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Medical Devices

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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.
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.
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.
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
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.
NEWS
June 12, 2015 | By Caroline Simon, Inquirer Staff Writer
Barely 36 hours after a horrific hit-and-run accident that cost him his right leg, stage actor Michael Toner focused on the future. "What can you say? Life is unpredictable," Toner, 68, said Wednesday from his hospital bed at Thomas Jefferson University Hospital. "I've been in much worse situations, let's put it that way. " Toner ended up at Jefferson after a vehicle ran him down before 1 a.m. Tuesday on Market Street between 11th and 12th Streets, where he remained until a passerby found him. Toner said he had been running errands when he was struck, which he thinks happened about 11 p.m. Otherwise, he doesn't remember anything.
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ARTICLES BY DATE
NEWS
June 12, 2015 | By Caroline Simon, Inquirer Staff Writer
Barely 36 hours after a horrific hit-and-run accident that cost him his right leg, stage actor Michael Toner focused on the future. "What can you say? Life is unpredictable," Toner, 68, said Wednesday from his hospital bed at Thomas Jefferson University Hospital. "I've been in much worse situations, let's put it that way. " Toner ended up at Jefferson after a vehicle ran him down before 1 a.m. Tuesday on Market Street between 11th and 12th Streets, where he remained until a passerby found him. Toner said he had been running errands when he was struck, which he thinks happened about 11 p.m. Otherwise, he doesn't remember anything.
NEWS
May 29, 2015 | By Marie McCullough, Inquirer Staff Writer
After a surgical device spread an aggressive but undetected uterine cancer inside anesthesiologist Amy Reed in late 2013, she and her husband launched a campaign to ban electric morcellators. Now, the Federal Bureau of Investigation has gotten involved, according to Reed's husband, Philadelphia heart surgeon Hooman Noorchashm, and Sarah Robinson, a California woman whose cancer was also worsened by the device. Both said Wednesday that they have been interviewed by FBI agents, and believe the FBI is looking into whether manufacturers failed to report deaths and serious injuries to the Food and Drug Administration, as required by federal law. "I had been trying to get the FBI's attention for a very long time," said Noorchashm, a heart surgeon at Thomas Jefferson University Hospital.
NEWS
March 16, 2015 | By Jane M. Von Bergen, Inquirer Staff Writer
The U.S. Labor Department jobs reports are glowing - unemployment down to 5.5 percent last month and a robust 295,000 jobs added to the nation's payrolls. Even in the Philadelphia suburbs, the latest figures show the rate even lower, at 5 percent. But why, if everything is so good, are monthly sessions packed at My Career Transitions, a local networking group of volunteers who help people looking for work? "It's not as rosy as the numbers indicate," said Michael Hughes. "I see new faces every month.
NEWS
March 15, 2015 | By Tom Avril, Inquirer Staff Writer
Thomas Jefferson University Hospital said Friday that eight patients in 2013 and 2014 tested positive for drug-resistant "superbug" bacteria after being examined with a special kind of tough-to-clean endoscope. Yet hospital officials said they had found no proof that the devices, called duodenoscopes, had actually transmitted the infections. Jefferson's finding came after an investigation lasting several months, with help from the U.S. Centers for Disease Control and Prevention - highlighting continued nationwide scrutiny being paid to the complex, $40,000 instruments, which are used to examine the bile and pancreatic ducts.
NEWS
February 19, 2015 | By Jane M. Von Bergen, Inquirer Staff Writer
A Chester County company that assembles surgical carts used in medical facilities faces more than $42,000 in fines for exposing workers to chemical hazards, the U.S. Labor Department said Tuesday. Following a complaint in September, the U.S. Labor Department's Occupational Safety and Health Administration found that Seitz Technical Products in Oxford did not properly label hazardous chemicals, provide eye wash stations, train employees in use of hazardous chemicals or maintain a library of chemical safety sheets.
NEWS
October 1, 2014 | By Marie McCullough, Inquirer Staff Writer
Two new studies add to a mountain of evidence that the U.S. Food and Drug Administration has done a poor job of making sure medical devices are safe. The studies, in the current issue of JAMA Internal Medicine, are accompanied by commentaries that point out that the agency recognizes the need for change and is in the midst of improving the device approval system. But critics say the FDA has an inherent conflict because of its dual role of protecting public health and encouraging medical innovation.
NEWS
May 24, 2014
New Jersey's sprawling Second District, which includes all or part of eight southern counties, has been hobbled by high unemployment and a suffering tourism industry. Those issues only heighten the importance of next month's primary to choose its candidates for Congress. For Republican voters, the easy choice is the incumbent, FRANK LoBIONDO , who has served his district for 20 years. His opponent, Mike Assad, a former member of the Absecon Board of Education, isn't ready for this job. LoBiondo has proved his worthiness by refusing to let party labels keep him from working with Democrats to end the government shutdown and extend unemployment benefits.
NEWS
March 19, 2014 | By Marie McCullough, Inquirer Staff Writer
The husband of a Berks County woman who died of a rare uterine cancer following a minimally invasive hysterectomy is suing the maker of the device used in her surgery at Reading Hospital. The lawsuit, filed Friday in federal court in Philadelphia, adds to controversy over electric tissue-cutting "morcellators. " The devices let doctors remove tissue through tiny abdominal incisions, shortening patients' hospitalization and recovery. In rare cases, the process can disseminate an aggressive uterine cancer, leiomyosarcoma, that routine diagnostic tests usually miss.
NEWS
March 10, 2014 | By Tom Avril, Inquirer Staff Writer
David Decker had all the signs. He often missed things that actors said on TV. Hearing in crowds was a challenge. And when he came home each day from work in a noisy data center, where cooling fans whirred nonstop, his wife would tell him he talked too loudly. Why not get hearing aids? A big reason: the cost. Decker, 70, of Northeast Philadelphia, learned what millions of aging baby boomers are starting to discover. High-end devices can cost $6,000 a pair, and most insurance plans cover a fraction of the cost at best.
BUSINESS
October 17, 2013 | By David Sell, Inquirer Staff Writer
The shifting landscape of American health care - for good or bad, depending on your opinion, status, employer, and particular changes - was evident Tuesday when one of the Philadelphia region's larger private employers, Johnson & Johnson, reported financial results for the third quarter of 2013. The health-care giant had increased sales and profits, but also greatly increased the money set aside to pay pending legal bills, and warned of possible layoffs in a local division because people are postponing elective surgery to repair knees, hips, and backs.
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