Preview Newsletter
Ethicon Media Monitoring 6/12/2018
-
Martinez Trial Underway – The FDA Debate
Jun 11, 2018 | Mesh Medical Device Newsdesk
By Jane Akre
The following story is retrieved from the first full day of the Ana Martinez v Boston Scientific trial being heard in Massachusetts Superior Court in Woburn, Mass. -
Mazie Slater Focused on Mesh, Benicar, Other Products Work in 2017
Jun 11, 2018 | New Jersey Law Journal
By David Gialanella
Mazie Slater Katz & Freeman does a variety of plaintiff work, but had a particularly strong 2017 when it came to products liability. The firm handled matters in state and federal courts, playing an important role in the ongoing pelvic mesh litigation.
Client Attorney Privileged/Attorney Work Product/At Request of Counsel
Online Sources
-
Martinez Trial Underway – The FDA Debate
Jun 11, 2018 | Mesh Medical Device Newsdesk
By Jane Akre
The following story is retrieved from the first full day of the Ana Martinez v Boston Scientific trial being heard in Massachusetts Superior Court in Woburn, Mass.
The judge’s instruction to the jurors began during day 4, on May 30, 2018, according to the trial transcript.
Martinez hopes to prove that the Pinnacle Pelvic Floor repair system and Obtryx Mid-urethral sling she was implanted with are defective, and the instructions to her doctor were inadequate.
She is also suing for loss of consortium on behalf of her husband.
Judge – The Honorable Thomas Billings
Plaintiff Attorneys – Kila Baldwin and Jim Waldenberger of Kline Specter
Defense Attorneys – Jim Keale, Susan Murphy for Boston Scientific.MARTINEZ V. BOSTON SCIENTIFICRight off the bat Ms. Murphy renewed a motion for a mistrial. The Motion is Denied, said the court.
Not a good way to start the day.
THE FDA APPROVAL/CLEARANCE – IN OR OUT?
The next item was Boston Scientific reminding the court that it had agreed that the jury be able to hear language that the devices are cleared and legally sold in the U.S.
That creates a problem, said the plaintiff.
Any suggestion that the FDA had done any sort of “review” and that mesh was “approved,” presumes it underwent some assurances of safety. Under the 510(k) “clearance to sell” process that is not true, said the plaintiff. Any suggestion that the FDA has put its stamp of approval on mesh could leave the wrong impression with the jury, Mr. Waldenberger objected.
“Your Honor, we don’t agree with this instruction, because it specifically is telling the jury that the products were cleared by the FDA. …I think you are injecting an issue that has been ruled out of the case. You’re raising questions in the jury’s mind and essentially undoing the ruling that you had previously made regarding the preclusion of this evidence.”
Instead, he suggests instead of mentioning “clearance” and the implications it carries say:
“Members of the jury, during the course of this trial, you may be wondering or considering or thinking about what involvement the FDA had relating to these devices. Please know that the FDA and any involvement of the FDA is not evidence in this case and is not to be considered by you during this trial or during your deliberations.”
Mr. Waldenberger added that even to mention the FDA’s 510(k) clearance process invites online research, even though jurors are warned against doing so.
“It’s putting the ideas in their head. The whole point of the instruction is to remove the idea of FDA from their heads; and just telling them that it’s not evidence in the case and that it shouldn’t consider it, and any potential involvement of the FDA doesn’t mean that this product was defective – was not defective, is really the point.”
The judge said he would look over it later.JUDGE THOMAS BILLINGS
The clerk then brought in 15 members of the jury to listen to Judge Billings’ opening instructions on the law.
“You are the sole and exclusive judges of the facts. That’s why you’re here, to determine, based on the evidence, what the facts are.”
“The Rules of evidence are designed to ensure that the evidence you receive is relevant to an issue or issues and is presented in a form that gives you a fair opportunity to evaluate its worth, its credibility and its weight.”~ Judge Thomas Billings
The Judge reminds the jurors the plaintiffs have the burden of proof. The jurors will get to decide if the evidence presented is credible and how much weight it deserves. The plaintiffs must make their case by the preponderance of the evidence, meaning it’s more likely than not the facts are true.
“The Rules of Evidence, their function, for the most part, is to ensure that the evidence you receive will be relevant to an issue in the case and will be presented in a form that gives you a fair opportunity to evaluate its worth.”
urors were told it is their job to determine if a witness appears to be telling the truth and whether they appear to be able to observe an event reliably. They are to determine whether the testimony is probably or improbably and how well it fits with the other evidence in the case. Also to be considered – whether the witness appears to have a bias or an interest in the outcome of the case. this goes for both expert witnesses and lay witnesses.
