A whistleblower lawsuit brought by two former sales reps for Johnson & Johnson’s Ortho-Biotech unit was dismissed earlier this week by a federal judge in Boston, who ruled that the pair didn’t clear several hurdles needed to prove their allegations under the False Claims Act. In doing so, however, the judge seems to have ignored an appeal court that last fall reinstated another whistleblower suit that was originally bounced, in part, for similar reasons.

First, some background. Mark Duxbury (pictured) and Dean McClellan peddled Procrit, an expensive med used to treat anemia caused by chemotherapy (you can read more about them here). They alleged Ortho-Biotech gave kickbacks to docs and hospitals to induce them to prescribe Procrit, including free samples; off-invoice discounts; rebates; consulting fees; educational grants; payments to participate in studies, and advisory board fees. They also charged Ortho-Biotech inflated Procrit’s average wholesale price; promoted higher dosing than what was approved by the FDA, which generated larger government reimbursements to health care providers; and ran “sham drug trials” to falsify Medicare reimbursement for off-label use.

The Department of Justice, however, declined to join the case. The biggest setback, though, came on Monday, when US District Court Judge Rya Zobel dismissed the claim. One reason - she decided the alleged false claims were publicly disclosed before the suit was filed, raising questions about whether the former reps were the original sources of info used to make the allegations. (This is the ruling).

Another key reason was their failure to meet the requirements of rule 9b, a controversial provision of the False Claims Act, which requires a whistleblower to provide specific information about false claims that were submitted to the government for payment. Generalizations aren’t sufficient; examples with details about amounts charged, individuals involved in billing and identification numbers, among other things, are desired.

But Zobel chose a strict interpretation.”Although Duxbury identifies providers and approximate amounts of free samples, discounts, ‘off-invoice’ rebates, and educational grants, he fails to identify a single false claim consequently filed by these providers,” Zobel writes in her Jan. 28 ruling. The same reasoning, by the way, was used to bounce a lawsuit brought against Pfizer by whistleblower Peter Rost, but an appeals court reinstated his suit last fall.

Duxbury, not surprisingly, is frustrated. “No provider will reveal evidence of a fraud in which they participated, even though the scheme was devised by a manufacturer,” he tells Pharmalot. “And no ordinary provider would have evidence that a manufacturer had a nationwide scheme to promote a drug off-label because they’re not part of the corporation perpetrating the fraud.”

And Jeb White of Taxpayers Against Fraud, a non-profit that’s supported by attorneys who represent whistleblowers, says: “It’s nearly impossible for an individual to show that kind of piece of paper. It’s a terrible way to rule on 9b and may derail what is a meritorious case. And she’s also thumbing her nose at the Rost decision.”

One legal expert, Joan Krause, a law professor and co-director of the Health Law Policy Institute at the University of Houston says it’s not clear whether the sales reps had the strongest case. But she allows that the ruling may make it harder for other whistleblowers to pass the 9b litmus test if other judges were to use similar reasoning.

“It seems the judge is taking a very hard line, harder than most courts take on rule 9b,” Krause tells us. While most cases may be more straightforward when it comes to 9b issues, this ruling is “a very strict interpretation and it could be difficult for someone to come up with that level of information, and make it much more difficult to proceed with a false claim. It’s not the usual standard applied to these cases.”