June 2011 Archives

FDA Needs More Oversight of Defective Medical Device Recalls to Prevent Adverse Events

June 28, 2011

A new report from the Government Accountability Office reveals that the U.S. Food and Drug Administration is not doing enough to follow up on defective medical devices, such as the recently recalled DePuy hip replacement system, that cause deadly side effects. Our Illinois product liability attorneys know that recalls are an important tool to prevent safety problems associated with defective devices. But more needs to be done in order to mitigate patient harm. The latest government report shows that the FDA is missing an important opportunity to protect consumers from medical devices that cause serious personal injury or death.

According to the report, more than 700 defective medical devices are recalled every year, and many of these devices carry a serious health risk. Cardiac devices are most commonly recalled, along with radiology devices. In 2010, a hip replacement system manufactured by DePuy Orthopedics hip replacement system was recalled, and hundreds of lawsuits are pending against the medical device manufacturer. Studies show that 1 in 8 patients who received a recalled DePuy hip required a second, painful revision surgery. Zimmer's NexGen line of knee replacement systems was also recently recalled, after patients experienced loosening and severe pain.

Even after these dangerous medical device products are recalled, the danger remains. The FDA is not doing its part to ensure that the recalled devices are off pharmacy shelves or hospital inventories. Surprisingly, the agency has no way of assessing whether or not manufacturers actually pulled every recalled device off the market. The report found several cases in which dangerous medical devices could not be located, and manufacturers just assumed that consumers threw them away.

This report is troubling because a significant number of recalled devices cause serious adverse health problems, and the FDA's lack of oversight exposes patients to unnecessary risk. Defective device patients and medical providers need to be consistently informed about potential product hazards in order to prevent permanent harm.

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Illinois Appellate Court Decision Helps Medical Malpractice Victims Harmed by MRSA Infections

June 27, 2011

A recent Illinois Appellate Court decision significantly advances the rights of medical malpractice victims harmed by hospital-acquired infections. Medical malpractice lawyers at Pintas and Mullins Law Firm are encouraged by the court's ruling on behalf of our client, which makes it easier for injured patients and their loved ones to take legal action against negligent health providers. Chicago area hospitals can no longer hide under a shield of liability when innocent patients are harmed by MRSA(methicillin-resistant staphylococcus). This decision entitles malpractice victims to valuable hospital infection data that reveals whether the hospital violated the legal standard of care. We strongly believe that allowing patients access to this critical data will improve the quality of care and ultimately save billions of healthcare dollars.

MRSA is a deadly infection that spreads though contact with doctors, nurses, and other health care workers who fail to take proper sanitary procedures. Hospital patients have weakened immune systems and are at great risk for infection when medical professional do not wash their hands or use contaminated equipment. The Centers for Disease Control and Prevention estimate that more than 2 million hospital infections are acquired each year, leading to chronic health conditions and permanent personal injuries. Sadly, many victims of MRSA are forced to amputate their limbs in order to prevent the spread of infection. Simple safety steps can be taken to prevent hospital-acquired infections, such as washing hands or sanitizing patient rooms before surgery. Unfortunately, Illinois hospitals and hospitals around the nation are not doing enough to prevent the deadly spread of MRSA.

Dziamara v. Advocate Christ Medical Center highlights the deadly consequences of inadequate medical care. Our experienced personal injury attorneys fought vigorously in this case to allow our client and other MRSA victims access to hospital records that support their malpractice claims. The family of Zigmund Dziamara came to Pintas & Mullins to investigate and prosecute a medical malpractice case against the hospital for the serious injury that Mr. Dziamara suffered. Dziamara and another patient, Joseph Zangara, contracted MRSA during their hospital stay at Advocate Christ Medical Center in 2005. Tragically,, Dziamara died and Zangara suffered permanent injury.

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FDA Approves New Hip Replacement System, Demands More DePuy Defective Hip Research

June 23, 2011

Illinois medical device lawyers at Pintas & Mullins have long questioned the safety of metal- on- metal hip implants. Our clients have suffered debilitating consequences from defective hip replacement systems and continue to experience serious hip implant complications. We are cautious about the first ceramic metal-on-metal total hip replacement system approved by the FDA on June 13, 2011. This system is similar to DePuy's recalled ASR hip systems, which released toxic metal particles into patients' bodies. The FDA recently ordered DePuy and 20 other hip implant manufacturers to conduct more research on the side-effects patients are experiencing, further raising concerns about the dangers of these devices.

