Last Updated December 10, 2020

The uses for talc don’t stop with body powders though. Its absorbent propensity makes it ideal for other use in consumer products such as cosmetics, where it has been adopted in the processes for manufacturing a long list of popular brands with everyday applications. Additionally, talc may even be used in some food items such as rice, chewing gum, and pill tablets.

For years, cosmetic manufacturers and other product developers have understood that talc is frequently mined in close proximity with asbestos, a potent known carcinogen that when inhaled can cause lung cancer and/or mesothelioma. Additionally, it is widely suspected that asbestos-contaminated talc is linked with incidences of ovarian cancer as well as some other illnesses when applied to female genitalia.  

Since 1976, the Cosmetic, Toiletry and Fragrances Association (now known as the “Personal Care Products Council”) has promoted a voluntary standard among its members requiring that their talc products be free of “detectable amounts” of asbestos. Unfortunately, the “detectable” standard is at odds with what many researchers consider safe. They believe that there are no safe levels of asbestos exposure – detectable or not.

What Cosmetic Products Typically Contain Talc?

Cosmetic manufacturers frequently use talc in their products because of its absorbency, caking prevention and improvements in consistency.  It typically appears in setting powder, eye shadow, liquid foundation or anything which absorbs oil on the skin surface.  Some of the other more common cosmetic categories featuring talc include:

Have Cosmetic Products Been Recalled for Asbestos Concerns?

In 2019, the U.S. Food and Drug Administration (FDA) issued alerts and warnings concerning at least two popular cosmetic brands and some of their product lines. First, in March 2019, the FDA advised consumers to not use some products by Claire’s because of suspected asbestos contamination.  Specifically, the FDA referenced the following lots of products:

• Claire’s Eye Shadows – Batch No/Lot No: 08/17
• Claire’s Compact Powder – Batch No/Lot No: 07/15
• Claire’s Contour Palette – Batch No/Lot No: 04/17

In June 2019, Claire’s and another store, Beauty Plus, voluntarily recalled products due to additional testing which found suspected asbestos contamination. The recall involved:

• Beauty Plus Global Contour Effects Palette 2, Batch No. S1603002/PD-C1179
• Claire’s JoJo Siwa Makeup Set, SKU #888711136337, Batch/Lot No. S180109

These actions were followed in September 2019, with another FDA warning and voluntary recall on more product lines by Beauty Plus Global which tested positive for asbestos:

• Beauty Plus Global Inc. City Color Collection Matte Blush (Fuchsia), SKU #849136008807, Lot No. 1605020/PD-840
• Beauty Plus Global Inc. City Color Cosmetics Timeless Beauty Palette, SKU #849136012958, Lot No. 1510068/PD-C864R
• Beauty Plus Global Inc. City Color Bronzer (Sunset), SKU #849136016017, Lot No. 160634/PD-P712M
• Beauty Plus Global Inc. Beauty Plus Global Inc. City Color Shimmer Bronzer (Caramel), SKU #849136017106, Lot No. 1612112/PD-840

The FDA advised consumers not to use any of these products.

Does Talc in Makeup Cause Cancer or Have Other Side Effects?

Going back to the 1960s, it has been understood that, even at low levels, asbestos is a potent carcinogen and the cause of lung cancer and mesothelioma. Since that time, the cosmetic industry has gone to great lengths to claim that products that contain talc have “non-detectable” levels of asbestos in them. The term “non-detectable” is a careful choice of words on the industry’s part. With that in mind, a multitude of studies has failed to draw a direct linkage between ordinary “non-detectable” or “asbestos-free” talc-containing products and lung cancer.

Ovarian Cancer

Physicians, consumer advocates, industry representatives, and patients have been aware of a suspected linkage between the sprinkling of talc on female genitalia (“perineal dusting”) and higher rates of ovarian cancer for decades. They also have vehemently different opinions about its existence. Despite the disagreement between these groups as to whether genital talc exposure causes ovarian cancer, a growing body of evidence increasingly suggests a possible connection. 

As a predicate, it is important to note that statistically, the rate of ovarian cancer in the general population is around 1%, which is substantially lower than the rate for breast cancer. However, a series of research studies involving large groups of women who have used talcum powder has uncovered that these women are about 30% more likely to be diagnosed with ovarian cancer. Naturally, the world’s largest manufacturer of talc powder, Johnson & Johnson, vehemently disputes these findings and to this day insists that its products are safe.

Alternatives to Talc in Cosmetics

The bottom line for consumers who are leery of the risks posed by talc in cosmetics is that they must pay close attention to labels and the business practices of the brands they shop. Specifically, consumers should look for the following on labels: talc; talcum powder; and/or magnesium silicate.

The good news is that there are a wide variety of cosmetic brands that manufacture products that do not feature talc or talc-derived ingredients.  For instance, some baby powder brands have switched from talc to corn starch. Additionally, organizations such as the Campaign for Safe Cosmetics have taken the lead in consolidating timely information about which products contain talc and where to look for alternatives.

Is the FDA Investigating Talc in Cosmetics?

In February 2020, the FDA opened a public docket to discuss and collect scientific data on talc ingredients in cosmetics. The FDA and members of an interagency working group continue to work together to evaluate the science surrounding talc, asbestos contamination, and cosmetics. The immediate goal of the group is to potentially develop recommendations for testing of asbestos in talc.

Last Updated December 18, 2020

Zantac is the brand name for ranitidine, a very popular medication used for the treatment of issues associated with heartburn, ulcers, and Gastro-Esophageal Reflux Disease (GERD). Ranitidine is part of a larger family of drugs known as histamine H2-receptor antagonists or “H2-blockers” for their method of action in blocking the action of histamine cells in the stomach lining.

Approved in 1983 for prescription use by the U.S. Food and Drug Administration (FDA), Zantac was wildly successful and by 1986 netted over $1 billion in sales for pharmaceutical giant, GlaxoSmithKline – making it one of biggest runaway hits in history. Zantac eventually went over-the-counter (OTC) in 1996 and following its move “off-patent” became an equally successful generic drug. In 2018, Zantac (ranitidine) ranked as one of the top-10 antacid tablets in the United States.

In 2019, things began to unravel for Zantac and the story of its meteoric rise to pharmaceutical sensation. A small, upstart testing laboratory in Connecticut revealed the presence of N-Nitrosodimethylamine, a potent carcinogen also known as “NDMA” in batches it sampled. It is now believed that the NDMA in Zantac may be the result of natural breakdown processes in ranitidine itself which potentially expands the range of exposure to nearly every person who has ever taken Zantac. In April 2020, the FDA announced a total recall of all Zantac (ranitidine) products from the market.

How does Zantac Function?

Histamine is a naturally occurring chemical present throughout the body which interacts with the cells in the stomach lining to promote the production of stomach acid. Drugs like Zantac work to block the histamine receptors traveling through the stomach, thereby limiting the signal to produce stomach acid.

How Long Does It Take Zantac to Work?

Zantac is absorbed into the bloodstream, unlike more traditional calcium carbonate antacids. However, in contrast to proton pump inhibitors (PPIs) which can take several days or weeks to activate, it will begin to work and provide relief of acid indigestion and heartburn within 1-2 hours.

How Many Brands of Zantac (ranitidine) Were on the Market at the Time of Recall?

The following is a list of branded Zantac and generic ranitidine brands at the time of recall:

What Are the Common Side Effects of Zantac?

Common Zantac side effects include, but are not limited to:

What is the Risk of Cancer from NDMA?

The International Agency for Research on Cancer (IARC) classifies NDMA as a Group 2A carcinogen which means they believe it is “probably carcinogenic to humans”. Specifically, it is believed that NDMA causes mutations in human DNA which can lead to harmful cancers. In humans intentionally poisoned with NDMA, severe liver damage and internal bleeding have resulted. Animal studies have revealed NDMA to be toxic even after short-term exposure.

What Cancers Are Associated with NDMA?

Research into NDMA and human exposure have yet to draw a definitive link between NDMA, Zantac, and cancer. The causes of cancers in humans are numerous and can range from factors involving behaviors such as smoking and drinking to a genetic predisposition to environmental factors and obesity. Accordingly, it is difficult to put a precise finger on what cancers could develop from NDMA contamination in Zantac. Nonetheless, researchers have theorized that long-term exposure through Zantac could be associated with the following types of cancer:

• Stomach
• Bladder
• Colorectal
• Liver
• Esophageal
• Small Intestinal

Although less prevalent in research, NDMA has also been linked to these types of cancers:

Does Zantac Interact with Other Medications?

Research has documented observations of Zantac interacting with common blood-thinners such as Warfarin. This interaction resulted in fluctuating levels of a blood test measuring prothrombin timing. Additionally, studies of Zantac suggest the possibility that it could interact with acetaminophen, ibuprofen, and metformin.

Is It True that Zantac Manufacturers Are Involved in Lawsuits?

