Kickbacks Allegedly Were Disguised as “Consulting Agreement” Compensation Teva Pharmaceuticals will pay $27.6 million to settle claims that it violated the False Claims Act by paying kickbacks to induce a physician to write more prescriptions for an anti-psychotic drug. The settlement resolves claims that the pharmaceutical company paid a physician to induce him to write prescriptions for generic clozapine, an anti-psychotic medication. Clozapine is usually considered a drug of last resort because it has serious potential side effects, especially for elderly patients. The side effects include a potentially deadly decrease in white blood cells, seizures, inflammation of the heart muscle, and increased mortality in elderly patients. The complaint alleged that the kickbacks were disguised as compensation under a “consulting agreement.” Under that agreement, the pharmaceutical company allegedly paid the doctor $50,000 per year and other benefits to induce him to switch his patients to generic clozapine. The other benefits included all-expenses paid trips to Miami for the doctor, his wife, and several of his employees. After entering into the “consulting agreement,” the doctor quickly became the largest prescriber of generic clozapine in the United States. The government claims that the payments and other benefits continued for many years, resulting in Medicare and Medicaid paying for thousands of generic clozapine prescriptions. The Anti-Kickback Statute prohibits pharmaceutical companies from offering or paying anything of value to induce prescriptions covered by Medicare or Medicaid. This kickback prohibition is designed to ensure that a physician’s medical judgment is based solely on the best interests of the patient and not compromised by improper financial incentives. Individuals who help the government uncover these types of healthcare frauds are entitled to significant rewards – up to 30% of the amount the government recovers. But you must follow a specific, confidential process to qualify. If you go to the government on your own or give your evidence to the media, you may lose your right to a reward. If you have evidence that a pharmaceutical company, hospital, or other healthcare provider is paying kickbacks in return for prescriptions or patient referrals, then you should consult with an experienced whistleblower attorney immediately to protect your rights. To arrange a free and confidential consultation with an experienced whistleblower lawyer, call John Howley, Esq. at (212) 601-2728 or click here to reach our offices via email. John Howley, Esq. The information you obtain at this site is not, nor is it intended to be, legal advice. You should consult an attorney for advice regarding your individual situation. I invite you to contact our law offices and welcome your calls, letters and electronic mail. Contacting us does not create an attorney-client relationship. Please do not send any confidential information to us until such time as an attorney-client relationship has been established. I practice law and offer legal services only in jurisdictions where I am properly authorized to do so. I do not seek to represent anyone in any jurisdiction where this web site does not comply with applicable laws and bar rules.
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FALSE CLAIMS ACT WHISTLEBLOWER WILL RECEIVE A $400,000 REWARD Pharmacy company Omnicare Inc. has agreed to pay more than $4 million to settle a whistleblower lawsuit alleging that it accepted kickbacks from pharmaceutical company Amgen Inc. The kickbacks allegedly were paid in the form of “rebates” to induce the pharmacy to switch Medicaid beneficiaries from a competitor drug to Amgen’s product Aranesp. The whistleblower’s complaint alleged that so-called “performance-based rebates” were actually kickbacks paid to the pharmacy in return for switching patients from their existing medications to Amgen’s Aransep product. The complaint also alleged that more traditional forms of kickbacks were paid disguised as grants, speaker fees, consulting services, data fees, dinners and travel. According to the whistleblower complaint, the pharmaceutical company agreed to a “rebate contract” that gave the pharmacy an incentive to convert patients at long-term care facilities from Procrit to Aranesp. The pharmacy allegedly earned rebates based on a sliding scale. For example, if the pharmacy purchased $9.9 million or more of Aranesp during one quarter, it would earn a 3% rebate. But if it purchased $13.4 million or more of Aranesp, the pharmacy would receive a 23% rebate. The Anti-Kickback Statute prohibits healthcare providers from soliciting or accepting anything of value in return for patient referrals or the selection of a particular pharmaceutical product. The purpose of the Anti-Kickback Statute is to ensure that decisions affecting Medicare and Medicaid beneficiaries, particularly vulnerable patients in skilled nursing facilities, are based on the best interests of the patients and are not improperly influenced by financial incentives. This