What Happened In The MassTorts World Last Week? 2020-Jun-01
Third “Wave” Of 41 Roundup Cases Identified For Trial.
The federal court system has identified the third “wave” of Roundup lawsuits amidst the thousand of unsettled cases alleging that the weedkiller leads to developing non-Hodgkins lymphoma among the users.
As mentioned in a joint letter submitted on May 20, the U.S. District Judge, who is looking over the federal litigation, was advised that the parties have selected a group of 41 cases filed in Hawaii or Texas as a part of the third wave of Roundup lawsuits for case-specific discovery.
The parties indicated that the fact discovery in the cases would be completed by April 2021, along with expert discovery and expert testimony by September 2021.
Previously, two other “waves” of cases were selected, which included 17 claims from California and Nebraska in the first wave and the second wave of 37 claims from Illinois and North Carolina.
The COVID-19 pandemic has postponed the dates for the proceedings and preparations of the Roundup trials, which has resulted in extending the deadlines of the second wave by sixty days. Deadlines for fact discovery of the cases is now set for July 28, 2020, expert discovery by October 7, and the court will hold the Daubert hearing on January 18, 2021.
Bayer executives, in an annual general meeting, indicated that the company is currently facing Roundup lawsuits brought by more than 52,000 plaintiffs.
The general meeting also had a shareholder vote, during which the executives informed the investors that the ongoing pandemic crisis slowed Roundup settlement negotiations, as the company is facing economic challenges resulting from the outbreak and due to difficulties caused by social distancing procedures.
The company, following substantial pressure from shareholders to negotiate settlements for Roundup claims, engaged in a court-ordered mediation process with lawyers nationwide.
Mediator attorney Kenneth Feinberg, appointed by the court, is overseeing the controversial lawsuit. 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.
U.S. District Judge Vince Chhabria is presiding overall the federal multidistrict litigation (MDL No. 2741; In Re: Roundup Products Liability Litigation) in the Northern District of California.
Bayer AG Reaches Deal On Major Portion Of Roundup Lawsuits
Actos (pioglitazone) is an oral diabetes medicine of the thiazolidinedione (TZD) class used to treat Type 2 diabetes. Actos is manufactured by Japanese pharma giant Takeda Pharmaceutical and marketed by Eli Lilly, one of the largest drug companies in the U.S. (Eli Lilly stopped marketing Actos in 2006). It is available in 15mg, 30mg, 45mg and is prescribed once a day. Actos increases the body’s sensitivity to insulin and decreases the amount of sugar that is stored in the liver. It can only be prescribed to patients who can make their insulin. Though being effective in treating Type 2 diabetes, concerns about Actos arose over serious diseases like kidney disease, bladder cancer, and bone fractures. It was approved by the U.S Food and Drug Administration (FDA) in 1999, in a tablet form (15 and 30 mg) for oral administration. Actos is used alone or in combination with other diabetes medications. On August 17, 2012, the US FDA announced its approval of the first generic version of Actos.
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SERIOUS ALLEGED INJURIES MAY INCLUDE:
- Increased Risk Of Bladder Cancer
- Chronic Kidney Disease
- Lactic Acidosis
- Bone Fractures
- Congestive Heart Failure
FDA SAFETY WARNINGS:
In 2007, the FDA also issued a black-box warning for congestive heart failure.
In a safety announcement published in June 2011, the FDA warned that patients using Actos can result in increased risk of bladder cancer. Long-term use of Actos is linked to several side effects and serious health complications, including bladder cancer that led to lawsuits against Takeda.
LEGAL UPDATES:
Defendants: Takeda Pharmaceuticals, Eli Lilly & Co.
Defendant Law Firm: Norton Rose Fulbright US LLP, Tucker Ellis LLP, and Bowman and Brooke LLP.
Allegations: Plaintiffs alleged that the drug manufacturer Takeda and the drug marketer Eli Lilly knew about the risk of bladder cancer and other side effects caused by the drug but failed to warn the public.
