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Medical Devices

FEATURED ARTICLES
BUSINESS
December 8, 1998 | By Andrea Ahles, INQUIRER STAFF WRITER
Bionx Implants Inc. shot its way into the stock market in April 1997 with a product called the Meniscus Arrow, which investors and analysts seemed to think had tremendous potential for profitability. Analysts estimated that the medical-devices company in Blue Bell would reach $33 million in revenue this year, compared with only $5 million in 1996. Bionx stock reached a high of $31.88 in February. But when the company announced in March that it expected its sales for the first two quarters to be $1 million to $2 million less than originally anticipated because of increased competition, the sell-off of its stock began.
NEWS
June 10, 2016 | By Jonathan Tamari, Washington Bureau
WASHINGTON - The medical procedure was supposed to help Amy Reed. Instead, it spread cancer through the Bucks County woman's body, and helped spark a national fight that arrived at the Capitol on Wednesday. With Reed and her family looking on, two lawmakers rolled out bills to increase oversight of medical devices like the one that harmed her. Reed, an anesthesiologist from Yardley, had a hysterectomy in 2013 to address what doctors thought were benign growths in her uterus. Her doctors used a power morcellator to chop up her uterus.
BUSINESS
July 25, 2012 | By David Sell, Inquirer Staff Writer
Generic competition - a billion-dollar problem for brand-name drug companies since the 1980s - is making inroads in the orthopedic-medical-devices industry. Last week, Cardinal Health Inc., one of the three biggest device wholesalers, said it was increasing its offering of lower-cost products for broken bones. This nascent trend, borne of increasing pressure to control health-care costs, represents a direct threat to brand-name device-makers, such as West Chester-based Synthes, which was bought in June by Johnson & Johnson for $19.7 billion.
NEWS
August 4, 1989 | By Kenneth J. Cooper, Inquirer Washington Bureau
Makers of various medical devices violated federal law by not reporting seven deaths and more than 100 serious injuries associated with their products in recent years, a consumer group alleged yesterday. The Public Citizen Health Research Group, founded by Ralph Nader, also criticized the Food and Drug Administration for failing to prosecute any companies for violating the reporting law, which took effect in late 1984. FDA documents obtained by the group indicated that 35 companies did not report seven deaths, 109 serious injuries and 265 malfunctions related to their products between December 1985 and June 1988.
NEWS
February 27, 2008
The Supreme Court stripped away a key consumer health protection for Americans last week by granting legal immunity to makers of federally approved medical devices, such as joint prosthetics, breast implants and defibrillators. As a result, injured patients who want to sue for damages in state court are basically out of luck. The impact from the high court's decision was immediate. Hours after the ruling, a state court judge in Florida asked attorneys with cases involving Johnson & Johnson's drug-coated Cypher heart stent whether the lawsuits should continue.
BUSINESS
April 5, 2012 | By David Sell, Inquirer Staff Writer
The emerging market for generic medical devices is the backdrop for a legal fight between Synthes Inc., and several former employees who created a company to sell similar products for less money. Headquartered in Switzerland but with facilities in Chester County, Synthes is a global leader in selling plates, rods, screws, and power tools to fix broken bones, which is why Johnson & Johnson has agreed to pay $21.3 billion for Synthes. Yearly global medical-device sales amount to about $300 billion and, with aging populations in developed nations, the market isn't going away.
BUSINESS
July 20, 2005 | By Thomas Ginsberg INQUIRER STAFF WRITER
Johnson & Johnson Inc.'s growing reliance on medical devices over pharmaceuticals paid off in the second quarter, helping to boost revenue 11 percent over a year earlier, the company said yesterday. J&J, which is based in New Brunswick, N.J., and has several subsidiaries in the Philadelphia area, said net income rose to $2.68 billion, or 89 cents a share, from $2.46 billion, or 82 cents, in the same period a year ago. The growth was powered mostly by a 20 percent increase in sales of medical devices and diagnostics, to $4.9 billion.
LIVING
July 24, 1995 | By Sue Chastain, INQUIRER STAFF WRITER
It's a phenomenon nearly everybody has experienced: You turn on the hair dryer, and suddenly there's snow on the TV set. Or you're using your cellular phone and you unexpectedly pick up local radio, or a stranger's conversation. It's called electromagnetic interference (EMI), and it refers to the fact that electrical devices emit electromagnetic energy that can interfere with other devices. Most of the time, this is nothing more than a momentary annoyance. However, if the device being disrupted is a piece of life-saving medical equipment - say, a pacemaker - the potential consequences can be far more serious.
NEWS
July 18, 2008 | By Richard Golomb
More than 200 years ago, America's greatest patriots convened to write a document that would empower us all with inalienable rights, liberties and freedoms. But on this past Monday in Philadelphia, the cradle of the Constitution, drug and medical-device companies met to unilaterally rewrite this contract and remove one of its most important pillars: the right to trial by jury. And to pour salt on the wound, a high-ranking official inside the Food and Drug Administration, the government agency tagged with protecting the public from dangerous drugs and devices, was a featured speaker at this meeting.
BUSINESS
June 23, 2009 | By Miriam Hill INQUIRER STAFF WRITER
Synthes Inc. handpicked the surgeons. The West Chester maker of orthopedic products also paid for the doctors' travel to training sessions in San Diego and Charlotte, N.C. There, company employees explained how to use their new bone-mending cement to fix a type of spinal fracture that afflicts hundreds of thousands of people yearly, most of them elderly. Federal prosecutors alleged in an indictment of the company last week that these training sessions were a dangerous, illegal, and less expensive substitute for clinical trials required by the Food and Drug Administration.
