Articles Posted in Pharmaceutical fraud

Eli Lilly & Co.,  manufacturer of insulin, is discounting the injectable drug by as much as 40%.  The move comes after several years of skyrocketing price increases in which top-selling insulins have more than doubled in price since 201. Some conclude that the increases are a result of  an increase of middlemen known as pharmacy-benefit managers who negotiate rebates and fees based on list prices.

Both the buying consumers and Congress have express their anger over the increase in drug prices generally.

Lilly announced that the cuts are being accomplished through a partnership with Express Scripts to reduce costs for people who pay full retail prices at the pharmacy. Its focus is individuals without health insurance or who are in  high deductible insurance plans.

The Food and Drug Administration announced that it has signed an agreement with PatientsLikeMe for access to data generated by the sites 350,000 members in order to help the FDA in post market surveillance of drugs on the market.The FDA needs the information because companies whose drugs are approved with minimal clinical trials do not provide much information on safety and effectiveness of a drug until after the public has tried it for a while. Companies often provide information and small populations, sometimes just a few hundred patients, from which the FDA is supposed to determine a drug’s risks.

“Most clinical trials only represent the experience of several hundred or at most several thousand patients, making it impossible to anticipate all the potential side effects of drugs in the real world. Patient-generated data give a more complete picture about a drug’s safety by providing a window into patients’ lives and healthcare experiences over time,” PatientsLikeMe Co-Founder and President Ben Heywood said in the press release. “We’re very encouraged by the FDA’s action to evaluate newer sources of data to help identify benefits and risks earlier.”

PatientsLikeMe allows members to interact with others with similar conditions and diseases, share experiences with drugs and volunteer medical data which can be used by industry, researchers, non-profit groups and now the FDA to get a better picture of the drug’s safety profile and provide better services. Patients can also learn what to expect or how to cope or avoid certain adverse events linked to drugs and medical procedures from other patients’ experiences.

Pharmaceutical company Shire Pharmaceuticals LLC will pay $56.5 million to settle civil allegations that it violated the False Claims Act as a result of its marketing and promotion of several drugs, the Justice Department announced today.  Shire, located in Wayne, Pennsylvania, manufactures and sells pharmaceuticals, including Adderall XR, Vyvanse and Daytrana, which are approved for the treatment of attention deficit hyperactivity disorder (ADHD), and Pentasa and Lialda, which are approved for the treatment of mild to moderate active ulcerative colitis.
The allegedly fraudulent promotional claims included marketing Adderall XR based on unsupported claims that the drug would prevent poor academic performance, loss of employment, criminal behavior, traffic accidents and sexually transmitted disease. Shire also allegedly promoted Adderall XR for the treatment of conduct disorder without approval from the Food and Drug Administration (FDA).

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The Irish drug manufacturer Amarin, has filed a lawsuit seeking to limit the powers of the Food and Drug Administration (FDA) in prohibiting so called “off  label” promotion of uses of drugs. The FDA gives approval of specific uses of drugs after reviewing the proper testing data submitted by the drug companies. That approval is the “on label” use allowed. However, many drug companies promote and sell their drugs to physicians for different uses. The lawsuit seeks to have a federal court rule that the FDA prohibitions of off-label promotion violates the company’s First Amendment rights and that its sales representatives should be able to convey off label uses to doctors.

Amarin filed the suit after the FDA denied the company the right to sell its prescription fish-oil pill Vascepa to individuals who do not have very high levels of triglycerides, a fat in the blood which can lead to heart disease. Presently the oil is allowed to be marketed only to individuals with very high levels of triglycerides. The pharmaceutical companies want more freedom to promote their products without constraint. Patient advocates say that this would undermine the drug-approval process and essentially allow the companies to go around the FDA.

The issue of off –label drug promotion is a problem with wide scale dimensions involving billions of dollars to the drug manufacturers. In November 2013, John & Johnson paid $1,391 Billion to settle a False Claims Act case for its off-label promotion of Risperdal, Invega and Natrecor. Risperdal had been approved only to treat schizophrenia by Janssen, a Johnson and Johnson subsidiary promoted it to physicians to treat elderly dementia patients for symptoms such as anxiety, agitation, depression and confusion. Continue reading

New York and 48 other states and the District of Columbia have reached a settlement with Daiichi Sankyo, Inc. (Daiichi), a global pharmaceutical company with US headquarters in New Jersey which will pay $39 million. It was alleged that Daiichi violated the False Claims Act by using lavish meals and speaker programs to improperly induce physicians to prescribe the drugs Azor, Benicar, Tribenzor and Welchol. Under the agreement, Daiichi agrees to pay the United States and the state Medicaid programs 39 million dollars, 10 million dollars to the state Medicaid Programs and 19 million to other Federal programs.

