationally-recognized trial attorneys of Parker Waichman LLP are currently investigating potential claims relating to the use of Juluca (dolutegravir and rilpivirine), an HIV drug, and the development of neural tube congenital disabilities when a woman takes Juluca in the early stages of pregnancy. If your child suffered neural tube congenital disabilities and you were taking Juluca at the time of conception or some other point in early pregnancy, you or your child may be entitled to compensation.
Juluca and Neural Tube Birth Defects – What You Should Know
Juluca is a medication used to treat the human immunodeficiency virus (HIV), and patients with HIV often take Juluca along with other HIV medications. Juluca is intended to help keep HIV at low levels in the body to the point where the virus may be undetectable, which in turn helps to prevent individuals with HIV from spreading the virus to others. Because HIV was once thought to be deadly for any person who contracts the virus (as many cases in the past ultimately led to acquired immunodeficiency syndrome (AIDs)), new HIV medications such as Juluca can be extremely helpful.
However, while Juluca may have benefits for HIV patients, there is a substantial risk of taking Juluca that every woman of childbearing age with HIV must know about, which is the link between using Juluca in the early stages of pregnancy and the development of neural tube congenital disabilities in unborn babies. A neural tube birth defect typically happens within the first four weeks of pregnancy, the most critical stage for the proper development of the brain, spine and other essential bodily functions. Such birth defects can be extremely debilitating for a child who may never live a healthy life. The consequences of congenital disabilities may be permanent, and a child may require round-the-clock medical care and assistance, which can be costly over the period of a child’s life.
The Food and Drug Administration (FDA) Issues Important Safety Notification Regarding Juluca
Last month, on May 18, 2018, the FDA issued a safety notification regarding the use of Juluca in early pregnancy and the development of neural tube congenital disabilities in unborn babies. The FDA often issues safety notifications when it learns of potential harmful effects of drugs and medical devices, many of which can be catastrophic. Whether information is gathered from a study or drug trial, or from reports submitted to the FDA, if there is evidence to suggest a strong link between a drug or medical device and harmful consequences, the FDA wants the public to know about it.
The FDA decided to issue a safety notification regarding Juluca and a few other HIV medications when it learned about the preliminary results of an ongoing observational study in Botswana which has demonstrated a clear link between taking Juluca in early pregnancy and the development of neural tube congenital disabilities in unborn babies. Many pharmaceutical and medical device companies provide safety information to the FDA and issue warnings to patients and physicians when they discover safety issues associated with a drug or medical device.
However, in the case of Juluca, it was the FDA, and not ViiV Healthcare, the manufacturer of Juluca, that shared important safety information about the HIV drug and the link to neural tube birth defects. Even though Juluca is a relatively new drug, ViiV Healthcare has a duty to ensure it adequately investigates all potential risks associated with a drug it is placing on the market.
It is certainly possible that some risks associated with a drug will not be fully known until after a drug has been on the market and used by thousands of patients over a period of many years. But, because of the importance of the proper development of a fetus during pregnancy, a manufacturer should take measures to test how a drug works during pregnancy before placing it on the market, and not after.
What the FDA Recommends for Women Taking Juluca
Most FDA safety alerts will provide a few recommendations to patients, physicians, and the medical community as a whole. The safety alert regarding Juluca states that pregnant women taking Juluca, or women taking Juluca who are considering getting pregnant, should continue taking the medication until they speak with their doctor. A doctor can then guide these women to help them better understand the risks and whether the risks outweigh the benefits of taking the drug.
The safety alert also recommends that doctors proactively inform pregnant women and women of childbearing age about the link between taking Juluca and the development of neural tube birth defects. For women who are not yet pregnant, they can consider alternative treatment options that may help to avoid the devastation of having a baby who suffers neural tube birth defects.
Do You Have a Potential Juluca Lawsuit?
All potential legal claims are evaluated by an attorney to determine if a client’s situation meets specific criteria. In the case of Juluca, a qualified attorney will want to know the following information to find out if a potential Juluca claim exists on behalf of an injured child:
- Whether a mother was on Juluca at the time of conception or shortly thereafter in the early stages of pregnancy;
- Whether a mother’s child was diagnosed with neural tube birth defects;
- Whether a mother was on any other medications in addition to Juluca during early pregnancy; and
- Whether the time period for filing a lawsuit has expired.
One of the main reasons why a law firm may decline a case is if the limitations period has expired for filing a lawsuit. However, because Juluca is a very new drug and the injured party is the child with neural tube birth defects, the statute of limitations has likely not expired.
In a majority of states, the statute of limitations is “tolled” or “paused” when a claim involves a minor, which allows a minor to apply the statute of limitations once he or she turns eighteen (18). As such, because a Juluca lawsuit will be filed on behalf of the injured child, the child will have more time to seek legal action than an adult would have. However, it is important to remember that all states have differing laws, and only a qualified attorney can determine if the time period for filing a lawsuit has expired for a particular claim.
Parker Waichman LLP – Obtaining More than $2 Billion for Injured Clients
Our firm has a reputation for success, obtaining in excess of $2 billion collectively for injured clients by settling claims and winning at trial. Our firm’s ability to help so many injured victims across the country has caught the attention of the legal community. In recognition of our devotion to clients and our ability to successfully obtain compensation for them, we have received the following ratings:
- 9.8/10 Rating by AVVO;
- “Preeminent Lawyers” AV Peer Review Rating (Martindale-Hubbell®);
- Highest Ranking of “5 Dragons” by Lawdragon; and
- Listing in Best Lawyers Publication Determined by Extensive Peer Review.
To learn more, it is essential to discuss your potential claim with a member of our dedicated legal team.
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