The FBI is investigating whether Johnson and Johnson was aware that a surgical device it manufactured could spread cancer in the women on whom it is used.
The FBI is investigating whether Johnson and Johnson was aware that a surgical device it manufactured could spread cancer in the women on whom it is used.
Johnson and Johnson is one of the leading manufacturers of the power morcellator — a surgical device that breaks down growths in the uterus so that they can be easily removed. However, in as many as one out of every 350 cases, an unknown cancer is hidden within growths, and the device could potentially worsen the condition.
Johnson and Johnson may have been alerted to to the risks as early as 2006. The company didn’t remove the device from the market, however, until July 2014. In November of that year, the U.S. Food and Drug Administration implemented its most serious warning on the device.
In that FDA warning, the agency noted that the device could “significantly [worsen] the patient’s long-term survival.”
The agency urged against the use of power morcellators.

Children’s Hospital Colorado launched the largest fundraising campaign in its history Thursday, hoping to bring in $400 million for pediatric research, clinical-care improvements and statewide partnerships and initiatives.
The scope of “Courage Is … The Campaign to Transform Children’s Health” outstrips even the $273 million that the hospital raised in 2007 to help it move from Denver to its current location on the Anschutz Medical Campus in Aurora.
Officials, who already have gathered $190 million of their target total, hope to bring in the rest of the money by the end of 2018.
Rather than going to construction of a new building, as many hospital fundraising campaigns do, the money will go to ongoing efforts that officials believe will keep the facility ranked among the top children’s hospitals in the country.
Those include breakthrough research into disease cures, the ability to treat more children and local partnerships offering preventive services and advocacy for children’s health across Colorado.
“Courage is, to me, the connective tissue that brings together all of the young patients and families in need, all of the caring health professionals, all of the technological marvels, and all of the pioneering research at Children’s Hospital Colorado,” said Steve Winesett, president and CEO of Children’s Hospital Colorado Foundation. “It is through philanthropy that we all can courageously partner in transforming pediatric healthcare.”
Officials announced the campaign at a ceremony that included hot-air balloons and a performance by "American Idol" winner Phillip Phillips.

Max Healthcare Institute Ltd (MHC) has inked agreements to acquire 76 per cent stake in NCR-based Pushpanjali Crosslay Hospital for Rs 287 crore.
"Max Healthcare Institute Ltd. has executed definitive agreements on May 28, 2015 to acquire a controlling stake of 76 per cent in NCR based Pushpanjali Crosslay Hospital (PCH) through a combination of fresh investment and acquisition of shares from existing promoters for an aggregate sum of Rs 287 crore," diversified group Max India said in a filing to BSE.
MHC is an equal joint-venture between Max India and Life Healthcare, South Africa, with both shareholders holding 46 per cent stake each in it, said the filing.
The 340-bed Pushpanjali Crosslay is located along the East Delhi-Ghaziabad-Noida corridor. It has the capacity to expand up to 540 beds and is NABH and NABL accredited. It has been operational since 2010, Max India said.
The hospital had reported revenue of Rs 143 crore at an EBIDTA margin of 14 per cent in FY 2014.
Max India stock was trading at Rs 469.05, down 2.32 per cent, on the BSE.

European private equity firm Cinven has agreed to buy French medical diagnostics provider Labco SA for 1.2 billion euros ($1.31 billion), a person familiar with the deal told Reuters.
The deal could be announced as soon as Thursday, the person said.
A buyout deal for Labco comes two weeks after the company abandoned plans for a 545 million euro initial public offering on Euronext Paris, citing "volatility across global financial markets."
Cinven and Labco could not be reached immediately for comment.
Labco registered net sales of 650 million euros for 2014, with earnings before interest, taxation, depreciation and amortisation at 131 million euros and EBITDA margin at about 20 percent, according to the person familiar with the matter.
The Financial Times first reported the deal.