The settlement resolves allegations that Daiichi caused the submission of false claims for reimbursement by the Medicaid program (and other federal programs) for Azor, Benicar, Tribenzor and Welchol. The claims were false because they resulted from kickbacks that Daiichi provided to prescribing physicians. Specifically, the agreement alleges that the kickbacks took the form of honoraria payments, meals and other remuneration to physicians who participated or supposedly participated in physician opinion & discussion programs from January 1, 2005 through March 31, 2011 and other speaker programs from January 1, 2004 through February 4, 2011.

It is contended that the programs were in fact kickbacks because the physicians were paid by Daiichi even if the physician spoke only to members of his or her own staff in their office; physician participants took turns accepting “speaker” honoraria for duplicative discussions; the audience included the honoraria physician’s spouse; the speaker was paid even if the event was cancelled beforehand; and/or the dinners were lavish and even exceeded Daiichi’s own internal cost limitations of $140 per person.

According to the Department of Justice, AstraZeneca LP, a pharmaceutical manufacturer based in Delaware, has agreed to pay the government $7.9 million to settle allegations that it engaged in a kickback scheme in violation of the False Claims Act, the Justice Department announced today.  AstraZeneca markets and sells pharmaceutical products in the United States, including a drug sold under the trade name Nexium.

The settlement resolves allegations that AstraZeneca agreed to provide payments to Medco Health Solutions, a pharmacy benefit manager, in exchange for Medco maintaining Nexium’s “sole and exclusive” status on certain Medco formularies and through other marketing activities related to those Medco formularies.  The United States alleged that AstraZeneca provided some or all of the remuneration to Medco through price concessions on drugs other than Nexium, namely on Prilosec, Toprol XL and Plendil.  The United States contended that this kickback arrangement between AstraZeneca and Medco violated the Federal Anti-Kickback statute, and thereby caused the submission of false or fraudulent claims for Nexium to the Retiree Drug Subsidy Program.

This civil settlement resolves a lawsuit filed under the qui tam, or whistleblower, provision of the False Claims Act, which allows private citizens with knowledge of false claims to bring civil actions on behalf of the government and to share in any recovery.  The lawsuit was filed by former AstraZeneca employees Paul DiMattia and F. Folger Tuggle, who will collectively receive $1,422,000.

Doctors were paid millions of dollars to sell a new generation of anticoagulents including Xarelto, Pradaxa and Eliquis, the largest payments being made by Novo Nordisk to promote its diabetes drug Victoza.

The report was published by the public interest journalism group Pro Publica on January 7, saying the companies behind the newest generation of blood thinners  paid doctors $19.4 million in the last five months of 2013 to sell their drugs for them. The payments were in the form of educational gifts, payments for promotional speeches, meals and consulting fees to both doctors and teaching hospitals.

The findings were drawn from federal data released last fall, comes from a database known as Open Payments. The payments by blood thinner manufacturers appear to be an attempt to promote the drugs successfully as a replacement for Coumadin, also known by the generic name warfarin, which has been the go-to blood thinner for patients with atrial fibrillation for the last 50 years.

International pharma giant Daiichi Sankyo which started in Japan has agreed to pay Uncle Same over $39 million for allegations of kickbacks paid to doctors to use its pharmaceuticals. That is illegal under U.S. laws.

A False Claims whistleblower case was brought in March 2010 by  Kathy Fragoules, a former Daiichi Sankyo sales representative, who revealed in allegations that Daiichi Sankyo had various programs used by its sales representatives to induce physicians to use its pharmaceuticals, including Welchol, Azor, Benicar, and Benicar HCT. According to the complaint, these inducements caused physicians to prescribe Daiichi Sankyo pharmaceuticals for government healthcare program beneficiaries in violation of the Anti-Kickback Statute.

