Preview Newsletter
Morcellation Media Monitoring 07/23/2015
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U.S. REP. MICHAEL BURGESS BLAMES DOCTORS, NOT FDA, FOR MEDICAL DEVICE'S DANGER
Jul 23, 2015 | The Dallas Observer
By Amy Silverstein
Congressman Michael Burgess, representing Denton and Tarrant Counties, is a former gynecologist, but that won't stop him from defending a medical device that's been known to spread cancer in women. The device is a tool called the power morcellator, which doctors have used in surgery to grind up benign uterine tumors, but not cancerous ones, supposedly. Doing that can cause the cancer to spread. -
Medical Research Bill with Device Safety Provision Passed
Jul 21, 2015 | Injury Lawyer News
By Katarina Siegfeld
A medical research bill with a device safety provision inspired by the controversy over power morcellator side effects passed the House of Representatives on July 10. While the bill as a whole includes several provisions encouraging federal funding for medical research and further regulations regarding the way medications receive approval, the amendment requires that the make or model number of a device used in medical procedures be incorporated into a patient’s records so that it can easily be traced if the need arises. -
FDA, Black Box Warnings and Morcellator Hysterectomy
Jul 21, 2015 | The Legal Examiner
By Shezad Malik MD JD
As the number of lawsuits filed against power morcellators increases across the United States, it is worthy to note the US Food and Drug Administration (FDA) response regarding the routine use of power morcellators during minimally invasive laparoscopic removal of uterus fibroids and hysterectomy. -
Gynesonics gets $43M to back pivotal trial of uterine fibroid ablation device
Jul 23, 2015 | Fierce Medical Devices
By Stacy Lawrence
One method of vanquishing uterine fibroids, power morcellation, is under close scrutiny from the FDA and insurers. That involves the internal cutting of the uterus--and the fibroids within it--in order to conduct a hysterectomy laparoscopically but it may spread cancer throughout the body if the fibroids are cancerous. -
Bill to Improve Safety Monitoring of Medical Devices Passes House
Jul 22, 2015 | The Legal Examiner
By M. Brandon Smith
A comprehensive medical research bill that passed the U.S. House of Representatives on July 10th includes a provision designed to improve the safety monitoring of medical devices. The amendment, proposed by Rep. Mike Fitzpatrick (R., Pa.), was inspired by a controversial gynecological device – the laparoscopic power morcellator. -
510(k) Reform on a High Wire
Jul 23, 2015 | Device Talk
By Jim Dickinson
As another 510(k) safety issue emerged in July and an injured-patients’ legislative 510(k) reform effort took an unexpected hit on Capitol Hill, the prospects for significant change in the status quo seemed to be wobbling on a high-wire act. The pivot-point is a basic question first presented by a controversial and widely ignored 2011 Institute of Medicine committee report that concluded that FDA’s 510(k) process “cannot be transformed into a premarket evaluation of safety and effectiveness as long as the standard for clearance is substantial equivalence to any previously cleared device.” It recommended scrapping the process and starting over. -
Morcellator Lawsuit News: Over 144 Deaths Since 2000 Involved Robotic Surgery
Jul 22, 2015 | The Digital Journal
By The Release Wire
Morcellator Lawsuit News: While robotic surgeries are being used more frequently in both men and women in minimally invasive surgeries, a new study has found that more than 100 patients have died over the past 14 years after robotic surgeries. The attorneys at Southern Med Law are highly aware of the risks of robotic surgeries after they have represented men and women in robotic surgeries lawsuits and are currently representing numerous women in morcellator lawsuits who have developed uterine cancer and even death after robot assisted hysterectomies involving uterince morcellation. -
Morcellator Lawsuits Grow, As Critics Indict Houses Rejection Of Medical Device Reforms, Tracey & Fox Reports
Jul 23, 2015 | KFJX Fox 14
By PressAdvantage
On July 10, 2015, the US House of Representatives passed the 21st Century Cures Act, a sweeping healthcare reform bill intended to accelerate innovative medical research. But critics representative of a growing movement, one devoted to ending the use of power morcellators, have roundly criticized the loss of several key amendments inspired directly by the morcellator crisis. -
Is Johnson & Johnson a Buy Now?
Jul 21, 2015 | The Motley Fool
By David Weinberg
Johnson & Johnson (NYSE:JNJ), the pharmaceutical giant known for such iconic brands as Band-Aid, Listerine, and Tylenol, recently reported second-quarter earnings with mixed results. Sales for the quarter were $17.8 billion, down a whopping 8.8% from the same quarter of 2014.
Client Attorney Privileged/Attorney Work Product/At Request of Counsel
Morcellation
Full Text of Stories Below
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U.S. REP. MICHAEL BURGESS BLAMES DOCTORS, NOT FDA, FOR MEDICAL DEVICE'S DANGER
Jul 23, 2015 | The Dallas Observer
By Amy Silverstein
Congressman Michael Burgess, representing Denton and Tarrant Counties, is a former gynecologist, but that won't stop him from defending a medical device that's been known to spread cancer in women.
