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.
Please share what you have learned!
Twitter: @JjrkCh

Saturday, September 16, 2017

Surgical Mesh: Harm-for-Profit Crimes Against Women

$57.1 Million Verdict Against Johnson and Johnson
$57.1 million was awarded against Johnson & Johnson and Ethicon to Ella Ebaugh, who was implanted with TVT-Secur transvaginal mesh that eroded through her urethra, caused her internal injuries and permanently damaged her urinary system leaving her incontinent. The jury verdict included $7.1 million in compensatory damages and $50 million in punitive damages. The Philadelphia Court of Common Pleas verdict was delivered September 7, 2017, marking the fifth TVM verdict against the mesh manufacturers.
$20 million was awarded to a woman who suffered after multiple surgeries to remove a TVT-Secur mesh implant. On April 28, 2017, the Philadelphia Common Pleas Court jury awarded  $2.5 in compensatory damages and $17.5 million in punitive damages. Plaintiff, Peggy Engleman’s mesh failed within a month of implantation causing pain as the mesh eroded into her tissues leaving shreds of mesh in her body. On May 26, 2017, Sharon Beltz was awarded $2.16 million for injuries caused by Ethicon’s Prolift implanted in 2006. Johnson and Johnson vows to appeal both cases to a higher court.
Transvaginal mesh bellwether trials and settlements are updated as follows:
MDL No. 2327 | In Re Ethicon, Inc., Pelvic Repair System Products Liability Litigation – Cases are being prepared for trials, dismissals or remands. Total Cases: 38,956 Total Closed: 7718  Past verdicts and settlements include:
  • Mullins, et al. v. Ethicon, Inc., et al., 2:12-cv-02952 (37 TVTs) trial continued
  • Edwards v. Ethicon, Inc., et al., 2:12-cv-09972-  Dismissed
  • Dianne Bellew v. Ethicon, Inc. (Prolift) settled March 6, 2015
  • Carolyn Lewis v. Ethicon, et al. Defense Judgment
  • Huskey v. Ethicon, et al. $3.27 Million Verdict for Plaintiffs
  • Brenda Lehrer v. Ethicon, Inc., et al. (Prolift) Dismissed
MDL No. 2325 | In Re American Medical Systems, Inc., Pelvic Repair System Products Liability Litigation – Settlement announced for all remaining mesh lawsuits in the MDL. Total Cases: 21,127  Total Closed: 17,248
MDL No. 2187 | In Re C. R. Bard, Inc., Pelvic Repair System Products Liability Litigation–  Cases are being prepared for trials, dismissals or remands. The court ordered Mandatory Settlement Conferences for unsettled Covidien LP, Sofradim and TSL plaintiffs.  Total Cases: 15,491  Total Closed: 10,452  Past verdicts and settlements include:
  • Wise, et al. v. C. R. Bard, Inc. – Settled
  • Donna Cisson v. Bard, Inc.  – $2 Million Verdict
  • Wanda Queen v. Bard, Inc. 2:11-cv-00012  – Settled
  • Carolyn Jones v. Bard, Inc. 2:11-cv-00114 – Settled
MDL No. 2326 | In Re Boston Scientific Corp. Pelvic Repair System Products Liability Litigation – Settlements in process with no trials scheduled. Total Cases: 25,029   Total Closed: 15,101   Past verdicts include:
  • Jeanie Blankenship – $4.25 million +  $1 million punitive damages
  • Chris Wilson – $3.75 million +  $1 million punitive damages
  • Carol Campbell – $3.25 million + $1 million  punitive damages
  • Jacquelyn Tyree  – $3.25 million + $1 million punitive damages
  • Juana Betancourt – $6.5 + million
  • Mania Nunez – $6.7 + million; and
  • Margarita Dotres – $6.7 + million;
  • Amal Eghnayem – $6.7 + million
MDL No. 2440 | In Re Cook Medical, Inc., Pelvic Repair System Products Liability Litigation – No trials have been scheduled. The following cases were dismissed: Ailey v. Cook Inc., Watkins v. Cook Inc., et al. Hovey v. Cook Inc., et al.  Total Cases: 629 Total Closed: 123
MDL No. 2387 | In Re Coloplast Corp. Pelvic Support Systems Products Liability Litigation – . There are no bellwether trials scheduled and the judge is conducting settlement conferences. Total Cases: 2610 Total Closed: 2397
