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medical device recall, medical product liability lawyerIn an executive summary of its Medical Device Recall Report, the FDA revealed that the annual number of recalls increased by a staggering 97 percent from 2003 to 2012. Over the past decade, the complexity of medical device recalls increased and 1,190 recalls were reported in 2012, almost double the amount in 2003. Manufacturers maintain product liability for devices they market and have a responsibility to the public to alert of any potential hazards.

The FDA categorizes recalls into one of three classes. Class II recalls reflected the most significant increase in the recall report with a reported 1,043 recalls in 2012, up from 460 a decade ago.

The largest single-day recall occurred last August when Customed, a surgical kit provider out of Puerto Rico, recalled 233 of its products due to sterility issues. Other medical device recalls, such as metal-on-metal hip implants, have led to thousands of patients being affected and billions of dollars in lawsuits against its manufacturers.

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Hurley McKenna & Mertz, P.C.Earlier this week, Hurley McKenna & Mertz, P.C. filed lawsuits against Chicago Presbytery on behalf of seven men sexually abused by Presbyterian minister Douglas Mason in the early ‘80s and ‘90s. The two separately-filed lawsuits follow an earlier lawsuit that was settled in 2007 with four accusers bringing sexual abuse claims against Mason. Church officials disclosed to the Chicago Tribune last year that the previously confidential settlement amount totaled $11 million.

The first lawsuit filed this past Wednesday details abuse occurring between the years of 1982 and 1986 when Mason, who died in 2004, was a pastor at the church the three plaintiffs, now in their 40s, attended. At the time, the Presbytery encouraged pastors to counsel young men in private, despite warnings of Mason’s pedophile behavior.

The second suit involves four men in their late 30s who were abused by Mason while they were members of San Marcos Youth Ministry. The molestation began in the ‘90s when the victims attended St. Gregory the Great High School. The pastor paid a part of each plaintiff’s school tuition and made regular visits. He also checked them out of school at least once a month with the purpose of sexually abusing them. School administrators, at the time, did not notify the parents that the students were being checked out.

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GM ignition switch, personal injury lawyer in ChicagoIn 2007, a Texas woman was charged with negligent homicide for losing control of her vehicle and crashing into a tree, which resulted in the death of her boyfriend. What was not revealed at the time of the case and her subsequent guilty plea was a long overdue admission by General Motors (GM), which finally came in November 2014, publicly linking the death of her boyfriend to an ignition switch defect in millions of its vehicles.

According to an article published by the The New York Times, GM had quietly conducted an internal review of the crash and ruled its vehicle to blame without alerting the woman or law enforcement. The woman’s Saturn Ion was one of the listed cars equipped with the defective part.

GM’s faulty ignition was known to cause loss of power brakes, power steering, and airbags. An estimated 35 deaths linked to this defect went unreported by GM for than a decade.

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transvaginal mesh, Illinois product liability lawyerWomen who suffer from stress urinary incontinence (SUI) or pelvic organ prolapse (POP) may be implanted with transvaginal mesh (TVM), a medical device that gives added support when weakened or damaged tissue is being repaired. According to statistics, up to 70,000 women have this medical device implanted each year, illustrating a reliance on TVM to correct certain medical problems.

However, the American Association for Justice reported the impact of dangerous medical devices such as these in 2013 and noted that there were early detections of problems linked to TVM even during its rising popularity in the early 2000s. TVM has been known to cause:

  • Bleeding;
  • Infection;
  • Pain;
  • Erosion or hardening of the device; and
  • Difficulty in removal of the device.

Additional surgeries are required to repair complications with mesh erosion and still do not solidify a guaranteed resolution to the adverse effects originally caused by TVM. These procedures mean costly hospital stays, prolonged medical care, and a diminished quality of life for a medical device that the FDA said did not necessarily improve post-surgical outcomes in many cases.

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nursing home care, Chicago nursing home negligence lawyersA law signed by Illinois Governor Pat Quinn went into effect at the first of the New Year to help protect the safety, care, and rights of senior citizens in the state. The law is designed to improve reporting procedures, investigations, and swifter resolutions for negligence and abuse of elders in nursing homes.

A National Center on Elder Abuse (NCEA) research brief reveals that over 50 percent of nursing home staff admitted to mistreating elder patients. Physical abuse was the highest reported type of abuse occurring in nursing homes and two-thirds of the incidents of mistreatment involved neglect. With research showing over 40 percent of people over the age of 65 will enter a nursing home before they die, these disturbing statistics are cause for high alert and concern among families.