Plaintiff Steering Committee:
Paul J. Pennock - Weitz & Luxenberg
Richard J. Arsenault - Neblett Beard & Arsenault
A.J. De Bartolomeo - Girard Gibbs
Andy D. Birchfield - Beasley Allen
Christopher A. Seeger - Seeger Weiss
Daniel S. Robinson - Robinson Calcagnie
Dawn M. Chmielewski - Neblett Beard & Arsenault
Dianne M. Nast - Nast Law
Donald C. Arbitblit - Lieff Cabraser
Jayne Conroy - Hanly Conroy
Jerrold S. Parker - Parker Waichman
Neil D. Overholtz - Aylstock Witkin & Sasser
Nicholas J. Drakulich - Drakulich Firm
Orran Brown, Sr. Brown Greer - Brown Greer: Greer Lynn C
Stephen B. Murray - Murray Law Firm
Tara Tabatabaie Sill Law Group - Troy A. Rafferty, Levin Papantonio
Vance R. Andrus - Andrus Hood & Wagstaff
W. Mark Lanier - The Lanier Law Firm
W. James Singleton - Singleton Law Firm
Lawsuit Status:
2011: More than 10,000 Actos side effects lawsuits were filed against the drug maker Takeda Pharmaceuticals.
Nearly 4,000 federal cases were a part of the Multidistrict Litigation (MDL) in the U.S. District Court for the Western District of Louisiana in Lafayette. U.S. District Judge Rebecca Doherty (In Re: Actos (Pioglitazone) Products Liability Litigation, 11-MD-02299, U.S. District Court, Western District of Louisiana. About 4,500 cases were filed in various state courts including Illinois, Pennsylvania, California, and West Virginia.
2015: About 5,000 federal multidistrict litigation (MDL) cases and 4,000 local, state and local Actos lawsuits were eligible for Actos settlement. Another 4,500 lawsuits were filed in state courts of Illinois, California, Pennsylvania, and West Virginia. Before Takeda announced its plan to pay $2.4B to settle Actos Lawsuits, nine cases went to trial. Takeda was ordered to pay more than $22 million by the trial juries to injured Actos users.
2018: The Actos MDL was closed in April 2018 as the majority of the cases in the MDL were resolved in the settlement.
MDL Status: Closed In April 2018
Important Verdicts And Settlement:
2014: In April 2014, plaintiff Terrence Allen, a former shopkeeper was awarded $9 billion in punitive damages and $1.5 million in compensatory damages by U.S. District Judge Rebecca Doherty in Louisiana as he was diagnosed with bladder cancer. The jury found Takeda 75 percent liable and Lilly 25 percent liable, awarding plaintiff with $6 billion in punitive damages against Takeda and $3 billion against Eli Lilly. Doherty stated that the original $9 billion damages award was excessive and violated the company's constitutional rights. She ordered Takeda to pay $27.6 million and Eli Lilly to pay $9.2 million a total of $36.8 million.
2015: Takeda settled about 9,000 Actos side effects lawsuits for $2.4 billion in 2015 without admitting any guilt and continued to believe the benefits of Actos outweigh the risk of cancer. Actos settlement became one of the largest Big Pharma settlements in the U.S. history. The settlement followed eight Actos jury verdicts. Before the opt-in deadline of September 11, 2015, the settlement amount was increased from $2.37 to $2.4B as a percentage of claimants exceeded. Average payments per person will be increased for more severe injuries, and reductions will occur where an individual had other likely causes of bladder cancer, such as smoking.
The U.S. District Court, overseeing Actos injury cases in the federal court nationwide issued an order recognizing that Takeda has agreed to settle all bladder cancer claims made against the company by Actos users provided three conditions are met:
They took Actos at some time prior to December 1, 2011,
They were diagnosed with bladder cancer on or before April 28, 2015, and
They are represented by counsel or retained counsel by May 1, 2015
Scoring Actos Cases:
1. A meticulous review of plaintiff's medical and pharmacy records of the entire treatment duration.
2. A thorough comparative analysis in light of risk and adjustment factors are needed to achieve the desirable and most appropriate compensation.
