Boston Scientific Loses First Federal Trial Over Mesh
Jurors in federal court in Miami deliberated about four hours yesterday before finding Boston Scientific officials defectively designed their Pinnacle pelvic-organ implants and failed to properly warn doctors and their patients about the device’s risks, Joseph Osborne, a lawyer for one of the women, said in an interview.
The verdict is the first in a federal case against Boston Scientific over the Pinnacle inserts and the first to combine more than one plaintiff’s claims.
“Boston Scientific better start giving serious consideration to doing a global settlement of these vaginal mesh cases,” Carl Tobias, who teaches product-liability law at the University of Richmondin Virginia, said in a phone interview. “This verdict reinforces the substantial liability they are facing and it’s growing with each verdict.”
Jurors awarded Amal Eghnayem, Osborne’s client, more than $6.7 million. The panel also awarded Margarita Dotres and Mania Nunez, two other women who got Pinnacle implants, more than $6.7 million each. Juana Betancourt, the final woman in the group, was awarded more than $6.5 million, Osborne said. The panel awarded only compensatory damages, he added.
Kelly Leadem, a Boston Scientific spokeswoman, said the company disagreed with the jury’s findings that the Pinnacle inserts suffered from design flaws and that company officials didn’t warn about the implants’ risks.
“We believe we have strong grounds to overturn the verdict on post-trial motions and on appeal,” she said in an e-mailed statement.
“The evidence we presented showed that the company completely mishandled this product, and I think the jury’s damage award reflects that,” Osborne said.
The women’s lawyers argued yesterday that Boston Scientific officials ignored internal calls for more testing of the pelvic-organ implant and hurried the device along to counter competitors’ products.
In September, a state court jury in Texas ordered Boston Scientific to pay $73 million in damages to a woman who blamed one of its incontinence implants for her constant pain. That verdict was cut to $34.6 million by the trial judge. The company has won other cases that have gone to trial in state court in Massachusetts.
The Natick, Massachusetts-based company, the second-largest maker of heart-rhythm devices, faces more than 23,000 suits over its vaginal implants in U.S. state and federal courts, as well as in Canadian and U.K. courts, according to filings with the U.S. Securities and Exchange Commission. Boston Scientific pulled Pinnacle from the U.S. market in 2011.
Many of the cases against Boston Scientific have been consolidated before U.S. District Judge Joseph Goodwin in Charleston, West Virginia. Others have been filed in state courts in Delaware,New Jersey, Missouri, Texas and California.
Goodwin, who’s overseeing all the vaginal-mesh suits filed in federal courts against Boston Scientific, presided over the trial of the four women’s claims.
Women contend the inserts are made of substandard materials and often erode once they are implanted, causing pain and organ damage, and making sex uncomfortable.
The women’s lawyers presented evidence showing the mesh used in the Pinnacle insert hadn’t been approved for use within the human body by the company that made it.
Boston Scientific’s lawyer told jurors in the Miami case the mesh used in the inserts has been relied upon for years by doctors and engineers properly designed the devices.
“There’s no such thing as a risk-free surgery,” Hildy Sastre, one of the company’s lawyers, told jurors. “Because somebody develops a complication, which they’ve been clearly warned of, that doesn’t mean there’s a defect with the product.”
Boston Scientific is expected to face closing arguments Nov. 17 in another multi-plaintiff trial in federal court in West Virginia.
The Florida case is Eghnayem v. Boston Scientific Corp., 14-cv-24061, U.S. District Court, Southern District of Florida (Miami).
