Lack Of Potency Led To Generic Yaz Birth Control Pill Recall

Lack Of Potency Led To Generic Yaz Birth Control Pill Recall
Tue, 12/21/2021 - 11:54

On July 23, FDA announced a recall on generic Yaz (drospirenone and Ethinyl estradiol) birth control pills sold by Jubilant Cadista Pharmaceuticals Inc. due to the risk of ineffective birth control, which may lead to unwanted pregnancies, even when taken as directed. 

According to the notice, the pills were ineffective as the absorption of the active ingredients was decreased, which left women with inadequate protection against becoming pregnant.

Ethinyl estradiol and drospirenone tablet is a generic estrogen/progestin combination oral contraceptive, widely used by women to treat symptoms of premenstrual dysphoric disorder, prevent pregnancy, and treat moderate acne.

The recall affected one lot of the generic Yaz pills distributed across the United States. It contains 3mg/0.01 mg packed in a carton with 3 blister cards, each card contains 28 film-coated, biconvex tablets with 24 round active pink tablets, and four inert while colored tablets. Lot number 183222 with NDC number 59746-763-43 and expiration date of 11/2020 was affected by the recall.  The company stated that they are notifying customers by email and sending a recall notification letter and response forms to return the product.

Yaz lawsuits were consolidated under MDL No. 2100, presided by Judge David R. Herndon in the Southern District of Illinois. As of January 2019, no cases are pending in the MDL.


Fourth Trial Against Roundup Set To Begin In August

Fourth Trial Against Roundup Set To Begin In August
Tue, 12/21/2021 - 11:53

The fourth trial against Bayer is all set to begin in St. Louis on August 19, over a claim filed by a plaintiff, who alleged 14 years of Roundup exposure led to her diagnosis of non-Hodgkin’s lymphoma. There are more than 10,000 similar claims that are currently pending in St. Louis, where juries often hit companies with huge damages.

Bayer has recruited four Missouri-based expert witnesses to make a strong stand as it has century-old roots in St. Louis. On July 16, Bayer announced it would create an additional 500 “high-paying” jobs in the St. Louis area, which some legal experts believe the company is trying to secure a favorable Roundup verdict by emphasizing its reputation as a major local employer. Bayer has been hit with massive verdicts in the first three Roundup trials after finding that the defendants knew about the Roundup cancer risks yet failed to warn consumers.

U.S. District Judge Vince Chhabria is presiding over more than 15,000 Roundup lawsuits consolidated under multidistrict litigation (MDL No. 2741; In Re: Roundup Products Liability Litigation) in the Northern District of California.


J&J's Prop 65 Case Over Baby Powder Dismissed Tentatively

J&J's Prop 65 Case Over Baby Powder Dismissed Tentatively
Tue, 12/21/2021 - 11:51

On July 29, U.S. District Judge George Wu of the Central District of California issued a tentative warning stating that he would dismiss the case brought under California’s Safe Drinking Water and Toxic Enforcement Act of 1986, commonly referred to as Proposition 65 (Prop 65), involving Johnson & Johnson (J&J).

The lawsuit was brought by accusing plaintiffs’ lawyer Mark Lanier, of The Lanier Law Firm in Houston over the health risks of J&J's talcum powder,  who later filed a motion to dismiss the lawsuit. The motion was filed to cite newly discovered evidence and add other defendants, to be followed by the filing of a new lawsuit.

J&J has objected as it was looking forward to having the court ruled that its baby powder is safe and does not require a cancer warning as the FDA has twice decided. This is an unusual twist for the defendants to not go along with plaintiffs who want their cases dismissed.

Businesses need to provide a “clear and reasonable warning” before exposing consumers to carcinogens and other toxins as per Prop 65 defined in California.

More than 14,000 Talcum Powder and Shower-to-Shower lawsuits are consolidated under multidistrict litigation MDL No. 2738; In Re: Johnson & Johnson Talcum Powder Products Marketing, Sales Practices, and Products Liability Litigation. Lawsuits are also pending in a coordinated California proceeding under Judicial Council Coordinated Proceeding No. 4877.


Bayer CEO Considers To Settle "Financially Reasonable" Cases

Bayer CEO Considers To Settle "Financially Reasonable" Cases
Tue, 12/21/2021 - 11:50

Bayer CEO, Werner Baumann, has indicated to settle "financially reasonable" Roundup lawsuits during an earnings conference call conducted on July 30, as the number of lawsuits is on the rise and is affecting the company's shares.

According to a statement by Bayer, more than 5,000 cancer claims were recently added to the massive litigation, totaling the lawsuits filed in the United States to around 18,400. Baumann, during the conference call, said that he is open for settlement as long as it resolved the costly and damaging litigation for which the company was “constructively engaging” with court-appointed mediator Ken Feinberg. He also reiterated that the herbicide is safe and the lawsuits have no merit.

Glyphosate, the active ingredient in Roundup, is the most popular weed killer in the world. But according to the World Health Organization, the herbicide is a probable human carcinogen, following an independent review linked occupational exposure to an increased risk of cancer, especially non-Hodgkin’s lymphoma, and its various subtypes.

There are more than 15,000 Roundup lawsuits consolidated under 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.


