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Morcellation Media Monitoring 06/04/2015
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FBI Investigating Hazards of Power Morcellators
Jun 3, 2015 | The Legal Examiner
By Steven Davis
The FBI is currently investigating the power morcellator, a controversial surgical tool that has been alleged to spread dangerous uterine cancers in women during gynecological procedures. -
Moving on Medical Device Surveillance
Jun 1, 2015 | MD+DI Device Talk (blog)
By Jim Dickinson
Although Congress has so far sidelined the issue of medical device surveillance in its wide-ranging 21st Century Cures legislation, other actors have emerged to keep it on Washington device watchers’ front burner. -
Johnson & Johnson: Scary News Offers Opportunities To Increase Dividend Income For Retirement
Jun 1, 2015 | Seeking Alpha
Johnson & Johnson (NYSE:JNJ) has been in the news lately and the news has sent the share price lower, actually hitting $99.75 last Friday. This is the lowest we have seen in a while and it nudged the dividend yield up over 3% for this dividend aristocrat. -
Morcellator manufacturer investigated by FBI
Jun 3, 2015 | Contemporary OB/GYN
By Judith M. Orvos ELS, Miranda Hester
What manufacturer Johnson & Johnson (J&J) knew about the safety of its morcellators and when is the subject of an investigation by the Federal Bureau of Investigation (FBI), according to several news reports. Coverage by The Wall Street Journal and The New York Times cites interviews with several individuals who spoke to the FBI as part of the probe but both accounts indicate that the agency itself refused to comment.
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Morcellation
Full Text of Stories Below
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FBI Investigating Hazards of Power Morcellators
Jun 3, 2015 | The Legal Examiner
By Steven Davis
The FBI is currently investigating the power morcellator, a controversial surgical tool that has been alleged to spread dangerous uterine cancers in women during gynecological procedures.
According to a May 27 report in the Wall Street Journal, three individuals have admitted that the FBI questioned them within the past few months about the surgical devices, which are used to grind up uterine tissue for removal through small incisions during hysterectomies and myomectomies.
Johnson & Johnson Apparent Focus of FBI Probe
Johnson & Johnson was the largest manufacturer of the power morcellator until last year when it pulled the device off the market after the Food and Drug Administration warned that women undergoing fibroid surgery or hysterectomy have a one in 350 chance of having uterine sarcoma, a cancer that cannot be consistently detected during pre-op screening. The FBI is reported to be focusing the investigation on J&J’s knowledge of the device’s risks, although a J&J spokesperson said the FBI has not yet contacted the company.
The people that FBI agents have allegedly interviewed include:A retired pathologist who in 2006 notified J&J of potential issues concerning morcellators in 2006;A Pennsylvania doctor who is pushing a morcellator ban after her own cancer was spread by morcellation in 2013; andA California woman who has compiled a list of nearly 400 patients and their families allegedly injured by the surgical tool.
Morcellators Once Used Extensively in Surgical Procedures
Morcellators were previously used in thousands of minimally invasive procedures each year, mainly in hysterectomies, and work by grinding up uterine tissue or fibroids for easy removal through a small abdominal incision. However, if uterine sarcoma is present, morcellation may spread the malignancy and cause it to upstage rapidly, making it more difficult to treat and severely jeopardizing the patient’s chances for survival.
Power morcellator lawyers are currently filing cases on behalf of women that believe the power morcellator spread or upstaged their cancer.
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Moving on Medical Device Surveillance
Jun 1, 2015 | MD+DI Device Talk (blog)
By Jim Dickinson
Although Congress has so far sidelined the issue of medical device surveillance in its wide-ranging 21st Century Cures legislation, other actors have emerged to keep it on Washington device watchers’ front burner.
Chief among these is the FBI which, while law makers in the waning days of May focused on rescuing intrusive NSA surveillance programs, was reported to have opened an investigation into what Johnson & Johnson knew about the cancer-spreading abilities of laparoscopic power morcellators, and when.
Like other law enforcement agencies, including FDA’s own Office of Criminal Investigations, the FBI famously does not confirm or deny the existence of an ongoing investigation—and J&J itself said it knew nothing of this one.
But “surveillance” being the buzzword of the moment, people to whom the FBI turned in its inquiries have publicly confirmed the FBI investigation’s existence.
These included Sara Robinson, a Los Altos, CA physician’s assistant who told the Wall Street Journal she had sent a list of 382 women and families of women, including herself, who believe their cancer was worsened by morcellators to an FBI agent on April 3.
Another who confirmed the FBI investigation’s existence was morcellator patient and Philadelphia anesthesiologist Amy Reed who, with her husband Hooman Noorchashm, a cardiologist, has been leading a highly visible campaign to ban the devices and goad Congress into beefing up postmarket surveillance of 510(k)-cleared devices.
Both Reed and Noorchashm told the Philadelphia Inquirer they had been interviewed by FBI agents, and believe the bureau is looking into whether manufacturers failed to report deaths and serious injuries to FDA as required by law. Noorchashm said the FBI’s focus seemed to be on how much J&J’s Ethicon division “knew and, despite knowing, how it continued marketing” its morcellator.
