Pennsylvania Injury Lawyer Blog

On January 17th, 2013 the Food and Drug Administration (FDA) Issued a Safety Communication on all Metal-on-metal Hip Implants. This message was directed to both recipients and prospective recipients of metal-on-metal hip replacements as well as orthopedic surgeons.

The safety communication comes almost two years after the May 2011 order for post-market surveillance that ordered 21 manufacturers of metal-on-metal hip implants to study and report back to the agency on the effectiveness of their products. This order came after the FDA received numerous adverse event reports from recipients of various metal-on-metal hip implants made by some of the top manufacturers.

DePuy Orthopedics, a subsidiary of Johnson and Johnson (J & J) got the ball rolling in 2010 when they announced a recall of the Depuy ASR Hip Resurfacing System and the ASR XL Acetabular System due to higher than expected early failure rates. As stated in The Star Tribune, this massive recall included 90,000 products that were sold worldwide. Since then, more than 30 similar products from various manufactures, including Zimmer and Stryker, have been recalled for the same reason.

As the FDA explains in their Metal-on-Metal Hip Implant Communication, the device fails because the metal ball and the metal cup slide against each other during walking or running, corroding the metal from parts where two implant components connect. When the metal corrodes it is released into the body. This can cause the patient to suffer an adverse reaction to metal debris, (ARMD) which includes damage to the bone and/or soft tissue surrounding the implant or the joint. ARMD is can also be referred to as an adverse local tissue reaction (ALTR).
Soft tissue damage can lead to pain or even metallosis, or metal poisoning, which will ultimately require the patient to undergo a difficult revision surgery. ARMD can also cause the device to loosen, which will also mean a revision surgery is needed.

Continue reading "What is the FDA Doing about Faulty Metal Hip Implants? " »

The U.S. Food and Drug Administration (FDA) has issued a warning letter to Stryker Corp due to a quality systems-related issue at the Portage, Michigan facility – where products from Stryker’s Instruments are produced – and the company’s marketing of unapproved medical devices including the Neptune Waste Management system.

Stryker issued a Class 1 recall of the Neptune system in June 2012, weeks before it also recalled the Stryker Rejuvenate and ABG II metal-on-metal hip implants after the devices were showing substantial rates of hip implant failure. The Neptune system, which collects surgical waste fluids and evacuates smoke during clinical procedures, was causing severe injuries, one of which resulted in death.

Stryker received the warning in response to its marketing products without adequate regulatory approval and failing to inform the FDA about the product recall.

The U.S. Food and Drug Administration (FDA) has issued a warning letter to Stryker Corp due to a quality systems-related issue at the Portage, Michigan facility – where products from Stryker’s Instruments are produced – and the company’s marketing of unapproved medical devices including the Neptune Waste Management system.

Stryker issued a Class 1 recall of the Neptune system in June 2012, weeks before it also recalled the Stryker Rejuvenate and ABG II metal-on-metal hip implants after the devices were showing substantial rates of hip implant failure. The Neptune system, which collects surgical waste fluids and evacuates smoke during clinical procedures, was causing severe injuries, one of which resulted in death.

Stryker received the warning in response to its marketing products without adequate regulatory approval and failing to inform the FDA about the product recall.

An estimated 80,000 surgical "never events," – events that should never happen during surgery according to universal professional agreement – occurred in American hospitals between 1990 and 2010, researchers at Johns Hopkins reported in the journal Surgery. They suggest that documenting the problem will help health care professionals take a step toward developing better systems to prevent surgical mistakes.

Researchers used a federal repository of medical malpractice claims to identify 9,744 claims and judgments that totaled $1.3 billion over 20 years. Using these published rates, the researchers estimate that more than 4,000 surgical never events occur in the United States each year.

The study estimates that a surgeon leaves a foreign object such as a towel inside a patient’s body after an operation 39 times a week, performs the wrong procedure on a patient 20 times a week and operates on the wrong body part 20 times a week. Sixty-two percent of the surgeons named were cited in more than one separate malpractice report.

"The events we’ve estimated are totally preventable," says study leader and associate professor of surgery at the Johns Hopkins University School of Medicine Marty Makary, M.D. M.P.H. "This study highlights that we are nowhere near where we should be and there’s a lot of work to be done."

