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What Jurors Won't Hear

judge mallet 200Due to Motions in Limine, that is, deciding what will and will not be presented to jurors in a trial, there are a number of things jurors won’t hear in the defective product/ medical malpractice case of Budke v. Ethicon.

 

* Jurors in this product liability, medical malpractice case will not hear that Ethicon, a division of Johnson & Johnson, is facing more lawsuits than any other pelvic mesh manufacturer. (See mdl, Charleston WV) here

* At this writing there are approximately 30,000 defective product cases filed in federal and state courts.  

* They also will not hear that the Prolift System and three other pelvic meshes, were quietly removed from the market by J&J in 2012 for “business reasons.”  Instead of selling the product in the U.S., Ethicon made the decision to sell it overseas. See Mesh News Desk story here.  You could even still buy it on eBay. See Mesh News Desk story here. 

An Ethicon spokesman said to Bloomberg:

“This is not a product recall and we continue to have confidence in the safety and efficacy of these products. Our decision to discontinue these products is based on their commercial viability in light of changing market dynamics, and is not related to safety or efficacy.”

* They will not hear that J&J launched the Prolift in March 2005, failing to file any application with the U.S. Food and Drug Administration, even a 510(k) exchange of paperwork. See more on 510(k) here.  See more on sales under the FDA radar here

* That Johnson & Johnson destroyed hundreds of thousands of pages of documents related to its pelvic mesh that were never produced under discovery rules, despite the fact the documents were on a litigation hold. See Mesh News Desk story here.  The company is considered culpable under the law but it’s never been punished. 

* What they will hear is how Joan Budke, 77, suffered before she died.

2 Comments

  1. David says:

    The “Siphoning” of Evidence away from the TRUTH

    How can justice (the truth) prevail when courts continue to purposely move “the goalpost” back for the plaintiffs’ side?…To misleadingly restrict the jury’s “big picture” – with the effect of balancing out the gravity of a defendant’s contextual wrongdoings – is to pave the pathway, for the injustice, of “the unleveled playing field”.

  2. David says:

    There is, I think, a grave misconception by the American public that high-risk implantable medical devices (like every non-inert, polypropylene surgical mesh device, across all indications, should be reclassified as) are regulated by the FDA for a safety and effectiveness understanding. This is simply not the reality. As the Institute of Medicine’s (IOM) Committee on the Public Health Effectiveness of the FDA 510(k) Clearance Process, could only correctly and unavoidably conclude (in my opinion) in their July 2011 FDA sponsored report, Medical Devices and the Public’s Health: The FDA 510(k) Clearance Process at 35 Years: “The 510(k) clearance process is not intended to evaluate the safety and effectiveness of medical devices with some exceptions” (first half of Conclusion 7-1).

    As juries are representational members of the greater American public at large, selected both by the courts and attorneys of the opposing sides, for their receptiveness to “view” a court’s presentation of evidence (without preconceived bias – discounting that which is to be presented and without awareness of the evidence which will not be considered), I also think that to not inform a jury that a surgical mesh device was never FDA approved for safety and effectiveness is a gross miscarriage of justice. The reason being – I believe that a jury (without an understanding of irrationalness of 510(k) device clearance) may be inclined to think they are changeling the reality that surgical mesh was a medical device approved by the FDA for safety and effectiveness. When in actually, what a jury is being indirectly* asked to do is the FDA’s job; the job the FDA never did: to now assess the safety and effectiveness of a surgical mesh device, to have not created an unreasonable risk of illness and injury….(With some empathy for the FDA because the 510(k) statute does not even allow it to proactively carryout its own mission statement of protecting the American public…and therefore I believe the reason behind some of the games the FDA plays.)

    * “Indirectly” because, via the real-world post-market performance outcome of a non-FDA approved medical device, a jury is being asked to render the verdict: if a device was properly designed to have been reasonably safe and effective for it’s intend use. The jury’s verdict follows the fact (as previously stated) that the 510(k) cleared surgical mesh device was never even first FDA approved for safety and effectiveness. And as we are all entitled to our beliefs, device manufacturers can choose to believe that there 510(k) cleared devices are safe and effective…but that is only their own belief, not reality!

    More so, as it would relate the inadequacy of device labeling, the jury’s understanding of a dangerous surgical mesh device’s post-market performance must be in the contextually reality that “substantially equivalent” surgical mesh devices are also dangerously, indiscriminately abused by surgeons in real-world clinical practice as their own best practice of medicine. This premeditative abuse to patients is then surgeon rationalized as “reasonable,” upon a surgeon’s failure to mitigate unreasonable “treatment” risk, when carrying out the standard of care. The surgeons’ “risk” is fixated on efficacy or the prevention of a display of their lack of competency. This is in defiance to the reality that the competently trained surgeon – able to perform a tissue repair in a patient’s best interest, does not need to indiscriminately abuse surgical mesh and patients in their own best interest.

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