MDL No. 2511 | In Re Neomedic Pelvic Repair System Products Liability Litigation – There are no bellwether trials scheduled. Settlement Program entered 11/2015. Total Cases: 137 Total Closed: 125
Transvaginal Mesh Verdicts 
A chronology of the verdicts, settlements, manufacturers, products, and jurisdictions follows:
  1. 7/12: $5.5 million – Christine Scott – C.R. Bard Avaulta Plus –  CA
  2. 2/13: $11.11 million – Linda Gross – Ethicon/JJ Prolift – NJ
  3. 8/13: $2 million – Donna Cisson – C.R. Bard Avaulta – MDL WV
  4. 2/14: $0 – Carolyn Lewis – Ethicon/JJ TVT-O – MDL WV
  5. 4/14: $1.2 million – Linda Batiste – Ethicon/JJ TVT-O  – TX
  6. 7/14: $0 – Diane Albright – Boston Scientific Pinnacle – MA
  7. 8/14: $0 – Maria Cardenas – Boston Scientific Obtryx – MA
  8. 9/14: $3.27 million – Jo Huskey – Ethicon/JJ TVT-O – MDL WV
  9. 9/14: $73.465 million – Martha Salazar – Boston Scientific Obtryx – TX
  10. 11/14: $6.7+ million – Amal Eghnayem – Boston Scientific Pinnacle – MDL FL
  11. 11/14: $6.7+ million – Margarita Dotres – Boston Scientific Pinnacle – MDL FL
  12. 11/14: $6.7+ million – Mania Nunez – Boston Scientific Pinnacle – MDL FL
  13. 11/14: $6.5+ million – Juana Betancourt – Boston Scientific Pinnacle – MDL FL
  14. 11/14: $5.25 million – Jeanie Blankenship – Boston Scientific Obtryx –  MDL WV
  15. 11/14: $4.75 million – Chris Wilson – Boston Scientific Obtryx – MDL
  16. 11/14: $4.25 million – Carol Campbell – Boston Scientific Obtryx – MDL
  17. 11/14: $4.25 million – Jacquelyn Tyree – Boston Scientific Obtryx – MDL
  18. 2/15: Settled – Wise v. Bard in the MDL
  19. 3/15: Settled  – Bellew v. Ethicon (Prolift) in the MDL;
  20. 5/15: Settled – Sanchez v. Boston Scientific (Pinnacle) – CA
  21. 3/15: $5.7 million – Coleen Perry – Ethicon/JJ Abbrevo sling – CA
  22. 5/15: $100 million – Deborah Barda v. Boston Scientific Pinnacle and Advantage Fit – DL
  23. 10/15: $0 – Carol Cavness v. Ethicon/JJ Prosima –  TX
  24. 10/15: $0 – Martha Carlson v. Boston Scientific Uphold – NC
  25. 12/15: $12.5 million – Hammons v. Ethicon/JJ (Prolift) –  PA
  26. 2/16: $0 – Sherrer v. Boston Scientific Solyx and Bard Align – MO
  27. 2/16: $13.5 – Carlino v. Ethicon/JJ (TVT)  – PA
  28. 4/17:  $20.0 million – Engleman v. Ethicon/JJ (TVT Secur) – PA
  29. 5/17: $2.16 million – Betz v. Ethicon/Prolift – PA
  30. 9/17: $57.1 million – Ebaugh v. Ethicon/JJ (TVT-Secur) – PA
TVM Verdicts and Trials
On February 10, 2016, $13.5 million was awarded by a Philadelphia jury in Carlino v. Ethicon. $10 million of that award was for punitive damages. The plaintiff suffered through three TVT sling revision and removal mesh surgeries following her Ethicon/Johnson and Johnson implant. 
This follows a $12.5 million jury verdict in a transvaginal mesh lawsuit against Johnson and Johnson’s Ethicon division on December 22, 2015. A Philadephia jury found that Patricia Hammons suffered injuries from a Prolift pelvic mesh implant, which was removed from the medical device market in 2012. The $12.5 million award included $7 million in punitive damages as the jury heard evidence of Ethicon’s document destruction. 
On February 2, 2016, a Kansas City, Missouri jury awarded nothing to the plaintiff in a Boston Scientific Solyx and C.R. Bard Align case. On October 16th,  2015, the jury awarded nothing to the plaintiff in Martha Carlson v. Boston Scientific in Statesville, North Carolina. On October 5th, 2015, the jury awarded nothing for the plaintiff in Carol Cavness v. Ethicon/ Johnson and Johnson in Dallas, Texas.  
As of August 3rd, 2016, eighteen (18) transvaginal mesh plaintiffs have won trials and the defendants have won six (6). Following the failed status conferences, TVM trials moved forward, resulting in two plaintiffs’ verdicts ranging from $100 Million to $5.7 Million and numerous confidential settlements.  Boston Scientific, Coloplast, AMS and Bard have begun offering settlements. 