Nursing home residents suffering neglect have been victim to:

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toy related injuries, Illinois product liability lawyerThe most active retail months are barely over and toy manufacturers have generated billions upon billions in revenue worldwide. The estimated cost for toy production is over two billion dollars in the United States alone as last reported in 2010. It is a booming industry that may be growing faster than safety officials can monitor.

Toys have evolved over time to include detailed parts and extra gadgets that require additional testing for their safety. They are packaged with age limit recommendations to keep babies and toddlers from choking on small pieces, but there are also unforeseen hazards in toys manufactured today which include:

  • Asbestos;
  • Carcinogens;
  • Lead; and
  • Product defectiveness.

The American Association for Justice reports a 54 percent increase of toy-related injuries from 1999-2008 ranging from choking to amputations to asphyxiation. The number of toys hitting the market largely outnumber the resources for inspection and safety tests available via the Consumer Product Safety Commission (CPSC).

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medical error rate, malpractice attorney in ChicagoMedical malpractice affects thousands of Americans every year due to hospital negligence or patients suffering from some type of preventable harm due to medical error. NPR referenced a Journal of Patient Safety study that concluded between 210,000 and 440,000 patient deaths occurred as a result of  preventable harm in hospitals, making it the third leading cause of death in America.

This number is more than double the 98,000 patients previously reported by the Institute of Medicine. When it comes to hospital safety, patients may be in harm’s way more often than they realize. The American Association for Justice points out more startling statistics that further emphasize a problem the nation continues to face. Its report concludes:

  • An estimated 40 wrong-site surgeries occur on a weekly basis;
  • Up to 1,500 medical sponges or surgical instruments are left inside patients every year; and
  • The same five percent of doctors are responsible for over half of all medical negligence cases.

These statistics prove that the problem is not being properly addressed. The consistent rate of medical error is cause for concern. Patients victim to medical negligence compromise not only their immediate health, but their future quality of life and financial stability. When patients must have corrective procedures or surgeries as a result of medical error, these costs cause undue hardship and health care providers need to be held accountable.

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car manufacturer safety issuesThe recent air bag recalls have affected millions of Americans who own vehicles that contain the faulty equipment. Only one car manufacturer to date has taken its recall nationwide, despite the demand of the National Highway Traffic Safety Administration for others to follow suit with repairs and the hundreds of injuries that have already been reported.

The American Association for Justice (AAJ) explored how this kind of passiveness is historically common among car manufacturers. In a published report released in June 2014, the AAJ emphasizes failure on the part of these companies to take responsibility unless required to do so in court.

Among its long list of examples the AAJ names the following defective car parts corrected only after manufacturers have faced litigation:

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infant medical device recall, Chicago product liability attorneyPhilips Healthcare initially recalled its Gel-E Donut and Squishon 2 medical devices in May 2014 after visible mold was detected on the outer surface of the products. This recall was for devices distributed from July 2012 to December 2013.

As of October 2014, the Food and Drug Administration (FDA) reported a Class I recall issued by the same manufacturing company for the same devices. These gel-filled products are used under supervision in hospitals to support an infant’s head and body. The following models have been recalled:

  • Gel-E Donut 92025-A;
  • Gel-E Donut 92025-B;
  • Gel-E Donut 92025-C; and
  • Squishon 2 91033-2.

The second recall included products manufactured from July 2012 through to August 2014. The defective devices prompted 12 new complaints of visible mold within just four months of the initial recall. Cladosporium and Penicillium Fungi were two of the molds identified, which can cause:

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colonoscopy screenings, illinois medical malpractice lawyerAccording to the American Cancer Society, colorectal cancer ranks third as the most commonly diagnosed cancer in the United States. A colonoscopy allows a doctor to examine the inside of the colon to detect polyps, diseases, or other abnormal results. The recommended time interval between procedures is 10 years beginning at the age of 50.

It is the responsibility of medical providers to ensure their patients are informed of the need for these types of health screenings in order to adhere to the standard of care. A recent report published by The Boston Globe refers to an Illinois gastroenterologist on the board of the American Gastroenterological Association who says there are substantiated reasons for people to have their screenings performed earlier than the recommended timeline, such as:

  • Patients may be under the guidance of their primary doctor who has recommended an earlier follow-up;
  • Patients may not have properly prepared for the screening the first time, which means a possibly skewed view of the entire colon;  and
  • Patients may fear history of colon cancer in their family.

