June 28, 2012

Not in My Backyard: Safety of Bloom Energy Solid Oxide Fuel Cells Questioned

CECON Project Manager Dr. Stanley Tocker was appointed to the Delaware State Coastal Zone Industrial Control Board by Governor Markell in 2011. Stan’s role on the committee is to provide a scientist’s perspective on issues that come before the committee. Previously, Stan served for eight years as a member of the Delaware Environmental Control Board.

Last week, a hearing was held on proposed Solid Oxide Fuel Cells to be built in the state of Delaware. The prior approval of this new energy technology was being challenged. Stan’s insights on that hearing are below:

June 21, 2012

Top Ten Mistakes Made When Hiring Consultants

While some businesses and law firms hire consultants and expert witnesses routinely, others look to outside expertise infrequently and may not know what to look for. Mistakes can be costly to your project or case as well as to your company.

The article below offers some good tips, whether you hire consultants once a week or once  a year.

Click here to read more.

The CECON Group specializes in placing consultants and expert witnesses and can guide you through the process of obtaining the specific consulting services you need for your job.

June 14, 2012

It's Summer & Everyone Wants to Work from Home

Managing remote teams, whether they are employees, consultants, or expert witnesses, can be challenging absent a plan for coordinating efforts. Click here to read an article that provides some good tips.

The CECON Group has been placing science and engineering consultants since 1985. Our scientifically trained project managers can help assemble teams of consultants and provide project managers to coordinate the consulting services  on your project.

June 8, 2012

Expert Testimony Survives Daubert Challenge

A CECON food safety expert shares his experience of having his testimony successfully survive a Daubert challenge. A circuit court had ruled his testimony inadmissible, but on appeal this decision was reversed and his testimony was allowed.

Because the food safety expert sufficiently connected the proposed testimony with the facts of the case and because the food safety expert's extensive background in food safety circumstantially suggests he used a valid methodology in drawing his conclusions, his testimony survived the challenge.

Simply put, the Appeals Court believed that the food safety expert's opinion should be admissible because he explained precisely how the conclusions were reached and pointed to an objective source to show that his conclusions were based on a scientific method used by at least a minority of scientists in the field. The Appeals Court believed that the conflict between the positions taken by the parties regarding the food safety expert's conclusions did not render his testimony unreliable, but instead created a jury issue regarding the weight to be given to the testimony. Accordingly, the Appeals Court found that the circuit court erred in excluding the food safety expert's testimony.
The case was eventually settled out-of-court.

Details surrounding the decision can be found below.

June 1, 2012

Right Expert Helps Land $500 Million Award

Placement Expert with Scientific Background Instrumental in Selecting Expert

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.