FDA Warns NSAID Use in Second Half of Pregnancy Could Cause Complications

The Food and Drug Administration (FDA) recently issued a Drug Safety Communication changing the labeling of NSAIDS, a class of painkillers, to warn that NSAIDS can cause a rare but serious kidney problem in unborn babies. According to the FDA, “These changes include new labeling to explain that if women take the medications around 20 weeks or later in their pregnancy, the drugs can cause rare but serious kidney problems in the unborn baby, which can lead to low levels of amniotic fluid (the protective cushion surrounding the unborn baby) and the potential for pregnancy-related complications.”

What Is an NSAID?

NSAID stands for NonSteroidal Anti-Inflammatory Drugs. NSAIDs are prescribed to treat pain and fever for many conditions. Some commmonly used NSAIDs are aspirin, ibuprophen (Motrin, Advil), naproxin (Aleve, Naprosyn) and celecoxib (Celexa). The FDA is now requiring a change to the warning label about the risk of kidney problems in unborn babies between 20-30 weeks of pregnancy.

Oligohydramnios and Fetal Injury

An unborn baby is enveloped in amniotic fluid, mostly water, from their mother from the beginning. But at 20 weeks the unborn baby’s kidneys begin to take over producing amniotic fluid. NSAIDs can cause a rare but serious kidney problem in the unborn baby, called oligohydramnios. Very simply, oligohydramnios is low levels of amniotic fluid in the baby.

Oligohydramnios can develop within days of taking an NSAID, but may be detected as far out as two weeks later. Once the mother stops taking NSAIDS, the conditition usually goes away.

FDA Warns About Serious Kidney Problems In Unborn Babies

The new warning label, approved by the FDA on October 15, 2020, recommends that pregnant women not use NSAIDs at 20 weeks or later in their pregnancies. It recommends that medical professionals also do not prescribe NSAIDs at this time in the pregnancy. If NSAID treatment is absolutely necessary, the FDA recommends prescribing the lowest possible effective dose for the shortest duration possible. If NSAIDs are prescribed for more than 48 hours at 20 weeks or later, monitoring of amniotic fluid should be considered.

NSAIDs already had a warning label against taking them after 30 weeks gestation, because of the risk of possible heart problems in the baby.

What Medical Conditions Can Low Amniotic Fluid Cause?

The FDA warns that low amniotic fluid (oligohydramnios) caused by taking NSAIDs during week 20 and after of pregnancy may cause the baby to suffer renal (kidney) damage or failure, and possibly death. Taking those drugs can also cause other serious pregnancy complications, including the development of the baby’s lungs, the muscles, and the digestive system.

What Can You Do?

If you took NSAID during weeks 20 and later of your pregnancy, and your baby suffered from or was lost to kidney, lung, muscle or digestive system damage, you may have a claim for damages. Contact the attorneys at Thornton Law Firm for a free, thorough evaluation of your legal rights at 1-888-491-9726. Or tell us your story using our online contact form. Like all lawsuits, birth defect claims related to NSAID use must be filed within short time limits. Seek legal advice as soon as possible to protect you and your baby’s rights.

$2.12 Billion Talc Verdict Against Johnson & Johnson Upheld

UPDATE: in June of 2021, the United States Supreme Court rejected the appeal by Johnson & Johnson of this verdict.

The Missouri Supreme Court has rejected Johnson and Johnson’s appeal of a $2.12 billion verdict entered against them in favor of 22 women alleging their ovarian cancer was caused by exposure to talc. The state’s highest court refused to take up the appeal by J&J, thereby affirming a decision by the Missouri Court of Appeals.

The appeals court upheld the jury’s finding that Johnson and Johnson was liable for the plaintiffs’ development of ovarian cancer while cutting the damages award from $4.69 billion to $2.12 billion. A Missouri jury had decided in 2018 that Johnson & Johnson’s baby powder and Shower to Shower talc products gave 22 women ovarian cancer.

The Missouri Court of Appeals ruled that the plaintiffs “proved with convincing clarity that defendants engaged in outrageous conduct because of an evil motive or reckless indifference.” They held that the jury reasonably inferred from the evidence presented at trial that Johnson & Johnson “disregarded the safety of consumers” in pursuit of profits, despite knowing that its talcum powder products caused ovarian cancer.

While they reduced the punitive damages award in line with controlling Supreme Court precedent, they upheld the award of punitive damages, stating “[w]e find there was significant reprehensibility in Defendants’ conduct,” finding the plaintiffs introduced:

“[E]vidence that Defendants discussed the presence of asbestos in their talc in internal memoranda for several decades; avoided adopting more accurate measures for detecting asbestos and influenced the industry to do the same; attempted to discredit those scientists publishing studies unfavorable to their Products; and did not eliminate talc from the Products and use cornstarch instead because it would be more costly to do so.”

