After DePuy Orthopaedics, a subsidiary of Johnson & Johnson, recalled two models of its metal-on-metal hip replacement products in August of 2010, thousands of lawsuits were filed against the product manufacturer.  DePuy Orthopaedics recalled its ASR Acetabular System and the ASR Hip Resurfacing System after reports of high rates of failures by the products, leading to the patients needing revision (removal) surgery.  Similarly, Stryker Orthopaedics recalled in July of 2012 its Rejuvenate and ABG II hip implant products after multiple reports of produMetal-on-Metalct failures due to heavy metal fretting and corrosion.  Thousands of lawsuits were also filed against Stryker thereafter.

There were essentially two classes of victims involved in the litigation.  The majority of the lawsuits were filed on behalf of individuals who had suffered injuries, including loosening or instability in the hip joint, dislocations, difficulty walking and moving the hip properly, pain, inflammation or swelling in the area of the hip implant, tissue destruction or tissue necrosis, and elevated levels of cobalt and chromium in the bloodstream, a condition known as metallosis.  These individuals had to undergo revision surgery or surgeries during which the metal-on-metal hip implant was removed and replaced with a more traditional hip replacement product that utilized a metal femoral head with a plastic liner in the cup.  Many of the lawsuits that were filed on behalf of individuals who had already undergone revision surgery or surgeries have settled.  A substantial number of lawsuits remain pending on behalf of individuals who were surgically implanted with these defective hip products, but who have not yet undergone revision surgery.  These individuals have not yet had revision surgery because the injuries and problems resulting from metal-on-metal have not yet manifested themselves, or the patients have symptoms or problems, but their physicians have not yet recommended revision surgery.

One of many problems associated with metal-on-metal hip replacement products was the corrosion or fretting caused by the metal femoral head (ball) rubbing against the metal cup.  The constant rubbing of the two metal surfaces caused scratching or corrosion of the femoral head, acetabular liner, and/or the metal cup.  This resulted in metal debris or particles known as ions getting into the bloodstream and adjacent tissues, contributing to implant failure and tissue destruction.  The metal components of the hip replacement products contain cobalt and chromium.  When metal ions containing cobalt and/or chromium are released into the bloodstream or adjacent tissue, these particles are toxic to soft tissue, bone and muscle.  In essence, this poisons the hip joint.  The term “metallosis” has been used to describe excess levels of cobalt and/or chromium in a victim’s bloodstream.  Surgeons who have removed the defective hips have seen and documented the extensive tissue destruction and necrosis surrounding the hip implant area.

Medical errors are now the third-leading cause of death in the United States, claiming more than a quarter of a million lives every year, more than lung disease, breast cancer, AIDS, plane crashes, drug overdoses, stroke or Alzheimer’s, according to a recent study published by the British Medical Journal. Diagnostic mistakes, lack of communication between treating physicians, inadequate discharge instructions, and incorrect medications are among the leading issues listed as contributing to these fatal medical errors. Only heart disease and cancer take more lives in the United States.Medical Errors

The study, led by Johns Hopkins surgeon Dr. Martin Makary, believe there needs to be changes in the way deaths are recorded to better tabulate fatal lapses in care to address this very serious problem. “We’re talking about patients dying from the care that they receive rather than the disease or injury for which they seek care. We’re talking about things that happen that shouldn’t happen,” said Dr. Makary. In an open letter, the researchers urge the Centers for Disease Control and Prevention (“CDC”) to immediately add medical errors to its annual list reporting the top causes of death.

The study discusses the difficulty in actually tracking the number of medical deaths that come about as a result of physician or hospital error.  This is due to the fact that there are no federal or state requirements for reporting when a patient dies as a result of a medical error. Moreover, the CDC currently has no good way of tracking deaths that result from medical mistakes.  The agency’s death statistics are pulled from the International Classification of Diseases codes that appear on death certificates. These codes were instituted in 1949 and do not include any that indicate a death was the result of a mistake in the hospital. As a result, the researchers believe the study’ actually understates the true incidence of death due to medical error because it relies on errors extractable in documented health records and includes only death that occurred inside of a hospital.

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.