Georgia Injury Lawyer Blog

Hospital-Acquired Conditions Data to Be Released Soon

September 15, 2014 | John Suthers

The Centers for Medicare and Medicaid Services (CMS) announced that it will make data public on eight hospital-acquired conditions in the near future. This data can be found on the CMS website. The data will include mistakes that occur in hospitals, such as foreign objects being left in patients following surgery and the wrong type of blood being given to patients. These and other so-called “hospital-acquired conditions” can be life-threatening.

This data was mysteriously removed from the CMS website recently, which led to criticism by several consumer organizations that publish safety ratings for hospitals. There has been mounting pressure on government officials and hospitals to be more transparent about safety, so that patients considering certain types of surgeries can make more informed choices about the hospital where the surgery will be performed. For example, a patient who chooses to have an elective surgery, such as a hip replacement or knee replacement, can investigate the infection rates at the hospitals they are considering. This is important information because infections can lead to more serious conditions, such as sepsis or septic shock, which can be deadly.

Not surprisingly, many hospital officials around the country opposed this release of information reflecting hospital mistakes. The hospitals contend that some incidents, such as foreign objects being left in patients after surgery, do not happen enough for the information to be reliable. However, a USA Today report in 2013 concluded that foreign objects were retained after surgery as often as 6,000 times a year, which was far greater than the government had estimated. The retention of foreign objects after surgery can lead to infections and other complications that can, in turn, lead to additional surgeries.

Bellwether Metal-on-Metal Hip Replacement Trial Begins

September 4, 2014 | Adam Harper

The first MDL bellwether trial began this week against DePuy Orthopaedics in connection with their Pinnacle metal-on-metal hip replacement product. This trial is the first of more than 6,000 cases filed across the country that have been consolidated in U.S. District Court in Dallas, Texas.

The Plaintiff in the case, Kathleen Herlihy-Paoli, aged 58, had two Pinnacle hips implanted in 2009 and soon began to complain of pain from the devices. Blood tests before her 2011 revision surgeries found the implants had released dangerous levels of cobalt and chromium into her bloodstream. Doctors found Mrs. Paoli’s cobalt blood serum levels were 85 times higher than normal, and an MRI also showed the presence of a sizable pseudotumor growing around her left hip implant.

In her Complaint, Ms. Herily-Paoli alleges that DePuy “knew, or should have known, of reports that metal-on-metal implants, such as the Pinnacle, generated unusually high amounts of metal debris over time due to unusual, premature or increased wear and tear,” and that the debris “can spread throughout the surrounding bone and tissue and cause serious complications and damage.” Further, the Plaintiff says DePuy officials misled patients and their doctors about the safety of the artificial hips, and sponsored a nationwide satellite telecast to orthopedic doctors to push the advantages of the Pinnacle device when they were already aware of the dangers of the product.

Hip Fractures Among the Elderly in Nursing Homes

July 28, 2014 | John Suthers

When an elderly person suffers a hip fracture, the injury is sometimes referred to as a “death sentence.” This is particularly true for elderly individuals who are residing in nursing homes. Studies going back to the 1980s showed that 27% of elderly persons who suffer a hip fracture die within one year following the injury. Even when elderly persons survive a hip fracture, they are usually left with decreased mobility and often require assistive devices to walk again. Falls and fall-related injuries can cause a loss of confidence and a fear of future falls, which can also lead to decreased mobility. This lack of mobility can, in turn, lead to other medical complications, such as the development of pressure sores, pneumonia and other serious health conditions.

