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Med Mal News

By ALM Staff | Law Journal Newsletters |
June 28, 2011

FDA: Formula-Thickening Agent Dangerous for
Premature Infants

Health care facilities that use the thickening product SimplyThick in infant formula intended for premature babies are being warned to discontinue the practice following reports to the U.S. Food and Drug Administration (FDA) that the product could cause a life-threatening condition known as necrotizing enterocolitis (NEC) in babies born prematurely. Reports that babies were contracting NEC, which is characterized by inflammation and death of intestinal tissue, began coming into the FDA in mid-May. Four medical centers around the country were affected. As of May 20, when the agency began warning parents and health care providers of the danger, 15 cases of NEC in premature infants given formula or breast milk mixed with SimplyThick had been identified, including two fatalities. “The current situation is unusual because NEC most often occurs in babies within the hospital early in their premature course,” the FDA stated in its announcement. “But among the ill babies of which FDA is aware, some had been discharged from the hospital to home on a feeding regimen that included SimplyThick and then fell ill at home.” Symptoms of NEC, which can occur in premature infants even several months old, include abdominal bloating, green-tinged vomiting, feeding intolerance and bloody stools.

Supremes Order Drastic California Prisoner
Population Cuts

In a decision judicial dissenters called, “perhaps the most radical injunction issued by a court in our nation's history,” the U.S. Supreme Court in May ordered the State of California to reduce its prison population because overcrowding was unconstitutionally impinging on the inmates' right to receive adequate medical care. In Brown v. Plata, the Court held that California prisoners had suffered enough: “The medical and mental health care provided by California's prisons falls below the standard of decency that inheres in the Eighth Amendment,” wrote Justice Anthony Kennedy for the majority. “This extensive and ongoing constitutional violation requires a remedy, and a remedy will not be achieved without a reduction in overcrowding.”

Dissenting Justice Antonin Scalia decried the Court-imposed remedy as not necessarily helping prisoners to get the medical attention they deserve, because the prisoners who will be released will not necessarily be those in need of medical treatment. And Justice Samuel Alito Jr., another dissenter, expressed worries for the larger society: “I fear that today's decision, like prior prisoner release orders, will lead to a grim roster of victims. I hope that I am wrong. In a few years, we will see.” California Governor Jerry Brown wants to move low-level criminals from state to county lock-up facilities as a means to comply with the Court's order yet not turn more than a quarter of the State's prisoners loose. However, as is so often the case in these uncertain financial times, questions of how to fund this change may delay or rule out the governor's plan.

California Revokes Medical License of Nadia Suleman's Fertility Doctor

The Medical Board of California announced June 1 that it has revoked the medical license of Beverly Hills physician Michael M. Kamrava, the fertility doctor responsible for implanting embryos into patient Nadia Suleman, who famously gave birth to octuplets in 2009. Although all of the children survived, the publicity generated by their story prompted a worldwide dialog on the ethics of fertility therapy and multiple births. Because of the unusual circumstances of the Suleman births, Dr. Kamrava was accused of violating Business and Professions (B&P) Code sections 2234(b) (Gross Negligence), and 2234(c) (Repeated Negligent Acts), as well as being charged with inadequate record-keeping. In a release announcing the revocation, the agency described the doctor's offense in the Suleman case: “Over the course of several years, prior to the transplant of these embryos, Kamrava repeatedly initiated a fresh cycle of oocyte retrieval when frozen embryos were available. Additionally, Kamrava never recommended or referred the patient to a mental health professional, although she was single and already had six children, all conceived through in vitro fertilization (IVF).” While the action was pending, more accusations were added, involving two other patients. One of them gave birth to quadruplets after being implanted with seven embryos. After Dr. Kamrava was found guilty in each case, his license was revoked, effective July 1, 2011.

FDA: Formula-Thickening Agent Dangerous for
Premature Infants

Health care facilities that use the thickening product SimplyThick in infant formula intended for premature babies are being warned to discontinue the practice following reports to the U.S. Food and Drug Administration (FDA) that the product could cause a life-threatening condition known as necrotizing enterocolitis (NEC) in babies born prematurely. Reports that babies were contracting NEC, which is characterized by inflammation and death of intestinal tissue, began coming into the FDA in mid-May. Four medical centers around the country were affected. As of May 20, when the agency began warning parents and health care providers of the danger, 15 cases of NEC in premature infants given formula or breast milk mixed with SimplyThick had been identified, including two fatalities. “The current situation is unusual because NEC most often occurs in babies within the hospital early in their premature course,” the FDA stated in its announcement. “But among the ill babies of which FDA is aware, some had been discharged from the hospital to home on a feeding regimen that included SimplyThick and then fell ill at home.” Symptoms of NEC, which can occur in premature infants even several months old, include abdominal bloating, green-tinged vomiting, feeding intolerance and bloody stools.

Supremes Order Drastic California Prisoner
Population Cuts

In a decision judicial dissenters called, “perhaps the most radical injunction issued by a court in our nation's history,” the U.S. Supreme Court in May ordered the State of California to reduce its prison population because overcrowding was unconstitutionally impinging on the inmates' right to receive adequate medical care. In Brown v. Plata, the Court held that California prisoners had suffered enough: “The medical and mental health care provided by California's prisons falls below the standard of decency that inheres in the Eighth Amendment,” wrote Justice Anthony Kennedy for the majority. “This extensive and ongoing constitutional violation requires a remedy, and a remedy will not be achieved without a reduction in overcrowding.”

Dissenting Justice Antonin Scalia decried the Court-imposed remedy as not necessarily helping prisoners to get the medical attention they deserve, because the prisoners who will be released will not necessarily be those in need of medical treatment. And Justice Samuel Alito Jr., another dissenter, expressed worries for the larger society: “I fear that today's decision, like prior prisoner release orders, will lead to a grim roster of victims. I hope that I am wrong. In a few years, we will see.” California Governor Jerry Brown wants to move low-level criminals from state to county lock-up facilities as a means to comply with the Court's order yet not turn more than a quarter of the State's prisoners loose. However, as is so often the case in these uncertain financial times, questions of how to fund this change may delay or rule out the governor's plan.

California Revokes Medical License of Nadia Suleman's Fertility Doctor

The Medical Board of California announced June 1 that it has revoked the medical license of Beverly Hills physician Michael M. Kamrava, the fertility doctor responsible for implanting embryos into patient Nadia Suleman, who famously gave birth to octuplets in 2009. Although all of the children survived, the publicity generated by their story prompted a worldwide dialog on the ethics of fertility therapy and multiple births. Because of the unusual circumstances of the Suleman births, Dr. Kamrava was accused of violating Business and Professions (B&P) Code sections 2234(b) (Gross Negligence), and 2234(c) (Repeated Negligent Acts), as well as being charged with inadequate record-keeping. In a release announcing the revocation, the agency described the doctor's offense in the Suleman case: “Over the course of several years, prior to the transplant of these embryos, Kamrava repeatedly initiated a fresh cycle of oocyte retrieval when frozen embryos were available. Additionally, Kamrava never recommended or referred the patient to a mental health professional, although she was single and already had six children, all conceived through in vitro fertilization (IVF).” While the action was pending, more accusations were added, involving two other patients. One of them gave birth to quadruplets after being implanted with seven embryos. After Dr. Kamrava was found guilty in each case, his license was revoked, effective July 1, 2011.

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