Catastrophic FAIL: Easier to Recall Spinach Than Medical Implants

Effort to improve tracking of medical devices divides industry, consumer groups

By Joe Carlson OCTOBER 21, 2017 — 2:00PM

.

Fictitious medical device label is shown for unique device identifier information.

In March 2015, Target Corp. alerted customers to throw out certain 10-ounce bags of organic chopped spinach because they were potentially contaminated with listeria bacteria, which can cause serious health problems.

The recall notice, filed with the U.S. Food and Drug Administration, urged people who bought the spinach to check UPC codes and a special nine-digit tracking code called the DPCI that Target includes on its sales receipts. The recall was routine, and no illnesses were publicly linked to the incident.

No such system exists for medical device consumers, however.

In fact, proposals to give insurers and patients access to the serial numbers on their implanted medical devices remain controversial.

Manufacturers say it would cost additional time and money with no guarantee of benefit to put the device serial numbers into insurance claim forms. Consumer safety officials and auditors argue the move would improve patient safety and enhance accountability.

To patient advocates like Lisa McGiffert, director of the Consumers Union's Safe Patient Project, omitting device serial numbers from an insurance claim would be like buying a car without getting its VIN number.

Doesn’t Add up: The medical industry is divided over adding a unique device identifier (UDI) to devices, which would make it easier to locate a device but at a higher cost for companies.

"We don't even have the make and the model" in insurance claims, McGiffert said. "We can put it on a car — why shouldn't we have it on a hip that you're putting in my body?"

Thousands of medical devices are recalled each year, but it can be hard to track them. In 2005, former Minnesota device maker Guidant Corp., now part of Boston Scientific, urgently recalled thousands of pacemakers because excess moisture could seep inside the life-preserving devices and ruin them.

A handful of patients with the devices went into cardiac arrest or experienced heart failure, and one death may have been linked to a pacemaker failure. Yet the Government Accountability Office (GAO) reported in 2011 that 1,732 of these recalled pacemakers were never recovered because there was "no implant record available."

Medicare, which pays hospitals to implant such devices in patients aged 65 and older, had no direct way of tracking down which of its patients may have gotten those 1,732 leaky Guidant pacemakers — nor, for that matter, any of the hundreds of thousands of other heart devices that have been recalled by the medical device industry in the years since then, critics inside and outside the government say.

Congress mandated a system of serial numbers to track medical devices known as UDIs, or unique device identifiers, back in 2007, and the Food and Drug Administration has been rolling out rules for how and when to use them ever since.

The med-tech industry and some doctors have fought hard to keep them out of Medicare claims and private insurance bills.

A two-year investigation by Medicare's inspector general office recently concluded that the publicly funded health insurer spent an estimated $1.5 billion over 10 years on surgeries and follow-up care for patients who had one of seven specific heart devices made by Minnesota manufacturers. The review did not include the Guidant pacemakers mentioned by the GAO and didn't examine other widely recalled types of devices, like metal-on-metal hip implants.

John Boujoulian, senior auditor on the Medicare inspector general investigation, said the lack of UDI numbers in Medicare claims makes it harder to locate patients affected by medical device recalls. But as it stands, Medicare would have to do a detailed review of medical records to find the UDIs to track down devices that it pays to have implanted or replaced.

"We had to go through all the medical records to find out," Boujoulian said in an interview about the audit. Using subpoenas to the device makers, "we had lists of all the people who had the medical devices implanted and the specific models, and we had to go through them all to see which ones had issues."

But going through the detailed medical records of patients is exactly what the medical device industry advocates.

"We support the collection of the UDI in the electronic health record, where it can actually be used to really help track patient outcomes and be used in a more proactive way around postmarket surveillance," said Don May, executive vice president for the Washington-based medical device manufacturer trade group AdvaMed. "If we are really concerned about patient safety, then let's go to the tool that makes the most sense."

Industry officials say the codes are too long and varied to put into insurance claims. AdvaMed says hospitals would have to invest in new bar code scanners and come up with ways to accurately transmit the data to payers. The American Medical Association says reporting UDIs in insurance claims would be cost prohibitive and insufficient for detecting widespread problems.

Organizations including Centers for Medicare and Medicaid Services and the Medicare Payment Advisory Commission have supported adding a short section of the UDI known as the "device identifier," or DI, to Medicare claims forms.

The full UDI, however, can run to 75 characters and comes in three different formats used by three different standards organizations. The full code contains not just model numbers, but batch and lot numbers, dates of manufacture and other information that would identify which specific devices are affected by problems.

AdvaMed Associate Vice President Zach Rothstein, who advocates on medical device regulation involving the FDA, said researchers who use just snippets of the UDI codes may draw inaccurate conclusions about devices that could negatively affect both medical device makers and patients.

"Think about all the food recalls where you go to your freezer and say, 'Well, was this done in that time frame and in that plant?' And the news gives you the code. It's not just this was Tyson chicken," he said. "Without [the full serial number], you just don't know."

