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Morcellation Media Monitoring 03/21/2016
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Johnson & Johnson Settling Cases Tied to Device That Spread Uterine Cancer
Mar 18, 2016 | The Wall Street Journal
By Jennifer Levitz
Johnson & Johnson is settling a series of legal claims and lawsuits alleging that its now-discontinued hysterectomy device harmed women by spreading a undetected hidden cancer, according to court documents and plaintiff lawyers with knowledge of the settlements. -
5 Things to Know About Morcellation
Mar 18, 2016 | The Wall Street Journal
By Jennifer Levitz
More than 20 years ago, gynecologists had a problem. Doctors in other fields were quickly introducing minimally invasive surgery—laparoscopic procedures done through tiny incisions—to remove organs like gallbladders and kidneys. But a laparoscopic hysterectomy to treat a uterus filled with fibroids, common benign growths that affect many women, can be far too cumbersome. That’s where devices called laparoscopic power morcellators came in. But in 2014, more than two decades after the surgical tools were cleared for use, the U.S. Food and Drug Administration cited evidence that the morcellators could spread cancer and issued a strong caution against the device, leading to a fallout that continues today. Here are five things to know about the controversy. -
J&J Settling Morcellator Cases, Plaintiffs' Attorney Says
Mar 18, 2016 | Law360
By Cara Salvatore
Law360, New York (March 18, 2016, 11:16 PM ET) -- Johnson & Johnson has begun settling product liability cases in its power-morcellator litigation mere months after many of the cases were consolidated by a judicial panel, a lead plaintiffs' attorney confirmed Friday -
What Are the Chances? A Tale of Love vs. Big Medicine
Mar 20, 2016 | Philadelphia Magazine
By Sandy Hingston
Hooman Noorchashm would not shut up. The emails went sailing out from his laptop at all hours of the day and night, to physicians, to government regulators, to legislators, insurers, hospital administrators, reporters, anyone who might possibly listen to what he had to say. His messages were inflammatory, harsh. Court records show that he accused his fellow doctors of being corrupt, unconscionable criminals. The emails seemed a bit … unhinged. Those he was sending them to tried to stop him. They threatened legal action, then went to court. They described his messages as “disturbing and threatening.” They called him a security threat. -
J&J Ethicon Settling Morcellator Cancer Cases After Hysterectomy
Mar 19, 2016 | The Legal Examiner
By Shezad Malik MD JD
According to the Wall Street Journal, Johnson & Johnson (J&J) the world’s largest medical device and pharmaceutical company is settling personal injury and product liability lawsuits alleging that its now-recalled hysterectomy device injured women by spreading an undetected hidden cancer.
Client Attorney Privileged/Attorney Work Product/At Request of Counsel
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Johnson & Johnson Settling Cases Tied to Device That Spread Uterine Cancer
Mar 18, 2016 | The Wall Street Journal
By Jennifer Levitz
Johnson & Johnson is settling a series of legal claims and lawsuits alleging that its now-discontinued hysterectomy device harmed women by spreading a undetected hidden cancer, according to court documents and plaintiff lawyers with knowledge of the settlements.
An estimated 100 cases have either been filed—or readied for lawsuits—against J&J’s Ethicon unit related to a device known as the laparoscopic power morcellator, said Paul Pennock, a plaintiff lawyer and co-lead counsel on the steering committee for consolidated litigation under way in a Kansas City, Kan., federal court.
Of the 100 or so claims, J&J has settled nearly 70 over the past few months, he said, and more talks are ongoing.
J&J’s total outlay on the claims likely runs into the many millions, though individual settlement sums vary case by case. Some of its settlements so far have ranged from $100,000 to roughly $1 million, according to a person with knowledge of some recently resolved cases.
The New Brunswick, N.J., health-care giant also is in talks to resolve other morcellator claims it faces, according to lawyers with knowledge of those talks.
J&J also faces a handful of separate morcellation cases that are still pending in state courts.
A J&J spokeswoman declined to comment on the settlements. The company suspended sales of its device in April 2014 and withdrew it from the market in July 2014.
“You certainly don’t always see a company step up and take responsibility this early on,” the plaintiff lawyer Mr. Pennock said. “That’s something we think is appropriate.”
Power morcellators cut up benign growths called fibroids so doctors can remove the tissue through tiny incisions. Surgeons routinely deployed the devices before April 2014, when the U.S. Food and Drug Administration warned that women undergoing fibroid operations have a 1 in 350 chance of harboring a uterine sarcoma that can’t be reliably detected before the procedure.
Morcellators can spray cancerous tissue within the abdomen and pelvis, significantly worsening a woman’s chances of long-term survival, the FDA said.
Doctors used power morcellators in tens of thousands of procedures a year, primarily hysterectomies. J&J’s Ethicon unit was just one morcellator maker, though it held the lion’s share of the market.
The U.S. Government Accountability Office continues to probe why the device was allowed to be on the market for two decades before the FDA warned it can spread uterine cancer, according to a person familiar with the investigation. In the past the FDA has defended the regulatory process used to approve morcellators and most devices as a good way to balance innovation and safety, and said the agency is bolstering surveillance of devices on the market.
The wrongful-death and product-liability claims against J&J’s Ethicon division generally allege that the company knew or should have known the surgical tools disseminated cancer but didn’t take adequate action, and that the products were essentially a defective concept given the difficulty of distinguishing a fibroid from a uterine sarcoma.
J&J said in a statement to the Journal last year that Ethicon morcellators “have always included cautions in their instructions for use about the potential spread of malignant (or suspected malignant) tissue.”
In a February hearing in the Kansas court, John Winter, a lawyer at Patterson, Belknap, Webb & Tyler, representing J&J, referred to past “confidential settlement discussions with numerous lawyers” and settlement “discussions, dialogue, resolution” according to a court transcript. Mr. Winter, who declined to comment through J&J, didn’t say during the hearing how many cases had been resolved.
