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.

Stephani LeFlore Takes On CVS Pharmacy

CVS Pharmacy's Medicaid Fraud

 

 

CVS pays $17.5 Million to settle Medicaid Fraud
CVS, the giant retail pharmacy chain, has agreed to pay $17.5 Million to settle a whistleblower lawsuit accusing it of Medicaid fraud (“welfare fraud”).

THE FRAUD
According to her False Claims Acts lawsuit, CVS pharmacist Stephani LeFlore of Minnesota brought evidence to the government that CVS used a billing system for years that was designed to overbill Medicaid on prescription charges. Ms. LeFlore is represented by Minnesota attorneys Neil Thompson, Brian Wojtalewicz, Robert Christensen, and James VanderLinden, with local counsel Aaron Halstead of Madison, Wisconsin, where the case was filed in federal court.
It was done in relation to dual-eligible customers – those legitimately on Medicaid who also maintained their private health insurance coverage. The insurance coverages required CVS to charge the insurance company a smaller amount for prescriptions, and limited co-pay from the customer. When a person is allowed Medicaid coverage, the government always obtains an assignment of the person’s rights under their private health insurance coverage. The government essentially takes over the citizen’s rights under the coverage. This includes the common right to pay a smaller co-pay amount on prescriptions.
Ms. LeFlore claimed in her federal and state lawsuits that CVS should only have billed the Medicaid program the same limited co-pay on prescriptions that it would have normally billed the customer under the insurance plan. She alleged that CVS designed a billing software program for its pharmacies that consistently overcharged Medicaid on these co-pays. She claimed that these overcharges occurred on hundreds of thousands of prescription sales for well over five years.
The $17.5 Million settlement covers over-billings by CVS in the states of Minnesota, California, Massachusetts, Michigan, Florida, Indiana, Alabama, Nevada, New Hampshire and Rhode Island.
Ms. LeFlore first complained internally, but she was told by a supervisor that “corporate took care of the billing” and that she need not be concerned. She then retained her attorneys and commenced the False Claims Acts (qui tam) lawsuit in September, 2008. The lawsuit stayed under seal (non-public), according to the False Claims Acts and court orders, until the announcement of this settlement.
Ms. LeFlore and her attorneys will receive $2,595,460.00 as the reward under the federal and state False Claims Acts. They are also entitled to receive attorney fees from CVS.

Who Is Jim VanderLinden? What Does He Stand For?

Jim VanderLinden featured on Minnesota Public Radio

 

The problem of Medicaid fraud has been in the news a lot lately in Minnesota. These small victories have only scratched the surface, as many cases of large-scale Medicaid fraud have – as of yet – continued without consequence. Minnesota Public Radio’s Mark Olson recently interviewed our own Jim VanderLinden for a report on the fight against Medicaid fraud.

St. Louis Park attorney James Vander Linden represents whistleblowers, company insiders filing claims for money recovered from employers suspected of stealing funds. He has spent years trying to recover Medicaid and Medicare dollars, and he doesn’t think the government has enough muscle to go after the big time health care fraud perpetrators.

“The real problem,” he says, “is corporate America.”

A team of lawyers including James G. VanderLinden, seated, and Robert P. Christensen, Brian Wojtalewicz and Neil P. Thompson took on Big Pharma and won. (Staff photo: Bill Klotz)

Once again, a team of Minnesota lawyers has taken on Big Pharma and won.
Neil P. Thompson, Robert P. Christensen, Brian Wojtalewicz and James G. VanderLinden recently settled a qui tam case against the pharmacy chain CVS for $17.5 million.  The whistleblower/relator, pharmacist Stephani LeFlore of Minnesota, alleged that CVS designed a billing software program that consistently overcharged Medicaid for prescription drugs.
LeFlore and her attorneys will receive $2,595,460 under the state and federal False Claims Acts, and are also entitled to receive attorney fees from CVS.  The reward is 16 percent of the settlement, a little bit more than the national average of 15.6 percent.  The amount of the attorney fee is still under negotiation.
The four lawyers also sued Walgreens in 2005 for using a billing system that cheated Medicaid. That case settled in 2008 for $9.9 million with the whistleblowers – Thompson, who is a pharmacist as well as a lawyer, and another man – receiving $1.44 million plus fees.
In the CVS case, the fraud arose in connection with customers who were on Medicaid and also had private health insurance coverage.  In the 10 states involved in the lawsuit – California, Massachusetts, Michigan, Minnesota, Florida, Indiana, Alabama, Nevada, New Hampshire and Rhode Island – CVS was supposed to charge the insurance companies a certain amount for prescriptions, with a limited co-pay charged to the customers. This limited co-pay was assigned to Medicaid.
But LeFlore, who is a pharmacist at CVS, alleged that CVS consistently overcharged Medicaid for the co-pays. She claimed that overcharges occurred on hundreds of thousands of prescription sales for over five years. To support her claims, she first gathered data from CVS’s computers, Christensen said.
LeFlore was told by her attorneys to look to see how much CVS had billed Medicaid, and then contact the state and the insurance companies to see how much CVS was entitled to.
Because the same attorneys had handled the Walgreens case, it was easier to know what to look for, Thompson said.
“She … had a tip as to what to look for, because of the previous cases,” he noted.
Once LeFlore had collected the information, she and her attorneys could run the numbers and see a pattern, Wojtalewicz said.
Before filing their case, LeFlore’s attorneys wanted to make sure they were bringing good information to the table.