The device is a tool called the power morcellator, which doctors have used in surgery to grind up benign uterine tumors, but not cancerous ones, supposedly. Doing that can cause the cancer to spread. Yet after two decades on the market, regulators realized that many doctors were mistakenly using the tool on women who did have cancer. Backlash against the device was led by Dr. Amy Reed, an anesthesiologist diagnosed with Stage 4 cancer after undergoing what was supposed to be minor surgery to remove her own benign uterine fibroids.
The Wall Street Journal has covered her case and others extensively; in 2014, healthcare company Johnson & Johnson pulled its product from the market. In March, the FBI began investigating Johnson & Johnson to see how much the company knew about the morcellator's hazards before the recall. Last year the FDA warned that women with uterine fibroids have a 1 in 350 risk of carrying cancer, and that most doctors should stop using the device.
For the outspoken Reed and others, that the morcellator stayed on the market for two decades before any regulators took any action is a sign of how broken the FDA's device-approval process is. It's a process, consumer advocates have agued, that gives manufacturers and Big Pharma too much freedom to get a new device approved at the expense of patient safety. Mike Fitzpatrick, a Republican congressman in Pennsylvania, recently took up the cause by proposing an amendment to a healthcare bill that, he said, would improve safety monitoring of medical devices. His inspiration for the amendment came from the power morcellators. "I think it's important to pause and to ensure we do not do more harm than good, given the experiences of thousands of women in just this one scenario," Fitzpatrick said in a Rules Committee hearing earlier this month.
But Fitzpatrick's suggestion was shot down by Texas' Burgess, who was still careful say that he does not use morcellators. "I did not or do use power morcellators in my practice," Burgess said, before offering a meek defense of the device anyway. Burgess said the problem with the device rested with doctors, who should be taught in medical school not to grind up suspicious tumors. "Every doctor who operates on the abdomen knows that if there is a Stage 1 encapsulated tumor," that disrupting the capsule could make the cancer spread, he said, adding later that "I think it was clinical judgement at fault, not the FDA's approval process."
In fact, the congressman expressed surprisingly warm feelings about the FDA, given his Tea Party affiliations. "My experience is the FDA has been good about recalling those devices when required. You don't think that's what happened in the case of the power morcellator, so be it."
Burgess has a received a few substantial campaign contributions from medical device-makers, including a $5,000 donation from Johnson & Johnson, the leading maker of the morcellator. Dr. Hooman Noorchashm, the wife of Amy Reed, is now asking Burgess in a Change.org petition for a meeting, "to explain to you the depth of your responsibility both as a United States congressman and a gynecologist."
Hyperlink to Rules Committee Hearing: https://www.youtube.com/watch?v=CtOqxdn90cw
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Medical Research Bill with Device Safety Provision Passed
Jul 21, 2015 | Injury Lawyer News
By Katarina Siegfeld
A medical research bill with a device safety provision inspired by the controversy over power morcellator side effects passed the House of Representatives on July 10. While the bill as a whole includes several provisions encouraging federal funding for medical researchand further regulations regarding the way medications receive approval, the amendment requires that the make or model number of a device used in medical procedures be incorporated into a patient’s records so that it can easily be traced if the need arises.
The medical device provision was sponsored by Rep. Mike Fitzpatrick of Pennsylvania who noted that information related to the device used in a procedure is not currently required as part of patient records and that this “makes it difficult to fully achieve the benefits to patient safety” where defective medical devices are concerned. Fitzpatrick said that he hopes to inspire a broader view about how medical devices in are approved and regulated.
Provision inspired by concern over morcellator side effects
Fitzpatrick notes that he was inspired to promote the amendment in response to problems with the power morcellator, a medical device used in gynecological surgery that appears to play a role in spreading cancer in some cases. The representative is a cancer survivor himself and states that “What happened with the power morcellator should never be allowed to happen again.”
Power morcellators are devices used to break down tissue removed during hysterectomies or myomectomies (surgery to remove uterine fibroid tumors) in order to facilitate minimally invasive versions of these procedures. While the use of morcellation has been touted as enabling operations that entail less bleeding, smaller incisions, and faster recovery times, small bits of undetected cancerous tissue may also be broken down and spread throughout the uterus or abdomen in the process.
A study published in Obstetrics & Gynecology earlier this year found that 1 in 368 women who have hysterectomies due to the presence of uterine fibroids actually have a previously unknown sarcoma, or kind of cancer, that could potentially be spread by the morcellator device.
