Testing was lacking in most recalled medical devices

“Things that we all take for granted – like a heart valve, we say ‘they must be safe or you couldnt sell them,'” says Zuckerman. “But many of them are not being tested scientifically on human beings before they were sold.”

Court rulings spark debate over generic drugs

“The U.S. Supreme Court asked the Obama administration this week for its position on an appeal filed by generic drug manufacturers who argue that federal law provides them complete immunity from state lawsuits, even when their products cause serious harm to patients.”
May 27, 2010

Medtronic Heart Device: More Fatalities Revealed

There are about 2,200 reports of serious injuries from the lead, reported to the Food and Drug Administration.

April 02, 2009

Judge Who Dismissed Sprint Fidelis Lawsuits Linked to Medtronic Law Firm

”A judge who recently dismissed hundreds of Medtronic Sprint Fidelis defibrillator lead injury lawsuits apparently has a personal connection to the device maker.  According to The Wall Street Journal, the son of Judge Richard H. Kyle of the federal district court in Minneapolis is employed by a law firm that has had Medtronic as a client for quite a while.”
February 13, 2009

Medtronic is warned on recall

”The Food and Drug Administration has issued a warning letter to Fridley-based Medtronic Inc. concerning how the company handled events leading up to a pacemaker recall in June.”
November 18, 2009

Medtronic Cardiac Rhythm Disease Management Site Gets FDA Warning Letter

“It took almost two years from when the missing propellant was initially identified to conduct a recall… According to the letter, training records indicated that the employee who evaluated MiniMed pump reports only had a high school diploma with some additional in-house training.”
November 19, 2009

Hospitals Dispute Medtronic Data on Wires

“Some leading hospitals are reporting failure rates for Medtronic Inc.’s fracture-prone defibrillator wires—including among young people—that are significantly higher than what the company has publicly disclosed.”
http://online.wsj.com/article/SB10001424052748704259304575043300593884216.html February 4, 2009

Firms Not Making Progress In Improving Recall Notifications, FDA Says

”More than four years after it was revealed that Guidant failed to properly warn patients and physicians about potentially fatal product malfunctions, an FDA official says the overall quality of manufacturer recall notifications has not improved.”
October 19, 2009

FDA Covertly Drops Inspection of Medical Device Labs

”The FDA has, without officially announcing any change in procedure, basically dropped the practice of inspecting the labs that carry out the first wave of tests on new medical devices, according to a report by the nonprofit organization The Project on Government Oversight.”
http://www.naturalnews.com/026355_the_FDA_medical_devices_natural_health.html May 30, 2009

FDA is too quick to OK heart devices, report finds

“A new medical study says many sophisticated heart devices such as those manufactured by large companies in the Twin Cities have been approved for use without sufficient support from medical research.”
December 29, 2009

Lawsuit alleges Medtronic pushed off-label stent use

“the suit alleges Medtronic “pressured and incentivized” its sales force to target doctors who would use the stents to treat common vascular conditions such as renal stenosis,”
February 24, 2009

FDA Scientists Allege Coercion In Medical Device Approval Process, House Panel Investigates

The scientists claim that they were threatened with removal or negative performance reviews if they did not modify their scientific data to obscure unscientific clinical and technical data submitted by device companies and legal violations, including a lack of informed consent from study participants.
November 19, 2009

Defective Medical Devices Are Costing Taxpayers Billions Because of Supreme Court Ruling

“Faulty medical devices are costing taxpayers billions of dollars that should be paid by the manufacturer, but because of the complete immunity status device manufacturers enjoy from a Supreme Court decision, taxpayers are left with the bill.”
April 13, 2010

JAMA review finds multiple flaws in FDA approval of CV devices

“The FDA approval process for cardiovascular devices contains multiple flaws and weaknesses, according to a new article appearing in JAMA.”
December 29, 2009