“We wanted to have some of the juice before we got to the government to build up our credibility, to prove our case,” Christensen said. “Not only do we have to sell it to ourselves, we have to sell it to the government lawyers and then it has to get sold to the defendant.”
Typically, a relator files a complaint under seal. This allows the government, if it decides to intervene, to investigate though its own channels before informing the object of the investigation.  If the investigation reveals a basis for going forward, a judge partially lifts the seal and advises the defendant of the case. Then the parties may negotiate a settlement, keeping in mind that the law allows for treble damages and a penalty of $5,500 to $11,000 for each claim falsely filed, VanderLinden said.
As the case develops, the relator’s attorneys may find themselves in conflict with the government over their share.
“We often end up negotiating with the government,” Wojtalewicz said.
He said that many private lawyers who work with qui tam cases become frustrated because the federal attorneys are “smothered” in False Claim Act matters.  “We think they cherry-pick.  They take the biggest and most easily proven, and you can’t blame them.”
In this case, the government almost backed away because they didn’t think there were enough damages to make it worth pursing. But LeFlore’s lawyers persisted and the government eventually came around.
Qui tam cases are frustrating for the relator, noted Thompson, because he or she is generally still employed by the defendant.
“One of the important take-aways for lawyers … is to emphasize that the whistleblower should get advice early before he or she reports inside the company,” Wojtalewicz said.  Otherwise, “you’re painting a big target on your back.”
Venue is an important issue in qui tam cases. In the LeFlore case, one of the first strategic decisions the team made was to sue in federal court in Wisconsin, which is in the Seventh Circuit. “Eighth Circuit opinions on false claims really are oriented to the corporations, not the whistleblower,” Wojtalewicz explained.

Apple Settles E Book Fixed Pricing Suit!



Apple Inc. has agreed to pay up to $400 million to settle claims brought by 33 state attorneys general and private class action Plaintiffs that the company conspired to fix prices on e-books, bringing possible compensation for e-book purchasers up to $566 million. Apple agreed to pay $400 million to consumers, as well as $50 million in payments to the states and attorneys’ fees, if the lower court’s July 2013 liability ruling against the company is affirmed by the Second Circuit.


If the decision is remanded for reconsideration, Apple will pay $50 million to purchasers, along with $20 million in attorneys’ fees and state payments. But Apple will pay nothing if the lower court’s ruling is reversed. When combined with the $166 million already paid by publishers in earlier settlements, consumers stand to receive up to $566 million if the lower court’s liability judgment against Apple is upheld.

So Cal Gas Settlement! Largest Personal Injury Jury Verdict In History!



A  jury last month returned a verdict of $19.8 million against Southern California Gas Co. (SoCal Gas). The verdict was in a personal injury action brought by a man who suffered severe burns and brain injuries after his rental home exploded as a result of SoCal Gas’ negligence. The jury found that SoCal Gas was negligent and that its negligence was a substantial factor in causing harm to the 24 year old Plaintiff. A SoCal Gas employee activated an illegally uncapped gas line running into the Plaintiff’s home. His room filled up with natural gas and exploded into flames when he tried to light a cigarette.

The Plaintiff continues to suffer from painful and life-altering injuries brought on by the “extremely traumatic event.” The jury verdict was said to be the largest personal injury jury verdict in history against SoCal Gas. It included about $17 million for past and future pain and suffering, $2 million for past and future medical expenses and $657,100 for past and future loss of earnings.

In 2011, a former SoCal Gas employee named Simon Youde opened a gas valve that activated a gas line running to the back house where Diao was sleeping. Youde left the property without ensuring it was leak-free, ultimately leading to the explosion, according to the Plaintiff’s counsel.
Diao received second- and third-degree burns on more than 20 percent of his body and was taken to a burn unit where he remained for about two weeks and had numerous surgeries. Diao was also diagnosed with a traumatic brain injury that left him with permanent cognitive deficits, according to court documents. SoCal Gas admitted fault in the incident but sought to impose some liability on the property owner. The company challenged the severity of the Plaintiff’s injuries and told the jury Diao should be awarded $1.4 million, but the jury disagreed.