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.

TO STAY UP TO DATE WITH THE LATEST LAW NEWS, BE SURE TO FIND US ON FACEBOOK AT https://www.facebook.com/dzwlaw AND FOLLOW US ON TWITTER AT https://twitter.com/DZWLAW and https://twitter.com/URHURT

DERRYBERRY ZIPS WADE LAWHORN, PLLC  http://www.dzwlaw.com and http://www.urhurt.com 

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.

Jury finds for Plaintiff in J&J vaginal mesh trial

J&J Failed to Warn of Vaginal Mesh Risks, N.J. Jury Rules

By David Voreacos – Feb 25, 2013 10:28 AM CT.

Johnson & Johnson (JNJ)’s Ethicon unit failed to properly warn of the risks of a vaginal mesh implant and made fraudulent misrepresentations to a South Dakota nurse who sued, a New Jersey jury ruled.
Jurors ordered J&J to pay $3.35 million to Linda Gross, the nurse, and her husband. Linda Gross, 47, had 18 operations after the device was implanted.
The jury ruled that J&J, the world’s biggest seller of health-care products, didn’t defectively design the mesh and didn’t make fraudulent misrepresentations to Gross’s doctor.
The verdict in state court in Atlantic City came in the first of more than 2,100 lawsuits to go to trial over claims that Ethicon’s Gynecare Prolift injured women.
Gross claimed that J&J failed to warn her and her doctor of the risks and made fraudulent misrepresentations to her. Her lawyers said company documents and e-mails showed Ethicon knew the mesh would cause pain and harm women. She blamed the mesh for constant pain that makes it hard to sit and for subsequent operations to remove mesh that hardened.
“We’ve established during this trial that this is something that never should have been sold,” Gross attorney Adam Slater told jurors in his summation on Feb. 15. “You had the words of the people at the company saying it shouldn’t have been sold. You saw them talking about that before it ever went on the market, that it was unreasonably dangerous.”
J&J claims the Prolift is safe and effective and it warned of the risks.
“Our position is that the Prolift is a safe and effective product, that Ethicon adequately warned doctors of the risks, that doctors knew of the risks,” J&J attorney Christy Jones said in her closing arguments.
Gross sought $3.38 million for lost earnings and past and future medical expenses. She also sought unspecified damages for pain and suffering.
The case is Gross v. Gynecare Inc., Atl-L-6966-10, Superior Court of Atlantic County, New Jersey (Atlantic City).
To contact the reporter on this story: David Voreacos in Atlantic City, New Jersey, at dvoreacos@bloomberg.net
To contact the editor responsible for this story: Michael Hytha at mhytha@bloomberg.net

First Transvaginal Mesh trial against Johnson & Johnson set to begin week of January 7, 2013

http://www.dzwlaw.com/mesh/

Johnson & Johnson (JNJ) is set to face its first trial over its vaginal mesh implant in a case brought by a South Dakota woman who blames the product for constant pain and 18 subsequent operations.

The lawsuit by Linda Gross, 47, is the first of 1,800 in state court in New Jersey to go to trial today over whether J&J’s Ethicon unit adequately warned of the risks of the device. Several manufacturers, who make the devices to shore up pelvic muscles, face lawsuits by women who blame them for organ perforation, pain, scarring and nerve damage.

“She can no longer sit comfortably for more than a few minutes without having to either stand up or lay down to try to reduce the level of pain,” Gross’s attorneys said in court papers filed in Atlantic City. “She requires various daily medications to treat her severe chronic pain.”

J&J, based in New Brunswick, New Jersey, denies Gross’s claims for failure to warn of the risks, defective design and negligence.

In August, the company stopped selling four mesh devices in the U.S., including the Gynecare Prolift that Gross had implanted on July 13, 2006. The former nurse claims her pain ruined her quality of life and keeps her from working.

J&J, the world’s biggest seller of health-care products, denies Gross’s allegations, according to an Ethicon spokesman,Matthew Johnson.

