Defective Products

The First Talcum Powder Lawsuit Against Johnson & Johnson

March 4, 2016 | Adam Harper

Last week we wrote in this blog about the family of a woman from Birmingham, Alabama, Jackie Fox, who successfully sued Johnson & Johnson after linking her use of their talcum powder products to her ovarian cancer. The family of Ms. Fox obtained a 72 million dollar verdict. However, Ms. Fox and her family were not the first in the United States to bring a lawsuit alleging these products caused ovarian cancer. That distinction belongs to a South Dakota woman named Deanne Berg.

Ms. Berg, wrote a very interesting story this week in the New York Post that detailed her struggle after being diagnosed with ovarian cancer in January of 2007. You can access the full story here. Ms. Berg had used Johnson & Johnson Talc powder for more than 30 years. She recalled the marketing for Johnson & Johnson’s Baby Powder and Shower to Shower as a feminine hygiene product when she first began using the products as an 18 year old. Tag lines such as “A sprinkle a day helps keep odor away,” and another that stated, “Your body perspires in more places than just under your arms.” She, as millions of others, felt that the use of these products to be perfectly safe. However, once she was diagnosed with ovarian cancer, she began to do research, and, to her surprise, found several studies that had long linked talcum powder use and ovarian cancer. Some going back decades.

In the article, she discusses the struggles that she went through on a daily basis dealing with her ovarian cancer:

Johnson & Johnson To Pay $72 Million in Talcum Powder Case

February 26, 2016 | Adam Harper

On Monday, a St. Louis jury awarded the family of an Alabama woman $72 million in a civil suit against Johnson & Johnson. The jury found Johnson & Johnson liable for the plaintiff, Jackie Fox’s ovarian cancer, which she claimed in the lawsuit was the result of using the company’s Baby Powder and Shower to Shower powder, both of which contained talcum powder.

According to the lawsuit, Ms. Fox, of Birmingham, Alabama, was diagnosed with cancer in 2013. She died last fall at age 62 after her ovarian cancer returned. The jury awarded $10 million for compensatory damages and $62 million for punitive damages to Ms. Fox’s estate. Deliberations lasted four hours, following a three-week trial. Jurors found Johnson & Johnson liable for fraud, negligence and conspiracy.

Currently, there are more than 1,200 civil suits against the company related to its talcum-containing products. Several studies have been conducted which link talc powder to ovarian cancer and talc is a common ingredient in many Johnson & Johnson products. In 23 case-controlled studies, conducted by the International Journal of Gynecological Cancer in May of 2015, the researchers found that talc use increased the risk of ovarian cancer by 30-60 percent. While studies had been previously unable to determine conclusively whether talc played a role in ovarian cancer, the International Journal of Gynecological Cancer concluded that their results “suggest that talc use causes ovarian cancer.” Several other recent studies, including one conducted by the Journal of the National Cancer Institute, confirmed those same results. The connection between talc powder and ovarian cancer was reinforced when scientists discovered talc minerals inside the cancerous tumors they were removing from women’s bodies. Ovarian cancer is the most lethal gynecological cancer there is and it is most often detected in the later stages of the illness when it is too late to effectively treat the cancer.

Baby Powder Use Linked to Ovarian Cancer

September 14, 2015 | John Suthers

Talc is a naturally occurring mineral that is one of the primary ingredients in products like Johnson & Johnson’s Baby Powder and Shower-to-Shower body powder. Manufacturers of products containing talc have promoted these products for decades, claiming that talcum powder eliminates friction, is gentle on the skin, and provides a fresh scent. They created ads with smiling, bare-bottomed babies, promoting the use of baby powder to reduce diaper rash, and other ads, promoting the use of talcum powder by women as a personal hygiene product. However, a large number of studies published in scientific and medical journals concluded that the use of talcum powder in the genital area increases a woman’s risk of developing ovarian cancer. This alarming information has been known by the manufacturers of products for many years, but the manufacturers chose not to put warnings on their products or in their ads.

Talc is a mineral that shares some similarities with asbestos, another mineral that causes deadly cancers. Just as asbestos fibers were found in the lungs of workers who breathed them, talc particles have been found in the ovaries of women who used baby powder containing talc in the vaginal area and developed ovarian cancer. When baby powder containing talc is applied to the genital area, talc particles can move up the vagina, into the fallopian tubes, and into the ovaries, where the talc particles can remain for decades. Scientific studies have shown that talc causes inflammation in healthy tissue. This inflammation may, in turn, contribute to the development of cancer.