Advocates say patient safety would benefit from the added transparency, dismissing arguments that it's too difficult or expensive. Ben Moscovitch, manager, health information technology at Pew Charitable Trusts, noted that the FDA's Sentinel program to root out problems with prescription drugs is based largely on claims data, which incorporates 10-digit National Drug Codes.

"Many of the safety challenges that occur with devices occur across the entire product line," Moscovitch said, "and to evaluate the safety of products in that capacity requires only the brand and model of the device, and not the production information that is included in the [full UDI]."

The three companies that made the recalled or defective heart devices that led to $1.5 billion in Medicare spending documented in the inspector general's report — Boston Scientific, Medtronic and St. Jude Medical owner Abbott Laboratories — all declined to comment for this story.

Asked whether the medical device companies' opposition to including UDIs in Medicare-claims forms was related to financial concerns like lost sales or increased litigation, May noted that product recalls are already costly.

"From a litigation perspective, I think malpractice attorneys are very aggressive in a lot of ways, and this just becomes one additional data source," May said. "But if you've got a product that is recalled, my guess is the company is already feeling a financial impact because it's a product that they've had to recall."

joe.carlson@startribune.com 612-673-4779 _JoeCarlson

http://www.startribune.com/effort-to-improve-tracking-of-medical-devices-divides-industry-consumer-groups/451942493/#comments

Deaf and Blind Medical Device Giant J&J: Harmed Patients Demand REAL Consumer Warranties!

How J&J’s Walmart relationship is inspiring its device business

By ARUNDHATI PARMAR  FiDA highlight

 Oct 31, 2016 at 6:02 PM

The Affordable Care Act has laid the groundwork for a seismic shift in the way the medical device industry operates.

Traditionally, large companies like Johnson & Johnson built up an army of sales reps who would have relationships with the same hospital customer but touting the New Jersey’s companies individual products — be it cardio, ortho or general surgery. As value-based care gains a footing, health systems are focusing on how they can lower costs and improve outcomes through services and solutions as opposed to buying more and more hardware and implants that device firms are known for.

J&J’s medical device business has been ill-equipped to adjust to this shift and its financial performance has been poor. Last year it garnered $25.1 billion, down 8.7% from 2014. The division has also restructured and announced it would be eliminating thousands of jobs earlier this year. In a phone interview, Gary Pruden, J&J’s executive vice president and worldwide chairman for medical devices, explained how the unit is undergoing a wholesale metamorphosis to take advantage of the opportunities afforded by value-based care. One inspiration has been to take a page out of the consumer business book and see how it manages a really large customer:Walmart.

Gary Pruden, worldwide chairman,                                               J&J Medical Devices

“I have more than a dozen companies in the U.S. for example and in the past, they would all go to the hospital system provider separately. They all have separate P&Ls, they all operate independently, they all go separately,” Pruden recalled. “We made a conscious decision and actually this year we integrated all the different business into one single P&L and I have one single strategic account management group in the U.S.”

This model is unlike how other large device firms are fulfilling their go-to-market strategy. For them, the product business and solutions business sit separately, Pruden declared referring to the likes of Zimmer Biomet and Stryker.

“They are trying to bring together a compilation of [offerings] and those solutions providers operate separately from those individual businesses,” Pruden claimed. “And when you talk to [hospital] customers, that’s a little challenging. They want to talk to one person.”

At J&J, that single account management group now has the power to speak on behalf of the product and service offerings of J&J Medical Devices with a single voice as well as to strike deals with hospital customers, partner with them and write contracts. The goal is not only to lower their costs but also share in the risk for clinical outcomes, Pruden said. If J&J  is able to achieve both, it wins with greater volume of products sold.

Pruden wouldn’t provide specifics about the value-based care offerings but said that there are certain demonstration projects with certain hospital customers, both U.S and globally. Through them, J&J’s medical device business can offer its expertise in providing end-to-end supply chain solutions for hospitals, perioperative efficiency, clinical standardization programs as well as in help in figuring out bundled payment programs.

In trying to create a model by which the devices team at J&J would be able to provide savings by managing a customer’s supply chain end-to-end, the inspiration came from the conglomerate’s consumer business.

“With Walmart, we have a very unique partnership where we have a large number of people working in Bentonville, on behalf of Walmart that help manage the end-to-end supply chain,” Pruden said.

This model is already being put to use in the U.S., but Pruden declined to identify the customer or customers with whom this program has rolled out. [In May, Pruden’s presentation to analysts showed the Medical Devices business had at least had eight such customers – or strategic partners. They include New England Baptist Hospital, OSF Healthcare, Saint Luke’s Health System, Grupo Angeles Servicios De Salud and Schulthess Klinic among others]

He was similarly elusive when asked about the types of products for which the corporation has taken on some risk. This is in direct contrast to other device companies that are not only providing full-throated support for alternative payment models that mean bearing more risk with hospitals but actually identifying the product at the heart of the matter.

Take Stryker for instance.