The amounts J&J paid in its confidential settlements to individual women who claimed they were harmed by the device could vary depending on such factors as a woman’s age, medical condition and whether she had children, according to people familiar with many of the resolutions.
The FDA began looking into possible risks of surgery with the device after then-40-year-old anesthesiologist Amy Reed, went public in a Wall Street Journal article detailing her worsened cancer after a hysterectomy using the device. She has sued another morcellator maker, Karl Storz GmbH, in a case pending in a Massachusetts state court, as well as the Boston hospital and doctors involved in her care. The company didn’t respond to a request for comment; the hospital, Brigham and Women’s Hospital, said it doesn’t discuss pending litigation. Responding in court filings, Karl Storz has moved to dismiss the lawsuit, while the hospital and doctors have denied wrongdoing.
Ms. Reed, a mother of six who now lives outside Philadelphia, has had multiple recurrences and continues to fight advanced cancer. Her husband, Hooman Noorchashm, also a doctor, on Friday lamented that settlements would prevent a public airing of all the facts.
“Each one of these cases is an opportunity to create a public record about what went wrong—both ethically and at a regulatory level—so nothing like it happens again,” he said.
Houston lawyer Sean Tracey, whose firm Tracey & Fox settled multiple morcellator cases with J&J in December, said in the Kansas court in February that he has “another 40 power morcellator cases against other defendants that I’m working on,” according to a court transcript.
Mr. Pennock believes many women never had the chance to seek redress through the courts. They “died because of this device but those they left behind have no idea what happened to them,” he said.
According to court filings, the Tracey & Fox litigation was on track, with an eye on a potential trial this year, before the settlements.
Before the firm settled with Ethicon in December, it had received 100,099 documents in discovery from the company—with the final delivery in November—and in September had formally requested the depositions of two former Ethicon medical directors, the firm’s lawyers said in a January filing in Kansas federal court.
Lawyers were pushing for the cases to move quickly given that many of the women were ill.
“Our highest priority has always been to ensure that this unique group of clients, many of whom may not live to see Christmas 2016, received recompense sooner rather than later,” wrote attorney Rebecca King, of Tracey & Fox in a December court filing.
One case that settled involved Molly Minihan, a Colorado woman who underwent a laparoscopic surgical procedure in April 2013, according to court filings. “During this surgery,” according to the lawsuit, “cancerous tissue was cut, shredded and spread throughout her body.”
By December 2015, her uterine leiomyosarcoma had recurred twice despite chemotherapy, her lawyer, Ms. King, wrote in a filing, saying she worried administrative delays would hurt her client and “rob her of her day in court.”
In a separate case, Mona Eldin, a family doctor in Michigan, confirmed Thursday that her case had settled.
In a previous interview Ms. Eldin, who is in her 40s, said that when she had a laparoscopic hysterectomy with morcellation for presumed fibroids, her doctor never mentioned the possible risks of a hidden cancer. Meanwhile, the pathology of the shredded tissue initially falsely came back benign. Later retesting of the original tissue—after a tumor grew in Ms. Eldin—revealed it had been sarcoma all along, illustrating another danger of morcellation, her husband, Usama Gabr, also a doctor, said in the previous interview: the device destroyed tissue that pathologists are trained to read. “You can imagine how many people just go undiagnosed,” he said. “The danger goes beyond” the FDA’s 1 in 350 estimate, he said.
“We’ve got people that are dying,” said their lawyer, François M. Blaudeau, whose Birmingham, Ala., firm, the Southern Institute for Medical and Legal Affairs, settled its morcellator cases against Ethicon, according to a February court transcript.
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5 Things to Know About Morcellation
Mar 18, 2016 | The Wall Street Journal
By Jennifer Levitz
More than 20 years ago, gynecologists had a problem. Doctors in other fields were quickly introducing minimally invasive surgery—laparoscopic procedures done through tiny incisions—to remove organs like gallbladders and kidneys. But a laparoscopic hysterectomy to treat a uterus filled with fibroids, common benign growths that affect many women, can be far too cumbersome. That’s where devices called laparoscopic power morcellators came in.
But in 2014, more than two decades after the surgical tools were cleared for use, the U.S. Food and Drug Administration cited evidence that the morcellators could spread cancer and issued a strong caution against the device, leading to a fallout that continues today. Here are five things to know about the controversy.
1) Power morcellators helped offer less-invasive surgery.
Doctors didn’t need powered morcellators, but they helped. Medical articles occasionally described tennis-elbow-like injuries for doctors wielding older, manual morcellators. In contrast, most powered versions let a tube-shaped motorized blade, inserted through a small hole in the abdomen, to do the work. Training videos show the blade cutting into the tissue, which is pulled up the tube in pieces. Tens of thousands of women had morcellator-aided hysterectomies every year, and proponents said the devices spared them longer incisions and got them back on their feet faster after surgery.
2) They also posed a potential danger that was largely overlooked.
Gynecologists saw from the beginning that morcellators can drop bits of tissue. They also knew that what looks like a fibroid can be a hidden cancer, but many doctors say they believed that happened rarely. In some cases, doctors discounted early hints of risk. A study from South Korea in 2011 turned heads at a medical conference by showing how morcellating these tumors, rather than removing them whole, was more likely to spread cancer and worsen survival rates.
3) Years later, the morcellator problem spilled into the public sphere.
The issue went mainstream in December 2013 with the well-publicized caseinvolving Amy Reed, a then-40-year-old anesthesiologist. Boston’s Brigham and Women’s Hospital said that, by using a power morcellator, it inadvertently worsened the cancer of Dr. Reed, who joined her doctor husband in callingattention to the problem. In court filings, the hospital, which is being sued by Dr. Reed, has denied wrongdoing.