J&J voluntarily withdrew its morcellator from the market last July, after FDA issued new safety warnings, but other companies did not.
Significantly, however, retired Pennsylvania pathologist Robert W. Lamparter told the New York Times and other news outlets that he told the FBI about a warning he had sent to Ethicon in 2006 about the morcellator’s cancer-spreading potential.
That’s eight years of continued marketing of a device the company knew, or to use a well-worn legalism, should have known was potentially lethal. FDA’s own statistics say one in 350 uses of power morcellators spreads cancer in women’s bodies.
For its part, J&J has been telling the news media that after Lamparter raised his concerns the company added new language to the device’s labeling and that it had already been recommending that where cancer was suspected surgeons should use a special bag with the morcellator to remove fibroid tissues.
Lamparter called this a “legal fig leaf” in a telephone interview with the New York Times, adding that J&J-provided training for gynecologists at his hospital “did not substantially change after he raised his alarm.”
All this pertains to perceptions of potential culpability on the part of J&J and other morcellator makers, and is no doubt the focus of the FBI’s ongoing investigation.
It also pertains to an apparently growing grassroots medical practitioner interest in the safety of medical devices generally—an issue that gets short shrift in the main regulatory portal for device entry to the marketplace, Sec. 510(k) of the Food, Drug and Cosmetic Act.
Despite Noorchashm’s—and a growing number of other—knowledgeable efforts to beef up the evidence of safety and postmarket surveillance aspects of 510(k), there is still little discernible interest on Capitol Hill or at FDA in doing so.
But a groundswell may be coming.
As news of the FBI investigation began spreading, visiting scholar Elisabeth K. Wynne at the Brookings Institute’s Center for Health Policy added her voice to calls for better medical device surveillance.
“For the majority of medical devices,” she wrote, “there is little to no data on the reliability, quality, or effectiveness of that device after it is released on to the market. Information gathered during the clinical trial stage is extremely useful; however, it often fails to answer many potential treatment and clinical use questions that arise, as a new medical device is widely available for patient use.”
A general surgeon from St. Louis, MO, Wynne referenced a recent collaborative report with FDA, her center, and other private sector parties to build a national system to capture postmarket safety and effectiveness information about medical devices.
Such “real-world evidence,” she wrote, “will allow us to evaluate important questions such as the quality of the device, short and long term outcomes, comparative effectiveness across devices of the same type, and how the devices work in subpopulations such as age, gender, or race.”
Wynne’s call is at the opposite end of the same continuum that Noorchashm, Reed, Lamparter and Robinson are all involved in: improved medical device surveillance.
At a time when terrorism-focused surveillance has become a Washington obsession that is likely to reach new heights in the coming election season, medical device surveillance may be swept along in its wake. FDA and other public safety agencies have unified roles in both arenas, albeit for different reasons.
At one end of the continuum, Wynne and her colleagues see a private-sector solution to medical device surveillance for improved safety and effectiveness, while at the other, Noorchashm et al see a legislative solution: revising Sec. 510(k) to include an evidence of device safety component and a postmarketing surveillance regulatory component.
They’re not mutually exclusive, but it has to be said that with the 21st Century Cures Act having already begun to leave the station without addressing 510(k) requirements, the private sector solution might have brighter prospects than the legislative one.
Indeed, on the narrow morcellator safety issue, the prodigious efforts of Noorchashm et al in conjunction with FDA’s labeling recommendations last year have seen pretty rapid success in the private sector through the deletion of coverage for this procedure by a growing number of health insurance plans along with associated lawsuits.
For many, this would be enough, but Noorchashm and Reed are not stopping. In a May 27 email to their network in the wake of media reports about the FBI investigation, they wrote:
“The FBI has risen to investigate an egregious violation of federal law leading to the loss of lives across the United States and abroad from corporate and professional negligence.
“It is time for the United States congress to rise and definitively secure the medical device regulatory space for patients. The FDA's Center for Devices and Radiological Health stands compromised and mission-corrupted.
“We await a loud and public response from the United States congress and the White House - many unsuspecting families have been harmed.”
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Johnson & Johnson: Scary News Offers Opportunities To Increase Dividend Income For Retirement
Jun 1, 2015 | Seeking Alpha
Summary
- Johnson & Johnson always seems to have "scary" news around it.
- In an industry that virtually is at the forefront of everyone's mind (healthcare), it always gets headlines.
- To the delight of DGI investors, it offers opportunities to add more share or open a position at higher dividend yields.
Johnson & Johnson (NYSE:JNJ) has been in the news lately and the news has sent the share price lower, actually hitting $99.75 last Friday. This is the lowest we have seen in a while and it nudged the dividend yield up over 3% for this dividend aristocrat. As I stated in the collaborative panel effort by Mike Nadel, JNJ is the one stock I would own if I only had one stock to choose from.
Here are the unedited words I used to explain my position:
"Human beings are always focused on health or health products to help us live our lives with more quality and length. Johnson & Johnson will always have a "consumer", will always have a massive assortment of products for today and into the future for every and any stage of life. The pipeline will continue to grow to either meet unmet medical needs or make those needs increasingly easier to manage, for a better quality of life. The dividend aristocrat status is more than impressive and this sector is where I would want to own a proven winner. If there was one company I would want to own forever, and only one selection, for my money it has to be JNJ."