FDA recommends morcellator restrictions
The FDA issued recommendations regarding power morcellators when it found similar statistics: 1 in 350 women undergoing uterine fibroid tumors have a uterine sarcoma risk. Such statistics prompted the administration to suggest that far fewer women undergo uterine procedures using the devices.
Guidelines governing the use of morcellators stipulate that they not be used for women over 50, for women who have been given tamoxien or pelvic radiation, for women who test positive for BRCA mutations, or for women who have other risk factors for uterine cancers. The FDA also added that surgeons should use small bags to catch any bits of cancerous material that may escape during the procedure and spread disease in the abdomen. Finally, they advise manufacturers to add boxed warnings and contraindications to the labels of such products.
While a number of individuals have called for an outright ban on the power morcellator, the FDA continues to see benefits to their use in certain circumstances.
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FDA, Black Box Warnings and Morcellator Hysterectomy
Jul 21, 2015 | The Legal Examiner
By Shezad Malik MD JD
As the number of lawsuits filed against power morcellators increases across the United States, it is worthy to note the US Food and Drug Administration (FDA) response regarding the routine use of power morcellators during minimally invasive laparoscopic removal of uterus fibroids and hysterectomy.
FDA Black Box Warning for Power Morcellators
The FDA has dinged laparoscopic power morcellators with the strongest warning possible, requiring the morcellator medical devices to have a black box warning concerning the risk of using power morcellators.
FDA Notes Increased Risk of Uterine Cancer Spread
According to the FDA, most women should not undergo a laparoscopic power morcellation hysterectomy because of the risk of spreading undiagnosed uterine cancer.
The FDA issued the black box warning in November 2014, alerting patients, doctors and hospitals about the risk of spreading unsuspected uterine cancer, which can sharply reduce the affected patient’s survival chances.
FDA: Power Morcellator Hysterectomy Contraindications
Contraindications were also included on the warning label, including that the laparoscopic power morcellator should not be used in women who are peri- or post-menopausal or who could have the uterus tissue removed intact, and those women in which the uterus tissue being morcellated is known or suspected to be cancerous.
The FDA stated, “Based on a quantitative analysis of currently available data, the FDA estimated that approximately 1 in 350 women who are undergoing hysterectomy or myomectomy for fibroids is found to have an unsuspected uterine sarcoma.
If laparoscopic power morcellation is performed in these women, there is a risk that the procedure will spread the cancerous tissue within the abdomen and pelvis, significantly worsening the patient’s likelihood of long-term survival.”
Since the black box warning, many doctors and hospitals had stopped using the morcellator. HCA Holdings, a company that runs almost 300 hospitals and medical centers in the US and England, has banned morcellators in its facilities
What is Power Morcellator Hysterectomy?
Power morcellator devices are used in minimally invasive laparoscopic procedures to remove fibroids, benign uterine tumors and during hysterectomies.
What is the problem with Power Morcellator Hysterectomy?
The major problem is that benign fibroids may harbor hidden or undiagnosed uterine sarcoma (a cancer). Morcellators grinds the uterine tissue with powerful blades, so it can be removed. But in that grinding process, the cancerous uterine tissue may spread through the abdomen.
In the case of uterine sarcoma, which cannot be diagnosed prior to surgery, the uterine tissue is a very aggressive cancer, resulting in a spreading of the cancer, which had been previously localized.
The FDA stopped short of an outright ban. The FDA noted that there are other options for women with uterine fibroids, including traditional surgery, laparoscopic hysterectomy and myomectomy without morcellation.
Power Morcellator Litigation
There are at least 22 lawsuits pending across 16 federal courts, alleging personal injury, wrongful death and product liability complaints against several manufacturers of power morcellators. All the plaintiffs claim that the devices caused the spread of uterine cancers during a laparoscopic hysterectomy or myomectomy, removal of benign fibroids.
Plaintiffs are requesting to centralize cases brought in the federal court system before U.S. District Judge Kathryn H. Vratil in the District of Kansas. The major manufacturers all oppose centralization of the litigation into a multidistrict litigation, stating that it would be impracticable and that there are not enough cases to justify it. A hearing is set for October, over whether to grant a power morcellator MDL.
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Gynesonics gets $43M to back pivotal trial of uterine fibroid ablation device
Jul 23, 2015 | Fierce Medical Devices
By Stacy Lawrence
One method of vanquishing uterine fibroids, power morcellation, is under close scrutiny from the FDA and insurers. That involves the internal cutting of the uterus--and the fibroids within it--in order to conduct a hysterectomy laparoscopically but it may spread cancer throughout the body if the fibroids are cancerous.
An alternative method of treating symptomatic uterine fibroids may be about to make its way through the FDA. Gynesonics has received $43 million from investors to support the clinical development of its Sonata System, which uses radiofrequency energy to ablate fibroids under intrauterine sonography guidance in a transcervical procedure that preserves the uterus.
