Judge Goodwin Expresses Confusion? 'Gold Standard' or Defective Pelvic Mesh?
*Editor’s Note~ MND editor has been the only reporter covering these trials so the comments by Judge Goodwin as the days testimony ended, were particularly noteworthy.
Judge Goodwin has shown a lighthearted spirit joking with the jurors and even the attorneys. Once calling a sidebar after an absence of one he said “I’ve missed you all.”
Certainly he has shown more of an upbeat attitude than he did during the other case against Ethicon he oversaw last February, Lewis v. Ethicon. After the plaintiff rested its case, Judge Goodwin granted a J&J motion to end the trial in the company’s favor granting the directed verdict.
His comments today might indicate how thinks the case is going.
Judge Goodwin seemed to be grasping for words when he waved his hands in the air at the end of today and said he was thinking about the upcoming jury instructions in this product liability case. He asked both sides to write up something explaining two legal concepts at odds with each other:
How we can have a “Gold Standard” and a “Standard of Care” meaning the TVT-O, transvaginal device used to treat incontinence, and at the same time a device that is “unreasonably dangerous” which it must be proven under strict liability law. How can a device when used by a physician be negligent in its design and manufacture?
Clearly Judge Goodwin is not aware that there is a divide among doctors, a growing voice of professionals that agree that polypropylene mesh represents an unreasonable risk, or is outright defective. Here is a background story on Doctors Divide.
There’s been an entire media blackout on reporting on these cases and women cannot make it here to Charleston because of injuries and instruction by law firms to stay away from speaking out. Jurors are not seeing the breadth of mesh-injuries in this trial.
Clearly Judge Goodwin and the jurors do not understand that an Institute of Medicine report issued in 2011 says the 510(k) approval process should be abolished because it is putting too many patients at risk and that the FDA should start collecting information to build the new process, including post-market data for devices which should be enacted by Congress. Read the report here.
This case has not allowed in the FDA July 2011 Alert that says Risks may Outweigh Benefits in regard to mesh for pelvic organ prolapse. It is the same mesh. Here.
Judge Goodwin said : “Failure to warn is an easier thing to wrap your head around,” he said. “I’ve got that.”
He asked if there was a standard when a medical device that is extraordinarily dangerous such as the black box warning when a medication is found to be harmful to patients.
Both sides can offer explanations to the Judge by tomorrow. He must then take that into consideration in providing jury instructions. The case for J&J should wrap up this week.
Readers of Mesh News Desk… What would you say to the judge? How do you explain this apparent contradiction?
First of all- Was there any evidence of a “Gold Standard” or does calling it that make it so?
Secondly- Isn’t the 100-thousand lawsuits, and around the world, claiming mesh-related injuries, evidence that there are problems with polypropylene mesh devices not to mention similar problems expressed by hernia patients ?
Thirdly- Unlike pharmaceuticals, there is no FDA oversight to assure the safety of the vast majority of medical devices before they are put on the market. Essentially, the public tests the devices, good, bad, or otherwise. Your thoughts?