A  California jury awarded $5.7 million to Coleen Perry, who was implanted with an Abbrevo sling device. Ms. Perry experienced pain after surgery, but the sling could only be partially surgically removed  because the mesh had grown into the tissues. The jury unanimously awarded $5 million in punitive damages finding Ethicon acted with malice.
Trial began March 2, 2015 in Bellew v. Ethicon in the MDL and settled March 6, 2015 for an undisclosed amount. This case involved removal of a Prolift mesh, a product which had been taken off the medical device market. 
Bard Bellwether Case Settles Before Trial
Wise v. Bard, the bellwether case set for trial February 18, 2015, was settled right before trial for a confidential amount.  On February 12, 2015,  Judge Goodwin appointed Ellen Reisman as Special Master to facilitate settlement negotiations in the Bard MDL. Christine Scott, the first Bard Avaulta Plus plaintiff who endured nine mesh revision surgeries stated, “Thank God, we can finally get the word out to women.”
$26.7 Million and $18.5 Million Verdicts Against Boston Scientific 
$26.7 million and $18.5 million verdicts against Boston Scientific were awarded in two transvaginal mesh MDL trials. On November 13, 2014, a Miami, Florida jury awarded $26.7 million to four women implanted with Boston Scientific’s Pinnacle mesh devices. On November 20, 2014,  a Charleston, West Virginia jury awarded  $18.5 million to four women implanted with Boston Scientific’s Obtryx mid-urethral slings. The Obtryx verdict included $4 million in punitive damages, with $1 million awarded to each plaintiff.
The women in the Florida Pinnacle trial were each awarded between $6.5 million and $6.7 million. Boston Scientific’s Pinnacle mesh devices were implanted during pelvic organ prolapse surgeries and are no longer on the market. The individual awards for the women in the Pinnacle mesh trial include: 
  1. Amal Eghnayem – $6.7 + million;
  2. Margarita Dotres – $6.7 + million;
  3. Mania Nunez – $6.7 + million; and
  4. Juana Betancourt – $6.5 + million
The women in the West Virginia Obtryx sling trial were each awarded between $3.25 million to $4.25 million, plus an additional $1 million each for punitive damages. The Obtryx sling devices are implanted during stress urinary incontinence surgeries and are still on the market. The individual awards for the women in the Obtryx sling trial include: 
  1. Jeanie Blankenship – $4.25 million +  $1 million punitive damages;
  2. Chris Wilson – $3.75 million +  $1 million punitive damages;
  3. Carol Campbell – $3.25 million + $1 million  punitive damages;
  4. Jacquelyn Tyree  – $3.25 million + $1 million punitive damages
Transvaginal Mesh Adverse Events
Click the TVM video link which contains medical legal animation, diagrams and warnings about TVM implants and the transvaginal mesh litigation. Failed Transvaginal Mesh Injury Lawsuit Podcast with Howard L. Nations
Transvaginal mesh and vaginal sling products have been linked to thousands of reported serious, life-threatening side effects or adverse events from seven surgical mesh manufacturers. The complications are associated with surgical mesh devices used to repair Pelvic Organ Prolapse (POP) and Stress Urinary Incontinence (SUI). The mesh devices are typically placed transvaginally for minimally invasive placement. Complications include:
  • erosion through the vaginal tissue
  • mesh contraction
  • mesh extrusion
  • inflammation
  • fistula
  • infection and abscess
  • pain
  • blood loss
  • chronic and acute nerve damage
  • pudendal nerve damage
  • pelvic floor damage
  • scar tissue
  • chronic pelvic pain
  • urinary problems and/or incontinence
  • recurrence of prolapse
  • bowel, bladder, and blood vessel perforation
  • dyspareunia or pain during sexual intercourse
Treatment of the complications includes additional surgical procedures to revise or remove the mesh, blood transfusions, drainage of hematomas, drainage of abscesses from infection, IV medication, pain injections, botox injections, physical therapy, among other treatments to alleviate the complications. 