The FDA gave the startup the go-ahead in October to start an IDE pivotal trial for the system; it is already CE-marked and sold in Europe. The company expects that Sonata could become the primary treatment option for symptomatic uterine fibroids.
The company sees the financing as an acknowledgement of "the large, underserved women's healthcare market and the significant unmet need for a safe and effective uterus-preserving, incision-free option for the treatment of symptomatic uterine fibroids," said Gynesonics President and CEO Christopher Owens in a statement. "We will continue to aggressively pursue our goal of establishing the Sonata System as the preferred choice of physicians and patients worldwide."
The financing was co-led by new investor Endeavour Vision, as well as existing investor Abingworth. Also participating were HealthCrest, InterWest Partners, Advanced Technology Ventures, HBM Partners, Correlation Ventures, and Hercules Technology Growth Capital, as well as an undisclosed "multi-national medical technology company."
"Endeavour Vision's newest fund is dedicated to transformational technologies in medical devices and digital health," said Endeavour Operating Partner Robert O'Holla in a statement. "We are pleased that our first investment from our med tech growth fund will support a company with the potential to make a significant improvement in the lives of millions of women globally who suffer from symptomatic uterine fibroids."
He added, "Sonata's potential to reduce the need for the large number of invasive procedures, such as hysterectomy, currently used to treat fibroids was compelling, especially as studies suggest women are increasingly looking for uterine-preserving, incision-free treatment options." Last September, Endeavour had a first close on a dedicated med tech fund of €89 million ($105 million).
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Bill to Improve Safety Monitoring of Medical Devices Passes House
Jul 22, 2015 | The Legal Examiner
By M. Brandon Smith
A comprehensive medical research bill that passed the U.S. House of Representatives on July 10thincludes a provision designed to improve the safety monitoring of medical devices. The amendment, proposed by Rep. Mike Fitzpatrick (R., Pa.), was inspired by a controversial gynecological device – the laparoscopic power morcellator.
The amendment is part of the bill known as the 21st Century Cures Act, which among other things, aims to increase federal funding for medical research and change the drug approval process. The provision will require unique device identifiers, information such as the make or model number of devices used in treatment, to be included in medical records so that patient harm can be more closely monitored.
Currently, these identifiers are not incorporated into all electronic health records, although the Food and Drug Administration (FDA) issued a guidance document in 2014 recommending that labels of medical devices include unique device identifiers and planned to phase the system in over the next several years. Supporters of the amendment said the provision would hopefully speed up the process.
Although there is no parallel bill in the Senate, Senator Lamar Alexander (R., Tenn.), the chairman of the Senate health and education committee, has commented that he hopes to get a measure through his panel by the end of 2015 and onto the Senate floor in 2016.
What are Power Morcellators?
Morcellators are medical devices that are used during minimally invasive laparoscopic hysterectomy and myomectomy procedures. The devices are used in thousands of procedures each year, and allow surgeons to grind up the uterus or uterine fibroids and remove the tissue through a small abdominal incision, with minimal scarring and reduced recovery time.
But because there is no definitive way to diagnose uterine cancer before using morcellator devices, when the tissue is ground up, the undetected cancer cells can be spread, leading to rapid upstaging of the disease. As a result the morcellator lawsuits are starting to increase as more and more women and their families realize the effects of these deadly devices.
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Jul 23, 2015 | Device Talk
By Jim Dickinson
As another 510(k) safety issue emerged in July and an injured-patients’ legislative 510(k) reform effort took an unexpected hit on Capitol Hill, the prospects for significant change in the status quo seemed to be wobbling on a high-wire act.
The pivot-point is a basic question first presented by a controversial and widely ignored 2011 Institute of Medicine committee report that concluded that FDA’s 510(k) process “cannot be transformed into a premarket evaluation of safety and effectiveness as long as the standard for clearance is substantial equivalence to any previously cleared device.” It recommended scrapping the process and starting over.
The long-slumbering rationale for introducing untested, redesigned, and new devices as “substantially equivalent” to pre-1976 predicates was next most visibly raised by Pennsylvania cardiac surgeon Hooman Noorchashm whose wife, physician Amy Reed, had suffered a pelvic cancer explosion from a power morcellator used in a routine hysterectomy.
He convinced their local congressman, Republican Mike Fitzpatrick, to introduce a battery of amendments to the 21st Century Cures Act that would, among other things, impose a requirement to prove safety on 510(k) submissions to FDA.
These were swiftly killed in the House Rules Committee by fellow Republican and ex-gynecologist Michael Burgess from Texas, on the grounds that any harms coming from morcellators were due to deficiencies in the state-regulated practice of medicine, not in the federally-regulated medical device clearance for marketing process.
“In this instance, I think that it was clinical judgment that was at fault, not the FDA approval process,” Burgess said dismissively, ignoring the nationwide nature of the morcellator tragedies.