To contact the reporter on this story: Jef Feeley in Wilmington, Delaware at email@example.com
On May 21, 2011, seventeen year old Martin Blea, Jr. entered the business premises of The Pussycat Lounge, an after-hours BYOB establishment located in Odessa, Texas. The Pussycat Lounge was located less than a half mile from an adult cabaret known as Jaguars Gold Club. The Pussycat Lounge and Jaguars Gold Club essentially had the same owners and operators on May 21, 2011 and in the years leading up to May 21, 2011, such that the owners and operators of The Pussycat Lounge knew that dangerous and violent people were in the area and frequently visited The Pussycat Lounge
Martin Blea, Jr. went to The Pussycat Lounge with his older sister, among other individuals. At some point, his sister went to the restroom. As she was returning from the ladies’ room, a man, who was unknown to the sister (and has never been fully identified) but who had previously been seen conversing with a man named Steve Uresti and other patrons of the Pussycat Lounge, approached the sister and grabbed her in a sexually provocative manner. When the sister rejected these advances, the unidentified man punched the sister in the face and knocked her to the ground. The man then jumped on top of her. Martin Blea, Jr. was dancing on the dance floor at this time and saw his sister in distress. He went to pull the unidentified man off of his sister and a fight broke out. While Martin Blea, Jr. was attempting to aid his sister, Steve Uresti pulled out a 9 millimeter handgun and fired several shots into the air. Mr. Uresti then fired several more shots, one of which hit Martin Blea, Jr. in the face and killed him. Mr. Uresti’s gun had made its way into The Pussycat Lounge despite the fact that a policy was in place where patrons entering the premises were required to be screened with a hand held metal detector wand and patted down as part of an effort to keep dangerous weapons out of the club..
After being shot, Martin Blea, Jr. fell to the floor of The Pussycat Lounge where he struggled to breathe until the paramedics arrived. An ambulance transported Martin Blea, Jr. to a hospital in Odessa, Texas, where he was pronounced dead from his gunshot wound. On November 29, 2012, a jury in Ector County, Texas, convicted Steve Uresti of manslaughter in connection with the death of Martin Blea, Jr. and sentenced him to 20 years of confinement in the Texas Department of Corrections.
The parents of Martin Blea, Jr. retained DZWL to investigate the viability of, and potentially prosecute a wrongful death and survival action against persons determined to be potentially civilly liable for the death of Martin Blea, Jr. Our clients asserted that the owners/operators of The Pussycat Lounge controlled the security and safety of The Pussycat Lounge on May 21, 2011, and owed a duty to protect people visiting the club, such as Martin Blea, Jr., from the criminal acts of third parties if they knew or had reason to know of an unreasonable and foreseeable risk of harm to people visiting the club.. In that regard, the evidence revealed that the owners/operators knew or should have known that in the approximately three-year period immediately prior to May 21, 2011: a) the Odessa Police Department had been repeatedly called to the Jaguars Gold Club, a stone’s throw from The Pussycat Lounge, for numerous and repetitive instances of violent criminal conduct at Jaguars Gold Club involving, among other things, armed robbery, assault, gunshot victims and shots fired; b) the Ector County Sheriff’s Office had been repeatedly called to the premises of The Pussycat Lounge (as well as the business previously operated at those premises which was also owned and/or operated by the same persons) for numerous and repetitive instances of violent criminal conduct at those premises, involving, among other things, assault, aggravated assault, assault with bodily injury, aggravated assault with a deadly weapon, deadly conduct, robbery and a subject with a gun; and, c) the Ector County Sheriff’s Office had been repeatedly called to the Jaguar’s Gold Club for numerous and repetitive instances of violent criminal conduct at Jaguar’s Gold Club involving, among other things, assault, aggravated assault with a deadly weapon, aggravated assault, sexual assault, robbery, aggravated robbery, shots fired, deadly conduct, stab victim, man with a gun and prohibited weapon. Therefore, our clients asserted that the owners/operators of The Pussycat Lounge knew or should have known of the risk that persons in the immediate vicinity of The Pussycat Lounge who visited the Defendants’ two business establishments in that locale might foreseeably injure other people visiting the The Pussycat Lounge, such as Martin Blea, Jr., and Defendants had a duty to protect persons, such as Martin Blea, Jr., from the imminent, probable and foreseeable harm posed by other patrons of Defendants’ establishments. Our clients asserted that their son died as a result of Steve Uresti’s foreseeable act of firing a gun that had been brought into the Pussycat Lounge as a result of the inadequate security measures employed by Defendants at The Pussycat Lounge on May 21, 2011.
