Product Liability

Consumer safety groups want to know if the U.S. Food and Drug Administration (FDA) actually looked at safety data before declaring silicone breast implants safe last year. The Washington Post quotes the National Research Center for Women and Families in a January 4 story stating that one in five, or 20 percent, of women will have to have their silicone breast implants removed and/or replaced within five years because of complications. The FDA decided last summer that silicone implants are basically safe, but that women must understand what can go wrong. An outside FDA panel of experts echoed the same conclusion and decided the controversial implants should stay on the market.

In a letter to the FDA, the group’s president asked why industry shows a decline in complications in silicone breast implants over time, and also questioned why the FDA did not share information from industry studies that show women seem to suffer a reduction in emotional and physical well-being after they’ve had the implanted breast medical devices.

The controversial implants are made by Allergan Inc. and Mentor, a division of Johnson & Johnson, who provided the FDA with data on safety and effectiveness in an eight and 10-year study.

Silicone gel breast implants have been controversial for more than 20 years. They were banned from the market in 1992 for fear the defective implants might cause cancer or auto-immune diseases. From 1992 to 2006, only saline implants were available for women who wanted to enhance their breast size or who requested implants following breast surgery. But silicone-filled implants returned to the market in 2006 with the FDA requiring the manufacturers to conduct post-implant studies.

A product is considered defective if it causes harm to the user. A defect can be in the manufacturing of the product, its design, or in its marketing. Farah & Farah’s Florida product liability attorneys understand how to determine where the defect exists and hold the manufacturer and those in the line of distribution responsible for your injuries.

Source: http://www.washingtonpost.com/business/technology/womens-health-advocates-question-fda-about-missing-safety-data-on-silicone-breast-implants/2012/01/05/gIQA2LO4cP_story.html

Legislation was introduced in the U.S. Senate on December 14 that would require medical device makers to track their products after they are implanted in patients. As amazing as it sounds, that doesn’t happen now. And even more astonishing, many implantable medical devices do not undergo a premarket review for safety before they are sold for use.

In recent years, the Food and Drug Administration (FDA) has overseen the recall of artificial hips which are known to fail prematurely in patients. Reports of complications from defective synthetic surgical mesh have increased five-fold in recent years, according to the FDA, and still it remains on the market. Both of these medical devices were approved without scrutiny for safety under the agency’s 510(k) approval process for marketing alone. It just requires the device be “substantially equivalent” to a device already on the market.

The Institute of Medicine reported this summer that the 510(k) process is “fatally flawed’ and should be abandoned in favor of patient safety, not the marketability of products.

The bill, introduced by Herb Kohl of Wisconsin, Richard Blumenthal of Connecticut, and Charles E. Grassley of Iowa, would require medical device manufacturers to track data on the device’s performance. The legislation would also give the FDA more authority to address product recalls.

The Florida medical product liability attorneys at Farah & Farah understand that this pro-patient bill was introduced to counter the rash of legislation introduced by industry-friendly Congress members that would actually streamline FDA rules and allow products to make it to market more quickly with less regulation.

As of October, The New York Times reports about 3,500 lawsuits have been filed against Johnson & Johnson over its Articular Surface Replacement artificial hip (ASR), a metal-on-metal product known to wear out well in advance of its 15-year lifespan. An Australian report said J & J knew there were problems with the device before the company issued a recall last year.

Unfortunately for about 93,000 patients who have received the implant, they must wait and see whether their medical device will fail too.

Source: http://www.nytimes.com/2011/12/15/business/bill-would-require-more-monitoring-of-implants.html?_r=2&scp=1&sq=medical%20devices&st=cse; http://www.bloomberg.com/news/2011-12-15/medical-devices-need-tracking-after-fda-clearance-senators-say.html

The news website Fair Warning reports that a chemical found in common household products, as well as a contaminant in groundwater, has been linked to Parkinson’s disease (PD) in a new study.

Published in the Annals of Neurology, the study looked at 99 sets of twins in which one of the twins suffered from Parkinson’s disease, a neurological disorder that is progressive and causes uncontrollable shaking. The study was conducted by the Parkinson’s Institute and Clinical Center (PI) in Sunnyvale, California, and after evaluating both of the twins’ exposure to environmental settings, researchers found that the twin who worked around or was exposed to trichloroethylene (TCE) had six times the risk of developing the disease. Other solvents have been linked to Parkinson’s, including perchloroethylene (or PERC) and carbon tetrachloride (or CCI4).