Just as this was happening, a new 510(k) safety issue was being raised for the first time in a JAMA Internal Medicine meta-analysis by five cardiologists that highlighted dire clinical consequences of off-label uses of SentreHeart’s 510(k)-cleared Lariat Suture Delivery Device.
With its associated devices it has become popular in an off-label surgical technique to prevent stroke by sealing the left atrial appendage, a pouch-like region of the left atrium of the heart, in patients with atrial fibrillation.
The cardiologists’ alert came from an analysis they conducted of adverse events reported in four private sector databases from January 2007 through August 2014 plus 45 adverse events reported to FDA’s online MAUDE database.
The reports they found, the five wrote, “describe six patient deaths and other serious medical complications including laceration and/or perforation of the heart, complete LAA detachment from the heart, bleeding (hemorrhage), low blood pressure (hypotension), fluid collection around the heart (pericardial effusion), fluid collection around the heart that causes low blood pressure and decreased heart function leading to shock (cardiac tamponade), and fluid collection around the lung (pleural effusion). Of the 45 adverse events reported to the FDA, 34 (approximately 75%) resulted in the need to perform emergency heart surgery.”
As the industry- and FDA-disparaged IoM committee report found, there have been numerous other, if less-dramatic, indictments of the 510(k) process and its failure to demand evidence of new device safety.
Surely, only the ideologically blinded or uninformed (or both) can fail to see that a 39-year-old statutory mechanism such as Sec. 510(k) could slowly, almost imperceptibly become fossilized to a lethal degree by the dizzying pace of technological advancement.
Precisely this point was made in a July 17 New York Times op ed by University of California San Francisco cardiologist Rita F. Redberg and Yale University clinical scholar Sanket S. Dhruva.
Writing that today’s device regulatory oversight has not kept pace with increasingly complex technology advances, they slammed the “disingenuously titled” 21st Century Cures Act for enabling high-risk device makers to submit anecdotal safety and effectiveness data and even lower-quality clinical evidence to FDA than is currently required.
Echoing earlier criticisms from former FDA commissioners David Kessler and Margaret Hamburg, they also charged that the bill as passed (overwhelmingly) in the House would shift evidence collection to the postmarket period for many devices, but these postmarketing studies are often delayed for a long time or not completed.
Some might wonder how industry advocates can be so quick in one breath to tout the “next generation” technological innovativeness of the newest devices and then in the next breath claim, in the rush to market, the same products’ scientific backwardness for purposes of regulatory review under Sec. 510(k).
Safety assumptions reasonably made in 1976 have been unable to withstand the assault of scientific developments in a creaky FDA regulatory world of coerced, unwritten interpretational elasticity.
Largely hidden from public view, this world cloisters the post-submission CDRH review of 510(k)s and the sometimes fractious horse-trading that can go on behind the scenes between sponsor and reviewer. Unlike the public PMA process, 90% of 510(k) devices go to market automatically, usually without FDA announcement or explanation.
Rarely does this furtive process burst negatively into the open, as it did a few years ago when FDA admitted that it had wrongly approved ReGen Biologics’ Menaflex collagen scaffold on the basis of inadequate scientific evidence and that the device had been intended by its sponsor “to be used for different purposes and is technologically dissimilar from devices already on the market, called ‘predicate devices.’”
At the time, FDA’s October 14, 2010 news release contended that the Menaflex episode was “unique” and did not implicate any other devices—yet now there emerges the Lariat study involving a substantially equivalent issue: off-label use of a 510(k)-cleared device. In both cases the intended uses of the devices in medical practice were not studied for safety.
Neither was the power morcellator’s intended use—just as the overwhelming majority of other 510(k)-cleared devices all escape safety assessments for their intended uses as well.
Until Rep. Burgess’ intervention, Noorchashm and his large Internet network expected the incubating 21st Century Cures Act would be a vehicle to correct this.
They still hope for this and have not yet folded their tents. But a change of direction will be needed, since the realities of politics on Capitol Hill make it unlikely that Burgess will change his mind, or that Fitzpatrick will keep plugging away at what now must seem a lost cause.
A slender chance exists on the Senate side, where Health and Education Subcommittee chairman Lamar Alexander (R-TN) has said he hopes to get a measure similar to the House’s 21st Century Cures Act through his panel before the end of the year.
However, any such multi-faceted legislative initiative has multiple pitfalls to navigate. In this case, increased funding for the National Institutes of Health is a contentious issue in the Senate that could delay or even defeat 510(k) reformers again.
So as the political season heats up for the coming elections, the prospects for 510(k) reform on the safety front look increasingly like a high-wire act, notwithstanding continuing action by the injured patient community.
