Category Archives: Product Liability

Questionable History of the Bard IVC Filter

Bard G2 IVC Filters have been linked to countless health complications. The cage-like device, meant to prevent pulmonary embolism, is implanted into the interior vena cava and is meant to stop the migration of blood clots into the lungs, according to the website of Habush Habush Rottier. However, the history behind the device and the company, C.R. Bard, has been littered with controversy and 921 FDA reports of complications linked to the device.

C.R. Bard released an earlier filter model known as the Recovery IVC Filter in 2003. However, as reports of fracture and migration of the device began to surface, C.R. Bard replaced the device with the Bard G2 IVC Filter. The company claimed the device had less of a risk of migrating and fracturing into other parts of the body, but still reports of the same deadly health complications began to occur. Many accused Bard of knowing of the risks and failing to properly warn patients or recall the product. It is suspected that as early as 2003, Bard’s own tests showed the deadly risks of their device. Although there are numerous accounts of C.R. Bard being aware of the dangers of their devices, no action was taken.

When the devices become fractured or lodged into other major organs in the body, individuals can experience deadly complications such as perforation of the lungs or strokes. Patients may seek to have the device removed, but many times surgically removing the filter and its parts from a patient can be too risky for a doctor to perform, leaving a victim with these life-threatening problems. Even after these risks became apparent, the Bard Company continued to market the device to doctors and hospitals. Now, as lawsuits continue to pile up against the company, it is clear that the Bard G2 IVC Filter has proven devastating for many individuals implanted with the device.

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Da Vinci’s Safety Record is “Exemplary,” Intuitive Says

“The ‘Apple’ of the medtech sector.” This is how Suraj Kalia, a Northland Capital analyst, described Intuitive Surgical’s robot, the da Vinci Surgical System. Intuitive believes that the robot is the answer to some of the inadequacies of open surgery, such as fast recovery and fewer blood losses.

Since its release in the year 2000, sale of the robot, which costs $1.5 million each, has continued to increase, while surgeries where it has been used has already climbed to 450,000 last year. Though doctors, who are seated a few feet away from the patient as they operate the robot through the use of consoles, miss that tactile feel (actual feeling the tissues in their hands during surgery), the enlarged 3-D and clear vision, without the pool of blood, compensates for everything.

Despite the growing concerns about the robot’s safety and the reported adverse events involving it, surgeons, worldwide, agree that, in the hands of well-trained or well-experienced surgeon, the machine is generally safe. Intuitive even stated that the robot’s safety record is unquestionably “exemplary,” considering the millions of yearly surgical procedures where it is used.

Nevertheless, some people have sustained severe injuries at the hands of inexperienced or ill-trained da Vinci operators. If you or someone you know has been hurt because of a robotic surgery mistake, you may be able to hold the responsible party accountable through a lawsuit.

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Slight Improvement on Bayer’s Situation with Yaz and Yasmin Litigation

A German drug manufacturer has been hit hard with thousands of lawsuits for its defective birth control product, but the situation is improving as the number of complaints taper off.

Bayer has been the focus of more than 13,000 lawsuits filed by users of oral contraceptive products Yaz and Yasmin, which contains drospirenone, a synthetic hormone, in combination with ethinyl estradiol. It has also been used “off-label” to prevent acne and some forms of severe premenstrual syndrome.

Numerous studies indicate that drospirenone increases the risk for developing blood clots by as much as 74%, which in turn can induce strokes, deep vein thrombosis or pulmonary embolism. This was confirmed by a study conducted by the Food and Drug Administration in 2011. Use of the drug declined sharply when the findings were published even as the number of lawsuits increased.

Recently, however, it seems that the influx of new cases is finally slowing down, although the company is still busy coping with existing litigation. This is good news for the beleaguered pharmaceutical company. On average, Bayer paid out $207,000 per case in settlements, for a total of more than $1.4 Billion.

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Robotic Surgery: Medical Malpractice or Product Liability?

When one gets injured while under the surgical knife, the first thing that comes to mind is medical malpractice. But what if the knife was actually being wielded by a robot? This is more likely to fall under product liability if the injury is a result of a manufacturing or design defect rather than surgical error.

Science fiction has once again become simply science with the growing popularity of robotic surgery. There are many advantages to using robots in surgery. Aside from the wow factor, robot arms don’t get tired even after hours of surgery, so there are fewer accidents that happen on the operating table. Using robots also allows surgeons to be more precise when they work, which is important when dealing in micro-millimeters rather than centimeters. It also makes invasive procedures less so by requiring smaller incisions.

The technology has been around for some time, and many hospitals are jumping on the bandwagon because it looks good on their brochures to offer such high technology options to their patients. Unfortunately, there are some bugs to the technology that has led to some serious injuries to patients. The most well-known robot assistant in surgery is the da Vinci surgical system manufactured by Intuitive Surgical Inc., which is being sued by at least 25 patients for a variety of injuries caused by burns. Although it may be intimidating to go against such a big company, taking legal action in such cases is the responsible thing to do.

According to the website of Jeff Sampson, these cases are considered product liability lawsuits. Product liability is an area of law that focuses on protecting people from dangerous products. These products could be poorly designed, malfunctional, defective, or mislabeled. When they cause undue injury to ordinary people, their manufacturers can be held accountable.

It is also posited that some of the problems that may accrue from robotic surgery is related to the steep learning curve from using the technology. Doctors are simply not trained well enough to use the technology effectively, and robotic surgery is not yet well regulated. Patients who are considering robotic surgery should do their research regarding the need for such precise surgery, the consequences, and the expertise of their surgeon with the technology before consenting to the procedure.

If you have already sustained injuries due to robotic surgery, consult with a personal injury in your area to determine if your case falls under medical malpractice or product liability. Your lawyer will know how to proceed depending on the findings.

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