In April 2014, the FDA surprised the medical community by advising doctors not to use power morcellators. The agency said 1 in 350 women undergoing the surgery actually have a cancerous tumor that looks like a fibroid and can’t be reliably detected before surgery. Johnson & Johnson, the largest manufacturer, suspended global sales and then withdrew its device from the market that July. In November 2014, the FDA called for manufacturers to placea “black-box” warning, the FDA’s strongest, on the device.
4) Warnings led to shift in surgeries on women.
The FDA didn’t ban the device; it said it wanted to leave a window open for the small number of women for whom the tool’s benefit may outweigh its risks. Still, the agency said any woman who does undergo the procedure should be warned that morcellation could spread unsuspected cancer.
In the new landscape, U.S. gynecologists have changed the way they perform hysterectomies now that they no longer can readily use morcellators, according to hospitals and studies.
While some surgeons remain dismayed about new limits imposed on the device, other doctors have said concerns that its loss would lead to major problems didn’t materialize. Instead, doctors say they turned to alternatives. The doctors are often choosing a “mini-laparotomy,” in which the uterus is removed through a small incision above the pubic bone. The incision is typically between 1 1/2 inches and 3 inches, versus roughly 1/2-inch to 3/4-inch incisions in procedures using the morcellator.
Meanwhile, the American Congress of Obstetricians and Gynecologistsrecommends vaginal hysterectomies, when feasible, as having the best outcomes and fewest complications.
5) Scrutiny of the device is still under way.
The controversy has moved to Washington and into the courts. Based on a request from Congress, the U.S. Government Accountability Officeis investigating why the device was marketed for two decades before the FDA warned it can spread uterine cancer.
In a statement on Friday, the FDA said its “primary concern is the safety and well-being of patients.” The FDA said it “was notified by the GAO of its investigation and plans to fully cooperate with the review.”
Though device applications and other records show the FDA knew early on that morcellators could spread dangerous cells, the agency said the magnitude of the risk wasn’t realized until the issue came into the spotlight in late 2013.
Meanwhile, dozens of other women have come forward, with many filing lawsuits. Some of these cases are being settled by J&J.
J&J said in a statement to The Wall Street Journal last year that its morcellators “have always included cautions in their instructions for use about the potential spread of malignant (or suspected malignant) tissue.”
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J&J Settling Morcellator Cases, Plaintiffs' Attorney Says
Mar 18, 2016 | Law360
By Cara Salvatore
Law360, New York (March 18, 2016, 11:16 PM ET) -- Johnson & Johnson has begun settling product liability cases in its power-morcellator litigation mere months after many of the cases were consolidated by a judicial panel, a lead plaintiffs' attorney confirmed Friday.
The medical products company has settled a number of the roughly 100 cases that have already been readied or filed, according to Aimee Wagstaff of Andrus Wagstaff, a co-lead plaintiffs’ attorney in the power morcellator multidistrict litigation.
Wagstaff also said that lawyers have many more potential plaintiffs in the pipeline.
"I know that there are hundreds that remain under investigation around the country," she said.
When the Judicial Panel on Multidistrict Litigation made the decision to consolidate in October, it noted that 650,000 women in the U.S. each year undergo surgery to manage symptomatic uterine fibroids, and that laparoscopic procedures with power morcellation had been gaining favor over conventional methods.
Then in November 2014, the U.S. Food and Drug Administration put out a guidance warning that laparoscopic power morcellators -- electric surgical tools used to break up large chunks of tissue so the fragments can be removed through a stomach incision -- may spread cancer and shouldn't be used in gynecological surgery that involves cancer or fibroids.
The FDA said that uterine tissue may contain unsuspected cancer and that using the morcellators may spread the cancer and decrease long-term patient survival.
Of the 500,000 hysterectomies performed every year, about 11 percent are done using power morcellators, the FDA said.
Although uterine fibroids are common and usually benign, about one in 350 women undergoing a hysterectomy or fibroid removal have an unsuspected uterine sarcoma, a type of uterine cancer.
The controversy over the tool's danger prompted the Johnson & Johnson unit Ethicon to execute a worldwide recall of its Morcelex brand devices in July 2014 after suspending sales of the devices that April.
In May 2014, Ethicon was hit with the first suit over the product in New York federal court.
“Because Ethicon acted appropriately and responsibly at all times in relation to our morcellation devices, we will defend ourselves in the lawsuits that have been filed against us,” an Ethicon spokesman told Law360 in October. An Ethicon representative was not immediately available for comment Friday evening.
Ethicon is represented by John Winter of Patterson Belknap Webb & Tyler LLP.
The plaintiffs are represented by Paul Pennock, Jerry Kristal, Ellen Relkin, Michael Pederson and Donald Soutar of Weitz & Luxenberg PC, Aimee Wagstaff of Andrus Wagstaff, Charles Childers of Childers Schlueter & Smith LLC, and others.
The case is In Re: Power Morcellator Products Liability Litigation, MDL number 2652, in the U.S. Judicial Panel on Multidistrict Litigation.
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What Are the Chances? A Tale of Love vs. Big Medicine
Mar 20, 2016 | Philadelphia Magazine
By Sandy Hingston
Hooman Noorchashm would not shut up. The emails went sailing out from his laptop at all hours of the day and night, to physicians, to government regulators, to legislators, insurers, hospital administrators, reporters, anyone who might possibly listen to what he had to say. His messages were inflammatory, harsh. Court records show that he accused his fellow doctors of being corrupt, unconscionable criminals. The emails seemed a bit … unhinged. Those he was sending them to tried to stop him. They threatened legal action, then went to court. They described his messages as “disturbing and threatening.” They called him a security threat.
None of that mattered to Hooman. He was on a mission. He had something to prove. At one of the finest, most reputable hospitals in the nation, a physician had used a medical device known as a power morcellator to mince and suction up his wife’s uterine fibroid — a type of benign growth experienced by more than half of all women. Unbeknownst to the doctor or to Hooman’s wife, Amy Reed, a rare cancer known as a leiomyosarcoma was implanted in her uterine wall. The power morcellator minced it up along with the fibroid, its spinning blades tossing bits and pieces of the cancer throughout her abdominal cavity.