Congress, after all, responds first to interests with deep pockets for campaign funding—unless public uproar in a particular district or state puts re-election at stake. Those deep pockets are not the constituencies clamoring for 510(k) reform.
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Morcellator Lawsuit News: Over 144 Deaths Since 2000 Involved Robotic Surgery
Jul 22, 2015 | The Digital Journal
By The Release Wire
Birmingham, AL -- (ReleaseWire) -- 07/22/2015 -- Morcellator Lawsuit News: While robotic surgeries are being used more frequently in both men and women in minimally invasive surgeries, a new study has found that more than 100 patients have died over the past 14 years after robotic surgeries. The attorneys at Southern Med Law are highly aware of the risks of robotic surgeries after they have represented men and women in robotic surgeries lawsuits and are currently representing numerous women in morcellator lawsuits who have developed uterine cancer and even death after robot assisted hysterectomies involving uterince morcellation.
Southern Med Law has recently settled the first morcellator cancer lawsuit in the country involving a 53-year-old Pennsylvania woman who died after undergoing a robot-assisted hysterectomy with uterine morcellation. Researchers from MIT, Rush University Medical Center, and University of Illinois at Urbana-Champaign, reviewed over 10,000 adverse events reports filed with the U.S. Food and Drug Administration (FDA) regarding robotic surgery from 2000 to 2013. According to the study, there were 144 patient deaths, 1,391 patient injuries and 8,061 device malfunctions reported to the FDA. Researchers said little or no information was provided in the reports for the majority of death events. Researchers concluded that "despite widespread adoption of robotic systems for minimally invasive surgery, a non-negligible number of technical difficulties and complications are still being experienced during procedures."
[arxiv.org/ftp/arxiv/papers/1507/1507.03518.pdf, 2015]
"This study supports the power morcellation claims in power morcellator lawsuits filed on behalf of women who either developed cancer or died as a result of undergoing a robot-assisted gynecological surgery in which a power morcellator was used," said Dr. Francois Blaudeau, a founder of Southern Med Law.
As stated by the law firm and the FDA, laparoscopic power morcellators are used in minimally invasive and robot-assisted hysterectomies and these devices have the potential to spread cancer during the surgery. When used to remove the uterus or uterine fibroids, power morcellators grind the uterine tissue into small fragments so that they can be removed through small incisions in the abdomen. However, when uterine tissue may have undetected cancer cells, the power morcellator can disseminate the cancer cells into the abdominal or pelvic cavity where they can be spread throughout a woman's body.
The controversy surrounding laparoscopic power morcellators was instrumental in prompting U.S. House Rep. Mike Fitzpatrick, R-Pa. to offer an amendment to a bipartisan bill regarding approval of drugs and medical devices. According to a Wall Street Journal report, Rep. Fitzpatrick's amendment is designed to improve safety monitoring of medical devices by requiring patients' medical records to include the make and model number of medical devices that were used in the event that patients are harmed by the devices during treatment. The 21st Century Cures Act, which was passed earlier this month, proposes to speed up the federal government's process for approving drugs and medical devices.
[wsj.com/articles/house-passes-bill-to-improve-safety-monitoring-of-medical-devices-1436736213, July 12, 2015]
The law firm comments that the injuries alleged in complaints regarding power morcellators have lead the FBI to launch an investigation into power morcellators. According to a Wall Street Journal report, the FBI is investigating whether Johnson & Johnson, the largest power morcellator manufacturer, and its Ethicon division hid the potential cancer risks associated with their power morcellators from U.S. health regulators and the medical community, and how long they knew that their Ethicon power morcellator surgical devices purportedly carried a cancer risk. Johnson & Johnson suspended sales and distribution of power morcellators after the FDA warned in April 2014 against using the devices in hysterectomies and for removing uterine fibroids.
[wsj.com/articles/fbi-is-investigating-surgical-device-1432746641, May 27, 2015]
Dr. Blaudeau was recently involved in settling a power morcellator lawsuit that was filed on behalf of Scott Burkhart, a Pennsylvania widower whose wife died of disseminated leiomyosarcoma in February 2013, after having a power morcellator hysterectomy. According to the power morcellator lawsuit, there was no evidence of disseminated cancer in Donna Burkhart prior to her robot-assisted hysterectomy that occurred March 6, 2012. Donna Burkhart was diagnosed with the aggressive leiomyosarcoma just 9 days after having surgery. The morcellator lawsuit contends that power morcellator manufacturers, LiNA Medical APS, Kebomed AG & LiNA Medical US, failed to adequately warn about the cancer risk associated with power morcellators. The terms of the settlement were not disclosed. (Case No. 5:14-cv-1557, U.S. District Court, Eastern District of Pennsylvania)
About Southern Med Law
Southern Med Law is a patient and consumer advocacy organization providing legal representation to the victims of negligent personal injuries, medical malpractice, dangerous drugs, faulty medical devices and defective products. Led by Dr. Francois Blaudeau, an attorney and a practicing obstetrician/ gynecologist, the legal staff at Southern Med Law possesses a deep understanding of the complex medical and legal questions at issue in all manner of product liability and personal injury claims. They're not afraid to take on the nation's largest corporations in their pursuit of justice, and are committed to ensuring that all victims have access to the type of aggressive legal advocacy that assures success. -
Jul 23, 2015 | KFJX Fox 14
By PressAdvantage
July 22, 2015 – /PressAdvantage/ – On July 10, 2015, the US House of Representatives passed the 21st Century Cures Act, a sweeping healthcare reform bill intended to accelerate innovative medical research. But critics representative of a growing movement, one devoted to ending the use of power morcellators, have roundly criticized the loss of several key amendments inspired directly by the morcellator crisis.
