What Happened In The MassTorts World Last Week? 2019-Dec-02
Monsanto Pays $10M For Spraying Illegal Pesticide
On Thursday, agrochemicals company Monsanto, a unit of Bayer AG, was found liable for spraying illegal pesticides on research crops in Maui, Hawaii.
According to the court documents, the manufacturer agreed to the misconduct of storing and using Penncap-M, an "acute hazardous waste" in 2014. The company was aware that the product was banned for use after 2013 and told the employees to reenter the area after seven days of spraying, whereas the set time was 31 days.
The fine includes a $6 million criminal fine and $4 million in community service payments, along with $200,000 fine for the spraying offense. The amount will be split between five Hawaiian government agencies, including the state's agriculture and health departments. The Department of Justice will drop the felony charges in two years if the company complies with the terms and pays the fines.
IARC, considered to be the apex in the field of cancer research, classified glyphosate as a “probable human carcinogen.” According to IARC, Roundup is made up of other ingredients that are toxic in themselves, and are also known to increase the toxicity of glyphosate. Monsanto has known this for many years but still refuses to study the link between cancer and Roundup.
Monsanto has a brief history of legal troubles and Glyphosate is just another herbicide of the company to attract lawsuits. Plaintiffs across the U.S. have filed numerous lawsuits. A plaintiff from one of the Roundup lawsuits claims that she worked as a grower’s assistant on a crop field in New York from 1994 to 1998 where Roundup was regularly sprayed indoors and outdoors resulting in chronic lymphocytic leukemia in 2012. She eventually quit the job and is currently seeking reasonable compensation and punitive damages in court.
The company is also facing several lawsuits with its weedkiller Roundup. The lawsuits are consolidated under federal multidistrict litigation (MDL No. 2741; In Re: Roundup Products Liability Litigation) in the Northern District of California, presided by U.S. District Judge Vince Chhabria.
FDA Issues Warning To Mylan Over Valsartan Recall
Mylan Pharmaceuticals received a warning letter from the U.S. Food and Drug Administration with regards to “significant deviations” from good manufacturing practices at its plant in Andhra Pradesh, India.
The warning letter issued on November 5, outlined the issues found during an inspection from May 27 to June 5, 2019. The inspection was the result of a recall of all valsartan batches by Mylan in December after it found that the batches had high levels of nitrosamine, a probable carcinogen. The letter cited that the manufacturer failed to have adequate written procedures for the receipt, identification and handling of raw materials to prevent contamination with nitrosamine impurities and failure to adequately clean equipment and utensils.
The agency issued Mylan 15 business days to respond with corrective measures, also suggested hiring a consultant to help with it.
Valsartan belongs to a class of drugs called Angiotensin II Receptor Antagonist and is used to treat high blood pressure (Hypertension), and Congestive heart failure.
Diovan (Valsartan) was manufactured by Novartis International AG and was approved by the FDA on August 14, 2002. Diovan lost its patent in September 2014. The launch of the generic drug had been on hold since patent expiry due to regulatory problems with the FDA. In 2014, a US-based Ohm Laboratories (Ohm), a subsidiary of Ranbaxy Laboratories, was the first to get the approval from FDA for generic Valsartan. Thereafter, many generic versions of Valsartan came into the market via many other pharma companies.
Valsartan lawsuits are consolidated under MDL No. 2875 (In re Valsartan Products Liability Litigation) in the United States District Court, District of New Jersey, presided by Judge Robert B. Kugler, U.S.D.J and Hon. Joel Schneider, U.S.M.J.
Mediator Indicates Progress In Roundup Lawsuits
Mediation attorney Kenneth Feinberg, overseeing the controversial weedkiller Roundup's settlement negotiations in the litigation, has indicated that progress is being made towards a potential resolution.
Bayer revealed that they are now facing more than 43,000 product liability claims nationwide brought on behalf of individuals diagnosed with non-Hodgkins lymphoma, allegedly caused due to the exposure to their weedkiller. The pharma giant was held liable in May and was asked to pay more than $2 billion, later reduced to under $87 million, in a lawsuit involving a husband and wife, who were each diagnosed with cancer following the use of the weedkiller.
U.S. District Judge Vince Chhabria, presiding over the federal litigation, ordered the parties to engage in a mediation process with prominent attorney Ken Feinberg before remanding the cases back to U.S. District Courts nationwide for individual trial dates.
Ken Feinberg has overseen some of the largest mass-tort settlements in recent years, which includes funds to pay claims related to the BP oil spill, Volkswagen emissions scandal, General Motors ignition switch recall, and September 11th Victim Compensation fund.
IARC, considered to be the apex in the field of cancer research, classified glyphosate as a “probable human carcinogen.” According to IARC, Roundup is made up of other ingredients that are toxic in themselves, and are also known to increase the toxicity of glyphosate. Monsanto has known this for many years but still refuses to study the link between cancer and Roundup.
