Articles Posted in Medical Transplant Malpractice

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The number of Americans and Chicagoans suffering from chronic kidney disease has drastically increased in recent years, driven by high rates of hypertension and diabetes. Likewise the reported cases of patients with end stage renal disease has risen, which can only be treated with dialysis or a kidney transplant. And despite improvements in dialysis technology and the possibility of transplant errors, the transplant remains the most effective and preferred treatment due to its better long term outcomes and quality of life.

According to the National Kidney Foundation, almost 80,000 Americans are currently on a waiting list for a new kidney. However, not everyone is considered a prime candidate for transplant surgery.

Consider the case of a stunned patient suffering from kidney failure who was informed by a group of physicians that her mother’s attempts to donate one of her own kidneys was out of the question. Like 3 out of 10 kidney-transplant candidates, this patient had tested positive on a panel reactive antibody (PRA) blood test, which revealed that the patient had high levels of PRAs, or proteins that attack foreign tissue. So even though her mother’s kidney would have been a good match based on its blood type and tissue, the patient’s body would have attacked it.

Until recently patients with high PRA levels had little chance of success for transplantation and were oftentimes forced to remain on dialysis. In fact, as recently as 10 years ago a kidney transplant was absolutely contradicted for patients with high PRA levels. Increased PRA levels can be caused by blood transfusions, pregnancy, or a previous transplant.

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Medtronic, the maker of Sprint Fidelis, a heart defibrillator cable, has taken its product off the market. But the problem with it still being used by some 150,000 people around Illinois and the country has resulted in several deaths in removing the defective cable.

Medtronic estimates that the cable has failed in a little more than 5% of patients after 45 months of being implanted. But as a preventive measure, some patients with working cables are having them removed.

Already 4 patients have died during extractions. It is feared that the toll could quickly rise if such procedures are not performed by skilled doctors at medical centers that have performed many of these operations.

“I think we are seeing the tip of the iceberg,” said Dr. Charles J. Love, a cardiologist at who specializes in cable extractions. For many patients around Illinois, the big issue is who is skilled enough to remove these defective heart implants. It is thought that some surgeons removing the cables do not have the required skill level.

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A California organ transplant surgeon was acquitted in a criminal action that alleged he had intentionally harmed a donor by prescribing excessive amounts of drugs in order to speed up the extraction of the patient’s kidney and liver. The surgeon’s attorney argued that the doctor had flown in from his San Francisco offices in order to retrieve the organs and had prescribed medications in attempts to ease the patient’s suffering after other doctors had failed to perform their duties.

Dr. Roozrokh, the transplant surgeon, was found not guilty of a felony count of abuse of a dependent adult. Two other charges for administering harmful substances and unlawful prescription medicines had both been dropped last spring.

This San Francisco jury trial drew attention to the medical and ethical issues surrounding the complexities of organ transplantation. Typically medical transplant cases are medical malpractice lawsuits, not criminal cases. In Illinois, these cases typically involve some sort of medical transplant error, whether infection or diseased donated organs. This is believed to be the first instance where a doctor had been accused of such criminal actions.

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The Illinois Appellate Court affirmed a Cook County jury’s $2.7 million verdict for institutional negligence against Loyola Medical Center in a Chicago transplant error case. Longnecker v. Loyola University Medical Center, 2008 WL 2550686 (1st Dist., June 25).

The issue in Longnecker was whether Loyola University Medical Center was negligent when they transplanted the decedent with a severely hypertrophic replacement heart. The harvested heart was severely diseased and was only considered for transplantation because the harvesting doctors did not examine it. Despite the diseased state of the new heart, the decedent’s heart surgeon went ahead with the transplant. The decedent died without ever waking up from the surgery.

Most times we think of medical negligence cases as those caused by doctors or medical personnel individually. But a hospital or institution is held to the same standard of care as a doctor or a physician. So when evaluating a case for institutional negligence one asks what a reasonably careful hospital would and should do under similar circumstances. Illinois Pattern Jury Instructions, Civil, No. 105.03.01 (1995). Jones v. Chicago HMO Limited of Illinois, 191 Ill. 2d 278 (2000).

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A California Appellate Court supported a trial court’s ruling that the Medical Device Amendments (MDA), Title 21 USC §360k(a), preempts any state law imposing safety requirements on manufacturers of a medical device. So even though the medical device did not pass all of the state’s safety requirements, in Blanco v. Baxter Healthcare Corp. the plaintiff’s claim was denied because the medical device in question met all the FDA requirements. As we see again and again, the MDA’s preemption claim is making it increasingly difficult to seek legal recourse for a faulty medical device. Of course, this would hold true for our cases in Chicago and around Illinois.

Claudia Blanco was diagnosed with mitral valve stenosis and needed to have her natural valve replaced with an artificial one. During surgery a bileaflet mitral heart valve manufactured by Baxter-Travenol Laboratories was inserted. A year after Blanco received the valve Baxter suspended marketing of its product due to reports of possible valve failures.

However, Blanco didn’t receive any notice of the valve problems for another five years. And while the notice advised her of the potential problems it did not advise her to have the valve removed or replaced. Less than ten years later Blanco’s artificial valve failed and she was rushed to the hospital for an emergency valve replacement, but died. After her death a representative from Baxter evaluated her valve and determined that the failure was in fact caused by a faulty valve.

But despite the evidence that the product was faulty Blanco’s claim was denied by both the trial and appellate courts. Because the medical device had passed a “rigorous” approval by the FDA it was protected from litigation for product liability. Also, because the device’s warnings were also approved by the FDA a claim cannot be brought for failure to warn.

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Loyola University Medical Center was held liable by a Cook County jury in 2006 for “institutional negligence” involving the unsuccessful heart transplantation attempt of Carl Longnecker, the plaintiff decedent. The hospital was held liable for not ensuring that a doctor understood his role on the heart transplant team. At the same time the jury found that the same doctor, also named as a defendant, was not guilty of Illinois medical negligence.

Longnecker had been waiting for a transplant for 14 months when he was notified that a heart had been found for him. Dr. Parvathaneni was responsible for obtaining that heart and getting it to Loyola, where the transplant would be performed. According to surgeons at Loyola, Parvathaneni played a crucial role in the process in that they relied on his inspection and evaluation when they accepted and used the heart. Dr. Parvathenani testified that he was unaware that he needed to perform a detailed assessment of the heart, but just was responsible for getting it to Loyola quickly. So when it became evident that the heart had significant disease and allegedly never functioned after its removal the question was who was responsible.

The transplant surgeons decided to go ahead with the surgery, stating that they needed to go ahead with the transplant of the diseased heart because Longnecker’s own heart had already been removed. However, it should also be noted that the doctors could have used an artificial heart in this case. Longnecker never regained consciousness after the surgery and died several days later.

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