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Med Mal News

By ALM Staff | Law Journal Newsletters |
March 03, 2004

Breast Implants Affect Cancer Diagnosis

In an article published Jan. 29 in The Journal of the American Medical Association, researchers reported that although women who have undergone breast augmentation are at no greater risk of developing breast cancer, the chance that their cancers will be diagnosed early is decreased by the presence of implants. The study also found no evidence that the presence of breast implants exacerbates the growth of cancerous tumors once they develop.

Kentucky House Passes Reform Bill

Legislation to aid doctors in fighting the rise in medical malpractice insurance premiums was passed by the Kentucky House of Representatives on Feb. 20. The bill, which calls for the creation of a mutual insurance authority to sell malpractice insurance, now heads to the Senate. An alternative bill passed earlier in the state's senate would have amended the Kentucky constitution (following voter approval) to allow the legislature to impose caps on non-economic damages.

Study Says Testosterone Replacement Therapy Doesn't Cause Prostate Cancer

A study published in The New England Journal of Medicine finds there is no causal relationship between testosterone replacement and heart disease or prostate cancer risk. The study, conducted by researchers at Beth Israel Deaconess Medical Center, involved review of 72 separate studies and their results. Testosterone replacement therapy has been considered a possible impetus to prostate cancer development because men with low testosterone levels are, in general, less likely to develop this type of cancer. Testosterone has also been suspected of causing heart disease, because such diseases affect men more than women.

Adverse Event Reporting Forms for SUDs Revised

The Food and Drug Administration has issued a revised MedWatch Voluntary Reporting Form (FDA Form 3500) and the revised Mandatory Reporting Form (3500A). The MedWatch voluntary and mandatory reporting forms are meant to facilitate the reporting by user facilities or distributors of adverse events involving single-use devices (SUDs) that have been reprocessed for reuse in humans. The revised MedWatch forms ask the addtional question, “Is this a single-use device that was reprocessed and reused on a patient?” If the answer to that question is “yes,” the new forms request entry of the name and address of the reprocessor. The newly revised MedWatch forms are available at FDA Form 3500 http://www.fda.gov/medwatch/safety/3500.pdf and FDA Form 3500A http://www.fda.gov/medwatch/safety/3500a.pdf. The instructions for the revised forms are available at FDA Form 3500 http:// www. fda.gov/medwatch/report/consumer/ instruct.htm and FDA Form 3500A http://www.fda.gov/medwatch/report/instruc.htm.

New Book Suggests Methods for Decreasing Medical Errors

A book about medical errors, titled “Internal Bleeding: The Truth Behind America's Terrifying Epidemic of Medical Mistakes,” was published last month by Rugged Land Publishers, New York. The book, written by two doctors at the University of California at San Francisco, discusses case histories involving medical mistakes and makes suggestions for decreasing the number of such errors in future. The authors, Robert M. Wachter, MD, chief of the medical service and chair of the patient safety committee at UCSF Medical Center, and Kaveh G. Shojania, MD, a UCSF assistant professor of medicine, contend that most medical mistakes are caused by faulty systems rather than bad practitioners, and that decreasing the incidence of errors will require new methods and changes in training for medical professionals.

Bush: Lawsuits Are 'Driving a Wedge' Between Doctors and Patients

In a speech given by President George W. Bush at Little Rock, AR's, Baptist Health Medical Center on Jan. 27, he characterized the United States as having a “culture of lawsuits,” a situation that threatens to undermine good doctor-patient relationships. The president noted that a survey of Arkansas doctors revealed more than half had discontinued at least some services because of a fear of lawsuits. Bush took the opportunity to reiterate in his speech that he supports a bill awaiting action by the U.S. Senate that would limit liability for noneconomic damages to $250,000.

Study Finds Promising Treatment for Avoiding Post-Op Infection

Researchers at the University of Chicago have released results of a study that seeks to find a method of reducing the incidence of post-operative patient infections. In order to conduct the test, mice (the study's subjects) underwent major surgery. Following surgery, their bowels were intentionally infected with Pseudomonas aeruginos, a lethal bacteria that under normal circumstances would be expected to kill them all within 2 days. However, some of the test subjects were injected with a protective coating of high-molecular-weight polyethylene glycol, while still others received an oral dose by mouth 4 to 8 hours after infection. The injections and oral medications protected all the treated mice from infection.

Pseudomonas aeruginosa is present in about 3% of the normal human population, but does not usually cause harm until the immune system is weakened. Following an operation, the bacteria can take hold, particularly when the post-operative patient is receiving nutrition intravenously, because the intestines are not functioning in the normal way and lose some of their protective mucus coating. Once that coating is weakened, the bacteria can bore through the intestinal wall to infect the bloodstream. The solution used on the subjects of this study mimicked their intestines' natural mucus coating, thus hindering the bacteria's ability to enter the bloodstream and infect the host's body.

