From the CECON Case Files:
Situation: A generic liquid injectable drug was sold in vials large enough to be used on multiple patients (50 ml vial used for 10ml dosage). The plaintiff developed Hepatitis C following a colonoscopy procedure during which vials were reused and apparently contaminated. Attorneys for the plaintiff complained that the medical clinic did not follow prescribed drug labeling and use procedures.
Expert Need: Attorney for the plaintiff sought a pharmaceutical consultant. The CECON Project Manager suggested that an expert with a slightly different background would be more appropriate.
Type of Expert Selected: A former FDA Branch Director and now a consultant and expert on regulatory issues and innovative/generic drug labeling. Expert gave reports and testimony on best practices for use of the drug.
Outcome: Judgment was for the plaintiffs, with a $500 Million Punitive Award.
Of Note: Legislation was introduced in both the Senate and House last month that would permit generic drug companies to update warning information about the drugs they manufacture, a change that could allow patients to sue the companies for failing to warn about the risks of taking their drugs. Click here to read more.
Current FDA regulations require a generic drug’s labeling to be essentially the same as that of the approved drug. Click here to read more.
CECON has over 180 distinguished pharmaceutical consultants with experience in drug discovery and development, documentation, regulatory matters, manufacturing, analysis and business management Pharma consulting is one of CECON’s core specialties.
CECON’s Project Managers are scientists and experts themselves with advanced degrees in technical disciplines and personal experience in various scientific and engineering fields. Their expertise allows them to provide insight regarding the exact expertise needed in different cases or projects.