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February 14, 2011

Recalled medical devices mostly untested, report says.
Two of the major television networks and a number of newspapers and consumer medical sites discussed a study published online Feb. 14 in the Archives of Internal Medicine about a possible link between fast approval of some medical devices and their subsequent recall. ABC World News (2/14, story 7, 2:55, Sawyer) reported "a new warning about some of the medical devices so many Americans have implanted," including "replacement hips and knees, heart valves," and "pacemakers."
The CBS Evening News (2/14, story 6, 2:25, Couric) reported, "The FDA approves new medical devices in the hopes of saving lives, but in 2006, some devices were linked to more than 2,800 deaths and close to 120 injuries. Today," a paper in "the Archives of Internal Medicine urged the FDA to improve the way devices are tested before they reach the public."
On the front of its Business Day section, the New York Times (2/15, B1, Meier) reports, "Most medical devices recalled in recent years by the Food and Drug Administration because they posed a high risk to patients were not rigorously studied before being cleared for sale." Researchers Diana M. Zuckerman, PhD, and Paul Brown, of the National Research Center for Women & Families, along with Steven E. Nissen, MD, of the Cleveland Clinic, "found that most medical devices that were the subject of high-risk recalls from 2005 to 2009 had been cleared through a regulatory pathway that requires little, if any, testing."
"Researchers examined the 113 devices that the FDA recalled between 2005 and 2009 for posing serious health risks, including endangering patients' lives," the Washington Post (2/15, Stein) reports. "Most of the devices -- 71 percent -- had been approved without undergoing testing in people."
On its front page, the Los Angeles Times (2/15, A1, Zajac) reports, "Cardiovascular devices, chiefly external defibrillators, made up nearly a third of the recalled medical products from 2005 through 2009, the time covered by the review," and "only 21 of the recalls in the new study involved products approved after clinical trials."
"The study found that most medical devices that were recalled over serious risks to patients were cleared through the Food and Drug Administration's 510(k) approval process or were exempt from regulatory scrutiny entirely," the Minneapolis Star Tribune (2/15, Moore) reports, explaining that "the 510(k) process requires device manufacturers to prove a new product is 'substantially equivalent' to one currently on the market -- usually without clinical data to prove the product is safe and effective." Because of previous criticism of this pathway to approval from both Congressional officials and consumer advocacy groups, "Dr. Jeffrey Shuren, the FDA's new device chief, has announced changes to strengthen the 510(k) process, and the Institute of Medicine will weigh in with the findings of its own review this summer."
Millions "may be at risk." According to the AP (2/15, Tanner), an invited commentary accompanying the study "says the analysis shows that 'millions of Americans may be at risk for device-related injuries and recalls from high-risk devices that were cleared by FDA without any supporting clinical trial data.'"
Modern Healthcare (2/15, McKinney) quotes the study authors' conclusion: "Our findings reveal critical flaws in the current FDA device review system and its implementation that will require either congressional action or major changes in regulatory policy."



January 25, 2011

Supreme Court's retaliation ruling a boon to employees.
In ongoing analysis of the Supreme Court's ruling on third-party retaliation suits, the Wall Street Journal (1/25, Jones) Law blog reported that Federal law prohibits employers from retaliating against a close relation of a worker who filed a discrimination complaint. Writing on behalf of a unanimous court, Justice Antonin Scalia noted an anti-discrimination provision in the Civil Rights Act of 1964 includes "a broad range of employer conduct" that could dissuade "a reasonable worker" from protesting prejudice.
The Wall Street Journal (1/25, Shellenbarger) "The Juggle" Blog suggested the ruling will prohibit employers from using retaliation as a scare tactic. It added that the opinion comes as the Equal Employment Opportunity Commission is seeing a rise in retaliation claims against employers.

January 19, 2011

Marketing concerns arise over Vitaminwater's health claims.
The AP (1/19) reported Britain's Advertising Standards Authority ordered the Coca-Cola Co. to stop running advertisements touting its Vitaminwater as "delicious and nutritious," because it contains too much sugar to carry the claim. The regulator explained, "Consumers wouldn't expect a drink marketed as nutritious to have between four and five teaspoons of added sugar." While "the ruling is little more than a regulatory rap on the knuckles ... it underlines trans-Atlantic concerns about the way in which Vitaminwater is marketed." The Center for Science in the Public Interest and US consumers are suing over claims the manufacturer "is using deceptive labeling to sell the drinks."

Study debunks "healthy" claims by children's food products.
The Los Angeles Times (1/19, Kaplan) "Booster Shots" blog detailed the findings of a Prevention Institute study which focused on "58 products that were deemed healthy by an industry group and that also made nutritional claims on their front-of-package labels. Among the 58 items were such staples as Campbell's Tomato Soup, Skippy Super Chunk Peanut Butter and Rice Krispies." Forty-nine of the 58 items, or 84% "failed to meet at least one of" the study's "criteria and were judged 'unhealthy'" by the researchers. The study called on the Food and Drug Administration "to create a rational, uniform and honest system for conveying nutritional information on food packages," adding that "nutrients associated with health, including vitamins A, C, D, calcium, and fiber, should not be included since they have the potential to mislead shoppers into believing that foods with a poor overall nutritional profile are healthful."