Dr. Daniel Cramer is a gynecologic oncologist and Harvard Medical School professor. In 1982, Dr. Cramer published the first study that linked talcum powder use in a woman’s genital area with an increased risk of ovarian cancer. In a recent interview, Dr. Cramer said “I have always advised gynecologists that if they examine a woman and see that she is using talc in the vaginal area, tell her to stop.” The association between talcum powder use and ovarian cancer was the subject of numerous epidemiological studies published throughout the 1980s and 1990s, which reinforced Dr. Cramer’s findings. As early as 1992, manufacturers were urged to put warning labels on talcum powder products because of this serious health threat to women.

Bard IVC Filter Lawsuits

August 19, 2015 | John Suthers

Medical device manufacturer, C.R. Bard, Inc., is back in the news and back in Federal Court. On August 18, 2015, the Judicial Panel on Multidistrict Litigation (JPMDL) announced that the lawsuits pending currently against C.R. Bard, Inc. and Bard Peripheral Vascular involving the IVC filter will be consolidated and transferred to the U.S. District Court for the District of Arizona. More than 200 pending cases will be transferred immediately, and it is believed that many more will follow.

An inferior vena cava (IVC) filter is a small medical device that is surgically implanted inside the body to capture blood clots before they migrate to other areas of the body, causing serious conditions such as a pulmonary embolism or stroke. However, a number of studies have shown that pieces can break away from the filter and migrate to other areas of the body, causing serious injuries and deaths. The New England Society for Vascular Surgery conducted a study, which concluded that the IVC filters fractured in 31% of the cases. These shards or splinters often migrated to the patients’ right ventricles of the heart. Another study found that in 25% of the patients studied, there were splinters that broke off, many of which migrated to the heart, lungs and the hepatic vein.

Before introducing these filters on the medical market, Bard knew that IVC filters were associated with serious side effects. However, this information was not conveyed to doctors. Bard knew the filters were prone to fracture, which could lead to perforations of the vena cava, surrounding vessels and organs, necessitating serious and life-threatening open surgical procedures. On July 13, 2015, the U.S. Food and Drug Administration (FDA) cited Bard for failing to report adverse events associated with the IVC filters and for illegally selling a device that was designed to retrieve the filters. It is believed that Bard has sold more than 500,000 IVC filters. With failure rates approaching 40% after five years of implantation, there are far too many patients with IVC filters who are at risk.

LUMBER LIQUIDATORS LITIGATION UPDATE

May 21, 2015 | Adam Harper

Suthers & Harper is continuing to investigate potential claims on behalf of individuals who purchased laminate wood flooring from Lumber Liquidators. Problems with the Lumber Liquidators’ flooring was first noted on CBS’ 60 Minutes. Reporters went undercover to factories in China that produce laminate flooring for Lumber Liquidators that the company says is “CARB 2″ compliant, meaning it complies with California standards (and soon to be federal standards). However, managers in these Chinese facilities acknowledged that inventory being produced for Lumber Liquidators was being labeled “CARB 2″ compliant, even though everyone in the facility was aware of the fact it was not. Independent tests performed by CBS News indicated the flooring failed to meet health and safety standards due to the high levels of formaldehyde. Formaldehyde is a colorless and flammable chemical, and is a common ingredient in the glue used in laminate flooring. During and after installation, it is released as a gas that causes burning eyes, nose and throat irritation, coughing, headaches, dizziness, joint pain and nausea. At long-term exposure, formaldehyde is listed as a known cause of cancer in humans by both the federal government and the State of California.

The following models of Lumber Liquidators lumber may contain excessive and illegal amounts of formaldehyde:

8 mm Bristol County Cherry Laminate Flooring

Alarming New Report Concerning Laminate Sold in Lumber Liquidators Stores Nationwide

March 31, 2015 | Adam Harper

Lumber Liquidators is one of largest retailers of both wood and laminate flooring in North America. In fact, there is more than 100 million square feet of the company’s laminate flooring alone sold and installed in American homes every year. In a startling recent report on CBS’ “60 Minutes”, the news show claims Lumber Liquidators has been selling laminate flooring that contains levels of formaldehyde in excess of regulatory standards.

