Now KV Pharmaceuticals is facing the prospect of an additional action: a class-action shareholder lawsuit as the result of an FDA inspection report. This is an important event, and here's why . . .
Judge: Regulatory Inspection Report Can Form Basis of Class Action Lawsuit - RAPS - News - Article View:
"On Monday, 4 June a federal appeals court ruled a securities fraud class action lawsuit could proceed against pharmaceutical manufacturer KV Pharmaceuticals for purportedly causing $1.5 billion in shareholder losses after first misleading FDA about manufacturing problems at a facility and later shutting down the facility’s manufacturing operations."
'via Blog this'
What's important to note is that this decision is a marked reversal from existing precedence, which has found Form 483 reports to be immaterial to federal securities law.
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