In July 1, 2012, Bard stopped selling the Avaulta Mesh in the United States because the FDA required additional clinical trials and testing.
On June 4, 2012: Johnson and Johnson/Ethicon withdrew four mesh products from the US Market, including its controversial Gynecare Prolift, Prolift+ M, TVT Secur and Prosima systems.
History of Warnings
Surgical mesh is a metallic or polymeric screen surgically implanted to reinforce and support weakened soft tissue or bone. On the market since the 1950s for use in abdominal hernias, gynecologists in the 1970s began using surgical mesh to reinforce vaginal tissue to treat pelvic organ prolapse. In the 1990s, surgeons began using surgical mesh to treat stress urinary incontinence in women.
Transvaginal mesh was approved for sale through the 510(k) process simply by comparing it to the kind of mesh used to treat abdominal hernias. Most transvaginal mesh products on the market today are based on Boston Scientific Corp.’s ProteGen mesh, which the FDA approved in 1996 as the first surgical mesh to treat stress urinary incontinence. Two years later, the FDA approved Johnson & Johnson’s Gynecare TVT mesh through the 510(k) process after the company claimed the mesh was substantially equivalent to ProteGen.
However, in October, 1999, the FDA recalled Boston Scientific’s ProteGen sling due to the large number of complications experienced by women, including erosion of the vaginal tissues. The complete irony is that a majority of the transvaginal mesh are based upon this recalled defective device.
On October 20, 2008, the U.S. Food & Drug Administration (FDA) issued an urgent public health notification to physicians and patients regarding serious complications associated with transvaginal placement of surgical mesh in repair of Pelvic Organ Prolapse (POP) and Stress Urinary Incontinence (SUI).
On May 16, 2011, the New England Journal of Medicine (NEJM) Study on Transvaginal Mesh Complications confirmed that the use of surgical mesh to treat pelvic organ prolapse carries the risk of serious side effects including bladder perforation and pelvic hemorrhaging.
On July 13, 2011, FDA issued an updated safety communication warning that surgical placement of transvaginal mesh to repair POP may expose patients to a greater risk of side effects than other treatment options. In addition to the increased risk of side effects, the FDA stated that vaginal mesh offers no greater clinical value or improved quality of life over other surgical methods.
On August 25, 2011, Public Citizen called on FDA to recall the vaginal mesh in response to a high number of reports linking vaginal mesh products to erosion, pain, bleeding and urinary incontinence.
Transvaginal Mesh Products & Manufacturers 
  • Secure
  • Prolift
  • Prolift +M
  • Gynemesh/Gynemesh PS
  • Prosima
  • TVT
  • TVT-Obturator (TVT-O)
  • TVT-Exact
  • TVT-Abbrevo
C. R. Bard
  • Align
  • Avaulta Plus™ BioSynthetic Support System
  • Avaulta Solo™ Synthetic Support System
  • Faslata® Allograft
  • Pelvicol® Tissue
  • PelviSoft® Biomesh
  • Pelvitex™ Polypropylene Mesh
  • PelviLace
  • InnerLace
  • Uretex
American Medical Systems 
  • SPARC®
  • Mini-Arc
  • Apogee
  • Elevate
  • Monarc
  • In-Fast
  • BioArc
Boston Scientific
  • Obtryx® Curved Single
  • Obtryx® Mesh Sling
  • Obtryx Transobturator Mid-Urethral Sling System
  • Prefyx Mid U™ Mesh Sling System
  • Prefyx PPS™ System
  • Uphold Vaginal Support System
  • Pinnacle Pelvic Floor Repair Kit
  • Advantage Transvaginal Mid-Urethral Sling System
  • Advantage Fit System
  • Solyx SIS System
  • T-Sling-Universal Polypropylene Sling
  • Aris-Transobturator Sling System
  • Supris-Suprapubic Sling System
  • Novasilk-Synthetic Flat Mesh
  • Suspend-Tutoplast Processed Fascia Lata
  • Exair-Prolapse Repair System
  • Axis-Tutoplast Processed Dermis
  • Restorelle
  • Smartmesh
  • Omnisure
  • Minitape

