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In 2000, Diana Levine lost a hand and forearm to gangrene after Phenergan was inadvertently injected into an artery during a so-called push IV injection, which is more potent and puts injected drugs into the body faster than a normal injection. Ms. Levine had gone to a medical facility in central Vermont for treatment of nausea.

The drug's labeling, approved by the FDA, included the injection method as an option but warned of risks like gangrene if the drug were injected into an artery. Ms. Levine sued, arguing Phenergan's labeling was unsafe, and a Vermont jury awarded her $6.8 million in damages. On appeal, the Vermont Supreme Court upheld the award, ruling that FDA drug regulations don't prevent a company from being sued under state law over drug labeling.

I would not have accepted the plea agreement I would have proceeded to trial and alerted opposing counsel that their clients had better get used to group showers and wearing orange jump suits. I would have appointed somebody from the FDA to personally oversea ALL of Purdue's marketing material for the next 5 years and then I would have confiscated the profits from the product for the periods in question. This is the only way to deal with people who put profits ahead of patient health especially when they commit a criminal act and lie about it. It's time to get tougher with weasels.

Dean McClellan, who worked for 12 years at J&J's Ortho Biotech unit selling Procrit, saved 15,000 pages of company memos, contracts and other work-related documents in a storage unit and shed he built off his garage. He says he was forced to retire in 2004 because the company told him his sales increases weren't high enough. He believes the company wanted him out because of his age, which was 55 at the time. Angry, he agreed to join a whistleblower lawsuit by another former Procrit salesman, Mark Duxbury. A brief filed by J&J says Mr. Duxbury was fired in 1998 for racial and sexual harassment. Through his attorney, Jan Schlichtmann, Mr. Duxbury says he was a star salesman for Ortho whom the company turned on after he told the truth about their business practices at a court-ordered deposition.

The Office of Inspector General of the Health and Human Services department put out new compliance guidelines in 2003 saying that marketing the spread may be in violation of anti-kickback laws. The Justice Department has been investigating drug companies for such marketing practices, resulting in big settlements of $875 million for TAP Pharmaceuticals in 2001 and $355 million for AstraZeneca in 2003. After extensive debate, Congress overhauled the Medicare reimbursement system in 2005 to prevent such practices. But drug companies continue to offer large buyers big rebates, which they say are lega

Mr. McClellan's documents on the marketing of Procrit show that in 2004 -- after Amgen Inc.'s competing drug Aranesp came on the market -- J&J made offers that would allow buyers of Procrit to receive discounts off an already-reduced price as well as rebates. For example, an internal company memo calculates that a physician who bought nearly $1 million of Procrit over 15 months would get a check for $237,885 back, or 24%.

Another J&J program offered hospitals an incentive to buy Procrit and shun Aranesp: discounts on purchases from across Johnson & Johnson's product line -- including some huge-selling drugs and medical devices sold by different subsidiaries -- if the hospital used Procrit at least 75% of the time when prescribing anti-anemia drugs. In addition, J&J created a "Right of First Refusal" contract for doctors, requiring them to allow Ortho Biotech to make a counteroffer if Amgen's Aranesp price undercut Procrit

Mr. McClellan also alleges the company pushed doctors to prescribe a higher dose years before it was approved as safe and effective by the FDA. For years, the company focused on educating health care providers on Procrit's medical benefits, he says. But in the mid-1990s at a national sales force meeting, an Ortho executive announced that the division was moving to promote what it called "QW dosing," switching patients from three, 10,000-unit doses a week to a single, 40,000-unit dose in cancer patients, Mr. McClellan says.

At that time, that dose wasn't approved for cancer patients. Many years later, the FDA approved the dose in cancer patients, but before then, pushing the unproved dose would have violated FDA rules.

But Pfizer’s marketing may not be enough to overcome the medical, economic, practical and legal concerns that have hurt Exubera. In theory, the drug’s biggest advantage over standard injectable insulin is that it is more convenient and does not require needle pricks. In reality, though, the Exubera inhaler is bulky and can be hard to use, doctors say. The device is nearly as large as a tennis ball can when it is open, and must be repeatedly pumped before the insulin can be inhaled. Making matters worse, Exubera doses differ from those for standard insulin, and converting doses can be complicated, the doctors say. Also, insurers have been reluctant to pay for Exubera, which costs about $5 a day, compared with $2 to $3 a day for injectable insulin. In addition, the needles now used for conventional insulin injections are smaller and less painful than they once were. “Out of 2,000 times or more I’ve tried to start patients on insulin, I’ve only been turned down twice,” said Dr. John Buse, professor of medicine at the University of North Carolina.