USA: Merit Medical $18 Millones por "Kickback"

 

In mid-October 2020, Merit Medical Systems, Inc. (MMSI) agreed to pay $18 million to resolve allegations that the company violated the False Claims Act and Anti-Kickback Statute by paying kickbacks to physicians and hospitals to induce the use of MMSI products.

As we covered in our September 2020 issue of our sister publication, Policy & Medicine Compliance Update, this case is somewhat unique because the qui tam suit was brought by the company’s former compliance officer.

Background

Charles Wolf, MD was the Chief Compliance Officer for MMSI until October 2015. Six months after he left his role as Chief Compliance Officer, in April 2016, he filed a qui tam complaint against the company, alleging that MMSI: caused the submission of false claims for services; made misrepresentations to the Food and Drug Administration (FDA) and others; engaged in false and misleading off-label marketing of its QuadraSphere Microsphere, Embosphere, and Endotek devices, as well as its CO2 kits; and systematically violated the Federal Anti-Kickback Statute.

Under the guise of an internal program known as the Local Advertising Program, MMSI allegedly provided remuneration to healthcare providers in the form of millions of dollars in free advertising assistance, practice development, practice support, and purported unrestricted “educational” grants to induce the healthcare providers to purchase and use a wide variety of MMSI products. Despite publicly claiming that its financial assistance was designed to “increase the awareness” of medical treatments, MMSI allegedly provided it only to select healthcare providers to reward past sales, induce future sales, and steer business to MMSI and away from MMSI’s competitors.

The complaint alleges that management at MMSI often spoke openly about compliance and even went so far as to create a numeric system to discuss how risky certain proposals would be. The risk evaluation system included a “chili pepper” scale from 1-3, indicating how much “heartburn” a particular action would give the company as far as compliance and ethics were concerned, the complaint said.

The government alleged that MMSI disregarded numerous warnings that its conduct may violate the Anti-Kickback Statute, including warnings from MMSI’s own Chief Compliance Officer, during the course of the alleged kickback scheme.(Más)

 

Más de Kickback en PHARMACOSERÍAS

Pro-Fentanyl Rap Video..."Great By Choice"

That drug companies have fueled the opioid crisis by flooding the market with deceptively advertised, highly addictive painkillers is no secret. But the antics of Insys Therapeutics, now being revealed in an ongoing federal court battle, seem especially evil. Well, evil and incredibly, supremely ridiculous.

On Wednesday, the AP reported, it emerged in court that Insys employees produced a rap video to motivate sale reps to keep pushing an especially potent spray applied under the tongue that’s derived from the synthetic opioid fentanyl.

The company’s spray, called Subsys, was approved for patients with severe, otherwise untreatable cancer pain. But in the face of flagging profits, the company is alleged to have done everything in its power to get its product sold, including breaking the law. Several states have sued the company or former executives over claims they orchestrated a kickback scheme of bribing doctors to prescribe Subsys. These lawsuits, along with a Congressional investigation, have also accused the Arizona-based company of setting up a program that had employees falsify cancer diagnoses for patients in order to get around payment restrictions set up by insurers.

Insys settled with the government over many of the individual state cases brought against it last December, to the tune of at least $150 million in fines. But the former executives the company has since dropped, including founder John Kapoor, are still on the hook for several lawsuits. The federal case currently on trial in Boston, where Kapoor and other former executives of the company are being prosecuted for racketeering, is the background for this latest bizarre revelation.



The video, a parody of A$AP Rocky’s 2012 song “Fuckin’ Problems,” was originally played for sales reps at Insys’ national sales meeting in 2015, according to prosecutors. It’s been rumored to exist since 2017, but it wasn’t until Wednesday that the jury got to see it. Gizmodo obtained a copy of the video from the Massachusetts U.S. District Attorney’s Office.

Titled “Great By Choice” and featuring two Insys employees who styled themselves “Z Real” and “A Bean,” it contains spellbinding lyrics referencing the process of titration, whereby doctors increase the dosage of a drug until it’s deemed to be correct: “I love titration, yeah it’s not a problem. I got new patients and I got a lot of ‘em.”

