What Happened In The MassTorts World Last Week? 2020-Mar-09

On February 27, Sangamon County filed a lawsuit against the opioid manufacturers and distributors due to the growing opioid crisis in Illinois, which resulted in 27 deaths in 2019. 

The Director of the Sangamon County Department of Public Health, Gail O'Neill, informed that the number of people affected due to the opioids in Illinois is on the rise, which is a matter of concern for the county. Adding further, he said that the main reason for the opioid crisis is the overprescribing of pills by the doctors.

Sangamon County State's Attorney Dan Wright said that filing a lawsuit is just one of the many fronts, which the people of Sangamon County are undertaking to fight against the opioid epidemic. The main focus of the case is to make the manufacturers and distributors realise their role in spreading the epidemic.

Johnson & Johnson, CVS, and Walgreens are some of the defendants in the lawsuit who play a major role in the growing opioid crisis.

Earlier in February, the jury awarded  $1.6 billion as a settlement for the thousands of lawsuits faced by Mallinckrodt, one of the largest opioid distributors over the opioid crisis. The issued order states that the company will pay 20% of the company’s outstanding shares to the plaintiffs. 47 states and territory attorneys approved the agreement but still, thousands of municipalities are yet to approve it. The settlement may also determine the fate of remaining claims against the different opioid manufacturers.

The state health department published a report that indicated the overexposure of opioids in the newborns in Maine. The report claims that the newborns experience health problems, from the womb itself. It also stated that the rate of which the newborns are affected is five times more than the national average.

The national rate of newborns affected because of opioids is seven per 1000 lives, whereas the rate of newborns being affected in Maine is more than 33 per 1000 lives. Statistically, the national average of women who smoke is 6.5% as compared to Maine, where the rate is 12%, which is also a reason for infants suffering from opioid problems.

Stephen Meister, president of the Maine chapter of the American Academy of Pediatrics, showed concern over opioid affected babies by considering the issue as a state crisis.

The government of Maine is taking the necessary steps to cope with the crisis by implementing relevant programs for the well being of the mother and the infant. The state has hired a full-time employee at the Maine Center for Disease Control and Prevention to tackle the issue of maternal substance use disorder and substance-exposed infants.

In a proposed settlement, Communities in West Virginia said that they would get $1.25 billion from the defendants, which would help end most of the litigation stemming from the opioid crisis in the state.

The companies are looking forward to settling about 3000 lawsuits nationwide. The deal is said to be one of its kind, which will make drug makers, distribution companies, and pharmacies pay for fuelling the opioids epidemic in the country resulting in 4,30,000 deaths in the U.S. since 2000. 

Paul Farrell, a West Virginia-based lawyer who is one of the leaders in the lawsuits nationwide, announced that West Virginia wants to settle the deal separately as they might get excluded from the $18 billion national settlement, which includes three dominant distribution companies, AmerisourceBergen, Cardinal Health, and McKesson. Farrell notified that even though the deal is confirmed, establishing a panel is necessary for further proceedings.

The settlement will include three major distributors along with Johnson & Johnson, and Teva. But it will not include the two key drug makers, Purdue Pharma and Mallinckrodt, as they both are trying to make a settlement in the bankruptcy court. 

Meanwhile, Clinton County commissioners will be mulling over until Friday to decide whether to drop their individual lawsuit against the opioid industry and join other local Ohio governments to group-negotiate a potential settlement. The Commissioners President Kerry R. Steed said the State of Ohio believes political jurisdiction will be stronger together than individually, and so the State is making a case to bundle together individual lawsuits around Ohio.

The U.S. Food & Drug Administrations (FDA) posted a recall notice on its website following which American Health Packaging recalled ranitidine tablets, as the heartburn medication contained unacceptable levels of N-Nitrosodimethylamine (NDMA), a probable human carcinogen.

The recall notice includes 11 lots of Ranitidine Tablets, USP 150 mg, 100 count Unit Dose Blisters, which American Health Packaging has notified its distributor to arrange the return of all recalled ranitidine products to lnmar Pharmaceuticals Services.

An online pharmacy Valisure first announced that it had detected high levels of NDMA in every drug sample it tested, following which Zantac and ranitidine recalls began last year. The pharmacy petitioned the FDA, noting that the NDMA levels sometimes far exceeded the agency’s recommended guidelines. It also asserted that the ranitidine molecule resulted in the production of NDMA when the drug was subjected to conditions that mimic human digestion, which the agency is yet to determine.

The U.S. District Judge Robin L. Rosenberg has appointed two small groups of attorneys to serve in leadership roles presiding over the Zantac lawsuits. The pretrial order was issued on February 24, when Judge Rosenberg appointed four attorneys to an Initial Census Team and four other attorneys to a Practices and Procedures Team.

The Initial Census Team will focus on planning a process to survey the number of filed Zantac claims and unfilled cases that attorneys are investigating nationwide. Practices and Procedures Team will work on creating an early dialog regarding the content and timing of procedural orders that may be helpful in the Zantac litigation. The initial status conference is scheduled for March 20.

Earlier, the U.S. District Judge Robin L. Rosenberg, presiding over all federal Zantac lawsuits, appointed two small groups of attorneys to serve in leadership roles.

