FDA to Study Meds Taken During Pregnancy

Reuters reports that the FDA announced on Wednesday that it will be collaborating with other researchers on a new study called the Medication Exposure in Pregnancy Risk Evaluation Program. The research will investigate the safety of medications taken during pregnancy. Gerald Dal Pan, a director at the FDA's Center for Drug Evaluation and Research, said the findings "will provide valuable information for patients and physicians when making decisions about medication during pregnancy."

FDA to Revise Rules on Medical Devices

The Wall Street Journal reports that a physician at Northwestern University is being accused of having experimented on humans after he implanted his invention, a Myxo ring, in over 150 patients to stop leaking heart valves without FDA approval. Edwards Lifesciences Corp., which manufactured the rings, decided not to seek approval because it determined the ring was sufficiently similar to approved rings. The dispute is said to have caused the FDA to review its current guidelines over whether medical devices require regulatory approval. Now, according to Bram Zuckerman, director of the FDA's Division of Cardiovascular Devices, the agency may issue revised guidance requiring manufactures to notify the FDA of any alterations to approved products.

Is Toyota Hiding Vehicle Defects?

The Los Angeles Times reported, "A peerless reputation for quality and safety has helped Toyota become the world's largest automaker. But even as its sales have soared, the company has delayed recalls, kept a tight lid on disclosure of potential problems and attempted to blame human error in cases where owners claimed vehicle defects." The Times relates several incidents illustrating that point, commenting, "The automaker's handling of safety issues has come under scrutiny in recent months because of incidents of sudden acceleration in Toyota and Lexus vehicles, which The Times has reported were involved in accidents causing 19 fatalities since 2001, more deaths from that problem than all other automakers combined."

FDA Cites Nestle Over Health Claims

Bloomberg News reports that the FDA issued a warning letter on its website finding that "Nestle SA's Juicy Juice and Boost beverages for children violate US rules about marketing health claims." The FDA ordered the firm "to remove claims about the brain development benefits and sugar content of its Juicy Juice product for infants." In addition, the agency "said content labeling for Nestle's orange tangerine and grape juices are 'misleading' because they claimed to be 100 percent juice." Finally, the agency "said Nestle's Boost Kid Essentials Nutritionally Complete Drink is falsely promoted as a 'medical food.'"

Multi-State Crackdown on Medicare Fraud

The AP reports that "federal agents arrested 26 suspects in three states Tuesday, including a doctor and nurses, in a major crackdown on Medicare fraud totaling $61 million in separate scams." HHS and the Department of Justice said that the 32 suspects arrested in Miami, Brooklyn, and Detroit "lined up bogus patients and otherwise billed Medicare for unnecessary medical equipment, physical therapy and HIV infusions." With Tuesday's arrests, the "Medicare Fraud strike force formed by the Justice and Health departments has now charged suspects accused of bilking Medicare of more than $1 billion in less than two years." Also on Tuesday, HHS Secretary Kathleen Sebelius announced "the operation will expand to Tampa, Fla., Baton Rouge, La., and Brooklyn."

CNN reports, "The largest case, in Miami, involved a doctor and nurses who allegedly ordered home healthcare services that were not medically necessary. 'When someone sends fraudulent bills to Medicare, they are stealing American taxpayer dollars that are intended for those most in need,'" said Assistant Attorney General Lanny Breuer."

Med-Mal Damages Caps Benefit Only Insurers

In a blog at California Progress Report, J.G. Preston, Press Secretary at the Consumer Attorneys of California, wrote, "A report from the American Association for Justice, 'Insurance Company Handout,' finds the only effect of [med-mal] caps on damages is higher insurance company profits. Despite rhetoric to the contrary, the average malpractice premiums for surgeons, internists and OB/GYNs is actually lower in states without caps than it is in the 30 states that have caps." Preston asks, "Are higher insurance company profits really a reason to prevent the victims of medical negligence who have the most severe injuries from receiving just compensation thanks to a cap on damages?"

Radiation Exposure from CT Scans Appears Higher than Earlier Estimates

A study published in the Archives of Internal Medicine by researchers at the National Cancer Institute "found that people may be exposed to up to four times as much radiation as estimated by earlier studies," USA Today reported--exposure that may lead to cancer and death. Read more.

NJ's AG Proposes Limits of Industry Gifts to Docs

The Philadelphia Inquirer reported that New Jersey "could become the first" state to make doctors accountable for the incentives they are provided by drug and medical-device manufacturers. State Attorney General Anne Milgram "has recommended banning doctors licensed in the state from accepting gifts that don't directly benefit their patients, and requiring them to report consulting fees greater than $200." Milgram maintained that doctors "should be conscious of how their relationships with manufacturers can influence care."

Kids' Injuries from Falling TVs Rise

The AP reported that "Studies suggest that the number of children killed or injured by falling televisions has risen even as more consumers replace their clunky old TVs with lighter flat screens." The CPSC "says more than 80 of the 180 furniture-related deaths from 2000 to 2006 involved televisions. And the number rose over the years."

Fast-Food Standards for Meat & Chicken Exceed Those for School Lunches

A USA Today investigation found that in "the past three years, the government has provided the nation's schools with millions of pounds of beef and chicken that wouldn't meet the quality or safety standards of many fast-food restaurants." While the U.S.D.A. claims the meat it buys for the National School Lunch Program "meets or exceeds standards in commercial products," USA Today says "That isn't always the case." Read more.

Daughter Sues Cellphone Industry for Mother's Death Caused by Distracted Driver

The New York Times reports that Jennifer Smith, whose mother "was killed last year when her car was hit by a driver talking on his cellphone," is suing "the companies that provided the driver's phone and wireless service. ... Legal experts said her lawsuit, currently the only such case and one of only a handful ever filed, faces steep challenges but also raises interesting questions about responsibility for behavior that is a threat to everyone on the road." Smith "argues that the industry's success in marketing to drivers is the reason people like" the driver responsible, Christopher Hill, "do not change their behavior or pay attention to what she characterizes as faint warnings by the industry."

Day Editorial on Stonington ZEO Probe

The Day editorializes about the Stonington First Selectman's probe of ZEO Joe Larkin. The First Selectman "estimated he has received 10 seemingly credible complaints alleging bias and uneven enforcement in the past two years and said he no longer could ignore them. And he shouldn't."

Administrative Appeal Filed in Zoning Dispute

The Westerly Sun reports on our administrative appeal filed this week, after the Stonington ZBA failed to reinstate a cease & desist order against the plaintiff's neighboring property owner that ordered the neighbor to restore a buffer it ripped out last winter. In August, we filed suit against the Town and the neighbor on account of the destruction of the buffer and failure to enforce Town zoning laws.

Study: BPA in 90% of Newborns

The Milwaukee Journal Sentinel reports that a study released Wednesday by Environmental Working Group "found that nine of 10 babies tested were born with bisphenol A in their systems" which finding "has renewed calls for the chemical to be banned." The study, which "found the chemical in nine of 10 randomly selected samples of umbilical cord blood," was released on "the same day a US Senate subcommittee met to consider an overhaul of laws governing the nation's toxic chemicals." The Sentinel says the FDA postponed their decision on BPA earlier this week, although "agency officials said they are working to complete it within weeks."