What Happened In The MassTorts World Last Week? 2019-Nov-04

J&J's Baby Powder Off-The-Shelf Over Asbestos Problem

Johnson & Johnson' s (J&J) Baby Powder is removed by several major pharmacy chains, following the recall announcement made by the manufacturer last week, after FDA tests confirmed the presence of chrysotile asbestos contamination in certain bottles.

Pharmacy giants including, CVS, Walmart, and Rite Aid are pulling, all 22-ounce bottles of the talc-based powder from their store shelves. The recall included bottles from lot# 22318RB, which can be found on the back of the bottle, directly underneath the cap. The recall, which impacted 33,000 bottles, was announced on October 25.

J&J is facing about 13,000 Baby Powder lawsuits and Shower-to-Shower lawsuits, alleging that the talc-based products cause asbestos-linked disease mesothelioma, as well as ovarian cancer among women who applied the product around their genitals for years.

Plaintiffs in the talc cases have accused Johnson & Johnson of failing to warn customers of the risks of asbestos contamination, despite being aware of concerns for decades. A New York Times investigation last year found internal memos and reports made public during litigation that document executives' concerns about potential contamination that date back 50 years.

J&J has repeatedly said that its talc products are safe, and that decades of studies have shown them to be asbestos-free and that they do not cause cancer.

The World Health Organization and other authorities recognize no safe level of asbestos exposure. While most people exposed never develop cancer, for some, even small amounts of asbestos are enough to trigger mesothelioma years later. A lot of lawsuits against the company involve women diagnosed with ovarian cancer.

While health risks increase with heavier and longer exposure to asbestos, the overall evidence suggests no level of asbestos exposure is safe, and disease has been found in people with only brief exposures, according to the National Cancer Institute.

Since the early 1940s, millions of American workers have been exposed to asbestos. Health hazards from asbestos fibers have been recognized in workers exposed in the shipbuilding trades, asbestos mining and milling, manufacturing of asbestos textiles and other asbestos products, insulation work in the construction and building trades, and a variety of other trades. Demolition workers, drywall removers, asbestos removal workers, firefighters, and automobile workers also may be exposed to asbestos fibers. Studies evaluating the cancer risk experienced by automobile mechanics exposed to asbestos through brake repair are limited, but the overall evidence suggests there is no safe level of asbestos exposure (3, 8). As a result of government regulations and improved work practices, today’s workers (those without previous exposure) are likely to face smaller risks than did those exposed in the past.

Individuals involved in the rescue, recovery, and cleanup at the site of September 11, 2001, attacks on the World Trade Center (WTC) in New York City are another group at risk of developing an asbestos-related disease. Because asbestos was used in the construction of the North Tower of the WTC, when the building was attacked, hundreds of tons of asbestos were released into the atmosphere. Those at greatest risk include firefighters, police officers, paramedics, construction workers, and volunteers who worked in the rubble at Ground Zero. Others at risk include residents close to the WTC towers and those who attended schools nearby. These individuals will need to be followed to determine the long-term health consequences of their exposure. 

The 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.

Philly. Jury Awards $33M Over IVC Filter Injury

In one of its first cases over inferior vena cava or IVC filters, a Philadelphia jury awarded more than $33 million to a woman who was injured by a defectively designed blood filter.

According to the court filings, the plaintiff, a Georgia resident, got blood filter implants, manufactured by Rex Medical and distributed by Argon Medical Devices, in December 2016. The device later penetrated through the wall of her vena cava, causing severe pain and complications, which induced fear and anxiety that the device may fracture and lead to casualties. The allegations include negligence, strict liability, design defect, manufacturing defect, breach of warranty, and negligent misrepresentation claims.

The jury awarded the plaintiff $1,045,764 million in future medical expenses and $2,322,650 million in future pain and suffering. The jury also awarded an additional $30,315,726 in punitive damages.

C.R. Bard, Cook Medical, and Boston Scientific are also facing similar allegations, each claiming that plaintiffs suffered painful and potential complications when the small devices moved out of position, penetrated internal organs, or fractured, causing small pieces to travel throughout the body.

Inferior vena cava, or IVC, filter complications include device penetration, fracture, migration, and eventual blood vessel narrowing with risk of leg swelling and blood clots. Most IVC filters will not result in complications after short dwell times, but the risk of complications increases the longer a filter remains implanted.

Blood clot filters are devices that are sometimes placed in the largest vein in the abdomen (IVC) to prevent large blood clots formed in the leg veins from traveling into the lungs. To reduce the risk of potential complications, experts recommend removing the filter as soon as the device is no longer needed and preferably within 2-3 months after implantation.

