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Showing posts with label cancer. Show all posts
Showing posts with label cancer. Show all posts
Wednesday, October 28, 2015
Thursday, October 15, 2015
QLasers False Claims Verified
A permanent injunction has been granted to the Food and Drug Administration (FDA) against Robert “Larry” Lytle, doing business as QLasers PMA and 2035 PMA based on evidence of false and misleading claims regarding the health benefits of these lasers, which in some cases, reportedly cause health problems.
According to the complaint for injunction filed by the Department of Justice on behalf of the FDA, Lytle has been manufacturing and distributing QLaser devices for more than a decade and markets the devices through private membership associations. Lytle and his businesses promote the devices with false and misleading claims that they treat cancer, cardiac arrest, HIV/AIDS, diseases and disorders of the eye and ear, venereal disease, diabetes and many other health conditions.
Although the FDA cleared two of the QLaser devices for providing temporary relief of pain associated with osteoarthritis of the hand (as diagnosed by a physician or other licensed medical professional), the FDA has not cleared or approved any of the devices to treat any other medical conditions. Further, as demonstrated by the evidence presented at trial, use of the QLaser devices according to the labeling could be dangerous to the health of the consumer.
Tuesday, April 7, 2015
Power Morcellation Causing Uterine Cancer!!
In November of 2014, the U.S. Food and Drug Administration (FDA) issued an updated Safety Communication regarding power morcellation and its alleged link to uterine cancer.
Power morcellation is a type of technique used in laparoscopic surgery. Laparoscopic surgery is a type of surgery wherein surgeons use small, specialized tools to perform the bulk of the procedure inside the patient’s body. This allows surgeons to cut through less healthy tissue, shortening recovery times and making surgery an option for many patients who would be too weak for regular invasive surgery. One of the few downsides to laparoscopic surgery is that in some procedures, like hysterectomies, surgeons must remove large tissue from the body through the small incisions, which has created the necessity for power morcellation.
Power morcellation is a type of laparoscopic procedure where surgeons use a power morcellator to cut tissue into pieces small enough to be removed from the body. But there are growing concerns regarding morcellation cancer, a dangerous side effect of using these convenient medical devices.
The FDA’s November morcellation cancer statement was an update to earlier safety communications from earlier in 2014 on the subject of power morcellation. In this statement, the FDA strongly recommended against the use of power morcellators for hysterectomies because of concerns regarding uterine cancer.
A common reason for the use of power morcellation in hysterectomies is due to the presence of uterine fibroids, a type of benign tumor. However, post-surgical reports have strongly suggested that the many women whom have uterine fibroids may also have malignant cancer cells bound up within the fibroids that have gone undetected. The process of power morcellation is alleged to liberate these cancer cells and spread them within the abdomen, a condition known as morcellation cancer. How far the cancer cells spread is a major predictor of how severe a case of cancer is.
The FDA has advised patients who have had robotic hysterectomies to be vigilant for signs of morcellation cancer and undergo follow-up testing. The FDA has also recommended strongly against the use of power morcellators in hysterectomies and related procedures since this discovery. The FDA, however, stopped short of a full ban on power morcellators, stating that further evidence was needed to justify a full ban. However, the FDA did issue new boxed warning that power morcellators shouldn’t be used to remove uterine fibroids.
Power morcellation lawsuits have been filed by women who developed advanced uterine cancer after their uteruses were removed by power morcellation. Power morcellation lawsuits typically allege that the makers of power morcellators were aware—or reasonably should have been aware—of the risk of morcellation cancer associated with their medical devices. Morcellation cancer lawsuits typically seek to recoup the costs of medical care, lost wages, and other costs allegedly linked to morcellation cancer.
Tuesday, September 23, 2014
Doctor Treating Non Cancer Patients With Chemotherapy
Dr. Farid Fata, a 49-year-old Michigan cancer specialist, pled guilty on Tuesday to administering medically unnecessary anti-cancer drugs and filing fraudulent Medicare claims. Besides health care fraud (19 counts), Fata’s indictment included conspiracy to pay and receive kickbacks (one count), unlawful procurement of naturalization (one count), and money laundering (two counts). Fata pled guilty to 16 out of the 23 counts against him. “It is the most aggravating case of health care fraud,” said U.S. Attorney Barbara McQuade, “that I have ever seen.” McQuade explained that this case is in an entirely different league than other healthcare fraud cases because patients were not simply billed for either extra or unreceived treatments but that Fata was “using [patients] as commodities in order to make money.”
According to federal prosecutors, Fata billed Medicare for more than $225 million for the six-year period of August 2007 to July 2013. Fata received as much as $91 million, and netted around $35 million in the fraud scheme. Fata was apparently looking for places to stash the money, including a furnished castle in Adma, Lebanon for $3,000,000. Fata, a native of Lebanon, wrote to his financial advisor in August of 2010 requesting that the advisor “pls get in contact with my dad and go see the house!”
The 2013 federal indictment accuses Fata of the “deliberate misdiagnosis of patients as having cancer to justify unnecessary cancer treatment” and administering chemotherapy to “end-of-life patients who will not benefit from the treatment.” Fata similarly fabricated other diagnoses such as anemia “to justify unnecessary hematology treatments.” Fata owned Michigan Hematology Oncology (MHO), which serviced about 1,200 patients in several offices within the suburban Detroit area.
A nurse practitioner who began working for Fata in 2009 told FBI agents that one patient at MHO fell and hit his head, and that Fata said the patient “must receive his chemotherapy before he could be taken to the emergency room.” The patient was taken to the emergency room after his chemotherapy but later died as a result of his head injury. Several civil suits have been filed against Fata. One of those suits alleges the intentional misdiagnosis of 78-year-old Donald Virkus, who was referred to Fata for a case of possible esophageal cancer. His daughter Donna said that a review of his medical file shows Donald did not have cancer but was administered chemotherapy for a period of two years. Because of the chemotherapy, Mr. Virkus developed a blood-related cancer that caused his death. In another suit, Dave Kroff alleges he was prescribed years of unnecessary chemotherapy, of which the immune-suppressing effects caused him to lose both his legs. Attorney Donna MacKenzie, who has filed several of the civil suits against Fata, believes that there were “a number of players who either knew or should have known what was going on.” Along with Fata, the civil suits target other doctors and nurses in Fata’s practice.
In addition to other doctors and nurses allegedly knowing what was going, a complaint against Fata had been filed in 2010 with the Michigan Department of Licensing and Regulatory Affairs by an oncology nurse who spent a mere 1.5 hours in one of Fata’s offices. Angela Swantek said that she was offered a job but quickly left the office “disgusted with what I observed.” Said Swantek, “I thought, ‘This is insane.’” Sitting in the parking lot, Swantek “was truly almost in tears just because of what I saw.” The following year, in 2011, investigators notified Swantek that they had found no wrongdoing.
Many of the people filing civil suits wonder why Fata was not charged with murder. Liz Lupo, whose mother died after being treated by Fata, reasons that if Fata has admitted knowingly administering drugs that are toxic even when needed, let alone not needed, then he should be charged with murder. U.S. Attorney Barbara McQuade said that the evidence found by investigators was not enough to charge Fata with murder.Fata faces sentencing in February of 2015. The government seeks a life-in-prison sentence. The prison sentences he faces according to the crimes he has admitted to are twenty years plus a $5 million fine for money laundering, ten years for health care fraud, and five years plus a $250,000 fine for conspiracy to receive kickbacks.
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