Yes. In 2019, several individuals suffering from cancer who believe that their illness stems from taking Zantac contaminated with NDMA filed lawsuits against manufacturers such as: 

• Boehringer Ingelheim Pharmaceuticals, Inc.
• Sanofi Aventis, S.A./Sanofi-U.S. Services, Inc.
• Chattem, Inc.
• Pfizer, Inc.
• GlaxoSmithKline, Inc.

Cases have now been consolidated into single multidistrict litigation (MDL-2924) taking place in West Palm Beach, Florida. New cases are being added at this time.

Updated November 21, 2020

Zantac is the brand name of ranitidine, one of the most popular medications ever used to treat and prevent conditions such as heartburn; ulcers, and Gastro-Esophageal Reflux Disease (GERD). It is part of a family of drugs known as H2-blockers for their method of action blocking histamine cells in the stomach.

Zantac was one of the best-selling drugs in history and made enormous profits for both GlaxoSmithKline and Sanofi as well as serving as a center of enormous prestige for both companies. However, those profits and prestige took a big hit in 2019 when a small testing lab in Connecticut discovered trace amounts of N-nitrosodimethylamine (NDMA) in batches of ranitidine. NDMA has been recognized by the U.S. Environmental Protection Agency (EPA) and the International Agency for Research on Cancer (IARC) as a probable human carcinogen.

Upon the release of these results, some generic manufacturers of ranitidine began voluntary recalls of their products in 2019. This was followed by the announcement of a mandatory withdrawal of ranitidine from the market by the U.S. Food and Drug Administration (FDA) on April 1, 2020.

What is NDMA?

According to the EPA, NDMA is a semivolatile organic chemical. Although it is not typically produced intentionally in the United States, it can be produced unintentionally through chemical reactions in products or industrial processes. It is believed that when NDMA is consumed, it modifies cellular DNA, increasing cancer risk substantially.  Studies of NDMA and cancer risk have largely taken place only in animals as direct research from humans is still very limited.

How Did NDMA Wind Up in Zantac?

Valisure, a small laboratory in Connecticut, was the first testing facility to discover and report on NDMA contamination in Zantac/ranitidine. The lab believes that the NDMA in ranitidine is the result of the molecular instability of the drug itself and may form as a natural byproduct of its breakdown over time.

What Cancers are Associated with NDMA?

Cancer risk can stem from a number of factors unique to each person and their circumstances. Cancer can be linked to things such as infectious agents; genetic predisposition; behavioral factors and habits like diet, smoking, alcohol use, obesity, and diet; or even exposure to pollution. Also, it is important to remember that researchers have not yet established a conclusive link between Zantac NDMA contamination and cancer. However, it is theorized that long-term exposure to NDMA could be linked with the following cancers:

• Stomach
• Bladder
• Colorectal
• Liver
• Esophageal
• Small Intestinal

Although less prevalent in research, NDMA has also been linked to these types of cancers:

• Breast
• Thyroid
• Testicular
• Leukemia
• Non-Hodgkin’s Lymphoma
• Multiple Myeloma

• Prostate
• Ovarian
• Pancreatic
• Lung
• Uterine
• Brain

Ranitidine Manufacturers and FDA Recall

Upon announcement of the Valisure laboratory results, several generic manufacturers of ranitidine, led by Sandoz, both halted the distribution of their ranitidine products and later recalled their brands from store shelves. However, Sanofi, the manufacturer of branded Zantac ranitidine tablets initially declined to halt sales of Zantac. The company instead publicly stated that “The FDA reported levels of [NDMA] in ranitidine in preliminary tests barely exceed amounts found in common foods”.

On April 1, 2020, the FDA announced a complete market withdrawal and removal from shelves of all prescription and over-the-counter (OTC) forms of Zantac and generic equivalents of ranitidine. The agency said its decision was prompted by Valisure’s testing as well as its own testing which revealed the presence of NDMA under normal storage conditions, and even higher amounts when ranitidine is stored at higher temperatures. Furthermore, the FDA’s testing revealed that the older a ranitidine product is (the length of time following manufacture) the greater the amount of NDMA is present.

Branded Zantac and Generic Ranitidine Brands Recalled/Withdrawn

---

Sources Cited (31):

1) “Popular heartburn drug ranitidine recalled: What you need to know and do” https://www.health.harvard.edu/blog/popular-heartburn-drug-ranitidine-recalled-what-you-need-to-know-and-do-2019092817911

2) “Technical Fact Sheet – N-Nitroso-dimethylamine (NDMA)” https://www.epa.gov/sites/production/files/2014-03/documents/ffrrofactsheet_contaminant_ndma_january2014_final.pdf

3) “The Zantac problem: What’s NDMA?” https://abcnews.go.com/Health/zantac-problem-whats-ndma/story?id=65799147

4) “FDA Requests Removal of All Ranitidine Products (Zantac) from the Market” https://www.fda.gov/news-events/press-announcements/fda-requests-removal-all-ranitidine-products-zantac-market

5) “FDA Updates and Press Announcements on NDMA in Zantac (ranitidine)” https://www.fda.gov/drugs/drug-safety-and-availability/fda-updates-and-press-announcements-ndma-zantac-ranitidine

6) “Recalls, Market Withdrawals, & Safety Alerts” https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

7) “NDMA, a contaminant found in multiple drugs, has industry seeking sources and solutions” https://cen.acs.org/pharmaceuticals/pharmaceutical-chemicals/NDMA-contaminant-found-multiple-drugs/98/i15

8) “Ranitidine Cancer Risk“ https://www.medpagetoday.com/meetingcoverage/ddw/86314

9) “Health Risks Associated with N-Nitrosodimethylamine (NDMA)” https://www.labmanager.com/insights/health-risks-associated-with-n-nitrosodimethylamine-ndma-656

10) “What We Know about the Possible Carcinogen Found in Zantac” https://www.scientificamerican.com/article/what-we-know-about-the-possible-carcinogen-found-in-zantac/#:~:text=In%20its%20petition%2C%20Valisure%20also,break%20down%20to%20form%20NDMA.

11) “The Finding of N‐Nitrosodimethylamine in Common Medicines” https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7288647/

12) “Oral intake of ranitidine increases urinary excretion of N-nitrosodimethylamine” https://pubmed.ncbi.nlm.nih.gov/26992900/

13) “Formation Mechanism of NDMA from Ranitidine, Trimethylamine, and Other Tertiary Amines during Chloramination: A Computational Study” https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4123930/

14) “Clinical Study to Investigate the Urinary Excretion of N-nitrosodimethylamine (NDMA) After Ranitidine Administration” https://clinicaltrials.gov/ct2/show/NCT04397445

15) “FDA asks manufacturers to remove ranitidine from market: What now?” https://www.aappublications.org/news/2020/07/01/focus-ranitidine070120

16) “Concerned about the ranitidine (brand name: Zantac) recall? Here’s what the FDA says” https://www.miamiherald.com/news/health-care/article236067123.html

17) “Some ranitidine (Zantac) has tested safe, but more recalled for too much carcinogen” https://www.miamiherald.com/news/health-care/article237219936.html

18) “A tiny pharmacy is identifying big problems with common drugs, including Zantac” https://www.washingtonpost.com/science/a-tiny-pharmacy-is-identifying-big-problems-with-common-drugs-including-zantac/2019/11/08/6dd009ca-eb76-11e9-9c6d-436a0df4f31d_story.html

19) “N-Nitrosodimethylamine (NDMA) as a Drinking Water Contaminant: A Review” https://superfund.berkeley.edu/pdf/231.pdf

20) “Questions and Answers: NDMA impurities in ranitidine (commonly known as Zantac)” https://www.fda.gov/drugs/drug-safety-and-availability/questions-and-answers-ndma-impurities-ranitidine-commonly-known-zantac#:~:text=FDA%20has%20found%20N%2Dnitrosodimethylamine,ranitidine%20they%20may%20currently%20have.