Hospitals are required by law to report to the NPDB never events that result in a settlement or judgment. The study assumes that their estimates of never events are low because health care professionals do not discover all items left behind after surgery, as these mistakes are typically found only when a patient experiences complications after surgery.

Common patient safety procedures have long been in place to prevent never events. These include a mandatory "timeout" before an operation to ensure medical records and surgical plans match the patient on the table. Other efforts involve procedures to count surgical items before and after surgery and the use of indelible ink to mark the surgery site beforehand. Some hospitals now use electronic bar codes on surgical materials to prevent human error.

Along with more foolproof procedures to prevent never events, Makary believes better reporting systems are also necessary. He suggests public reporting of never events, an action that would give consumers the information to "put hospitals under the gun to make things safer."

This past spring, the vaginal contraceptive ring NuvaRing followed in the footsteps of Yaz, Depo-Provera and Ortho Evra to become the next big thing in birth control lawsuits. Less than six months later, NuvaRing is losing the spotlight to the popular intrauterine device (IUD) Mirena.

At least 16 lawsuits were filed in the Superior Court of New Jersey by women suffering from perforation and similar Mirena injuries. The alleged Mirena injuries listed in the complaint are different than the side effects of NuvaRing or Yaz. The side effects of Mirena surrounding the litigation involve spontaneous migration of the IUD.

Mirena is a small T-shaped plastic device that measures 32 mm by 32 mm. A reservoir containing synthetic hormone levonorgestrel (LNG) surrounds the vertical stem of the device. The LNG is released at a rate of 20 micrograms per day and declines to a rate of 14 micrograms after 5 years, which is still within the range of clinical effectiveness. The LNG is released directly into the uterus. Most of the hormone stays inside the uterus. Only a small amount gets absorbed into the rest of the body.

Attached to a loop at the end of the device is a monofilament brown polyethylene removal thread. The thread allows physicians and patients to check and make sure the IUD is still in place. This thread also allows easy removal of the IUD.

Mirena was approved by the Food and Drug Administration (FDA) in 2000 for contraceptive use. It was later approved for the treatment of heavy menstrual bleeding in 2009. Mirena was permitted to remain in the body for up to five years.

Continue reading "Lawsuits Filed in New Jersey over Injuries resulting from Popular Mirena IUD" »

This past spring, the vaginal contraceptive ring NuvaRing followed in the footsteps of Yaz, Depo-Provera and Ortho Evra to become the next big thing in birth control lawsuits. Less than six months later, NuvaRing is losing the spotlight to the popular intrauterine device (IUD) Mirena.

At least 16 lawsuits were filed in the Superior Court of New Jersey by women suffering from perforation and similar Mirena injuries. The alleged Mirena injuries listed in the complaint are different than the side effects of NuvaRing or Yaz. The side effects of Mirena surrounding the litigation involve spontaneous migration of the IUD.

Mirena is a small T-shaped plastic device that measures 32 mm by 32 mm. A reservoir containing synthetic hormone levonorgestrel (LNG) surrounds the vertical stem of the device. The LNG is released at a rate of 20 micrograms per day and declines to a rate of 14 micrograms after 5 years, which is still within the range of clinical effectiveness. The LNG is released directly into the uterus. Most of the hormone stays inside the uterus. Only a small amount gets absorbed into the rest of the body.

Attached to a loop at the end of the device is a monofilament brown polyethylene removal thread. The thread allows physicians and patients to check and make sure the IUD is still in place. This thread also allows easy removal of the IUD.

Mirena was approved by the Food and Drug Administration (FDA) in 2000 for contraceptive use. It was later approved for the treatment of heavy menstrual bleeding in 2009. Mirena was permitted to remain in the body for up to five years.

Continue reading "Lawsuits Filed in New Jersey over Injuries resulting from Popular Mirena IUD" »

December 3 is International Day of Persons with Disabilities, a chance for everyone to address the difficulties disabled people face in the community and to promote accessibility and understanding on a global level. At the same time, the day is a great opportunity to remember that some disabilities happen by accident when an infant is delivered in the hospital. Sometimes, the carelessness or mistake of a health care professional can leave a newborn with a lifetime of disabilities, and that isn’t fair.