settlement resolves a lawsuit filed under the qui tam, or whistleblower, provision of the False Claims Act. Whistleblowers who help the government recover money for false claims to Medicare and Medicaid earn rewards based on the amount of money recovered. The whistleblower who brought the lawsuit in this case will receive a reward of almost $400,000. If you are aware that a pharmaceutical company, hospital, or other healthcare provider is giving pharmacists or doctors anything of value -- rebates, cash, or below-market office space and staff -- in return for patient referrals or prescriptions, then you should contact an experienced whistleblower attorney immediately to protect your rights. You may be entitled to a significant reward and other whistleblower protections. To arrange a free and confidential consultation with an experienced whistleblower attorney, call John Howley, Esq. at (212) 601-2728 or click here to reach our office via email. John Howley, Esq. The information you obtain at this site is not, nor is it intended to be, legal advice. You should consult an attorney for advice regarding your individual situation. I invite you to contact our law offices and welcome your calls, letters and electronic mail. Contacting us does not create an attorney-client relationship. Please do not send any confidential information to us until such time as an attorney-client relationship has been established. I practice law and offer legal services only in jurisdictions where I am properly authorized to do so. I do not seek to represent anyone in any jurisdiction where this web site does not comply with applicable laws and bar rules. A pharmacist who owned and operated a Medicine Shoppe pleaded guilty to billing Medicaid for drugs and supplies that were never dispensed to patients. She was accused of stealing more than $93,000 from the New York Medicaid program. The pharmacist and pharmacy owner pleaded guilty to larcency in state court. She will be sentenced to three years of probation. She will also be required to pay restitution of $93,406.02 to the Medicaid program. This case is typical of many Medicaid fraud cases involving pharmacists and their pharmacies. This pharmacist was caught because she allegedly billed the Medicaid program for approximately 18 different drugs, treatments and supplies that she did not purchase. Other pharmacists have been caught and convicted of Medicaid fraud because their claims for drugs allegedly dispensed to patients far exceeded their purchases. New York Medicaid fraud investigations are usually conducted by lawyers, investigators, and auditors assigned to the state’s Medicaid Fraud Control Unit (MFCU). It is a very large, active and aggressive unit within the New York State Attorney General’s office. In 2012, MFCU investigations and prosecutions resulted in more than $335 million in restitution to the state from individuals and companies engaged in Medicaid fraud and abuse. If you are under investigation or have been charged with Medicaid fraud, then you should consult with an experienced Medicaid fraud attorney immediately to protect yourself. The penalties for Medicaid fraud can be severe. Failing to handle the investigation properly could result in the loss of your livelihood, your license, and your freedom. To arrange a free and confidential consultation with an experienced Medicare and Medicaid fraud attorney, call John Howley, Esq. at (212) 601-2728, or click here to reach our office via email. John Howley, Esq. The information you obtain at this site is not, nor is it intended to be, legal advice. You should consult an attorney for advice regarding your individual situation. I invite you to contact our law offices and welcome your calls, letters and electronic mail. Contacting us does not create an attorney-client relationship. Please do not send any confidential information to us until such time as an attorney-client relationship has been established. I practice law and offer legal services only in jurisdictions where I am properly authorized to do so. I do not seek to represent anyone in any jurisdiction where this web site does not comply with applicable laws and bar rules. Two former pharmaceutical sales representatives will share a $4.4 million whistleblower reward for reporting their former employer’s off-label promotion of a drug to treat weight loss in AIDS patients. Michael McKeen and Courtney Combs started a qui tam or whistleblower lawsuit against their former employer, Par Pharmaceuticals, under the False Claims Act. They alleged that Par Pharmaceuticals, a generic drug company, promoted Megace® ES for uses that were not approved by the Food and Drug Administration (FDA) and not covered by federal healthcare programs. While the FDA approved Megace® ES to treat dangerous weight loss in AIDS patients, Par actively promoted the drug for cachexia or weight loss suffered by elderly patients with no diagnosis of AIDS. This was not an FDA-approved use, nor was this use covered by Medicare or Medicaid. Under the federal False Claims Act, sales representatives