J&J Discontinues Sales of Talc-Based Baby Powder

Johnson & Johnson announced today it was discontinuing sales of its talc-based baby powder products in the United States and Canada amid a firestorm of lawsuits claiming its signature product contains asbestos. The announcement comes just weeks after US District Judge Freda Wolfson ruled to allow testimony from plaintiffs’ experts in the New Jersey-based Multidistrict Litigation. Thousands of claimants have argued that regular exposure to the baby powder has caused them to develop ovarian cancer and mesothelioma.

Was Decision To Pull Talcum Powder Related To 2019 Recall?

In October 2019, J&J issued its first ever recall of talc-based baby powder after FDA testing found trace amounts of asbestos in the product. The company claims its decision to now cease sales has nothing to do with the safety of the product and cited lawsuits as the reason for a decline in consumer demand. The pharmaceutical giant will continue to sell its cornstarch-based powder.

Ruling Clears Plaintiffs For Bellwether Trials

Judge Wolfson’s ruling allows plaintiffs to argue that J&J’s Talc-based baby powder contains asbestos and can contribute to the development of ovarian cancer. The decision opens the path for bellwether trials to begin in the MDL sometime in 2021.

Let Us Help

GoldenbergLaw is currently litigating cases where individuals have been diagnosed with ovarian cancer or mesothelioma after long term talcum powder exposure.  To get in touch with us regarding any potential talcum powder cases we may investigate on your behalf, please contact our Senior Partner Stuart Goldenberg at slgoldenberg@goldenberglaw.com or by phone at 612-335-9960, or our Partner Noah Lauricella at nlauricella@goldenberglaw.com or by phone at 612-335-9977. 

Contact us today, and let us deliver the Gold standard advocacy you deserve.

Letters Warn About NTM Infections After Open Heart Surgery

If you received a letter warning about a contaminated heater-cooler unit used in your open heart surgery, you may be at risk of contracting a nontuberculous mycobacteria (NTM) infection and should contact your doctor immediately.

Why Did I Receive A Warning Letter After My Open Heart Surgery?

On June 1, 2016, the Food and Drug Administration (FDA) advised hospitals to determine a method for patient follow-up and surveillance due to the elevated risk of contracting an infection after open heart surgery. The elevated risk was assigned to patients whose open heart surgeries involved a Sorin Stöckert 3T heater-cooler, also known as a LivaNova 3T heater-cooler unit, contaminated with a rare nontuberculous mycobacterium called Mycobacterium chimaera (M. chimaera) that can cause deadly infections.

On October 13, 2016, the Center for Disease Control and Prevention (CDC) announced its laboratory tests had matched NTM bacteria found in open-heart surgery patients to bacteria found in contaminated 3T heater-cooler devices. After announcing this finding, the CDC advised hospitals to notify patients who underwent an open heart surgery involving a contaminated heater-cooler unit that they are at risk of contracting an NTM infection.

As a result, warning letters were sent out to patients nationwide.

What is M. Chimaera?

M. chimaera is a bacteria commonly found in soil and water throughout the world. When an open heart surgery patient is exposed to M. chimaera through a contaminated heater-cooler unit, the bacteria can cause devastating injuries and potentially even result in death.  However, an open heart surgery patient exposed to M. chimaera through a contaminated heater-cooler unit may not experience symptoms for months or even years after surgery. The median amount of time post-surgery that symptoms occur is 18 months; however, symptoms have occurred 3 months to even 5 years after the surgery.

According to the CDC, the risk of post-surgical NTM infection is in the range of 1 in 100 patients to 1 in 1,000 patients in hospitals where at least one contaminated heater-cooler unit or infection have been identified.

It is important to be aware of the symptoms associated with an M. chimaera infection and contact a medical professional immediately if you experience them. Below is a list of possible NTM infection symptoms:

  • Fatigue
  • Fever
  • Pain
  • Redness, heat, or pus at surgical site
  • Muscle pain or aches
  • Joint pain
  • Night sweats
  • Unexplained weight loss
  • Abdominal pain
  • Nausea
  • Vomiting
  • Chronic cough
  • Septic shock (sepsis)
  • Endocarditis (heart lining infection)
  • Coughing up blood (hemoptysis)
  • Pulmonary disease (lung infection)
  • Inflammation of lymph nodes (lymphadenitis)
  • Abscesses in abdomen, aorta, or heart valve

How did the Heater-Cooler Units Become Contaminated?

