BOSTON SCIENTIFIC LOSES ITS FIRST FEDERAL TRIAL AND IS ORDERED BY A FLORIDA JURY TO PAY FOUR VICTIMS OF ITS VAGINAL MESH PRODUCTS A TOTAL OF $26.7 MILLION

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.”

Four Awards

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.Female-Patient-Doctor

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.

23,000 Suits

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.

Substandard Materials

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 jfeeley@bloomberg.net

To contact the editors responsible for this story: Michael Hytha at mhytha@bloomberg.net Andrew Dunn, Peter Blumberg

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What do I do if I am injured by a defective product?

Top 10 things to do if you are injured by a product:

by Daryl L. Derryberry, Member of Derryberry Zips Wade Lawhorn, PLLC

Defective tires de tread frequently and can cause serious injuries or death to the occupants of the vehicle.

  1. 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. 
  2. Obtain the name of the product manufacturer and the make and model number of the product.
  3. Send all worker’s compensation forms, if any, to your lawyer before signing.
  4. Take photographs of your injuries if possible.
  5. Take photographs of the scene of the incident if possible.
  6. Do not give any written or recorded statements to any insurance company or company representative without consulting with an attorney.
  7. 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.
  8. If you do not have health insurance, contact an attorney.   We may be able to assist you in obtaining medical care.
  9. 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.
  10. 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.

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GM HALTS TRUCK SALES- AIR BAG ISSUES

GM Halts Pickup Sales While Searching for Air-Bag Fix

The issue affects an undisclosed number of 2015 Chevrolet Colorado and GMC Canyon midsized pickups. The air bags were wired incorrectly, which will disrupt the firing process, the company said in a statement yesterday.

“GM is working to validate the correction for the condition,” Alan Adler, a spokesman for the Detroit-based automaker, said in the statement. “Once that service procedure is released to dealers, customer deliveries can resume.”

The largest U.S. automaker is trying to move beyond a year in which it has recalled almost 30 million cars and trucks in North America. Chief Executive Officer Mary Barra faced four separate congressional hearings over the handling of an ignition-switch recall now tied to 23 fatalities.

GM introduced the Colorado at the Los Angeles Auto Show in November, when it touted the vehicle’s capacity to tow greater loads than Toyota Motor Corp.’s Tacoma model. The Canyon, which sold 11 models in September, is the GMC version of the truck. Colorado sales totaled 36 that month. “The volumes are low and there are very few cars in customer hands,” said John Krafcik, president of TrueCar Inc., an auto-buying website based in Santa Monica, California.

Recall Planned

“It comes down to when sales can start again. They’ve started marketing the car, so if a consumer comes in and can’t buy one, then it becomes an inefficiency,” Krafcik said in a phone interview yesterday.

GM is preparing to conduct a safety recall for the trucks, meaning it will notify U.S. regulators and repair the vehicles for free. The company doesn’t know of any crashes, injuries or fatalities connected to the error, Adler said. The automaker has recalled about 26.4 million cars in the U.S. this year. That eclipses Ford Motor Co. (F)’s single-year record of 23.3 million in 2001.

Customers are being notified by overnight letter as well as being contacted by phone to bring their trucks to a dealer as soon as possible, Adler said. Free loaner vehicles will be provided.

To contact the reporter on this story: Jeff Plungis in Washington at jplungis@bloomberg.net  To contact the editors responsible for this story: Jamie Butters at jbutters@bloomberg.net Niamh Ring, John Lear

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Texas Worker Safety is the Worst

Workplace Deaths Decline, But Texas Still Fares Worst

Hurting for Work


How disdain for government regulation sparked a “Texas miracle” economy — while tearing down protections for the workers who built it.

Texas saw a decline in the number of people killed on the job in 2013, but the state still leads the nation in workplace fatalities, according to preliminary government data released Thursday.

There were 493 fatal work injuries in Texas in 2013, compared with 536 a year earlier, the U.S. Bureau of Labor Statistics reported. That represents a decline of about 8 percent. The 2013 figures are considered preliminary and will be revised in the spring.