“The evidence will show that Ethicon acted appropriately and responsibly in the research, development and marketing of pelvic mesh products to treat debilitating conditions affecting many women,” Johnson said in an e-mail.

Jury Selection

Jury selection began today when more than 100 potential jurors began filling out questionnaires. Lawyers will select a jury panel Jan. 9, with opening statements expected the next day. The trial is scheduled to last more than a month.

The U.S. Food and Drug Administration told J&J, C.R. Bard Inc. and 31 other manufacturers last January to study rates of organ damage and complications linked to implants. Doctors implanted more than 70,000 mesh devices in U.S. women in 2010, threading them through incisions in the vagina to fortify pelvic muscles that failed to support internal organs.

J&J said in June that it would end sales worldwide based on their commercial viability, not their safety and effectiveness.

Superior Court Judge Carol Higbee has wrestled in recent days with what lawyers for Gross and J&J can tell jurors about how the company introduced the Prolift device in March 2005.

No Application

J&J began selling the Prolift without filing a newapplication under the agency’s so-called 510(k) application process, which requires companies to show that a device is“substantially similar” to others on the market.

The company determined on its own that it was substantially similar to the Gynecare Gynemesh, one of the company’s devices already approved by the FDA, J&J said last year in an e-mail.

The FDA disagreed with J&J’s interpretation and required a new application in August 2007, saying Prolift sales began“without appropriate” clearance, an agency spokeswoman, Morgan Liscinsky, said last year in an e-mail.

J&J has said it began sales after citing an agency guidance document, “Deciding When to Submit a 510(k) for a Change to an Existing Device,” according to Liscinsky and Johnson.

The company faced no sanctions because the FDA determined that it applied the guidance in good faith and promptly complied when the agency required a new application, Liscinsky said. The FDA cleared the device in May 2008 after nine months of negotiations with J&J.

Addressing Jury

Higbee heard arguments Jan. 4 about what jurors could hear about the device’s regulatory history.

“We’re entitled to say they were required to get 510(k) clearance, and they didn’t get it,” Gross’s attorney, David Mazie, told Higbee.

“We continually hear that we marketed the device without clearance,” William M. Gage, J&J’s lawyer, told the judge. That’s not true. We marketed it under the guidance.”

“If they’re going to go in and say we didn’t get clearance, we’ve got to be able to say we did get clearance,”Gage said.

Higbee barred Adam Slater, the lawyer who will give an opening statement for Gross, from using words like “fraud,” “illegal” and “similarly inflammatory language” in addressing the jury.

‘Mental Illness’

On Jan. 3, Mazie argued that J&J should not be allowed to let a psychiatrist testify that Gross suffers from a “serious mental illness” that contributes to the excruciating pain she’s suffered. The doctor would testify that Gross refused to go a pain management center and wants to “hold on to her pain” so she can continue to claim disability, Mazie said.

At the hearing on Jan. 4, Higbee said jurors can hear about Gross’s various medical problems.

“I don’t foresee that defense counsel is going to stand up there and say this woman is responsible for her injuries,”Higbee said. “I have very little doubt that that would be a mistake.”

Possible witnesses for Gross include Alex Gorsky, who became J&J’s chief executive officer last April and was elected chairman Nov. 30.

Gorsky joined J&J’s Janssen unit in 1988 as a sales representative, according to a company biography. He left the company in 2004 to join Basel, Switzerland-based Novartis AG (NOVN), where he headed North American pharmaceuticals.

Four years later, he returned to J&J. He was named global chairman of the devices and diagnostics groups in 2009.

The case is Gross v. Gynecare Inc. Atl-L-6966-10, Superior Court of Atlantic County, New Jersey (Atlantic City).

To contact the reporters on this story: David Voreacos in Newark, New Jersey, at  dvoreacos@bloomberg.net; Jef Feeley in Wilmington, Delaware, at  jfeeley@bloomberg.net.

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