The flooring at issue is Lumber Liquidators’ laminate flooring made in China. (American-made laminates sold at Lumber Liquidators had acceptable levels of the formaldehyde.) Independent test performed by CBS News indicated the flooring failed to meet health and safety standards due to the high levels of formaldehyde. Formaldehyde is a colorless and flammable chemical, and is a common ingredient in the glue used in laminate flooring. During and after installation, it is released as a gas that causes burning eyes, nose and throat irritation, coughing, headaches, dizziness, joint pain and nausea. At long-term exposure, formaldehyde is listed as a known cause of cancer in humans by both the federal government and the State of California.

On the program, Dr. Philip Landrigan, a physician at New York’s Mt. Sinai Hospital, said that long-term exposure to formaldehyde from the Lumber Liquidators flooring increases the risk for chronic respiratory irritation, reduced lung function and asthma. Dr. Bernard Goldstein, a physician, toxicologist and former dean of the University of Pittsburgh Graduate School of Public Health stated that this is especially true in children. “For flooring I’d be more concerned about acute health effects, particularly for infants crawling over the floor. Children breathe in more air relative to their small body sizes than do adults. When they work hard, as they do when they crawl or run, they will have maximal respiratory uptake of anything gassing off the floor. Pets too,” he added.

Takata Airbag Recalls

November 14, 2014 | John Suthers

Eleven major automobile manufacturers have issued recalls on more than 7.8 million cars equipped with defective airbags manufactured by Takata Corporation. There have been reports of the airbags exploding and shooting metal shrapnel at passengers in the cars. Complaints that were filed recently indicate that Takata has known about this serious safety hazard for longer than 10 years. The National Highway Transportation Safety Administration (NHTSA) is now opening an investigation into Takata’s defective airbags. Several United States Senators have recently called upon the U.S. Department of Justice to open a criminal investigation as a result of recent reports that Takata erased the results of tests that indicated the existence of defects in the airbags. Thus far, complaints and/or lawsuits filed against Takata claim that Takata’s defective airbags are responsible for the deaths of 4 individuals and injuries to 139 individuals.

The recall is focused on geographic areas with high humidity, since the alleged defect is thought to be triggered by exposure to excessive moisture. The following is a list of the manufacturers and models recalled involving Takata airbags:

BMW

NuvaRing Contraceptive Product Lawsuit Update

January 22, 2014 | John Suthers

At present, more than 1,700 women have sued the manufacturers of NuvaRing, a prescription contraceptive device. NuvaRing was manufactured originally by Organon USA, Inc., a company which was subsequently acquired by Merck & Co., and was approved by the U.S. Food and Drug Administration (FDA) in October of 2001. The product consists of a vaginal ring that contains the hormones estrogen and progestin. NuvaRing was designed to be used monthly. It was marketed as being more convenient than daily birth control pills, but equally effective. A study that was commissioned by the FDA and published in 2011 reported a 56% increase in blood clot risks for NuvaRing users, including an increased risk of deep vein thrombosis (DVT) and pulmonary embolism (PE), when compared to birth control pill users. In 2012, studies published in The New England Journal of Medicine and The British Medical Journal stated that the side effects of NuvaRing included an increased risk of blood clots, strokes and heart attacks.

One case that is pending against the manufacturers involves a then 20 year old college student, who began using NuvaRing in 2008. After using NuvaRing for more than a year, she suddenly became ill and began spitting up blood. She was rushed to the hospital, where she spent 10 days receiving anticoagulants in an effort to thin her blood. Her doctors had a hard time believing she had a blood clot in her lung because she was only 22 years old at the time, she did not smoke, and she had no family history of blood clots. Her doctors eventually concluded that she had developed a blood clot in her lung, a condition known as pulmonary embolus, which can be fatal. Because she was a healthy 22 year old at the time and did not have other risk factors for blood clots, her doctors concluded that NuvaRing caused the blood clot.

A 24 year old woman who had used NuvaRing was not so fortunate. She suffered what was described as a massive pulmonary embolism that, in turn, triggered four heart attacks, resulting in her untimely death. Her doctors also believed that NuvaRing was the cause of her pulmonary embolism. In 2011, her parents filed a lawsuit against the product manufacturers.