Maker of Heart Device Kept Flaw From Doctors

“In interviews in recent days, a top Guidant executive, Dr. Joseph M. Smith, said that the company had not seen a compelling reason to issue an alert to physicians about the defibrillators because the failure rate was very low and replacing the devices might pose greater patient risks.”
May 24, 2005

Diabetes Drug Maker Hid Test Data, Files Indicate

“In the fall of 1999, the drug giant SmithKline Beecham secretly began a study to find out if its diabetes medicine, Avandia, was safer for the heart than a competing pill, Actos, made by Takeda…But instead of publishing the results, the company spent the next 11 years trying to cover them up,”
July 12, 2010

J&J’s Other Headache: Foreign Bribery Probe Targets Shanghai Unit

“As if Johnson & Johnson (JNJ) didn’t have enough problems with the Tylenol recall, the company’s medical devices unit in Shanghai is being investigated for allegedly paying bribes to Zhang Jingli, a deputy chief of the Chinese state FDA, according to Chinese media.”
June 25, 2010

The Higher Costs of Bribery in China

“And in late June, the Chinese press reported that Johnson & Johnson was under investigation by local prosecutors for allegedly bribing a Chinese drug regulator.”
http://www.businessweek.com/magazine/content/10_29/b4187011931530.htm July 13, 2010

FDA issues warning letter to St. Jude Medical for unapproved claims about heart device

“The Food and Drug Administration issued a warning letter to medical device maker St. Jude Medical Inc. for promoting its device for an unapproved use.”
May 18, 2010

Doctors With Ownership in Surgery Center Operate More Often, Study Finds

“When doctors become invested in an outpatient surgery center, they perform on average twice as many surgeries as doctors with no such financial stake, according to a new study from the University of Michigan Health System.”
April 06, 2010

House Committee Holds Hearing On Medical Liability

“Lawmakers said the number of malpractice suits and the dollar amounts awarded to plaintiffs have gone down, but insurance premiums for businesses and doctors have not.”
April 27, 2010


Health System Bears Cost of Implants With No Warranties

“In January, William R. Morris’s artificial hip, just three years old, was failing so badly that it had to be replaced during an extensive procedure that cost about $50,000.”
April 2, 2010

Feds found Pfizer too big to nail

“Imagine being charged with a crime, but an imaginary friend takes the rap for you. That is essentially what happened when Pfizer, the world’s largest pharmaceutical company, was caught illegally marketing Bextra, a painkiller that was taken off the market in 2005 because of safety concerns.”
April 2, 2010

Scientists Say F.D.A. Ignored Radiation Warnings

“I was first ignored, then pressured to change my scientific opinion, and when I refused to do that, I was intimidated and ultimately terminated,” he said in an interview. “And I’m going to tell the committee exactly that at this meeting.” http://www.nytimes.com/2010/03/29/health/policy/29fda.html?pagewanted=2&partner=rss&emc=rss
April 2, 2010

Medicine in the dark

“Clinical trials focus on new drugs, which doesn’t help doctors compare the effectiveness of one treatment with another.”
March 10, 2010


Doctors’ Spat Exposes FDA Loophole

At Northwestern University’s prestigious research hospital, one heart doctor is making a serious accusation against another. Nalini Rajamannan alleges that Patrick McCarthy, her former professional idol, engaged in “human experimentation” on patients’ hearts without their approval.

December 22, 2009


Interventional cardiologist sues hospital under Whistleblower’s Act

“pressured other doctors at the hospital to increase use of Medtronic products. It alleges that Piemonte earns “substantial yearly income” serving on the Medtronic speakers’ bureau and that Piemonte’s wife has had a ‘lengthy employment” with Medtronic and holds stock in the company.’”
November 3, 2009


Bad Bargain: The Dangers of Generic Drugs

“The average citizen would want to know that someone is checking that manufacturers are making the drugs they got approval to make,” says William K. Hubbard of Chapel Hill, N.C., associate commissioner for policy and planning for the FDA from 1991 to 2005 (and no relation to Beth). “That’s not happening, and the risk to consumers is potentially huge. I take generic drugs when they’re prescribed for me, but my confidence in them is lower than it was a year ago—and going down.”