 

January 18, 2011

Solar Inverters Recalled over Injury Risk

The Consumer Product Safety Commission announced the recall of 25,000 solar inverters due to risk of injury. The product's manufacturer, Schneider Electric, said gases can build up in the inverter and blow the compartment cover off with a large amount of force, potentially causing injury. The company has received five reports of covers being blown off, but no injuries occurred. Staff Report, PR Newswire 01/18/2011

Read Article: PR Newswire


 

January 14, 2011

Candy Bars Recalled over Lead Content

Candy bar maker Toxic Waste has recalled its Nuclear Sludge Chew Bars after high amounts of lead were found in its cherry-flavored products. The recall will cover all flavors of the bars that were distributed between 2007 and 2010. Eating the candy can pose serious health risks, especially to infants, small children and pregnant women. Douglas Stanglin, USA Today 01/14/2011
Read Article: USA Today



 

January 2011

FDA Launches website explaining regulations to food, drug companies.

The Associated Press (1/7) reports, "The Food and Drug Administration is launching a website explaining its regulations to companies as part of a broader effort to rebrand itself as a more transparent, accessible agency."  The website, called 'FDA Basics for Industry, ' features answers to frequently asked questions about the regulation of food, drugs and medical devices."  FDA leadership has "pledged to reform the agency's policies, which they say have hurt its credibility with the public."

According to CQ HealthBeat (1/6, Adams), "Jeffrey K. Francer, the assistant general counsel for the Pharmaceutical Research and Manufacturers Assocation (PhRMA), was happy to see that the FDA is moving ahead on one of the trade group's recommendations of posting presentations by FDA officials on the agency's website, along with other materials such as a compilation of guidances to industry."  Francer "also was pleased that the agency adopted the idea of answering emails within five days, which was similar to a PhRMA recommendation."  In short, he "called the announcement 'one beneficial step in a larger process of making the FDA more transparent and more responsive'".


December 15, 2010:

Jury rules against J&J in antibiotic suit
By PATRICK CONDON Associated Press

MINNEAPOLIS (AP) - A federal court jury has ordered pharmaceutical company Johnson & Johnson to pay damages of $1.8 million in the case of an 82-year-old Minnesota man who sued over claims the antibiotic Levaquin caused him severe tendon injuries.

John Schedin (SHED'-in) of Edina was prescribed Levaquin five years ago to treat a diagnosed case of bronchitis. After three days on the drug, Schedin ruptured both his Achilles tendons. In 2008, the Food and Drug Administration required Johnson & Johnson and makers of similar drugs to print warnings on the risk of tendon injuries.

That same year, Schedin sued Ortho-McNeil-Jansen Pharmaceuticals, the J&J unit that markets Levaquin. The Minneapolis jury on Wednesday decided the drug company must pay Schedin $700,000 in actual damages and $1.1 million in punitive damages, though actual damages will be reduced by $70,000 under the jury's finding of 75 percent liability for the company.

The trial was the first on more than 2,600 other U.S. lawsuits making similar claims.



December 7, 2010

Aspirin may cut cancer deaths, but caution urged
By MARIA CHENG AP Medical Writer

LONDON (AP) - A new report from British scientists suggests that long-term, low-dose aspirin use may modestly reduce the risk of dying of certain cancers, though experts warn the study isn't strong enough to recommend healthy people start taking a pill that can cause bleeding and other problems.

In a new observational analysis published online Tuesday in the medical journal Lancet, Peter Rothwell of the University of Oxford and colleagues looked at eight studies that included more than 25,000 patients and cut the risk of death from certain cancers by 20 percent.

While some experts said the analysis adds to evidence of aspirin's potential to cut cancer risk, others said it falls short of changing advice to healthy people, and it failed to show the benefits apply equally to women.

The trials mostly compared men who took a daily dose of at least 75 milligrams of aspirin for heart problems to people who took a placebo or another drug. On average, the studies lasted at least four years.

Researchers used national cancer registries to get information on participants after the studies ended, though they weren't sure how many aspirin takers continued using it or how many people in the comparison groups may have started.

The researchers said that the projected risk after two decades of dying from cancers like lung and prostate would be 20 percent lower in groups who had taken aspirin and 35 percent lower for gastrointestinal cancers like colon cancer. These odds are figured from smaller numbers - there were 326 lung cancer deaths in all, for example.

