Latest News

FDA Increases Oversight of Medical Radiation

The federal Food and Drug Administration said Tuesday that it would take steps to more stringently regulate three of the most potent forms of medical radiation, including increasingly popular CT scans, some of which deliver the radiation equivalent of 400 chest X-rays.

With the announcement, the F.D.A. puts its regulatory muscle behind a growing movement to make life-saving medical radiation — both diagnostic and therapeutic — safer. To see the complete article: Click Here.

Andrew Testa for The New York Times

A push to reduce unnecessary radiation exposure from CT scans, above, nuclear medicine studies, and fluoroscopies.

Rob Harris/The New York Times

The government is focusing on overradiation by CT scans.

Long-Term Health Care Facilities Can Be Dangerous: Issues in Hospital Medical Malpractice

Hospital medical malpractice has been steadily increasing according to numerous studies.  Less often quoted are long term health care facilities.  More than 400 similar facilities, called long-term acute care hospitals, have opened nationally in the last 25 years. Few of them have doctors on staff, and most are owned by for-profit companies. The Kansas City hospital is part of a chain called the Select Medical Corporation, a publicly traded Pennsylvania company that runs 89 long-term hospitals, more than any other company.

Lawsuits, state inspection reports and statistics deep in federal reports paint a troubling picture of the care offered at some Select hospitals, and at long-term care hospitals in general.

To see the complete article: Click Here.

Medical Group Urges New Rules on Radiation

The leading professional organization dedicated to radiation oncology has called for enhanced safety measures in administering medical radiation, including the establishment of the nation's first central database for the reporting of errors involving linear accelerators — machines that generate radiation — and CT scanners. To read the entire article: Click Here.

FDA Takes Action Against Doctor Promotions

The FDA has recently sent a warning letter to one of the most prominent highly quoted dermatologist and clinical researcher in the nation, citing the doctor for expressing irresponsible and premature enthusiasm in the media for an injectable antiwrinkle drug that the FDA has not yet approved.  Her comments, say the FDA, violated restrictions on drug promotions.

Under the Obama administration, the FDA has stepped up scrutiny of drug advertising particularly as it relates to symbiotic relationships some physicians have with pharmaceutical companies.  This has clear implications for lawyers who practice pharmaceutical personal injury law.  Now there is support from the government in those cases where patient injury results from drugs that have either not been properly tested or have not yet passed FDA scrutiny.

See the full article: Inadvertently deleted.  If interested, go to January 31, 2010 New York Times Health Archive to view.

Cardiovascular Devices Poorly Regulated by FDA

A study in the December 23-30 issue of JAMA says that pre-market approval by the FDA of cardiovascular devices is often based on studies that lack adequate strength or may have been prone to bias.

The researchers found that of nearly 80 high-risk devices, the majority received approval based on data from a single study alone.

Cardiovascular devices are increasing in number and usage. In 2008, at least 350,000 pacemakers, 140,000 implantable cardioverter-defibrillators, and 1,230,000 stents were implanted. Although there has been recent scrutiny of evidence used in the U.S. Food and Drug Administration (FDA) drug approval process, less attention has been paid to the approval process for medical devices. The evidence for approval should consist of randomized, double-blinded studies with adequate controls, sufficient duration, and thorough follow-up on prespecified primary end points without bias. But it doesn't.

Sanket S. Dhruva, M.D., of the University of California, San Francisco, and colleagues analyzed the type and quality of study evidence used by the FDA for the premarket approval (PMA) of cardiovascular devices. These types of devices were included in the study because it was expected they would undergo the most stringent approval process, given their increasing usage and potential impact on illness and risk of death. The authors conducted a systematic review of 123 summaries of safety and effectiveness data (SSEDs) for 78 PMAs for high-risk cardiovascular devices that received PMA between January 2000 and December 2007, examining the methodological characteristics and primary end points. SSEDs are intended to present a reasoned, objective, and balanced critique of the scientific evidence which served as the basis of the decision to approve or deny the PMA.

The researcher found that of the 78 PMAs, 51 (65 percent) were supported by a single study. Of the 123 studies, only 98 SSEDs (80 percent) reported the number of participants enrolled. Of 123 studies in SSEDs, 27 percent were randomized and 14 percent were blinded. Fourteen percent of the studies reported did not have a primary end point stated. Of the 213 primary end points, 52 percent were compared with controls.

The authors write that there are several possible reasons why the criteria on which FDA device approval is based appear to be less rigorous than those for drug approvals. First, device approvals are a more recent activity for the FDA, having begun in 1976 with the FDA Device Amendment, so the agency has less experience with devices than it does with drugs. Further, the last decade has brought a significant increase in the number and complexity of devices. They add that new surgical operations do not require FDA approval, and new devices, which are nearly always implanted, are between surgical operations and drugs on the FDA approval continuum.