Breast Implants Affect Cancer Diagnosis

In an article published Jan. 29 in The Journal of the American Medical Association, researchers reported that although women who have undergone breast augmentation are at no greater risk of developing breast cancer, the chance that their cancers will be diagnosed early is decreased by the presence of implants. The study also found no evidence that the presence of breast implants exacerbates the growth of cancerous tumors once they develop.

Kentucky House Passes Reform Bill

Legislation to aid doctors in fighting the rise in medical malpractice insurance premiums was passed by the Kentucky House of Representatives on Feb. 20. The bill, which calls for the creation of a mutual insurance authority to sell malpractice insurance, now heads to the Senate. An alternative bill passed earlier in the state's senate would have amended the Kentucky constitution (following voter approval) to allow the legislature to impose caps on non-economic damages.

Study Says Testosterone Replacement Therapy Doesn't Cause Prostate Cancer

A study published in The New England Journal of Medicine finds there is no causal relationship between testosterone replacement and heart disease or prostate cancer risk. The study, conducted by researchers at Beth Israel Deaconess Medical Center, involved review of 72 separate studies and their results. Testosterone replacement therapy has been considered a possible impetus to prostate cancer development because men with low testosterone levels are, in general, less likely to develop this type of cancer. Testosterone has also been suspected of causing heart disease, because such diseases affect men more than women.

Adverse Event Reporting Forms for SUDs Revised

The Food and Drug Administration has issued a revised MedWatch Voluntary Reporting Form (FDA Form 3500) and the revised Mandatory Reporting Form (3500A). The MedWatch voluntary and mandatory reporting forms are meant to facilitate the reporting by user facilities or distributors of adverse events involving single-use devices (SUDs) that have been reprocessed for reuse in humans. The revised MedWatch forms ask the addtional question, “Is this a single-use device that was reprocessed and reused on a patient?” If the answer to that question is “yes,” the new forms request entry of the name and address of the reprocessor. The newly revised MedWatch forms are available at FDA Form 3500 http://www.fda.gov/medwatch/safety/3500.pdf and FDA Form 3500A http://www.fda.gov/medwatch/safety/3500a.pdf. The instructions for the revised forms are available at FDA Form 3500 http:// www. fda.gov/medwatch/report/consumer/ instruct.htm and FDA Form 3500A http://www.fda.gov/medwatch/report/instruc.htm.

New Book Suggests Methods for Decreasing Medical Errors

A book about medical errors, titled “Internal Bleeding: The Truth Behind America's Terrifying Epidemic of Medical Mistakes,” was published last month by Rugged Land Publishers, New York. The book, written by two doctors at the University of California at San Francisco, discusses case histories involving medical mistakes and makes suggestions for decreasing the number of such errors in future. The authors, Robert M. Wachter, MD, chief of the medical service and chair of the patient safety committee at UCSF Medical Center, and Kaveh G. Shojania, MD, a UCSF assistant professor of medicine, contend that most medical mistakes are caused by faulty systems rather than bad practitioners, and that decreasing the incidence of errors will require new methods and changes in training for medical professionals.

Bush: Lawsuits Are 'Driving a Wedge' Between Doctors and Patients

In a speech given by President George W. Bush at Little Rock, AR's, Baptist Health Medical Center on Jan. 27, he characterized the United States as having a “culture of lawsuits,” a situation that threatens to undermine good doctor-patient relationships. The president noted that a survey of Arkansas doctors revealed more than half had discontinued at least some services because of a fear of lawsuits. Bush took the opportunity to reiterate in his speech that he supports a bill awaiting action by the U.S. Senate that would limit liability for noneconomic damages to $250,000.

Study Finds Promising Treatment for Avoiding Post-Op Infection

Researchers at the University of Chicago have released results of a study that seeks to find a method of reducing the incidence of post-operative patient infections. In order to conduct the test, mice (the study's subjects) underwent major surgery. Following surgery, their bowels were intentionally infected with Pseudomonas aeruginos, a lethal bacteria that under normal circumstances would be expected to kill them all within 2 days. However, some of the test subjects were injected with a protective coating of high-molecular-weight polyethylene glycol, while still others received an oral dose by mouth 4 to 8 hours after infection. The injections and oral medications protected all the treated mice from infection.

Pseudomonas aeruginosa is present in about 3% of the normal human population, but does not usually cause harm until the immune system is weakened. Following an operation, the bacteria can take hold, particularly when the post-operative patient is receiving nutrition intravenously, because the intestines are not functioning in the normal way and lose some of their protective mucus coating. Once that coating is weakened, the bacteria can bore through the intestinal wall to infect the bloodstream. The solution used on the subjects of this study mimicked their intestines' natural mucus coating, thus hindering the bacteria's ability to enter the bloodstream and infect the host's body.

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