21) “Our Mission” https://www.valisure.com/about-us/

22) “Formation Mechanism of NDMA from Ranitidine, Trimethylamine, and Other Tertiary Amines during Chloramination: A Computational Study” https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4123930/

23) “The Finding of N‐Nitrosodimethylamine in Common Medicines” https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7288647/

24) “Oral intake of ranitidine increases urinary excretion of N-nitrosodimethylamine” https://pubmed.ncbi.nlm.nih.gov/26992900/

25) “Zantac, Ranitidine Pulled From Market, Here Are FDA’s Latest Cancer Concerns” https://www.forbes.com/sites/brucelee/2020/04/02/zantac-ranitidine-pulled-from-market-here-are-fdas-latest-cancer-concerns/#e60d6fb2b8c5

26) “Zantac is prescribed 15 million times a year. So how did it become a potential cancer risk?” https://www.usatoday.com/story/news/health/2019/11/07/how-did-zantac-become-potential-cancer-risk-fda-wants-find-out/2509043001/

27) “Ranitidine (Zantac) recall expanded, many questions remain” https://www.health.harvard.edu/blog/ranitidine-zantac-recall-expanded-many-questions-remain-2020040218044

28) “Lab finds NDMA in Zantac can develop during storage” https://www.fiercepharma.com/manufacturing/lab-finds-ndma-zantac-can-develop-during-storage-bloomberg

29) “FDA Recalls All Ranitidine (Zantac) Products, Citing Increased Risk of Cancer” https://www.ajmc.com/view/fda-recalls-all-ranitidine-products-zantac-citing-increased-risk-of-cancer

30) “Valisure Detects NDMA in Ranitidine” https://www.valisure.com/blog/valisure-news/detection-of-ndma-in-raniditine/

31) “COVID-19 and Beyond: Oversight of the FDA’s Foreign Drug Manufacturing Inspection Process – Hearing before the United States Senate Committee on Finance (June 2, 2020)” https://www.finance.senate.gov/imo/media/doc/02JUN2020.VALISURE.LIGHT.STMNT.pdf

Last Updated November 20, 2020

Valsartan has experienced widespread adoption and been a popular drug since its introduction in the 1990s. It is typically prescribed alone or in conjunction with other medications to combat high blood pressure. It is also considered a “second choice” treatment for patients who have not enjoyed success with other drugs such as ACE inhibitors such as ramipril or lisinopril.

The FDA has recalled some batches of generic Valsartan due to fears over contamination with N-Nitrosodimethylamine (NDMA), a potent carcinogen. It is believed that the contamination resulted from poor quality control practices at factories in India and China. The complete list of recalled batches and manufacturers can be found here.

Valsartan Pregnancy Warning

The FDA classifies Valsartan as a “Category D” medication, meaning there is “positive evidence” of human fetal risk based on adverse reaction data from investigations. Accordingly, Valsartan’s label comes with a prominent black box warning concerning pregnancy and fetal toxicity. The use of drugs like Valsartan can reduce fetal renal function and increase the chances of fetal death. Women who learn they are pregnant should discontinue the use of Valsartan as soon as possible.

Common Side Effects of Valsartan

Studies of Valsartan have revealed the following side effects which tend to occur in 1 or more out of 100 people taking the medication:

• Dizziness/Spinning (vertigo)
• Headaches
• Nausea
• Vomiting and diarrhea
• Joint/Muscle Pain

Liver Damage

Through its post-marketing analysis, the FDA has received reporting from drug manufacturers and physicians potentially linking Valsartan with acute liver injuries, impairment of liver function, and elevated enzymes. Symptoms will typically start to manifest one to eight weeks after starting the use of Valsartan. Patients who experience the following symptoms should contact their physician for further review:

• Jaundice
• Itchy Skin
• Chronic Fatigue
• Dark Urine
• Irregular Stool Color
• Abdominal Pain/Swelling
• Easily Bruising

Valsartan FDA Recall and Cancer Risk

In 2018, the FDA began a series of voluntary recalls following random tests of generic Valsartan which revealed NDMA contamination. NDMA is considered to be an extremely potent carcinogen.

The cancer risk associated with NDMA in Valsartan must be understood in combination with other risk factors such as genetic predisposition; environment; smoking; drinking and eating habits; and obesity. However, researchers theorize that long-term exposure to NDMA could be linked with the following cancers:

The FDA offered some perspective on the risk associated with contaminated Valsartan. In its updated announcement, the agency estimated that if 8,000 patients took 320mg of valsartan (the highest dose) contaminated with NDMA, there may be one additional cancer case during the lifetimes of those patients. The estimate is based upon average impurity levels in a single tablet of valsartan.

Last Updated November 2, 2020

Valsartan is a popular anti-hypertensive drug that has been in widespread use since the 1990s. It can be used alone or in conjunction with other medications to combat high blood pressure/hypertension or to aid in recuperation following a heart attack episode. In recent years, as generic manufacturers moved into the market for Valsartan, they took the production of this drug into factories located in India and the People’s Republic of China. The decision to move the manufacturing of generic varieties of Valsartan offshore was a fateful one as it was later discovered that some batches made in these factories were contaminated with potent carcinogens which later found their way into the U.S. drug supply.

Beginning in 2018, the U.S. Food and Drug Administration (FDA) began wide-ranging recalls of generic Valsartan.  Now, individuals suffering from various forms of cancer are suing these generic manufacturers and their lawsuits have been consolidated into a large multidistrict litigation (MDL-2875) taking place in federal court in New Jersey.

Contamination of Generic Valsartan Supplies

Valsartan is manufactured in generic formats by firms around the world. Most of the “Active Pharmaceutical Ingredient” (API) for generic Valsartan is itself subcontracted out to a handful of factories in the People’s Republic of China and India. FDA testing of certain generic brands of Valsartan revealed that some batches were contaminated with N-Nitrosodimethylamine (NDMA), an extremely potent carcinogen.  In 2018, the FDA announced recalls of contaminated batches of Valsartan as well as other similar medications such as Losartan and Irbesartan. The complete list of recalled batches and manufacturers can be found here.

It is believed that improper manufacturing processes at plants in Zhejiang, China, and Telangana, India, are to blame for NDMA contamination. These factories were outsourced by generic drug manufacturers to maximize the profitability of their brands and operated with little or no oversight or monitoring for safety and quality. Consequently, contaminated medications made their way through the supply chain and into batches circulated through the United States, Canada, and Europe.

Here is a list of some of the larger generic Valsartan manufacturers:

What Are the Risks from NDMA Contamination?

NDMA is a Group 2A carcinogen meaning that it is likely to cause cancer in humans because research has shown it to cause cancer in animals. Animals exposed to NDMA for periods over several weeks tended to show some development of liver and lung cancers as well as other types of cancer.  

A prospective study published in a 2011 issue of the American Journal of Clinical Nutrition found that NDMA is associated with a higher incidence of gastrointestinal cancer as well as rectal cancer in humans. Other studies have linked NDMA to higher incidences of esophageal, oral cavity, and pharynx cancers.

Valsartan Lawsuits

The first lawsuits naming manufacturers for their role in placing contaminated Valsartan into the drug supply began cropping up in state courts in 2018. Many of these lawsuits were removed to federal courts and in 2019 consolidated into single multidistrict litigation (MDL-2875). As of August 2020, there were 339 plaintiffs involved in this MDL.

The majority of the complaints filed by injured parties in the MDL assert that they were prescribed certain generic forms of Valsartan which were contaminated with NDMA and that in turn, they believe that the contamination is behind their cancer diagnosis. In particular, some claimants allege that contaminated Valsartan is behind a range of gastrointestinal and gastroesophageal cancers as well as liver and pancreatic cancers. Finally, claimants allege that the manufacturers were, at a minimum, negligent in their manufacturing processes and safety/quality control standards.

It is important to note that not all batches of generic Valsartan were contaminated. Lawsuits are focused entirely on generic batches that were subject to FDA recall. The domestic brands of Valsartan, such as those marketed by Novartis, under the brand name Diovan, are not part of the FDA recall.

Additionally, some potential claims alleging illness from contaminated generic Valsartan may be thwarted by the applicable statute of limitations in each state. Accordingly, if you believe you have taken contaminated generic Valsartan and have suffered an injury, you should consult with an attorney as soon as possible. An attorney can advise you about the statute of limitations and other matters that could affect your ability to file.

---

Sources Cited (16):

1) “In re: Valsartan NDMA Contamination Litigation” https://ecf.jpml.uscourts.gov/doc1/8501984141

2) “Leanne Gentry et al. v. Solco Healthcare U.S., LLC et al.” https://ecf.mowd.uscourts.gov/doc1/10916957329

3) Use of N-nitrosodimethylamine (NDMA) contaminated valsartan products and risk of cancer: Danish nationwide cohort study” https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6134800/#:~:text=Valsartan%20is%20an%20angiotensin%20II,treat%20hypertension%20and%20heart%20failure.&text=In%20July%202018%2C%20some%20valsartan,N%2Dnitrosodimethylamine%20(NDMA).

