FDA Getting Kickbacks For Favorable Evaluations?

“Pharmalot” blog reports on an analysis conducted by the

Journal that revealed that many of the physicians and

other professionals who sit on FDA advisory panels to review

medical devices have financial ties to manufacturers,

although the agency has refrained from disclosing the

relationships. The analysis reviewed panels from 2012

through 2014, and found that of the 122 people who sat on

the panels evaluating devices, one-third received some form

of compensation, including money, research grants or travel

and food from companies. Additionally, almost 10% of FDA

advisers received compensation directly from the specific

company whose product was up for evaluation. The

regulatory agency only disclosed 1% of the connections. FDA

Associate Commissioner Jill Hartzler Warner explained to the

Journal, “If you have a financial interest with a sponsor or a

related firm, but it’s not related to the product at the meeting,

it’s not disqualifying.”

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.

Boston Scientific Mesh Case hit with $73.5 million jury verdict

 

 

 

How the mesh case verdict was decided!

A jury hit Boston Scientific with $73.5 million in damages this week in one of thousands of suits the device maker faces over an implant intended to treat incontinence.

The verdict in a Dallas court is part of a recent overload of product-defect and failure-to-warn litigation the device industry faces over similar products. Boston Scientific, which had won two similar suits in Massachusetts, has 23,000 more pending against it.

 

The plaintiff in the Texas case, 42-year-old Martha Salazar, is the first to win an award against the company over alleged defects with its Obtryx sling. Salazar said she suffered nerve damage and persistent pain and infections from the vaginal implant.

 

“I think it’s a really big case,” said David Matthews, the Houston personal-injury lawyer who represented her in the two-week trial. “A woman’s life was turned upside down because of a device she was using for a minor issue of urinary incontinence.”

 

Boston Scientific, which has a large workforce in the Twin Cities, said in an e-mailed statement that it was disappointed in Monday’s ruling and vowed to appeal.

The company argued at trial that doctors’ continued widespread use of the devices shows that they understand the benefits and risks.

 

“Devices like the Obtryx serve an important public medical need,” company attorneys wrote in legal filings.

“The prevalence of their usage in the medical community demonstrates that mesh slings are beneficial to patients.”

 

Seven companies are sued

 

A total of seven companies are facing lawsuits over alleged defects in vaginal mesh devices, including C.R. Bard and Johnson & Johnson’s Ethicon subsidiary, Reuters reported. Last April, a subsidiary of Dublin-based Endo International agreed to pay $830 million to settle about 20,000 defect lawsuits without admitting wrongdoing.

 

The devices are designed to treat incontinence and the shifting of organs from pelvic-floor prolapse, which can occur with age and after childbirth. Mesh slings are supposed to support weakened or damaged internal tissues, and may be removable or permanent.

 

Salazar accused Boston Scientific of negligence for designing and marketing the flawed Obtryx device even though it had a safer alternative design before January 2011, when her doctor implanted her device. The jury agreed, and awarded Salazar and her husband, Felix, $23.5 million in compensatory damages and an additional $50 million in punitive damages.

 

The jury verdict form said the Dallas jurors decided that the company’s actions amounted to gross negligence because executives knew of the risk from the product and sold it “with conscious indifference to the rights, safety or welfare of others.”

 

Company lawyers strongly dispute the strength of Salazar’s evidence at trial. They said she failed to show the device was “unreasonably dangerous” and never proved that the company failed to warn doctors of the risks inherent in the device.

 

“As explained by Ms. Salazar’s treating surgeon, Dr. Lopez, the Obtryx is recognized by the medical community as the standard of care,” company lawyers wrote in court filings before the verdict, referring to stress urinary incontinence.