 

Johnson and Johnson faces thousands of trials nationwide over claims that its talc products caused cancer. In 2018 Reuters and the New York Times published extensive investigations into Johnson & Johnson’s knowledge that its talc contained asbestos, a known carcinogen. In March of 2020, the FDA released data from testing of multiple samples of talc powders including Johnson & Johnson’s which showed the presence of asbestos. Following those reports, Johnson & Johnson withdrew its talc-based powders in May 2020 from the United States and Canadian markets, although they still sell talc products in the rest of the world.

Johnson & Johnson has announced plans to appeal this case to the United States Supreme Court.

Anyone who uses talcum powder is recommended to switch to arrowroot, cornstarch, or any other non-talc powder. If you or a loved one has been diagnosed with ovarian cancer after using talcum powder, call the talc powder lawyers at Thornton Law Firm for a confidential, no-charge consultation. Call 1-888-341-1405 or tell us your story online for a thorough, comprehensive evaluation of your legal rights. If you have developed ovarian cancer and believe your cancer is related to your use of baby powder, Shower to Shower powder, or other talc powder, you should seek legal advice as soon as possible. Do not delay seeking legal advice; the courts apply strict time limits to all legal claims.

Johnson & Johnson Withdraws Talc Baby Powder From US Market

Johnson & Johnson has announced that it is withdrawing all talc baby powder products that are sold in the United States and Canada from the market. J&J, the world’s largest maker of health care products, faces thousands of lawsuits alleging that the talc in its powders caused cancer.

The company says that demand for its talc-based powders is declining, and blames that change in consumer habits on what it calls “misinformation around the safety of the product“. Investigations published by Reuters and The New York Times in 2018 showed that Johnson & Johnson knew that its talc contained asbestos, a cancer risk, for four decades.

While Johnson & Johnson has claimed that the talc it sold was asbestos-free, internal company documents show that Johnson & Johnson received many reports over the years, starting in 1971, that its talc contained asbestos. Although J&J never turned the many reports they received over to the FDA or any other governmental regulatory agency, internally the company’s doctors, lawyers, scientists, mine managers, and executives discussed the asbestos problem.

There are approximately 19,400 cases pending against Johnson & Johnson nationwide claiming using J&J talc products caused cancer, including baby powder and Shower to Shower powder. There are two cancers that have been linked to talc powder: ovarian cancer, thought to be related to using talc powder for feminine hygiene purposes, and mesothelioma, a type of cancer related to exposure to asbestos.

Over one billion dollars in verdicts have been issued against Johnson & Johnson in trials of these talc cancer cases. There have been 15 trial verdicts issued against J&J; they have successfully defended 12 trials, and 7 resulted in mistrials. All of those trial wins were appealed and some of those appeals have been successful.

Johnson & Johnson has a cornstarch baby powder on the market, which will continue to be sold. Retailers will be allowed to sell the remaining Johnson & Johnson talc powder products that are in stock. J&J also plans to continue to sell talc baby powder to the rest of the world.

Women who use talcum powder are recommended to switch to arrowroot, cornstarch, or any other non-talc powder. If you or a loved one has been diagnosed with cancer after using talc powder, call the talcum powder lawyers at Thornton Law Firm for a confidential, no-charge consultation. Thornton Law Firm has represented victims of asbestos exposure for 40 years. Call 1-888-341-1405 or tell us your story online for a thorough, comprehensive evaluation of your legal rights. If you have developed cancer and believe your cancer is related to your use of baby powder or other talc powder, you should seek legal advice as soon as possible. Do not delay seeking legal advice.

Zantac Brand Heartburn Drug Recalled

Heartburn Drug Ranitidine (Brand Name Zantac) Recalled

On Wednesday, April 1, 2020 the FDA requested the immediate removal of all Zantac and ranitidine products from the market by manufacturers. The FDA has been studying the cancer-causing properties of Zantac and its generic equivalents since it announced in September 2019 that NDMA was found in some samples.

NDMA, which stands for N-nitrosodimethylamine, is classified as a probable human carcinogen. Recalls of over the counter (OTC) ranitidine products have been occurring regularly since last September. Consumers are advised to stop taking their OTC ranitidine or Zantac. Patients taking it under a doctor’s prescription are advised not to stop taking the drug until they have consulted with their physician to substitute another drug in its place. You should retain any unused medication if you believe you may have a legal claim.

Why is Zantac Being Recalled?

The latest FDA research shows that the level of NDMA in ranitidine increases as it sits in the container over time and that it increases, even more, when the drugs are stored at high temperatures. High temperatures can occur during shipping and storage. In the recall notice, the FDA said that testing and evaluation showed NDMA in ranitidine increased even under normal storage conditions. The older the product is (the longer since it was manufactured) the greater the level of probable carcinogen NDMA.

In September, CVS, Walgreens, and Walmart all announced that they would no longer carry Zantac or ranitidine products sold over the counter. Novartis also announced that it would recall all OTC ranitidine products made by Sandoz.

