Articles Posted in Product Liability

Johnson Johnson Hip Replacement RecallIt was two years ago that Johnson & Johnson (J&J) recalled its ASR metal-on-metal hip devices due to the high failure rate of the implants. The recall was considered one of the most expensive medical device failures in U.S. history – and history, according to Reuters, seems to be repeating itself.

Pinnacle metal-on-metal hip implants, which succeeded the ASR implants, are experiencing the same kinds of problems as its predecessor. Pain, swelling, infection, difficulty in walking, elevated levels of chromium and cobalt in the blood, and implant failure requiring revision surgery are some of the complaints lodged in the 1,600 lawsuits currently pending against the Pinnacle metal-on-metal hip implants.

While the Pinnacle line covers non-metal models as well, it is the class of metal-on metal hip devices in general that are drawing the most scrutiny from doctors, patients, and federal authorities.
Continue reading

The U.S. Food and Drug Administration (FDA) is investigating why Fresenius Medical Care, the nation’s largest operator of dialysis centers in the U.S., failed to inform customers about the potentially lethal risk posed by one of its products.

It is estimated that the company treats one-third of the 400,000 Americans who currently receive dialysis treatment. The German-based supplies dialysis machines and products for its clinics and for many other non-company dialysis clinics as well.

In November of 2011, the company sent an internal memo to the physicians working at its clinics stating that improper use of one of its products, GranuFlo, could substantially increase the risk of patients dying of cardiac arrest.
Continue reading

Florida Food PoisoningThe maxim “you are what you eat,” may or may not be true, but when it comes to imported foods, what you eat may be putting you at a higher risk of becoming hospitalized due to a dangerous foodborne illness, according the Centers for Disease Control and Prevention (CDC).

The CDC reported that foodborne illnesses caused by imported foods rose in 2009 and 2010. From 2005 to 2010, there were 39 outbreaks and 2,348 illnesses linked to imported foods – 17 of those outbreaks occurred in 2009 and 2010 alone. According to CDC experts, the reported number of outbreaks may wildly underestimate the true total since the origin of many foods that cause outbreaks is either unknown or not reported.
Continue reading

Last year, the Florida Legislature banned the sale of “bath-salts,” – dangerous synthetic drugs that had been marketed as bath salts and were sold in head shops, corner stores, and online, where they were easily bought by teenagers. Before the ban, the products had been sold legally. But Florida authorities moved against the products, which contained the synthetic drug MDVP, because of reports of hallucinations, violent behavior, muscle damage, kidney failure, and even death associated with their use.

As a result, several forms of synthetic cathinones (bath salts) and synthetic cannabinoids (known as K2) were banned by the state of Florida. In September of 2011, The Drug Enforcement Administration (DEA) also placed an emergency ban on products that contain MDPV and methylone – key ingredients of “bath salts.”

But now, chemists have tweaked the formula to get around the law and the drugs are back in Florida.

New batches of the product are being marketed as bath salts, herbal cigarettes, and plant food, and have been implicated in the recent hospitalizations of three Charlotte County high-school students who overdosed on it. Florida lawmakers want to make it a third-degree felony to manufacture or sell the drugs in their new form.
Continue reading

With the reauthorization of the Medical Device User Fee Act (MDUFA) currently being debated in Congress, medical device industry lobbyists, congressmen, and consumer watchdog groups are locking horns in a battle for the future of medical device regulation.

The MDUFA, which has to be reauthorized every five years, requires a user fee to be levied on medical device manufacturers seeking approval for a new device. A recent agreement reached between the industry and the U.S. Food and Drug Administration (FDA) would double the current user fee level – fees the agency claims are needed to hire more qualified device reviewers and managers to speed up the approval process.

Some consumer groups are crying foul. Public Citizen, a consumer watchdog group, claims that members of Congress, influenced by powerful medical device industry lobbyists, have introduced 14 bills that aim to speed up the approval process at the expense of patient safety. They go on to state that the current approval process is far less rigorous than the one used for new drugs, and point to a study by the Institute of Medicine that concluded the FDA process used to clear 95 percent of moderate- and high-risk medical devices, and even the process for approving the highest-risk devices, fails to ensure they are safe and effective.
Continue reading

Retail giant Walmart has pulled the 12.5-ounce can of Enfamil after an infant died from a bacterial infection after consuming the product. The Associated Press reports the lot number is ZP1K7G and the product is Newborn powder formula, made by Mead Johnson Nutrition. The company can be contacted at (800) 222-9123.