Monsanto has a brief history of legal troubles and Glyphosate is just another herbicide of the company to attract lawsuits. Plaintiffs across the U.S. have filed numerous lawsuits. A plaintiff from one of the Roundup lawsuits claims that she worked as a grower’s assistant on a crop field in New York from 1994 to 1998 where Roundup was regularly sprayed indoors and outdoors resulting in chronic lymphocytic leukemia in 2012. She eventually quit the job and is currently seeking reasonable compensation and punitive damages in court.
Opioid Makers Face Criminal Investigation
A criminal investigation is being started by federal prosecutors against pharmaceutical companies, stating whether the makers and distributors intentionally supported to flood the community with the addictive painkiller opioid.
According to a regulatory filing, around six companies, including drugmakers Teva Pharmaceutical Industries Ltd., Mallinckrodt PLC, Johnson & Johnson, and Amneal Pharmaceuticals Inc. and distributors AmerisourceBergen Corp. and McKesson Corp., have received grand-jury subpoenas from the U.S. attorney’s office in the Eastern District of New York, which is believed to be in reference to Brooklyn federal probe.
If the investigation results in criminal charges, it could become the largest prosecution so far involving drug companies alleged to have contributed to the opioid epidemic. The federal prosecutors, this year, began using the federal Controlled Substances Act against opioid makers and distributors, under which the companies are required to monitor commonly abused drugs, including reporting suspicious orders, maintaining compliance programs, and disclosing suspicious pharmacy customers to the government.
Companies manufacturing opioids convinced the medical community that these medications were not addictive and were purely beneficial. This belief raised the number of prescriptions and sales unwarrantedly, resulting in a mass misuse of these drugs, to the extent that this was identified by the U.S. Food and Drug Administration (FDA) as a public issue and named it an opioid crisis.
Federal data states that around 400,000 people have died in the U.S. from opioid overdose since 1999. Thousands of lawsuits have been brought by cities, counties, and states against major pharmaceutical companies for fuelling the opioid crisis.
Brattleboro Back Into Opioid Negotiating Class
On Tuesday, the Brattleboro Selectboard decided to move back into an opioid national negotiating class, after opting out a week ago.
The class, which includes every town, city, and county in the country, is formed to seek comprehensive settlements with drug companies, distributors, and pharmacy chains involved in the lawsuit. In the meantime, the town will also proceed with an individual lawsuit.
The class includes more than 34,000 potential class members, managed by 49 counties and cities serving as class representatives, negotiating with up to 13 corporate defendants.
The members of the class have the right to vote on any proposed settlement with a majority of 75 percent approval. Also, being a part of the class will not prevent a town or city from bringing its own lawsuit, and a municipality can’t collect twice from the same defendant.
Companies manufacturing opioids convinced the medical community that these medications were not addictive and were purely beneficial. This belief raised the number of prescriptions and sales unwarrantedly, resulting in a mass misuse of these drugs, to the extent that this was identified by the U.S. Food and Drug Administration (FDA) as a public issue and named it an opioid crisis.
More Roundup Lawsuits In Canada
Bayer, who is currently facing several Roundup lawsuits, is now slammed with a $500 million class-action lawsuit in Canada.
According to reports, around 360 Canadians have contacted law firms to join the class action lawsuit against Bayer. People affected with cancer, allegedly caused due to glyphosate, the active ingredient in Roundup, want more information about the lawsuit.
A law firm filed the first class-action lawsuit in Canada concerning the effect of Glyphosate used in Roundup. The lawsuit filed by the firm states that Glyphosate used in Roundup is the main reason for cancer among Saskatchewan farmers and other Canadian residents.
Another Canadian firm also filed a series of lawsuits in three different provinces against Bayer. On the other hand, Bayer has defended glyphosate by stating that it is not a carcinogen to cause cancer.
IARC, considered to be the apex in the field of cancer research, classified glyphosate as a “probable human carcinogen.” According to IARC, Roundup is made up of other ingredients that are toxic in themselves, and are also known to increase the toxicity of glyphosate. Monsanto has known this for many years but still refuses to study the link between cancer and Roundup.
Monsanto has a brief history of legal troubles and Glyphosate is just another herbicide of the company to attract lawsuits. Plaintiffs across the U.S. have filed numerous lawsuits. A plaintiff from one of the Roundup lawsuits claims that she worked as a grower’s assistant on a crop field in New York from 1994 to 1998 where Roundup was regularly sprayed indoors and outdoors resulting in chronic lymphocytic leukemia in 2012. She eventually quit the job and is currently seeking reasonable compensation and punitive damages in court.
There are many more lawsuits in the United States as compared to Canada, which sums to approximately 18,000. The lawsuits are consolidated under federal multidistrict litigation (MDL No. 2741; In Re: Roundup Products Liability Litigation) in the Northern District of California, presided by U.S. District Judge Vince Chhabria.