and other individuals with knowledge of off-label marketing may start a whistleblower or qui tam lawsuit on behalf of the government and share in any recovery. The qui tam lawsuit is filed “under seal” (in secret) and provided only to the U.S. Attorney. The U.S. Attorney then must conduct an investigation into the claims in the sealed lawsuit. In this case, the government found that “Par deliberately and improperly targeted elderly patients with weight loss residing in nursing homes, regardless of whether such patients suffered from AIDS or any other medically accepted indication.” The government therefore intervened or joined in the qui tam lawsuit. After the government intervened, Par agreed to pay $22.5 million to settle the qui tam lawsuit. The company admitted that it promoted Megace® ES for older patients without AIDS, and that it instructed its sales staff to falsely claim that the drug was more effective than other products. The settlement agreement provides that the two whistleblowers will receive $4.4 million as their whistleblower reward. Par will also pay their attorneys’ fees. If you are aware of off-label promotion of pharmaceuticals, or other false and fraudulent marketing practices involving prescription drugs, then you should consult with an experienced whistleblower attorney immediately. You may be entitled to a significant whistleblower reward and legal protections. The consultation is completely free and confidential. No attorneys’ fees are charged unless your lawsuit is successful. To arrange a free and confidential consultation with an experienced whistleblower attorney, call John Howley, Esq. at (212) 601-2728 or click here to reach our offices via email. John Howley, Esq. The information you obtain at this site is not, nor is it intended to be, legal advice. You should consult an attorney for advice regarding your individual situation. I invite you to contact our law offices and welcome your calls, letters and electronic mail. Contacting us does not create an attorney-client relationship. Please do not send any confidential information to us until such time as an attorney-client relationship has been established. I practice law and offer legal services only in jurisdictions where I am properly authorized to do so. I do not seek to represent anyone in any jurisdiction where this web site does not comply with applicable laws and bar rules. The New York Attorney General's Office recovered more than $335 million last year from companies and individuals who engaged in Medicaid fraud and abuse. New York has one of the most aggressive Medicaid Fraud Control Units (MFCU), with a staff of more than 315 people across the state. They work closely with the Medicaid Inspector General in the NYS Health Department to detect and prevent Medicaid fraud. The most common forms of Medicaid fraud in New York last year included:
The largest Medicaid fraud recoveries came from pharmaceutical companies. Abbott Labs, Boehringer-Ingelheim, Dava Pharmaceuticals, GlaxoSmithKline, K-V Pharmaceutical, McKesson, Merck, and other pharmaceutical companies paid more than $250 million to settle allegations that they submitted false price reports to Medicaid and/or promoted their products for uses not approved by the federal Food and Drug Administration (off-label marketing). Other significant recoveries involved pharmacists, hospitals, and dental clinics. Pharmacy Fraud: Four pharmacists and a pharmacy owner agreed to pay $9.9 million in restitution after pleading guilty to billing Medicaid for drugs that they never dispensed to their patients. Stark Law Violations: Cayuga Medical Center paid $3.1 million to settle a whistleblower or qui tam lawsuit alleging that the hospital billed Medicaid and Medicare for patients referred by physicians who had financial relationships with the hospital. The Stark Act prohibits a physician from referring patients to a hospital if the physician has a financial relationship with the hospital, unless an exception applies. The whistleblower in this case, a physician at the hospital, received 18% of the settlement (approximately $560,000) as his whistleblower reward. Dental Fraud: Kaleida Health repaid $1.6 million to Medicaid after an internal audit revealed that it had billed Medicaid for patients who received teeth cleanings more often than once in six months, which violated Medicaid reimbursement rules. The audit also revealed that the dental clinic had billed Medicaid for multiple visits to complete exams, x-rays, and cleanings. Medicaid regulations require dental clinics to perform and bill these tasks in one office visit. If you are under investigation or have been charged with Medicaid fraud, then you should consult with an experienced Medicaid fraud attorney immediately, before you speak with government investigators. Anything you say to the investigators can and will be used against you. To arrange a free and confidential consultation, call John Howley, Esq. at (212) 601-2728 or click here to reach our office via email. You should also consult with an experienced