The newly approved hip implant system combines a ceramic ball with a metal socket. A two-year clinical trial found no difference between patients implanted with the ceramic-on-metal system and patients implanted with a metal-on-metal system. As the Wall Street Journal reports, DePuy Orthopedics must conduct post-market studies to monitor the side effects that patients experience. The FDA is primarily concerned with early failure rates and complications that lead to increased metal concentrations in the blood. These dangerous health effects led DePuy Orthopedics to recall more than 100,000 metal-on-metal hip implants in August of 2010. Independent studies show that as many as 49 percent of defective DePuy hips failed, causing patients severe pain and forcing many of them to undergo expensive corrective surgeries. As the metal-on-metal hip implants deteriorated, they shed metallic ions into the surrounding tissue and bloodstream, leading to problems ranging from deafness to heart failure.

Depuy hip manufacturer Johnson & Johnson faces more than 1,000 Depuy hip lawsuits, including a recently filed Illinois suit by a hip recall victim who suffered from dangerous levels of chromium in his bloodstream and was forced to undergo a second hip implant operation. Like thousands of DePuy hip victims around the country, he reasonably relied on the advice of his doctors and experienced life-changing complications. Our Chicago hip implant lawyers hope that the latest ceramic hip implant device can avoid causing patients similar health complications, but only time will tell whether problems will arise.

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Government Report Reveals Overuse of Double CT Scans at Illinois Hospitals That Expose Patients to Dangerous Radiation Levels

June 22, 2011

A troubling new government report first published in the New York Times shows that Illinois physicians are exposing patients to unnecessary chest scans that generate more revenue for hospitals and radiologists. The national report on medical imaging practices is the first of its kind, and it reveals some startling information about the overuse of repeated scans. Although experts say almost all chest problems can be detected with a single CT scan, hospitals are increasingly using double scans that subject patients to higher levels of radiation. Illinois hospital patients are particularly at risk, because Illinois physicians exceeded the national average, providing twice as many double CT scans as other hospitals around the country.

Edward Hospital in Naperville, Illinois, is one of the hospitals cited in the Hospital Compare report for overusing powerful CT scans and needlessly subjecting patients to dangerous radiation levels. In 2008, 70 percent of hospital patients received two CT scans instead of one, compared to just 5 percent nationally. This imaging practice is extremely harmful, because double radiology scans expose patients to 700 times more potentially cancer-causing radiation than a single chest x-ray.

Our Chicago medical malpractice lawyers understand that Edward Hospital officials are taking a closer look at CT policies and procedures, but major changes are not likely to happen. CT chest scans cost more than conventional x-rays, so hospitals that perform more double CT scans earn more money. A double CT scan on a Medicare patient costs just over $400, compared to $245 for a conventional scan without contrast dye. Patients are responsible for paying a third of the cost. Unfortunately, Medicare does not restrict the use of double scans or penalize hospitals who overuse them. Our medical malpractice attorneys are concerned with a medical imaging practice that is subjecting patients to double doses of radiation and adding millions of dollars in healthcare costs.

The overuse of double CT chest scans is clearly a problem in Illinois, and it is also a subject of growing concern nationwide. According to the government report, about 78,000 patients received double scans in 2008. This figure does not include patients with private insurance, no insurance, or Medicaid, which drives up the number even more.

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Loud Operating Rooms Put Patients at Greater Risk for Surgical Site Infections

June 20, 2011

When medical mistakes are made during surgery, innocent patients suffer devastating consequences and are often forced to undergo additional, painful procedures to correct the errors. Our Illinois medical malpractice lawyers recently learned of a new study confirming that too much noise in the operating room contributes to an increased number of preventable medical mistakes. This study, performed by Healthday, shows that noisy operation rooms pose a significant threat to patient safety and negatively impact surgical outcomes.