An award-winning business supplying specialist devices for paediatric, neonatal, and adult intensive care is being lined up for a reverse takeover.
Inspiration Healthcare, of Earl Shilton, looks set to join forces with AIM-listed, Rotherham medical equipment supplier Inditherm.
The reverse takeover will see Inditherm buy the entire share capital of the privately owned Leicestershire business.
Inditherm said the move will strengthen its position as a technology supplier to the NHS and overseas markets.
Reverse takeovers allow private companies like Inspiration to become publicly traded without resorting to an expensive initial public offering.
Shares in Inditherm initially doubled following today's announcement.
Its chairman Mark Abrahams said: "We have believed for some time that there is underlying value in Inditherm, but the combination of small scale and overhead costs have been a constraint.
"This transaction has the potential to unlock shareholder value and represents an excellent outcome to our review of strategic options which we have undertaken over the last year."
Inspiration was founded in 2003 and provides critical care and surgical products in more than 40 countries, including the UK, USA, Russia, Canada and India.
It has a range of own-branded critical care products and has a technical support business maintaining and repairing medical equipment.
In the year to January 31 it recorded revenue of £9.5 million – compared to £8.8 million a year earlier.
Earnings before tax and other costs were £1 million, compared to £600,000 the previous year.
Overseas sales account for a third of the company's business and several million pounds in turnover.
Last month it won the International Trade Award at the Leicester Mercury Business Awards.
The deal will depend on approval by Inditherm shareholders at a general meeting of the company on June 23.
The reverse takeover values Inspiration at £7.2 million, and the new company will be named Inspiration Healthcare Group plc.
Inditherm said Inspiration has an unbroken track record of year-on-year sales growth since 2003, while its range of own-branded critical care products complemented Inditherm's existing range.

Boston-based PureTech Health plans to raise $160 million in a London listing, filling its coffers to fund product development and delivering a vote of confidence in the British life sciences sector.
The move by the U.S. health technology firm follows a similar decision by California-based drug discovery group Verseon to raise $100 million in London earlier this month.
PureTech's high-profile board includes former Sanofi (SASY.PA) chief executive Chris Viehbacher, Pearson's (PSON.L) one-time CEO Marjorie Scardino and John LaMattina, a past research head at Pfizer (PFE.N).
The planned initial public offering (IPO) on the main market of the London Stock Exchange is expected to happen in June, the company said in a statement on Tuesday.
The group specializes in building a portfolio of early-stage science and technology in the healthcare sector, typically from academia, and nurturing these ideas into commercially viable businesses.
The focus is particularly on the convergence of new technologies in the healthcare space. Many traditional tech companies, such as Google (GOOGL.O) and Apple (AAPL.O), are now investing in health, leading to new opportunities for merging different approaches to treating patients.
"With the acceleration of scientific discovery and the convergence of new and disruptive technologies being applied to life sciences, we believe the healthcare industry is on the cusp of a major transformation," said CEO Daphne Zohar.
PureTech currently has 12 operating companies which are actively developing technologies.
The proceeds of the London fundraising will help PureTech take its most advanced product candidates to the revenue-generating stage.
PureTech, which seeks to maintain high ownership in its operating companies and currently has a 76 percent average shareholding in its businesses, has already raised $250 million in past private fundraisings.

Medical device company SI-BONE raised $21 million in growth capital financing on Tuesday to treat lower-back pain. In addition, the company named a new chief financial officer: former Auxogyn executive Laura Francis.
New investor Redline Capital Management led the round, with participation from all existing major investors, including OrbiMed Advisors, Montreux Equity Partners, Skyline Ventures and Novo A/S. The company has raised $61.1 million to date.
Chief Medical Officer Mark Reiley co-founded San Jose-based SI-BONE in 2008 to pioneer the use of the iFuse Implant System, a minimally invasive surgical device indicated for fusion for certain disorders of the sacroiliac joint, located in the pelvis. Now run by CEO Jeffrey Dunn, the company will use the funds to further expansion in the U.S. and Europe in anticipation of increased demand.
"I could not be more excited to welcome Laura to the SI-BONE team,” Reiley said in a press release welcoming Francis to the company. “She has extensive corporate finance experience in both large and small, public and private, companies. This, coupled with her experience with acquisition transactions in global markets and managing a successful public offering, will help us achieve our growth goals in the coming years."
Prior to joining SI-BONE, Francis served as CFO for Auxogyn, a venture-backed life science startup headquartered in Menlo Park. Prior to Auxogyn, she was vice president of finance, CFO and treasurer for Promega Corp., a privately held life sciences company.
SI joint dysfunction has been linked to up to 30 percent of cases of low back pain. The demand for SI joint fusion operations is expected to grow from 8,000 surgeries in 2014 to 50,000 per year by 2020, according to the company, citing a study by iData Research's 2014 SI joint fusion market report.
Medical device companies have been a hot investment in Silicon Valley in the past couple months. Outset Medical raised $60 million just last week. Autonomic Technologies raised $38 million and AEGEA raised $36 million earlier this month, while Scanadu and EBR Systems raised $35 million and $20 million, respectively, in April.

