What Happened In The MassTorts World Last Week? 2020-Jul-20
Judge Skeptical Over Roundup Settlement Deal
Last week, U.S District Judge Vince Chhabria, presiding over all Roundup lawsuits, indicated that he is doubtful about the agreement that affirms a settlement of more than $10 billion to resolve thousands of claims alleging that the weedkiller causes cancer.
The concern is only with one part of the deal, which includes a plan for handling future claims brought by the users who develop non-Hodgkin’s lymphoma, a type of cancer, and regarding its approval, the judge in a filing said that he "is skeptical of the propriety and fairness of the proposed settlement, and is tentatively inclined to deny the motion.” He also asked questions about the formation of a scientific panel to determine whether the key ingredient, glyphosate, causes cancer and whether the agreement unfairly limits potential plaintiffs from suing.
The agreement was announced last month, which indicated that the deal would include a payment of $8.8 billion to $9.6 billion to resolve 75% of the current lawsuits and a fund of $1.25 billion to address future claims against the manufacturer would be set.
Following the indication of skepticism, the group of plaintiffs who had initially filed a motion for preliminary approval of the class settlement meant to address future Roundup claims has withdrawn the motion.
Bayer, in response to the judge's filing, said that it would address the concerns raised at the preliminary approval hearing, scheduled for next week.
Until now 17 countries have put a restriction on the usage of Roundup. In July, Los Angeles County stated that they would stop the use of glyphosate-based herbicides in their property due to the fear of the development of non-Hodgkin lymphoma.
Roundup herbicide was once considered the best gift for agricultural fields. It ruled the market right from the mid-70s until 2013 when some shocking hidden facts were unveiled about this product.
In March 2013 an email sent by a senior toxicologist from Environmental Protection Agency (EPA) to her colleague mentioned the carcinogenic attributes of Roundup herbicide, which were not disclosed to the public due to Monsanto’s strong control over EPA.
Bayer is eagerly waiting to sort out its troubles related to Roundup, especially after losing their last three multimillion-dollar verdicts. The herbicide manufacturer has insisted that any settlement should largely resolve the issue of future litigation.
The jury panel would currently check whether glyphosate used in Bayer’s herbicide leads to cancer and if yes, what amount of exposure could be considered dangerous. Till date, at least 30,000 people have reached lawyers with the claim that the product had caused cancer. However, the claimants have not yet agreed to settle.
Currently, Bayer is facing more than 125,000 Roundup lawsuits, and the company has acknowledged the filing of 52,500 lawsuits. The lawsuits are consolidated under MDL No. 2741 in the U.S. District Court for the Northern District of California.
1-in-5 Women Affected By Essure's Allergic Reactions: FDA
Food and Drug Administration's (FDA) ongoing study over Essure indicates that more than 20% of women implanted with the birth control device may be suffering from allergic or hypersensitivity reactions, which increases the risk of chronic abdominal pain, abnormal bleeding, and higher rates of gynecological surgical procedures.
The preliminary results were issued in a press release on July 8, confirming several serious problems associated with Bayer's birth control device, which is no longer available in the market.
Essure was suspended from the market in most of the countries since 2017, but Bayer continued to sell the device in the U.S. until the end of 2018. In July 2018, Bayer announced to remove all the Essure devices from the U.S. market by December 31, 2018. Following the removal, the FDA required Bayer to extend the postmarket surveillance study and take measures to ensure long-term Essure supervision.
The previous reports of the FDA prove that women using Essure have a higher tendency to develop chronic lower abdominal pain and abnormal uterine bleeding in comparison to women who use laparoscopic tubal ligation for birth control. Also, women who have implanted Essure have to go through various gynecologic surgical procedures as compared to patients who bring tubal ligation in use for birth control. The pregnancy risk rates are also found to be similar to Essure and tubal ligation.
Meanwhile, FDA has recommended the continuation of going with Essure to women who have been using it without any complication. However, if Essure patients come across any pain, they should consult with their doctor and take guidance to take further steps. Also, before deciding on birth control device removal, it is necessary to understand the risk associated with it by discussing it with health care providers.
The FDA has taken necessary actions to monitor the safety of Essure. The agency has been updating people about the risk of this birth control device and they will continue to show full cooperation to patients in making them aware of the post-market safety of Essure.
Bayer is currently facing 18,000 lawsuits nationwide, each claiming that the Essure birth control coils were dangerous and defectively designed and the women experienced painful and debilitating complications, including migration injuries, perforations, severe reactions, and other problems.
Worldwide 750,000 women have been implanted with the device, of which 70% are from the U.S. as estimated by Bayer. The FDA is taking several actions to monitor the safety of Essure and is updating the public about it regularly.
Study Links PPI Drugs And Risk Of COVID-19 Infection
Researchers from Cedars-Sinai Medical Center in Los Angeles published a study in the American Journal of Gastroenterology, last week, indicating that the use of a class of medications known as proton pump inhibitors (PPI), which includes Nexium, Prilosec, Prevacid, Protonix, and other similar heartburn drugs could increase the risk of contracting COVID-19 infection.
