It has been reported that the medical devices that pose the greatest safety risk to patients, including the metal-on-metal hip implants, are allowed into the marketplace without sufficient evaluation for safety and effectiveness.

According to a recent New England Journal of Medicine article, it was found that previously cleared medical devices, including  the metal-on-metal hip implant, were cleared without being fully assessed for safety and effectiveness.

The medical device amendments of 1976 created three classes of devices:  Class I included low-risk devices like a toothbrush; Class II devices were of moderate-risk like an infusion pump; and a Class III medical device would be one that would put a patient at high risk, such as the metal-on-metal hip implants.

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South Korean immigrant Young Bahng, 60, was admitted to the University of Chicago Hospital on April 18, 2006. He was there to undergo a live-donor liver transplant from his son. Bahng was self-employed in the conveyor system business. He was suffering from end stage liver disease as a result of having hepatitis B since 1990. 

On April 19, 2006 in the early morning hours, Bahng fell in his hospital room while attempting to walk to the urinal. He struck his head in the fall and sustained a massive subdural hematoma and intracranial bleed, which required immediate surgery.

By the time the surgery was under way, Bahng had sustained profound brain damage and was placed on life support immediately following a craniectomy. He died as a result of his brain trauma on April 25, 2006 and was survived by his wife and children.

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Kody Myrick, 17, suddenly slumped over at his job and had difficulty speaking. He was brought to Bakersfield Memorial Hospital’s emergency department. A nurse there made note of a possible stroke. Then an emergency room physician diagnosed profound neurological deficits and ordered a brain CT scan. The scan results showed an abnormality.

Four hours after the onset of symptoms, Kody was seen by a hospitalist to arrange admission to the hospital. The doctor called in admission orders and included a diagnosis of possible stroke. However, Kody was not seen by a doctor for the remainder of that night.

Kody’s neurological condition worsened suddenly the next morning. He was later diagnosed as having an ischemic stroke, which resulted in significant damage to his brain stem. Kody now suffers incomplete tetraplegia and requires 24-hour care.

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A Cook County jury has decided that Northwestern Memorial Hospital was not negligent after a back surgery on 83-year-old JoAnn Smith went wrong. 

On Aug. 5, 2010, Smith underwent an L4-5 microendoscopic foraminotomy and discectomy at Northwestern Memorial Hospital for management of her back pain. After the surgery, she was diagnosed with multiple deep vein thromboses, pulmonary embolism and a blood clot in her right internal jugular vein. Heparin was given to help with the clotting issue.

On Aug. 8, 2010, Smith developed abnormal neurological signs and symptoms. An MRI revealed internal bleeding and cord compression in the cervical, thoracic and lumbar spine. An emergency decompression surgery was done.

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Danute Paulaviciene, 57, came to the office of the defendant internist, Dr. Edmund Vizinas, on Dec. 27, 2008 complaining of fever, shortness of breath and poor sleep. She had recently visited the caves in Missouri. On examination, she was noted to have a fever of 100.5 degrees, pulse of 110, respirations of 16 and 94 percent oxygen saturation level.

Dr. Vizinas ordered a chest x-ray, complete blood count and metabolic profile. The patient returned to Dr. Vizinas two days later and told him she was feeling better and had no shortness of breath on exertion. Her temperature was normal. Dr. Vizinas told her that her chest x-ray revealed extensive bilateral infiltrates, her complete blood count was essentially normal with a normal white count and a slight rise in neutrophils and her metabolic profile showed slightly decreased albumin, elevated sedimentation rate, slightly decreased total cholesterol and slightly elevated liver function.

Dr. Vizinas started her on Avelox, an antibiotic given for community acquired pneumonia. On Dec. 31, Paulaviciene’s daughter-in-law checked on her at 4 a.m. and found that she had a fever, but by 6 a.m., it had come down. At 8 a.m. she was coughing but not gasping or having difficulty breathing. However, by 9 a.m., she was extremely short of breath, gasping and unable to speak. She was rushed to Edward Hospital in Naperville, Ill., with severe shortness of breath and 82 percent oxygen saturation levels while on oxygen. She was sent to the ICU at the hospital and placed on a ventilator. Her condition never improved, and she died 11 days later survived by her adult son and a daughter who lives in Lithuania.