Chinese regulator probes Siemens healthcare role in bribing hospitals to buy expensive disposable products
A Chinese regulator investigated Siemens AG last year over whether the German group's healthcare unit and its dealers bribed hospitals to buy expensive disposable products used in some of its medical devices, three people with knowledge of the probe told Reuters.
The investigation, which has not previously been reported, follows a wide-reaching probe into the pharmaceutical industry in China that last year saw GlaxoSmithKline Plc fined nearly $500 million for bribing officials to push its medicine sales.
China's State Administration for Industry and Commerce (SAIC) accused Siemens and its dealers of having violated competition law by donating medical devices in return for agreements to exclusively buy the chemical reagents needed to run the machines from Siemens, the people said.
Reuters was unable to determine whether Siemens had denied the accusations or if any action was taken against the company or the dealers.
A senior spokesman for Siemens in Germany said he was "not aware" of the investigation and declined to comment on specific questions about the investigation.
"We are not aware of any situation that conforms to what you describe," said Germany-based spokesman Matthias Kraemer in response to questions emailed to Siemens in China and to the group's headquarters. He declined to comment further.
SAIC declined to comment.
China-based lawyers said it was not uncommon for regulators to conduct investigations behind closed doors and for legal teams to then negotiate settlements to keep probes under wraps.
The Siemens investigation, which involved as many as 1,000 hospitals, could signal further probes into other medical device makers, one of the sources said. It comes as Beijing pushes hospitals to use more locally-made medical devices and reduce a reliance on imports that account for three-quarters of a Chinese market worth around $34 billion.
Other foreign medical device firms operating in China include General Electric, Koninklijke Philips, Medtronic and Johnson & Johnson.
"COMMERCIAL BRIBERY"
SAIC accused Siemens and its dealers of having committed "commercial bribery" under Article 8 of the Anti-Unfair Competition Law, the sources said, and the regulator took a tough line on a practice that, while technically illegal, is relatively common in China's healthcare sector.
Chinese medical institutions are prohibited from accepting donations under conditions that impede fair competition or otherwise affect procurement decisions, according to China's National Health and Family Planning Commission.
The three people, two of whom have direct knowledge of the investigation, asked not to be named. The third works closely with Siemens' healthcare team in China and was briefed on the investigation.
Medical device makers work closely with their dealers, and contracts to sell equipment to hospitals are usually signed by both the manufacturer and the distributor. The Siemens investigation involved a range of medical devices, including those used to carry out blood tests, the sources said.
Reuters was unable to ascertain which dealers were involved.
Siemens had China sales of 6.44 billion euros ($6.94 billion) in 2014, around 8 percent of its total. It employs 32,250 people in China, where it also has units operating in sectors from railways to energy.

Varian Medical Systems, Inc. and Flatiron Health, inc. said that under a strategic alliance, they will develop the the next generation of cloud-based, electronic health record or EHR, data analytics and decision support software for cancer care providers around the world.
Together, the companies will build upon their existing respective software platforms to deliver a cloud-based integrated medical oncology, radiation oncology and data analytics product suite.
As a first step in the collaboration, both companies will offer customers OncoEMR, Flatiron Health's cloud-based medical oncology EHR. Later this year, OncoEMR will be made seamlessly interoperable with Varian's award-winning ARIA oncology information system, now in use at over 3,800 cancer centers around the world.

DENTSPLY International Inc., a global leader in professional dental products, today announced that it has reached agreement with the applicable works councils in Germany to proceed with restructuring portions of its laboratory business, consistent with its earlier announcement of September 17, 2014. The realignment of the lab business is designed to increase emphasis on innovative prosthetic materials while exiting portions of the lab equipment and fabrication businesses. The majority of this restructuring effort will be implemented during the remainder of fiscal 2015 and 2016.
The Company expects to incur total costs in the range of $33 to $38 million related to this initiative, the majority of which are expected to be recorded in the fiscal second quarter of 2015.  It is anticipated that approximately 85% of these costs will be cash outlays, including costs related to severance and employee related obligations.  This initiative impacts certain manufacturing operations from two sites in Germany, one of which will be closed and another that will be downsized.  The Company noted that this action is part of its broader efficiency program and the anticipated impact was included in the adjusted earnings guidance as previously provided (which excludes restructuring charges).