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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 thJJ-baby-powder-shower-shower-crop-300x270-300x270an 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 & Harper 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 researcheCelrs, 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.

JJ-baby-powder-shower-shower-crop-300x270-300x270Talc 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.

A great injustice is taking place in this country:  the use of pre-dispute binding arbitration clauses in nursing home admissions contracts by the nursing home industry.  These clauses provide that victims of abuse and neglect in nursing homes give up their right to a jury trial. This directly undermines the spirit and intent of the Nursing Home Reform Act of 1987:  to improve the quality of care and clinical outcomes for our most vulnerable citizens.

Elderly nursing home residents and their spouses are being pressured or mislead into signing arbitration clauses, frequently when they lack the mental capacity, authority or true willingness to do so.  If arbitration was a level playing field and fair to both sides without any negative repercussions to the resident or family, does anyone really believe that the nursing home industry would feel the need to so aggressively enforce them and seek to bury these provisions within 50 pages of admissions materials?

Arbitration provisions lead to protracted litigation, not faster results or less expensive resolution of cases.  The nursing home industry uses them to stall cases, take appeals and delay justice.  An elderly surviving spouse may not live long enough to see justice when nursing home corporations take this approach.

Invokana is part of a new class of type 2 diabetes drugs known as sodium-glucose-cotransporter-2 (SGLT2) inhibitors.   SGLT2 inhibitors are designed to control diabetes by blocking reabsorption of glucose by the kidneys, impacting normal kidney function and allowing more sugar to be passed from the body through urine.   However, the FDA has recently issued a new warning for a number of SGLT2 inhibitors, including Invokana (canagliflozin). The agency has stated that these diabetes therapies can cause high levels of acid to build up in the blood, causing diabetic ketoacidosis, which can lead to diabetic coma or death.

In the FDA’s announcement, the agency warned patients using SGLT2 inhibitors that they should seek immediate medical attention if they experience any symptoms of ketoacidosis, including:

  • Unusual fatigue or sleepiness

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
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