She alleges that because she had asked for two bedrooms in her suite and not two bathrooms, this in effect amended the contract.
GE Marquette Medical Systems is a company that had engaged the Biomedical Systems Corp. to make home uterine activity monitors (a.k.a. HUAM) These medical devices are regulated by the FDA. The contract between GE and Biomedical contained stipulations which stated that GE had to obtain pre-market notification clearance from the FDA, which for that purpose, Biomedical needed to give 90 days notice of intent to market the device to the FDA. The 90 day notice is for the FDA to check if the HUAM is substantially similar to other devices already approved for sale.
However, GE instead requested that the FDA reclassify the HUAM device, which is a process that took over three years to complete. Thus, Biomedical sued GE for breach of contract and the jury awarded it damages. GE filed an appeal on the allegation that that the clearance procedure Biomedical wanted in the contract violated FDA procedure.
The Supreme Court affirmed the lower ocurt's ruling. The Court struck down GE's raising the defense of illegality because this defense is not available. The contract with Biomedical clearly stated that GE would apply for clearance which it failed to do. ...Show more