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Janelle Jones, 57, underwent a cardiac catherization at Medical Center of Southeast Texas. Jones complained of chest pain before she was discharged. She underwent some testing. Jones was told to follow up with her treating physician in one week or go to the hospital if her pain increased. 

Four days after she was discharged from the hospital, Jones met with her treating cardiologist and complained of shortness of breath, chest pain and increased heart rate. The doctor diagnosed a stomach issue and prescribed medicine.

Four days after that, Jones went to the emergency room at the hospital, where she later died of a fatal heart attack. She was survived by her husband and four children. 

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The U.S. Court of Appeals for the Seventh Circuit in Chicago has affirmed a district court’s order dismissing a medical negligence case brought against the Department of Veteran Affairs.

Jerome Augutis underwent reconstructive surgery on his right foot at Illinois’ Edward Hines Jr. Veterans Administration Hospital in July 2006. Because of complications during the surgery, the doctors amputated Augutis’s right leg below the knee on Sept. 22, 2006. 

Augutis maintained that the amputation was the result of negligent treatment. He filed an administrative complaint with the Department of Veteran Affairs in July 2006. His claim was denied in September 2010 and Augutis filed a request for reconsideration in March 2011. 

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On May 27, 2005, Dennis Swallow  came to the office of the defendant internist, Dr. Bryan Moline, for preoperative clearance for an upcoming orthopedic hip surgery. Swallow was 51 years old at the time and had a history of a neurological event in 1996. He was taking 325 mg of aspirin daily as a stroke preventative measure since that time. Swallow also had a history of severe migraine headaches for which he was receiving treatment from the Diamond Headache Clinic. 

Dr. Moline told Swallow to stop taking aspirin before the planned surgery and cleared him for the surgery, which was done by Dr. Mitchell Sheinkop at Rush Oak Park Hospital on June 15, 2005.

After the hip surgery, Swallow suffered a severe embolic stroke the following day, June 16, 2005, which caused severe disability with inability to talk or care for himself.  He died on Sept. 11, 2009.

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There are more than 2,000 cases filed in the Actos Multidistrict Litigation (MDL) pending before a United States District Court judge in the Western District of Louisiana. The Actos MDL bellwether cases involve identifying two of the best plaintiff cases and a third case selected by the defendant Takeda Pharmaceuticals. Takeda is the manufacturer of Actos, which has been associated with bladder cancer. Actos is in a class of insulin-sensitizing drugs known as Thiazolidinediones, which was approved to treat Type II diabetes.

The Western District of Louisiana bellwether trials are scheduled to start Jan. 27, 2014;  a second will begin in April 2014.

There are about 3,000 cases pending in the Circuit Court of Cook County, Ill.  The bellwether process here is under way.  The cases in Chicago’s Circuit Court are being handled by Judge Deborah Dooling. 

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Nereida Sepulveda was an 80-year-old retiree who underwent a bilateral knee replacement surgery at Advocate Illinois Masonic Medical Center on Nov. 9, 2009. The surgery was performed by an orthopedic surgeon, Dr. David Hoffman. Sepulveda suffered an artery occlusion in the right leg as a complication of the procedure. The defendant, Dr. Iyer, was called for a vascular consult later that afternoon. 

Because Sepulveda complained of chest pain, the hospitalist would not permit any additional surgery on the right leg until he had ruled out a heart attack. Dr. Iyer then had to wait to obtain surgical clearance.

The next afternoon, Nov. 10, 2009, Dr. Iyer received medical clearance to do the surgery but decided to postpone the vascular surgery until Nov. 13 because the patient’s condition had improved.The surgery was elective and Sepulveda had just eaten.  However, it was noted that on Nov. 11, 2009, Sepulveda’s condition had worsened, and she suffered a foot drop. Dr. Iyer performed an 8-hour revascularization procedure to repair the right popliteal artery that day. 

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