The Estate of the deceased, Martin Blea, Jr., incurred funeral and burial expenses of $11,423.06 and medical expenses of $1,193.50. The parents sought to recover damages under the Survival Statute for the alleged conscious pain and suffering endured by Martin Blea, Jr. between the time he was shot and the time he was pronounced dead. The parents also sought to recover for damages to the parent-child relationship, including loss of affection, solace, comfort, companionship, society, assistance, emotional support and love, loss of pecuniary value of the services of Martin Blea, Jr. and past and future mental anguish, grief and sorrow.
Despite the various contentions of the owners/operators, their insurance company paid our clients the insurance policy limits of $1,000,000 to settle their claims. The net recovery for our clients, after payment of attorneys’ fees and case expenses, was $555,494.39.
Top 10 things to do if you are injured by a product:
by Daryl L. Derryberry, Member of Derryberry Zips Wade Lawhorn, PLLC
- Contact a lawyer immediately to prevent the product from being destroyed or disposed of. An attorney can send a spoliation letter to preserve the product for inspection which is crucial to your case. Do not sign any documents prior to consulting with an attorney.
- Obtain the name of the product manufacturer and the make and model number of the product.
- Send all worker’s compensation forms, if any, to your lawyer before signing.
- Take photographs of your injuries if possible.
- Take photographs of the scene of the incident if possible.
- Do not give any written or recorded statements to any insurance company or company representative without consulting with an attorney.
- Immediately seek medical attention at a hospital or from a doctor if you are injured. If you do not seek medical attention, then the insurance company and/or product manufacturer will contend that you delayed in treatment and are not injured.
- If you do not have health insurance, contact an attorney. We may be able to assist you in obtaining medical care.
- Prepare a brief summary of the incident. Our memories fade about the details of an accident as time passes. This is helpful later in jogging your memory of the details of the incident.
- Obtain a police report if one is available.
Daryl L. Derryberry is one of the two founding partners of the firm now known as Derryberry Zips Wade Lawhorn, PLLC (the “Firm”). Daryl and Craig Zips started the Firm in May, 2002 and have enjoyed great success since the Firm’s inception. Daryl’s legal career spans two decades and includes successfully securing jury verdicts and settlements on behalf of his clients in oil rig accidents, 18 wheeler wrecks, medical negligence, products liability, broker malpractice, breach of fiduciary duty and other cases.
Our client, age 52, and employed as an inventory specialist, was turning into her employer’s parking lot from a two-lane road in Tyler, Texas. Austin Gray, in a Ford F-350 pickup, attempted to pass her on the right, and the vehicles collided. Our client was in a mid-size sedan. Gray was in the course and scope of his employment with LCR-M, L.P. He received a ticket for passing unsafely on the right and did not contest the ticket.
Our client sued Gray for passing unsafely on the right and causing the wreck. She also sued LCR-M under respondeat superior. Our client testified that Gray actually entered the parking lot to pass her on the right and that the impact occurred in the parking lot. Gray and LCR-M contended that our client was stopped in the middle of the road without her turn signal on and that the wreck occurred on the road.
Our client went to the ER later the night of the wreck and again the next morning. She sustained an internal disc disruption at L4-5. She tried physical therapy, but testified it did not provide her any relief from the constant pain. She underwent pain management with injections and then, on 4/16/13, an anterior lumbar fusion and posterolateral lumbar fusion at L3-4 and L4-5 was performed on her.
Our client’s paid medical bills were about $90,000. She also claimed past and future loss of household services, past and future loss of earning capacity, past and future disfigurement, past and future physical impairment, and past and future physical pain and mental anguish.
Our client had been working full time and making $13 an hour. The Social Security Administration declared plaintiff completely disabled as a result of the injuries she sustained in the wreck.
The Defendants contended that the impact was minor and that our client’s back injury could not have been caused by the wreck because the vehicle photos showed little damage to either vehicle.