Mylan workers overrode drug quality controls

The violations of standard operating procedure at the world’s third largest generic drug company, uncovered May 11, were “very serious,” the report stated, involving “falsifying information” and “altering product.”
July 26, 2009

If You Can’t Beat ‘Em, Hire ‘Em

Daniel Troy served as chief counsel for the U.S. Food and Drug Administration from 2001 to 2004. Starting September 2, 2008, he will be head counsel for the pharmaceutical company GlaxoSmithKline.
July 23, 2008

Medtronic Settles a Civil Lawsuit on Allegations of Medicare Fraud

“Two insiders had said Kyphon, which Medtronic acquired in 2007, improperly persuaded hospitals to keep people overnight for a simple outpatient procedure to repair small fissures of the spine.”
May 23, 2008

Medtronic unit will pay $75 million to settle whistleblower Medicare fraud case

“Medtronic Spine LLC, formerly known as Kyphon Inc., has agreed to pay $75,000,000 to the federal government to settle a whistleblower lawsuit that exposed the spinal medical device company’s sales and pricing strategy to increase its profits by defrauding Medicare.”
May 22, 2008

Part I: Medical device payments to doctors draw scrutiny

A recently unsealed whistleblower lawsuit, and Congressional and Justice Department investigations, are finally bringing into public view the practice of handsomely reimbursing top doctors to consult for medical device companies.
September 08, 2008

Product Recalls in the Medical Device Industry: An Econometric Analysis of the Costs of Poor Quality

The market seems to expect medical device firms to make mistakes, some severe and others minor. The findings suggests that the penalty imposed on firms by the market for product quality failures are not severe. Another way to interpret this is that the shareholder losses do not dependably deter dubious firm practices in the production of defective medical devices.

Guidant Defibrillator Malfunction and the FDA

Guidant’s annual report covering the months from June 1, 2003 to May 31, 2004 – which included the information that the type of defibrillator involved in Mr. Oukrop’s death was short-circuiting at a rate of about once a month – was not submitted to the FDA until February 2005.

Device Maker Charged With Unlawful Clinical Trials

The indictment charges Norian with a total of 52 felony counts: conspiracy to impair and impede the lawful functions of the FDA and to commit crimes against the United States; 7 counts of making false statements in connection with an FDA inspection; and 44 counts of shipping adulterated and misbranded Norian XR in interstate commerce with intent to defraud.
June 19, 2009

Company caught in cover-up of medical device malfunctions.

EndoVascular Technologies, Inc., a subsidiary of medical device manufacturer Guidant Corporation, has pled guilty to 10 felony counts and agreed to pay more than $92 million in civil and criminal penalties over allegations that it covered up malfunctions in one of its devices used to treat aortic aneurysms.
June 16, 2003

Heart Device Sold Despite Flaw, Data Shows

When the Guidant Corporation told doctors last week that a popular implantable heart defibrillator had failed in a small number of cases because of an electrical flaw, it also said that it had fixed the flaw in devices produced after mid-2002. http://www.nytimes.com/2005/06/02/business/02guidant.html?_r=1
June 02, 2005

Medical devices: Problems on the rise

In September the FDA issued its own report for its fiscal year 2006, saying it had seen a 25 percent increase in adverse events linked to medical devices over FY 2005, including 2,830 deaths, 116,086 injuries, and 96,485 device malfunctions. http://www.consumerreports.org/health/healthy-living/home-medical-supplies/problems-with-medical-devices-12-07/overview/medical-devices-ov.htm
December 2007

Report Criticizes F.D.A. on Device Testing

“So on the one hand, the manufacturer wheels in their new Ferrari to the F.D.A. and says, ‘Look, it’s a car just like the Model T,’ ” said Dr. Peter B. Bach, a pulmonary physician at Memorial Sloan-Kettering Cancer Center in New York and a former senior adviser to Medicare and Medicaid. “Then they go out in the marketplace and say to doctors, ‘Why would you drive anything but a Ferrari?’ This drives up the cost of care without any necessary actual improvement in outcomes.”
January 15, 2009