And even as the rappers encourage the reps to “build relationships that are healthy,” the song also talks up how great it is to drive more sales by buying doctors and their staff lunch. It closes by featuring Alec Burlakoff, the company’s former VP of sales, taking off a costume of the Subsys spray, though not before a version of the costume danced along to a parody of Eminem’s “Rap God.” Burlakoff later pleaded guilty to racketeering charges and is set to testify for the prosecution.

The video comes on the heel of yet another bombshell from the Boston case. Last month, a former Insys employee testified that she saw one of the co-defendants, former regional sales manager Sunrise Lee, provide a lap dance to a Chicago doctor whom they were trying to convince to sell more of their product. Lee’s attorneys argued that the doctor, Paul Madison, was in fact taking advantage of Lee, who had formerly worked as a exotic dancer. Madison was later convicted of unrelated charges, including health care fraud.

The trial is expected to last for several more weeks, the AP reported, so who knows how many more awful things we’ll learn before it’s all said and done?

In 2015, the year this creatively and morally bankrupt video was first shown, 33,000 Americans died from opioid overdoses. A shocking number that would soon be dwarfed by 2016's death toll of over 42,000 and 2017's toll of over 47,000.

Novartis...en jeans

 
Jeans and other drugs: 


Novartis CEO Narasimhan's prescription for a millennial-friendly culture

 

What does it take for a company to attract millennials? An inspiring culture—and jeans, according to Novartis CEO Vas Narasimhan.

“When you look at successful innovation-driven companies, you have to have people who feel inspired and empowered and feel the curiosity to come up with the best ideas,” Narasimhan said at the recent Forbes Healthcare Summit.

When Narasimhan first took the reins in February, he embarked on a journey to not only focus Novartis as a “medicines company” but also to “un-boss” the Swiss drugmaker and make it more attractive for employees.

About half of Novartis’ staffers are millennials, and “they expect to work in a very different environment,” said Narasimhan. So, he’s aiming to shift Novartis from a top-down hierarchical culture where people wait for instructions from their bosses to a place where employees “feel much more empowered and inspired by our mission.”

A big change of direction like that starts with small things, such as a different dress code, he figures. “We start to wear jeans to the office,” said the Swiss pharma’s chief executive. “We really try to open up transparency in the company using technology and social media.”

Loosening up on dress code sounds like a trend spread from Silicon Valley. According to an article from Inc., 40% of millennials look up to Facebook founder Mark Zuckerberg as their business inspiration, the guy who always appears in a gray t-shirt and jeans so he can focus on productivity, not fashion.

A drugmaker is also a tech company, in a sense. Instead of being confined in formal business attire, allowing employees to dress as they like caters to millennials’ desire to feel independent, comfortable and creative, said the Inc. article.

But, just as Narasimhan himself said, changing the rules on dress or adopting the trendy internal social media platform Yammer are the small things. The company's mission also has to make millennials feel inspired. In that sense, Narasimhan and his predecessor Joe Jimenez seem to be on the same page.

“The modern-day global workforce, especially the millennial generation, wants to work for a company they believe in,” wrote Jimenez in the opening sentence of an article featured in the third-quarter 2015 issue of Ethisphere magazine. 
Citing a 2015 Deloitte Millennial Survey, the former Novartis CEO pointed to company values and issues people care about as important factors in retaining employees, especially millennials. A 2016 Harvard Business Review article also highlighted “addressing larger societal concerns” as a factor that has affected millennials’ career choices.

Ironically, Novartis has some serious catching up to do in that realm. Kickback allegations, bribery charges and, more recently, a notorious $1.2 million consulting deal with President Donald Trump’s personal lawyer Michael Cohen clearly disappointed and frustrated many of its employees.

Ver:
Todo sobre Joe Jimenez/Novartis/Michael Cohen en PHARMACOSERÍAS

Narasimhan, in a letter to employees right after the Cohen news broke, said he was “[d]etermined to fight for all of you so you continue to feel proud, inspired and empowered to transform the health of the world every day.”

