Joint replacements are the #1 expenditure of Medicare. The process of approving these medical devices is flawed according to the Institute of Medicine. It is time for patients' voices to be heard as stakeholders and for public support for increased medical device industry accountability and heightened protections for patients. Post-market registry. Product warranty. Patient/consumer stakeholder equity. Rescind industry pre-emptions/entitlements. All clinical trials must report all data.
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Wednesday, September 10, 2014

$73M verdict: Observations on Martha Salazar v Boston Scientific Obtryx Surgical Mesh Trial

The $73M (compensatory and punitive) Martha Salazar (MS) v. Boston Scientific (BS) Obtryx verdict is in.  The Dallas jury (Texas 95th District) that was mixed racially, by age and gender executed the highest civilian peacetime service.  The were aware that even with an appeal it is likely that their unanimous verdict on punitive damages will stand.  The 10-day trial ended Monday, September 8, was conducted by Judge Ken Molberg with great decorum and attention to Texas state law.  Each side had excellent lawyers who vigorously defended their rights.  The jury was spared the convoluted and weak logic of FDA involvement in implanted medical device clearance for the U.S. market. Judge Molberg and the plaintiff attorneys had recently 'done that dance' at the Linda Batiste v Ethicon surgical mesh trial that ended with a $1.2M verdict(compensatory) in May 2014 and it was agreed by both parties that FDA 510(k) blessing was meaningless.
Instead, talk was about standard of care and standards of the industry.  Boston Scientific reasoning was akin to "everyone else is doing it" and "we have all been doing it this way forever, so it is OK".  In light of the excellent presentation of the plaintiff Martha Salazar on the stand, I believe the jury found BS reasoning not credible particularly when the MSDS (material safety data sheet) from the manufacturer of the resin in 2004 warned that the product was not to be medically implanted in a human body.  Martha Salazar's injuries began with the implantation of the surgical mesh at the time of a hysterectomy for another medical reason.  Her SUI(stress urinary incontinence) was not a recurrent, serious or main complaint, but an afterthought.  She was not given adequate warning of the irreversibility, severity, permanence or cascade of harm she may encounter with the implantation:  the doctor was not informed.  The jury learned from BS internal 'discovery' documents presented by Salazar's attorneys showing that BS knew of the potential for these injuries and suppressed the information so that it was not in the DFU (directions for use).
The jury verdict reflects an elevated communal decision to send a strong and irrefutable message to businesses that would knowingly harm for profit.  Both compensatory and punitive verdict figures far exceed the estimates of the plaintiff expert life planner witness and her attorneys.

The next trial in Dallas is Figueroa v. Boston Scientific beginning October 6, 2014.

More references:
http://www.classaction.org/blog/boston-scientific-to-pay-73-million-what-next-for-tvm-suits

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