In the Healthday study, researchers revealed that patients exposed to an increased noise levels during surgery are at greater risk for surgical site infections. Surgical site infections occur after the surgery is performed and often require additional surgeries to treat. Signs of a surgical site infection include redness and pain around the surgery area, surgical wound drainage, and fever. These infections lead to longer and more expensive hospital stays. As one doctor explained, patients suffering from a surgical site infection spend up to 13 days longer in the hospital, tripling the cost of surgery. The results of this groundbreaking study will be published in the July issue of the British Journal of Surgery.

In the healthcare setting, telephones, cell phones, conversations between surgical staff, equipment, and music played to relax surgeons and their staff all contribute to the noise level. In large Illinois hospitals, the risk for noise is even greater because more staff and equipment are present. Noise is linked to an increased number of surgical site infections because it drowns out patient monitor alarms and creates dangerous communication barriers. In a loud operating room, medical professionals are likely to mistake similar-sounding medication names or hear incorrect medication doses. Unnecessary noise is extremely distracting and stressful when surgeons are performing a complicated medical procedure.

In addition to creating communication barriers that negatively impact patient health, noise can directly harm patients, causing elevated blood pressure and increased heart rates. Post surgery, patients exposed to extreme noise levels often require more medications and continue to show signs of distress, recalling staff conversations and other noises during recovery.


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Illinois Doctors Are Not Being Disciplined for Medical Malpractice and Other Dangerous Violations

June 17, 2011

A new survey shows that state medical boards are not doing enough to discipline Illinois doctors whose medical malpractice violations pose an immediate threat to public health. Medical malpractice lawyers at Pintas & Mullins Law Firm understand that Illinois hospital patients place a great deal of trust in their doctors and they deserve protection from substandard medical care. More action needs to be taken to increase the rate of discipline for offending doctors who continue to practice medicine even after they have committed serious violations.

The consumer advocacy group Public Citizen recently found that the rate at which state medical boards discipline doctors has significantly declined over the last decade. In Illinois, the doctor disciplinary rate dropped for the first time in six years. Illinois now ranks 20th in the nation for disciplining doctors who have committed medical malpractice. This suggests a failure on the part of state medical boards to protect patients from preventable medical mistakes. The Illinois Department of Financial and Professional Regulation has taken several steps to improve patient safety, but the latest data indicates that more still needs to be done. The department has attempted to streamline medical disciplinary procedures by immediately requesting medical records when a violation is committed, even before an initial hospital investigation is completed.

Regulators have also tried to act more swiftly to discipline doctors who have been disciplined in other states. But these measures do not go far enough to make Illinois health care safe. Physicians are not being adequately suspended for behavior that poses a threat to patient safety and dangerous doctors are being allowed to maintain their clinical privileges to the detriment of the public. In Illinois, nearly 69 percent of negligent doctors who were disciplined by hospitals were not disciplined by the state. As a result, these doctors continued to hold a license to practice, endangering thousands of hospital patients in our area. One Illinois doctor permanently lost his clinical privileges after accumulating 10 medical malpractice reports. The doctor's errors included failing to diagnose and failing to identify fetal distress, which led one patient to become a quadriplegic due to a brain injury. Yet, in spite of these serious deviations of physician behavior, Illinois failed to take licensing action against the doctor.

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Medical Malpractice Payments in Illinois and Across the Nation Drop to All-Time Lows

June 16, 2011

A new study shows that medical malpractice lawsuit payments in Illinois and across the country are at their lowest level on record. This drop is largely due to the efforts of lawmakers who are making it more difficult for malpractice victims to recover for their injuries. Legislative efforts such as the Health Act of 2011 grant virtual liability to the healthcare industry and restrict the ability of injured patients to file suit. Medical malpractice attorneys at Pintas & Mullins Law Firm find it troubling that this decline in litigation has not been matched by a reduction in medical errors. While innocent victims of medical negligence are increasingly without recourse for their injuries, the healthcare system is still plagued by medical mistakes that kill hundreds of thousands of people every year. Negligent doctors and hospitals are not being held accountable for preventable harm, and patients are suffering without any means of compensation.

According to Public Citizen, inflation-adjusted data for 2010 shows that malpractice payments fell to their lowest dollar value since 1998. Meanwhile, health care spending rose 90 percent. The study also showed that malpractice payments accounted for a mere one-thirteenth of one percent of national health costs. Most of the awards that were granted went to victims of serious, permanent injuries or the families of victims who suffered fatal injuries.