Jeffrey Newman represents whistleblowers but did not represent Ms. Fragoules.

Federal regulations  require nursing homes to retain consulting pharmacists such as those provided by Omnicare to ensure that residents’ drug prescriptions are appropriate. The United States alleges that Omnicare solicited and received kickbacks from Abbott in exchange for purchasing and recommending the prescription drug Depakote for controlling behavioral disturbances exhibited by dementia patients residing in nursing homes served by Omnicare.  Omnicare’s pharmacists reviewed nursing home patients’ charts at least monthly and made recommendations to physicians on what drugs should be prescribed for those patients, the Government says. The government also alleges that Omnicare touted its influence over physicians in nursing homes in order to secure kickbacks from pharmaceutical companies such as Abbott.

Abbott allegedly made payments to Omnicare described as “grants” and “educational funding,” even though their true purpose was to induce Omnicare to recommend Depakote, an anti-seizure drug for patients with dementia. For example, according to the complaint, Omnicare solicited substantial contributions from Abbott and other pharmaceutical manufacturers to its “Re*View” program. Although Omnicare claimed that Re*View was a “health management” and “educational” program, the complaint alleges that it was simply a means by which Omnicare solicited kickbacks from pharmaceutical manufacturers in exchange for increasing the utilization of their drugs on elderly nursing home residents.

In internal documents, Omnicare allegedly referred to Re*View as its “one extra script per patient” program. The complaint also alleges that Omnicare entered into agreements with Abbott by which Omnicare was entitled to increasing levels of rebates from Abbott based on the number of nursing home residents serviced and the amount of Depakote prescribed per resident. Finally, the complaint alleges that Abbott funded Omnicare management meetings on Amelia Island, Florida, offered tickets to sporting events to Omnicare management, and made other payments to local Omnicare pharmacies.

In May 2012, the United States, numerous individual states, and Abbott entered into a $1.5 billion global civil and criminal resolution that, among other things, resolved Abbott’s civil liability under the False Claims Act for paying kickbacks to nursing home pharmacies.

In a prior case in June, federal officials Wednesday accepted the company’s offer to pay $124.2 million to settle a suit accusing the company of allegedly offering improper financial incentives to skilled nursing facilities in northern Ohio in return for their continued selection of Omnicare to supply drugs to elderly Medicare and Medicaid beneficiaries.

Last February, the company paid $4 milion to resolve allegations that Omnicare solicited and received kickbacks from California-based drug manufacturer Amgen Inc. in return for implementing programs designed to switch Medicaid beneficiaries from a competitor drug to Amgen’s Aranesp product.

In August 2012, it settled a 2007 lawsuit claiming it paid a kickback in buying a pharmacy company, and that it submitted false claims for reimbursement to government health insurers. Additional terms of the settlement were not released.

In May 2012, Omnicare settled another case with the U.S. Department of Justice for $50 million. The agency called it the “largest controlled substance settlement in history,” and said Omnicare gave nursing home residents medicines without a prescription, with missing prescription information or without documentation. It resulted in the company being agreeing to operate under a corporate integrity agreement with the federal government.

Finally, Omnicare agreed in November 2009 to pay $98 million to settle civil allegations by the U.S. government and various states that it took kickbacks from Johnson & Johnson.

Jeffrey Newman represents whistleblowers

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A former paralegal from Sanofi, Diane Ponte has filed a whistleblower action alleging that Sanofi paid tens of millions of dollars to pharmacy groups and hospitals, through consultants Accenture and DEloitte using contracts that looked legitimate but which were in fact inducements to buy Sanofi products. Ultimately the kickbacks were used to spike sales of diabetes drugs in the States, according to the suit. The suit also alleges that about $1 billion is “unaccounted for” at the company.

The lawsuit, filed in New Jersey Superior Court in Newark, names Sanofi, Viehbacher and several other top executives, CNBC reports.

Two years ago, Sanofi paid $109 million to settle U.S.  allegations that it had provided free syringes of its arthritis injection Hyalgan to doctors to get them to prescribe the medication. The suit said the doctors then charged payers the regular rate for the doses they received at no cost. Giving meds away can be considered an inducement to prescribe and then charge federal programs for drugs that might not otherwise have been prescribed.