The director of endoscopy from Boston Medical Center supports this by saying that the bigger issue is people are not undergoing these important health screenings. An estimated 40 percent of Americans over the age of 50 have not been screened for colon cancer in any way.

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Chicago medical device recall lawyerPatients rely on hospitals to ensure that safety protocols and education for medical staff are current and privy to any changes regarding medical device recalls. For over 45 years, ECRI has helped in this effort by focusing on improved patient care by studying the effectiveness of medical products, procedures, and processes. Based on an article published by Modern Healthcare, ECRI experts reveal certain hospitals are failing to update their medical device recall programs to meet today’s standards.

Over 1,000 medical device recalls were reported by the Food and Drug Administration in 2012, a figure almost doubling the number reported nearly a decade previous. The number and complexity of recalls have increased over the years, which carries concerns regarding hospital efficiency in tracking its defective products.

A Medical Equipment Management Plan issued by the Joint Commission has issued standards for hospitals to:

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FDA product recalls, Chicago product liability lawyerThe FDA has instituted a final guidance document in order for companies to clearly distinguish a recall from a market withdrawal. Part of the draft version of the new guidance called for reporting of any enhancement of a product, a factor critical when determining potential health risks and dangers to consumers.

Many in the medical device industry were concerned about additional paperwork rather than focusing on the importance of detailed documentation for the benefits of safety. Certain devices have been approved for market that have represented an upgrade, innovation, or correction to a previous device and have resulted in recalls.

It is a manufacturer’s responsibility to find the original source of the problem and not look at a defect as an isolated incident. One of the main intentions of the new guidance is to clarify when a change to a device constitutes a product recall. One example states, “a change to a marketed device to address false or misleading labeling or other labeling violations would generally constitute a medical device recall.”

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Chicago airbag recall lawyerHonda has become the first and only automotive company thus far to meet the demand from the National Highway Traffic Safety Administration (NHTSA) to repair vehicles nationwide after the recent recall of Takata airbags.

Previously, the recall for airbags were limited to high-humidity states only. An increase in humidity was found to cause the airbags to inflate too fast, leading to an explosion, which caused shrapnel to spew out.

According to a report, Honda is expanding its repairs to over 2.6 million for a total of 5.4 million vehicles. The following models are included in this expansion:

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laproscopic surgery risk for women, FDA morcellator recallA hysterectomy ranks second behind a cesarean section ("C-section") as the most frequently performed medical procedure women undergo. In fact, the National Women’s Health Network lists statistics reporting an estimated 600,000 hysterectomies performed every year.  It is common for laparoscopic power morcellators to be used during this type of surgery as well as for myomectomies (removal of uterine fibroids). Unfortunately, nearly 1 in 350 women who undergo one of these two surgeries has unsuspected uterine cancerous tissue.

The use of laparoscopic power morcellators during either of these procedures puts women at risk of having previously undetected cancerous cells spread throughout the abdomen and pelvis. The FDA recently updated its safety alert regarding these medical devices and warns against their use during a hysterectomy or myomectomy in the majority of women. The administration emphasizes that laparoscopic power morcellators should not be used in women with suspected or known uterine cancer.

The FDA has also issued a guidance document with a manufacturer recommendation to update product labeling to include specific safety information through a boxed warning. The boxed warning advises that laparoscopic power morcellators should not be used:

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DUI accident victims, personal injury lawyer in ChicagoAccording to statistics from the Illinois Secretary of State, nearly 10,000 drivers were arrested for DUI in Cook County in 2012, leaving thousands of victims vulnerable to motor vehicle accident injuries and fatalities.

In recent weeks, the Chicago Tribune reported a man was charged with leaving the scene of an accident that left a woman trapped inside her vehicle upside down. Later the woman was taken to the hospital where her left hand had to be amputated as a result of the collision.

Police on the scene were able to capture the license plate number of the driver responsible and he was taken in and held on $100,000 bond. Investigation into the case had not yet reported alcohol-related driving as a factor, but regardless of a DUI charge, leaving the scene of an accident resulting in personal injury or death is a Class 4 felony in Illinois. It carries a possible sentence of jail time of up to three years.

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nursing home abuse, Chicago nursing home neglect attorneyTransitioning a family member into a nursing home is a decision that takes time, research, and careful thought before selecting a placement. The chosen facility needs to be safe with resources and staff available to create a suitable living environment. These expectations of proper security have been under scrutiny more recently as new research from the Gerontological Society of America has shown that nearly one in five people living in a nursing home is a victim of abuse.