4) FDA Updates and Press Announcements on Angiotensin II Receptor Blocker (ARB) Recalls (Valsartan, Losartan, and Irbesartan)” https://www.fda.gov/drugs/drug-safety-and-availability/fda-updates-and-press-announcements-angiotensin-ii-receptor-blocker-arb-recalls-valsartan-losartan

5) “Plaintiffs: Valsartan Manufacturers Should Have Known About NDMA Contamination” https://newyork.legalexaminer.com/health/plaintiffs-valsartan-manufacturers-should-have-known-about-ndma-contamination/

6) “Search List of Recalled Angiotensin II Receptor Blockers (ARBs) including Valsartan, Losartan and Irbesartan” https://www.fda.gov/drugs/drug-safety-and-availability/search-list-recalled-angiotensin-ii-receptor-blockers-arbs-including-valsartan-losartan-and

7) “FDA Expands Valsartan Products Recall” https://www.pharmacytimes.com/resource-centers/cardiovascular-health/fda-expands-valsartan-products-recall

8) “Valsartan, Losartan & Other BP Med Recalls 2018-19” https://www.webmd.com/hypertension-high-blood-pressure/valsartan-losatran-bp-med-recalls-2018-19

9) “NDMA, a contaminant found in multiple drugs, has industry seeking sources and solutions” https://cen.acs.org/pharmaceuticals/pharmaceutical-chemicals/NDMA-contaminant-found-multiple-drugs/98/i15

10) “What We Know about the Possible Carcinogen Found in Zantac” https://www.scientificamerican.com/article/what-we-know-about-the-possible-carcinogen-found-in-zantac/

11) “Does NDMA Cause Cancer?” https://www.verywellhealth.com/ndma-cancer-risk-5083965

12) “N-Nitrosodimethylamine” https://pubchem.ncbi.nlm.nih.gov/compound/N-Nitrosodimethylamine

13) “Use of N-nitrosodimethylamine (NDMA) contaminated valsartan products and risk of cancer: Danish nationwide cohort study” https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6134800/

14) “A survey of feeding N-nitrosodimethylamine (NDMA) to domestic animals over an 18 year period” https://pubmed.ncbi.nlm.nih.gov/7228298/

15) “Dietary intakes of nitrate, nitrite and NDMA in the Finnish Mobile Clinic Health Examination Survey” https://pubmed.ncbi.nlm.nih.gov/8799716/

16) “Inflammatory bowel disease stimulates formation of carcinogenic N-nitroso compounds” https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1774505/

Last Updated November 3, 2020

Generally, hearing loss is considered preventable. If properly fit hearing protective devices are consistently and routinely worn under situations involving loud noise exposure, tinnitus and noise-induced hearing loss can be avoided. Otherwise, damage done to the hearing of veterans can be debilitating. Tinnitus can make it difficult to sleep, concentrate, or relax; and progressive hearing loss is linked to anxiety, depression, heart disease, and impaired cognitive function.

Hearing Loss Symptoms and Causes in Military Veterans

According to the Hearing Loss Association of America, there are three types of hearing loss:

Conductive Hearing Loss

Conducting hearing loss is usually characterized by a malformation in either the outer ear, ear canal, or middle ear structure. It can also be caused by other factors such as a severe ear infection, benign tumors, hereditary disorders, or even impacted ear wax. This type of hearing loss is generally treated with either surgery, antibiotic medications, or with the assistance of hearing devices, such as cochlear implants or hearing aids.

Sensorineural Hearing Loss

Sensorineural hearing loss is typically caused by factors such as exposure to loud noise, head trauma, viral infections/autoimmune responses, Meniere’s disease, otosclerosis, or just plain aging. Irreversible sensorineural hearing loss, the most common form, is usually treated with hearing aids or surgically implanted devices such as cochlear implants.

Mixed Hearing Loss

A combination of conductive damage in the outer or middle ear combined with sensorineural damage in the inner ear and/or the auditory nerve.

In addition to hearing loss, many veterans suffer and cope with Tinnitus. In fact, it is the number one disability among veterans and affects nearly 10% of American adults. Described as ringing/buzzing sounds, or high-pitched whistles – the origins or tinnitus can actually be attributed to a number of causes. It could result from close proximity to an Improvised Explosive Device (IED) blast, repeated exposure to long rifle fire engagements, long term exposure to loud equipment, or something as mundane as a switch in medication. However, it is known that tinnitus and hearing loss often go hand-in-hand and tinnitus is often the first symptom of hearing damage.

Veterans and those on active duty generally have a higher risk of permanent hearing loss. Common causes of hearing loss among veterans include:

Firearms and Explosive Weapons Noise

Constant exposure to the operation of some military weapons, especially those that create noise over 140 decibels will put anyone at greater risk for loss of hearing. Additionally, they can cause “high-frequency” hearing loss making it difficult to hear anything that is 2000 hertz or higher (high-pitched voices; noisy conversions in crowded rooms; use of consonants in speech).

Ship Engines and Carrier Deck Noise

Navy veterans, especially those involved with naval aviation, are at high risk due to the loud noise involved with engine room and carrier deck operations. Engine noise can frequently exceed 112 decibels and result in hearing loss later in life. On the other hand, jet engines routinely produce sounds in excess of 160 decibels creating greater risks for pilots and deck crews of high-frequency hearing loss and tinnitus.

Jet Fuel Exposure

Kerosene-based military-grade jet fuel (also sometimes referred to as JP-8) is made up of a combination of petrochemicals that when combusted, can produce fumes interfering with neurological pathways in the brain that decipher speech and language.  Combined with other loud noise factors, jet fuel can increase a veteran or servicemember’s risk for later developing tinnitus or hearing loss.

How to Prevent Service-Related Hearing Loss

Without a doubt, hearing protection devices are key to protecting the hearing of servicemembers against damaging noise levels which can result in hearing loss or tinnitus.  

Typical hearing protection devices include:

• Triple/Quad Flange Earplugs
• Tactical Earplugs
• Tactical Communication and Protective Systems (TCAPS)
• Noise Muffs
• Foam Earplugs

According to the Hearing Center of Excellence, hearing protection devices do not ordinarily cause decreased situational awareness. Service members need to choose proper hearing protection based upon the environment, situation, noise type, and level of noise to which they are exposed.

3M Combat Arms Earplugs – Defective Protection Devices

Between 2003 and 2015, it is believed that the U.S. military purchased at least one pair of “Combat Arms” earplugs for every serviceman and servicewoman sent abroad for foreign deployment. Manufactured by a subsidiary of one of the world’s largest corporations, the 3M Company of Minnetonka, Minnesota, these earplugs were furnished to this nation’s fighting men and women for the ostensible purpose of protecting their hearing from the loud and often concussive sounds experienced during combat and training. However, veterans who were equipped with these devices now report that they experience a multitude of hearing issues which they believe stem from the defective design of the 3M Combat Arms earplugs.  

In July 2018, 3M agreed to settle a whistleblower claim brought under the False Claims Act by a competitor in U.S. ex rel. Moldex-Metric, Inc. vs. 3M Co. The allegations in that suit focused on the false statements 3M and Aearon made to the U.S. Government concerning the defective nature of the earplugs. However, as part of the settlement, 3M made no admission as to its liability or wrongdoing.

The Veterans Administration and Hearing Loss

The Veterans Administration does provide benefits and compensation for service-related disabilities involving hearing loss and tinnitus. Typically veterans must establish that their hearing issues were caused by military duty and establish:

• A current diagnosis of a hearing condition
• Evidence of an event in service that caused the condition
• A medical opinion linking the hearing issue to the service-related event

The hearing condition diagnosis, in order to be deemed service-related, must be conducted by a licensed audiologist and involve two tests:

• Maryland CNC Test
• Puretone Audiometric Test

The Veterans Administration will use these auditory test results and its regulatory formula to determine an actual rating to assign. Typically, ratings for hearing loss are 0% or 10%. Severe or profound hearing loss can qualify for a higher rating.

Noise-Induced Hearing Loss Treatment

Noise-induced hearing trauma is usually permanent in nature and at the moment, cannot be remedied with surgery or procedures removing fluid or wax blockages. Standard options to treat or ameliorate noise-induced hearing damage to involve:

Hearing Aids

Damage to the inner ear and resulting hearing loss can be remedied with a hearing aid. An audiologist can review the service member’s case file and discuss options for a device type that will present the best fit.

Cochlear Implants

More severe types of hearing loss may be more suited to a cochlear implant. This device amplifies sound and directs it into the ear canal, bypassing damaged areas in the ear structure. Service members interested in this type of solution should consult their audiologist as well as an Ear-Nose and Throat (ENT) specialist.

Last Updated November 13, 2020

Valsartan is the generic name for anti-hypertension medication frequently marketed under the names Diovan and Prexxartan in the United States. It is part of a class of drugs known as Angiotensin II Receptor Blockers (ARBs) used to primarily treat high blood pressure, heart failure, and diabetic nephropathy (kidney disease). ARBs are widely accepted within the medical community as a valuable tool to help combat the range of complications associated with type-2 diabetes. However, since moving “off-patent” and into the market for generic availability, Valsartan found itself the focus of unwanted scrutiny and lawsuits after certain batches were contaminated with N-Nitrosodimethylamine (NDMA), an extremely potent carcinogen.

Many of the claims involving Valsartan have been consolidated into multidistrict litigation (MDL) now before a federal court in New Jersey (MDL-2875). In these lawsuits, claimants allege that the manufacturers of contaminated Valsartan knew or should have known about the NDMA issue going back to at least 2012, and that they failed to warn patients and physicians about the risk.

