Here is a rough “flow of consciousness” outline of thoughts about a drug device product case. I find it helpful to outline ideas picked up from focus studies, reading and just thinking about the case which I then narrow down and refine to useable themes, cross examination ideas and trial approaches to trial. Maybe something here will trigger ideas in your case.
- Any risk of serious injury or death is unacceptable if reasonable prevention methods would eliminate or minimize the danger.
- People protection requires eliminating the hazard to safety. If that’s not possible guarding people from the danger. If that’s not possible, warning people about the danger.
- Risk – benefit analysis: (1) How serious is the potential harm (2) What is the likelihood of harm (3) What is the cost of elimination, protection or warning (4) how long will it take (5) how effective would it be and (6) are means available to do so
- The corporation had all the knowledge about the product defect
- The corporation was in the best position to share the knowledge with doctors and hospitals
- The issue is:
(1) What did the corporation know and when did they know it.
(2) What did the corporation reveal and what did they conceal
(3) What did the corporation do to protect patients
(4) Did they do everything they could to prevent it
- This machine had a bug, a flaw it in
- It was like a computer with a virus
- This was preventable, avoidable and inexcusable
- This corporation cut corners
- This corporation had a duty to analyze, investigate and test it’s products
- Doctors, hospitals and patients have a right to expect a corporation will act reasonably to protect patients from harm
- They handled this like the best kept secret in America
- THE SWEPT THE PROBLEM UNDER THE RUG
- COMPANY WAS AFRAID TO LET THE CAT OUT OF THE BAG THAT IT’S TEST WAS DEFECTIVE
- THEY “PARKED” THE INFORMATION IN THEIR FILES
- LED THE DOCTORS & PATIENTS DOWN THE PRIMROSE PATH
- IT WAS LIKE THE DOCTORS WERE DIALING 9-1-1 AND THE COMPANY KEPT HANGING UP ON THEM
- THIS COMPANY KNEW WHAT PHYSICIANS DIDN’T KNOW
- ONLY THIS LAWSUIT BROUGHT THIS TO THE LIGHT OF DAY
- LACK OF KNOWLEDGE MEANS BAD MEDICAL CHOICES
- Failure of accountability and responsibility
- They want to play the “blame game” and blame others for their carelessness
- They are like a child with frosting all over it’s face claiming they didn’t eat the cake
- THIS CORPORATION SHOULD BE HELD ACCOUNTABLE FOR VIOLATING THE TRUST PLACED IN THEM BY DOCTORS & PATIENTS
- WHO’S MINDING THE STORE
- SHADING THE TRUTH, HIDING THE BALL & OUTRIGHT LIES
- THIS IS NOTHING BUT A SMOKE SCREEN FOR THEIR OWN ACTS
- COMPANY AFRAID TO LET THE CAT OUT OF THE BAG THAT THEIR PRODUCT WAS DEFECTIVE
- SHIFT THE BLAME FOR WHAT YOU ARE RESPONSIBLE & ACCOUNTABLE FOR TO ANYONE ELSE
- THEY COVERED UP
- THEY PLAYED RUSSIAN ROULETTE WITH THE HEALTH OF PEOPLE
- CORPORATION JUST SHRUGGED THEIR SHOULDERS” & WENT BACK TO BUSINESS AS USUAL
- WHEN IT CAME TO RESPONSIBLE, SAFE CONDUCT, THIS CORPORATION CUT CORNERS
- WHY NOT SEND A WARNING TO THE TREATING DOCTORS?
- WAS THE REASON WAS TO PROTECT THE PATIENT OR THEIR PROFIT MARGIN?
- COULD THEY HAVE WARNED THE DOCTORS? IF SO, THERE MUST BE A REASON WHY THEY DIDN’T.
- “WHAT IS THE POSSIBILITY THIS COMPANY CONCEALED THE FACTS IN ORDER TO MAKE MONEY?