Bexar County Opioid Lawsuit Gets 2020 Trial Dates

Bexar County Opioid Lawsuit Gets 2020 Trial Dates
Tue, 12/21/2021 - 11:48

On Tuesday, a Texas Judge announced that the Opioid lawsuits brought by Dallas and Bexar Counties in the state consolidated MDL, alleging that the opioid makers and distributors made false and misleading statements about drugs, will face their first trials in October 2020. The announcement followed a decision on Friday by Judge Robert Schaffer, who is overseeing the MDL in Texas that Dallas’ lawsuits will be the first bellwether to go to trial.  

Bexar County Judge Nelson Wolff stated that the trial date is a major milestone in litigation and Bexar County will become the site for the first wave of trials in the MDL. The judge also stated that Bexar County was the first in the area to have recognized this epidemic and has been a leader in developing a task force to tackle this problem.

According to a statement by counsel Martin J. Phipps of Phipps Deacon Purnell PLLC, Bexar County is seeking $1B in damages, a conservative estimate of the costs borne by taxpayers. Phipps also stated that the pharmaceutical companies mislead patients, regulators, and physicians about the risks and benefits of opioids to treat pain.

U.S. District Judge Dan Polster is presiding over all opioid lawsuits consolidated under MDL No. 2804 (In Re: National Prescription Opiate Litigation).


Merril Hoge, A Former NFL Player Files Roundup Lawsuit

Merril Hoge, A Former NFL  Player Files Roundup Lawsuit
Tue, 12/21/2021 - 11:47

A lawsuit was filed last month by a Former NFL running back and ESPN analyst against Roundup, alleging that the popular weedkiller caused his cancer which resulted in permanent "physical pain and mental anguish."

According to the lawsuit, in 1977, the plaintiff, now 54, began working on a farm as a boy in Idaho where he was exposed to Roundup and was diagnosed with non-Hodgkin’s lymphoma in 2003. He accused Monsanto of negligence and said the company promoted “false, misleading, and untrue” statements about the safety of Roundup. The lawsuit now joins 18,400 other plaintiffs who have alleged Roundup causes non-Hodgkin’s lymphoma or NHL. The case has now been transferred to multidistrict litigation in Northern California.

In a written statement, Bayer said: “We have great sympathy for any individual with cancer, but the extensive body of science on glyphosate-based herbicides over four decades supports the conclusion that Roundup does not cause NHL.”

Bayer is facing more than 15,000 Roundup lawsuits 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.


A Final Bid To Hold J&J Responsible For Opioid Crisis

A Final Bid To Hold J&J Responsible For Opioid Crisis
Tue, 12/21/2021 - 11:45

Oklahoma Attorney General Mike Hunter made his final bid on Wednesday forcing Johnson & Johnson to pay $17 billion for its role in fueling the opioid epidemic, stating that the drugmaker’s "egregious" marketing resulted in an oversupply of addictive drugs and overdose deaths. Hunter argued that the evidence presented during the first trial in litigation over the epidemic showed J&J as the root of this crisis.

The state’s lawyers stated that the evidence presented during the seven-week trial that began in May, showed that the defendant’s decades-long marketing campaign convinced doctors and the public that opioid is the first-line treatment for everything from headaches to sprained ankles. They also stated that the defendant and its subsidiaries abandoned all standards of responsible conduct in their blind resolve to make money from their drugs, which created a public nuisance in the form of an opioid crisis.

According to the U.S. Centers for Disease Control and Prevention, opioids were involved in almost 400,000 overdose deaths from 1999 to 2017. The Oklahoma case is being closely watched by plaintiffs in other opioid lawsuits. OxyContin maker Purdue Pharma LP and Teva Pharmaceutical Industries Ltd. were also defendants in the case. Purdue settled its claims for $270 million and Teva for $85 million with Oklahoma in May.

U.S. District Judge Dan Polster is presiding over all opioid lawsuits consolidated under MDL No. 2804 (In Re: National Prescription Opiate Litigation).


5000 Plus Bair Hugger Lawsuits Tossed

5000 Plus Bair Hugger Lawsuits Tossed
Tue, 12/21/2021 - 11:44

On Wednesday, U.S. District Judge Joan Erickson of the District of Minnesota granted summary judgment against more than 5,000 lawsuits over 3M’s surgical warming blankets that sought to exclude the plaintiffs’ general causation experts.

The lawsuits coordinated in the MDL alleged that the defendant’s forced-air warming system increased the risk of infection.

Todd Fruchterman, General Manager of 3M Medical Solutions Business, stated that there is no legitimate scientific support for the plaintiffs’ theory. He also stated that they want physicians and patients to understand that the practice of patient warming is supported by leading health care institutions, professional societies, and the U.S. Food and Drug Administration.

The U.S. Judicial Panel on Multidistrict Litigation coordinated the MDL over the Bair Hugger in 2015. In the first bellwether trial, the defendant won the verdict as a federal jury sided with them. After trial, the defendant filed a motion for the judge to reconsider a 2017 summary judgment. In the renewed motion filed on January 24, they cited newly released scientific research that refuted claims from plaintiffs’ attorney that Bair Hugger disrupted protective “forcefield” around patients during surgery, an idea that plaintiffs’ own expert called “absolute rubbish” and “silly” during the first bellwether trial.

Bair Hugger infection cases are consolidated into multidistrict litigation (MDL No. 2666; In Re: Bair Hugger Forced Air Warming Devices Products Liability Litigation) in the District of Minnesota before U.S. District Judge Joan Ericksen.