More recent studies have reaffirmed the potentially devastating effect that a fractured hip can have upon an elderly nursing home resident. Researchers at the Perelman School of Medicine at the University of Pennsylvania examined 60,000 nursing home residents who were hospitalized after suffering fractured hips between 2005 and 2009. What they found was alarming. Their study revealed that within six months of being hospitalized for a hip fracture, 1/3 of the nursing home residents had died. The study also found that of those nursing home residents who survived a hip fracture for longer than six months, 28% remained immobile and became dependent upon caregivers to move around. When the researchers extended the time period to one year for individuals who suffered hip fractures in nursing homes, a staggering 50% of the nursing home residents had died. Statistics for those who were living outside of the nursing home when they suffered a hip fracture were markedly different, as only 20% died within one year of the fracture versus the approximately 50% of nursing home residents.

Risk factors for falls in nursing homes include the resident’s age, mental status, means of voiding, a history of falling within the previous six months, visual impairment, confinement to a chair or bed, gait and balance problems, and medications. The most common causes of falls in nursing homes include failing to properly to assess the resident’s risk of falling, inadequate supervision of the resident, hazardous conditions within the nursing home (slippery or cluttered floors, inadequate lighting, inaccessibility to call lights, improper use of assistive devices), improper height of beds, failure to use bed and wheelchair alarms, and failure to consider the effects of medications which increase a resident’s risk of falling. These common causes of falls in nursing homes almost always boil down to staffing issues; either understaffing or inadequately trained staff, both of which are the responsibility of the owners and operators of the nursing homes.

Testosterone Lawsuits Consolidated in Illinois Federal Court

July 16, 2014 | Adam Harper

AndroGel testosterone gel is a topical testosterone replacement therapy (TRT) manufactured by AbbVie, Inc. and formerly Unimed Pharmaceuticals of Abbott Laboratories, Inc. AndroGel is approved by the Food and Drug Administration (FDA) to treat men with low testosterone or “Low T,” associated with a diagnosed medical condition. AndroGel 1% and AndroGel 1.62%, are both applied topically to the skin. Patients apply it directly to their upper arm and shoulder and it is absorbed through the skin to deliver testosterone to the patient for approximately 24 hours. The drug has been heavily prescribed over the past several years as a safe way to treat men with low testosterone. However, numerous recent studies suggest that men taking AndroGel have a far greater risk of suffering a heart attack, stroke, congestive heart failure, or other adverse cardiovascular problem. The most recent study, known as the PLOS ONE study, performed on January 29, 2014, found that men 65 years and older who took testosterone injections or used the gel, had double the risk of a heart attack in the months after starting the treatment. On Jan. 31, 2014, after reviewing these studies, the FDA announced it would be investigating the risks of heart attack, stroke and death in men using prescription testosterone products.

On May 29, 2014, an order was issued that established a federal testosterone multidistrict litigation (MDL) before U.S. District Judge Matthew F. Kennelly in the Northern District of Illinois. The purpose of creating an MDL is to facilitate faster progression of a large number of lawsuits that have certain allegations of fact in common. An MDL is designed to eliminate inconsistent court rulings among these cases, as well as expensive and unnecessary duplication of discovery. All of the lawsuits that were transferred to the Northern District of Illinois allege that drugs such as AndroGel, AndroDerm, Axiron, Foresta, Testim and others caused serious, and sometimes fatal, cardiovascular problems in men. According to the June 6 Order, Plaintiffs predict the number of lawsuits associated with testosterone therapy side effects could eventually be in the thousands. (June 6, 2014 Order).

Suthers & Harper is currently investing claims on behalf of individuals who used AndroGel or other testosterone therapies and suffered heart attacks, strokes or other serious medical complications. Other testosterone therapies that have been associated with cardiovascular complications include Bio-T Gel, Delatestryl, Depo-Testosterone, Striant and Testopel.

Medication Errors

June 5, 2014 | John Suthers

Medication errors remain one of the leading causes of injuries and deaths in hospitals. These incidents occur in several, different scenarios.