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ARTICLES BY DATE
NEWS
July 15, 2016
By Michael T. Hamilton Pennsylvania, one of the first colonies-turned-states to declare unalienable a person's right to life, must act soon to avoid becoming one of the last states to secure for terminally ill patients the right to try to save their own lives. It is natural for people to try to extend their lives and improve their quality of life, and it is fitting for people whose lives are at risk to do all they can to save themselves. Most will agree people have a fundamental right to do so, provided they exercise this right without encroaching on the rights of others.
NEWS
June 10, 2016 | By Jonathan Tamari, Washington Bureau
WASHINGTON - The medical procedure was supposed to help Amy Reed. Instead, it spread cancer through the Bucks County woman's body, and helped spark a national fight that arrived at the Capitol on Wednesday. With Reed and her family looking on, two lawmakers rolled out bills to increase oversight of medical devices like the one that harmed her. Reed, an anesthesiologist from Yardley, had a hysterectomy in 2013 to address what doctors thought were benign growths in her uterus. Her doctors used a power morcellator to chop up her uterus.
NEWS
May 27, 2016 | By Marie McCullough, Staff Writer
Over the last 15 years, the Food and Drug Administration has approved numerous high-risk women's health devices based on weak clinical studies, including some that showed no effectiveness, according to an analysis by Northwestern University researchers. Using the FDA's database, the researchers looked at all 18 high-risk devices approved between 2000 and 2015, including products for fetal monitoring, contraception, and reducing abnormal uterine bleeding. Of the 18, four devices did not demonstrate effectiveness, six were not required to conduct postmarketing safety studies, and three have been withdrawn from the market by makers because of safety or other problems.
NEWS
April 17, 2016 | By Chad Terhune, KAISER HEALTH NEWS
The number of potentially deadly infections from contaminated medical scopes is far higher than what federal officials previously estimated, a new congressional investigation shows. As many as 350 patients at 41 medical facilities in the U.S. and worldwide were infected or exposed to tainted gastrointestinal scopes from Jan. 1, 2010, to Oct. 31, 2015, according to the Food and Drug Administration. A separate Senate investigation released in January found 250 scope-related infections at 25 hospitals and clinics in the U.S. and Europe.
BUSINESS
February 27, 2016 | By Chris Mondics, Staff Writer
For much of his congressional career, U.S. Rep. Mike Fitzpatrick focused on policy issues from national security, to taxes, to health care. Medical device safety wasn't high on the list. But that changed in 2014 when Fitzpatrick had a chance meeting with cardiac surgeon Hooman Noorchashm and his wife, Amy Reed, an anesthesiologist, during a Christmas parade in Yardley. Noorchashm and Reed approached Fitzpatrick and in an hour-long talk in the chilly rain told him the disturbing story of how a widely used device called a power morcellator had spread an aggressive uterine cancer through Reed's abdomen during a hysterectomy.
NEWS
February 20, 2016 | By Chad Terhune, KAISER HEALTH NEWS
As superbug outbreaks raised alarm across the country last year, a prominent doctor at Fox Chase Cancer Center wrote in a leading medical journal about how to reduce the risk of these often-deadly patient infections. Jeffrey Tokar, director of gastrointestinal endoscopy, pointed to recent outbreaks from contaminated medical scopes, and discussed steps doctors and hospitals could take to ensure patient safety, in his Sept. 22 article in the Annals of Internal Medicine. "Health-care facilities and providers should strive to establish an environment of open information exchange with patients about what is being done to maximize their safety," Tokar and his two coauthors wrote.
BUSINESS
February 4, 2016 | By Jane M. Von Bergen, Staff Writer
Jay Timmons was preaching to the choir in GlaxoSmithKline's sun-drenched lobby at its Navy Yard offices. Timmons, who heads the National Association of Manufacturers, emphasized the value of manufacturing, expressed concerns about what he described as business-stifling regulation and overtaxation, and stressed the importance of introducing young people to careers in manufacturing. His audience of about 60 manufacturers, business association officials, and consultants didn't sing out any amens - it wasn't that kind of crowd that gathered Tuesday to hear Timmons' talk as part of his nationwide 2016 State of Manufacturing tour.
BUSINESS
January 21, 2016 | By Joseph N. Distefano, Staff Writer
Johnson & Johnson plans to cut about 3,000 employees, or 1 in 20, from its global medical-device workforce in hopes of saving up to $1 billion in yearly costs. The drug and medical-supply company will use that money to invest in "new growth opportunities," J&J said Tuesday. In a statement to employees, J&J said the cuts would "accelerate its pace of innovation. " The company expects a pretax restructuring charge of up to $2.4 billion by 2018, including $600 million later this year.
NEWS
January 13, 2016 | By Marie McCullough, Staff Writer
Thousands of women around the country who claim harm from Essure sterilization coils hope a federal judge in Philadelphia will allow five lawsuits to proceed against manufacturer Bayer Healthcare despite the device's protected status. But at a hearing on Monday, U.S. District Judge John R. Padova sounded unimpressed with some of the legal arguments submitted by lawyers for the five women. Padova directed lead attorney Marcus Susen of Fort Lauderdale, Fla., to resubmit part of the case with more specifics by Friday.
BUSINESS
November 15, 2015 | By Tom Avril, Inquirer Staff Writer
The U.S. Food and Drug Administration ordered a Bucks County manufacturer Friday to recall all 2,800 of its automated washing machines that are used to clean and disinfect endoscopes in hospitals and outpatient clinics. The FDA said its action against Custom Ultrasonics, of Ivyland, was prompted by continued violations of federal law and of a consent degree that the company entered into in 2007. Citing reports of serious bacterial infections at hospitals that use the company's machines, formally called reprocessors, the agency said in a news release that technicians should use alternate cleaning methods such as manual disinfection.
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