FDA lax on scrutiny of some medical devices, report finds

In a related matter, a group of FDA doctors and scientists last week wrote the Presidential Transition Team that managers in the agency division responsible for regulating devices “have ignored the law and ordered physicians and scientists to assess medical devices employing unsound evaluation methods,”
January 15, 2009

FDA Approved Medical Devices Without Scientific Review

The Los Angeles Times reports that various medical devices, including “certain hip joints” and “a type of defibrillator,” gained approval from the Food and Drug Administration without first going through “a close, scientific review,” according to a congressional investigation.
January 19, 2009

Watchdog Says FDA Abandoned Safety Measure

The watchdog says the decision by officials at the FDA’s Center for Devices and Radiological Health reversed a policy on good laboratory practice (GLP) instituted in 1979.
February 18, 2009

Internal FDA Doc Reveals Agency Stopped Enforcing Safety Standards

Since 2006, the Food and Drug Administration has ignored its own internal regulation and stopped requiring manufacturers of medical devices – such as pacemakers, heart valves and other life-sustaining inventions – to meet specific safety requirements before they are deemed safe enough to be implanted in humans.
February 18, 2009

The FDA’s Deadly Gamble with the Safety of Medical Devices

These officials decided, without public notice, to ignore the long-standing Good Laboratory Practice (GLP) regulation. The GLP regulation sets specific requirements for the testing of medical devices, including life‑sustaining devices such as cardiac defibrillators, pacemakers, replacement heart valves, and coronary artery stents. The requirements for GLP testing are supposed to be met before CDRH deems these devices safe…
February 18, 2009

Political Lobbying Drove FDA Process

The recent approval of a new device to treat knee injuries followed a lobbying campaign that overcame repeated rejections by scientists within the Food and Drug Administration, agency documents show.
March 06, 2009

Nothing’s “Knee-Jerk” About The Importance of Passing The Medical Device Act

But what makes the story so incredibly disturbing isn’t so much the ailment or the device, but the obscenely politicized process by which the Menaflex was granted fast-track FDA approval.
March 11, 2009


Letter to President Obama

April 02, 2009

Medical Devices: Shortcomings in FDA’s Premarket Review, Postmarket Surveillance, and Inspections of Device Manufacturing Establishments

For example, in 2006 FDA reported that the agency’s ability to understand the risks related to the use of medical devices is limited by the fact that the volume of submitted reports exceeded FDA’s ability to consistently enter or review the reports in a routine manner.
June 18, 2009

Medical devices, the hearing

June 18, 2009

Questions about FDA Oversight of Medical Devices Leave Patients Vulnerable

The hearing comes a week after another Medtronic device – 37,000 pacemakers – were recalled because the devices were found to seriously, even fatally, injure patients. Removal of the pacemakers is the recommended course of action, further putting patients’ health at risk by subjecting them to invasive surgery.
June 19, 2009

U.S. FDA device chief leaves, changes seen

August 11, 2009

Setting Time Bombs in Our Chests: Our Unreliable FDA

Needless to say, device manufacturers are not always forthcoming. Throughout the 1980s and 1990s, a device known as the Björk-Shiley heart valve malfunctioned in hundreds of the 86,000 patients it was implanted in–resulting in at least 900 deaths. Yet, according to a year-long investigation conducted by the House Subcommittee on Oversight and Investigations, the product remained on the market for years because its manufacturer “continually provided the medical community with incomplete and misleading information regarding the number of strut fractures and the severity of the problem.”
March 31, 2009

Chamber Threatens Lawsuit if EPA Rejects Climate Science ‘Trial’

The nation’s largest business group is asking U.S. EPA to hold a public debate on climate change science — or face litigation — as the agency prepares to regulate greenhouse gas emissions under the Clean Air Act.

