Remove 2005 Remove FDA Remove FDA Compliance Remove Regulations
article thumbnail

Dealing with the Pennsylvania Supreme Court’s Non-Decision on Standards Compliance Evidence

Drug & Device Law

It is not evidence of the underlying attributes of the product that make it compliant with regulations or standards, which is presumably admissible subject to the ordinary Rules of Evidence. The OAJC’s view of standards compliance evidence, moreover, suggests that “door opening” may no longer be appropriate. 3d 1245 (N.J.

article thumbnail

Federal Officer Removal Fails In California

Drug & Device Law

142 (2007), mere regulation of the product or conduct at issue—the medical walker is a non-prescription, Class I medical device with general controls only—is not a basis for removal under this statute. 308 (2005), which comes up not infrequently in drug and device product liability cases. Since the Supreme Court decision in Watson v.