Earlier this year, the Kalamazoo, Michigan orthopedic company announced that it is providing no less than a “money-back guarantee” for customers who use its SurgiCount system to keep track of the surgical sponges that in some cases may inadvertently get misplaced, ending up inside surgical patients. Stryke said that it would offer up to $5 million in product liability indemnification to hospitals and an additional guarantee to refund the incremental cost hospitals bear to invest in its SurgiCount program compared with the hospital’s previous sponge spending for up to three years.

Medtronic, the largest pure-play device company, has also gone at-risk with its Tyrx absorbable antibacterial envelope. The mesh device is meant to encapsulate a pacemaker and ICD  and release antimicrobial agents over a period of seven days to prevent surgical site infections of such cardiac devices.

While Pruden didn’t provide any specific example of products that J&J Medical Devices, he was very emphatic about the need for device makers to assume some risk with their products as they become more of a strategic partner to hospitals than a supplier. And that can mean the difference between a supplier relationship always on the verge of being cut and a long-term strategic partner.

“That’s the essence of what I am doing – aggregating our businesses at scale, offering some willingness to take some risk and leveraging the enterprise and some of the things we can do to create some value,” he said. “Partnerships that only go one way don’t last very long.”

http://medcitynews.com/2016/10/jjs-medical-device-chief-taking-inspiration-consumer-business/

Medtronic $8.45M 'settlements' to two harmed patients: deny any wrongdoing!

Patients who received Medtronic product to get $8.45 million in settlements

By Jim Spencer Star Tribune AUGUST 2, 2016 — 10:22AM

Two patients who were injured by Medtronic’s controversial Infuse bone graft product will receive a combined $8.45 million in settlements with the University of California Los Angeles, where a doctor with financial ties to the company used the product on them.

Patients Ralph Weiss and Jerome Lew alleged that hundreds of thousands of dollars in Medtronic consulting, grants and royalty payments to UCLA surgeon Jeffrey Wang created conflicts of interest that led to risky treatments about which they were not informed. They said they were not told that they were receiving Infuse or that it was being inserted into mechanical devices with which it had never been tested for safety.

Claims of injuries from such “off-label” use have plagued Infuse almost from the time of its introduction into the market in 2002, and the company’s possible role in promoting those treatments has sparked government investigations and lawsuits. Studies have shown that the bone growth product is used 85 percent of the time in ways the FDA did not specifically approve.

Medtronic denied any wrongdoing in the Weiss or Lew cases. The company settled with Lew for an additional amount of money that it declined to reveal.

“Medtronic’s company policies and extensive training expressly provide that we promote our products only for those uses that are consistent with the labeling approved by the FDA,” a spokesman said in a statement.

Both Weiss and Lew ended up with unwanted bone growth in their spines that caused nerve damage. Weiss got $4.25 million from UCLA, while Lew got $4.2 million and settled separately with Medtronic for an additional undisclosed amount.

Weiss had lumbar spine surgery. Lew’s spine surgery involved placement of Infuse in his neck, where the FDA had warned it could cause nerve and breathing problems.

In addition to allegations of improper use of Infuse, Lew’s suit said Medtronic illegally misbranded the cage device that Wang implanted in Lew’s neck to hold the synthetic bone growth product. Lew’s suit alleged that Medtronic got the U.S. Food and Drug Administration (FDA) to approve the device without testing by saying it would be used in the chest and lower spine, but that Medtronic designed the device so that it was too small and the wrong shape to fit anywhere but the neck.

Records in the Lew case show that one of the device’s designers testified that he intended it to be used in the neck. Lew’s lawyers also found an e-mail from a Medtronic employee to UCLA officials noting that “because of its small size many surgeons prefer to use it in the cervical spine.”

Lew’s principal attorney, Robert Vaage, told Los Angeles Superior Court Judge Terry Green that he could find no examples of the cage being used anywhere except the neck.

Medtronic said decisions on which devices to use rested with the physician and the patient. “The upper vertebrae in the thoracic spine can be quite small so the system comes in a variety of sizes to accommodate the unique anatomies of different sized patients,” the company said in its statement.

The company said that Wang was not paid for using the Medtronic products used in Lew’s surgery, and that as of the time of the surgery involving Lew he was not a consultant for Medtronic.

UCLA did not respond to the specific allegations of the suits but said it settled so the school and its medical system “could move forward with their ongoing commitment to excellence in patient care, research, education and community service.”

Wang’s lawyer did not respond to a request for comment. Records show that Medtronic paid Wang nearly $300,000 in grants, royalties and consulting fees from 2000-2009. Wang’s image and quotes remain on Medtronic’s neck pain website. He is now chief of the orthopedic spine service at the University of Southern California medical school.

Medtronic has already written-off $140 million to pay for “probable and reasonably estimated damages” in Infuse cases, as well as $90 million to settle a shareholder Infuse suit. In October, the company faces a leadoff trial among hundreds of lawsuits filed by Infuse recipients who say the product injured them.

Weiss’ and Lew’s individual awards are large in comparison to other announced Infuse settlements, which have averaged less than $30,000 per patient.

