Procrit Home About This Drug Injuries and Warnings Who's to Blame Your Legal Rights Frequently Asked Questions Free Evaluation
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WHO'S TO BLAME?

Who's to blame for the injuries and deaths caused by Procrit? In short, the drug companies are to blame.

Procrit was on the market for years before the life-threatening risks associated with it were made public. Further, Ortho Biotech encouraged physicians to prescribe Procrit in ways not approved by the FDA. The drug company engaged in a nationwide scheme using illegal promotions and kickbacks to increase Procrit sales. All of this was done with complete indifference to the rights and safety of the patients. As Procrit sales increased, so did the number of Procrit patients suffering from early death and life-threatening injuries.

DECEPTIVE ADVERTISING

Ortho Biotech promoted Procrit for off-label use and engaged in deceptive advertising. In their promotional and advertising materials, in their marketing tactics in face-to-face meetings with physicians, and in their press releases, Ortho Biotech misled doctors and patients by withholding information and suggesting false information about the safety of Procrit.

On June 20, 2003, the FDA ordered Amgen and Ortho Biotech to immediately pull all Procrit advertising and promotional materials that contained false and misleading statements. According to the FDA, the Procrit ads were a direct violation of the federal Food, Drug, and Cosmetic Act. The notification letter discusses several misleading and unsubstantiated claims in Procrit advertising and promotional materials, including advertisements in the Cancer Management Handbook. The violations mostly dealt with claims that Procrit would bring a patient's hemoglobin to normal levels, that it should be used until hemoglobin levels are normal, and that it is more effective than has been demonstrated.

Ortho Biotech was also promoting and marketing Procrit as a treatment for the fatigue associated with chemotherapy. Procrit is not FDA-approved to treat fatigue. This marketing and advertising was not only illegal, but also unethical because their claims that Procrit was an effective treatment for fatigue were not substantiated by medical research. What little medical evidence there was, was mostly funded by Procrit's manufacturer, Amgen.

You may remember one particular Procrit commercial. It features a kindly, elderly gentleman who appears weak and tired. He is talking to his concerned wife about his tiredness, weakness and lethargy. He has a beautiful home, his dog by his side, the sky is blue, but he's discouraged. Then Procrit comes to the rescue. The commercial advises cancer patients who are undergoing chemotherapy to "ask their doctor if Procrit is right for them". In the final scene, the kind gentleman is seen after taking Procrit, and he is vibrant, energized, happy and healthy. "Ask your doctor about Procrit" is the final statement.

Physicians at M.D. Anderson Cancer Center in Houston conducted an independent study which was published in the Journal of Palliative Medicine. The researchers concluded that anemia is not a major cause of fatigue in cancer patients on chemotherapy. Journal editor Charles von Gunten stated that "these data will help physicians resist the patient and family pressure to use erythropoietin because they saw it on television ... Erythropoietin is ineffective in relieving fatigue if anemia is not the cause. It is an expensive placebo."

Ortho Biotech intentionally misled the medical community and consumers in an effort to increase their sales and income, showing complete indifference to the health and safety of the patients who were taking Procrit.

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INFLATED DOSING SCHEME

A "whistle-blower" lawsuit has been filed against Ortho Biotech claiming that the company used illegal promotions and kickbacks to induce the off-label use of Procrit. The suit alleges that Ortho Biotech induced doctors to administer Procrit to chemotherapy patients at a dosing rate of 40,000 IU one time a week, instead of the approved rate of 10,000 three times a week. This would obviously require more Procrit, thereby increasing Procrit sales.

Although physicians can legally prescribe drugs for "off-label" use, the drug companies are strictly prohibited from promoting their drugs for such use.

Ortho claims that there was no health risk involved in this off-label promotion. But this doesn't hold up in light of the recent findings that Procrit at increased doses can cause heart attacks, heart failure, stroke, blood clots, and death. These risks warranted a black box warning advising physicians to use the "lowest possible dose" of Procrit. By promoting this increased, off-label dosing, Ortho Biotech increased the chances that patients would suffer from life-threatening injuries.

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INFLATED PRICING SCHEME

The "whistle-blower" lawsuit also claims that Ortho Biotech used illegal kickbacks and promotions to encourage physicians to prescribe Procrit.

Healthcare providers buy Procrit to administer it to their patients. Medicare reimburses the provider for the Procrit. The amount paid by Medicare is pre-determined and is called the Average Wholesale Price (AWP). This is not necessarily the same amount that the provider actually paid for the drug. The difference between the amount actually paid and the amount reimbursed is called "the spread. Ortho Biotech unlawfully and intentionally inflated the spread so that providers were making a significant profit by using Procrit. The idea behind this is that doctors are more likely to use Procrit as opposed to other ESAs if they know they will make substantial profits from doing so.

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RIVALRY BETWEEN THE DRUG COMPANIES

When Procrit was still being developed, Amgen licensed the drug to Johnson & Johnson, keeping Epogen for itself. The idea was that Procrit would be marketed for patients with chronic kidney failure who were not on dialysis and Epogen would be marketed for dialysis patients. By keeping the dialysis market for itself, Amgen clearly meant to corner the larger market. As it turns out, Procrit was then approved for use in cancer patients, HIV patients, and patients undergoing major surgery. This exceeded the dialysis market. So, Amgen developed a new longer-acting ESA, Aranesp, which was approved by the FDA in 2001.

Amgen subsequently launched a massive marketing campaign that included direct to consumer television commercials to promote the use of Aranesp for treating fatigue related to chemotherapy. Johnson & Johnson responded with its own advertising campaign. Patient demand for the drugs soared.

In 2005, Ortho Biotech filed an anti-trust lawsuit against Amgen. They claimed that Amgen was using illegal marketing practices to try to force Procrit out of the market. Amgen sells the ESAs Aranesp and Epogen. They also sell Neupogen and Neulasta, which are used for chemotherapy patients. Amgen has a virtual monopoly on this type of drug. According to the lawsuit, Amgen was informing cancer clinics that the only way they could continue to receive Neupogen and Neulasta at a discounted price was if they also agreed to buy Aranesp. This left clinics and providers with only one economically feasible option - to buy Aranesp rather than Procrit. This is referred to as an anti-competitive tying arrangement and is unlawful.

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PLACING PROFITS OVER PATIENTS

Competition in the pharmaceutical world is fierce. Drug companies are so eager to get the next drug out on the market, they are often willing to overlook and sometimes even cover up, problems with the drug. New drugs are introduced prematurely without adequate testing and warnings, resulting in tragic losses that could have been avoided if the drug company had taken more time to test and develop the drug, and provided adequate warnings about its use.

Procrit is no exception. The pharmaceutical companies failed to adequately test the drug before and after it was on the market, they failed to warn patients and doctors about the risks involved with taking Procrit. Once on the market, the pharmaceutical companies used cheating, bullying and deception in an attempt to increase their sales. Their priority was clearly to make money rather than to protect the patients taking their medications. Many Procrit patients were harmed as a result.

The law firm of Howard L. Nations represents people who have been harmed from Procrit, Epogen, or Aranesp. If you or someone you know has suffered serious side effects from taking these medications, please contact our offices for a free case review by one of our pharmaceutical attorneys.

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