As the Texas Tribune reported in its Hurting For Work series this summer, Texas has led the nation in worker fatalities for seven of the last 10 years. That trend held firm with the release of the 2013 data. Stretching back to 2000, Texas has experienced more job fatalities than any other state for 10 of those 14 years.

Other large U.S. states had significantly fewer workplace fatalities last year: California had 385, while Florida had 234 and New York had 160. (It’s worth noting that Texas has experienced comparatively high employment over the last decade. Since 2003, a third of the net new jobs created in the United States were in Texas).

While fatalities fell overall nationwide last year, deaths among Latino workers went up 7 percent nationwide between 2012 and 2013 — or 797 last year compared to 748 the year before. Texas has a large Hispanic workforce, particularly in the construction industry, but racial and ethnic breakdowns by state weren’t available Thursday.

Transportation accidents, accounting for 213 deaths, caused the most workplace fatalities in Texas, followed by contact with objects and equipment, 76; falls, slips and trips, 73; violence by persons or animals, 66; fires and explosions, 32; and exposure to harmful substances or environments, 31.

Heavy truck and tractor-trailer drivers proved to be the most dangerous occupation in Texas in 2013, accounting for 104 incidents, the data shows.

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Mesothelioma Verdict of $18.6 Million for Worker at Kelly Springfield/Goodyear Plant in Tyler, Texas

Tyler Morning Telegraph – Family gets $18.6M Goodyear mesothelioma case

The family of a Tyler man, who died after contracting mesothelioma after years of exposure working at the Kelly Springfield/Goodyear plant, was awarded $18.6 million by a Dallas County jury last week, and attorneys for the plaintiff said the amount was warranted.

Christopher J. Panatier, of the Dallas-based law firm Simon Greenstone Panatier and Bartlett, said Goodyear plainly ignored standards set in place in 1972 by the Occupational Safety and Health Administration.

“Carl Rogers worked at the plant for 30 years before being diagnosed with mesothelioma, a deadly cancer caused by exposure to asbestos fibers. Jurors found Goodyear grossly negligent for allowing Mr. Rogers’ continued exposure to asbestos,” he said.

Mr. Rogers worked as a tire builder at the Kelly-Springfield Tire Co. in Tyler, a Goodyear subsidiary. He worked with Goodyear machines that exposed him to asbestos on a constant basis. He was further exposed to asbestos-wrapped piping while maintenance work was happening at the plant. Mr. Rogers was diagnosed with mesothelioma in August 2008 and died in September 2009.

Panatier said the verdict, which was handed up in the Dallas County Court At Law 5, includes $2.7 million in non-economic damages, $900,000 in economic damages and $15 million in punitive damages.

“Mr. Rogers’ family just wanted a jury to hear the story of their husband and father. He did nothing wrong and still died because his employer did not protect him,” he said. “Goodyear plainly ignored OSHA standards to protect workers from asbestos disease and never dealt honestly with them.”

Panatier said Goodyear admitted during the trial that the levels of asbestos were 10 to 100 times greater than the average person would breathe outside of the plant.

He said three other former workers at the plant have been diagnosed with mesothelioma.

“The mesothelioma rate is usually one case per million people, so to have four at one plant is about a 900 percent increase to those having the disease,” he said.

Panatier said he believes there may been an appeal filed in the case, but that could take up to six months.

Written by Kenneth Dean, kdean@tylerpaper.com

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Vaginal Mesh Manufacturers May Resolve All Claims– Great News for Women Who Had These Products Implanted

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.

50,000 Claims

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.

Following Process

“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.

‘Possibly Unfounded’

“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.

Trial Losses

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.

J&J Sales

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.