Zantac (ranitidine hydrochloride) is an antacid and an H2 (histamine-2) receptor blocker used for treating and preventing ulcers in the duodenum, stomach, and intestines. It is also used for treating erosive esophagitis, heartburn, gastroesophageal reflux disease-GERD, Zollinger-Ellison syndrome. In 1983, Glaxo Holdings Ltd, a company which is a part of GlaxoSmithKline PLC, received approval from the FDA to sell Zantac in the U.S. However, owing to patent expiry in 1987 in the United States, Glaxo had to face stiff competition by the generic alternatives launched immediately by competitors. Since 2017, the OTC version of Zantac was marketed by Sanofi in the United States and Canada. In 2004, Pfizer gained FDA approval to sell the Zantac OTC in the United States.

According to the pretrial order issued on February 24, Judge Rosenberg appointed four attorneys to an Initial Census Team and four other attorneys to a Practices and Procedures Team.

The Initial Census Team will assist to outline the process for surveying the number of filed Zantac claims and unfiled cases that attorneys nationwide are continuing to investigate. This will help the Court gauge the size of the litigation and the best way to manage the pretrial proceedings.

The duties of the Practices and Procedures Team, as described in a pretrial order issued on February 20, include the creation of an early dialog regarding the content and timing of procedural orders that may be helpful in the Zantac litigation.

An initial status conference with the presiding judge is scheduled for March 20, during which the appointed attorneys will meet with the Court for the first time. A larger group of Zantac injury attorneys will be appointed around the time of this conference, who will take certain actions that benefit all plaintiffs and argue motions before the Court.

A group of 20 cases and five alternates has been identified by the U.S. District Judge Casey Rodgers, to be a part of early 3M earplug bellwether trials, set to begin next year.

According to a pretrial order issued on February 27, Judge Rodgers identified cases that will be a part of an initial pool from both filed and pending claims identified through a census program organized by the Court.

The parties must respond to written discovery by May 15, and complete core discovery by July 31, as per a previous order. The court will then create four trial groups and assign five cases to each group, which will be eligible to go before juries. The other five cases will serve as alternates.

Currently, more than 100,000 claims are filed by veterans, each raising similar allegations that their hearing loss injuries were caused by defective 3M earplugs that were standard issue by the government between 2003 and 2015.

The Combat Arms Earplugs Version 2 (CAEv2) was manufactured by Aearo Technologies, Inc. before being taken over by 3M in 2008. The dual-ended 3M CAEv2 combat earplugs served as a standard form of military hearing protection in foreign conflicts for more than a decade, from 2002 to 2016. The 3M military earplugs are made of green and yellow with a double-ended design. The green end is inserted to block all sound, and insertion of the yellow end reduces the sound of gunfire and explosives but still allowed the service personnel to be part of a conversation. According to several lawsuits filed, the defective military earplugs cause two primary medical issues, tinnitus and hearing loss, mostly among veterans in the Navy and Air Force. The product was discontinued in 2015.

SERIOUS ALLEGED INJURIES MAY INCLUDE:

• Hearing Loss

• Tinnitus Or Loss Of Balance

FDA SAFETY WARNINGS:

Though the FDA website listed 45 3M products under their recalled list, it does not include military ear protection or any medical device recalls for Aearo Technologies.

Boston Scientific has agreed to pay $21.5 million to a group of 325 women who suffered side-effects of their medical device called transvaginal mesh.

According to Ontario Superior Court Justice Paul Perell, the proposed class-action settlement will get final approval in June. The share of money between the plaintiffs would depend on the severity of their medical issues.

The lead plaintiff in the class action and her husband sued Boston Scientific, claiming that the devices were defective and unsafe. The allegations also included that the mesh was negligently designed and sold and that recipients had to undergo intensive surgical interventions to reduce the side-effects.

Boston Scientific, the Canadian subsidiary of its Delaware-based parent, is the sole distributor of the company’s transvaginal mesh devices in Canada, which has been implanted in thousands of Canadian women.

Transvaginal mesh is a surgical net-like implant, manufactured by various companies such as Ethicon, C.R. Bard, American Medical Systems, Boston Scientific, Coloplast, Cook Medical, Neomedic. It is used in the form of a sling to treat stress urinary incontinence (SUI) and Pelvic organ prolapse (POP) in women since the 1990s. The insertion of this mesh or a bladder sling through the vagina is known as a transvaginal mesh. The Food and Drug Administration (FDA) approved the first surgical mesh specifically designed for SUI in 1996. Later, in 2004, the FDA approved the first surgical mesh specifically for use in POP.

FDA began issuing warnings for complications in 2008 and 2011. The FDA focused its regulatory efforts on transvaginal mesh for POP, a procedure that the agency finds riskier. In 2016, it classified mesh for POP as a high-risk, Class III device. Then in April 2019, the Food and Drug Administration (FDA) ordered manufacturers to stop selling all remaining surgical mesh products indicated for the transvaginal repair of pelvic organ prolapse. The agency said it did not find adequate evidence to assure that the probable benefits of these devices outweighed the probable risks.