Nolan & Auerbach provides experienced pharmaceutical fraud attorneys for employees with knowledge of pharmaceutical kickbacks, pharmaceutical fraud, and pharmaceutical pricing fraud schemes under the qui tam provisions of the Federal False Claims Act. This area of the Nolan & Auerbach site provides information for whistleblowers with information regarding the pharmaceutical industry. Nolan & Auerbach currently has numerous pharmaceutical fraud cases under seal.

The purpose of the qui tam provisions of the False Claims Act is to encourage private individuals who are aware of pharmaceutical off-label marketing fraud, pharmaceutical kickbacks, pharmaceutical pricing fraud and other fraudulent activities being perpetrated against the government to bring such information forward. Nolan & Auerbach has broad experience in preparing, investigating, and filing False Claims Act cases involving inter alia, drug company kickbacks, pharmaceutical pricing schemes, false average sales price cases, and off-label whistleblower cases.

In increasing numbers, pharmaceutical fraud whistleblowers have come out of the woodwork to target the pharmaceutical industry. Several hundred pharmaceutical fraud cases covering more than 500 drugs are now under investigation by the U.S. Department of Justice under the False Claims Act. Settlement of the first 16 pharmaceutical fraud cases (including kickbacks, Medicaid rebate fraud, and best price violations) brought by whistleblowers has returned over $4 billion to the U.S. On the radar screen in addition to pricing schemes, off-label marketing fraud and pharmaceutical kickbacks, are NDA fraud, cGMP fraud, clinical trial fraud, average sales price fraud, Medicaid rebate fraud, and a variety of other fraudulent schemes exposed by whistleblowers.

Recent News Focus:

Nolan & Auerbach represents whistleblowers in Schering-Plough Qui Tam Case

2 of the 3 whistleblowers in this case are clients of Nolan & Auerbach. Their recovery relates to the off-label marketing of Temodar, Rebetron and Intron A. The final relator share recovery by our two clients is over $12 million.

In January 2007, Schering Sales Corp. and its parent company were sentenced to pay $435 million as part of a settlement with the Justice Department over accusations it improperly marketed drugs for unapproved uses and lied to the government about drug prices. Under the settlement which was announced in August 2006, Schering Sales pleaded guilty to conspiracy and agreed to pay a criminal fine of $180 million. Its parent company, Schering-Plough Corp., agreed to pay another $255 million to resolve civil aspects of the case, including a qui tam lawsuit. The qui tam lawsuit included allegations that Schering-Plough marketed drugs for uses that had not been approved by the Food & Drug Administration. One drug was Temodar, a drug the FDA approved only to treat a rare type of brain tumor called anaplastic astrocytoma. The company also promoted the unapproved use of Intron A for the treatment of cancer on the surface of the bladder.

Kickbacks

In April 2007 the Government announced that Pharmacia & Upjohn Company Inc. will plead guilty to a single count of offering to an outside vendor a kickback in the form of an award of a contract to manage a Genotropin patient assistance program as an inducement for recommending the purchase of its medicines.

Federal law prohibits pharmaceutical kickback fraud because it is thought to color the judgment of the physician, i.e. the physician will prescribe a prescription drug based not on what is best and economical for the patient, but based upon what prescription drug product most increases the physician's bottom line. This is bad for the patient and bad for Medicare, Medicaid and other Government healthcare programs. Other examples of kickbacks are as follows:

Offering Pharmaceutical Kickbacks to Physicians in the Form of Phony Drug Studies - Some pharmaceutical companies have provided remuneration for clinical studies as a means to induce physicians to prescribe their products. The "research" performed has no legitimate value, and is merely a pretext for payments for referrals.

"Phony Speaker fees" paid for by Honoraria - Some pharmaceutical companies have used "honorarium" fees or "speaker" fees for physician marketing. Approved by management, they were ostensibly compensation to physicians for agreeing to speak at a formal speaking engagement. In most instances, they were kickbacks for prescriptions, with the physician never speaking at any formal function.

Phony Grants - Approved by management, pharmaceutical sales representatives have been allowed by certain companies to give "grants" to physicians, physician groups and medical facilities ostensibly for an educational program or research program. They have actually been used to provide kickbacks to physicians and companies to do whatever they wanted with the money, in return for business.

Phony Unlimited Preceptorships - Preceptorships are ostensibly a teaching session in which a physician would teach the sales representatives certain technical aspects of his practice in exchange for a sum of money, say $500.00. If the preceptorships were used to induce the physicians to prescribe a drug product (rather than in exchange for teaching), the payment violates the Anti-kickback Statute.

Phony Investigator Meetings - In some pharmaceutical companies, investigator meetings are ostensibly called for physicians to talk about potential non-indicated uses of drugs. Sales representatives are allowed and instructed to spend lavishly on all physicians, both the speakers and invitees. It has been typical for investigator meetings to last only two hours, yet pharmaceutical companies paid for the physicians' airfare, hotel, golf, spa treatments, etc. at luxury hotels around the country.

