Viagra and Mellenoma is There a Link?

Recent studies have suggested a possible link between the erectile dysfunction medication, Viagra® (Sildenafil) and melanoma, a deadly form of skin cancer often caused by extensive ultraviolet radiation exposure. Viagra®, manufactured by Pfizer Labs, was approved in 1998 by the U.S. Food and Drug Administration (FDA) to treat erectile dysfunction. Since Viagra’s inception, Pfizer has seen its annual sales of the erectile dysfunction medication reach nearly $1.9 billion.

A recent study published in the Journal of the American Medical Association indicates that men using Viagra® may be 84 percent more likely to develop the deadly form of skin cancer than men who have not used the drug. Preliminary research indicates that phosphodiesterase 5A (PDE5A) inhibitors, such as Viagra®, may increase the rapid spread of melanoma cells through a process known as “melanin synthesis,” causing the development of melanoma.

Statistical data from the American Cancer Society suggest that physicians in the United States diagnose approximately 76,000 cases of melanoma per year.  Approximately 6,400 men die each year from melanoma. The group being diagnosed with melanoma at the highest rate is men older than 49, also the target group for the erectile dysfunction drug. Researchers suggest that further investigation of the correlation between Viagra® use and melanoma is underway.

If you think you may have been affected please contact www.vanderlindenlaw.com today!

Whistleblower Settlements Summary 2014

There were a number of settlements and verdicts around the country in whistleblower cases in August. This is an area of litigation that is expanding rapidly.



COMMUNITY HEALTH SYSTEMS TO PAY $98 MILLION IN SETTLEMENT

The nation’s largest operator of acute care hospitals, Community Health Systems, Inc., has agreed to pay $98 million to settle claims that the company billed government health care programs for inpatient services that should have been billed as significantly less expensive outpatient or observation services. CHS was said to have engaged in a corporate-driven scheme to increase inpatient admissions of Medicare, Medicaid and TRICARE beneficiaries older than 65. The government further claimed that the inpatient admissions were not medically necessary and should have been provided in a less costly outpatient or observation setting.

The settlement resolves lawsuits filed by several whistleblowers under the qui tam provisions of the False Claims Act. Since January 2009, the Justice Department has recovered more than $20.2 billion through False Claims Act cases.


MCKESSON TO PAY $18 MILLION TO END CDC DRUG SHIPMENT CLAIMS

Pharmaceutical distributor McKesson Corp. will pay $18 million to settle whistleblower claims that it improperly set temperature monitors outside contractual limits when shipping vaccines for the Centers for Disease Control and Prevention . The U.S. Department of Justice announced the settlement on August 8. San Francisco-based McKesson signed a contract with the CDC in 2007 requiring it to set electronic devices in shipping containers to detect whether temperatures strayed outside a slim range just above freezing. The False Claims Act suit, filed by a former financial director, alleged the company instead set the monitors for a much wider range that would have allowed vaccines to freeze or reach room temperature without alerting personnel.

The CDC said the monitors were a backup system and that the vaccines were properly packed in insulated containers and transported at the right temperatures. McKesson maintained that the temperature monitors complied with the contract. The relator in the lawsuit, Terrell Fox, alleged that from April to November, McKesson shipped vaccines from manufacturers to health care providers and set monitors to go off only if the vaccines were colder than -1 degree Celsius and warmer than 25 degrees.
It was alleged that the vaccines were supposed to stay refrigerated and never freeze and that the correct range should have been from 2 to 8 degrees Celsius. Fox said that McKesson violated the contract and knowingly submitted false claims in an attempt to avoid liability for replacing potentially ruined vaccines. The vaccines shipped by McKesson were intended for children. 

VASCULAR SOLUTIONS SETTLES FALSE CLAIMS ACT CASE

Vascular Solutions (VSI) will pay $520,000 to resolve allegations that it caused false claims to be submitted to federal health programs by marketing a medical device for the ablation (or sealing) of perforator veins without U.S. Food and Drug Administration (FDA) approval and despite the failure of its own clinical trial. VSI, a medical device company based in Minneapolis, Minn., markets and sells medical devices that treat varicose veins by sealing the veins with laser energy – endovenous laser ablation. Their products include consoles, which generate the laser energy, and accessory kits.
In 2010, DeSalle Bui, a former Vascular Solutions salesperson, sued the company. The U.S. Attorney’s Office in Texas subsequently intervened in the case. The lawsuit accused VSI of “off-label promotion” of its Vari-Lase products, saying the company marketed the product for the treatment of perforator veins despite the fact that it wasn’t approved for such uses. The lawsuit alleged that the improper promotion of the product, as well as kickbacks that VSI paid to physicians, caused the government to lose roughly $20 million, as health care providers submitted claims to government programs such as Medicare.