Valsartan and Cancer Risk

As a preliminary matter, it’s important to know that not every batch of Valsartan was contaminated with NDMA. Only certain batches of Valsartan and other ARBs were subject to testing and recall. A complete list of the recalled ARBs can be found here.

NDMA is an organic chemical that is listed by the International Agency for Research on Cancer (IARC) as a group 2A carcinogen – meaning it is likely to cause cancer in humans because research has shown it to cause cancer in animals. In animal studies, NDMA has been shown to be acutely toxic to rats and even short bursts of exposure can lead to multiple organ damage in other animals. NDMA can occur both in nature or as the result of industrial manufacturing processes.

Once Valsartan became available for manufacture by generic pharmaceutical firms, most of the fabrication of its “Active Pharmaceutical Ingredient” (API) was outsourced to factories in India and the People’s Republic of China. It is believed that two facilities in particular – in Zhejiang, China, and Telangana, India, produced the API for Valsartan and are also to blame for the batches contaminated with NDMA. These batches of medication later were processed through the supply-chains throughout the United States, Canada, and Europe.

Later testing by the European Medicines Agency (EMA) and the FDA discovered the presence of N-Nitrosodiethylamine (NDEA) in other batches of ARBs from the same factories in China and India. NDEA is another similarly potent carcinogen and it is believed the poor production environment in these factories created the opportunity for both NDMA and NDEA to form as a byproduct of manufacturing.

FDA Recall

The U.S. Food and Drug Administration (FDA) began a series of voluntary recalls in 2018 following testing of batches of generic Valsartan. Since then, the FDA has continued its investigation into contaminated Valsartan as well as other ARBs such as Losartan and Irbesartan. The FDA estimates that based on its own testing NDMA and NDEA may have been present in contaminated ARB batches for up to four years.  

The FDA offered some perspective on the risk associated with contaminated ARBs. In its updated announcement, the agency estimated that if 8,000 patients took 320mg of valsartan (the highest dose) contaminated with NDMA, there may be one additional cancer case during the lifetimes of those patients. The estimate is based upon average impurity levels in a single tablet of valsartan.

Last Updated December 9, 2020

Proton Pump Inhibitors (PPIs) are prescription and over-the-counter (OTC) drugs that are designed to limit the production of digestive acid in the stomach. In patients who suffer from maladies such as Gastro-Esophageal Reflux Disease (GERD), ulcers, or other digestive conditions, PPIs are a potent tool in the arsenal to combat painful symptoms. Today, there are several brands of PPIs on the market that have generated several billions of dollars for global pharmaceutical manufacturers.

Now, decades after first being introduced onto the market, questions have emerged concerning the potential for illness and disease associated with long-term PPI use. Medical journals and research professionals have raised the possibility of PPIs being linked to kidney injuries and increased risk of permanent renal failure. In 2014, the U.S. Food and Drug Administration (FDA) imposed a requirement that all PPIs carry warnings on their labels concerning a kidney-disease precursor condition known as Acute Interstitial Nephritis (AIN).

How Do PPIs Function?

PPIs are ingested and dissolve straight into the bloodstream. When they reach a certain type of acid-producing cellular tissue in the lining of the stomach, they disrupt the production of acid-pumping enzymes.

How Long Does It Take PPIs to Work?

PPIs are meant to be taken as part of a planned regimen that accrues over several weeks. They are not meant to be taken “on-demand” or to provide immediate relief like other medications such as antacids or histamine blockers.

How Many Brands of PPIs Are On The Market?

There are several brands of OTC and prescription PPI brands on the market in the United States:

What Are the Approved Uses for PPIs?

The FDA has approved PPIs for use in adults to treat: GERD; gastric ulcer risk; Helicobacter pylori; duodenal ulcers and Zollinger-Ellison syndrome. Dosages and duration for use of PPIs will depend upon the particular brand of PPI as not all brands are exactly similar or approved for all types of illness.

What Are the More Common Side Effects Associated with PPIs?

Documented side effects from PPIs use include:

• Headache
• Nausea
• Stomach Pain
• Gas
• Constipation
• Diarrhea
• Rash
• Vomiting
• Constipation
• Fever
• Cold or Flu-like Symptoms

Are There More Serious Side Effects Associated with PPIs?

There are some more serious conditions associated with PPIs where the FDA has either taken the additional step of issuing safety communications or warnings. These include:

• Acute Interstitial Nephritis (AIN)
• Hypomagnesemia
• Clostridium Difficile Associated Diarrhea (CDAD)
• Small Intestine Bacterial Overgrowth (SIBO)
• Hip/Wrist/Spinal Fracture Risk

What is Acute Interstitial Nephritis?

AIN is a kidney disorder in which the spaces between kidney tubules become inflamed and swollen. If left unchecked, AIN can deteriorate kidney function to the point where sufferers develop Chronic Kidney Disease (CKD). Long term suffering from CKD can eventually lead to End-Stage Renal Disease (ESRD) – also known as complete renal failure. ESRD requires either a kidney transplant or dialysis for continued survival.

Do PPIs Interact with Any Other Medications?

Omeprazole, the most commonly prescribed and purchased PPI is believed to interact with at least 194 other drugs on the market. If these interactions, at least 16 are believed to be serious, 132 are thought to be moderate and 46 are minor. One of the more serious drug interactions with omeprazole (and esomeprazole) involves the blood-thinner clopidogrel (also sold under the brand names: Ceruvin, Clopilet, and Plavix). Omeprazole and esomeprazole both stall the production of the enzyme CYP2C19 which is critical to the body’s ability to metabolize clopidogrel. The FDA issued a warning in 2009 asking patients taking clopidogrel to avoid taking omeprazole and esomeprazole.

Is It True That Some PPI Manufacturers Are Involved in Lawsuits?

Yes. Lawsuits alleging kidney disease and renal injuries from PPI use were initially filed in 2016. One of the first victims to file suit was Charles Bowers, a Tennessee man who took Nexium from 2003-2008 until he was diagnosed with acute kidney disease. Mr. Bowers currently undergoes kidney dialysis 3 days a week while he awaits a kidney transplant. From there, individuals filing lawsuits naming PPI manufacturers like AstraZeneca (among others) have mushroomed considerably. Cases from across the country have now been merged into single multidistrict litigation taking place in federal court in New Jersey (MDL-2789).  

Last Updated December 7, 2020

Since the early days of e-cigarettes and vaping in the United States, manufacturers such as Juul and others, have made spurious claims that their devices are either “safe” or “safer than tobacco”. The practice of touting the ostensible “benefits” to vaping and Juul use went unchallenged for several years while those in the scientific and medical communities became increasingly concerned that not only are they not safer, they may in fact pose new and unique dangers to human health.

It’s helpful to remember that despite whatever beneficial claims manufacturers make, these devices are designed and built for the express purpose of delivering nicotine, a dangerous and addictive chemical, either just as or more efficiently than combustible cigarettes. Furthermore, the vapors created by vaping and Juul contain additives and ingredients which may be linked to severe lung damage in adults and teens.

The potential for adverse side effects from vaping and Juuling has become so pronounced that the U.S. Food and Drug Administration (FDA) extended regulatory power over e-cigarettes and Juul to its Center for Tobacco Products in 2016. Later, in 2018, the U.S. Surgeon General declared e-cigarette use “…an epidemic among our nation’s young people”.  Most recently, in April 2020, the FDA used its authority to ban the sale of flavored e-cigarette and Juul cartridges (except for menthol and tobacco flavors).

Now public health officials throughout the United States have started to document and publish studies into the association between vaping, addiction, and respiratory distress.

Commonly Associated Side Effects of Vaping

Vaping and Juul use have commonly understood side effects from their use. These side effects may be more noticeable among new users and may disappear over time once the use of vaping or Juul products have been discontinued:

• Coughing
• Dry or Sore Throat
• Dry Eyes
• Headaches
• Nausea
• Dizziness
• Dry Mouth
• Shortness of Breath

Nicotine Addiction and Withdrawal Side Effects

E-Cigarettes and Juul are nicotine delivery devices and contain nicotine just like combustible cigarettes. They may even be more potent at putting nicotine into the bloodstream given the high concentrations deposited by the vaping mechanism. Added to this potency is the fact that many vaping systems sell high concentration nicotine cartridges or allow voltage to be augmented to bump up the amount of nicotine.

It is well understood that nicotine is extremely addictive and is dangerous for adults and teens alike. Short term exposure to nicotine has been demonstrated to induce tremors and an increase in heart rate, blood pressure, and respiration. It is suspected to cause issues in early teen and fetal brain development. Furthermore, long-term exposure to nicotine is linked to tumor growth and promotion.

