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The U.S. Food and Drug Administration is a federal regulator without a key regulatory power: Recall. blindinglight

That’s why when investigators with the agency confirmed there were high levels of a potentially lethal toxin in toddler teething tablets, there was really nothing they could do other than announce it. The manufacturer of the tablets refused to issue a recall, and the FDA was powerless to force them to do so.

This could soon change. At least, that is the hope of lawmakers supporting the Recall Unsafe Drugs Act. This measure, H.R. 1108, would give the FDA the authority to order mandatory recalls on dangerous drugs and homeopathic products. The measure would revise the current law for the FDA to be allowed to issue mandatory recalls for products it does not directly regulate. The proposed law would also give the agency the power to issue mandatory recalls of pharmaceuticals that have been shown to cause serious health consequences and/or death.  Continue reading

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A widow has filed a wrongful death lawsuit alleging her husband’s death while at work on an aerial lift doing tree removal was preventable, had it not been for alift defective lift.

Plaintiff, as representative of her husband’s estate, alleges the manufacturer of that aerial lift is liable for designing and selling defective equipment that was unreasonably dangerous.

Legal Newsline reports the product liability lawsuit stems from a fatal work accident that happened in May 2015, when decedent, working for a tree removal and maintenance service, was working as part of a team with two other men using an aerial lift to remove a tree from the site. According to reports of the incident, decedent was on the ground gathering up debris while a co-worker was working behind the vehicle when he felt it suddenly – and oddly – shake. When the co-worker investigated further, he discovered that the boom arm had collapsed. The third co-worker, who had been operating the lift, was ejected, while the aerial lift bucket violently struck decedent. He died of his injuries even before emergency medical responders arrived.  Continue reading

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A subsidiary of product manufacturing behemoth Johnson & Johnson is facing a product liability lawsuit for allegedly selling defective breast implants to unsuspecting women, causing them to suffer health woes such as muscle pain and nausea. The defective implants are reportedly made of a silicone base, and leakage has resulted in a host of problems for patients. woman

Bloomberg reports the subsidiary, Mentor Worldwide, is accused of negligence for its alleged failure to carry out proper studies of its implants. In particular, plaintiff alleges the company refused to explore potential health risks, as it was required by federal regulation agencies to do. The lawsuit, filed in a state court in California, alleges that leaks occur as a result of normal use, and the silicone in the products cause serious injury when it seeps out of the device and into the body.

You may recall that the U.S. Food & Drug Administration had forbidden any companies from selling silicone-based breast implants for nearly 15 years, beginning in 1992. The devices were shown to cause cancer and Rheumatoid arthritis. Initially, a $4 billion settlement was reached to cover all those claims, but that deal eventually fell apart and several firms filed for bankruptcy. The blanket ban on breast implants was lifted in 2006 and today, there are still only three companies – Mentor Worldwide included – that are permitted to sell silicone-based breast implants. Last year, the total market for breast implants nationally topped nearly $640 million. According to the American Society of Plastic Surgeons, about 8 in 10 women undergoing breast implant procedure choose to have the silicone-based product. Continue reading

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An alleged vehicle defect of the throttle caused a motorist to suffer personal injuries when the car rapidly decelerated without warning, according to a proposed class action lawsuit filed in a federal court in California recently. speedway

The lawsuit further asserts the auto manufacturer, Ford, was aware of this defect for years and failed to warn consumers about it.

Plaintiff asserts that the defective electronic throttle body control systems decelerate both suddenly and unintentionally, causing a potentially fatal error. The design flaw allegedly extends not just to the 2012 Ford Explorer, which is what plaintiff was driving at the time of this reported incident, but also to other models of Ford, Lincoln and Mercury vehicles. Rather than own the error and make consumers aware of it, plaintiff says, defendant manufacturer has publicly downplayed the potential danger and has refused to offer to fix the alleged defect or to reimburse vehicle owners for the cost of necessary repairs. Continue reading

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Tesla Motors has come under fire in the last year after a series of collisions – one fatal – that involved the use of its Autopilot assisted driving system. The question is whether Tesla improperly deployed and marketed this system, which despite the name still does require substantial involvement from the driver. steering wheel

The aggressive “beta-test” of its Autopilot self-driving technology forced government regulators to step in, with input from other car manufacturers, to consider how human drivers should interact with increasingly more sophisticated vehicles and whether the advancements were simply too much too soon. A recent analysis by Consumer Reports magazine urged Tesla to disable the automatic steering feature until either the software is updated to require drivers’ hands on the steering wheel or else until no driver involvement is required at all.