Advisory Board Meetings - These meetings are typically for the ostensible purpose of getting input/feedback from physicians on drug performance, how they treat disease states. During Advisory Board meetings, honoraria, lavish entertainment and expenses for physicians have been paid for by the pharmaceutical companies.

Offering Pharmaceutical Kickbacks to Physicians in the Form of Samples - Some pharmaceutical companies have encouraged and facilitated the widespread provision of free vials of injectable drugs to physicians. How much the physician is given depends upon what the sales representatives negotiate. It is attractive to the physicians because each vial provided as a "free sample" is worth from $100.00 to $1,000.00 in revenue. Due to this inducement, the physician then determines that it would be quite profitable to start treating his patients with the injectable drug that he profits most on.

A physician and a former vice president for sales for TAP Pharmaceutical Products ("TAP") exposed a pharmaceutical kickback scheme in a case, which settled for $875 million ($290 million in criminal fines and $585 million in civil damages and penalties). TAP, Abbott Laboratories' joint venture with Takeda Chemicals of Japan, pled guilty to a criminal charge of conspiring with doctors to overbill government insurers for Lupron. The allegations involved manipulating the AWP (used at the time to set reimbursement rates for the Medicare program), and providing pharmaceutical kickbacks in the form of free samples to physicians.

Off-label Marketing

Off-label whistleblowers have caused several pharmaceutical companies to modify their illegal promotions where the FDA has not.

In April 2007 the Government announced that Pharmacia & Upjohn Company LLC entered into a Deferred Prosecution Agreement with the Department of Justice (DOJ) that includes a fine of $15 million to address the improper promotion of Genotropin, supposedly based upon a full self-disclosure of the off-label promotion of Genotropin by a Pharmacia subsidiary before Pharmacia was acquired by Pfizer.

In May, 2004, Pfizer, Inc.'s Warner-Lambert unit agreed settle a qui tam lawsuit that alleged it promoted its epilepsy drug Neurontin, for uses not approved by the FDA. In addition to pleading guilty to criminal charges (which included a $240 million criminal fine) that it misbranded the drug, the company paid a civil fine of $152 million and agreed to pay an additional $38 million to various state consumer protection agencies, bringing the total settlement amount to $430 million for this pharmaceutical fraud case.

Clinical Trial Fraud

An article that appeared in The Wall Street Journal Europe reveals how pharmaceutical trials sponsored by pharmaceutical companies as well as those conducted by the government and other public entities may not always produce the same results, with results seemingly too often being in favor of the entity funding the study. For example, in an analysis published in the American Journal of Psychiatry, it was found that in every publicly available trial funded by Pharma that compared five new antipsychotic drugs against each another, the results of nine out of 10 studies concluded that the best drug was the one manufactured by the pharmaceutical company sponsoring the study. The article suggests that such divergent results can be the result of biases in trial design and even in interpreting the study outcome. Experts say that this situation is even more prevalent in trials that measure symptomatic relief as opposed to whether or not a disease was actually cured, as such trials lend themselves to less stringent results interpretation this is a case of pharmaceutical fraud. Nolan & Auerbach is currently representing whistleblowers in sealed qui tam cases involving drugs that were approved by the FDA based upon fraudulent manipulation of clinical trial data - clinical trial fraud.

cGMP Fraud

A corollary of clinical trial fraud are violations of the current Good Manufacturing Practices. cGMP fraud is a practice that also frustrates the scientific process and jeopardizes the integrity of the drug product. "cGMP" fraud is the acronym for the current good manufacturing practice regulations.

The cGMP regulations stem from Congressional concern over the danger that impure and otherwise adulterated drugs might escape detection under a system predicated only on seizure of drugs shown to be in fact adulterated. That is, Congress desired to require manufacturers to abide by laws that, if complied with during the manufacturing stage, would theoretically prevent pharmaceuticals from contamination, bioavailability, or potency defects, for example. The cGMPs require manufacturers to have adequately equipped manufacturing facilities, adequately trained personnel, stringent control over the manufacturing process appropriate laboratory controls, complete and accurate records, reports, appropriate finished product examination, and so on.

Nolan & Auerbach provides experienced legal representation to individuals with knowledge of pharmaceutical kickbacks or other pharmaceutical fraud under the qui tam provisions of the False Claims Act, representing whistleblowers who have information about pharmaceutical fraud (including clinical trial fraud, cMPG fraud, NDA fraud, pharmaceutical kickbacks, off-label, and pharmaceutical pricing fraud (average sales price fraud, Medicaid rebate fraud, best price fraud, and so on). Complete our Pharmaceutical Questionnaire for a quick response. We understand and we care.

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