Since that initial operation in 2013, Amy has had four more operations to remove new tumors generated by the morcellator’s “upstaging” of her original cancer. The makers of power morcellators and the doctors who favor the devices insisted that the chances someone like her had such a tumor were minuscule, negligible — one in 10,000. Those chances sound pretty good.
But Hooman and Amy have since learned that for women suffering from fibroids serious enough to prompt surgery, the odds are more like one in 350. That’s not a chance you or I would likely take.
The overriding duty of a physician is so well known that it’s a cliché: First, do no harm. But Amy and Hooman say her oncologist knew about the greater risk when she was operated on. That there were other women like her — including one who lay dying in the same hospital while Amy had her initial operation, performed with the same device that had caused that other woman’s cancer to spread. And that because the device made the operation easier and faster and cheaper, and all of medicine today is geared toward easier and faster and cheaper, no one was looking for problems that device might cause.
Amy’s a doctor herself, married to a doctor who worked in the same hospital where she was operated on. If she and Hooman weren’t told the truth about what might happen to her, what are the chances you or I would be? How blind is our faith in physicians, and how daunting our inability to know what questions to ask? That’s the bone that’s stuck in Hooman’s craw, and that turned his email campaign against morcellation into an all-out war against the wobbly, opaque health-care system that endangers us all.
WHEN HOOMAN NOORCHASHM first heard of morcellation, he didn’t know how to spell it. “I used an S,” he says as he sits at the kitchen table of the couple’s home in Morrisville, Bucks County. It’s an ancient farmhouse in the midst of a newer subdivision, surrounded by lawn and trees. There’s spaghetti on the blacktop driveway where their kids—they have six—spilled it on their way to feed leftovers to the chickens in the family chicken coop. Their youngest, three-year-old Ryan, threw up last night; he’s cranky from a virus. Amy settles him in with a cartoon in the family room, part of an addition whose construction she just oversaw.
Hooman, who is 43, and Amy, 42, weren’t living here when she was diagnosed in 2013; they were in Needham, Massachusetts, where they moved after graduating from Penn’s medical school and completing their residencies at HUP. She had her fibroid operation at Harvard-affiliated Brigham and Women’s Hospital in Boston, 13 months after Ryan was born. “I was still breastfeeding,” she recalls. She’d been miserable from pain and bleeding ever since his birth. On the basis of a colleague’s referral, Amy went to see gynecological oncologist Michael Muto, who examined her, diagnosed a fibroid and not cancer, and sent her on, in turn, to his young colleague Karen Wang, a Brigham-based gynecological surgeon. Amy and Hooman say that Muto and Wang talked Amy out of the traditional open-abdomen surgery she expected — “I said, cut me open! My stomach is a mess, I have six kids” — in favor of a less invasive laparoscopic procedure. (According to court records, Muto and Wang contest this allegation.) Recovery will be quicker, Amy recalls Muto saying. We’ll get you back on your feet. She says no one mentioned a morcellator then. (Muto has admitted he didn’t discuss morcellation at her initial consultation. He and Brigham declined to speak with this magazine on the advice of counsel.)
Hooman, a cardiothoracic surgeon, was, like Amy, teaching at Harvard’s medical school, and working at Brigham and Women’s. When she scheduled her fibroid operation, though, he was in North Carolina, learning to transplant lungs. “I had to go to Duke for six months,” he explains. “It was like playing in the NBA. Harvard wanted me trained at Duke. They sent me there.”
“I was not happy,” Amy puts in. “I didn’t think it was necessary.” There she was in Needham, far from her mother and sisters back in Bucks County, with six kids, the oldest 12, the youngest Ryan. For months she’d been feeling low. Her obstetrician noticed that she was anemic and put her on iron and birth control pills. They didn’t help. In late summer, she went back to that doctor and said, “Something’s wrong. I’m not normal.” There were MRIs, biopsies, ultrasounds, and then the operation that was supposed to fix it all.
At the kitchen table, Hooman pulls up the notes from Michael Muto’s initial meeting with Amy. He has reams of documents and data about Amy’s case, about morcellators, about leiomyosarcomas, on his laptop. He does most of the talking on this bright December morning. Amy flits around the kitchen, dusting, sweeping, straightening, only alighting at the table from time to time. “When Muto met with me,” she tells me, “he said, ‘You do not have cancer. You don’t need me.’” She sprays organic cleaner on the glass tabletop. “We’re doctors,” she says tightly. “We don’t say ‘never’ unless we’re sure.”
Hooman flew home from North Carolina for Amy’s fibroid operation. It went smoothly. But she didn’t want him to go back afterward. She’d been through so much in Boston. The kids got sick; she’d been alone. “I told him, ‘I would never ask this of you,’” she says. After all the years of training, after hundreds of thousands of dollars in student debt, there was finally light at the end of the tunnel: their teaching jobs at Harvard Med, his position at Brigham, hers at Beth Israel Deaconess Medical Center. But she couldn’t quarrel with his dedication. That spring, she’d been the critical-care attending on duty the morning of the Boston Marathon bombing. She’d treated the victims — and then the wounded bomber, Dzhokhar Tsarnaev, after he was brought in. Do no harm. …
Amy’s operation was on October 17th. About a week later, she got a call from Karen Wang, the doctor who’d performed her surgery. “Are you alone?” Wang asked. The pathology report on her fibroid had come back. It showed an unusually aggressive form of cancer — leiomyosarcoma. Wang said she was sorry and hung up. Then Muto contacted Amy at Wang’s request. Muto said Amy would need another operation; they’d have to take out her ovaries.
