Struggling with a complicated case?
A patient may be injured, and the drug or medical device may (or may not) be the actual cause, but what really happened? What was the proximate cause of the problem?

Conversely, you may be defending a product liability lawsuit, but is the product being held to an unrealistic (infeasible) standard? Is the evidence against the product really all that sound? Are there mitigating factors or alternate explanations that may be involved?

Modern medical devices are complex systems, usually designed, validated, and manufactured by teams of specialists. Each specialist may be an expert in his or her particular area, yet be unaware of how issues affecting one area can impact the performance of the entire system. Unfortunately, given commercial pressures and potentially inexperienced upper management, the temptation to "streamline" or "cut corners" on proper validation does exist. Occasionally this can result in potential drug or device malfunction and occasional patient injury.

On the other hand, given the potential for high tort liability damages, there are also a fair number of situations where litigation has commenced that ultimately is based on less than a firm set of facts. How do you distinguish between "sound" and "unsound" facts in this situation?

How I Can Help
As a former pharmacology professor, as well as a former medical device (therapeutic drug monitoring) CEO and Chief Technology Officer, I have been responsible for many aspects of medical devices, from initial R&D and design trough scale-up, clinical trials, FDA approvals, manufacturing, and post-launch product monitoring and corrective action.

I have an undergraduate degree in physics, much experience in electronics, and understand devices from low-level software, mechanical design, electronics, and biochemistry up through systems analysis, FDA regulations, operations, labeling, marketing materials, financial analysis, and investor relations.

Sometimes drugs or devices deteriorate with time and/or improper storage, transport, and handing. I have published extensively in the areas of drug and device time-temperature stability, and can help pick-up on important facts here.

Because I've actually "been there and done that", I have a deep understanding of how these many different factors relate. In your product liability analysis work, regardless of which side your are on, why not use a product liability expert or biomedical (medical device) expert witness that can see these many connections?