Weiss’ case was strictly about an unapproved use of Infuse in Weiss’ lower spine, said Vaage, who represented both Weiss and Lew. Medtronic was dropped from the suit as a defendant because Wang admitted he knew the risks of Infuse, Vaage said.

Doctors are allowed to use medical devices in non-FDA-approved ways if they think it will help their patients. But federal law says device makers are not supposed to promote those uses.

Lew’s suit is among the first — if not the first — to successfully raise the issue of misbranded spinal cages for off-label uses of Infuse. Vaage said the case settled for a “confidential amount” after he interviewed current and former Medtronic employees, including Dr. Zafar Khan, one of the designers of the cage that went into Lew’s neck.

Khan testified under oath that the cage was designed and intended for use in the cervical spine, Vaage said. Vaage also unearthed correspondence that he says showed that Medtronic marketed the device for use in the neck despite the fact that the company told the FDA it was not supposed to be used there. Medtronic produced a “surgical technique guide” that showed the cage being used in the neck, Vaage said.

“We took the position that but for this cage being made available, Infuse would never have been used in Jeremy Lew’s neck,” and he never would have been injured, Vaage said.

The law does not require doctors to disclose to patients if they are receiving off-label treatments. But patient advocates say cases like Weiss’ and Lew’s show why public policy should pay more attention to informed consent.

Patients “assume that if the doctor says do it, that it’s been approved and tested and all of those things,” said Lisa McGiffert of Consumer Union’s Safe Patient Project. “There’s a lot of off-label use and patients don’t really understand that.”

Staff writer Joe Carlson contributed to this report.

http://www.startribune.com/patients-who-received-medtronic-product-to-get-8-45-million-in-settlements/388947831/

jim.spencer@startribune.com 612-270-1266 SpencerStrib

FDA/CDRH - Celebrates 40 year old (unsafe and ineffective) Medical Device Amendments

FDA Celebrates the 40th Anniversary of the Medical Device Amendments

Posted on June 22, 2016 by FDA Voice

By: Jeffrey Shuren, M.D., J.D.

In 1976, Steve Jobs and Steve Wozniak founded Apple and a gallon of gas was $.59. And in another action that has had long term impact, President Ford signed the Medical Device Amendments that closed the dangerous gap between what he called FDA’s “horse and buggy authority” and “laser age problems.”

Jeffrey Shuren, M.D., J.D., FDA’s Director of the Center for Devices and Radiological Health, speaking at FDA’s Celebration of the 40th Anniversary of the Medical Device Amendments

Unlike the pharmaceutical industry, which was born from large chemical companies that discovered medical uses for the products they made, the device industry sprung to life as a scrappy sibling—mostly mom-and-pop businesses addressing the needs of individual patients and physicians through invention.

Although Congress had first given FDA explicit authority over medical devices in the 1938 Food, Drug, and Cosmetic Act, the focus was on fraudulent products. Efforts to extend FDA’s oversight on medical devices failed in 1962 and again in 1970.

Then in 1975, reports emerged that thousands of women had been harmed, some even died, from pelvic inflammatory disease, as the result of using the Dalkon Shield, an intrauterine device for contraception. Congress responded the following year by enacting the Medical Device Amendments, which authorized FDA to classify all medical devices based on risk into one of three classifications, to require premarket approval for Class III devices, and for devices to comply with reporting and GMP requirements.

The law ushered in a new era for medical technology innovation, patient access, and patient safety, but also created a tension, contributing to a political environment where the pendulum continues to swing between these objectives, defining and driving the medical device ecosystem ever since.

In signing the legislation, President Ford noted that, when “well designed and well-made and properly used” medical devices “support and lengthen life.” But when medical devices are “poorly designed, poorly made, and improperly used” they can “threaten and impair” life.” His words still ring true today.

The initial Medical Device Program started with about 180 people. Today, FDA’s Center for Devices and Radiological Health (CDRH) is 1,700 strong; a vibrant family of individuals with a wide range of scientific, clinical, engineering, legal, and other expertise, who hail from a variety of backgrounds, and who are ready to tackle the latest scientific advancement.

And the mom and pop industry has transformed into a world of sophisticated software algorithms, miniaturization, combination products, wearable sensors, non-invasive procedures and diagnostics, robotics, and artificial intelligence.

Along the way, CDRH has adapted its expertise and regulatory approaches to meet the needs of such rapidly evolving innovation. While we will continue to adapt, more importantly, we are focusing on proactively anticipating where we need to be so that regulatory innovation is out in front of medical device innovation. We’re doing this now in the digital health space, by designing regulatory frameworks around the type of technology and its unique evidence generation and innovation cycle rather than applying a one-size-fits-all approach.

We are implementing new models for evidence generation. They include the establishment of a National Evaluation System for health Technology, or NEST, that could transform the historical tension between device innovation, patient access and patient safety into an alignment of interests to drive the development and more timely access to life-saving, life-enhancing, and life-advancing devices. This is consistent with our vision: That patients in the U.S. have access to high-quality, safe and effective medical devices of public health importance first in the world.