Over one billion people live with a physical and emotional disability, according to the United Nations. These people often face stigmas, discrimination and inequality, and some must overcome significant obstacles on a daily basis. But accidents sometimes happen and leave people with disabilities they never had before. Families’ lives can be interrupted suddenly and without warning by a hospital error or medical negligence. Sadly, babies can suffer birth injuries that leave them with permanent physical and mental challenges that they may not have had if someone had given their delivery a bit more care.

Although today’s technology has minimized the risks involved in giving birth, health care professionals still sometimes fail to provide appropriate care during labor, delivery, prenatal or postnatal period. Hospital negligence can result in a life-long birth injury that creates a difficult situation for both the child and the parents. Suddenly, parents may have to think about long-term medical care, therapy, medication or equipment, all because of someone else’s mistake.

Families should not have to face these obstacles alone. If a child was injured at birth and now has a disability as a result, contact the birth injury lawyers at Anapol Schwartz who have had tremendous success in representing clients like you. Let this Day of Persons with Disabilities be a reason to come forward and get the help you and your child will need in the years to come.

A recent study concludes that a popular type of antidepressants called selective serotonin reuptake inhibitors (SSRIs) should be given cautiously to pregnant women because of an increased risk of miscarriage, premature birth and health problems in both the mother and her infant.

Antidepressant use has increased 400 percent over the past 20 years, the researchers reported. These drugs are the most commonly prescribed medication in the U.S. for people 18 to 44 years of age – childbearing years for most women, according to a CBS News article.

Boston researchers reviewed earlier studies that examined pregnant women who took antidepressants. Results showed “…clear and concerning evidence of risk with the use of the SSRI antidepressants by pregnant women, evidence that these drugs lead to worsened pregnancy outcomes,” said study author Dr. Adam Urato. “There is no evidence of benefit, no evidence that these drugs lead to better outcomes for moms and babies …. We feel strongly that patients, obstetrical providers, and the public need to be fully aware of this information."

SSRIs, some of which include Prozac, Paxil, Celexa, Zoloft and Lexapro, have been known to cause birth defects such as permanent damage to an infant’s heart, cleft palate and lip, Down syndrome and spina bifida. The review found an increase in miscarriage, pregnancy-induced hypertension and preeclampsia in pregnant women who took antidepressants. Premature birth was the "most pressing" complication, according to Dr. Urato. Researchers also reported increased rates of respiratory distress and low birth weight in newborns.

Sadly, many people are unaware of the increased SSRI birth defects risk until it’s too late. It is for this reason that many families have already filed lawsuits against the drug companies who failed to adequately warn them of the associated dangers to mothers and newborns. Those who suspect an injury caused by SSRI use during pregnancy should contact birth injury lawyers Gregory Spizer and Thomas Anapol at Anapol Schwartz immediately. There are long-term costs to think about.

Last Month, the United States Senate Finance Committee reported that medical device manufacturer, Medtronic, Inc. paid authors over $200 million to manipulate the data reported in medical studies. Medtronic paid these industry leaders to promote Infuse bone graft for uses not approved by the Food and Drug Administration (FDA) which violates the agency’s regulations.

Infuse Bone Graft is a genetically engineered product that converts stem cells into bone cells. Designed to grow bones, Infuse is made up of three parts: recombinant engineered human bone morphogenetic protein-2 (RhBMP-2), a sponge manufactured from bone Type 1 collagen which is a natural carrier for delivery, and a cage which holds the BMP-soaked sponges that gradually release and reabsorb the protein.

Infuse was approved by the FDA in 2002 for use in dental, oral and spinal surgeries with an anterior (frontal) approach. Infuse was not approved for anterior (back) approach spinal surgeries, because too many patients experienced complications in the 1999 clinical trials.

Some neck surgeries and other types of procedures in which Infuse was used were performed “off-label,” which is the term applied to describe the use of a product for a reason other than its intended purpose. . Some operations were anterior approach spinal surgery.

The FDA permits doctors to use drugs and medical devices off-label as they see fit. However, medical device manufacturers are prohibited from promoting off-label use.

Continue reading "Medtronic Faces Infuse Lawsuits over Misleading Reports" »

Meningitis is an infection of the meninges, the membranes that surround the brain and the spinal cord. Meningitis can come from a virus, (viral meningitis), a fungus (fungal meningitis) or bacteria (bacterial meningitis). Meningitis can be acute or chronic, mild or severe. No matter what type of meningitis you may have, you should see a doctor immediately if you experience signs of meningitis as the results can be fatal.

