A second trial out of more than 1,000 lawsuits alleging Johnson & Johnson products containing talcum powder caused cancer began this week in Missouri.  The Plaintiff, Gloria Ristesund, age 62, developed ovarian cancer in 2011 after having used Johnson & Johnson’s Baby Powder in her genital area for several decades.  Ms. Ristesund alleged that her cancer was caused by the talcum powder that is in the Baby Powder product.  She also alleged that J&J continued to sell its Baby Powder product despite being aware of the link between talc and ovarian cancer.

In his opening remarks, Ms. Ristesund’s attorney told the jury that J&J was aware of studies connecting talcum powder use and ovarian cancer, but the corporate giant continued to sell Baby Powder containing talc, unlike other manufacturers who switched to corn starch-based powder.  The Plaintiff’s attorney also argued that J&J employed a strategy designed to prevent Government regulation of talc and at the same time, disregarded the Government’s requests that J&J either remove talc from its Baby Powder product or issue warnings to its customers.  J&J’s attorneys contended that the studies linking talcum powder use and ovarian cancer are not conclusive and that the medical and scientific community still does not know what causes ovarian cancer.

This is the second case pending in State Court to go to trial over the alleged link between ovarian cancer and use of Johnson & Johnson’s Baby Powder.  In February of 2016, jurors returned a $72 million verdict for the family of a Missouri woman who had used J&J’s Baby Powder for more than 35 years and died from ovarian cancer.  Roughly 1,000 similar cases are pending, and a growing number of lawsuits are being filed regularly throughout the U.S.

According to new research out this month, a popular group of medications used to treat heartburn, gastroesophageal reflux disease (GERD), stomach ulcers and irritation of the esophagus caused by acid reflux could increase the user’s risk of developing kidney disease and kidney failure.  The drugs are known as proton pump inhibitors (PPI), and are marketed and sold under well-known names such as Nexium, Prilosec and Prevacid.  Proton pump inhibitors work by blocking the production of stomach acid.

The new study published by the American Society of Nephrology linked these popular stomach acid medications to an increased risk developing chronic kidney disease.  The study utilized data from the United States Department of Veterans Affairs.  Researchers discovered that individuals who took PPIs had a 96% increased risk of developing kidney failure.  The study also concluded that such individuals had a 28% increased risk of developing chronic kidney disease compared to patients who took other medications, such as histamine H2 receptor blockers, instead to treat problems associated with stomach acid.  The study also concluded that individuals who took PPIs for a longer time period were more likely to develop kidney problems.

It is estimated that in America alone, 15 million people take prescription proton pump inhibitors.  However, that number is likely underestimated since a number of these medications are now available over-the-counter.

J&J Powder-2Last 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:

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.

Thousands of lawsuits have been filed over the past six years against various manufacturers of surgical mesh products used to treat conditions such as pelvic organ prolapse and stress urinary incontinence in women.  These lawsuits challenged the safety and effectiveness of these products, after years of reports of women experiencing pain, bleeding, infection and other complications caused by the mesh implants.  Often, the complications resulted in women having to undergo multiple surgeries to repair or remove the mesh product.  Now, the United States Food & Drug Administration (FDA) is finally getting on board with those of us who have been stating for years that these products are neither safe nor effective.

In July of 2011, the FDA concluded that women who were surgically implanted with vaginal mesh products had more complications than those who underwent traditional surgery involving stitches.  At that time, the FDA issued an update on serious complications associated with the transvaginal placement of mesh for the condition known as pelvic organ prolapse (POP).  This condition occurs when the tissue that holds the pelvic organs in place becomes weakened or stretched, resulting in the organs prolapse or bulge into the vaginal area, causing various and serious complications.  In its 2011 update, the FDA informed doctors and patients that serious complications associated with the use of transvaginal mesh products for repair of pelvic organ prolapse were “not rare.”

This week, the FDA took a stronger stand against the use of surgical mesh products to repair POP in women, classifying transvaginal mesh products as “high-risk” medical products and subjecting them to additional regulatory scrutiny.  Previously, these products were considered “moderate-risk” products.  Now, the manufacturers of pelvic mesh products will have to submit new applications to the FDA, demonstrating both the safety and effectiveness of these mesh devices.

Zofran
Suthers Law Firm is actively investigating cases of birth defects caused by the drug Zofran.  Recently, several medical studies have identified an association between Zofran (ondansetron) and birth defects.  The manufacturer, GlaxoSmithKline (GSK), promoted the off-label use of the drug as a remedy for morning sickness in addition to its approved use as a drug for controlling nausea and vomiting after chemotherapy and surgery.  However, Zofran was never approved for use during pregnancy, but GSK chose to market the drug to doctors treating pregnant women with morning sickness.  Although it is not illegal for doctors to prescribe medications off-label, it is illegal for drug companies to market drugs for off-label uses. In 2012, GSK agreed to pay more than $1 billion to settle allegations that it illegally marketed medications – including Zofran – for off-label use

The results of studies done on Zofran’s risks to a developing fetus are very troubling.  Because morning sickness most often occurs during the first trimester, the pregnant mother is taking Zofran at the infant’s most critical and fragile stage of development, when drugs can do the most damage. Birth defects that have been linked to Zofran include the following:

  • Cleft lip

A recent study performed by researchers at Florida State University found that receiving cell phone notifications, such as a ringtones, vibrations or alarm bells, while operating an automobile can be just as distracting and dangerous as talking or texting while driving.  This is the first study to examine the relationship between of cell phone notifications and mental performance.

The researchers, who published their findings in the Journal of Experimental Psychology: Human Perception and Performance, determined that when your cell phone sends out an alert, your mind starts to wander and lose concentration.  “The level of how much it affected the task at hand was really shocking,” FSU researcher Courtney Yehnert said.  “Although these notifications are generally short in duration, they can prompt task-irrelevant thoughts, or mind-wandering, which has been shown to damage task performance.  Cellular phone notifications alone significantly disrupt performance on an attention-demanding task, even when participants do not directly interact with a mobile device during the task.”

The National Highway Traffic and Safety Administration reported in April 2013 that an estimated 660 thousand drivers use cell phones or electronic devices while driving at any given daylight moment in spite of the fact that 44 states and the District of Columbia have outlawed texting while driving. Unsurprisingly, the National Safety Council has found that twenty five percent of all traffic accidents are caused by distracted driving, specifically cell phone use while driving.

Federal and state laws require that nursing homes maintain or attain the highest practicable mental, physical, and psychosocial well-being for their patients.  These laws provide that nursing homes must ensure that their patients’ nutrition and hydration needs are met, as proper nutrition and hydration are two critical components for nursing home residents to maintain their overall health and well-being inside the facility.

The elderly are particularly at risk for both malnutrition and dehydration.  Due to decreased body reserves and other diminished capacities, the elderly are much more susceptible to malnourishment than younger adults. Moreover, many aging patients have dental problems or experience loss of appetite caused by health problems or medications. Thus, they need to be monitored by nursing home staff carefully for any signs of malnutrition. Often times this is not done.

Another reason patients become malnourished while residing in nursing homes is that many cannot feed themselves without assistance, and are not properly fed by nursing home staff. Each year thousands of nursing homes across the country receive citations for inappropriate feeding tube insertions or improper feeding methods.

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.

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.