CNN reported federal auto safety investigators with the National Highway Traffic Safety Administration (NHTSA) cleared Tesla of having an inherent vehicle defect resulting in a fatal car accident in Florida in which Autopilot system was engaged, but failed to detect an oncoming white tractor-trailer against the brightness of the mid-day sky. The Autopilot system was built to keep a vehicle in its own lane, and the car is capable of braking on its own. The feature is designed to be used on limited access highways with on- and off-ramps and not, as decedent driver was using it, on roadways where cars or trucks can cross in front of the Tesla.  Continue reading

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With the goal of helping to reduce child injuries and deaths, the U.S. Consumer Product Safety Commission recently rubber-stamped updated federal safety guidelines for infant carriers, specifically of the sling variety. This mandatory standard applies to those sling carriers caregivers wear to transport a single infant or toddler, usually up to 35 pounds, though some go up to 50 pounds. mother

The designs can range from hammock-like products that are mostly unstructured and hang from the caregiver’s body to a wrap of fabric that girds around the adult’s body. The caregiver wears the carrier, and once the child is inside, he or she is supported by either one or both shoulders of the adult. The carrier can be used either in front or in back, either with the child facing away or toward the adult, or else reclined in the front.

Updated federal safety standards are based on the most recently updated standard voluntarily adopted by the industry and outlined by ASTM International. However, there is an additional requirement regarding label attachments. ASTM F2907-15 is the standard, and it establishes the performance requirements, testing methods and manufacturing requirements that must be met in order to ensure that use of these sling carriers is safe.  Continue reading

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Some products are dangerous even when manufactured correctly. For example, when a mining company buys a stick of dynamite and a blasting cap, there is no question that this product is capable of exploding and causing serious damage or loss of life, even when used correctly.  If the product wasn’t capable of exploding, it would not be of any value to the mining company, so they wouldn’t buy it.

tobaccoThe same could be said about a chainsaw.  While it won’t explode if manufactured correctly, it is definitely dangerous and capable of inflicting serious injury or death.  If it wasn’t, it would not be able to make quick work of a log or tree as it was designed to do.  In other words, some products are inherently dangerous, and as long as it was not unreasonably dangerous, defectively designed, or the company did not adequately warn consumers of the proper way to the use the item safely, the company may not be liable for any personal injuries. Continue reading

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According to a recent news article from KXAN, one of the side effects of using testosterone replacement therapy (TRT) drugs is that it has been shown to lower a patient’s sperm count.  This reported side effect has been especially pronounced with topical testosterone creams.

sadWith testosterone replacement therapy becoming such a big business, there are a variety of competing products on the market, and these products come in many forms.  There are oral medications, a film that is placed under the tongue, a stick deodorant, injectable testosterone and of course topical skin gels and creams. Continue reading

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A federal judge in Illinois is overseeing a multi-district litigation action against the maker of testosterone replacement therapy drugs, with plaintiffs alleging the treatment caused them to suffer heart ailments. The litigation has been ongoing for some time – and is still not at the trial phase. doctor

The MDL represents hundreds of men who say they were harmed by the company’s failure to warn of this possible risk.

Now, the judge in the U.S. District Court for the Northern District of Illinois issued a ruling that will work to plaintiffs’ advantage at future trials. The judge ruled that plaintiffs’ expert medical witness, a doctor who penned the rebuttal report for plaintiffs’ steering committee, only be allowed to submit a portion of that report. The San Jose State University professor authored a report in October, which included citations of a number of cross-studies. Defendant argued there should be a limitation on how many of those studies the expert witness could use in his report.  Continue reading

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Total knee replacement is now one of the most common elective surgical procedures in the United States, with over 300,000 implants conducted each year.  With this rise in popularity comes a lot of advances in the manner in which surgeons perform the operations.

surgerySome of these advancements include the use of robots to perform the surgery and the use of computer mapping scanners and software and even 3D printers to make the artificial knee implant.  We are also seeing a lot of different advances being made by the medical device manufacturers. Continue reading