Amy called Hooman in North Carolina. He was in the midst of an operation when his phone started buzzing and beeping. It didn’t stop. “Who’s calling you?” a nurse finally asked. He scrubbed out and took the call. He knew what leiomyosarcoma was. His phone rang again — it was Karen Wang. “I said, ‘Did you get it out in one piece?’” Hooman says. “I assumed — the way you treat any mass, you take it out in one piece. You never chop it up. She said, ‘No, we morcellated it.’” That was when Hooman first wrote the word down, with an S. He told his colleagues he had to leave and headed for the airport.
“It wasn’t part of my working knowledge,” he explains. “I knew doctors used to do that to spleens to get them out. So I sort of knew what we were up against.” He knew, too, that he was done at Duke. In the cab, he called Michael Muto. Muto told him that what had happened was very, very rare, Hooman recalls. That Amy was just so unlucky.
If the sarcoma had been taken out whole, her five-year survival rate would have been 50 percent. With the cancer morcellated, it was between zero and 20 percent. “Basically,” says Hooman, “they created a man-made stage four cancer.”
AMY WAS EDUCATED by nuns — the Sisters of St. Casimir — at Villa Joseph Marie, a tiny Catholic girls’ school in Holland, Bucks County. She came from a big family — her parents, who divorced and then both remarried, numbered eight kids between them — and she always wanted a big family of her own. She went to Penn State after high school, then to grad school at Penn. When she got there, she saw t-shirts that said NOT PENN STATE. She didn’t understand why that was funny. She’ll tell you that herself.
What she won’t tell you, her husband says, is the rest of the story — that she was valedictorian at Villa Joseph Marie, that at Penn State she was Phi Beta Kappa, Golden Key and dean’s list. That when, after getting her PhD in immunology, she decided to apply to med school, she got into every one she applied to except Cornell and Harvard. That by the time she graduated from Penn Med, she had three kids. She carried two of them, Joseph and Nadia, onto the stage to accept her diploma. She got a standing ovation from the crowd.
Hooman first saw her shortly after she started at Penn, in 1995. They were both going after their doctorates then. “I noticed her walking down the hall with a lab bucket,” Hooman says. “I was star-struck. That was that.” In their kitchen, he smiles, waves a hand toward her, then himself. “We’re basically a testament to my persistence,” he tells me.
“Pretty much,” she agrees.
Except that they’re both doctors and have six kids, they’re like any couple you know. He’s compact but strong, with forearms that remind you how physical surgery can be. She’s wavy-haired and pretty, though she sometimes looks tired. “We’re in sync in a lot of ways — we both wanted a big family, we’re strong on social service — but in other ways we’re diametrically opposed,” says Amy. “He likes to read autobiographies.”
“She likes Stephen King,” says Hooman.
“I do like Stephen King. I like medical fiction, historical fiction.”
“She reads a lot about influenza epidemics,” Hooman says, and laughs. In a discussion of why they chose the medical specialties they did, he’s the one who points out that Amy is dual-board-certified, in critical care and anesthesiology.
“Being in the intensive care unit is just like being at home,” Amy says. “There’s always a clamor, only they’re not saying ‘Mom!’”
They’d been living in Narberth for 10 years when Hooman got his fellowship at Brigham and Amy landed her job at Harvard. She wasn’t sure about moving. “To do what I do — we had five kids at the time. I had to rely on the infrastructure I’d built up.” In Boston, they’d be isolated. She’d have to start all over again with church, community, friends. But they found a similar town in Needham. They found a great house, serendipitously, though it needed work. (“There was only one bathroom,” Amy says.) They found a school for the kids. They made more friends. They had Ryan. And Amy had that operation to make her right again.
When you train to be a cardiac surgeon, Amy mentions, they teach you to walk into a room where a patient is waiting and say, “I need to cut into you right now.” There isn’t any space for self-questioning or doubt. You know that old joke about how God sometimes thinks he’s a doctor? Becoming a heart surgeon does that to you.
So it really shouldn’t have surprised anybody at Brigham and Women’s when Hooman, as he sat in the airport waiting to fly back to Boston from Duke, did a Google search for “morcellation.” He learned how to spell it. He learned that doctors performed 100,000 to 200,000 operations like the one on his wife each year. “So I’m thinking,” he says, “even if it is one in 10,000, that’s still 10 or 20 women” with sarcomas that were spread.
So he did more research. He came across a paper that had been published in November of 2012, about a year before Amy first went to Michael Muto. “Peritoneal Dissemination Complicating Morcellation,” it was called. “Guess who was one of the authors?” he asks me. “Dr. Muto. The research had been done at Brigham. With morcellation! By Dr. Muto.” His voice gets increasingly high. “He’s telling me one in 10,000,” Hooman says — but the Brigham doctors found unexpected sarcomas in 10 out of 1,091 samples of tissue from women who’d undergone uterine morcellation — suggesting, the paper said, an “apparant associated increase in mortality much higher than appreciated currently.” That, Hooman says, is when he started to get “a little bit upset.”
And Penn and Harvard and Brigham had all trained Hooman to be cool, unafraid, to walk into rooms and tell strangers the last thing they wanted to hear.
“They made him this way,” Amy says with a shrug.
BACK IN NOVEMBER, there was a little article about Amy in the Inquirer. She’d bought a package of organic grapes at BJ’s in Langhorne and found a black widow spider inside. Amy recognized the potential danger. She and Hooman alerted the local media. A TV station sent a reporter. That made the couple laugh. “It took three months to get the media onto the morcellation story,” Hooman told the Inquirer. “We call them about a spider and they’re here.”
The only reason the media “got onto” the morcellation story was because of Hooman’s barrage of emails. He knows that a rare cancer spread by a gruesome process — he makes me watch a YouTube video of morcellation — isn’t an easy sell. “There are plenty of nut-jobs out there making phone calls and sending emails,” he says. But he sensed that he could use what had happened to Amy — smart, beautiful, young mother of six — to push for what he wanted: to have power morcellators banned, so that no other woman would ever go through what his wife was going through.