Medicaid and Medicare fraud lawyer if you know that your employer is submitting false claims to the government. You may be entitled to a substantial whistleblower reward and legal protections if you help the government recover money paid on false and fraudulent claims. Call our office today to schedule a free and confidential consultation. John Howley, Esq. The information you obtain at this site is not, nor is it intended to be, legal advice. You should consult an attorney for advice regarding your individual situation. I invite you to contact our law offices and welcome your calls, letters and electronic mail. Contacting us does not create an attorney-client relationship. Please do not send any confidential information to us until such time as an attorney-client relationship has been established. I practice law and offer legal services only in jurisdictions where I am properly authorized to do so. I do not seek to represent anyone in any jurisdiction where this web site does not comply with applicable laws and bar rules. Pfizer Inc. and Endo Pharmaceuticals agreed to resolve Medicaid fraud allegations by paying the State of Texas a total of $36.34 million. Both pharmaceutical companies were accused of filing false price reports with Medicaid. The false price reports allegedly misstated the prices charged for their pharmaceutical products. Under state and federal law, drug companies must file price reports setting forth the prices they charge pharmacies, wholesalers and distributors for their products. The price reports are used to establish Medicaid reimbursement rates. The difference between the Medicaid reimbursement amount and the actual market price is referred to as the “spread.” The government alleged that Pfizer and Endo filed the false price reports in order to increase the spread and thereby induce pharmacies and other providers to purchase their products. The improper price reports were first identified by Ven-A-Care of the Florida Keys Inc., a pharmacy that filed a qui tam or whistleblower lawsuit on behalf of the government. Individual citizens who have knowledge of false claims can file these types of lawsuits on behalf of the government and share in any recovery. Under state and federal False Claims Acts, the whistleblower’s share or reward is usually between 15% and 30% of the amount recovered by the government. The qui tam lawsuit was initially filed “under seal” (in secret) so the government could conduct an investigation before the defendants knew that they were under investigation. No one other than the government and the court knew about the lawsuit until the government completed its investigation. In this case, the State of Texas conducted an investigation and decided to intervene in the case to recover overpayments made by Medicaid to pharmacies based on the false price reports. The pharmacy that brought the suit will therefore receive a share of the overall recovery as its whistleblower reward. Pfizer and Endo will also pay the whistleblower’s attorney’s fees. If you are aware that false price reports are being submitted to the government – or that other types of false claims are being submitted to Medicare or Medicaid – then you should consult with an experienced Medicare and Medicaid fraud attorney immediately. You may be entitled to legal protections and a substantial reward as a whistleblower. To arrange a free and confidential consultation, call John Howley, Esq. directly at (917) 652-6504 or click here to reach our office via email. No attorney’s fees will be charged unless you win, in which case the attorney’s fees will be paid out of the total amount recovered. John Howley, Esq. The information you obtain at this site is not, nor is it intended to be, legal advice. You should consult an attorney for advice regarding your individual situation. I invite you to contact our law offices and welcome your calls, letters and electronic mail. Contacting us does not create an attorney-client relationship. Please do not send any confidential information to us until such time as an attorney-client relationship has been established. I practice law and offer legal services only in jurisdictions where I am properly authorized to do so. I do not seek to represent anyone in any jurisdiction where this web site does not comply with applicable laws and bar rules. Amgen Inc. has agreed to pay $612 million to settle ten whistleblower lawsuits alleging that the company illegally promoted a misbranded drug. Under the qui tam provisions of the False Claims Act, the whistleblowers are entitled to a reward of between 15% and 30% of the amount actually paid to the government as a result of their efforts. The lawsuits involved the drug Aranesp, which was approved by the FDA for treatment of anemia in patients with chronic renal failure. The FDA approval was specific to calibrated doses for particular patient populations. The lawsuits alleged that Amgen knowingly promoted the sale and use of Aranesp for dosing regimens and indications that were not approved by the FDA. The off-label marketing