Nicotine addiction is insidious and difficult to overcome.  In adults and teens alike, nicotine triggers a dopamine “reward” effect which encourages the user to keep using nicotine over and over again. Consequently, when e-cigarette and Juul users attempt to quit vaping, they tend to suffer nicotine cravings and other side effects such as:

• Feeling irritable
• Headaches
• Increased sweating
• Anxiety
• Sadness
• Feeling tired
• Difficulty with concentration
• Insomnia or difficulty sleeping
• Increased hunger

Breathing Issues

Over several decades, the American public has been made well aware of the numerous hazards associated with smoking combustible cigarettes such as heart disease, emphysema, and lung cancer. Regrettably, because e-cigarettes and Juul remove the combustible element inherent in traditional cigarettes, many people believe that these devices pose no risk at all to lung health. However, the scientific and medical communities are now voicing new concerns about vaping compounds and lung health that introduce a range of new potential side effects.

Bronchiolitis Obliterans Organizing Pneumonia (BOOP)

Researchers recently published an article concerning the prevalence of Bronchiolitis Obliterans Organizing Pneumonia (also known as “BOOP”) in the American Thoracic Society (ATS) Journal. BOOP is a lung disease which causes inflammation in the small air tubes (bronchioles) and air sacs (alveoli). Ordinarily, BOOP symptoms include: shortness of breath, dry cough and fever. Some symptoms may be much more acute than others.   BOOP is typically treated with a drug regiment focused on corticosteroids such as prednisone.

E-Cigarette or Vaping Associated Lung Injury (EVALI)

EVALI was first recognized by the U.S. Centers for Disease Control (CDC) in August 2019 following the combined work of several public health officials across the United States to study cases of severe and sometimes fatal lung infections in several otherwise healthy people. The individuals who required hospitalization complained of symptoms such as shortness of breath and fever. The common factor among all of them was that they were recent users of e-cigarettes and vaping products. The CDC and the New England Journal of Medicine have conducted further research which suggests, Vitamin E Acetate, a thickening agent used in some vaping products, may be linked with EVALI.

Adam Hergenreder

Eighteen-year-old Adam Hergenreder was a steady e-cigarette user for over two years.  His favorite flavors were mint and mango. In September 2019, he was hospitalized complaining of acute lung issues and shortness of breath. After undergoing chest X-rays, his doctors told him he had the lungs of a 70-year old man and that his lungs may never truly heal.

Vaping-Related Acute Lung Injury

The December 2019 Mayo Clinic Proceedings examined the potential for breathing issues and vaping in its article: “Vaping-related Acute Lung Injury: A New Killer Around the Block.” Among the article’s highlights was the conclusion that the incidence of vaping-related acute lung injury is increasing and that electronic cigarette compounds present the potential for a range of detrimental effects on the human respiratory system.

Neurological Issues

Alleged Hemorrhagic Stroke

In 2017, 22-year old Syracuse University student Maxwell Berger suffered a severe hemorrhagic stroke which paralyzed the left side of his body and caused him to lose half of his vision in both eyes. Maxwell began vaping with Juul in 2015 and quickly developed a two-pod-per-day habit.  In a lawsuit he filed in 2019, Maxwell alleges that his use of Juul caused his stroke as well the cognitive brain impairment he has experienced as a consequence.

FDA Investigation Into Possible Link to Seizures

In a series of 2018 internal communications uncovered by Bloomberg News, the FDA took a hard look at three cases of seizures that occurred alongside Juul use. To be sure, the FDA did not detail any direct causal link between Juul and the seizures. However, they did believe that at a minimum, there was an “association” between the seizures and Juul. Over the next few months, the FDA uncovered an additional 32 reports of vaping and seizures and in April 2019, the agency announced a formal investigation into a linkage.

Juul Pod Contamination

A former Juul Labs executive filed a 2019 lawsuit in federal court in California alleging that at least one million contaminated Juul pods made it onto the market despite numerous warnings to the company’s leadership. In his lawsuit, Siddarth Breja alleged that Juul’s CEO Kevin Burns told him: “Half our customers are drunk and vaping like mo-fos, who the f**k is going to notice the quality of our pods?” Juul’s CEO has publicly denied the allegations.

Last Updated October 28, 2020

Talcum-based powder has been a staple in American bathrooms and medicine chests since global pharmaceutical and medical device conglomerate, Johnson & Johnson, first developed and sold its baby powder in 1893. Marketed as a convenient and comforting method to eliminate moisture for both babies and women, baby powder was, for years, touted as “safe” and leaving the skin “delicately soft and dry”. The success of Johnson & Johnson’s baby powder spawned a host of other entrants to the market including “Shower to Shower” (itself developed by Johnson & Johnson, then later sold to Valeant) and “Gold Bond” body powders, all of which continued telegraphing to consumers that their products are “safe” and appropriate tools for maintaining “freshness and cleanliness” for women and babies.

Despite manufacturer claims of health and safety, increasing evidence of the risks associated with talc began to mount in the 1960s, in particular with respect to risks from talc and asbestos exposure. Furthermore, since 1982, there have been at least 21 studies by doctors and scientists around the world which concluded that talc presents an elevated risk of ovarian cancer when applied to female genitals. This increasing awareness of the health concerns associated with talc has led tens of thousands of people to file lawsuits alleging that talcum powder manufacturers were aware of the potential for cancer caused by their products and still did nothing to warn consumers.

Talc Background

A naturally occurring mineral, Talc is composed of magnesium, oxygen, and hydrogen and is known chemically as a “hydrous magnesium silicate”.  In its natural form, talc appears as grey/green or white and typically has a somewhat greasy feel to it. Talc is the main substance within talcum powders such as Johnson & Johnson’s branded baby powder. Talc is usually mined in proximity to concentrated deposits of asbestos, a known deadly carcinogen. As a consequence, it has been understood for quite some time that, in its natural form, talc will contain asbestos and that exposure to natural asbestos from talc must be limited. 

Top-Selling Talc Products (Historically)

Since 2017, many manufacturers of talcum powder products have either withdrawn their brands from the U.S. market or switched to a safer alternative like cornstarch powder. Historically however, the following are/were the leading talcum powder brands on the market throughout the United States:

• Cashmere Bouquet (Colgate Palmolive)
• Gold Bond Powders and Sprays (Chattem)
• Johnson’s Baby Powder (Johnson & Johnson)
• Shower to Shower (Valeant/Johnson & Johnson)

Talc Exposure and Mesothelioma

Malignant mesothelioma is cancer that arises within the mesothelium – a very thin layer of tissue within the body that covers many internal human organs. Due to the presence of this important tissue throughout the body, a diagnosis of mesothelioma is usually a final one. There are not many available treatments and the cancer is very aggressive. There are different types of mesothelioma. However, the most common form is pleural mesothelioma which involves tissue around the lungs.

Asbestos exposure is considered to be one of the primary risks for developing mesothelioma. Airborne asbestos fibers can settle into the lungs or stomach when inhaled or ingested and then fester for years possibly leading to mesothelioma. In fact, it is believed that mesothelioma may develop as late as 20 to 60 years following initial asbestos exposure.

For years, talc product manufacturers, in particular Johnson & Johnson, asserted that their powder products were safe and did not contain asbestos. However, as the result of recent litigation, Johnson & Johnson was compelled to hand over thousands of pages of internal company documents for examination by plaintiffs. Some of these documents detail that going back to at least 1971, the company knew on multiple occasions that its talc-based powders were testing positive for small amounts of asbestos. It is worth noting that the World Health Organization (WHO) does not recognize any safe level of exposure to asbestos.

Worse yet, internal Johnson & Johnson documents also show that the company could have easily substituted corn starch in the place of talc in all of its products. Johnson & Johnson knew that cornstarch is absolutely free of asbestos yet refused to make the change.

In the belief that their mesothelioma was caused by exposure to asbestos from talc powder (as well as the powder itself), several victims have filed lawsuits and obtained critical verdicts supporting their claims.

• A Missouri jury ruled in favor of four plaintiffs in 2019, who each claimed that exposure to asbestos leaden talcum powder used on them as children caused their mesothelioma. The jury awarded $37.2 million in damages to the group.

• In 2018, a New Jersey jury found that Stephen Lanzo’s mesothelioma diagnosis was likely the result of his exposure to asbestos after years of regular use of Johnson’s Baby Powder. The jury awarded Mr. Lanzo $117 million, including punitive damages after finding that Johnson & Johnson “acted with deliberate indifference” to the rights of Mr. Lanzo.

• After a six-week trial in 2017, a California jury awarded a $22 million verdict to Richard Booker. Mr. Booker died at the age of 72 from mesothelioma and claimed that his diagnosis came after years of exposure to asbestos in paint and ceramics which used talc as a primary ingredient. The jury award included $4.6 million in punitive damages against one of the largest talc mining companies in the world, Imerys.