Hostile and unsafe incidents among elderly residents, including physical assault, are occurring at such a common rate at long-term care facilities that staff members almost seem unaware of the growing problem. This negligence is leading to injuries, such as bruises, lacerations, and fractures, putting residents in danger in their own home.

Lead author of this latest study, Karl Pillemer, a professor at Weill Cornell Medical College and Cornell University, attributes part of the problem to crowded conditions and lack of adequate staff for the number of residents needing care. In order to shed light on this dangerous reality of nursing home abuse, he says data collection of the incidents is just the beginning.

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America medical errors, Chicago medical malpractice lawyerThe risk of medical errors is a concern for a majority of patients in the United States. According to a Wolters Kluwer Health survey conducted in 2012, 73 percent of patients expressed concern about potential medical errors. Nearly 30 percent of those surveyed reported either they or a family member had been a victim of a medical mistake.

Common causes of negligent medical care include:

  • Miscommunication among hospital staff;
  • Doctors, nurses and other medical personnel being in a hurry;
  • Staff fatigue; and
  • Staffing shortages at hospital.

People seeking medical care should feel confidence in doctors and hospitals and their capabilities to provide care in the patient’s best interest. This occurrence of medical misconduct is not acceptable and it is causing Americans to delay necessary medical procedures.  The survey lists almost one in five people rescheduling a procedure to avoid the weekend or end of the week, so that the doctor may be better rested.

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Graco stroller recall, Chicago product liability lawyerChild safety is the number one priority for all parents. They are dependent on products that have been adequately tested and approved for use. When manufacturers fail to meet these requirements, they must be held responsible for damages. Graco, a popular baby product company, recently had almost five million of its baby strollers recalled due to the threat they pose to infants.

This recall affects 11 models of Graco strollers from over the past decade. An investigation by ABC News has revealed that there have been at least 11 cases of finger injuries, including fingertip amputations and lacerations, reported to Graco so far. Millions of families remain in danger due to the availability of these strollers.

It is illegal to sell recalled products. However, baby merchandise, such as these defective strollers, are easily obtainable for resale. Graco has informed stroller owners to contact the company for a free repair kit, but where does that leave families in the meantime? They have a product unsafe for use and in some cases, they may not even be aware of the risks.

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missed diagnoses in Chicago, Illinois medical malpractice attorneyThere have been several studies published in recent years that shine light on aspects of health care that are considered increasingly unsafe. In particular, there is concern about the level of care performed by medical providers on the weekend compared to on a weekday.

A study published in the Journal of Pediatric Surgery concluded that pediatric surgical patients who underwent common urgent operations during the weekend faced a higher risk of mortality, blood transfusion, and surgical complications.  Another Johns Hopkins Medicine study revealed the same type of “weekend effect” for head trauma victims. Its review of more than 38,000 patient records reflected a higher mortality rate in older adult patients who sustain head trauma injuries over a weekend than those hospitalized on a weekday.

These findings have been previously documented in cases of heart attack and stroke, but now have been linked to head trauma care as well. Researchers surmise that there is not a medical explanation for these statistics, but rather a hospital operational insufficiency due to reduced staffing and lack of accessibility to specialists during the weekend.

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medical malpractice lawsuits, Chicago medical negligence lawyerWhen the U.S. Department of Justice (DOJ) ranked the consequences of medical malpractice, the DOJ listed death as the most common injury in medical malpractice cases, followed by injuries such as:
  • Organ damage/infection;
  • Brain or head injury;
  • Chronic pain; and
  • Back/neck injury.

The Institute of Medicine estimates that recorded deaths due to preventable medical errors every year exceeds the number of deaths linked to breast cancer, AIDS, and motor vehicle accidents. However, the amount of filed medical malpractice cases are significantly less.

A law review article published by the Northern Illinois University College of Law explores and debunks four myths regarding medical malpractice lawsuits:

  • Plaintiffs file frivolous medical negligence lawsuits;
  • Premiums are on the rise due to skyrocketing jury awards;
  • Access to healthcare is restricted; and
  • Doctors fear negligence liability.

Medical errors occur at a rate that is not matched by statistics of court-filed claims. The first of the listed myths is debunked by research that states that the majority of medical errors do not result in a lawsuit. The second myth is contradicted by research which shows that most victims of medical malpractice are never compensated for their injuries.

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