allegedly included promoting Aranesp for treatment of anemia caused by cancer, anemia caused by chronic disease, chronic anemia, and anemia caused by myelodysplastic syndrome. Under the Food, Drug and Cosmetic Act, it is illegal for a drug company to promote a drug for uses or at doses not approved by the FDA. This is known as “off-label” marketing and renders the drug “misbranded.” Promotion of a misbranded drug may also violate the False Claims Act because any resulting claims for reimbursement from Medicare or Medicaid are considered “false claims.” As the whistleblowers filed their lawsuits, the government conducted investigations and decided to intervene in the actions. The government alleged that Amgen engaged in three types of illegal conduct: Off-Label Marketing: The government alleged that Amgen promoted Aranesp and two other drugs that it manufactured, Enbrel and Neulasta, for off-label uses and doses that were not approved by the FDA and not properly reimbursable by federal insurance programs. The government also alleged that Amgen used journal articles that were insufficient to support the safety and efficacy of the off-label uses at issue, and improperly obtained listings in medical compendia in an effort to establish that the off-label uses were medically accepted and thereby eligible for coverage by federal health care programs. Kickbacks: The government alleged that Amgen offered illegal kickbacks to influence health care providers to select its products for use, regardless of whether they were reimbursable by federal health care programs or were medically necessary. The Anti-Kickback Statute prohibits offering, paying, or accepting anything of value in return for recommending the use of a product or service that will be reimbursed by Medicare and certain other government healthcare programs. False Price Reports: The government alleged that Amgen engaged in false price reporting practices, including knowingly submitting false Average Sales Prices, Best Prices, and Average Manufacturer Prices for several drugs. Pricing reports from pharmaceutical companies are used by Medicare, Medicaid, and other government healthcare programs to set reimbursement rates. The qui tam or whistle-blower provisions of the False Claims Act allow private citizens to bring lawsuits on behalf of the United States and share in any recovery. The lawsuits are initially filed “under seal” (in secret) to give the government an opportunity to conduct an investigation. If the lawsuit is successful, the whistleblower is entitled to a reward of between 15% and 30% of the amount actually paid to the government. If you are aware of off-label marketing, kickbacks, false price reports, or other types of false or fraudulent marketing of pharmaceuticals, you may be eligible for a substantial reward and legal protection as a whistleblower. To arrange a free and confidential consultation with an experienced False Claims Act attorney, call John Howley, Esq. at (917) 652-6504 or click here to contact our office via email. No legal fees are charged unless the case is successful. John Howley, Esq. The information you obtain at this site is not, nor is it intended to be, legal advice. You should consult an attorney for advice regarding your individual situation. I invite you to contact our law offices and welcome your calls, letters and electronic mail. Contacting us does not create an attorney-client relationship. Please do not send any confidential information to us until such time as an attorney-client relationship has been established. I practice law and offer legal services only in jurisdictions where I am properly authorized to do so. I do not seek to represent anyone in any jurisdiction where this web site does not comply with applicable laws and bar rules. Former pharmaceutical sales representative Mark Giddarie will receive an $18.5 million reward for helping the government pursue a False Claims Act lawsuit against Sanofi US. The reward will be paid out of Sanofi's $109 million settlement to resolve allegations that it gave doctors kickbacks in the form of free products and submitted false average sales price (ASP) reports to the government. The case involved Hyalgan, a pharmaceutical used to relieve knee pain due to osteoarthritis. Hyalgan is injected directly into the knee joint to restore the cushioning and lubricating properties of normal joint fluid. It is prescribed for individuals whose pain cannot be managed with simple painkillers, exercise or physical therapy. The government alleged that Sanofi US sales representatives entered into illegal sampling arrangements with physicians, using free units of Hyalgan as kickbacks and promising to provide more free “samples” in order to lower Hyalgan’s effective price. According to the government, Sanofi US provided its sales representatives with thousands of free “sample” Hyalgan units and trained its sales representatives to market the “value add” of these units to physicians. The government provided the following examples of what it contended were illegal kickbacks:
Offering physicians anything of value to induce them to purchase or prescribe your product violates the Anti-Kickback Statute. Any claims for reimbursement submitted to Medicare or Medicaid for those products then become "false claims" in violation of the False Claims Act. According to the government, Sanofi US chose not to compete by lowering the actual invoiced price of Hyalgan for fear of setting off a price war with its competitor that would lead to a “downward spiral” in prices and reimbursements. The $109 million settlement also resolves allegations that Sanofi US submitted false average sales price (ASP) reports for Hyalgan. The ASP reports were false, the government contends, because they did not account for the free units that were distributed to physicians based on their purchases. ASP reports submitted by pharmaceutical companies are used to set reimbursement rates for government healthcare programs such as Medicare and Medicaid. The government alleged that the false ASP reports submitted by Sanofi caused government programs to pay inflated amounts for Hyalgan and the competing product. This case may never have been brought except for one pharmaceutical sales representative, Mark Giddarie, who consulted with a False Claims Act attorney. Under the False Claims Act, an individual who has knowledge of false or fraudulent claims may commence a qui tam lawsuit on behalf of the U.S. Government. The individual who commences the lawsuit is called a “relator.” The qui tam lawsuit is filed under seal (in secret) while the government investigates the allegations and decides whether to pursue the case. If the government recovers money from the defendant, the relator is entitled to a reward of between 15% and 30% of the amount the government recovers from the defendant. If you have information that a pharmaceutical company is offering kickbacks in the form of cash, free samples conditioned on purchases, or lavish gifts, dinners, speaking fees or other benefits, then you should consult with an experienced False Claims Act attorney immediately. No attorneys’ fees are charged unless your case is successful. To arrange a free and confidential consultation with John Howley, Esq., call (917) 652-6504 or click here to contact our office via email. John Howley, Esq. The information you obtain at this site is not, nor is it intended to be, legal advice. You should consult an attorney for advice regarding your individual situation. I invite you to contact our law offices and welcome your calls, letters and electronic mail. Contacting us does not create an attorney-client relationship. Please do not send any confidential information to us until such time as an attorney-client relationship has been established. I practice law and offer legal services only in jurisdictions where I am properly authorized to do so. I do not seek to represent anyone in any jurisdiction where this web site does not comply with applicable laws and bar rules. The owners of five pharmacies in New York City have pleaded guilty to defrauding Medicaid of millions of dollars by submitting bills for drugs that they never dispensed to their patients. The pharmacy owners and corporations they controlled pleaded guilty to stealing a total of $9.9 million from Medicaid. The government developed evidence of the pharmacy fraud by conducting an audit comparing the amount of drugs each pharmacy legally purchased against the total amount Medicaid paid each pharmacy. Auditors from the New York State Attorney General’s Medicaid Fraud Control Unit (MFCU) determined that the pharmacies had not purchased enough inventory to fill all of the prescriptions billed to and paid by Medicaid. Each of the defendants admitted in court that they used their positions in the pharmacies to steal from the Medicaid system by billing or having pharmacy employees bill Medicaid for drugs that they never dispensed to their patients. The defendants reached plea agreements that will result in widely varying sentences – from up to three years in prison plus $7.7 million in restitution for the worst offender, to a conditional discharge and 300 hours of community service plus restitution of $160,000. Sanjay K. Patel and corporations he controlled were accused of stealing the most money from Medicaid -- $7.7 million. He was sentenced to a term of one to three years in a state prison. In addition, Mr. Patel has already paid Medicaid approximately $3 million and he has agreed to pay another $4.7 million in restitution to New York State. Divy Dixit, a part owner and supervising pharmacist of Akshar Pharmacy in the Bronx, was charged with stealing more than one million dollars from Medicaid. He pleaded guilty to Grand Larceny and will be sentenced to five years probation and 300 hours of community service. He must pay the Medicaid program full restitution of $1,041,491.77 plus interest before he is sentenced. Sanjay R. Patel, a part owner and supervising pharmacist of Nayosha Pharmacy in the Bronx was charged with stealing more than one million dollars from Medicaid. He pleaded guilty