Now, with transforming Novartis' culture and rebuilding trust and reputation as top priorities, Narasimhan has some proving to do. And he's hoping that, after four or five years of work, the company's culture will really make a change. (Ver)

ABBOTT / AbbVie "pagan" de nuevo: Allegations of Decade-Old Anti-Kickback Claims

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After several years of legal sparring, Abbott Laboratories and AbbVie will pay $25 million to settle allegations of paying kickbacks to doctors and illegally marketing the TriCor cholesterol pill. 

The case began with a whistleblower lawsuit filed in 2009 by a former saleswoman for Abbott, which marketed the medicine at the time and later transferred the rights after spinning off AbbVie. The sales rep, Amy Bergman, alleged she was “trained, directed, incentivized, and encouraged” to promote TriCor for so-called off-label marketing and medically unnecessary uses.

Ver:
ABBOTT ahora es también AbbVie
ABBOTT "infringe" de nuevo...

On October 26, 2018, it was announced that Abbott Laboratories and AbbVie Inc. (collectively “Abbott”) settled allegations that the company employed kickbacks and other unlawful methods of marketing and promotion to induce physicians to prescribe the drug TriCor®. 
A former Abbot sales representative, Amy Bergman, brought the lawsuit under qui tam provisions of the False Claims Act.

The case resolves allegations that from a period from 2006 and 2008, Abbott knowingly paid kickbacks to physicians to get them to prescribe TriCor, including improper gift baskets, gift cards, and other items. Abbott also allegedly engaged health care providers for consulting services and speaking engagements, where one purpose of the remuneration for the programs was to induce or reward physicians for prescribing TriCor prescriptions.

In addition to the alleged kickbacks resolved by this settlement, allegations of unlawful methods of off-label marketing and promotion for TriCor for unapproved indications were also resolved.

During the period in question, the FDA had approved TriCor for patients with hypertriglyceridemia or mixed dyslipidemia. 
However, Abbott marketed the drug for

• (1) use in treating, preventing, or reducing cardiovascular events and other cardiac health risk; 
• (2) use in combination with statin drugs, and 
• (3) use as a first-line treatment of diabetic patients, including treatment to prevent or reduce cardiac health risks in diabetic patients,

uses not FDA-approved and not covered by federal healthcare programs.

United States Attorney General William McSwain announced the settlement, saying, 
“Kickback schemes are a form of illegal pay-to-play business practices that have no place in our health care system; they interfere with physician-patient relationships and drive up the cost of health care. Off-label promotion and marketing practices similarly prioritize drug companies’ profits over patient care. We are proud to partner with HHS-OIG to protect the integrity of our health care programs.”

RELATED POSTS

The settlement figure is $25 million, of which the federal government will receive $23.2 million and state Medicaid programs will receive $1.8 million. 
Ms. Bergman, the qui tam relator, will receive $6.5 million as her share of recovery in the case.(Más)

Ver también:
Whistleblowers*: Uno de los oficios mejor pagados del mundo




Prior Allegations and Settlements

Abbott is no stranger to False Claims Act or off-label marketing allegations and settlements. In 2012, Abbott Laboratories, Inc. agreed to pay $1.6 billion to resolve civil and criminal allegations that it promoted Depakote for uses not approved by the United States. 

Ver:

ABBOTT la paga...por Depakote.

ABBOTT paga...$1.6 billion

In that case, it was more than just a settlement resolving allegations, Abbott actually pled guilty to one misdemeanor violation of the Food, Drug and Cosmetic Act for misbranding. At that point, Abbott entered into a Corporate Integrity Agreement (CIA) for five years.