  • Surgisis

Wednesday, September 13, 2017

Mandamus Denied. The Trial Begins September 18 in Dallas.

Update: September 20, 2017 is the first day of the trial.  September 18 was a pre-trial meeting(lawyers only, no observers) and a questionnaire to potential jurors.

In Re DePuy, 17-10812 (5th Cir. 08/31/2017)

September 12, 2017

  • United States Court of Appeals, Fifth Circuit
  • 17-10812
  • Over 9300 plaintiffs alleged the defendants designed, manufactured and distributed an allegedly defective hip-implant device. Their lawsuits were transferred to the Northern District of Texas by the Judicial Panel on Multi-district litigation. While an MDL court can conduct all pretrial proceedings, it can only try cases over which it had venue without its MDL status, unless the parties otherwise waive arguments regarding venue (a " Lexecon objection"). The parties worked with a special master to identify cases to be tried as "bellweather" cases. The special master's report to the MDL court proposed four trials from a group of eight, and stated that the defendants would not raise Lexecon objections. A first trial, of a single case, resulted in a defense verdict. A second trial, consisting of five cases filed by Texas plaintiffs consolidated as a bellweather trial, resulted in a plaintiffs' verdict. A third trial, consisting of six cases filed by California plaintiffs, resulted in a plaintiffs' verdict. Prior to the third trial, the defendants argued they had only waived their venue objections for the first two trials; the MDL court found that they had waived them for all MDL trials. When the MDL court selected ten cases involving New York plaintiffs for a fourth bellweather trial, the defendants sought a writ of mandamus. The court agreed that the defendants only waived their venue arguments with respect to the first two trials, and that the MDL court erred by declaring a global and permanent waiver to venue and personal jurisdiction. It also held that mandamus relief would otherwise be appropriate, given that the MDL court apparently intended to apply the "waiver" to all trials. But, the court held, the defendants had not shown that they had no other adequate means to obtain relief, because the defendants could appeal from any adverse verdict on personal jurisdiction grounds. The court held that, while the defendants would undoubtedly incur significant defense fees in the trials, this was not a basis upon which to order mandamus The court accordingly denied the petition for a writ of mandamus. In re Depuy Orthopaedics, Inc. Fifth Circuit, No. 17-10812, 8/31/17.

Follow the Money: Justice is on Trial.