Jurors are allowed to take notes. The notebooks stay in the courtroom and are shredded at the end of the case.
Jurors are charged with finding whether Boston Scientific’s Pinnacle Pelvic Floor Repair Kit and Obtryx Sling System-Halo are defective and whether Boston Scientific was negligent (and that caused her injury), and whether the company failed to adequately warn doctors.
Negligence that was the proximate cause of her injures will result in damages, which includes a monetary award for medical expenses, past and future, lost earnings, past and future. Also, Jose and Ana Martinez are suing for loss on consortium on behalf of her husband.
Given all that, “It will be up to you to decide whether the case has been proved or not proved.
https://www.meshmedicaldevicenewsdesk.com/martinez-trial-underway-the-fda-debate/
-
Mazie Slater Focused on Mesh, Benicar, Other Products Work in 2017
Jun 11, 2018 | New Jersey Law Journal
By David Gialanella
Mazie Slater Katz & Freeman does a variety of plaintiff work, but had a particularly strong 2017 when it came to products liability. The firm handled matters in state and federal courts, playing an important role in the ongoing pelvic mesh litigation. Also last year, Mazie Slater helped resolve upward of 2,000 cases pending against Daiichi Sankyo and Forest Laboratories in the years-long Benicar litigation.
** The responses were provided by partner David Mazie. **
What were some of the department’s most satisfying successes of 2017, and why?
2017 was an excellent year for Mazie Slater, and in particular our product liability practice. We were lead counsel in the $358 million mass tort settlement for Benicar, a blood pressure drug. The settlement benefits thousands of individuals from around the country. We also won a $15 million jury verdict against Johnson & Johnson and its subsidiary, Ethicon, in the second pelvic mesh bellwether case to ever go to trial in New Jersey. The jury verdict included $10 million of punitive damages. We also negotiated an $11.24 million product liability settlement on behalf of a client who was seriously injured by a defective product. Finally, we settled an $8.6 million nationwide class action involving defects in BMW vehicles. Each of these wins was significant to us because we faced some of the largest law firms in the world and we came out on top. For example, in the pelvic mesh trial, we were against five different law firms from around the country. The fact that a litigation boutique with only 12 lawyers has accomplished so much against such large corporate defendants with unlimited resources is a testament to the talent, aggressiveness and creativity of our law firm.
Being a Litigation Department of the Year means more than providing good counsel. How does your group go a step further for clients?
Most of our clients are catastrophically injured individuals. By fighting on their behalf against large corporations, we are able to not only provide them with the justice they deserve, but actually change their lives. For example, many times our clients have little or no income and face financial ruin because they are unable to work, but have significant medical and other expenses. By winning these cases on their behalf, we can change their lives and allow them to obtain the care and treatment they require. Once we win a settlement, we then work with other professionals in order to ensure that our clients receive exactly what they need; this includes purchasing a new home, altering their home to accommodate their disability, purchase of specially fitted vans for transportation, establishment of special needs trusts, and many other essential items they require.
In an era of increasing law practice portability, what does it mean to be an effective litigator in New Jersey?
While the “walls have come down,” allowing out-of-state litigators to practice more regularly in New Jersey, we have found that there is an advantage to being a New Jersey-based law firm. We have much greater familiarity and understanding of New Jersey practice and procedure, and we are much more familiar with the judges, juries and the workings of New Jersey courts. We have found this to be true in the bellwether cases we have tried on behalf of catastrophically injured pelvic mesh clients, and we believe it is a distinct advantage in our favor.
Is it true that clients now more than ever wish to avoid litigation, and if so, how do law firms manage the business of operating a litigation department in the new marketplace?
We have not found that defendants seek to avoid litigation any more than they did in the past. Because the cases we handle are all high-value matters, we have not seen any greater willingness on the part of defendants to settle these cases any earlier.
Litigators are extraordinarily busy people. What does the firm do to ensure that they remain engaged with pro bono work, their communities and their families?
We encourage all of our lawyers to spend time with their families, as we believe there is nothing more important than family. Because we are on the smaller side, we have the luxury of really knowing each other’s family members. We also encourage our employees to give back to their own communities.
Technology and other factors have changed work capabilities and habits. How do you offer flexibility while also effectively managing attorneys and others professionals?
We have successfully employed technology in trying many of our cases. We regularly present our cases to the jury by using videotaped depositions as well as custom designed graphics. The days of reading deposition transcripts to the jury and using cardboard display boards are long over.
https://www.law.com/njlawjournal/2018/06/11/mazie-slater-focused-on-mesh-benicar-other-products-work-in-2017/?slreturn=20180512015409
Client Attorney Privileged/Attorney Work Product/At Request of Counsel
Online Sources
Add recipients
Suggested