I refer you to my "must-own" article on JNJ, which goes into great detail about this extraordinary company. Value investors can scream all they want about how JNJ will not perform the same as it did 53 years ago when it began paying and increasing dividends every consecutive year since, and they could be correct. Actually, with the advances in the healthcare sector, JNJ has the clout, money, and brand to grow even faster in my opinion.Bad News Moves The Stock
At the time I wrote the article on JNJ being a must-own stock for dividend growth investors, the share price was over $104.00. Today it is about $100/share due in large part to the following headlines:
JNJ Earnings Off 9% And Lowers Guidance
- Johnson & Johnson (JNJ) Q1 results ($M): Total Revenues: 17,374 (-4.1%); Consumer: 3,390 (-4.7%); Pharmaceutical: 7,726 (+3.0%); Med Devices & Diagnostics: 6,258 (-11.4%).
- Sales growth has decelerated last three quarters in Pharmaceuticals: U.S.: 36.6%, 33.1%, 22.7%, 16.9%; International: 6.8%, 2.8%, -2.7%, -10.7%.
- Sales growth also decelerating in global business: 9.1%, 5.1%, -0.6%, -4.1%.
- Product leaders: Imbruvica: 116 (+999%); Concerta/Methylphenidate: 224 (+49.3%); Xarelto: 441 (+38.2%); Stelara: 549 (+20.4%); Simponi/Simponi Aria: 300 (+15.8%).2015 Guidance: EPS: $6.04 - 6.19 from $6.12 - 6.27
None of those bullet points outlined by our SA news staff are pretty to look at, and here is another one that sent shivers down JNJ investors' spines:
JNJ in FBI's crosshairs over power morcellator
- The FBI is investigating what Johnson & Johnson knew about the hazards of its laparoscopic power morcellator before it pulled it off the market in July of last year. The FDA warned the medical community last November that the device, which was used to cut up uterine fibroids for removal through tiny incisions in the abdomen, could increase a woman's risk of cancer. According to the agency, women undergoing fibroid surgery have a one in 350 chance of harboring uterine sarcoma. The cutting action of the morcellator blades could contribute to the spread of the cancer cells to other parts of the body.
- The FBI has interviewed a retired pathologist who alerted the company in a letter about the potential risk in 2006 and a California woman who has collected ~400 names of patients and families who may have been harmed by the device.
- Company spokesman Matthew Johnson confirmed the pathologist's 2006 letter and added that the firm revised its operating instructions as a result, adding to language already present which cautioned about the potential spread of suspected malignant tissue.
- The FBI also interviewed a Pennsylvania anesthesiologist who underwent the procedure in 2013 at a Boston hospital. The hospital acknowledged that it worsened her cancer in addition to another patient the year before.
Tell me that the FBI is investigating ANYTHING and I am going to have a serious look at it, even if it is JNJ. That being said, the SA news staff encapsulated what Wall street was aware of and these two events over-shadowed some positives that the company reported and sent the share price to a rapid 5% decline, which enabled the yield to skip over 3% and this DGI'er (me) took advantage of the dip with a filled limit order of $99.90 on Friday. Truth be told the average share price in my own personal account is much lower but that will not stop me from picking up a few more shares with dry powder, to increase my overall income.
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Morcellator manufacturer investigated by FBI
Jun 3, 2015 | Contemporary OB/GYN
By Judith M. Orvos ELS, Miranda Hester
What manufacturer Johnson & Johnson (J&J) knew about the safety of its morcellators and when is the subject of an investigation by the Federal Bureau of Investigation (FBI), according to several news reports. Coverage by The Wall Street Journal and The New York Times cites interviews with several individuals who spoke to the FBI as part of the probe but both accounts indicate that the agency itself refused to comment.
The FBI, it appears from the interviews, is attempting to determine whether J&J knew more about possible hazards of power morcellation than it reported before taking its device off the market. In April 2014, the Food and Drug Administration (FDA) issued a safety communication discouraging use of power morcellation during hysterectomy or myomectomy for fibroids because of concern about risk of inadvertent spread of unsuspected cancer to abdominal and pelvic cavities. Three months later, J&J removed its morcellation device from the market. The FDA estimates that approximately 1 in 350 women undergoing hysterectomy or myomectomy for treatment of fibroids has an unsuspected uterine sarcoma.
The actions by FDA and J&J followed a nationwide campaign to ban morcellation, led by a patient with an unsuspected sarcoma who underwent the procedure and whose disease spread. She, her husband, and a pathologist who was not involved in her case have been interviewed by the FBI, according to The New York Times account. The Wall Street Journalsaid that J&J has acknowledged correspondence with the pathologist, and that “his concerns spurred the company to revise its instructions for the [morcellation] device.” The patient’s husband reportedly contacted an FBI agent because he “suspected that morcellator manufacturers and some doctors and hospitals using the devices had violated a federal law requiring that adverse events be reported to the FDA,” said The New York Times report.
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Morcellation
Full Text of Stories Below
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