Along the way, he made some amazing discoveries. He found, for example, that there hadn’t been any pre-market testing of the morcellator in women with fibroids; the FDA didn’t require it. Morcellators had been grandfathered into use in the early 1990s via an expedited process in which devices deemed similar to ones already on the market are approved for other purposes without clinical trials. Morcellators became popular mostly because they made it easy for doctors to chop up fibroids inside the body and vacuum out the pieces.
There had been reports, in the years since the morcellator’s approval, that the devices sometimes scattered the tissue they were decimating. In the video Hooman showed me, a big hunk of fibroid breaks off from the whirling blades and lands atop the morcellator itself, perched like a cup of Dunkin Donuts on the roof of a car. In 1998 a medical journal reported on a scrap of morcellated fibroid that landed near a woman’s liver, requiring major surgery. There were other reports of bits and fragments that landed and grew. When morcellators are used for other types of operations, doctors regularly add an attached surgical bag to catch the cut-up tissue, so they don’t spread infection or something worse. But the FDA didn’t require the use of such bags. Johnson & Johnson, until recently the largest morcellator manufacturer — though it didn’t make the one used on Amy — recommended using a bag with the device when a malignancy was suspected. But it never manufactured such a bag, and it didn’t feature bags in its training. What were the chances of a woman with a fibroid having a hidden cancer? Ten thousand to one?
Still, there had been hints the risks might be greater. In 2006, a pathologist in Lewisburg, Pennsylvania, contacted the FDA expressing concern about cancerous cells he was finding in morcellated uterine tissue. His report fell through a crack in the system; because he didn’t cite an experience with a patient, it was labeled a “complaint” and didn’t trigger a review. A South Korean study in 2011 showed that morcellation of leiomyosarcoma more than doubled the death rate in patients compared to removing the tumor whole, but it only looked at 56 patients. Further studies confirmed those results, though. And then there was that peer-reviewed study by Brigham doctors, including Michael Muto, that examined 1,091 morcellation procedures and found the rate of sarcoma was much higher than previously believed — the study that got Hooman upset.
Hooman was proud to be a Brigham doctor. That and his Harvard teaching appointment were the culmination of a long, strange life’s journey. In the 1960s, his parents were part of “a generation of Iranian kids who got subsidized to get their educations here in the U.S., go back to Iran, and build the country,” he says. Hooman was born here before his parents returned to their homeland; when they did, they got stuck there, “under duress,” as he puts it, for 10 long years. The family was involved in anti-Islamic activities. An uncle was executed. He and his parents finally got out and back to the U.S. when he was 13.
“Iran was a country run by thugs,” he says now. “There was no concept of individual rights.” His life experience taught him to honor dissent. When he found out how dangerous morcellation was, “The way it played out in my head was, I’ll tell them and they’ll shut it down. This is Harvard! This is the most powerful medical establishment in the country.” If Harvard stopped using morcellators, everybody else would, too. The lives of thousands of women would be saved.
But it didn’t go that way. When the couple went through what Amy calls “the kumbaya sessions” at Brigham, she says doctors and administrators were soothing but noncommittal, saying, “We’re having a conversation with our malpractice insurers.” The liability experts had looked at the odds. The gynecological surgeons didn’t want to stop using the easier morcellation technique. They insisted it cut down on complications — that it was safer for patients. Except, of course, for those one in — what? Ten thousand? One thousand? — for whom it proved deadly instead.
A Boston physician who was a friend of the couple, Michael Paasche-Orlow, combed through medical journals and studies, searching for sarcomas that showed up after hysterectomies for fibroids. He found a lot more than he expected. When he analyzed 10 studies, he found that while a woman’s general risk of having a hidden uterine sarcoma morcellated is one in 10,000, among women whose fibroids caused symptoms severe enough for surgery, it was one in 415.
That number, plus Brigham’s reluctance to curtail the use of morcellators, convinced Hooman to go nuclear.
THERE’S A FRAMED PHOTO on a windowsill in Amy and Hooman’s living room from the day of their 2001 wedding. She’s in lacy white; he stands behind her, looking over her shoulder with a grin. When he first started with the emails, she wasn’t exactly on board. She thought his energy and time would be better spent on their children. And she worried about the effects of his campaign professionally. “This had huge implications for him,” she says. “I look at myself and wonder — would I have stood by me? I don’t know. People are just trying to make it in life, you know? Even our good friends … ”
“Everyone was standing on ceremony,” Hooman says.
“Doctors are very protective of other doctors,” Amy explains.
Hooman kept the emails flying. He wrote to morcellator manufacturers, medical societies, doctors at Brigham. He threatened to quit. He pulled his diplomas off the wall. Colleagues considered him mad with grief.
Amy, meanwhile, was examining her options. She did her own searches of medical literature, looking for the most aggressive treatment of her cancer she could find. In November of 2013, she underwent an unusual seven-hour operation known as a “Sugarbaker procedure,” named for the oncologist who developed it. Doctors sliced her open, removed bits of uterine tissue that had adhered to her bowel, cut out a leiomyosarcoma from her bladder (its presence showed the disease was already spreading), scraped suspicious-looking tissue from her other organs, then poured a heated chemotherapy mixture into her abdomen and sewed her shut. (Also removed: her gallbladder, appendix, ovaries and some supporting membranes.) After the mixture had sloshed around in her abdominal cavity for an hour and a half, doctors opened her back up and drained it away. She was hospitalized for more than a week, then had a brief respite before a six-month regimen of standard chemotherapy began.
And just then, finally, one of Hooman’s emails rooted, took hold. In December of 2013, the Wall Street Journal published a front-page article about morcellation that included Amy’s story. In January 2014, a British medical journal took note of her case in a piece on the process of approval for medical devices. In February, Michael Paasche-Orlow submitted his research paper to the FDA. The paper called for a moratorium on morcellator use, stating that its risks were “too high to be accepted as a standard of care.” With the publicity, more and more cases were coming to light. The Journal of the American Medical Association published an editorial on the dangers of morcellation. In mid-February, Temple University Hospital — whose CEO, Larry Kaiser, had been Hooman’s mentor at Penn — became the first U.S. hospital to tightly limit the use of morcellation, requiring containment bags. Other hospitals, including Brigham, soon did the same.