The Defendants also contended that our client’s lower back problems were related to injuries she sustained in a rollover wreck around 1989. In that wreck, our client sustained compression fractures at L3 and L4, and the Defendants argued that this prior injury necessitated her surgery, not this wreck.
The Defendants further argued that our client’s earnings history was insufficient to support her claim for future lost earning capacity. And, the Defendants disputed our client’s need for any future surgery or other future medical treatment.
Finally, the Defendants note that our client’s workers’ compensation carrier determined that our client’s lower back injury was a preexisting injury related to the 1989 rollover and not related to this wreck. Despite this contention, our firm was able to negotiate a $400,000 settlement of this case for our client at mediation as reported by Verdict Search.
From Bloomberg News:
C.R. Bard Inc. and four other makers of vaginal-mesh implants accused of injuring women are in talks to settle thousands of lawsuits, people familiar with the discussions said.
Lawyers for Bard, Endo Health Solutions Inc. (ENDP), Boston Scientific Corp. (BSX) and two other companies making vaginal inserts to support women’s pelvic muscles and treat incontinence have begun talks about settling all suits over their products, the people familiar with the matter said. Johnson & Johnson, which also faces suits over the inserts, isn’t involved in the talks, said the people, who asked not to be identified because they weren’t authorized to speak publicly.
Boston Scientific said in an August regulatory filing it faces more than 12,000 suits over its vaginal devices. Photographer: JB Reed/Bloomberg News
Patients’ lawyers want U.S. District Judge Joseph Goodwin in Charleston, West Virginia, who is overseeing federal suits targeting the implants, to appoint a settlement committee, the people said. The group would include plaintiffs’ lawyers Henry Garrard, lead counsel on the Bard cases, and Joe Rice, a lawyer who helped negotiate a $246 billion tobacco-litigation accord on behalf of state attorneys general, the people said.
“I know you all are considering settlement protocols and the possibility of resolutions,” Goodwin said at a Sept. 18 court hearing. He noted the talks were going on “behind the scenes.”
The discussions are aimed at resolving more than 30,000 implant suits already filed that have been consolidated before Goodwin for pre-trial information exchanges, the people said. The talks also include insert makers Coloplast A/S (COLOB) and Cook Medical Inc., they said.
The total number of suits could swell to more than 50,000 as more claimants seek to join the potential settlement, the people said.
“The liability seems pretty clear on these cases, so settlement makes sense,” Carl Tobias, who teaches product-liability law at the University of Richmond in Virginia, said in an interview. “Given how serious the injuries are and the number of cases, when you do the math, you can easily come up with a multibillion-dollar settlement.”
Scott Lowry, a spokesman for Murray Hill, New Jersey-based Bard, didn’t return a call and an e-mail seeking comment on the settlement talks. Ulla Lunhus, a Coloplast spokeswoman, said she couldn’t comment on the talks.
“We are following a process that is in accordance with U.S. law,” she said in a phone interview. “As long as that process is ongoing, we are not able to make any comment about it.”
Marsha Lovejoy, a spokeswoman for Bloomington, Indiana-based Cook; Peter Lucht, a spokesman for Natick, Massachusetts-based Boston Scientific; and Blaine Davis, a spokesman for Malvern, Pennsylvania-based Endo declined to comment on the talks.
Bard’s implants have been targeted in more than 12,000 cases while Boston Scientific said in an August regulatory filing it faces more than 12,000 suits over its vaginal devices.
Endo’s American Medical Systems Inc. unit faces about 13,500 vaginal-mesh claims between state and federal suits, Davis said in an interview. Coloplast and Cook face about 1,000 claims combined, the people added.
J&J faced 12,250 pelvic mesh claims through June 30, according to a regulatory filing. Sheri Woodruff, a spokeswoman for the Ethicon unit of New Brunswick, New Jersey-based J&J, said it would be “inappropriate” to discuss litigation involving other manufacturers.