By Bexis on August 28, 2017
Today’s guest post is by Reed Smith Houston office associate Curtis Waldo.  Given the Noachic weather down there recently, one might ask “where’s Waldo?”  The answer is safe and sound, if not quite high and dry.  Curt is really dedicated – we offered him more time, but he said he didn’t need it.  In this post, Curt is acting the part of our on-the-scene reporter from last week’s Pinnacle Hip mandamus hearing before the Fifth Circuit.  Since things might move rather quickly (weather permitting) we wanted to bring his report to our readers ASAP.  As always our guest posters are 100% responsible for the content of their posts.  Curt deserves all the credit, and any blame, for what follows.
First, thank you for all the support and well wishes sent to those of us in Southeast Texas riding out Hurricane Harvey.  It is a scary and challenging time, but we will recover.  Two days before Harvey’s arrival, as John Sullivan posted last week, a Fifth Circuit panel in Houston hosted a fascinating oral argument on the writ of mandamus filed by defendants in the Pinnacle hip implant litigation.  As a Reed Smith associate who works three blocks from the courthouse, I was fortunate enough to attend.
The writ has been covered by this blog here and here.  In sum, there are two issues before the court:  (1) did the district court err in holding defendants waived their personal jurisdiction rights?, and (2) if the district court did err, is it the kind of error that warrants the “extraordinary remedy” of a writ of mandamus?  The oral argument was divided about 50-50 between these two questions.  Defendants argue they did not waive their personal jurisdiction rights; plaintiffs argue they did.  Defendants argue a writ of mandamus is appropriate; plaintiffs argue it is not.  The panel was comprised of Judges Jerry Smith, Edith Jones, and Gregg Costa.
First to argue was John Beisner of Skadden Arps for defendants.  Mr. Beisner began with an analogy:  Your acquaintance invites you to dinner once.  You agree.  Your acquaintance invites you to dinner a second time.  You agree.  By agreeing to attend two dinners, have you now agreed to attend all dinners that may be called by the acquaintance in the future?
As tends to happen at oral argument, the judges wasted little time in interrupting.  Judge Smith:  Even if this was error, why a writ of mandamus?  Defendants could wait until the trial concluded and appeal the jurisdiction waiver at that time.
Mr. Beisner’s answer was twofold:  (1) why waste everyone’s time with an unnecessary trial if the appellate court can decide the issue at the outset, and (2) if plaintiff’s waiver theory is believed, defendants have waived their personal jurisdiction rights in 9,300 pending cases, which is exactly the sort of situation that is “not effectively reviewable” by a normal appeal.  As Judge Jones later pointed out, if the plaintiffs and defendants spend $50 million trying cases that are later obviated on appeal, does that $50 million not come straight from the pockets of plaintiffs and defendants, and right into the pockets of lawyers?
While this argument might make sense to anyone who is not a lawyer, Judge Costa pointed out rightly the slippery slope down which that argument might take them—should appellate courts step into district court proceedings at any stage where their input would be dispositive?  One could imagine such a system, but it is not the one we have in the federal courts.  Surely, Judge Costa asked, avoiding expense by itself is not enough to justify mandamus relief?  Mr. Beisner rightly avoided this logical sinkhole and clarified that no, it is not merely the avoidance of expense but also the likelihood of recurrence, which here is profound given the upcoming bellwether trials and thousands of other cases on the horizon where defendants have allegedly waived their constitutional rights.
Moving on to the waiver issue, Mr. Beisner framed the issue as revolving around the interpretation of a single email sent by defendants’ counsel in December 2014.  By agreeing “to allow the Court to select the next round of bellwether cases,” surely defendants were not agreeing to waive their right to object to personal jurisdiction in all 9,300 cases in the MDL and effectively agreeing that all 9,300 cases could be tried in Texas.  This, Mr. Beisner correctly emphasized, was simply not how the MDL process works.  The MDL system is for pre-trial purposes only.
Let us take a moment to consider that in a given day, we may send 100 emails or more, some of which we put more thought into than others.  I have never had one of my emails quoted at length in appellate briefs and dissected by a panel of Fifth Circuit judges, but I can’t imagine it is a good feeling.
Mr. Beisner had to explain why the email at issue referred to “bellwether cases,” and not only the bellwether case that would be tried.  He clarified that the case(s) to be tried in a single bellwether trial came from a larger pool of cases (but still not the 9,300 in the MDL), and it was this slightly larger subset that the email was referring to.  The judges appeared both intrigued and confused at the system used by the district court to select bellwether cases.  I thought Mr. Beisner made his point, but it is hard to say.  In any event, Mr. Beisner came back to his take-home message:  to waive one’s constitutional rights, surely such waiver must be clear and unambiguous, which here it was decidedly not.  Overall, the judges’ questions of Mr. Beisner on the waiver issue were not nearly as hard-hitting as the questions on the propriety of mandamus.
Next it was plaintiffs’ turn, for which plaintiffs turned to Kenneth Starr—former D.C. Circuit judge, solicitor general, law professor, Clinton investigator, and Baylor non-investigator.  Mr. Starr began his argument by quoting the All Writs Act from 1789.  
Unsurprisingly, the panel did not let him finish his quote, and Judge Smith injected with the first question, which similar to his first question during Mr. Beisner’s argument cut to the chase:  Just what exactly are plaintiffs saying defendants waived?  Mr. Starr’s response was blunt:  in theory, defendants had waived their right to object to personal jurisdiction in all 9,300 MDL cases.  Mr. Starr hedged by saying this was only in theory, and plaintiffs did not plan to try 9,300 cases in Texas.  In reality, per Mr. Starr, this was only about the two bellwether trials set in the Northern District of Texas.  Despite Mr. Starr’s reassurances, his answer about the scope of the purported waiver seemed to make the panel uncomfortable.
Judge Jones took the opportunity to highlight what was really at stake—the big “M”.  While she did not say so explicitly, what is really “unreviewable” is the shift in momentum that occurs when a big verdict comes in while an appeal is pending.  Mr. Starr fought back:  This isn’t about momentum or settlement; this is about defendants trying to cut in line.  While the law may be under-developed on the issue of what contacts in a direct file case are sufficient to allow for jurisdiction, mandamus is not the proper vehicle to develop the law.  What is at stake, according to Mr. Starr, is our system of permitting trial courts to conduct trials, and leaving appeals for a later, orderly process.
Mr. Starr got out his talking points on his waiver argument, but it was hard to say he made any impact on the judges here.  Perhaps sensing that his stronger point was the impropriety of mandamus, Mr. Starr highlighted that defendants had an adequate remedy (they could appeal!), and the waiver issue was not so “clear and indistinguishable” as to justify mandamus.  Moreover, Mr. Starr brought up (for the first time by anyone) that a trial was actually set to start in September.  Lawyers and witnesses were ready to go, and his clients wanted their day in court.  Judge Jones countered that while plaintiffs may want their day in court, it would do them no good to have their verdict overturned a year later.

Ultimately it was a fascinating hour of argument—the waiver issue appears to revolve around a couple sentences in a CMO and a lawyer’s email from three years ago.  The mandamus issue cuts to the core of what role appeals courts should play in the federal system.  And overriding all of the argument was the judges’ curiosity and at times bafflement at the MDL system.  MDLs are supposed to encourage efficiency and coordination, but how do we achieve them while at the same time serving other purposes of the judiciary such as a deliberative appeals process, consistency, and finality?  What role should the court assign practical litigation considerations such as settlement momentum?  The courtroom was packed with law clerks and at least one district court judge, and the atmosphere of the courtroom had an academic and suspenseful quality.  Given the upcoming trial date, we should expect a decision soon.

