Introduced in the 1990s, the power morcellator is a surgical tool for laparoscopic or minimally invasive procedures performed to remove noncancerous growths called uterine fibroids. Considered as one of the most common conditions to affect women in their childbearing age, uterine fibroids can cause a host of different symptoms depending its size and location. While there are instances when these growths cause little to no issues, there are also times when it can lead to heavier and more painful menstrual cycles, pain in the back and pelvic area, issues with urination, as well as complications during pregnancy. As a result, morcellators have proven to be very useful in providing women the option to undergo surgical treatment without the burden of a lengthy recovery time.
Unfortunately, it seems clear that the use of power morcellators isn’t as beneficial as the medical community once thought. As pointed out on the website of Williams Kherkher, there has been growing evidence pointing to significant dangers caused by morcellation. In particular, these safety concerns point to the fact that morcellators could potentially cause undiagnosed cancer to spread more quickly and become even harder to treat. These concerns have caused the FDA to act and issue a warning that the extreme risks outweigh any potential benefits from the use of morcellators. They offer stats to back up their assessment. The FDA estimates that 1 in every 350 patients that undergo procedures using morcellators can have undiagnosed uterine sarcoma. The process of morcellation, which involves fast-spinning blades that cut down tumors, can only spread the malignancy and cause the cancer to become even more aggressive.
At present, the FBI has started an investigation to learn more about the dangers of power morcellators. According to a report by The Wall Street Journal, Johnson & Johnson, the top manufacturer of the medical device, is included in the inquiry started by the FBI. In particular, the bureau is said to be interested in learning more about whether or Johnson & Johnson had been aware of the cancer risks linked to their product before they had pulled it out of the market in 2014.
There are more than 5,500 Granuflo lawsuits filed against German manufacturer Fresenius as of July 2014. More than 2,000 of these lawsuits with similar assertions have been consolidated into multidistrict litigation (MDL No. 2428, In re Fresenius GranuFlo/NaturaLyte Dialysate Litigation) under U.S. District Judge Douglas P. Woodlock in the District of Massachusetts by November 2014 and the first two bellwether trials have been scheduled for January 11 and February 16, 2016.
Dry acid concentrate Granuflo and its liquid counterpart NaturaLyte are solutions that are used in dialysis, a procedure undertaken to remove waste and toxins from the blood of individuals suffering from kidney failure. Granuflo side effects that pose danger to patients is associated with the higher-than-average amount of bicarbonate produced with the use of solution, which in turn can cause severe cardiovascular problems. Plaintiffs allege that Fresenius knew or should have known about this risk and failed to warn doctors and patients about it.
In fact, it is turning out that Fresenius was aware of the danger because an internal memo dated November 2011 surfaced which warned Fresenius Medical Care clinics about these dangers from overdosing with Granuflo and NaturaLyte. However, this information was not circulated to non-FMC clinics until March 2012. The Food and Drug Administration (FDA) circulated a warning to the medical community and products recalled in May 2012.
Soon after, the first lawsuits began to be filed by those who suffered injury or by family members of a patient who suffered a fatal cardiovascular event, alleging that it had been caused by using the product. According to the website of law firm Williams Kherkher, there are other side effects that may provide a basis for a product liability lawsuit against Fresenius such as metabolic alkalosis in the future. It will depend on developments in the medical and legal investigations.
Fresenius has not extended any settlement offers to plaintiffs, but legal experts anticipate that this will be a distinct possibility after the bellwether trials have been conducted. If you have been injured from Granuflo side effects, you could be eligible to seek compensation from Fresenius as well. Contact an experienced Granuflo lawyer in your area for more information.