Sean Tracey, Esq., lead partner at Tracey & Fox, says the so-called Fitzpatrick Amendments promised to reform the way in which medical devices were approved and monitored after approval, but were dropped from the Act before its passage. “Only now that morcellator cancer lawsuits are being filed and public outcry has brought this tragedy to the nation’s attention, are we getting a true picture of how many women’s lives have been cut short by power morcellators. The damage done over twenty years is unimaginable,” Tracey says, “but it’s even more shocking that American legislators have failed to pass these necessary reforms.”
Amy Reed, MD, PhD and Hooman Noorchashm, MD, PhD have become vocal leaders in the effort to ban power morcellation completely. After undergoing a hysterectomy in which a power morcellator was used to grind “fibroid” tissue, Reed, an anesthesiologist in Philadelphia, was diagnosed with uterine cancer. She quickly learned that morcellation had spread her leiomyosarcoma, a cancer that develops in soft tissue, worsening her prognosis. Boston’s Brigham and Women’s Hospital, where Reed’s procedure took place, publicly acknowledged the role morcellation played in “upstaging” her cancer, and agreed to stop using the dangerous devices in 2014.
Eventually, the US Food & Drug Administration would caution surgeons to avoid using power morcellators in the majority of women undergoing fibroid removal procedures. In a statement sent to ABC News, the agency recognized Reed for having brought the safety risks of morcellation to their attention. As hospitals began to limit or stop utilizing morcellators, and health insurers restricted coverage for procedures involving the device, Reed’s advocacy appeared to be spearheading a real shift in the healthcare industry.
“21st Century Cures” was to be the next step, an Act intended to reform the FDA approval process. Introduced to the House of Representatives on May 19, 2015, the Act contained several amendments written by Mike Fitzpatrick, a Republican congressman from Pennsylvania and cancer-survivor himself. Noting major deficiencies in the FDA’s medical device approval process, and citing the continued use of power morcellators as a case example, Fitzpatrick urged the House to support a “modernized” system for medical device postmarket surveillance, that would “allow [industry and government] to catch issues like the power morcellator faster.”
In a statement delivered before the House of Representatives on June 17, 2015, Fitzpatrick continued: “Unfortunately, it’s becoming clear that the reporting system for faulty and deadly devices is broken.” He noted a Wall Street Journal investigative report that found Johnson & Johnson, once the world’s largest manufacturer of power morcellators, had been alerted to the device’s severe risks as early as 2006. “It took the FDA and industry nearly a decade to come to the same conclusion.”
Fitzpatrick’s full statement before the House can be found here.
But on July 8, one day before the House was set to vote on “21st Century Cures,” all but one of the Fitzpatrick Amendments were rejected. In a Hearing of the House Rules Committee, Congressman Michael Burgess, a Republican from Texas and former gynecological surgeon, framed the morcellation crisis as a problem caused not by inadequate FDA oversight, but by inadequate physician education. While Fitzpatrick agreed that physicians should have used morcellators more cautiously, he took issue with the FDA’s 510(k) Approval Process.
510(k), what Fitzpatrick referred to as an “expedited” process, allows the FDA to approve new medical devices quickly if a substantially similar “predicate” device has already been approved. Fitzpatrick noted that the first power morcellator had been approved twenty years ago, when the risk of a woman harboring an unsuspected uterine cancer was estimated to be approximately 1 in 10,000. “That number was wrong,” Fitzpatrick testified, “the number that’s being discussed today is 1 in about 350 [...] Once we determine it’s doing more harm than good, how is the public notified? How’s the FDA notified? And what’s the process to reach back and say that one particular [predicate] device needs to be recalled?”
Reed and Noorchashm, in an editorial published by the Philadelphia Inquirer, say that Fitzpatrick’s call to action fell on deaf ears, noting that 7 out of the Congressman’s 8 amendments failed to pass. Sean Tracey continues to offer free legal consultations to women who believe that a power morcellator procedure spread an undetected uterine cancer. He routinely advises patients injured by dangerous medical devices on their legal rights and options. For more information, call 713-495-2333.