In 2010, due to rising filter-related complications reported to its database of adverse events, the FDA issued a Safety Alert on IVC Filters. The complication of IVC includes migration to the heart or lung, vein perforation, blockage of blood flow causing clots, misplacement, and access site bleeding. 

Depending on the type of complication, many patients may experience no immediate symptoms while others may develop immediate pain or severe problems years later. In some instances, the side effects can be painful and dangerous.

If a filter has been implanted for several years, patients should initially consult with their local doctor to assess the status of their device. It could be evaluated with routine x-rays or a CT scan, and they should at least be followed by a local physician. If there is any uncertainty regarding possible complications, then the case should be reviewed by a knowledgeable specialist.

When a filter strut breaks loose, makes its way through the bloodstream, and enters into the heart or lungs, this is called embolization. These patients can suffer acute chest pain similar to a heart attack.
Adverse event reports submitted to the U.S Food and Drug Administration (FDA) between 2005 and 2010, included 146 reports of embolization out of 921 total reports. Embolization of IVC filters to the heart and lungs can have serious and sometimes deadly consequences. Signs and symptoms of this condition might include acute chest pain, abnormal heart rhythm, shortness of breath, feeling faint, and loss of consciousness.

Taxotere Lawsuit: Plaintiff Asks For A New Trial

A plaintiff in the first Taxotere lawsuit to go before a jury, has asked the Louisiana federal court for a new trial, which went in favor of the defendants last month.

The verdict rendered on September 26 was passed in favor of Sanofi-Aventis U.S. LLC by a federal jury in New Orleans. It was the first trial to come out of the multidistrict litigation, which involves nearly 12,000 lawsuits. The lawsuit was initially filed in December 2016, after the plaintiff learned about the link between Taxotere, which she used from June 2011 to November 2011, and permanent hair loss.

Taxotere, also known as docetaxel, is a chemotherapy drug that doctors prescribe to treat several different cancers, mostly breast cancer. While the drug is effective at treating breast cancer, it is associated with several side effects, ranging from common skin reactions to very rare instances of leukemia.

Since Taxotere is a strong chemotherapy drug, its side effects tend to be more extreme than drugs that treat less serious issues such as high cholesterol or blood pressure. Doctors may lower the dose or prescribe drugs that reduce the risk of allergic reactions to deal with these types of side effects. 

The drug carries a black box warning that includes five complications that can be severe or fatal: toxic death, low blood cell counts, liver toxicity, fluid retention, and hypersensitivity reactions.

Taxotere can occur during treatment or shortly after. Doctors check liver, 
kidney, and bone marrow function to make sure a patient can tolerate the chemotherapy drug and that any acute reactions can be treated.
Low white blood cell counts, also called neutropenia, can occur in people who take Taxotere. A more serious version accompanied by fever is called febrile neutropenia. Sometimes, it can be serious enough to cause an infection that requires hospitalization.

Neutropenia is a common side effect of most chemotherapy drugs. Usually, white blood cell counts drop around 10 days to 14 days after patients first get chemotherapy. 

Lawsuits state that Taxotere’s manufacturer Sanofi-Aventis as well as other manufacturers were aware of Taxotere linkage with permanent hair loss, or alopecia, but failed to warn doctors and their patients of the risk. 
The lawsuits filed by breast cancer survivors and their families have been centralized under multidistrict litigation, or MDL, which aims to increase efficiency by allowing a single judge to oversee similar cases. 

The U.S. Judicial Panel on Multidistrict Litigation created the MDL in October 2016, transferring 33 lawsuits from 16 districts to the Eastern District of Louisiana. At the time, another 56 related lawsuits were pending in 25 districts.

In September 2017, the court denied Sanofi’s motion to dismiss all counts. As of April 2019, 11,430 Taxotere lawsuits were pending.
In August 2018, The New Jersey Supreme Court created a Taxotere multicounty litigation (MCL). MCLs are New Jersey’s method of combining similar state cases. The New Jersey MCL consolidated 353 Taxotere lawsuits into a court in Middlesex County.

Similar lawsuits are consolidated under MDL No. 2740 before U.S. District Judge Jane Triche Milazzo. Several other pharmaceutical companies involved in the manufacturing and/or distribution of Taxotere or docetaxel, namely Pfizer Inc., Hospira Inc., Actavis PLC, McKesson Corp are also facing similar allegations.