Then, in December 2013, Abbott Laboratories agreed to pay $5.475 million to resolve allegations that it violated the False Claims Act by paying kickbacks to induce doctors to prescribe several different vascular prescriptions, including paying physicians for teaching assignments, speaking engagements, and conferences.(Ver)

Ver también:
Abbott Laboratories Pays U.S. $5.475 Million to Settle Claims That Company Paid Kickbacks to Physicians

NOVARTIS: "Lava la ropa sucia" con...Siemens / Klaus Moosmayer (II)

Ver anterior: 

NOVARTIS: "Lava la ropa sucia" con...Siemens / Klaus Moosmayer (I)

Struggling to shed a bad rep for a string of ethics scandals capped by the explosive accusations of several US Senators that company execs recently misrepresented the cozy relationship between former CEO Joe Jimenez and President Donald Trump’s personal attorney Michael Cohen, Novartis is once again looking to clean up its act.

CEO Vas Narasimhan has recruited a prominent German attorney to lead their ethics, risk and compliance efforts.

Klaus Moosmayer will now be charged with keeping the company clear of any new ethics scandals, which have come fast and frequently at the pharma giant. The lawyer has spent the past few years as chief compliance officer at Siemens and chairs the Anti-Corruption Taskforce of the Business and Industry Advisory Committee at the Organization for Economic Co-operation and Development.

Moosmayer is taking the place of Shannon Thyme Klinger, newly promoted to group general counsel in the wake of Felix Ehrat’s abrupt resignation during the crisis that hit Novartis as it struggled with revelations about their $1.2 million in payments to Cohen.

Novartis’ explanation — echoed by newly retired CEO Jimenez — was that this was a simple way to gain insights into Trump’s new administration and its healthcare policies. But some company insiders viewed it more like a simple way to pay for access.

A few weeks ago, a group of Democrats in the Senate released their own quick report, concluding that the company’s contention that top execs had only a brief, inconsequential exchange with Cohen and were forced to pay out the contract misrepresented the numerous contacts Jimenez had with Cohen.

“What he was selling was a line of access to the Trump administration,” said Sen. Ron Wyden in an interview with ABC News in July. “That would be how I would characterize it.” Wyden and his colleagues outlined numerous contacts Jimenez had with Cohen.

After initially bemoaning the need to do better in follow-up meetings with staff, Narasimhan and his top staff now insist that the whole issue is behind them. 

The 600-pound gorilla, though, remains in the room, even if it’s not referred to in the company’s statement on its new hire.

Not helping much is that Novartis shook up its ethics and compliance operations last fall in the wake of kickback and bribery accusations. A Korean investigation determined company execs had been conducting a kickback scheme in that country while Novartis also faced corruption charges in Greece.

The chain of scandals has severely interrupted Narasimhan’s campaign to make over Novartis’ rep and present the company as a giant eager to do right by patients and healthcare systems, pursuing the latest in digital strategies to improve care.

“As we aspire to reimagine medicine, we must hold ourselves to (the) highest ethical standards and always aim to win and maintain the trust of society and our many stakeholders,” the CEO said in a statement. “Klaus has extensive experience in leading Compliance for large global organisations and is internationally recognized in his field.”

USA. Pfizer paga multa...$23.85 million

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BOSTON – The U.S. Attorney’s Office announced today that pharmaceutical company Pfizer Inc. has agreed to pay $23.85 million to resolve allegations that it violated the False Claims Act by paying kickbacks to Medicare patients through a purportedly independent charitable foundation. 

When a Medicare beneficiary obtains a prescription drug covered by Medicare Part B or Part D, the beneficiary may be required to make a partial payment, which may take the form of a co-payment, co-insurance, or deductible (collectively “co-pays”). These co-pay obligations may be substantial for expensive medications. Congress included co-pay requirements in these programs, in part, to encourage market forces to serve as a check on health care costs, including the prices that pharmaceutical manufacturers can demand for their drugs. The Anti-Kickback Statute prohibits pharmaceutical companies from offering or paying, directly or indirectly, any remuneration – which includes money or any other thing of value – to induce Medicare patients to purchase the companies’ drugs. (Más)

Insys: Founder and Owner Arrested and Charged with Racketeering (extorsión)

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BOSTON – The founder and majority owner of Insys Therapeutics Inc., was arrested today and charged with leading a nationwide conspiracy to profit by using bribes and fraud to cause the illegal distribution of a Fentanyl spray intended for cancer patients experiencing breakthrough pain.