Also around that time, the FDA disclosed that it had been investigating whether the advantages of morcellation outweighed the risks. In response, gynecologic surgeons who relied on the procedure started a campaign of their own. The American College of Obstetricians and Gynecologists and the American Association of Gynecologic Laparoscopists argued that laparoscopic procedures were safer than abdominal surgeries because there were fewer complications and infections. Morcellation proponents considered Hooman to be overreacting. The vice president of ACOG, inadvertently hitting “Reply All” to one of Hooman’s mass emails in March of 2014, wrote, “As we have repeatedly said, nothing is going to create any ‘peace’ in this man.”
Then, in April, the FDA issued an advisory opinion that discouraged the use of morcellators for fibroid surgery. Its own review of the data showed the risk for undetected uterine sarcomas in women seeking fibroid surgery was one in 350. In July, Johnson & Johnson withdrew its morcellators from the market. Insurers, including Blue Cross Blue Shield, began refusing to pay for hysterectomies performed with the devices. In November, the FDA for the first time ever flexed its “Immediately in Effect” authority, bypassing public comment to put a black-box warning — its strongest possible — on morcellators and declare them contraindicated for removal of fibroids or uterine tissue. “The FDA decision today is based on what we believe is best for patients,” the agency’s chief scientist said.
Hooman and Amy had won.
ONLY THEY HADN’T WON, really. Because Amy still had cancer. And instead of joining what the couple considered a crusade to save patients’ lives, their fellow doctors were pushing back against these rogues in their midst. At Brigham, Hooman’s colleagues were told not to have any contact with him. “Until then, I never believed all of that stuff about repercussions for whistle-blowers,” Amy says.
“They were trying to shut me off,” says Hooman. “People were scared.” The final straw came when Amy returned to Boston for a follow-up operation to remove a new tumor. (By then the family had moved to Bucks County, to live in what Hooman calls “the triangle of love,” in the midst of Amy’s mom and two sisters.) When she and Hooman got to Brigham, they were searched. Then they were informed that a security guard would accompany Hooman while he was in the hospital. Amy was at her most vulnerable, and Brigham was doubling down. “I support my husband’s efforts,” she says today, “but I couldn’t have done it. When I found out what they were doing, I was frantic. His response was: Bring it on.” Hooman sought a restraining order against the hospital, charging retaliation for his emails. A judge agreed and ordered Brigham to lift the security. “It’s like a classic David and Goliath story,” Hooman says. “If they had stepped back for a moment and thought it out — did they really think I would back down?”
Hooman sees the conflict as one between medical ethics — that “do no harm” dictate — and the demands of corporate medicine as it’s practiced in America today, with analytics and cost-cutting and cramming in as many patients as you can. “What’s happened here is, an entire establishment is willing to say, ‘We’re going to take the collateral damage.’” So he’s expanded his reach. He’s convinced his Bucks County Congressman, Mike Fitzpatrick, and U.S. Senator Bob Casey Jr. to work to get Congress to change the process the FDA uses to approve medical devices, along with how manufacturers are required to report adverse events. Due to their efforts, the FBI began investigating whether hospitals and physicians who didn’t report leiomyosarcomas after morcellation violated federal law, and the Government Accountability Office is looking into the FDA approval process. Hooman compares the situation to a terrorist attack: “Say you have one woman in 350 over 20 years subject to an avoidable procedure. Their cancers get upstaged, and their lifetimes are shortened. That’s thousands of women. And the costs to the system are massive.” Amy’s hospital saved a few thousand bucks with a laparoscopic surgery, but her subsequent bills have totaled about a million dollars. “That’s why our insurance costs go up — because of this framework,” says Hooman. He sees pursuance of this grievance as his patriotic duty. “We are the system,” he says. “This goes to the heart of what government is for — to protect individual rights, property and health. The Declaration of Independence is a human-rights document. You can’t sacrifice a minority for the sake of the majority.”
Those are powerful words. But the truth is, we make such sacrifices all the time. That’s what’s behind the current battles over how often women should get mammograms and whether men should be screened for prostate cancer. For the vast majority of women, waiting an extra year between trips to the radiologist won’t make a difference. Insurers will save a ton of money. So could consumers. The delay will only matter to those one-in-how-many women whose cancers appear and spread in the interim. Morcellators really became doomed once insurance companies began refusing to pay for fibroid operations utilizing them.
And the Affordable Care Act, which was designed to pressure everyone involved in health care to tamp down costs, which emphasizes data-gathering and employs analytics to establish “best practices,” is one big game of “What Are the Chances?” That doesn’t mean it’s a bad law. It just codifies and encourages what medicine has always done. Last year, the FDA approved a new cystic fibrosis drug that costs $259,000 per patient, per year. Who should get it? Who should pay for it? “First, do no harm” to whom — the patient? The economy? The population at large?
HOOMAN AND AMY are on leave from their jobs now, staying home, striving to keep life as normal as they can between Amy’s operations and radiation treatments. “We have six children,” she says. “We have to decide what high school to send them to. We have sports, exams, deadlines, car payments.” Hooman keeps up the emails and phone calls — “I was just talking to Mike Fitzpatrick last night.” The Change.org petition Hooman set up calling for an end to gynecological morcellation is turning up more and more women who developed sarcomas after the procedure — and has more than 90,000 signatures. He and Amy have testified before the FDA. And they’ve expanded their efforts to other suspect medical devices. They’re working with the “E-Sisters” on fighting the makers of the Essure coil, a birth-control device that has caused organ perforation, pain and even death in some users. One woman had laparoscopic surgery with morcellation to remove her Essure implant. The morcellator spread an undetected cancer — the bad-luck equivalent of hitting the Powerball.
