Brain Solutions NV

Healthy Thinking

The Roles of FDA and CPSC in Public Safety

Posted by on Mar 9, 2016

Millions of people in the United States purchase different products every day, whether those things are something they want or need. Since people pay for those things with their hard-earned money, it is just right to expect that they get their money’s worth. These products are expected to be manufactured and marketed properly before they even hit the shelves, according to the website of Pohl & Berk, LLP. Unfortunately, there are products that are proven to be defective even after they’re sold. Some discover the fault in production and informs the public, and some are overlooked and only reviewed after reports of injuries surface. Fortunately, the United States government has two federal agencies that protect consumers from such situations: the U.S. Food and Drug Administration (FDA) and the U.S. Consumer Product Safety Commission (CPSC).

The U.S. FDA, a federal agency of the U.S. Department of Health and Human Services, deals with the inspection and supervision of food- and medical products. There are federal standards implemented by the FDA that manufacturers are required to follow. The product recalls are classified based on the severity of possible adverse reactions to the consumed product. Typically, once a defect is discovered by the FDA, the manufacturer is forced to stop the production until the source of the problem is known.

The U.S. CPSC, on the other hand, is the agency that handles the public’s protection from possibly dangerous consumer products, from simple dysfunctional cooking pans to faulty recreational vehicles. Cases of injuries are usually what prompt the agency or the company to recall the product, and just like the FDA, CPSC sets a federal standard for production.

Generally, if you were affected by a product and you have probable cause for filing a lawsuit against the liable party, your claim might have a higher chance of winning when the alleged product was deemed defective by these agencies.

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Recall on Millions of Vehicles in the US: The Very Reality of Auto Defects

Posted by on Oct 11, 2015

One of the very important tasks of the National Highway Traffic Safety Administration or NHTSA is to save lives by passing and enforcing traffic safety rules that will reduce road accidents, and prevent injuries and/or untimely death. The NHTSA, which is an arm of the US Department of Transportation, partly accomplishes this task by making sure that designers and makers of cars comply with federal standards on vehicle safety and excellence.

The federal government imparts on car manufacturers the major and legal obligation of seeing to it that all their vehicles, prior to leaving the manufacturing plant, will never put any lives at risk and that no unit has any defective design or has been equipped with a defective part; well, at least these are how things really should be. However, the contrary is what usually happens. This is why, in 2013, NHTSA’s records show as many as 22 million vehicles recalled by more than 10 car manufacturers due either to defective design or parts, which included seat belts, tires, steering wheel, child seats, brake pads, wipers, and air bags that just deploy despite the vehicle not crashing. There was also a case where gas leaked from the engine, thus increasing the risk of fire. Well, if it’s any consolation, the 22 million in 2013 was still quite low, considering the fact that, in 2004, vehicle recall hit a high or 30.8 million.

There are different occurrences that can lead to a vehicle recall. It can be: through an investigation by the NHTSA to confirm complaints filed by consumers; the manufacturers making the recall themselves after discovering the defect; or, through reports (from insurance companies) that are received by the NHTSA or by the manufacturers of the cars that most frequently figure in accidents. Many times, however, recalls only happen after customers find out about the defect. Sadly though, they discover it after they themselves have been in an accident, wherein they suffer often fatal injuries.

As mentioned in a website, called Cazayoux Ewing Firm, a car accident can result to serious and long-lasting physical and emotional consequences especially for the victim and his/her family. And while it is true that the effects of injuries sustained in it can no longer be undone, vehicle defects should be taken into serious importance in order to limit these issues in the future.

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Too Little, too Late for Some Morcellator Patients

Posted by on Jun 14, 2015

The side effects of morcellators were apparently known long before the Food and Drug Administration (FDA) issued its first official warning in 2014. This is a disturbing revelation for those who are already suffering the consequences as patients or their families.

Power morcellators were considered an important breakthrough back in 1991 for routine hysterectomies or myomectomies because it was minimally invasive. The device was a drill-like apparatus that could slip through a 2-centimeter incision or through the vagina canal to remove and excise uterine fibroids or other abnormal tissue. This method was more efficient and clean than traditional surgical methods for the surgeon, and the healing time was quicker for the patient. About 600,000 hysterectomies are performed in the US every year. Morcellation understandably became the method of choice for many gynecologists.

However, doctors noticed as early as the late 1990s that tissue fragments often were left behind, and in 2003 there were indications that at least some of these fragments may have been malignant. It is standard practice in most surgical procedures to use a surgical bag to contain suspect tissue—uterine fibroid are usually benign, but not always—but this was not the case with morcellators. This is because manufacturers did not include a surgical bag as part of the device’s equipment nor warn doctors about the risks, so doctors believed the risk was low.

These two things contributed greatly to the number of preventable deaths and cases of uterine sarcomas that developed over the years. As it is turning out, the risks are very high; to the tune of one in every 350 cases, in fact. Considering that about 12% of 600,000 women chose morcellation for their procedure, this means that of the 72,000 or so patients every year, about 200 women will end up with uterine cancer. Since morcellators has been in use since 1991, a conservative estimate would still put these preventable cancers in the thousands.

If you suffered serious injury or loss from power morcellators, you are not alone. You have the right to sue for compensation, just as others have done, because the manufacturers failed in their duty of care. Contact a competent morcellator lawyer in your area as soon as possible to get the best possible assessment of your case.

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