And we are also going to new places with patients by establishing a foundation for engaging with them as our partners and routinely incorporating their perspectives in our decisions. And that’s fitting because improving the health and the quality of life of patients by assuring they have timely access to medical technologies that will benefit them is at the heart of who we are and what we do.

As we look ahead to the future, it is our work, our care and our dedication that will allow us to reach our vision.

Jeffrey Shuren, M.D., J.D., is FDA’s Director of the Center for Devices and Radiological Health

For more information read: Remarks at FDA’s Celebration of the 40th Anniversary of the Medical Device Amendments, by Jeffrey Shuren, M.D., J.D.

.entry-content

This entry was posted in Innovation, Medical Devices / Radiation-Emitting Products and tagged 40th anniversary of the medical device amendments, FDA's Center for Devices and Radiological Health (CDRH), FDA’s oversight on medical devices, National Evaluation System for health Technology (NEST) by FDA Voice. Bookmark the permalink.

http://www.fda.gov/NewsEvents/Speeches/ucm508146.htm

Remarks at FDA’s Celebration of the 40th Anniversary of the Medical Device Amendments

Remarks of Jeffrey Shuren, M.D., J.D.

Director of the Center for Devices and Radiological Health

U.S. Food and Drug Administration

June 22, 2016

1976.

Anyone thought about where they were or what they were doing in 1976?

I was in junior high school with no clue what the FDA was but very focused on a girl I had a crush on.

In 1976, Nadia Comaneci won 3 gold medals in gymnastics in Montreal.

The Steelers won the Super Bowl.

Steve Jobs and Steve Wozniak founded Apple.

The first “punk rock” single—by a group called The Damned—flopped horribly.

A gallon of gas was $.59 and the Dow Jones Industrial Average closed the year at 1004.

And, as we know and are here today to celebrate, President Ford signed the Medical Device Amendments that closed the dangerous gap between what he called FDA’s “horse and buggy authority” and “laser age problems.”

How we got here has been quite a journey. We’ve been using medical devices for thousands of years, including tools to punch holes in the skull to let out evil spirits and sticks to help the disabled walk. In 1850, a German scientist, Hermann von Helmholz, invented one of the first modern day medical devices, the ophthalmoscope, using a light source and lenses to view the interior of the eye.

At about the same time, Willhelm Roentgen, a professor of physics in Bavaria, discovered that radiation can penetrate solid objects of low density, which led to the invention of X-ray machines. In 1927, the respirator was introduced. In 1939, the first heart-lung bypass machine came on the market.

However, unlike the pharmaceutical industry, which was born from large chemical companies that discovered medical uses for the products they made, the device industry sprung to life as a scrappy sibling—mostly mom-and-pop businesses addressing the needs of individual patients and physicians through invention.

I’ll give you an example: Earl Bakken and his brother-in-law Palmer Hermundslie co-founded Medtronic in 1949 in a garage in Minneapolis. The company started as a repair service for hospital electrical equipment and a regional distributor for other manufacturers. They would build new equipment on order or customize standard instruments for laboratory or clinical researchers. They would install equipment, train personnel on their use, troubleshoot and repair it as necessary. At the time, they were barely getting by.

Enter Walton Lillehei. This world-renowned cardiac surgeon at the University of Minnesota pioneered techniques for the repair of congenital defects as part of the rapidly evolving field of open heart surgery.

Despite successful repair of the congenital defect, about 1 patient in 10 developed post-operative, complete heart block due to damage of the conducting system while the surgical repair was being performed. It was thought that temporary cardiac rhythm support via pacing would keep the patient alive until recovery of the conducting system occurred. However, the high voltage pacing stimuli delivered across the chest by the machine invented by Zoll was believed to be too traumatic on young children.

Dr. Lillehei and his co-workers developed the myocardial wire – a multi-stranded, braided stainless steel wire in a Teflon sleeve that could deliver low voltage pulses. One end of this wire was implanted directly into the heart muscle and the other end was connected outside the body to the physiology lab stimulator.

Early attempts to use the device were successful until October 31, 1957,  when a 3-hour municipal power failure resulted in the tragic death of a baby. The hospital had emergency power generation in its surgical suites and recovery area but not in its patient rooms.

The very next day, Lillehei asked Bakken to see if Medtronic could come up with something better.

Initial attempts at building a more reliable and portable pacemaker involved adding an automobile battery with an inverter to convert 6 volts direct current into 115 volts alternating current.

This didn’t work. So, Bakken found a back issue of Popular Electronics where he had seen a circuit for an electronic, transistorized metronome. He modified the two-transistor circuit and placed it, without the loudspeaker, into a four-inch-square and inch-and-a-half-thick aluminum box with terminals and switches on the outside. The circuit was run by a miniature 9.4 volt battery housed within the box.

From that determination and ingenuity sprung the field of “medical electronics.” Prior to 1957, there had never been a partly or completely implantable electrical device.

