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Consumer Fraud Claims for Makers of Generic Valsartan Blood Pressure Drugs

In New Jersey, on Friday, January 29, 2021, U.S. District Judge Robert Kugler permitted numerous fraud allegations to move forward against a group of generic blood pressure drugmakers that consumers claim consciously sold their valsartan medications with the presence of possible carcinogen N-nitrosodimethylamine (NDMA). The companies in question include but are not limited to: China’s Zhejiang Huahai Pharmaceutical, Prinston Pharmaceutical, Hetero Drugs, Mylan, Aurobindo Pharma, Teva, Arrow Pharm Malta, and Actavis Pharma.

In 2018, the FDA discovered that NDMA and the similar N-nitrosodiethylamine (NDEA) could be created during the manufacturing of certain drugs. The results led to a global recall of hundreds of lots of blood pressure drugs valsartan, irbesartan, and losartan. The FDA then launched a thorough investigation into how the contamination may have occurred as well as the risk it could present for U.S. consumers. 

Buyers hope to hold the companies responsible for the recall of drugs containing valsartan, which is the active ingredient in Novartis’ Diovan, due to a failure to mention the potential presence of NDMA. According to the lawsuit, the plaintiffs believe that the drugmakers would have found the NDMA impurities sooner had they followed FDA guidelines, suggesting that the manufacturers “either knew of or recklessly disregarded the contamination,” according to Ruben Honik, an attorney for the consumers. 

Judge Kugler simultaneously threw out claims against distributors of the generic drugs, claiming that wholesalers Cardinal Health, McKesson, and AmerisourceBergen as well as pharmacies including CVS Health, Walgreens Boots Alliance, and Rite Aid couldn’t have known that they were stocking tainted products. 

Johnson & Johnson to Stop Selling Talcum Powder

After manufacturing a talc-based baby powder for over a century, Johnson & Johnson (J&J) announced in May that it’ll stop selling the product in the United States and Canada. In recent years, they’ve faced several lawsuits related to regular use causing both ovarian cancer and mesothelioma. Still, it wasn’t these lawsuits that caused them to stop manufacturing the product. It was the rapid spread of COVID-19 this spring and the need to place a priority on producing higher-demand items as well as the need to practice social distancing at both manufacturing and distribution facilities. Stores will continue to sell their existing inventory with no restocks planned.

Johnson & Johnson’s History of Lawsuits

Given the history of lawsuits related to J&J’s talcum powder, it’s surprising that the product has never been recalled. 

Despite tens of thousands of lawsuits filed by women who developed ovarian cancer after using talcum powder — and the loss of multimillion dollars as a result of these cases — J&J continues to stand behind the safety of the product. Other companies have put warning labels on their talcum powders, but J&J refuses to do so. More research needs to be completed, but it’s important to note that some scientific studies do show that women have an increased risk of ovarian cancer after consistent use of talcum powder in their genital area.

A separate set of lawsuits ties the product to mesothelioma, as talc is often mined near asbestos. Scientists testified that they found asbestos in samples of the product, but J&J argued that their product was asbestos-free. 

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JUUL Labs Faces “Substantive Scientific Review” from the FDA

JUUL Labs, one of the companies behind the production of electronic cigarettes, has landed itself in the headlines again. A recent study from Stanford University’s School of Medicine revealed that teens and young adults who use e-cigarettes are at “a substantially increased risk of COVID-19.” Specifically, the study divulged that young people who used both cigarettes and e-cigarettes in the previous month were five times as likely to experience COVID-19 symptoms as someone who never smoked or vaped.

To read more about E-Cigarettes and Vaping, click here

The Need for Regulation of Electronic Cigarettes

In response to these results, JUUL Labs filed Premarket Tobacco Product Applications for its e-cigarettes and nicotine cartridges, which will undergo a “substantive scientific review” by the Food and Drug Administration (FDA). 

“Now is the time,” stressed Dr. Bonnie Halpern-Felsher, the study’s author. “We need the FDA to hurry up and regulate these products. And we need to tell everyone: If you are a vaper, you are putting yourself at risk for COVID-19 and other lung diseases.”

Currently facing over 650 lawsuits as well as a criminal investigation that was launched in September 2019, JUUL Labs is committed to working collaboratively with regulators, legislators, attorneys general, and public health officials to “combat underage use and transition adult smokers from combustible cigarettes.” As part of the process, the company has halted all television, print, and digital advertising as it builds up the science and evidence-based research behind its products. 

Bayer Roundup Claims

Bayer will be paying $10.5 billion to settle U.S. claims that Roundup, its weedkiller, has lead to cancer in nearly 100,000 patients.