Medication dosage errors are the most common. It can be particularly dangerous when a decimal point describing the dose is placed in the wrong location. For example, suppose a doctor writes a prescription for Colchicine. Instead of ordering the intended dose of “1.0 mg,” he accidently writes or orders “10.0 mg,” resulting in the patient getting ten times the dose prescribed. This decimal error can have catastrophic consequences for the patient. The higher dose could lead to Colchicine poisoning, which is similar to arsenic poisoning. The patient’s internal organs could shut down and the patient would likely die within twenty-four to seventy-two hours.

Mistaken medication types are another common form of medication error. The names of some drugs are very similar to others, and a pharmacist or hospital nurse can mistake one drug for another, leading to the patient receiving the wrong medication.

Dangers of Extreme Obstacle Races

June 2, 2014 | Adam Harper

Tough Mudder.jpg Running events have steadily increased in popularity over the past decade. A runner looking to compete in a race never has to look very far from their own home to find a 5k, 10k, or marathon to participate in. Last year millions competed in traditional road races, but nearly 4 million racers finished what are known as non-traditional obstacle races. Non-traditional races such as Tough Mudder, Spartan Race, and Warrior Dash are extreme fitness events, exploding in popularity, that involve the traversal of obstacle courses filled with military-style obstacles.

Though these races have been unquestionably successful and extremely popular over the past several years, many believe there is a real cause for concern. Dr. Alex Diamond, a sports medicine expert at Vanderbilt University says that many of these obstacles in non-traditional races are just inherently dangerous, and therefore lead to serious injuries. “They’re literally jumping over fire, into rock pits, diving head-first into ponds.” Moreover, Diamond says the problem is that these races have no governing body to determine which obstacles go too far, which is obviously a cause for concern.

Many participants may feel because of the overwhelming popularity of these events they must be safe, however that has proven to be far from the truth. Below are just few examples of serious injuries that have occurred over the last several years in these races:

Medtronic Pays $22 Million to Settle Spinal Fusion Lawsuits

May 14, 2014 | John Suthers

Medical product manufacturer, Medtronic, announced that it is paying $22 million to settle the claims of approximately 950 individuals involving Medtronic’s Infuse spinal surgery product. Moreover, Medtronic anticipates setting aside millions more to cover a larger number of claims that remain pending or will be filed in the future.

The Infuse product contained a drug known as BMP-2. BMP-2 is a genetically engineered bone morphogenetic protein-2. This product was approved by the United States Food and Drug Administration (“FDA”) in 2002. In conventional spinal fusion surgery, the surgeon normally harvests a small amount of bone from the patient’s hip and uses it in fusing the spine. Infuse and BMP-2 were considered to be an alternative to the traditional method of harvesting bone from the hip. The product turned out to be very popular with spine surgeons, leading to sales of approximately $800 million annually. To date, it is estimated that Infuse was implanted in more than 1 million people worldwide.

The Infuse litigation uncovered a conflict of interest between certain spine surgeons and the manufacturer. After the product was approved by the FDA, some prominent surgeons began authoring papers in medical journals, touting the benefits of the product, but failing to mention several potential, serious complications associated with the product. These complications included cancer, growth of unwanted bone, and sterility in men. When another group of doctors became concerned about the fact that these complications had been ignored by the authors of the articles, they began their own study and published the results in 2011 in the medical publication, Spine Journal. According to the study results, the risk of adverse events associated with BMP-2 is 10 to 50 times the original estimates that were reported in the industry-sponsored articles.

Nursing Home Wandering and Elopement

May 13, 2014 | Adam Harper

Elopement, sometimes referred to as wandering, is defined in the context of the nursing home setting, as a cognitive-challenged resident leaving the facility and exposing themselves to potential dangers. Individuals who are the most at risk for wandering in nursing homes are those who suffer from dementia. It is estimated that approximately half of all nursing home residents suffer from some form of dementia, most commonly Alzheimer’s disease. Those residents who suffer from dementia often experience severe anxiety that is associated with not knowing where they are, what they are supposed to be doing, who the people are around them and perhaps not even their own name, which can lead to wandering/elopement.