Every journey brings new inspiration and experience—and, inevitably, bumps, potholes, and dead ends.

Following Medtronic’s early success, the pace of innovation picked up dramatically. But, the transition from garage to manufacturing facility didn’t always include rigorous scientific and clinical evaluation. Instead, it continued to rely on bedside observation for benefit and risk determinations.

Which led to problems. And tragedy.

Congress first gave the FDA explicit authority over medical devices in the 1938 Food, Drug, and Cosmetic Act, with our focus primarily on fraudulent products. However, in 1962 when Congress passed a new regulatory framework for drugs, they dropped President Kennedy’s proposal to include medical devices.

Then in 1970, President Nixon established the Cooper Committee – chaired by Dr. Theodore Cooper, then director of the National Heart and Lung Institute – to study medical devices as part of the President’s endorsement of medical device legislation. The committee recommended that any new legislation be specifically targeted to the device industry, because devices presented entirely different issues from drugs. It also suggested that different classifications for medical devices be created, which would tailor the regulatory controls to the risks involved. But Congress couldn’t agree on a bill.

In 1975, reports emerged that thousands of women had been harmed, some even died, from pelvic inflammatory disease, as the result of using the Dalkon Shield, an intrauterine device for contraception. Congress responded by enacting the Medical Device Amendments, which authorized the FDA to classify all medical devices based on risk into one of three classifications, to require premarket approval for Class III devices, and for devices to comply with reporting and GMP requirements.

The law ushered in a new era for medical technology innovation, patient access, and patient safety, but also created a tension, contributing to a political environment where the pendulum continues to swing between these objectives, defining and driving the medical device ecosystem ever since.

“Today, devices are routinely implanted in our bodies. They replace limbs, bones, tissues, even entire organs. They permit treatment of forms of illness that can be accomplished in no other way. They magnify and speed 10 thousandfold the diagnostic power of the human eye and brain.

“Medical and diagnostic devices have produced a therapeutic revolution, but in doing so they have also become more complex and less easily understood by those who use them. When well designed, well made, and properly used they support and lengthen life. If poorly designed, poorly made, and improperly used they can threaten and impair it.”

While I’d like to take credit for those words—I can’t. While they sound suspiciously recent—they are not.

These are President Gerald Ford’s words—a succinctly accurate and descriptive summary of why, in 1976, America desperately needed the law he was signing to allow the FDA to regulate medical devices based on risk.

Medical devices can save and give us better lives. I know because my family has relied on them for years – from cardiac stents to implantable hips to the mammogram that picked up my wife’s cancer in time to get her the treatment she needed. But we can rely on these medical miracles because of the careful oversight we provide here at CDRH.

When my wife had to decide what course of treatment to pursue, she was given the results of a laboratory developed test. However, it wasn’t until she and I had the results from an FDA-approved test that we had the information and the confidence we needed to make fully informed decisions.

It is our work, our care, and our dedication that will allow us to reach our vision—that patients in the U.S. have access to high-quality, safe and effective medical devices of public health importance first in the world.

CDRH’s vision—our shared vision – intentionally begins with “patients” because improving the health and the quality of life of patients by assuring they have  timely access to medical technologies that will benefit them is at the  heart of who we are and  what we do.

After 40 years, we live in a world of sophisticated software algorithms, miniaturization, combination products, wearable sensors, non-invasive procedures and diagnostics, robotics, and artificial intelligence. And, all along the way, we at CDRH have had to adapt our expertise and regulatory approaches to meet the needs of rapidly evolving innovation. That has been our history.

Make no mistake:  We are as scrappy and as enterprising as the industry we regulate.

As we look to the future, however, we will continue to adapt, but, more importantly, we will and have already begun to focus on proactively anticipating where we need to be so that regulatory innovation can get out in front of medical device innovation. We’re doing this now in the digital health space, by designing regulatory frameworks around the type of technology and its unique evidence generation and innovation cycle needs rather than applying a one-size-fits-all approach.

 And we are implementing new models for evidence generation, such as through the establishment of a National Evaluation System for health Technology, or NEST, that could transform the historical tension between device innovation, patient access and patient safety into an alignment of interests to drive the development and more timely access to life-saving, life-enhancing, and life-advancing devices.

We are going to new places with the patients who drive our mission, by establishing a foundation for routinely incorporating their perspectives in our decisions. After all, they are our most important customer and should be our partner in best serving them.

Forty years ago, the initial Medical Device Program started with about 180 people, and our country was celebrating its 200th anniversary. That year, NASA unveiled its first space shuttle – The Enterprise – which, as a Star Trek fan, I thought was very, very cool. As a nation we were ready to soar.

Forty years later, CDRH is 1,700 strong; a vibrant family of individuals with a wide range of scientific, clinical, engineering, legal, and other expertise, who hail from a variety of backgrounds, and who are ready to tackle the latest scientific advancement, including what one day soon may be the first Star Trek-like tricorder. While our mission and vision guide us, and patients drive us—it is our people and their diverse personal and professional backgrounds, experiences, and expertise who are fundamental to our success as a public health agency.