Talc Exposure and Ovarian Cancer

Going back decades, talc-based powder manufacturers touted their products as a safe and effective means for managing genital perspiration and as a genital deodorant. Products such as Johnson’s Baby Powder and Shower to Shower were aggressively promoted as non-irritating daily-use solutions for vaginal odor. The campaign was wildly successful and by the mid-2000s, adults accounted for 91% of Johnson’s Baby Powder use.  

Johnson & Johnson’s marketing was even slickly targeted to emergent consumers – in particular “curvy” and “overweight” women. As the WHO began to scrutinize talc-based powders as being “possibly carcinogenic” in 2006, Johnson & Johnson shifted its marketing gears to target overweight and African American women who they considered as a viable consumer opportunity at the time.

The first suggestion of a linkage between ovarian cancer and talc usage emerged in the early 1960s. At that time, researchers felt that since some talc powders contain asbestos, and it was known that animal studies showed the potential for asbestos to migrate to the ovaries from the genitals – there was at least the possibility in humans. It wouldn’t be until 1982 when a case-control study first linked talc use with ovarian cancer.  Since that time, dozens of studies have followed confirming an association.

Despite the studies and evolving knowledge concerning the association between talc-based powders and ovarian cancer, Johnson & Johnson and other manufacturers continue to insist that their talc-based powders are asbestos-free and do not cause cancer. Nevertheless, in May 2020, Johnson & Johnson announced that it was discontinuing sales of talc-based powder products in North America. The company will allow existing bottles of baby powder to be sold by retailers until supplies run out.

Talc and Ovarian Cancer Lawsuits

At present, there are large lawsuits taking place in state courts in New Jersey, California, and Missouri involving claimants who believe that talc-based powder products caused their ovarian cancer. Beyond these state court claims, there is a massive multidistrict lawsuit pending in a federal court in New Jersey (MDL-2738) with nearly 18,000 plaintiffs cases consolidated. Several powder manufacturers are named in these lawsuits, however, Johnson & Johnson is named in the overwhelming lion’s share of cases.

In October 2020, Johnson & Johnson agreed to settle 1,000 of the MDL cases for $100 million dollars. Johnson & Johnson has also agreed in the past to settle some individual cases for undisclosed amounts. The rest of the MDL will likely proceed into the bellwether trial stage in 2021.

Notable Ovarian Cancer and Talc-Based Powder Verdicts

• A Missouri jury sided with ovarian cancer sufferers in 2018 who alleged that years of use of Johnson’s Baby Powder caused their cancer. The $4.7 billion award included $4.14 billion in punitive damages against Johnson & Johnson for the company’s “reprehensible conduct” concerning its longtime knowledge of the presence of asbestos in its talc-powder products.
• Eva Echevarria was awarded a verdict of $417 million by a Los Angeles, California, jury after it found that Johnson & Johnson failed to adequately warn her of the cancer risks associated with talc-based products.
• Jacqueline Fox used Johnson’s Baby Powder daily going back several decades and was shocked to learn that it was potentially the cause of her ovarian cancer diagnosis. In 2016, a jury in Missouri awarded her $72 million, $62 million of which were punitive damages on the basis of the conduct of Johnson & Johnson.

---

Sources Cited (75):

1. “In re: Johnson & Johnson “Baby Powder” et al.” https://ecf.jpml.uscourts.gov/doc1/8501743867

2. “Nancy Bors, Administrator of the Estate of Maureen Broderick Milliken, Deceased, v. Johnson & Johnson, et al.” https://ecf.paed.uscourts.gov/doc1/153115544596

3. “James Chakalos, as Personal Representative on behalf of the Estate of Janice Chakalos v. Johnson & Johnson et al.” https://ecf.njd.uscourts.gov/doc1/11919337500

4. “Special Report: As Baby Powder concerns mounted, J&J focused marketing on minority, overweight women” https://www.reuters.com/article/us-johnson-johnson-marketing-specialrepo/special-report-as-baby-powder-concerns-mounted-jj-focused-marketing-on-minority-overweight-women-idUSKCN1RL1JZ

5. “The Association Between Talc Use and Ovarian Cancer: A Retrospective Case–Control Study in Two US States” https://dash.harvard.edu/bitstream/handle/1/26860307/4820665.pdf

6. “Talc, Asbestos, and Epidemiology: Corporate Influence and Scientific Incognizance” https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6784763/#:~:text=In%202000%2C%20%E2%80%9Ccosmetic%E2%80%9D%20talc,list%20talc%20as%20a%20carcinogen.

7. “Testing Status of Talc 10167-P” https://ntp.niehs.nih.gov/whatwestudy/testpgm/status/ts-10167-p.html?utm_source=direct&utm_medium=prod&utm_campaign=ntpgolinks&utm_term=ts-10167-p

8. “Talc Asbestiform and Non-Asbestiform” https://ntp.niehs.nih.gov/ntp/roc/talc_archive/roctalcbg20001213.pdf

9. “Cancer Prevention Coalition Letter – November 17, 1994” https://www.reuters.com/investigates/special-report/assets/usa-health-fda-talc/epstein-petition.pdf

10. “FDA urged to regulate talc because of cancer concerns” https://chemicalwatch.com/2745/fda-urged-to-regulate-talc-because-of-cancer-concerns

11. “JAMA Study Finds No Significant Link Between Talc Powder, Ovarian Cancer” https://www.ajmc.com/view/jama-study-finds-no-link-between-talc-powder-ovarian-cancer

12. “IARC Monographs on the Evaluation of Carcinogenic Risks to Humans” https://monographs.iarc.fr/wp-content/uploads/2018/06/mono93.pdf

13. “Health Canada: Learn about talc and if it’s safe.” https://www.canada.ca/en/health-canada/services/chemicals-product-safety/talc.html

14. “Safety Data Sheet” https://www.gusmerenterprises.com/wp-content/uploads/2015/12/Talc-SDS.pdf

15. “FDA In Brief: FDA Releases Final Report of Talc-containing Cosmetic Products Tested for Asbestos” https://www.fda.gov/news-events/fda-brief/fda-brief-fda-releases-final-report-talc-containing-cosmetic-products-tested-asbestos

16. “Toxicology and Carcinogenesis: Studies of Talc” https://ntp.niehs.nih.gov/ntp/htdocs/lt_rpts/tr421.pdf

17. ““Non Detected”: The Politics of Measurement of Asbestos in Talc, 1971–1976” https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6603445/

18. “PRELIMINARY RECOMMENDATIONS ON TESTING METHODS FOR ASBESTOS

IN TALC AND CONSUMER PRODUCTS CONTAINING TALC” https://www.fda.gov/media/134005/download

19. “Safety Assessment of Talc as Used in Cosmetics” https://www.cir-safety.org/sites/default/files/talc032013rep.pdf

20. “Ovarian Cancer and “Tainted Talc”: What Treating Physicians Need to Know” https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6461309/

21. “October 2020 Talc Lawsuit Update: Johnson & Johnson Agrees to Pay $100 Million Settlement” https://www.natlawreview.com/article/october-2020-talc-lawsuit-update-johnson-johnson-agrees-to-pay-100-million#:~:text=October%202020%20Talc%20Lawsuit%20Update,to%20Pay%20%24100%20Million%20Settlement&text=Facing%20almost%2020%2C000%20lawsuits%20by,of%20these%20cases%20in%20bulk.

22. “Talcum Powder Cases Selected for Bellwether Pool in Talc-Ovarian Cancer MDL” https://newyork.legalexaminer.com/legal/talcum-powder-cases-selected-for-bellwether-pool-in-talc-ovarian-cancer-mdl/

23. “It’s Past Time to Pull the Plug on Use of Talc” https://www.wsj.com/articles/its-past-time-to-pull-the-plug-on-use-of-talc-11594843155

24. “Federal Judge Allows Plaintiffs’ Experts to Testify in Talc-Ovarian Cancer Litigation” https://www.prnewswire.com/news-releases/federal-judge-allows-plaintiffs-experts-to-testify-in-talc-ovarian-cancer-litigation-301047889.html

25. “Johnson & Johnson to End Talc-Based Baby Powder Sales in North America” https://www.nytimes.com/2020/05/19/business/johnson-baby-powder-sales-stopped.html

26. “Johnson & Johnson Ends North American Sales of Talc-Based Baby Powder” https://www.cancerhealth.com/article/johnson-johnson-ends-north-american-sales-talcbased-baby-powder

27. “Talc Miner Imerys Strikes Deal to Resolve 14,000 Cancer Lawsuits” https://www.claimsjournal.com/news/international/2020/05/18/297125.htm

28. “J&J Loses Appeal in Talc-Based Ovarian Cancer Lawsuit but Gets Verdict Reduced” https://newyork.legalexaminer.com/health/jj-loses-appeal-in-talc-based-ovarian-cancer-lawsuit-but-gets-verdict-reduced/