John N. Kapoor, 74, of Phoenix, Ariz., a current member of the Board of Directors of Insys, was arrested this morning in Arizona and charged with RICO conspiracy, as well as other felonies, including conspiracy to commit mail and wire fraud and conspiracy to violate the Anti-Kickback Law. 
Kapoor, the former Executive Chairman of the Board and CEO of Insys, will appear in federal court in Phoenix today. He will appear in U.S. District Court in Boston at a later date.

The superseding indictment, unsealed today in Boston, also includes additional allegations against several former Insys executives and managers who were initially indicted in December 2016.(Más)

Fentanyl

Sintetizado por primera vez en 1960 por el farmacólogo belga Paul Janssen, el fentanilo es un potente analgésico y anestésico de la familia de los opiáceos, con un efecto 50 veces más poderoso que la heroína y 100 más que la morfina. Se consume inyectada, pero también por vía oral, en pastillas o piruletas o por absorción cutánea a través de parches. Correctamente administrado con la prescripción de un facultativo, el fentanilo no es peligroso. Suele utilizarse para el tratamiento de dolores agudos, a menudo asociados al cáncer, pero también como apoyo e inducción de la anestesia general durante cirugías. 

De hecho, los soldados del ejército estadounidense heridos en combate son tratados con piruletas de fentanilo

Ver:
 Una piruleta analgésica alivia los dolores del soldado herido

...la industria farmacéutica también se ha visto salpicada por el escándalo. 

En diciembre, varios ejecutivos de Insys Therapeutics, una compañía que cotiza en el índice Nasdaq, fueron detenidos en Boston y acusados de una conspiración a escala nacional por haber sobornado a decenas de médicos para recetar Subsys, un espray sublingual de fentanilo.

Ver:
Ex-Insys sales manager arrested in U.S. fentanyl-kickback case

Por si todo esto fuera poco, la droga ya tiene un nuevo competidor: el carfentanil, una variante 100 veces más potente, utilizada para tranquilizar elefantes, sobre cuyo peligro ya ha alertado la DEA. Los traficantes la consiguen en China, donde no es una sustancia controlada, y la cortan con heroína. Ya ha causado la muerte a cientos de personas. (Más)

Ver también:

USA: Autorizan a Insys Therapeutics a producir marihuana sintética

TEVA: Corrupción "en genérico"...

Ver

Ver también:
Teva hit with $27.6M settlement in clozapine kickback case  

Novartis Wines -- er, Beers -- and Dines Docs at Hooters!

The U.S. Justice Department announced yesterday that it has filed a second civil false claims lawsuit against Novartis Pharmaceuticals Corp. involving alleged kickbacks paid by the company to health care providers (read the details here).

 DOJ claims that Novartis violated the Anti-Kickback Statute by paying doctors to speak about certain drugs, including its hypertension drugs Lotrel and Valturna and its diabetes drug Starlix, at events that were often little or nothing more than social occasions for the doctors. The payments and lavish dinners given to the doctors were, in reality, kickbacks to the speakers and attendees to induce them to write prescriptions for Novartis drugs, says DOJ.

 Many speaker programs were held in circumstances in which it would have been "virtually impossible for any presentation to be made, such as on fishing trips off the Florida coast," the suit claims.

 "Other Novartis events were held at Hooters restaurants."

 Stories like this are why I love my job! It's a great excuse for me to Google images of Hooters' girls -- even with Mrs. Pharmaguy peering over my shoulder -- to come up with the following interview of a Hooter's Waitress of the Month who was present on several occasions when Novartis reps and their clients held "educational" events at her Hooters restaurant:

Click sobre imagen para ampliar...

BTW, do pharma sales reps take female physicians to Chippendales? Just askin'

Ver anterior:

USA: Novartis acusada de sobornar para prescribir...

Tomé "prestado" a Pharmaguy/John Mack de su Pharma Marketing Blog

AMGEN acusado de "Illegal Kickbacks"*...en USA.

Más...

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(*) kickback (kickbacks plural )A kickback is a sum of money that is paid to someone illegally. (Diccionario Collins English)