If our mission and vision are our North Star, if patients are our compass, then our ship – our USS Enterprise – that will boldly go where no person has gone before – is CDRH, and you are its crew.

Captain James T. Kirk once said, “You know the greatest danger facing us is ourselves, an irrational fear of the unknown. But there’s no such thing as the unknown — only things temporarily hidden, temporarily not understood.”

I don’t know what new worlds we will discover or the new technologies we will encounter, but I look forward to traveling there with you wherever we may go.

Happy anniversary.

Medtronic leaves Minnesota for Dublin: Senators Franken, Klobuchar cuckolded?

Medtronic-Covidien Deal Is a Marriage ofConvenience

By JEFFREY GOLDFARB and ROBERT CYRAN JUNE 16, 2014 11:53 AM

FiDA Highlight

The marriage of Medtronic and Covidien looks to be one of convenience. The $42.9 billion deal includes a premium that exceeds the estimated cost savings. Stents and sutures are not an obvious fit. And moving Medtronic’s headquarters from Minneapolis to Covidien’s Dublin base will not obviously cut the American company’s tax bill. Freeing up overseas cash is too shallow a reason to tie the knot.

There is reason to suspect a rush to the altar. Pfizer’s advance on AstraZeneca this year attracted the attention of lawmakers in Washington to merger tax arbitrage. Congress is now kicking around proposals to restrain so-called inversions, where a buyer finds a target overseas to reduce what it owes Uncle Sam annually. Medtronic’s pledge to invest an extra $10 billion in technology over the next decade as part of the deal suggests some political concern.

Yet while buying Covidien will relocate Medtronic to Ireland, there does not seem to be any immediate tax savings. Over the last two years, the companies have paid on average almost the same effective rate of about 18 percent.

What is more, although both companies operate in the medical supplies industry, they do not necessarily complement each other. Medtronic manufactures high-tech devices implanted in people while its target makes basic surgical materials. These require different mind-sets with regard to research, development and regulation.

Even so, there will be back-office, supply-chain and other costs to hack, estimated at $850 million a year. Taxed and capitalized, these would be worth about $7 billion today. Yet Medtronic’s cash and stock offer includes a premium of nearly $10 billion. Therefore, it is either overpaying or expects to reap greater benefits elsewhere.

Medtronic alludes to some tantalizing possibilities. It says the combination is expected to generate significant free cash flow, “which it will be able to deploy with greater strategic flexibility,” especially in the United States. One interpretation could be that by moving overseas, Medtronic would be able to distribute more cash to shareholders because it would no longer keep profit earned outside America offshore, as many United States companies do, to avoid paying taxes.

That’s a nice perk, but a bit like getting hitched for the party and the presents. Corporate betrothal, like the personal kind, ought to have greater meaning.


Jeffrey Goldfarb is an assistant editor and Robert Cyran is a columnist at Reuters Breakingviews. For more independent commentary and analysis, visit breakingviews.com.

$10M Settlements to whistleblowers do not prevent patient harm: they protect the perpetrators!

UC OKs paying surgeon $10 million inwhistleblower-retaliation case

The settlement ends a case brought by the ex-head of UCLA's orthopedic surgery department, who says the medical school allowed doctors to take industry payments that may have compromised patient care.

By Chad Terhune          Los Angeles Times     FiDA highlight

April 22, 2014, 8:27 p.m.

University of California regents agreed to pay $10 million to the former chairman of UCLA's orthopedic surgery department, who had alleged that the well-known medical school allowed doctors to take industry payments that may have compromised patient care.

The settlement reached Tuesday in Los Angeles County Superior Court came just before closing arguments were due to begin in a whistleblower-retaliation case brought by Dr. Robert Pedowitz, 54, a surgeon who was recruited to UCLA in 2009 to run the orthopedic surgery department.

In 2012, the surgeon sued UCLA, the UC regents, fellow surgeons and senior university officials, alleging they failed to act on his complaints about widespread conflicts of interest and later retaliated against him for speaking up.

UCLA denied Pedowitz's allegations, and officials said they found no wrongdoing by faculty and no evidence that patient care was jeopardized. But the UC system paid him anyway, saying it wanted to avoid the "substantial expense and inconvenience" of further litigation.

As department chairman, Pedowitz testified, he became concerned about colleagues who had financial ties to medical-device makers or other companies that could unduly influence their care of patients or taint important medical research.

He also alleged that UCLA looked the other way because the university stood to benefit financially from the success of medical products or drugs developed by its doctors.

One of the orthopedic surgeons that Pedowitz complained about testified at trial about receiving $250,000 in consulting fees in 2008 from device maker Medtronic. In memos to university officials, Pedowitz raised concerns about the financial dealings of other doctors as well.

Inside the courtroom Tuesday, Pedowitz sat in the front row with his wife and daughter as the judge told jurors that a settlement had been reached. He said he felt vindicated by the outcome.