29. “J&J Flags ‘Moral Hazard’ In Imerys’ Del. Ch. 11 Disclosure” https://www.law360.com/delaware/articles/1323283/j-j-flags-moral-hazard-in-imerys-del-ch-11-disclosure

30. “Women With Cancer Awarded Billions in Baby Powder Suit” https://www.nytimes.com/2020/06/23/health/baby-powder-cancer.html

31. “New Jersey Reinforces the Trial Judge’s Gatekeeper Function in Expert Admissibility” https://www.jdsupra.com/legalnews/new-jersey-reinforces-the-trial-judge-s-97522/

32. “Johnson & Johnson’s $100 Million Baby Powder Lawsuit Settlement Is Overdue For Black & Hispanic Women” https://www.forbes.com/sites/korihale/2020/10/14/johnson–johnsons-100-million-baby-powder-lawsuit-settlement-is-overdue-for-black–hispanic-women/?sh=5966ac7363b3

33. “MDL Judge Reviews Expert Evidence Over Talc’s Ties to Ovarian Cancer” https://www.law.com/njlawjournal/2019/07/24/mdl-judge-reviews-expert-evidence-over-talcs-ties-to-ovarian-cancer/

34. “Fla. State Court to Oversee Hearing on Sufficiency of Asbestos-Talc Lawsuit” https://www.harrismartin.com/publications/26/Talc/articles/25868/fla-state-court-to-oversee-hearing-on-sufficiency-of-asbestos-talc-lawsuit/

35. “Clubman Didn’t Test Its Talc, VP Admits In Asbestos Trial” https://www.law360.com/articles/1252814/clubman-didn-t-test-its-talc-vp-admits-in-asbestos-trial

36. “J&J’s Creative Attempt to Consolidate Nationwide Talc Cases” https://www.lexology.com/library/detail.aspx?g=2470242e-63c0-4a8f-b3ca-e610ac6c9525

37. “Stanford Law Experts on Johnson & Johnson’s Product Liability Exposure” https://law.stanford.edu/2019/10/14/stanford-law-experts-on-johnson-johnsons-product-liability-exposure/

38. “Jury Hits J&J With $750M Talc Verdict” https://www.law.com/njlawjournal/2020/02/06/jj-hit-with-185m-verdict-after-judge-reduces-jurys-750m-award/

39. “How NJ Talc Case May Shift NY Courts On Expert Testimony” https://www.law360.com/articles/1278170/how-nj-talc-case-may-shift-ny-courts-on-expert-testimony

40. “Judge Allows PA Talcum Powder Cancer Lawsuits to Proceed” https://newyork.legalexaminer.com/health/judge-allows-pa-talcum-powder-cancer-lawsuits-to-proceed/

41. “Talcum Powder MDL Judge Issues Order Randomly Selecting 1,000 Cases for Discovery” https://www.harrismartin.com/publications/26/Talc/articles/25409/talcum-powder-mdl-judge-issues-order-randomly-selecting-1000-cases-for-discovery/

42. “Talcum Powder Daubert Hearing” https://medtruth.com/articles/legal-developments/talcum-powder-cancer-daubert-hearing-ruling-opinion/

43. “J&J Can’t Boot Experts To Sink Asbestos-In-Talc MDL” https://www.law360.com/articles/1267849/j-j-can-t-boot-experts-to-sink-asbestos-in-talc-mdl

44. “Parties in Talc MDL File Letters, Motion Regarding Completeness of Discovery Pool Plaintiffs” https://www.harrismartin.com/publications/26/Talc/articles/26061/parties-in-talc-mdl-file-letters-motion-regarding-completeness-of-discovery-pool-plaintiffs/

45. “J&J Prepares for MDL Trials; BASF Agrees to $72.5M in Settlement Over Asbestos-Tainted Talc” https://newyork.legalexaminer.com/legal/jj-prepares-for-mdl-trials-basf-agrees-to-72-5m-in-settlement-over-asbestos-tainted-talc/

46. “Talcum Powder MDL Court Grants Motion to Seal Certain Exhibits in PCPC Summary Judgment Briefing” https://www.harrismartin.com/publications/26/Talc/articles/26240/talcum-powder-mdl-court-grants-motion-to-seal-certain-exhibits-in-pcpc-summary-judgment-briefing/

47. “Talcum Powder MDL Judge Severs Medical Malpractice Claim and Remands, Retains Jurisdiction over Product Liability Claims” https://www.harrismartin.com/publications/26/Talc/articles/26149/talcum-powder-mdl-judge-severs-medical-malpractice-claim-and-remands-retains-jurisdiction-over-product-liability-claims/

48. “Perineal talc use and ovarian cancer: a critical review” https://pubmed.ncbi.nlm.nih.gov/18287871/

49. “Fighting Independent Risk Assessment of Talc and Glyphosate: Whose Benefit Is It Anyway?” https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6603472/

50. “Ovarian cancer and talc: a case-control study” https://pubmed.ncbi.nlm.nih.gov/7083145/

51. “Talc use, variants of the GSTM1, GSTT1, and NAT2 genes, and risk of epithelial ovarian cancer” https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2630413/

52. “Talc – Potential Risk of Lung Effects and Ovarian Cancer” https://www.healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2018/68320a-eng.php

53. “UPDATE: HEALTH CANADA ISSUES WARNING ABOUT TALCUM POWDER” https://www.iheartradio.ca/newstalk-1010/news/update-health-canada-issues-warning-about-talcum-powder-1.8599898

54. “HEALTH AND SAFETY OF TALC” https://www.eurotalc.eu/health-and-safety

55. “Final Review report for the basic substance Talc E553b Finalised in the Standing Committee on Plants, Animals, food and Feed at its meeting on 22 March 2018

in view of the approval of Talc E553b as basic substance in accordance with Regulation (EC) No 1107/2009” https://Review%20Report%20for%20talc%20.pdf

56. “Talc (containing no asbestos and less than 1% quartz)” https://www.cdc.gov/niosh/npg/npgd0584.html

57. “Talc Immediately Dangerous to Life or Health Concentrations (IDLH)” https://www.cdc.gov/niosh/idlh/14807966.html

58. “Asbestos in commercial cosmetic talcum powder as a cause of mesothelioma in women” https://pubmed.ncbi.nlm.nih.gov/25185462/

59. “Talc and mesothelioma: mineral fiber analysis of 65 cases with clinicopathological correlation” https://pubmed.ncbi.nlm.nih.gov/32183579/

60. “J&J to Pay $37.2 Million to Group Blaming Powder for Cancers” https://www.bloomberg.com/news/articles/2019-09-11/j-j-to-pay-37-2-million-to-group-blaming-powder-for-cancers

61. “Johnson & Johnson knew for decades that asbestos lurked in its Baby Powder” https://www.reuters.com/investigates/special-report/johnsonandjohnson-cancer/

62. “Johnson & Johnson Loses Bid to Overturn a $4.7 Billion Baby Powder Verdict” https://www.nytimes.com/2018/12/19/business/johnson-johnson-baby-powder-verdict.html

63. “J&J ordered to pay $417 million in trial over talc cancer risks” https://www.reuters.com/article/us-johnson-johnson-cancer-lawsuit/jj-ordered-to-pay-417-million-in-trial-over-talc-cancer-risks-idUSKCN1B121D

64. “Johnson & Johnson wins the reversal of a $72 million verdict over a cancer death linked to one of its popular products” https://www.businessinsider.com/r-update-1-jj-wins-reversal-of-72-mln-verdict-over-talc-cancer-risks-2017-10

65. “Pulmonary talcosis 10 years after brief teenage exposure to cosmetic talcum powder” https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3185388/

66. “Douching, Talc Use, and Risk of Ovarian Cancer” https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5141580/

67. “FDA Advises Consumers to Stop Using Certain Cosmetic Products” https://www.fda.gov/cosmetics/cosmetics-recalls-alerts/fda-advises-consumers-stop-using-certain-cosmetic-products

68. “Talcum Powder and Ovarian Cancer” http://www.center4research.org/talcum-powder-ovarian-cancer/

69. “FDA bowed to industry for decades as alarms were sounded over talc” https://www.reuters.com/investigates/special-report/usa-health-fda-talc/

70. “Talcum Powder and Cancer” https://www.cancer.org/cancer/cancer-causes/talcum-powder-and-cancer.html

71. “What Is Talc, Where Is It Used and Why Is Asbestos a Concern?” https://www.nytimes.com/2018/12/14/business/talc-asbestos-powder-facts.html

72. “Asbestos and Talcum Powder: A History of Industry Pushback” https://sum.cuny.edu/asbestos-talcum-history/

73. “Talc, Asbestos, and Epidemiology: Corporate Influence and Scientific Incognizance” https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6784763/

74. “Mesothelioma: A Review” https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3307510/

75. “Malignant mesothelioma” https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3905399/