M. chimaera has been discovered in water from Sorin Stöckert 3T heater-cooler units used around the world. More importantly, the bacteria was found in unused heater-cooler units at a LivaNova manufacturing site in Germany and in water samples from the same manufacturing site. The bacterial strains from the manufacturing site matched those found in patients diagnosed with serious infections after 3T heater-cooler units were used in their open heart surgeries, indicating that the heater-cooler units were contaminated during assembly.

LivaNova is the company that manufactures the Sorin Stöckert 3T heater-cooler units. At the time the contaminated heater-cooler units were discovered, LivaNova accounted for the manufacturing of 60% of the heater-cooler units used in cardiac surgeries in the United States—there are 250,000 open heart surgeries in the U.S. every year—and was also a major supplier of the heater-cooler units for cardiac surgeries worldwide.

What Does a Heater-Cooler Do in Open Heart Surgery?

Heater-cooler units regulate a patient’s body temperature during open heart surgery.

The heater-cooler unit contains two water tanks and a system of tubing. One tank contains warm water that keeps the patient warm during surgery through indirect thermal transfer (the transferring of heat) to a warming blanket. The second water tank contains cold water which is used to indirectly cool the cardioplegia solution—what slows or stops the heart during surgery.

However, if the water within the tanks becomes contaminated, then the bacteria is aerosolized (converted into a spray or vapor within the air), enters the operating room, and there is risk of the bacteria entering the patient and causing an infection.

Do I have a Heater-Cooler Infection Case?

If you or a loved one has suffered an infection after an open heart surgery, contact one of the defective medical device lawyers at GoldenbergLaw for a free heart surgery infection lawsuit consultation. We have over 30 years of experience bringing justice to victims of negligent medical device manufacturers.  Let us deliver the Gold standard advocacy you deserve.

GoldenbergLaw Partner Marlene Goldenberg Appointed To Zantac MDL Leadership

Partner Marlene Goldenberg
Marlene Goldenberg

On May 8, 2020, Judge Robin L. Rosenberg of the US District Court for the Southern District of Florida appointed GoldenbergLaw Partner Marlene Goldenberg to the Plaintiffs’ Steering Committee as part of the leadership structure for the Zantac Multidistrict Litigation (MDL). Marlene is currently serving on the Plaintiffs’ Executive Committee for the Valsartan, Losartan, and Irbesartan MDL in the District Court of New Jersey and previously served as the head of the discovery committee for the Abilify MDL in the Northern District of Florida. Marlene and GoldenbergLaw look forward to holding the manufacturers of Zantac accountable for their actions.

Zantac FDA Recall

Zantac is a popular heartburn medication that is also used to treat acid indigestion, sour stomach, gastroesophageal reflux disease (GERD), and ulcers. Millions of Americans have taken Zantac and its generic formulation ranitidine, which is sold over-the-counter and prescribed.

In September 2019, the FDA began to announce recalls of Zantac and ranitidine products by various manufacturers due to contamination with the probable human carcinogen N-nitrosodimethylamine (NDMA). After more than a dozen manufacturers and distributors issued recalls, the FDA finally issued a universal recall of all Zantac and ranitidine products from the US market in April 2020.

How Does Contaminated Zantac Cause Cancer?

NDMA has been classified as a probable carcinogen by global health organizations and is often given to rats in medical studies to cause cancer. NDMA is so toxic it was formerly used to produce rocket fuel and has no approved uses in the United States.

As a member of the Plaintiffs’ Executive Committee in the Valsartan, Losartan, and Irbesartan MDL, which also involves drugs contaminated with NDMA, Marlene Goldenberg has spent nearly two years immersed in litigation surrounding NDMA contamination. The prevailing science currently demonstrates that as a result of consistently taking Zantac and ranitidine, many Americans have or will develop cancer.

What Cancers Can Zantac Cause?

The medical literature suggests that NDMA in Zantac and ranitidine can cause the following types of cancer:

  • Bladder Cancer
  • Breast Cancer
  • Colon/Colorectal Cancer
  • Esophageal Cancer
  • Intestinal Cancer
  • Kidney Cancer
  • Leukemia
  • Liver Cancer
  • Multiple Myeloma
  • Non-Hodgkin’s Lymphoma
  • Pancreatic Cancer
  • Prostate Cancer
  • Stomach Cancer
  • Testicular Cancer
  • Thyroid Cancer
  • Uterine Cancer

Let Us Help

GoldenbergLaw is currently investigating cases where an individual has taken Zantac or ranitidine and been diagnosed with one of the cancers listed above. If you or one of your clients developed one of these cancers after taking Zantac or ranitidine, please contact us so we can discuss your legal rights.

Please feel free to contact Marlene directly at 612-436-5028, via email at mjgoldenberg@goldenberglaw.com, or by visiting our Zantac Resource Center.