"These are serious issues that patients should be worried about," Pedowitz said in an interview. "These problems exist in the broader medical system and they are not restricted to UCLA."

The seven-week trial in downtown Los Angeles offered a rare glimpse into those potential conflicts at a time when there is growing government scrutiny of industry payments to doctors.

Starting this fall, the federal Physician Payments Sunshine Act, part of President Obama's healthcare law, requires public disclosure of financial relationships between healthcare companies and physicians.

Many doctors and universities defend long-standing industry arrangements as essential for carrying out cutting-edge research and top-flight medical education.

In a statement Tuesday, the UC regents said they "resolved this lawsuit to end a prolonged conflict and permit UCLA Health Sciences to refocus on its primary missions of teaching, research, patient care and community engagement."

The statement added that "multiple investigations by university officials and independent investigators concluded that conduct by faculty members was lawful. Patient care was not compromised."

This latest settlement eclipses a $4.5-million payout the UC regents made last year to resolve a racial discrimination lawsuit filed by another UCLA surgeon.

Pedowitz, as part of his settlement, left the UCLA faculty, effective Tuesday. He had agreed to step down as department chairman in 2010 after initially voicing his concerns to top UCLA officials. He filed a whistleblower retaliation complaint in March 2011.

Experts in medical ethics say the UCLA case shows much more needs to be done within academia and by government regulators to address potential conflicts of interest in medicine.

Susan Chimonas, associate director of research at Columbia University's Center on Medicine as a Profession, said some medical schools are still reluctant to take on specialists who bring in considerable money from patients, medical research and patents on breakthrough products.

"Institutions can be dependent on the money these big-earning specialties like orthopedic surgery bring in," Chimonas said. "They are the cash cows and they can set their terms. This is not the first time I've heard of medical schools having policies that are not well enforced."

In an interview last week, the chief compliance officer at the UCLA Health System flatly rejected the notion that the university didn't enforce its policies or look fully into Pedowitz's allegations. She also said industry ties are unavoidable at a big medical school and rules are in place to prevent conflicts.

"We have processes in place to identify those relationships in a transparent fashion and ensure they don't have any inappropriate influence on the actions of the university," said Marti Arvin, chief compliance officer. "In order to meet our mission, it is important we have both the brilliant minds we have at UCLA and collaboration with industry."

Arvin said the university "thoroughly and objectively investigated those allegations of noncompliance raised by Dr. Pedowitz. We were able to determine the vast majority were unsubstantiated."

She said two doctors fell short of university expectations in their handling of outside income, but there was no violation of law or university policy in either instance.

Arvin cited the case of Dr. Nick Shamie, the orthopedic surgeon who testified at trial about receiving $250,000 from Medtronic for consulting work. She said department policy at the time didn't require Shamie to send that outside income through UCLA's faculty compensation plan.

At trial, Pedowitz said he was deeply troubled by the large amount of money Shamie was paid. He testified that he was particularly concerned that Shamie was trying to enroll patients in a research study involving Medtronic at the time.

"I saw this as an obvious problem," Pedowitz testified.

In court, Shamie said he abided by university policy and didn't pursue the study further because finding patients was too difficult. He couldn't be reached for additional comment.

The other physician cited by Arvin for a potential shortcoming was Dr. David McAllister, vice chairman of clinical operations for the orthopedic surgery department.

He didn't report payments from the Musculoskeletal Transplant Foundation, a nonprofit tissue bank that does business with UCLA, because he didn't think disclosure was required in that instance because it didn't involve a for-profit entity, Arvin said.

McAllister also declined to comment, referring a call to UCLA.

Shortly before Pedowitz joined UCLA in 2009, the university was already facing criticism from Congress over the failure of a top spine surgeon to report nearly $460,000 in payments he received from Medtronic and other medical companies while researching their products' use in patients, government records show.

Dr. Jeffrey Wang, who left for USC Spine Center last fall, stepped down as head of UCLA's spine program in 2009 after U.S. Sen. Charles Grassley (R-Iowa) publicized his lapse in disclosure as part of a larger investigation into medical conflicts of interest.

Several patients are now suing Wang and UCLA in state court for negligence, fraud and malpractice in connection with surgeries involving Medtronic's controversial Infuse bone graft. UCLA said it doesn't comment on pending litigation. Wang couldn't be reached for comment.

Shortly after raising his concerns, Pedowitz said, he was pressured to step down as department chairman in 2010. Pedowitz said he was further retaliated against by being denied patient referrals and prevented from participating in grants and other activities.

Before UCLA, Pedowitz worked at UC San Diego and as chairman of orthopedics and sports medicine at the University of South Florida.

Mark Quigley, an attorney representing Pedowitz, said the case could have been avoided if the UC system enforced the policies it already has in place.

"What good are all the policies if they protect the wrongdoers and fail to protect the actual whistleblower?" Quigley said. "The university wanted to cover it all up."

chad.terhune@latimes.com

Twitter: @chadterhune