The study points out that the emphasis at the FDA in the last 17 years since the Prescription Drug User Fee Act has been rapid approval of new drugs. This study suggests that the emphasis for the FDA in 2009 and beyond must be approvals based on research that meets rigorous scientific standards for evidence of benefit and lack of harm to patients. To uphold the FDA's mission of ensuring 'safe and effective' medical devices, it is essential that high-quality studies and data are available.

The medical legal implications are obvious. Even with adequate informed consent, hardware used by cardiovascular surgeons and interventionalists that have not been subjected to intense research scrutiny may ultimately have higher rates of failure and/or complications. This will inevitably lead to increasing litigation in this area.

Changes in Doctor Training

A national panel of medical experts proposed significant and costly changes for training new doctors in the nation's hospitals, recommending mandatory sleep breaks and more structured shift changes to reduce the risk of fatigue-related errors.

The report, issued by the Institute of Medicine, focused on the grueling training of medical residents, the recent medical school graduates who care for patients under the supervision of a fully-licensed physician. The medical residency, which aims to educate doctors by fully immersing them in a particular specialty and all aspects of patient care, is characterized by heavy patient workloads, 80-hour workweeks and sleep deprivation.

Dr. Gustin's comments: Fatigue causes errors; errors of omission and errors of commission, because judgment is affected. This leads directly to patient injury and potential medical malpractice actions.

To read the full article: Click Here.

No Praise For Doctors In Training: Avoiding medical practice errors that spawn medical malpractice litigation

As Dr. Pauline W. Chen notes in today’s “Doctor and Patient” column, new doctors receive much of their medical training in a culture of fear and negative feedback. Doctors in training are on the defensive from the beginning and focus much of their energy on avoiding medical practice errors that spawn medical malpractice litigation.  She recalls that during her own early training, praise was rare.

"Negative reinforcement during those early years taught me to be a cautious and conscientious doctor. Our teachers rarely praised us for good work and never allowed us to forget our errors. But sometimes the lessons had little to do with learning how to care for patients-"

 To see the complete article, Click Here.

Hospitals See Drop in Paying Patients

In another sign of the economy's toll on the nation's health care system, some hospitals say that they are seeing fewer paying patients even as greater numbers of people are showing up at emergency rooms unable to pay their bills.

While the full effects of the downturn are likely to become more evident in coming months as more people lose their jobs and their insurance coverage, some hospitals say they are already experiencing a fall-off in patient admissions.

Some patients with insurance seem to be deferring treatments like knee replacements, hernia repairs and weigh loss surgeries, the kind of procedures that are among the most lucrative to hospitals. 

 TO SEE THE FULL ARTICLE CLICK ON THE FOLLOWING LINK:  Click Here.

News Tidbits from Late 2007 and 2008

2007-2008 News Of The Day

In a Virginia case a circuit court held that a consulting review of medical records by a doctor does not establish a doctor-patient relationship between the reviewer and another doctor's patient. In finding for the defendant doctor, the court reasoned that there was no allegation that the doctor undertook the plaintiff's care by consent. 12-06-07.

— Virginia Medical Law Report

Four organ transplant patients at three Chicago hospitals contracted HIV and the hepatitis C virus from organs from a high-risk donor. The infections were discovered in late 2007. Officials blamed the viral infections on a rare flaw in the testing procedures. The last time HIV was contracted through organ transplants was more than 20 years ago. 12-08-07.

— Chicago Tribune

A brain-damaged toddler will receive $11.5 million for his medical care and life-long expenses after an alleged botched birth. A settlement was reached in a case that claimed a doctor failed to use a vacuum extractor. 12-08-07.

— AP

Japanese and U.S. scientists announced in early December that a gene has been discovered that, when activated by cholesterol drugs (statins), causes toxicity to muscles. Muscle weakness and pain are sometimes side effects of these drugs. 12-13-07.

— UPI

A new software called SimVascular takes MRI data and converts it into imagery that allows doctors to better gauge the correct heart surgery for a patient.

— Stanford University

On Aug. 1, 2007, the Centers for Medicare and Medicaid Services (CMS) proposed in the Federal Register that home medical equipment (HME) suppliers be required to purchase a surety bond in the amount of $65,000. This proposal is based on the Balanced Budget Act (BBA) of 1997.

— Elizabeth E. Hogue, Esq.

The rate of accidental poisonings from prescription drugs increased sharply from 1999 to 2004.

— Morbidity and Mortality Weekly Report

Healthcare providers who receive Medicare or Medicaid money must ask admitted patients if they have a living will or other directive.