Walmart pulled the product voluntarily from about 3,000 stores nationwide out of “an abundance of caution,” according to a spokesperson. The action follows the Sunday, December 18, death of a 10-day old boy from Missouri who became “gravely ill’ after drinking the formula. Tests showed he had a rare bacterial infection known as Cronobacter sakazakii. The Missouri Department of Health is investigating the death and the agency has sent samples of the formula to the Centers for Disease Control and Prevention (CDC), which is testing both the formula and the water used to make it as it’s not yet definitive which contained the bacteria. Powdered infant formulas are milk-based and Missouri health officials believe it is linked to the rare infection.

CNN reports the family said the infant was sweating profusely before he died yet he was cold to the touch. Mead Johnson says it’s confident in the safety and quality of their products.
Continue reading

Weight loss, muscle building, and sexual enhancement are the three big areas of the supplement industry that seem to attract marketers trying to make a lot of money and quickly. The U.S. Food and Drug Administration (FDA) is consistently finding those areas attract all sorts of bogus products and producers. In the latest crackdown, the FDA and the U.S. Federal Trade Commission (FTC) have sent seven Warning Letters to companies making “homeopathic” weight loss products. The products claim to contain human chorionic gonadotropin (HCG) which is found in the urine of pregnant women and in human placenta. It is approved as a prescription drug for some types of female infertility.

The letters say there are no FDA-approved uses of HCG for weight loss, according to a story by Consumer Affairs, and that it is against the law to sell the drug over-the-counter and to make unfounded claims.

The product makers claim that someone can lose 20 to 30 pounds in 30 to 40 days as the pills “reset your metabolism,” reports USA Today.
Continue reading

The Food and Drug Administration (FDA) has announced plans to make changes to the fast-track system for getting many medical devices on the market without premarket testing, but for some women the slow-acting agency announcement is too little too late. In July, the FDA issued a second, stronger-worded warning that complications from mesh may not be “rare” as the agency had previously stated in 2008. Instead there may be a 10 percent complication rate, says the FDA warning, based on adverse reaction reports coming into the agency. Those reports are believed to represent just a fraction of what occurs in the real world. The FDA will convene a panel of experts in September to discuss mesh, but in the meantime it remains on the market and it is estimated that about 75,000 women receive the medical device for pelvic organ prolapse every year.

One woman tells Florida Today about feeling like she has barbed wire inside of her after she had synthetic surgical mesh implanted to treat pelvic organ prolapse. Four women from the Melbourne area of Florida are now part of dozens of lawsuits that have been filed against mesh manufactures involving hundreds of women from 34 states. A federal judge in West Virginia is overseeing the discovery process. The lawsuits can be settled or sent back to the plaintiff’s state for a jury trial.
Continue reading

The U.S. Consumer Product Safety Commission (CPSC) which oversees the safety of all types of consumer products, has decided to toughen third party testing requirements to make children’s toys safer.

In recent years, children’s products, many imported from China, have been found to have cadmium and lead in excessive levels which can be ingested by a child. In a 5-0 vote Wednesday July 20, the CPSC approved a new testing requirement to be conducted by a third party specified by manufacturers. Toy makers have until December 31, 2011 to identify and pay for third party testing which will result in a certification.
Continue reading

On August 14th the allowable lead level in children’s toys will be lowered from 300 parts per million (ppm) to 100 parts per million. That decision came in a 3-2 vote Wednesday, July 13 by the U.S. Consumer Product Safety Commission (CPSC). The question now is what do retailers do with the inventory of children’s jewelry and toys that have too much lead paint after August 14th?

The CPSC says there is no safe level of lead. Back in 2008, the Consumer Product Safety Improvement Act required the 100 ppm limit so the CPSC phased in the reduced levels beginning with 300 ppm in August 2009.

The commission’s two Republicans complained that the additional regulations will cost business and force some to close.
Continue reading