Tuesday, September 12, 2017

Medical Device Manufacturing Jobs/NAFTA: Silence on Patient Safety

September 11, 2017 | 3:00 PM
Listen to this story

Listen To The Story
Negotiations over the North American Free Trade Agreement are currently still underway. President Donald Trump has called NAFTA “one of the worst deals ever.”  But it turns out, there are more than a few mayors in the U.S. who disagree.
That list includes Kevin Faulconer, the Republican mayor of San Diego. Kai Ryssdal spoke with Faulconer about why he disagrees with the Trump Administration on NAFTA as well as the decision to phase out DACA. Below is an edited transcript of their conversation.
Kai Ryssdal: First things first, with NAFTA re-negotiations ongoing, I want to touch base for a second on what that deal has meant to the city of San Diego both in the past and going forward. Where do you see this playing out for your city?
Kevin Faulconer: It's been incredibly important. And when we talk about the strength of our two cities, particularly San Diego and Tijuana, we talk about it in terms of one region and the benefits that that brings to both of our cities. NAFTA has been phenomenally successful. In just a couple of quick examples: trade between Mexico and the U.S. moving through San Diego has increased threefold, about $60 billion each year alone. Our exports have grown. It's a strength. It's a competitive advantage and one that we're going to fight to continue.
Ryssdal: So talk to me more about that. When you go out and you schmooze and you do that Mayor thing and you go to small businesses or companies that are dependent on this deal, what do they say to you about the prospect of this deal either being renegotiated or as the president has said, terminated?
Faulconer: Well that it’s working. And again, this is something that, you know, when we have the opportunity to tell our story, as I say if we're not telling our story nobody else is going to tell it for us. As these negotiations are taking place in Washington I'm going to be in Washington myself with the mayor of Tijuana in a couple of weeks telling our story directly to Congress about how successful this relationship has been and how we have to ensure that we need to keep it going. Look at tweaks. Look at changes. But free trade has worked and we need to continue to promote this.
Ryssdal: If the president listens to corporate America, NAFTA will not be terminated and it will not be undone. But spitball it for me: What happens if this whole deal goes down the drain?
Faulconer: Well look it would be extremely bad for our for our region. But I think in so many regions across the entire border and other places across the country. I'll just give you just one small example. If you take what we're doing in medical device manufacturing in San Diego and what Tijuana is doing in medical device manufacturing, you put our our two cities together, we are the largest region of medical device manufacturing on the planet. Again that's a strength. That's a competitive advantage and one that we are going to work very very hard to continue.
Ryssdal: Let me get to the, I guess, the flip side of this issue right — it's related but different. And that is DACA and the president's decision on that recently and what the next six months might hold if Congress doesn't get its act together. You have said young people who came here under DACA they need quote “Legal certainty. They need to be able to contribute to the business and the economy of San Diego and this country.” What happens now?
Faulconer: Well, it is time for Congress to act. And look, the young men and women who are here under DACA, you know, many of whom have been in the only country that they have ever known. They're students, they're innovators, they're business owners and veterans who enrich our country and contribute greatly to our economy and to our culture.
Ryssdal: Are you confident Congress is going to step up and get something done?
Faulconer: Well, the opportunity is there.
Ryssdal: He says, not answering the question.
Faulconer: But look, I think you know when you get down to it this isn't a partisan issue. This is what's the right thing that we should be doing. And I think when you look at it through those terms and through that prism, it's not about partisan politics. It's about doing the right thing. And so I'm actually probably more optimistic that when push comes to shove that this will get done. And I plan on being a vocal voice to help get it done.

Follow Kai Ryssdal at @kairyssdal

Friday, September 8, 2017

$57M Verdict: J&J Pelvic Surgical Mesh harmed Ella Ebaugh

J&J unit ordered to pay $57.1M to Pa. woman in pelvic mesh suit
Updated: SEPTEMBER 7, 2017 — 4:18 PM EDT

A Philadelphia jury on Thursday ordered a subsidiary of Johnson & Johnson to pay $57.1 million in damages to a Pennsylvania woman who was left chronically incontinent and in constant pain after receiving defective pelvic mesh implants.