EVIDENCE:
- Duration Of Usage
- Usage In Pharmacy Records
- Indication Of Usage In Medical Records
Medical Record Review and claim validation of Actos case should take approximately 5 hours in most instances; however, this approximation may vary in cases based on the volume of records.
Opioids Prescription Violations Costs CVS Subsidiary $15.3M
The U.S. Attorney for Colorado, Jason R. Dunn, announced that Omnicare Inc., a subsidiary of CVS Health, has agreed to compensate $15.3 million in penalties to settle allegations of dispensing opioids and other drugs without a valid prescription.
Omnicare owns two pharmacies in Colorado, one in Pueblo and the other in Grand Junction. The company supplied medications daily to the patients of long-term care facilities and also organized the kits for emergency drug dispensations.
The authorities claimed that Omnicare violated the Controlled Substances Act while delivering prescription medications to facilities. The company allowed the employees of the care facilities to remove opioids and other controlled substances from emergency kits before obtaining prescriptions from doctors, and the medications did not contain necessary documentation.
Along with the monetary settlement, the company will also increase its auditing and monitoring of the emergency kits. The Drug Enforcement Administration’s Denver field division was also involved in the investigation along with the attorney.
Earlier, West Virginia Attorney General reached a multistate settlement against a pharmaceutical company over allegations of falsely and aggressively marketing and promoting opioids.
According to a news release, Indivior, a global pharmaceutical company, will pay more than $5.2 million to West Virginia. $1.36 million of the settlement amount will be kept by the state and the remaining amount will be paid to the federal Medicaid programs.
The attorney general said that deceptive marketing of the products claiming that it is safe to use can have dangerous outcomes.
From 2010 to 2015, Indivior promoted the sale and use of Suboxone by encouraging physicians to prescribe the drug to users without a medical prescription. The company purposely promoted the opioid sale, even after knowing that it is unsafe for use.
In September 2012, Indivior submitted a petition to federal regulators that stated discontinuation of Suboxone tablet to prevent generic competitors from entering the market. The petition was fraudulent and the agreement even resolves those allegations.
It is only the second settlement of Medicaid fraud allegations in West Virginia. In 2019, the first settlement of $700 million was announced against Reckitt Benckiser Group.
NDMA Contamination Leads To Another Recall
The latest drug to undergo recall due to high levels of the cancer-causing chemical N-Nitrosodimethylamine (NDMA) is metformin, a medication used to control high blood sugar in type-2 diabetes patients.
The Food and Drug Administration (FDA) asked five unidentified drug manufacturers to voluntarily recall the widely used diabetes drug. The federal regulators also issued a metformin NDMA alert to the patients and healthcare professionals, warning about the presence of the toxic chemical in a higher-than-acceptable level that could potentially cause cancer.
The recall was the result of a citizen’s petition filed by the independent online pharmacy Valisure, who urged the FDA to issue metformin recalls in March 2020, after finding high levels of NDMA during independent testing. The FDA confirmed findings on some lots that Valisure had raised concerns about, and not all of them were agreed.
Lately, popular heartburn drug Zantac and blood pressure medication Valsartan also faced a widespread recall post the detection of the toxic chemical. The users of both drugs have reported developing various types of cancers following long-term use, including breast cancer, bladder cancer, stomach cancer, testicular cancer, and other injuries.
More than 230 Zantac lawsuits are pending in the Southern District of Florida. The lawsuits are consolidated and centralized before U.S. District Judge Robin L in Florida under MDL No: 2924, for coordinated discovery and pretrial proceedings.
Nearly 130 product liability lawsuits and class action claims involving Valsartan are currently pending in the federal court system. Valsartan claims are consolidated under MDL No. 2875 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.