ZymoGenetics, King Pharma Brawl Over Drugs to Control Surgical Bleeding

11/9/09Follow @xconomy

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with the FDA. (The agency is expected to provide an answer to the petition by February, says ZymoGenetics spokeswoman Susan Specht.)

But King didn’t stop there, it brought its side of the case to its local U.S. District Court, in front of Judge Ronnie J. Greer. King’s suit names not only ZymoGenetics as a defendant, but also “John and Jane Does 1-50″ who are paid presenters for the company, medical opinion leaders, sales reps, and medical science liaisons who King says it can’t identify unless the judge allows it to go ahead with legal discovery—essentially digging through all kinds of internal ZymoGenetics files.

In its 83-page legal complaint, King says that ZymoGenetics used false and misleading statements about the two companies’ products despite a warning from the FDA in April 2008. King says there’s no evidence from ZymoGenetics’ own clinical trials that links formation of antibodies to cow proteins in Thrombin-JMI with any serious adverse events in surgery patients. “Notwithstanding the lack of evidence and the reprimand from the FDA, [ZymoGenetics] and its agents and representatives continue to make the aforementioned claims in a willful and malicious attempt to scare away King’s existing and potential customers of King’s thrombin product, knowing that without such tactics, consumers prefer King’s well-established and clinically tested Thrombin-JMI product.”

King goes on to argue in its suit that it has found out that ZymoGenetics and its representatives have started telling customers that “King’s thrombin product causes death” and that they should quit using it immediately or else risk medical malpractice lawsuits. “Having exhausted all other means to quell [ZymoGenetics'] wrongful actions, King is left with no other option than to seek relief from the court,” King said in its filing.

There are a flurry of documents being filed daily in the case, but ZymoGenetics’ Specht summed up the company’s defense. “We believe the allegations from King are baseless,” Specht says.

Analyst David Miller of Biotech Stock Research, who follows ZymoGenetics, says the case bears watching, but that Zymo should win. “The FDA is the arbiter of proper marketing materials for approved drugs, which includes a review of materials for accurate claims. As long as Zymo is using approved materials, and they are, this suit goes nowhere,” Miller wrote in a note to clients on November 5.

This case is headed toward a November 16 initial court date.

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  • JK

    I am an unbiased observer to this case but as a person familiar with FDA activities I must say that this is a very poorly researched article. While the article is correct when it quotes Mr. Miller as saying that “The FDA is the arbiter of proper marketing materials for approved drugs,” the article (and Mr. Miller) fail to mention that in April of 2008 the FDA’s division that reviews marketing materials actually sent an untitled letter to Zymogenetics claiming that some of its promotional materials were misleading and therefore in violation of FDA rules on product promotion (http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/ComplianceActivities/Enforcement/UntitledLetters/ucm093490.htm). These materials specifically related to Zymogenetic’s claims vis-a-vis King’s product and were mentioned in King’s lawsuit. While it is unclear if Zymogenetics is still making similar claims and unclear whether they patched things up successfully with the FDA, the letter is clearly relevent to the case. The letter also calls into question the second half of Mr. Miller’s quote “As long as Zymo is using approved materials, and they are, this suit goes nowhere.” I agree that if Zymogenetics is using appropriate materials they are safe, but the FDA reviews (rather than approves) individual advertising peices and it is not clear that the FDA agrees with Zymogenetics’ marketing activities.

  • http://www.xconomy.com/author/ltimmerman/ Luke Timmerman

    JK—this story does include a reference to the FDA’s warning to ZymoGenetics about its marketing practices in April 2008, but that’s nothing new. The more interesting question is whether ZymoGenetics has crossed the line in its marketing again in the view of the FDA, and I don’t know the answer to that. Certainly, the company stepped up its attacks on King with the citizen petition in August, and it will be interesting to see how the FDA views this new tougher communication to doctors. If you have any evidence of them, or King, or anyone else making claims to physicians that are flat wrong or misleading, I’d like to look into that as a follow up. –Luke

  • Sarah Lake

    Interesting, just 2 deaths in 14 years (or 14 million cases, according your acticle) -not much evidence…