Ella Ebaugh, 51, of York County, received two implants of the Ethicon devices, which later eroded into her urethra, said her attorney, Kila Baldwin of Kline & Specter. Surgeons operated three times to remove the devices.
The Common Pleas Court verdict is the fifth, and largest yet, awarded in a pelvic mesh suit, Baldwin said, It included $50 million in punitive damages. In December 2015, an Indiana woman was awarded $12.5 million; in February 2016, a New Jersey woman received a $13.5 million award; in April 2017, a Cinnaminson woman was awarded $20 million; and in June, a Pennsylvania woman received $2.1 million.

A spokeswoman for Ethicon said the company would appeal the verdict.
“We believe the evidence showed Ethicon’s TVT and TVT-Secur devices were properly designed, Ethicon acted appropriately and responsibly in the research, development and marketing of the products, and the products were not the cause of the plaintiff’s continuing medical problems,” said Kristen Wallace.
Thousands of women are believed to have been implanted with the devices, said Baldwin, who tried the case with Tracie Palmer and Elia Robertson, also of Kline & Specter.

Evidence introduced during the trial asserted J&J intentionally manipulated the literature regarding problems with the products and withheld information about complications and injuries from doctors, Baldwin said.
“I am pleased the jury recognized the reckless conduct of Johnson & Johnson,” Baldwin said, “and I hope the company takes notice of this verdict and the other verdicts in Philadelphia and amends its practices accordingly so as not to hurt other women.”
BREAKING: J&J Slammed With $57M Verdict In Philly Mesh Case
Law360, Philadelphia (September 7, 2017, 2:48 PM EDT) -- A Philadelphia jury on Thursday awarded $57.1 million in damages to a woman who accused a Johnson & Johnson unit of manufacturing a defective pelvic mesh implant that scarred her urethra and left her incontinent. 
The award, which included $50 million in punitive damages, easily eclipses verdicts won by plaintiffs in four prior cases tried in the Philadelphia County Court of Common Pleas as part of a mass tort program over allegedly defective pelvic mesh implants sold by Ethicon Inc.

The jury on Thursday unanimously backed claims from plaintiff Ella Ebaugh that a pair of negligently and defectively designed mesh devices had “mutilated” her urethra and left her with little control over her urinary flow.

Kila Baldwin, an attorney with Kline & Specter PC representing Ebaugh, said she hoped the verdict sent a message to Ethicon.

“Hopefully they recognize that their conduct was reckless,” she told Law360. “I hope this sends a clear message that they did something wrong with these products and that they really think, going forward, about what they do.”

Ebaugh’s case, which kicked off in early August, focused on two Ethicon mesh products — the TVT- Secur, which is no longer on the market, and the company’s “standard” TVT product, which is still being sold.

Ebaugh was implanted with a so-called TVT-Secur mesh device in May 2007 to treat symptoms of stress urinary incontinence and ultimately received a second TVT implant in the summer after her condition did not improve.

After reporting to her doctor three years later that she was having sudden urges to urinate and significant pelvic pain, it was discovered that the mesh had eroded into her urethra.

A series of surgical interventions followed that included one operation in which Baldwin said her client was cut open from “hip to hip” in an effort to remove as much of the mesh as possible. Despite the operations, scarring from the mesh implants had essentially propped open her urethra and left her all but incontinent, Baldwin told jurors during closing arguments on Tuesday.

Ethicon came into the Ebaugh case with a losing record after four out of five juries in prior trials in Philadelphia County sided with plaintiffs to the tune of nearly $50 million in total damages.

A jury in the fifth case decided in June that while the TVT-Secur had been defectively designed, it was not the cause of an Ohio woman’s injuries. A judge, however, agreed a month later that the verdict was inconsistent and ordered a new trial on damages.

Until Thursday, the largest verdict the company had faced in a mesh case in Philadelphia had been a $20 million award handed down in April. That award included $17.5 million in punitive damages.

Ethicon spokeswoman Kristen Wallace said in a statement on Thursday that the company "empathized" with individuals suffering from urinary stress incontinence and stood behind the safety and efficacy of its products.

"We believe the evidence showed Ethicon’s TVT and TVT-Secur devices were properly designed, Ethicon acted appropriately and responsibly in the research, development and marketing of the products, and the products were not the cause of the plaintiff’s continuing medical problems," she said.

She added that the company planned to appeal.

Ebaugh is represented by Kila Baldwin of Kline & Specter PC.

Ethicon is represented by W. Curt Webb and Kat Gallagher of Beck Redden LLP.

The case is Ella Ebaugh et al. v. Ethicon Inc. et al., case number 130700866, in the Court of Common Pleas of Philadelphia County, Pennsylvania.

--Additional reporting by Dan Packel. Editing by Christine Chun.