How does one encounter these hazards?

TCE is found in dry-cleaning and carpet solutions, adhesives, paints, and as a grease remover for industry. The U.S. EPA (Environmental Protection Agency) has declared it a human carcinogen, but because of its extensive use it is found in up to 30 percent of drinking water in the U.S., as well as soil and air. Even if you don’t work around these chemicals, you are exposed through common household products such as carpet cleaners, paints, glues, and spot removers. Millions of pounds of these solvents are still released into the environment each year.

The study researchers caution against making a direct link between chemical exposure and Parkinson’s disease and say the results need to be replicated in other studies, though environmental exposure has long been thought to be linked to PD. The product liability lawyers in Jacksonville of Farah & Farah can help if you have been injured or become ill due to a dangerous or defective product. Please call (800) 533-3555 for a free consultation.

Source: http://www.fairwarning.org/2011/11/common-household-solvent-linked-to-parkinsons-disease/;http://www.thepi.org/index.php?src=gendocs&ref=Solvent_Exposures_and_Parkinsons_Disease_Risk_in_Twins&category=News_Events&submenu=NewsEvents

A New Jersey company has been fined $1,100,000 by the Consumer Product Safety Commission (CPSC) for failing to report a defective toy dart gun set. Manufacturers are required to report product failures to the federal agency immediately after they hear of a defective product and/or an injury that results from the product.

The CPSC says that manufacturer, Henry Gordy International Inc., misrepresented to the CPSC what it knew and when it first knew the toy dart set was defective.

In this case, the toy darts can be inhaled by a child causing him or her to choke and there were three deaths associated with the toy, which was sold at Family Dollar Stores between 2005 and 2009. A toy recall of about 1.8 million of the dart gun sets occurred in May 2010 after the company initially refused to recall the $1.50 item.

Under federal law, a manufacturer, retailer, or distributor must report within 24 hours any risks that consumers encounter with products such as choking, breaking, exploding – anything that endangers a consumer. If you are endangered by a product that is regulated by the CPSC such as toys, power tools, cribs, or household chemicals, among other consumer products, call the agency’s hotline at (800) 638-2772 to report the injury.

Product Liability Law

Under Florida’s product liability laws you can hold the manufacturer, distributor, or retailer responsible for the injuries that result from a defective product. The Jacksonville product liability attorneys at Farah & Farah will offer you a complimentary consultation to discuss an injury that results from the use of a defective product. Call us at (800) 533-3555 so we can begin looking into your options.

Source: http://www.cpsc.gov/cpscpub/prerel/prhtml12/12010.html?tab=news

A one-year-old Jacksonville baby has been hospitalized with life-threatening injuries after being tangled in blinds near its crib. The story on the Channel 4 news website does not say if the baby was a girl or boy, only that police responded to the 4000 block of Starratt Road on the Northside around noon on Friday, October 14 and found the baby tangled in the cords. Jacksonville Fire Rescue took it to Shands Jacksonville. There is no updated word on the baby’s condition.

Let’s hope this baby survives this devastating strangulation injury. Please pray for the baby’s life.

Window Blind Dangers
Millions of blinds have been recalled by the Consumer Product Safety Commission (CPSC) after reports of strangulation or near strangulations. In some cases, a beaded chain becomes entangled around the child’s neck if the chain is not attached to the wall. In other cases, the cord that is found behind the cloth of the blind can be pulled out if it is exposed and a child can wrap him- or herself around it.

If a family is renting a home, they may not have any choice in the window coverings. However, they do have a choice in the placement of the crib to help prevent product child injuries.

According to the CPSC, about 200 children have died from becoming entangled in blind cords over the last 20 years.

The CPSC wants to tighten up standards and force manufacturers to create blinds with the cords inside the window shade and not exposed, but there is resistance from the industry. The Window Covering Manufacturers Association wants more lax standards which allow exposed cords to continue as long as they are tied down. That way the industry does not have to spend money on a total redesign of blinds and saves money.

Consumer groups argue that the plastic that ties down the cord can become dislodged or fall off the wall, leaving the cord exposed. Industry usually has the final say on standards and federal regulators are limited in their authority to issue a mandatory requirement for safety, due to amendments passed under the Reagan administration, reports the Chicago Tribune.

In this case, the CPSC’s director says the agency may require industry to follow mandatory standards.

Source: http://www.news4jax.com/news/29487205/detail.html; http://www.cpsc.gov/cpscpub/prerel/prhtml10/10261.html;