Individuals with a weak immune system, such as AIDS patients or cancer patients are more at risk for contracting the disease. Patients who are taking medications known to weaken the immune system are also at a higher risk for developing meningitis than those without a compromised immune system. However, meningitis is not limited to those individuals. Anyone can be diagnosed with any of the three types of meningitis: fungal, bacterial or viral.

Fungal meningitis is not contagious and is less common than bacterial meningitis. This rare form of meningitis is caused by a fungus spreading through the bloodstream from somewhere else in the body to the spinal cord and into the central nervous system.

The fungus can be transmitted by inhaling contaminated soil. Such contaminates include bird droppings, bat droppings and decaying organic matter. Fungal meningitis can also be contracted intradermally, as with the recent outbreak in which the contaminant was directly injected into the body. More than 200 patients who received a tainted injection of the steroid methylprednisolone acetate have been diagnosed with fungal meningitis. An additional 13,000 patients are potentially at risk. Patients sickened by the contaminated steroid may be eligible to file a fungal meningitis lawsuit.

Continue reading "Fungal Meningitis vs. Bacterial Meningitis and Viral Meningitis" »

Eleven people are dead from fungal meningitis and 119 infections have been reported after a batch of steroid injection vials were contaminated with a common environmental fungus. An investigation is underway by the Centers of Disease Control and Prevention (CDC), U.S. Food and Drug Administration (FDA) and Massachusetts Board of Registration in Pharmacy.

New England Compounding Center (NECC) has voluntarily recalled more than 17,000 vials of contaminated methylprednisolone distributed to about 75 clinics in 23 states. As many as 13,000 people may have received injections that were potentially contaminated, according to the CDC. Some patients who received a contaminated dose have also suffered strokes linked to meningitis. Because fungal meningitis symptoms develop so slowly, it is impossible to know how many thousands of people may suffer or die from the disease in the coming days.

Meningitis is an inflammation of the membranes that protect the brain and spinal cord. Fungal meningitis can develop when the fungus reaches the central nervous system through the bloodstream. A fungal meningitis outbreak is extremely rare. Signs of meningitis include headache, nausea, fever and neck stiffness, but people with fungal meningitis may also experience disorientation and discomfort from bright lights. Fungal meningitis symptoms may be mild at first and appear more gradually. People who have these symptoms after having received a methylprednisolone acetate injection are urged to consult a physician as soon as possible.

Methylprednisolone uses include treatment of back pain, arthritis, blood disorders, severe allergic reactions and certain cancers.

A new study concludes that although misdiagnosis in the intensive care unit (ICU) may lead to as many annual deaths as breast cancer, this preventable problem does not receive enough attention. Researchers at the Johns Hopkins Armstrong Institute for Patient Safety and Quality found that 28 percent of patients had at least one hospital misdiagnosis at time of death, and in eight percent of those patients, the diagnosis error may have either caused or contributed to death.

“Our study shows that misdiagnosis is alarmingly common in the acute care setting,” said Bradford Winters, M.D., Ph.D., lead author and associate professor at the Johns Hopkins University School of Medicine. “To date, there's been very little research to determine root causes or effective interventions.”

The study found that adult ICU patients are up to two times more likely to be the victim of fatal medical misdiagnosis than adult hospital patients overall. The most common diagnosis errors in the ICU involve heart attack, pulmonary embolism, pneumonia and aspergillosis. Together, these four conditions accounted for about one-third of all illnesses that doctors misdiagnose in ICU patients.

At the same time, less life-threatening patient safety risks have received greater attention. “It may be counterintuitive to think that the patients who are the most closely monitored and frequently tested are more commonly misdiagnosed, but the ICU is a very complex environment,” Winters said.

ICU misdiagnosis is preventable. This study indicates two frightening aspects of ICU care. First, 28 percent of ICU patients will die either directly or indirectly from a misdiagnosis. Second, an untold percentage of people will likely be gravely injured as the result of misdiagnoses in the ICU. Surviving family members of the deceased will suffer the pain of an untimely death, and those who are merely harmed by ICU misdiagnoses may experience the consequences for decades. These statistics call into question the purpose of an intensive care facility in the first place.