Interestingly enough, while medical malpractice premiums and claims are at historic lows, insurance industry profits are skyrocketing. Prices have not dropped in line with malpractice claims, and the insurance industry is reaping significant benefits. This shows that money is being taken away from innocent patients and lining the pockets of medical malpractice insurers.

Since only a fraction of medical malpractice victims in our area and nationwide are able to file suit against negligent health care professionals, there is little incentive to eliminate preventable medical mistakes. The Institute for Healthcare Improvement estimates that medical harm occurs 15 million times a year. This includes approximately 200,000 deaths caused by preventable medical errors. Some of the most common mistakes are surgical errors, hospital-acquired infections, and operations done on the wrong site of a patient.

These errors do more than just compromise patient safety, they are also extremely costly. Adverse medical errors cost Medicare up to $4.4 billion a year. This puts a heavy burden on taxpayers who are being forced to pay a hefty price for the negligence of health care professionals. We have worked with many malpractice victims and their families whose lives have been forever changed by medical negligence. We know that litigation is necessary to prevent patients from being injured. Malpractice suits motivate unsafe hospitals to take better care of patients, and allow innocent victims to be compensated for their pain and suffering. If doctors are not held accountable for committing malpractice, medical mistakes will continue to destroy the lives of patients and their families.


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Federal Health Act Victimizes Innocent Patients Harmed by Medical Malpractice

June 14, 2011

Chicago medical malpractice attorneys at Pintas & Mullins Law Firm said today that federal legislation involving non-economic damage caps violates the legal rights of patients who have been injured by medical negligence. The HEALTH Act of 2011, or H.R.5, further victimizes those who have been injured by inadequate medical care by limiting the amount of recovery that they can seek.

On May 12, 2011, lawmakers delivered a striking blow to innocent victims of medical negligence by advancing the HEALTH act through Congress. The House Energy and Commerce Committee voted 30-20 to approve this dangerous piece of legislation that places an arbitrary $250,000 cap on non-economic damages in any personal injury or wrongful death lawsuit. The broad scope of this bill is troubling because it extends to victims of nursing home abuse and those harmed by defective drugs or medical devices. It also shortens the statute of limitations and eliminates joint and several liability.

We believe that the law should provide protection for injured patients and their families who have been injured from defective drugs and negligent medical professionals. The Institute of Medicine estimates that 98,000 patients die every year as a result of preventable medical mistakes. The health care industry needs to be held accountable in order to protect patient safety and deter future injuries.

Consider the case of Lebron v. Gottlieb Memorial Hospital, where the Illinois Supreme Court struck down a similar medical malpractice cap in February 2010. The Chicago Tribune reports that the case involved a baby who was born with permanent injuries because the hospital failed to perform a timely emergency cesarean section when problems developed at birth. The injuries that resulted from the hospital's malpractice included cerebral palsy, cognitive impairment, and severe brain damage. The court struck down a state statute that limited recovery to $1.5 million, on the grounds that it was unconstitutional. The court reasoned that the damage limitation unlawfully infringed on the authority of the jury to determine an appropriate remedy.

Although Lebron was decided by an Illinois court, the principles of justice underlying this case apply across the nation. Doctors and hospitals argue that non-economic damages need to be limited in medical malpractice cases in order to reduce insurance rates. Our experience in medical malpractice law has shown that the insurance industry is to blame for driving insurance premiums, not large damage awards. Medical malpractice insurance premiums constitute a relatively small portion of overall health care costs. And a recent study by the Congressional Budget Office shows that a national cap on non-economic damages would only decrease total health care spending by 0.4%. A damage cap would actually increase the burden on taxpayers because injured patients will be forced to turn to Medicaid and Medicare for compensation. If legislators want to keep lower insurance rates, they should pass insurance reforms that introduce more competition into the market rather than unnecessarily focusing on tort reforms.

Another baseless argument that advocates of the HEALTH Act assert is that a damage cap will prevent quality physicians from moving to other states that offer lower medical liability costs. But Illinois is a clear example that even specialists like gynecologists and neurosurgeons who face the highest malpractice insurance rates are not in short supply. In fact, the number of Illinois physicians and specialists has steadily increased every year since the 1960s, outpacing the growth of doctors in more than a dozen neighboring states.

