Articles Posted in Medical Transplant Malpractice

A 34-year-old patient, Sally Arbogast, underwent a vaginal delivery but experienced sharp abdominal pain and moderate bleeding right afterward.  She had delivered her last child by a Cesarean section. The obstetrician who cared for her performed a manual exploration and curettage procedure to rule out uterine scar rupture and later diagnosed uterine atony — a loss of tone in the muscles in the uterus.  It has been noted that 90% of all postpartum bleedings are associated with uterine atony, which is the failure of the uterine muscles to contract normally after the baby and placenta are delivered.

For an hour and a half, Arbogast remained hypotensive and tachycardic. Her blood work showed lower hemoglobin and hematocrit levels compared to before the baby was born.

While the doctors were looking into the patient’s hypotension, she coded.  After resuscitation measures and a blood transfusion, Arbogast received multiple units of packed blood cells and fresh frozen plasma over the next five hours.

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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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It was announced in June 2013 that Johnson & Johnson, the maker of many healthcare products, will discontinue the sale of its metal-on-metal hip replacement products.  Although these metal-on-metal hip replacement products have not been recalled by Johnson & Johnson, it claims that decreased sales are the reason it is being discontinued. The decrease in sales — almost a 90% drop since 2007 —  has been caused by questions about the safety and effectiveness of the hip replacement joint.

The Food and Drug Administration (FDA) had proposed a rule requiring manufacturers of metal-on-metal hip replacement products to follow an extensive safety process if they chose to continue selling the product. Johnson & Johnson did recall the DePuy ASR Acetabular System in August 2010 after reports of worldwide failings.

In addition, DePuy sold and marketed the Pinnacle Acetabular Cup System, which included inserts that held the replaced joint made of plastic, ceramic and metal. The health issue was related to the metal liner. 

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The journal of Science Translational Medicine published an article describing the surgical procedure developed at Northwestern Memorial Hospital regarding organ transplantation. The article, co-authored by Dr. Joseph Leventhal, a surgeon at Northwestern, said the new organ transplant procedure would help eliminate the need for numerous medications that individuals must take to prevent the body’s immune system from rejecting a new organ.

The reported study described the procedure in which a recipient’s immune system accepts a mismatched organ, even one with a high rate of rejection, from a donor who is unrelated. Those kinds of organ donors represent the majority of the roughly 28,000 organ transplants each year in the United States.

In traditional organ transplant procedures, recipients take medications for the rest of their lives to prevent the body’s immune system from rejecting the organ.

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Over the years, medical advances have led to countless innovative inventions that have saved many lives. However, not every medical innovation lives up to its expectations. The recall of DuPuy’s metal-on-metal hip joint is a perfect example of a medical device that failed to delivery as promised.

The first artificial hip joint was developed in the 1960s and was made of a metal ball placed in a plastic cup, which were meant to replicate the thigh bone and hip socket, respectively. Then, metal-on-metal hip implant devices were developed in response to studies showing that metal and plastic hip devices were leading to bone loss in some patients.

The medical community believed the medical device changes made to metal-on-metal hip implants would revolutionize the future of artificial hips. Not only would the newer design lead to less bone loss in patients, but by replacing plastic with metal, the belief was that the new medical device would last longer than the original metal and plastic version. Medical professionals viewed metal-on-metal hip devices as the final solution to hip implant patients’ problems.

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A recent New York Times article reported that a new study indicated that in recent years the Food and Drug Administration (FDA) has not rigorously studied or tested many of its approved medical devices before clearing them for sale. The study specifically assessed many medical devices which have been the subject of major recalls over the past few years, such as mechanical ventilators, hospital infusion pumps, and external heart defibrillators.

Diana Zuckerman and Paul Brown, both with The National Research Center for Women and Families, headed up the study along with cardiologist Steven Nissen, M.D. of the Cleveland Clinic. The study, published in The Archives of Internal Medicine, focused on those medical devices that have since been labeled as high risk for recalls between 2005 and 2009. It found that most, if not all, of the medical devices were cleared for public use by the FDA without being first being tested. The FDA and a trade group representing medical device manufacturers called The Archives of Internal Medicine study flawed.

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Prior to the 1980s, the risk of transmitting HIV through transplanted organs was fairly high, at a time when even blood transfusions put patients at risk for contracting the deadly virus. However, in 1985, HIV antibody testing became available, which enabled doctors and medical staff to test to see whether organs were infected with HIV. Therefore in today’s medical climate it is unlikely that an organ transplant recipient would receive organs infected with HIV.

However, in 2007, four Chicago patients were found to have transmitted HIV by way of their transplanted organs. While the transplant surgeries were done at three different Chicago Hospitals, each of the four patients received organs from the same organ donor. At the time of the transplant surgery the donor was not known to be infected with HIV. His organs passed the standard tests for HIV antibodies; however, those tests could not have detected HIV if the donor acquired the infection within a few weeks of his death.

Critics of the way these 2007 transplant surgeries were handled argue that a nucleic acid test could have detected the HIV infection earlier. However, the nucleic acid test was not approved by the FDA until 2009 and even today is not effective 100 percent of the time; too many false positives make the nucleic acid test unreliable as an universal screening tool.

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When analyzing cases for possible Illinois medical malpractice, sometimes the resulting injury is a reasonable outcome of the procedure and as such does not quality as medical malpractice. However, sometimes you encounter a medical malpractice lawsuit where not only was the resulting injury not a foreseeable outcome, but it could have easily been avoided.

Lauro Ortiz’s medical malpractice lawsuit is such a case where the resulting injury would not have occurred if not for medical negligence. The kidney transplant malpractice lawsuit resulted in a $6 million settlement from Rush University Medical Center.

Ortiz presented for a kidney transplant at Rush University Medical Center. The 39 year-old had been born with only one kidney and also suffered from diabetes. At the time Ortiz was on dialysis and was hoping that the kidney transplant would free him from the regular dialysis treatments and allow him to live a more normal life.

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