Unfortunately, the risk of elopement endangerment in nursing homes is on the rise. Over the last several years, the number of reported cases of elopement has increased by 38 percent. When a nursing home resident elopes and leaves the nursing home grounds unattended, they put themselves, and others, at risk of injury. Residents who have eloped may be exposed to extreme heat or cold, suffer a fall when walking over uneven or unfamiliar territory, or suffer severe injuries or death as a result of wandering into traffic or bodies of water.

Elopement by nursing home residents is generally preventable, and usually is a consequence of the nursing home staff failing to meet two specific areas of care: supervision and security. Nursing homes are required by law to provide each resident with the appropriate level of supervision to address elopement and wandering behaviors. Proper supervision by nursing home nurses employees is a critical component to a safe nursing home facility. Moreover, there must be a proper care plan in place to address the security needs of each resident. The ideal care plan is resident-specific and adapts to any changes in a resident’s condition that would impact the safety of the resident. To ensure the care plan meets a resident’s changing needs, the plan must be continually evaluated.

Government Report Says One-Third of Nursing Home Patients Harmed in Treatment

March 7, 2014 | Adam Harper

According to a study released this week by Medicare’s Inspector General, one in three patients in skilled nursing facilities suffered a medication error, infection or some other type of harm related to their treatment. A “skilled nursing facility” is defined as a facility that provides specialized care and rehabilitation services to patients following a hospital stay of three days or more. There are more than 15,000 skilled nursing facilities nationwide, and about 90 percent of them are also certified as nursing homes, which provide longer-term care.

Researchers found that 22 percent of patients suffered events that caused lasting harm, and another 11 percent were temporarily harmed. In 1.5 percent of cases the patient died because of poor care, the report said. During August 2011 alone, the study estimated that 21,777 patients were harmed and 1,538 died due to substandard skilled nursing care.

Shockingly, the study revealed that 59 percent of the errors and injuries were preventable. Most of the injuries and deaths were caused by substandard treatment, inadequate monitoring, delays or the failure to provide needed care. Many of the deaths involved problems such as preventable blood clots, fluid imbalances, excessive bleeding from blood-thinning medications and kidney failure.

Talcum Powder Linked to Ovarian Cancer

February 20, 2014 | Adam Harper

Talcum Powder, a household item that is sold globally for use in cosmetics and personal hygiene products, has recently been linked to ovarian cancer after prolonged use. Talcum powder is commonly found in baby powder and other adult products including body and facial powder.

In October of last year, a South Dakota jury determined that Johnson & Johnson failed to adequately warn consumers about the risk of ovarian cancer from talcum powder product. The lawsuit was brought against Johnson & Johnson by Deane Berg, 56, who developed ovarian cancer in 2006 after using Johnson and Johnson’s Shower to Shower body powder for 30 years. According to the plaintiff, she had no other risk factors for ovarian cancer. Three separate doctors who examined her cancer tissue found talc in the tissue using an electron microscope, and determined that her cancer was caused by Shower to Shower. One of Berg’s treating physicians, Harvard University Professor Daniel Cramer, has been looking into links between talc and ovarian cancer for 30 years. He testified that talcum powder probably caused 10,000 cases of ovarian cancer every year.

Shockingly, numerous studies dating as far back as the 1970s reveal a link between the use of talcum powder and ovarian cancer, yet Johnson and Johnson failed to warned consumers, despite being aware of the risks associated with its use from these studies. According to the National Institutes of Health, women that use talcum powder on a weekly basis have a 33 percent increased chance of developing ovarian cancer. The studies show that Talc particles may enter the female reproductive through direct dusting or through the use of feminine products dusted in baby powder. Once inside the body, talc can migrate to the ovaries. Talc particles that reach the ovaries are thought to cause an inflammatory response, yielding conditions that are friendly to the growth of cancer cells, accounting for the increase in risk of developing ovarian cancer.