to Grand Larceny and will be sentenced to six months home confinement and five years probation. He must pay the Medicaid program full restitution of $1,266,483.59 plus interest before he is sentenced. Alpesh Patel, a part owner and supervising pharmacist of Yogi Pharmacy in the Bronx, was charged with stealing more than $250,000 from Medicaid. He pleaded guilty to Petit Larceny and will be sentenced to a conditional discharge and 300 hours of community service. He must pay the Medicaid program full restitution of $252,401.62 plus interest before he is sentenced. Bharat Patel, the supervising pharmacist of Family Care Pharmacy in the Bronx, was charged with stealing more than $150,000 from Medicaid. He pleaded guilty to Petit Larceny and was sentenced to a conditional discharge and 300 hours of community service after paying the Medicaid program full restitution of $158,385.38 plus interest. If you are under investigation or accused of Medicare or Medicaid fraud, you should consult with an experienced Medicaid fraud attorney immediately. An experienced trial lawyer can help you prepare your defense, negotiate with the government to help avoid or reduce the charges against you, move to dismiss the charges, fight the charges in court, and help you negotiate a resolution. Do not delay. How you respond to the investigation or charges at the early stages can make all the difference between a favorable resolution of your case or a stiff prison sentence. To arrange a free and confidential consultation with an experienced healthcare fraud lawyer, call John Howley, Esq. at (917) 652-6504 or click here to reach our office via email. John Howley, Esq. The information you obtain at this site is not, nor is it intended to be, legal advice. You should consult an attorney for advice regarding your individual situation. I invite you to contact our law offices and welcome your calls, letters and electronic mail. Contacting us does not create an attorney-client relationship. Please do not send any confidential information to us until such time as an attorney-client relationship has been established. I practice law and offer legal services only in jurisdictions where I am properly authorized to do so. I do not seek to represent anyone in any jurisdiction where this web site does not comply with applicable laws and bar rules. Pfizer Inc. has agreed to pay $55 million plus interest to settle allegations that Wyeth LLC, a Pfizer subsidiary, promoted the prescription drug Protonix for off-label use. Protonix is a proton pump inhibitor (PPI) that was used by physicians to treat various forms of gastro-esophageal reflux disease (GERD). The Food and Drug Administration (FDA) approved Protonix for short-term treatment of erosive esophagitis, a condition associated with GERD that can only be diagnosed with an invasive endoscopy. The government alleged that Wyeth engaged in a “multifaceted” campaign to promote Protonix for all forms of GERD, including symptomatic GERD, which was far more common and could be diagnosed without an endoscopy. These other uses were not approved by the FDA. Under the Federal Food Drug and Cosmetic Act, manufacturers must obtain FDA approval for any indication for use for which a manufacturer intends to market a drug. A prescription drug that is intentionally marketed for unapproved off-label uses is considered “misbranded.” The government alleged that Wyeth intentionally engaged in the following conduct to promote Protonix for off-label use:
Pfizer denied the allegations, and the settlement resolves the case without a finding of guilt or innocence. While the Pfizer case was brought by the government directly, many off-label promotion cases are brought by whistleblowers. Under the qui tam provisions of the False Claims Act, whistleblowers are entitled to a reward of up to 30% of the amount of money the government recovers. In some cases, the rewards in pharmaceutical cases have reached millions of dollars. If you have information that a pharmaceutical company is promoting its drugs for off-label uses, then you should consult with an experienced False Claims Act attorney immediately. To schedule a free and confidential consultation by telephone or in person, call my office today at (917) 652-6504 or click here to communicate with me via email. John Howley, Esq. The information you obtain at this site is not, nor is it intended to be, legal advice. You should consult an attorney for advice regarding your individual situation. I invite you to contact our law offices and welcome your calls, letters and electronic mail. Contacting us does not create an attorney-client relationship. Please do not send any confidential information to us until such time as an attorney-client relationship has been established. I practice law and offer legal services only in jurisdictions where I am properly authorized to do so. I do not seek to represent anyone in any jurisdiction where this web site does not comply with applicable laws and bar rules. |
John Howley, Esq.
350 Fifth Avenue 59FL New York, NY 10118 (212) 601-2728 |