— Patient Self-Determination Act

Americans spend about $275 billion per year on prescription medicines. By 2012, about $60 billion worth of these drugs will lose their patents. Patients will have more and cheaper drug choices.

— The New York Times

Connecticut has been experimenting with GPS devices to track criminals, as opposed to keeping them incarcerated.

— NPR

A new use for DNA testing: Archaeologists have found that DNA can be extracted from the saliva of North American humans who have been dead for thousands of years. The saliva is nestled in quids, blobs of plant matter from plants such as yucca, that ancient people chewed and then spit out.

— NPR

Half of all traffic accidents involving commercial vehicles are not caused by the commercial vehicles.

— NPR

An Ohio court has ruled the child sex offender "1,000 ft." rule to be unconstitutional.

— NPR

The teen and young adult suicide rate jumped about 8 percent from 2003 to 2004 (76 percent for young girls). In 2003 the FDA issued black-box warnings about anti-depressant drugs (SSRIs) such as Zoloft, Prozac and Paxil, and SSRI prescriptions dropped 22 percent afterward. Some experts believe that lessened use of the medicines is linked to the increased suicide rate. The rate among teens lowered during the 1990s after the SSRI drugs were released in 1988. Experts are skeptical of making any causal links.

— wire services, The New York Times

The demand for lawyers has grown at about half the rate of the rest of the economy since 1988. The number of JDs conferred has risen from about 38,000 in 2001-02 to almost 44,000 in 2005-06, while legal work in some sectors (med mal, PI, securities class actions) has fallen, and the number of law schools has increased by 11 percent since 1995 to 196. The top one-fourth of law school graduates have seen starting salaries rise, while the bottom 75 percent have actually seen income drops. Adding to young attorneys' pain: tuition rates have tripled those of inflation in the last 20 years.

— Wall Street Journal, 9-24-2007

A large study found that half of all abortions in the world are unsafe. The study also showed that the abortion rate is fairly consistent worldwide, even in countries where abortions are illegal.

— Guttmacher Institute, WHO

The first kidney removal via a small incision in the navel has been completed, eliminating the usual long scars to the lower back.

— University of Texas Southwestern Medical Center

As cars are made lighter to increase fuel efficiency, the death rate in accidents rises as a result of the reduced weight.

— National Center for Policy Analysis

A new and simple Alzheimer's blood test has proven about 90 percent accurate in early testing.

— Stanford University

A jury in Massachusetts awarded $26 million to a boy who suffered brain damage in a delivery gone wrong. The case is one of the largest in the state's history.

— The New York Times

The average RN makes $56,558 per year if paid by the hour, and about $68,000 per year if on salary.

— RN

Tattoo inks are approved by the FDA for cosmetic use, but not for subcutaneous injections. The FDA does not track adverse events stemming from tattoo inks.

— Science News

Three children in Albany, N.Y., were awarded $2.5 million in late October for exposure to lead paint and dust found in two apartment buildings where they once lived. The siblings, Jasmine, Tina and Juan Vasquez, suffer from learning disabilities.

— Newsday

The FDA is requiring that impotence drugs like Viagra, Cialis and Levitra bear label warnings about the possible side effect of hearing loss.

— wire services

Baby crib bumper pads are too dangerous when compared with the benefit they give, according to a study from Washington University School of Medicine.

— Health Day News, The Washington Post

Johnson & Johnson must pay $1.25 million for the death of a 14-year-old who died from blood clots linked to use of the Ortho Evra® birth control patch. Thousands of lawsuits have been filed claiming that clots and strokes resulted from the patch's use.

— Bloomberg

Scientists are exploring the possibility of prodding female human eggs to spontaneously grow (parthenogenesis) as a way to create stem cells. Some species of fish, reptiles, birds, insects and plants can create viable young from eggs that have not been fertilized, but humans cannot. Such "virgin" eggs in humans will not grow into a fetus for chromosomal-defect reasons. Tricking human eggs into growing in such a manner would create clumps of cells (blastocysts) that could be used as stem cells, but because the cells cannot grow into a viable fetus, ethical concerns are skirted. President Bush's Council on Bioethics, and even the Roman Catholic Church, have not yet dismissed these eggs on ethical grounds.

— Science News

A new HPV blood test is purported to be significantly better than Pap smears in detecting cervical cancer.

— New England Journal of Medicine

A Spanish chemist has modified a common CD player to read biochemical reactions that are smeared onto the surface of what used to be CDs. The inexpensive modified CD players perform as well as $40,000 to $80,000 micro array detectors and can have as many as 300,000 samples crammed onto a single disk. Commercial uses may include homes, doctors' offices and use in outdoor settings

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