But Hooman is still finding plenty more targets to tilt at. And he — and Amy, when she’s able — are back where they first met, in the lab, hoping to find something, anything, that will help keep her alive.
The couple has filed a civil lawsuit in Suffolk County Superior Court against Brigham and Women’s, Michael Muto, Karen Wang and Karl Storz, the German manufacturer of the morcellator used on Amy. In their responses to the suit, Brigham, Muto and Wang deny any negligence and state that Reed was fully aware of the risks of her operation; at press time, Karl Storz had not yet filed a response.
Hooman and Amy acknowledge that one reason their efforts have borne fruit is that they were attacking the system from within. “One of the advantages we have,” says Hooman, tapping on his laptop at the kitchen table, “is that we know so many people. We’re plugged into the system. That’s not how it happens normally. People fall through the cracks.”
Amy, rooting in a toolbox for a screw-
driver to fix a cabinet handle, says wryly, “I fell through the biggest crack of all.” What she and her husband have been through would have crushed many couples. Instead — because of their personalities, their training, or perhaps very good counseling — they seem totally on the same page. When they discuss past disagreements, like how Amy didn’t want Hooman to go to Duke, it’s with an air of having moved past the emotion of the moment. Amy says she hopes to be able to treat her cancer as a chronic condition. She refuses to talk or even think about the odds. And despite the ways the medical community failed her, “I still believe the system rights itself,” she says. “But maybe not if my husband hadn’t pushed so hard.”After my visit, Hooman adds me to his email list. I’m swamped with a tsunami of his wrath, copied daily on messages of rebuke and recrimination. I read them, and I think of Amy rummaging in her toolbox, and I wonder: What are the chances I could be loved that way?
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J&J Ethicon Settling Morcellator Cancer Cases After Hysterectomy
Mar 19, 2016 | The Legal Examiner
By Shezad Malik MD JD
According to the Wall Street Journal, Johnson & Johnson (J&J) the world’s largest medical device and pharmaceutical company is settling personal injury and product liability lawsuits alleging that its now-recalled hysterectomy device injured women by spreading an undetected hidden cancer.
Court documents note that there are about 100 cancer spread cases after hysterectomy cases have either been filed or readied for filing against the J&J’s Ethicon unit, a subsidiary. The litigation is centered around a medical device known as the laparoscopic power morcellator.
According to sources J&J has settled nearly 70 cancer injury cases over the past few months, and several are in settlement discussions. J&J’s final settlement pay out on the cases will end up way past the hundred million dollar mark, by the time it is all said and done.
What are Power Morcellator Devices?
Power morcellators grind up fibroids which are benign growths in the uterus, so doctors can remove the chopped up or morcellated tissue through small incisions during a laparoscopic hysterectomy. Laparoscopic hysterectomy is a very popular procedure in the United States with several hundred thousand cases being performed annually.
Gynecological surgeons routinely used the devices before April 2014, when the U.S. Food and Drug Administration warned that women undergoing fibroid operations have a 1 in 350 chance of a uterine sarcoma that can’t be reliably detected before the procedure.
The FDA said that power morcellators can broadcast undiagnosed uterine cancer tissue within the abdomen and pelvis, significantly worsening a woman’s chances of long-term survival. Women who developed uterine cancer after hysterectomy, in many cases are facing a death sentence with an appalling 5 year survival, despite aggressive chemotherapy regimens which is usually ineffective.
Doctors used power morcellators in hundreds of thousands of hysterectomy procedures cases per year. J&J’s Ethicon unit had the largest morcellator share of the market, with over 70% of units used.
J&J Ethicon Morcellator Wrongful Death Claims
The plaintiffs have filed wrongful-death and product-liability claims against J&J’s Ethicon division alleging that the medical device giant company knew or should have known that the surgical tools sprayed undiagnosed cancer cells but didn’t take adequate action, and that the products were essentially a defective design because of the difficulty of differentiating a fibroid from a uterine sarcoma.
FDA Reluctantly Investigates
The FDA began looking into possible risks of laparoscopic hysterectomy surgery with the device after a 40-year-old anesthesiologist Amy Reed, went public in a Wall Street Journal article detailing her worsened cancer after a hysterectomy using the device.
Dr Reed has sued another morcellator maker, Karl Storz GmbH, in a case pending in a Massachusetts state court, as well as the Boston hospital and doctors involved in her care. Dr Reed, a mother of six who now lives in Philadelphia, has had multiple recurrences and continues to fight advanced metastatic cancer.
According to several medical experts, many women never had the chance to discover why they developed the deadly cancer and those they left behind have no idea what happened to them. There must be be hundreds of grieving families who to this date have not made the connection to the death of their loved one from post hysterectomy cancer and the deadly morcellator device.
Sad Stories of Unfinished Lives
One case that settled involved Molly Minihan, a Colorado woman who underwent a laparoscopic surgical procedure in April 2013. “During this surgery,” according to the lawsuit, “cancerous tissue was cut, shredded and spread throughout her body.”
According to Mrs Minihan’s attorney, “By December 2015, her uterine leiomyosarcoma had recurred twice despite chemotherapy, and she worried administrative delays would hurt her client and rob her of her day in court.”
In a separate case, Mona Eldin, a family doctor in Michigan, confirmed settlement of her case. Ms. Eldin, who is in her 40s, said that when she had a laparoscopic hysterectomy with morcellation for fibroids, her doctor never mentioned the possible risks of a hidden cancer.
The pathology of the macerated uterine tissue initially came back benign. Later retesting of the original tissue, after Ms. Eldin developed a malignant tumor, found that the tissue had been sarcoma all along, demonstrating another danger of morcellation, that the process of morcellation alters tissue samples. This alteration of the tissue during the grinding process can make the pathological diagnosis difficult.
Client Attorney Privileged/Attorney Work Product/At Request of Counsel
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