According to the pre-print report published, the study is the result of an online survey conducted from May 3 to June 24. The population-based survey asked 53,130 participants regarding the use of drugs like Nexium and Prilosec, and whether they have tested positive for a COVID-19 infection.
The findings revealed that 3,386 participants tested positive for the novel coronavirus. After analyzing the data, the researchers learned that people who took PPI drugs once a day were two times more likely to test positive for the virus, and those who took it twice daily were more than three and a half times likely to test positive. The study suggests that the usage of drugs should be added to the list of factors that increase the risk of a COVID-19 infection.
The researchers also found that those who take non-PPI heartburn drugs, like Tagamet, did not show any signs of being suspected to the infection.
PPIs have already been in the news after people started filing lawsuits claiming the risk of kidney damage and kidney failure, which the manufacturers knew yet failed to warn the users.
PPIs are the most widely used drugs in this world prescribed for the treatment of gastrointestinal (GI), acid reflux, and acid-related disorders like GERD. Mostly, they are prescribed without a clear indication of the infection. The long-term use of PPI puts patients at risk of bone fracture, chronic kidney disease, and GI infections. The use of PPIs has risen to 7.6% in 2015 from 1.6% in 1998. This class of medication has recently received negative limelight for its linkage with COVID-19 infection. There are pieces of evidence to show that the use of PPIs increases the risk of COVID-19, however, there are still patients continuing the usage of these drugs due to their effectiveness in the treatment of severe gastroesophageal reflux and ulcer disease.
The recent study by Dr. Spiegel and his colleagues to check PPI association with COVID-19 disease was published on July 7 in the American Journal of Gastroenterology. The study shows that the use of PPIs increases the chances for the development of enteric infections which include the SARS-CoV-1 virus related to COVID-19, SARS-CoV-2. Dr Spiegel in his study stated that the use of PPI results in pH levels going above 3 in the stomach which will enable the virus to enter the GI tract with ease.
The researchers in the recent study found that people who take PPI daily at least once a day was twice as likely to get infected with coronavirus as compared to the ones who do not take these drugs for GI treatment.
Patients for whom PPI dosage every day are mandatory can continue taking this drug. However, these patients are immunocompromised, they should take extra care like maintaining social distance, continuously wearing a mask while in public, washing hands frequently to avoid getting exposed to the COVID-19 virus.
Lawsuits involving Nexium, Prilosec, Prevacid, and other PPIs have grown up to nearly 15,000 cases filed across the federal court system. The lawsuits are consolidated under MDL No. 2789 presided by U.S. District Judge Claire C. Cecchi.
Hidden Documents Over Essure's Complications Revealed
In an article published by the legal public watchdog group, Public Justice, on July 9, the group revealed hundreds of recently unsealed documents over the complications associated with Bayer’s birth control device, Essure, which is no longer available in the market.
In February, the group had filed a motion against Bayer to unseal many of the records, which the manufacturer had claimed confidential. Following the motion, hundreds of documents that were once kept hidden have been disclosed for public filing.
The documents indicate that the manufacturer was aware of the problems since it acquired Conceptus, the original creator of the Essure design, in 2013, and may have hidden the reports, which seem to confirm women’s claims about the complications, from the Food and Drug Administration's (FDA) for years.
The report unfolded a day after the FDA issued the preliminary results indicating that more than 20% of women implanted with the birth control device may be suffering from allergic or hypersensitivity reactions, which increase the risk of chronic abdominal pain, abnormal bleeding, and higher rates of gynecological surgical procedures.
It has been known that Bayer has been hiding various documents from the public related to the Essure implantation procedure, which has caused injury and death of many people. The document provided by the U.S. Food & Drug Administration gives a factual written account of important historical events.
The Washington Post reports that Bayer failed to comply with obligations in their reporting, which led to FDA not reporting Essure’s warning.
In the year 2013, Bayer acquired Conceptus, the originator of Essure, and continued the wrong practice of keeping the content hidden which include detail of complaints made to the FDA.
Essure forms scar tissue in the fallopian tubes nearly after three months of the implantation of the birth control device. This tissue formed serves as a barrier in the process of fertilization. This product is currently not in use in the United States for the last two years, however, women who have got it implanted continue to face struggle due to the defective quality of the product.
There was a total of 15,083 reports related to Essure defectiveness registered to FDA in the year 2019. While in 2017 and 2018, 11,854 and 6,000 medical device reports were made, respectively. In the year 2020, 91% of the reports submitted to FDA cited litigation, while in 2018 95% of submitted reports filed legal suits followed by 73% of all submitted reports applying for a legal in the year 2017 and 2018. The litigation filed gave reference to the device report submitted to FDA previously.
Bayer is currently facing 18,000 lawsuits nationwide, each claiming that the Essure birth control coils were dangerous and defectively designed and the women experienced painful and debilitating complications, including migration injuries, perforations, severe reactions, and other problems.