Settlement Architect

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 reporters on this story: Jef Feeley in Wilmington, Delaware atjfeeley@bloomberg.net; David Voreacos in Newark at dvoreacos@bloomberg.net

To contact the editor responsible for this story: Michael Hytha at mhytha@bloomberg.net

 

Bard Settles Second Bellweather Vaginal Mesh Case

Bard settles second bellwether mesh case after plaintiff verdict in first trial

Female-Patient-Doctor

By Courtney L. Davenport

Following a plaintiff verdict in the first transvaginal mesh bellwether trial in a federal MDL against C.R. Bard, Inc., the device maker settled the second bellwether case shortly after jury selection. About 4,400 suits are pending in that MDL, and about 25,400 federal suits are pending in MDLs against other mesh manufacturers. (In re C.R. Bard, Inc., Pelvic Repair Sys. Prods. Liab. Litig., MDL No. 2187 (S.D. W. Va. Aug. 23, 2013).)

Last month, a jury awarded Donna Cisson and her husband $2 million, including $1.75 million in punitive damages, against Bard after transvaginal mesh implanted to treat pelvic organ prolapse (POP) eroded, causing bleeding, pain during intercourse, and bladder spasms and requiring additional surgeries. The Cissons alleged Bard defectively designed the mesh and failed to warn doctors when it learned of the risks.

Less than two weeks later, Bard settled with Wanda Queen and her husband for an undisclosed amount. Queen’s specific injuries were not disclosed in the complaint, but attorneys said that despite six corrective surgeries, her injuries are permanent.

Harry Bell of Charleston, W. Va., coliaison counsel in the MDLs, said the Cisson verdict may have prompted Bard to settle with the Queens because Queen’s case was even more egregious. But he does not know what impact the positive resolutions will have on the two remaining bellwether suits or the other MDL plaintiffs.

“From the perspective of the manufacturer, how’s it going to look to the public to have two adverse verdicts back to back and with the verdict amounts increasing? They made the decision they couldn’t take that risk,” he said. “Whether Bard makes the decision to settle [the others], one never knows. Bard has to be considering settlement considering the cases it is losing.”

Transvaginal mesh is surgically implanted in the vagina or abdomen to treat POP—in which the bladder, bowel, or other pelvic organs protrude into the vagina—and stress urinary incontinence. But shortly after it became popular in the late 2000s—in 2010 alone, mesh was implanted in 300,000 women—the FDA started receiving reports of serious injury when the mesh eroded, scraping tissue and protruding into the vagina or other organs, causing chronic pain, incontinence, infection, pain during intercourse, and other problems. Sufferers often require multiple surgeries to remove all of it. In 2011, the FDA warned that serious complications are “not rare” and advised that transvaginal mesh should not be used to treat POP, because it had not proved to be more effective than safer alternatives.

Thousands of mesh recipients and their families sued Bard; Johnson & Johnson subsidiary Ethicon, Inc.; American Medical Systems, Inc.; Boston Scientific Corp.; Coloplast Corp.; and Cook Medical, Inc. The suits allege the manufacturers did not test the defectively designed mesh before putting it on the market, nor did they properly train physicians. Federal MDLs were established against each defendant. State lawsuits are also pending against many of them, and at least two plaintiffs have obtained jury verdicts.

In July 2012, a California state court jury awarded Christine Scott—who suffers fecal incontinence and chronic pain and cannot have sexual relations after mesh eroded into her colon and vagina—and her husband $3.61 million against Bard. (Scott v. C.R. Bard, Inc., No. S-1500-CV-266034 (Cal., Kern Co. Super. July 24, 2012).) Earlier this year, a New Jersey court jury awarded Linda Gross and her husband $11.11 million against Ethicon. Gross underwent 18 surgeries to remove eroded mesh and permanently suffers such severe pain in her legs and pelvis that she cannot sit comfortably, be active for more than a few minutes, or have sexual intercourse. (Gross v. Ethicon, Inc., No. Atla-L-6966-10 (N.J., Atlantic Co. Super. Feb. 25, 2013).)

Bard asked that the court stay the other bellwether trials or certify an interlocutory appeal of an order in Cisson that excluded evidence of the FDA 510(k) device-approval process and the FDA’s decision not to recall Bard’s mesh devices. The judge has denied the request, holding that “I remain unconvinced that Bard is likely to succeed on the merits of any appeal related to the 510(k) issue” and that Bard will not be irreparably injured by waiting for the outcome of the remaining bellwether trials, the first of which is set to begin Oct. 8.