Only one-third of people in the analysis were women - not enough to calculate any estimates for breast cancer. There appeared to be no benefit to taking more than 75 milligrams daily - roughly the amount in a European dose of baby aspirin and a bit less than the baby aspirin dose in the U.S.

The analysis left out a high-quality experiment that tested aspirin every other day in nearly 40,000 U.S. women. No reduction in cancer risk was seen except for lung cancer deaths in that trial.

No funding was provided for the new Lancet analysis but several of the authors have been paid for work for companies that make aspirin and similar drugs.

Scientists said it would take some time to digest the study results and figure out which people should take aspirin.

Eric Jacobs, an American Cancer Society epidemiologist, called it a "major contribution" and said the study results, in addition to previous research, suggested aspirin's effects on the risk of dying from several cancers "appear likely."

Others said the study wasn't strong enough for doctors to start recommending aspirin.

"I definitely think we wouldn't want to make any treatment decisions based on this study," said Dr. Raymond DuBois, a cancer prevention specialist who is provost of the University of Texas M.D. Anderson Cancer Center.

One concern is that the studies were designed to look at cardiovascular risks, so the groups of people being compared may differ on things that affect cancer risk, such as family history of the disease. DuBois also questioned drawing conclusions about people's cancer risk beyond the several years they were tracked.

Aspirin has long been recommended for some people with heart problems. But it can have serious side effects, like bleeding in the stomach and intestines, and poses risks in groups like the elderly who are prone to falls.

"Balancing the risks and benefits of aspirin is really important and probably something that needs to be done on an individual basis," said Ed Yong, Cancer Research U.K.'s head of health evidence and information. He was not linked to the study.

"If anyone is considering aspirin on a regular basis, they should talk to their doctor first," Yong said. He warned people should not think of aspirin as a guarantee against cancer and other prevention strategies like not smoking and keeping a healthy body weight were essential.

A U.S. health task force specifically recommends against aspirin for people with an average cancer risk.



December 2, 2010

As our temperatures drop around Northeast Florida, make sure you keep your family safe with these tips from the National Fire Protection Association:

Heating safety tips
Heating equipment is a leading cause of home fire deaths. Almost half of home heating equipment fires are reported during the months of December, January, and February. Some simple steps can prevent most heating-related fires from happening.
Safety tips

•Keep anything that can burn at least three feet away from heating equipment, like the furnace, fireplace, wood stove, or portable sapce heater.
•Have a three-foot “kid-free zone” around open fires and space heaters.
•Never use your oven to heat your home.
•Have a qualified professional install stationary space heating equipment, water heaters or central heating equipment according to the local codes and manufacturer’s instructions.
•Have heating equipment and chimneys cleaned and inspected every year by a qualified professional.
•Remember to turn portable heaters off when leaving the room or going to bed.
•Always use the right kind of fuel, specified by the manufacturer, for fuel burning space heaters.
•Make sure the fireplace has a sturdy screen to stop sparks from flying into the room. Ashes should be cool before putting them in a metal container. Keep the container a safe distance away from your home.
•Test smoke alarms monthly.


December 1, 2010

'Don't Tread on Me' License Plates Become a Growing Trend
Fans of the Gadsden Flag may soon be able to display its familiar rattlesnake and "Don't Tread on Me" message every time they pull out of the driveway. At least three states -- Virginia, Nevada and Texas -- are weighing or have already approved proposals to add "Don't Tread on Me" specialty license plates to their state rosters.


November 22, 2010

FDA Pulls Common Pain Med Off the Market (From CNN.com)
Washington (CNN) -- The pharmaceutical company that makes the prescription pain medications Darvon and Darvocet has agreed to withdraw the drugs from the U.S. market at the request of the U.S. Food and Drug Administration, the FDA said Friday.

The FDA says the drug, propoxyphene, puts patients at risk of potentially serious or fatal heart rhythm abnormalities. Since 2009, 10 million people have been prescribed some form of the drug.

"We recommend to physicians stop prescribing the drugs. As for patients, do not stop taking it, but we urge you to contact your health care professional. Do not delay," said Gerald Dal Pan, director of the FDA's Office of Surveillance and Epidemiology.

Xanodyne Pharmaceuticals Inc. manufactures Darvon and Darvocet, two brand name versions of propoxyphene. The FDA also asked generic makers of the pain medicine to voluntarily remove their products.

The decision to remove the drug came after the FDA reviewed a new trial study that looked at the drug's impact on heart rhythms.

"The drug's effectiveness in reducing pain is no longer enough to outweigh the drug's serious potential heart risks," the FDA said in a statement released Friday.

Propoxyphene, first approved by the FDA in 1957, is an opioid used to treat mild to moderate pain. It is sold under various names both alone, such as Darvon, or in combination with acetaminophen, such as Darvocet.

Since 1978, the FDA has received two requests to remove propoxyphene from the market, but concluded that the benefits of propoxyphene for pain relief at recommended doses outweighed the safety risks.