“Ethicon is now focusing on trying to efficiently manage thousands of unverified and possibly unfounded complaints,” Woodruff said in an e-mail. The company will “request dismissal of meritless claims, including claims with no compensable injury, claims barred by the statute of limitations, misfiled claims, and improperly filed claims.”
Some manufacturers, such as Bard and Endo, already have settled some suits over the devices. Earlier this year, Endo officials paid $54.5 million to settle an unspecified number of cases alleging the company’s vaginal-mesh inserts were defective.
Coloplast, based in Humlebaek, Denmark, is the furthest along with talks to settle all of the more than 600 cases it faces over its vaginal implants, the people said. The company is aiming to resolve all litigation over the devices by the end of the year, they added.
Bard officials also have settled some vaginal-mesh cases after losing two trials over the devices. A California state court jury last year found Bard liable for a woman’s injuries related to an Avaulta implant in the first case to go trial in a U.S. court. Jurors said the company should pay $5.5 million in damages. Bard is liable for $3.6 million under that state’s law.
Goodwin presided at the first federal trial of claims over Bard’s Avaulta Plus vaginal mesh in August. A jury ordered the company to pay a total of $2 million in damages to a Georgia woman who said the device damaged her organs.
Bard officials pulled the Avaulta implants off the market last year after the U.S. Food and Drug Administration ordered all makers of the devices to study rates of organ damage, infection and pain during sex linked to their products.
Bard faces more than 8,000 federal claims over Avaulta, which women allege can cause organ damage and make sexual intercourse painful when the devices erode.
J&J, which opted out of settlement talks, has battled court claims against its withdrawn line of vaginal implants. A New Jersey jury ruled in February the company must pay $11.1 million in damages to a woman who blamed J&J’s Gynecare Prolift for her injuries. It was the first case over the devices to go to trial.
Officials of J&J’s Ethicon unit told Goodwin last year they would stop selling some vaginal implants after suits over the devices. The company’s executives have declined to participate in settlement talks, the people said.
“I expect Johnson & Johnson (JNJ) to discuss settlement when they think the time is right,” Adam Slater, a New Jersey lawyer who won the February verdict against the company over vaginal devices, said in an interview. Slater said he is preparing for his next trial in March 2014.
Goodwin said in the September hearing that he’s struggling to find ways to move the “mountain” of vaginal-mesh cases through the federal courts and is considering combining multiple plaintiffs’ claims for trial.
“I’m going to keep the bulldozer moving to deal with these cases,” he said.
Lawyers for women suing over the inserts have recommended that Goodwin tap plaintiff lawyers Garrard, Rice, Bryan Aylstock of Florida and Clayton Clark, a Texas-based litigator, for a settlement committee empowered to conduct talks with all mesh manufacturers, the people said.
Rice, one of the architects of the 1998 tobacco settlement, is known for his ability to put together accords in high-profile cases. Last year, the 59-year-old lawyer helped negotiate a now $9.6 billion settlement of suits against BP Plc (BP/) over the 2010 oil spill in the Gulf of Mexico. He declined to comment on his role in the vaginal-mesh talks.
The vaginal-mesh litigation poses a challenge for Rice and other settlement negotiators because they are faced with cases over more than 50 different implants manufactured by six different companies, the people said. Some of those products have been pulled from the market while others are still being implanted, they added.
Rice is focusing his attention first on cases involving American Medical Systems’ inserts, the people said. Ellen Reisman, a Los Angeles-based lawyer representing the device maker, was one of BP’s lawyers in Gulf oil spill settlement announced last year, they noted. Reisman was at the Sept. 18 hearing in West Virginia.
The Bard consolidated cases are In re C.R. Bard Inc. (BCR) Pelvic Repair System Products Liability Litigation, 10-md-02187, U.S. District Court, Southern District of West Virginia (Charleston). The J&J consolidated cases are: In re Ethicon Pelvic Repair System Products Liability Litigation, 12-md-2327 U.S. District Court, Southern District of West Virginia (Charleston).
To contact the editor responsible for this story: Michael Hytha at firstname.lastname@example.org