Government Demands Chrysler Recall 2.7 Million Jeep SUVs

June 5, 2013 | John Suthers

On June 3, 2013, the National Highway Transportation Safety Administration (NHTSA) wrote a letter to Chrysler, stating that a safety-related defect exists in 2.7 million Jeep Grand Cherokee and Jeep Liberty vehicles, and demanding that Chrysler recall them. The model years for the Grand Cherokee were 1993-2004, and the model years for the Jeep Liberty were 2002-2007. The alleged defect is related to the rear fuel tanks, which cause an unreasonable risk of a fire occurring in the event of a rear-impact collision. Specifically, there are concerns about the likelihood that the fuel tanks will leak gasoline and catch fire in rear-impacts, resulting in serious injuries and fire-related deaths.

There is presently a lawsuit pending in the Superior Court of Decatur County, Georgia, involving the death of 4 year old Remi Walden, who was a passenger in a 1999 Jeep Grand Cherokee when it was struck in the rear by a Dodge Dakota truck. The collision occurred in Bainbridge, Georgia. Remi was properly restrained in his booster seat in the backset of the Grand Cherokee when the rear-impact collision occurred. The Grand Cherokee, which had a fuel tank located just inside the rear bumper of the car, ruptured upon impact, causing a fire. The Grand Cherokee was quickly engulfed in flames, witnesses were unable to rescue Remi, and he died from fire-related injuries. Remi Walden’s death was one of the incidents referred to by NHTSA in its recall letter to Chrysler.

In the 1970s, 27 deaths were attributed to Ford Pinto rear-impact fires. There was a 1972 accident which resulted in the famous court case known as Grimshaw v. Ford Motor Company, in which a California appellate court ultimately upheld a compensatory damages award of $2.5 million and punitive damages of $3.5 million against Ford, ostensibly because Ford had been aware of the design defects for several years but had decided against altering the design. It was later discovered that Ford had done a “cost-benefit analysis” to compare the cost of a recall and repairs against the cost of settlements or verdicts for injuries, deaths, and vehicles burning up.

GranuFlo (Dialysis Product) Litigation

January 17, 2013 | John Suthers

Lawsuits continue to be filed against the manufacturer of the dialysis product known as GranuFlo. This product is the powder form of a solution used to clean and remove waste from the blood during dialysis. Fresenius Medical Care, a German company whose American headquarters is located in Massachusetts, created the product to replace a liquid solution that was previously used for this purpose. The idea was to create a product in powder form, so that dialysis clinics could mix it with water and use it in the facility.

Lawsuits filed against Fresenius Medical Care contend that the product has twice the level of acetate as the liquid solution. When used during dialysis, it can affect the patient’s blood’s pH level and disrupt the patient’s heart rhythm, a condition known as arrhythmia. One of the lawsuits involves a patient who went in for his routine dialysis treatment during which GranuFlo was used. The patient went into cardiac arrest and died while he was still connected to the dialysis machine.

In March of 2012, the United States Food and Drug Administration (FDA) issued a Class 1 recall of GranuFlo. The basis for the recall was the FDA’s finding that an excess bicarbonate level in the bloodstream can cause a drop in blood pressure, low blood oxygen, a drop in the potassium levels in the blood, and cardiac arrhythmia, which can result in the patient suffering cardiac arrest. Lawsuits allege that Fresenius Medical Care knew about the inherent risk of elevated bicarbonate levels in the blood, but failed to warn clinics to change the settings on the dialysis machines to account for the elevated bicarbonate levels. Company memos revealed that 941 patients at dialysis clinics owned by Fresenius had experienced cardiac arrest while being treated with GranuFlo. Fresenius warned its clinics to reduce the acetate value when using GranuFlo in its concentrated form. However, the lawsuits allege that the company failed to warn thousands of other dialysis clinics about the increased risk of suffering cardiac arrest while using GranuFlo. It is unknown at present exactly how many patients who were treated with GranuFlo experienced cardiac arrhythmia and/or cardiac arrest. Plaintiffs’ lawyers have estimated that the potential number of injured victims from all dialysis clinics across the U.S. could range between 5,000 and 10,000.