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Is Johnson & Johnson a Buy Now?
Jul 21, 2015 | The Motley Fool
By David Weinberg
Johnson & Johnson (NYSE:JNJ), the pharmaceutical giant known for such iconic brands as Band-Aid, Listerine, and Tylenol, recently reported second-quarter earnings with mixed results. Sales for the quarter were $17.8 billion, down a whopping 8.8% from the same quarter of 2014.
As was the case in the first quarter of this year, the majority of the decline was due to foreign exchange issues, with 7.9% of the decline being directly attributable to currency fluctuations. Earnings, however, exceeded second-quarter results from last year -- the company earned $4.5 billion and $1.61 per share this year compared to $4.3 billion and $1.51 per share last year.
On the heels of these results, the company increased its guidance for 2015. J&J now expects per-share earnings for the year to be in the $6.10 to $6.20 range, an increase from earlier estimates of $6.04 to $6.19. Investors did not seem all that impressed by the change in guidance, however, as the company's stock price declined 0.5% the day of this announcement.
Revenue from all three of the company's divisions (consumer products, medical devices, and pharmaceuticals) saw quarterly declines year over year.
Declines in the pharmaceuticals division, which is the most important of the three business segments, were also a result of the enormous, but anticipated, sales decline for J&J's now essentially obsolete hepatitis C drug, Olysio, due to the superiority of Gilead Sciences' Harvoni. Along with drugs becoming obsolete, J&J investors may also be concerned about impending patent cliffs, especially for the company's top-selling drug, Remicade, which holds a massive 75% market share in the U.S. IV immunology marketplace. The Remicade patent has already expired in Europe, and the drug should have patent protection until 2018 in the U.S.; however, J&J's stranglehold on this marketplace may be in jeopardy sooner than that. Time will tell if ongoing litigation surrounding this patent is resolved in the company's favor.
Regardless, Remicade sales continue to grow -- second-quarter sales in the U.S. jumped by 6.6%. Two other drugs, rheumatoid arthritis drug Simponi and psoriasis drug Stelara, also helped offset the lost revenue from Olysio by increasing their sales this quarter by 30% and 9%, respectively.
The king is dead, long live the king
To mitigate concerns about Remicade and the patent expirations for the company's other top-selling drugs, J&J has many new drugs on the horizon. The company's research and development group has several potential blockbuster drugs in the pipeline, 10 of which the company believes have the possibility of becoming $1 billion drugs.Two of the drugs, daratumumab for the treatment of multiple myeloma and esketamine for patients with treatment-resistant myelofibrosis, are being fast tracked by the FDA. While the future in the drug sector may seem bright, the same can't be said for the medical devices division.
Left to its own devices
There is concern in the medical devices division as sales figures declined for the fourth consecutive quarter, exclusive of currency issues, and there doesn't seem to be much growth on the horizon in the division, especially as noncore segments are divested. While slowing sales growth may be somewhat troublesome, there are potentially larger issues involving possible litigation from product recalls for various hip and knee replacement devices.There's also an ongoing FBI investigation into the company's power morcellation surgical device, which was used to perform some 50,000 hysterectomies annually. Consequently, investors need to be mindful of potential legal expenses tied to lawsuits that Johnson & Johnson will inevitably encounter.
Truly an aristocrat
Thanks to strong free cash flow, the company's dividend remains strong. J&J increased its dividend earlier this year by more than 7%, marking the 53rd consecutive year that it has increased its dividend. It is a member of an elite group of just 10 companies in the S&P 500that have increased their annual dividend payouts for 50 years or more.This distinguished achievement marks J&J as a Dividend Aristocrat, a company that can be viewed as a reliable anchor for retirees seeking dependable dividend income. It also may be a good investment for anyone seeking a company that's currently paying a dividend yielding 3% -- roughly 50% higher than the S&P 500's own yield.
Is Johnson & Johnson a buy now?
While I view Johnson & Johnson as an excellent long-term investment and a company that will continue to provide its investors with solid dividend payouts each and every quarter for many years to come, I would not be looking to invest in this company today. Presently, I view it as fairly valued, and while many investors may be willing to invest in such companies, I am always looking for bargains.I'm typically looking to invest in companies when they are priced 20% below their fair value estimate. The 20% discount is not a hard-and-fast rule; after all, fair value estimates are just that -- estimates. Occasionally I make exceptions for truly great companies like Johnson & Johnson, and might consider making investments when such companies are priced 10%-15% below their fair value.
I have been a longtime J&J investor and expect to be one for many years to come. However, because the stock is currently priced almost exactly at what I see as its fair value, I won't be adding any new money now. I'll just continue to be a content investor, happily cashing those quarterly dividend checks, hopefully for another 53 years.
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