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Preventable Wrong-Site Surgeries Continue to be a Serious Medical Malpractice Problem

June 13, 2011

Wrong-site surgery is a horrific type of medical negligence in which surgery is performed on the wrong patient, the wrong side of the patient's body, or where the wrong surgical equipment is used. These surgical errors are devastating for the patient and the entire surgical team. The sad part is that these serious medical mistakes are completely preventable. Following simple safety procedures make the difference between the life and death of a patient. Unfortunately, negligent medical professionals are overlooking the smallest steps resulting in serious harm. According to new data by the Joint Commission on Accreditation of Hospitals, wrong-site surgeries are the second most frequently reported adverse event. The scope of these problems are even larger than Illinois medical malpractice lawyers at Pintas & Mullins are aware of since many doctors fail to voluntary report these acts of medical negligence.

The Oregonian recently reported the tragic case of 4-year-old Jesse Matlock, who underwent surgery to correct his wandering right eye. Unfortunately, his doctors mistakenly operated on his healthy left eye. Like other wrong-site patients, Jesse will have to undergo several more difficult and expensive surgical procedures to correct this serious medical mistake. Because of the severe trauma that wrong-site patients often experience, these medical errors are considered a "never event" and are never supposed to happen in any hospital. Yet wrong-part, wrong-patient, and wrong-procedures continue to happen around the nation. A national study estimates that these preventable mistakes harm as many as 2,700 people a year.

Under the Adverse Healthcare Events Reporting Law in Illinois, hospitals are required to report wrong site surgeries, however this law has yet to be fully implemented. This law requires anywhere from $500,000 to $600,000 to enforce, which is unlikely to happen. National efforts by the Joint Commission have also failed to significantly reduce the frequency of wrong-site medical errors.

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Medicaid Refuses to Pay for Serious Medical Mistakes Caused by Negligent Doctors

June 10, 2011

It is an unfortunate reality in our nation's healthcare system that preventable medical errors kill hundreds of thousands of Americans every year. Our Illinois medical malpractice attorneys have seen far too many innocent patients suffer the devastating consequences of medical mistakes caused by negligent hospital employees. Now federal officials are stepping in to try and reduce the most serious medical errors, which are called "never events" because they are so shocking that they should never occur under any circumstances. On July 1, 2011, Medicaid will stop paying for more than two dozen "never events" in hospitals nationwide. The goal is to financially discourage doctors from committing careless medical mistakes resulting in catastrophic patient injuries.

Our medical negligence lawyers are encouraged by several aspects of this new rule. Not only does it prohibit states from reimbursing negligent health-care providers, it also expands the list of preventable medical conditions that Medicaid will not cover. Currently, 28 events are considered to be "never events," including operating on the wrong patient, performing the wrong procedure, or leaving a foreign object in a patient's body. These preventable mistakes lead to an alarming number of serious problems or death. The Institute of Medicine estimates that these errors kill nearly 100,000 people a year and severely injure thousands of others.

In addition to these grave mistakes, states will have the flexibility to add more injuries to the list of preventable medical The latest regulation is part of an ongoing effort by federal and state governments to improve poor patient hospital care. In 2007 Medicare instituted a similar regulation protecting the elderly patients. Also, private insurers have adopted policies that prohibit reimbursements for complications that should never occur in a hospital setting. In Illinois, one of the first states to create a "never event" law, hospitals must report and take corrective action for all medical mistakes. Unfortunately, simple, preventable mistakes continue to happen on a regular basis. The Joint Commission Center on Transforming Healthcare recently reported that at least 40 wrong site or wrong patient procedures happen every week. Even more disturbing is that fact that more than 60 percent of these "never" events lead to a fatal result. No patient is immune from harm.

Even a high-powered Chicago executive fell victim to a fatal medical error at the prestigious University of Chicago Medical Center. James Tyree, the Chicago Sun-Times CEO, died in April after doctors at the hospital removed his catheter incorrectly while treating him for pneumonia. An air bubble went into Tyree's bloodstream, leading to his wrongful death. This is a clear example of the type of gross negligence that is occurring in hospitals each and every day. Although penalizing hospitals for medical negligence is one way to improve patient safety, it still may not be enough to end this horrific epidemic of medical malpractice.

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