August 25, 2009

A handshake that made healthcare history

Partners HealthCare was born in 1993, but its powerhouse potential didn’t fully hit home until 2000. That’s when the emerging giant cut a quiet deal with Blue Cross to ratchet up insurance costs across the state. Nothing in Massachusetts healthcare has been the same since.
http://www.boston.com/video/viral_page/?/services/player/bcpid1119284117&bctid=5836563001 December 28, 2008

Made in America: Corporate Gall

Here is what the president of the Chamber’s legal arm wrote in an open letter to Obama: “We understand the critical necessity of revitalizing the economy by restoring American jobs, encouraging the growth of U.S. businesses, and protecting the savings and investments of millions of Americans. However, we are concerned that the potential expansion of legal liability significantly impairs these much needed steps toward a national recovery.”
December 20, 2008

The Cost Conundrum

That explanation puzzled me. Several years ago, Texas passed a tough malpractice law that capped pain-and-suffering awards at two hundred and fifty thousand dollars. Didn’t lawsuits go down?
June 1, 2009

Georgia high court considers tort reform law

Weeks after surgery, her skin began to die because the medical procedures cut off the flow of blood to her face. Gaping wounds opened from her temples to her chin. After extended treatment, the real estate agent was left permanently disfigured.
September 15, 2009

The Great Medical Malpractice Hoax

In Florida, one of the AMA’s “crisis” states, the Office of Insurance Regulation reported that the 15 largest medical malpractice insurers saw profits of $803 million in 2005
January, 2007

Supreme Court Inc.

The Supreme Court term that ended last June was, by all measures, exceptionally good for American business. The chamber’s litigation center filed briefs in 15 cases and its side won in 13 of them — the highest percentage of victories in the center’s 30-year history.
March 16, 2008

Setting the Stage – A Supreme Court Friendly to Business.

Ms. Conrad earlier remarked that the 2006-07 term was the strongest showing for the business community in the past 30 years.

More Docs Messin’ w/ Texas… While Texas Messes with Patient-Plaintiffs

On the cover of today’s NYT, medical malpractice tort “reform” in Texas. Although you’ve got to get two-thirds into the article to reach it, the article does include some voices of reason to offset its healthy dose of tort “reform” rhetoric about the doom of the world being caused by lawsuits.

The Real Cost of Medmal

”After reviewing thousands of patient records, medical researchers have estimated that only 2 to 3 percent of cases of medical negligence lead to a malpractice claim. Even if we eliminated medmal suits entirely, the cost savings would be pretty modest.”
September 23, 2009

Medical Malpractice System Breeds More Waste

”After reviewing thousands of patient records, medical researchers have estimated that only 2 to 3 percent of cases of medical negligence lead to a malpractice claim. For every notorious error — the teenager who died in North Carolina after being given the wrong blood type, the 39-year-old Massachusetts mother killed by a chemotherapy overdose, the newborn twins (children of the actor Dennis Quaid) given too much blood thinner — there are dozens more. You never hear about these other cases.”
September 22, 2009

The Truth About Malpractice Lawsuits

Doctors say the suits send health-care costs soaring, but studies show reforms would have little effect.
http://www.businessweek.com/magazine/content/09_39/b4148030880703.htm September 16, 2009

Growth in Malpractice Claims Is Exaggerated, Report Says

The New York Public Interest Research Group reviewed 15 years of federal data on medical malpractice payments and concluded that the amount of money paid for malpractice claims in New York has actually fallen in recent years, and that the number of overall claims has remained “remarkably stable.”
June 5, 2009

Medical Papers by Ghostwriters Pushed Therapy

Newly unveiled court documents show that ghostwriters paid by a pharmaceutical company played a major role in producing 26 scientific papers backing the use of hormone replacement therapy in women, suggesting that the level of hidden industry influence on medical literature is broader than previously known.
August 4, 2009