A lab in California petitioned the FDA to remove all ranitidine products from the market. Their testing found that after being stored for only 5 days above 70 degrees Celsius (158 degrees Fahrenheit) the level of NDMA had risen above the FDA limit. 

What is Zantac Used For?

Zantac is a popular heartburn treatment. The drug decreases stomach acid production. It was initially available as a prescription only but began being sold over the counter in approximately the mid-1990s. Developed in the 1970s, it was one of the world’s biggest-selling prescription drugs by 1987. Twenty years later in 2017, it was still the 48th-most-often prescribed drug in America.

Are Other Heartburn Medications Contaminated with NDMA?

There are newer drugs commonly used to treat heartburn. The FDA has found no NDMA in famotidine (Pepcid), cimetidine (Tagamet), esomeprazole (Nexium), lansoprazole (Prevacid) or omeprazole (Prilosec). These are available over the counter. If you were taking Zantac or ranitidine with or without a prescription, please consult your doctor or pharmacist for advice on what to use as a replacement.

Trust Our Massachusetts Zantac Lawyers to Help

If you were diagnosed with cancer while using ranitidine or Zantac, you may have a legal claim for damages. Contact the Boston law firm of Thornton Law Firm LLP online or at 1-888-341-1405 for a free consultation with a recognized leader in Massachusetts drug and medical device litigation. You have nothing to risk. We offer a fair and accurate assessment of your ca

 

J&J Ordered to Pay $344 Million for Deceptively Marketing Pelvic Mesh

The Johnson and Johnson subsidiary Ethicon has been ordered to pay $343.99 million dollars for deceptively marketing vaginal mesh products in the state of California. San Diego County Superior Court judge Eddie Sturgeon ruled that the deceptive marketing was intended to deceive doctors and tens of thousands patients about the risks and dangers of the vaginal mesh products.

California’s suit charged Johnson & Johnson with violating the state’s false advertising and unfair competition laws. The California Attorney General asked for a fine of $800 million. In the lawsuit, the California Justice Department said that its years-long-investigation had shown that Johnson & Johnson’s Ethicon unit failed to inform patients and doctors of the possible severe complications and risks of using the mesh products, and misrepresented the severity and frequency of those risks. The trial last two months; Judge Sturgeon’s 88 page verdict was issued four months later.

The court found that Johnson & Johnson had deceptively marketed two products: Tension-free Vaginal Tape, or TVT, which was first sold in 1998 to treat stress urinary incontinence (SUI), and the Prolift, sold beginning in 2005 to treat pelvic organ prolapse (POP). These meshes were implanted in women via incisions in the vagina, and after implantation the mesh often eroded, causing a host of problems including pain, infection, vaginal bleeding or discharge, urinary problems, severe pelvic or groin pain, pain during intercourse, and even organ perforation from mesh eroding into surrounding tissue.

Ethicon discontinued four mesh products for vaginal use in 2012. Ethicon did not recall vaginal mesh products that were already sold or implanted, and some of their mesh products were relabeled for abdominal implantation only. The FDA banned all vaginal mesh products in 2019.

California is the first state to go to trial alleging deceptive marketing of vaginal mesh implants by J&J’s Ethicon. Other states with pending litigation against Ethicon are Kentucky, Mississippi, Oregon, and West Virginia. Forty-two other states had already settled their claims against Ethicon for a total of $117 million dollars, and the state of Washington settled for $9.9 million.

Johnson & Johnson sold more than 470,000 pelvic mesh products nationally between 2008 and 2004. More than 30,000 were sold in California. Around the world, more than 2 million women have had these vaginal mesh implants. In the United States, more than 35,000 lawsuits have been filed against Johnson & Johnson for defective vaginal mesh damages and injuries.

California Attorney General Xavier Becerra issued this statement on the verdict: “Johnson & Johnson intentionally concealed the risks of its pelvic mesh implant devices. It robbed women and their doctors of their ability to make informed decisions about whether to permanently implant the products in patients’ bodies,” he said. “Today we achieved justice for the women and families forever scarred by Johnson & Johnson’s dishonesty.”

Ethicon and Johnson and Johnson have announced plans to appeal.

The case is California v. Johnson & Johnson et al., case number 37-2016-00017229-CU-MC-CTL, in the Superior Court of the State of California, County of San Diego.

If you have implanted mesh for any medical reason and are having any symptoms connected with the implant you should contact your doctor immediately. Do not delay seeking medical attention if you have any symptoms you believe are related to your mesh implant.

To discuss your legal options regarding your mesh implant, call the vaginal mesh lawyers at Thornton Law Firm at 888-491-9726 to talk with Attorney Marilyn McGoldrick. You can also tell us your story online for a confidential, free evaluation of your claim. All legal claims have strict time limits for filing so call now if you believe you have a case.

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