Amphastar is taking its battle with Momenta Pharmaeuticals to federal court, albeit in a roundabout way. The company has jumped into a mass tort case against Baxter and Scientific Protein Laboratories, in which plaintiffs claim they were harmed by Baxter-branded heparin imported from China. The case stems from that massive recall of the blood thinner, found to be tainted somewhere along the company's Chinese supply chain.
Baxter and SPL want to keep some depositions under confidential seal, including some that involve Momenta, which helped investigate the tainted heparin. Momenta recently won FDA approval for a new form of the blood thinner--and therein lies the rub, at least for Amphastar, which has been trying to get the agency's nod for its version of the drug.
So, Amphastar has challenged an Aug. 3 ruling that gave Baxter and SPL the confidentiality they'd requested. Amphastar claims that the sealed depositions could reveal key information about heparin-making in China.
Problems with heparin safety are a public health issue--and should be an issue for Momenta, the company claims, because heparin is the raw material for the Momenta blood thinner's active ingredient. Plus, Amphastar claims, the depositions could be important to a congressional investigation into the FDA's role in the heparin crisis. Baxter and SPL wouldn't comment for the Wall Street Journal on the confidentiality issue. Momenta also wouldn't comment.
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