Bayer AG introduced on Wednesday it struck an about $10.5 billion deal to work out countless claims with U.S. complainants affirming the firm’s Roundup herbicide causes cancer. Wednesday’s deal complies with months of talks between Bayer and also plaintiffs’ lawyers.

Bayer, which additionally makes pharmaceuticals, inherited countless legal actions against Roundup’s developer Monsanto Co. when it acquired the U.S. farming titan in 2018. Bayer has actually argued that Roundup is safe and also has repetitively protected the Monsanto bargain.

As part of the case, Bayer will pay some $9.5 billion to settle claims brought by attorneys standing for some 95,000 plaintiffs. It will set aside an added roughly $1.1 billion to establish and fund a panel to examine whether the item causes cancer cells to support future cases.


Bayer to pay $10.5B to settle 100,000 Roundup cancer claims in US

Politico

Bayer has agreed to pay about $10.5 billion to settle claims in the U.S. that its weedkiller Roundup led to cancer in nearly 100,000 patients exposed to the popular herbicide, according to a law firm representing some of the plaintiffs.

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Bayer to Pay Up to $10.9 Billion to Settle Lawsuits Over Roundup Weedkiller

Wall Street Journal

Bayer AG said Wednesday it would pay up to $10.9 billion to settle tens of thousands of lawsuits with U.S. plaintiffs alleging the company’s Roundup herbicide causes cancer, a milestone in the German company’s legal battle that has been weighing down its share price for nearly two years.

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Roundup Maker to Pay $10 Billion to Settle Cancer Suits

The New York Times

Bayer faced tens of thousands of claims linking the weedkiller to cases of non-Hodgkin’s lymphoma. Some of the money is set aside for future cases.

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Bayer agrees to pay $10 billion to settle Roundup weedkiller cancer claims

Axios

Bayer has agreed to pay just over $10 billion in order to settle roughly 125,000 claims that its Roundup weedkiller cases cancer and resolve potential future litigation, the company announced on Wednesday.

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Bayer reaches $10.5 billion Roundup settlement

Market Watch

Bayer AG is set to announce on Wednesday it struck a roughly $10.5 billion deal to settle tens of thousands of lawsuits with U.S. plaintiffs alleging the company’s Roundup herbicide causes cancer, a milestone in the German company’s legal battle that has been weighing down its share price for nearly two years, according to a person familiar with the deal.

Read More >>


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Hormonal Birth Control Pills Linked to Breast Cancer

Since the introduction of oral contraceptive pills (OCPs) in the 1960s, women have been celebrating the opportunity to regain control of their reproductive health. And while OCPs are largely recognized as safe by the medical community, recent studies have indicated that combined birth control pills (those which use a variation of estrogen and progesterone type hormones) have been linked to an increase in breast cancer.

While these studies are still new, and the risk is considered quite low, the danger of taking these OCPs can be markedly high for those who are part of an at-risk demographic. We here at DrugLawJournal firmly believe that women should be informed of these risks to help empower them in making the best decision for themselves when it comes to birth control.

What did the studies reveal?

Back in 1989, researchers decided to follow nearly 120,000 nurses who ranged from their mid-twenties to their early forties to determine if there were any risks to taking oral birth control. When they followed up with these same nurses some twenty years later, the results were surprising. The researchers discovered that there was a slight increase in breast cancer incidences.

The risk was noted more frequently in the women who took what was known as a “tri-phasic” birth control pill. In fact, breast cancer wasn’t the only type of cancer found in these participants. These women also had an elevated likelihood of developing cervical cancer. On the other hand, there was a reduced risk of ovarian, endometrial, and colorectal cancer in these individuals.

Does this include all types of birth control?

Not all birth control is made the same. While the tri-phasic birth control as more commonly correlated with an elevated breast cancer risk, there are many different types of birth control on the market. Multiphasic birth control (the kind that has different doses of hormones administered depending on the stage of the menstrual cycle) wasn’t even introduced until the 1980s.

There are also monophasic birth control methods, progestin-only pills (POPs), and even IUDs. IUDs can include hormonal and non-hormonal (copper-based) intrauterine devices. While the same level of scrutiny hasn’t been given to these types of birth control, it doesn’t necessarily mean that they’re safe. It means that more research is required. Furthermore, for those who were affected by the OCPs, it’s important to remember that the lifetime risk of developing breast cancer was 13 in 100,000. That said, the risk is still there, and all women should be mindful of their own body’s reaction to birth control.

Can you reduce your risk of developing breast cancer?

Breast cancer has been associated with a variety of other factors. While OCPs are suspected to increase the chance of developing it over one’s lifetime, other things can come into play, too. Lifestyle, diet, and history of smoking can also increase the likelihood of developing breast cancer. By maintaining a healthy weight and engaging in healthy behaviors overall, the chance of getting breast cancer can be dramatically reduced.

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