JURY AWARDS $730,000 IN WHISTLEBLOWER LAWSUIT

A jury has returned a $730,000 verdict in favor of a whistleblower who reported on an unethical pain management study on prison inmates by researchers at the University of California, Davis. Janet Keyzer, a former UC Davis administrative nurse, claimed in a lawsuit that her career was ruined when she raised questions about whether the research project on physically and mentally disabled inmates at San Quentin Prison had obtained consent from its subjects. The Superior Court jury’s verdict was in favor of the 59-year-old Keyzer. She had worked for the university’s Center for Healthcare Policy and Research for more than nine years at the time of her termination in 2007.

Whistleblower-Rules To Live By

 

WARNING: If you believe your employer or individuals at your work place are committing federal fraud, DO NOT communicate with us from your company e-mail, computers, fax, phone or any communication device.

If you have information about fraud taking place in your workplace, we can help you resolve the problem without risking your job, your health, or your family. There may also be a substantial cash reward for reporting the fraud, sometimes in the millions of dollars. But we can’t help you if you get fired for calling us or emailing us from your workplace.

Because we cannot guarantee that your employer is not monitoring your communications, we recommend contacting us from your home telephone or computer. We can help you if you are worried about what will happen because you did the right thing and reported potential fraud, but there is no need to take unnecessary risks.

So please, be safe and use your home computer or telephone to talk with us. We’re here to help.

SPAM--IF IT DOES THIS KIND OF DAMAGE TO THE PROCESSOR WHAT'S IT DOING TO THE CONSUMER?

 

On the cut-and-kill floor of Quality Pork Processors Inc.in Austin, Minnesota, the wind always blows from the open doors at the docks where drivers unload trailers of screeching pigs, through to the "warm room" where the hogs are butchered, to the plastic-draped breezeway where the parts are handed over to Hormel for packaging, the air gusts and swirls, whistling through the plant like the current in a canyon. In the first week of December 2006, Matthew Garcia felt feverish and chilled on the blustery production floor. He fought stabbing back pains and nausea, but he figured it was just the flu—and he was determined to tough it out. Garcia had gotten on at QPP only 12 weeks before and had been stuck with one of the worst spots on the line: running a device known simply as the "brain machine"—the last stop on a conveyor line snaking down the middle of a J-shaped bench [DC] called the "head table." Every hour, more than 1,300 severed pork heads go sliding along the belt. Workers slice off the ears, clip the snouts, chisel the cheek meat.

 

Matthew Garcia

 

They scoop out the eyes, carve out the tongue, and scrape the palate meat from the roofs of mouths. Because, famously, all parts of a pig are edible nothing is wasted. A woman next to Garcia would carve meat off the back of each head before letting the denuded skull slide down the conveyor and through an opening in a plexiglass shield.
On the other side, Garcia inserted the metal nozzle of a 90-pounds-per-square-inch compressed-air hose and blasted the pigs' brains into a pink slurry. One head every three seconds. A high-pressure burst, a fine rosy mist, and the slosh of brains slipping through a drain hole into a catch bucket. (Some workers say the goo looked like Pepto-Bismol; others describe it as more like a lumpy strawberry milkshake.) When the 10-pound barrel was filled, another worker would come to take the brains for shipping to Asia, where they are used as a thickener in stir-fry..

Garcia inserted a compressed-air hose

 and blasted the pigs' brains into a pink slurry.

 One head every three seconds

Tasks at the head table are literally numbing. The steady hum of the automatic Whizard knives gives many workers carpal tunnel syndrome. For eight hours, Garcia stood, slipping heads onto the brain machine's nozzle, pouring the glop into the drain, then dropping the empty skulls down a chute. By early December, Garcia would return home spent, his back and head throbbing. But this was more than ordinary exhaustion or some winter virus. On December 11, Garcia awoke to find he couldn't walk. His legs felt dead, paralyzed. His family rushed him to the Austin Medical Center.
Doctors there sent Garcia to the Mayo Clinic in Rochester, about an hour away. By the time he arrived, he was running a high fever and complaining of piercing headaches. He underwent a battery of exams, including MRIs of his head and back. Every test revealed neurological abnormalities, most importantly a severe spinal-cord inflammation, apparently caused by an autoimmune response. It was as if his body was attacking his nerves.
By Christmas, Garcia had been bedridden for two weeks, and baffled doctors feared he might be suicidal. They sent a psychiatrist to prepare him for life in a wheelchair.

Soon after Daniel was ill 16 other employees on the same line came down with the same symptoms. All of them were eventually sent to the Mayo Clinic, where the best diagnosis for all of them was severe neurological damage. 6 of the 16 were conveniently fired for being here illegally. The other 10 learned not to admit anything because of what they had seen their co workers go through. Eventually those 10 did receive a settlement of approx. $12,500 each with continuing medical coverage, however 0 of the 10 have ever recouped to their status before these problems started.
It's scary how fast your life can change. Take nothing for granted, be aware of your surroundings and be aware of your co workers--it just may save your life!