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

Conflicted FDA DEFENDS illegal Olympus, device, that killed 2

FDA: Manufacturer never had permission to sell device connected to superbug deaths

By Elizabeth Cohen, CNN Senior Medical Correspondent

Updated 1:04 AM ET, Wed March 4, 2015

Story highlights

1. FDA official says Olympus never got permission to sell its endoscope
2. Medical device is connected to CRE outbreak in California that's left two people dead

(CNN)CNN has learned that the manufacturer of the endoscope involved in two superbug deaths at UCLA never obtained permission to sell the device, according to an official at the Food and Drug Administration.

Olympus started selling its TJF-Q180V duodenoscope in 2010, but the FDA didn't notice until late 2013 or early 2014 that the company had never asked for clearance to put it on the market, according to Karen Riley, deputy director of strategy for the FDA's Office of External Affairs.

"Why didn't we notice it? I don't know," Riley said.

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"Can you imagine a prescription drug getting out on the market that didn't go through the approval process?" asked Dr. Steven Nissen, the chief of cardiovascular medicine at the Cleveland Clinic, who's testified to Congress about device safety problems. "Devices need to be regulated more vigorously. This is really disturbing."

Mark Miller, a spokesman for Olympus, did not respond to calls and emails from CNN seeking comment for this story.

Outbreak started at UCLA

Seven hospital patients at Ronald Reagan UCLA Medical Center were infected with the deadly superbug CRE -- also known as carbapenem-resistant Enterobacteriaceae -- between October and January, according to hospital officials. Two of those patients died.

The patients caught CRE after routine endoscopic treatments. Hospital officials believe two medical scopes that still carried the deadly bacteria even after disinfection guidelines were followed were the cause of the superbug outbreak.

The medical center has contacted 179 others who had endoscopic procedures between October and January and is offering them home tests to screen for the bacteria.

In a separate outbreak on the other side of the country, 18 people contracted CRE in North Carolina, and one of those died.

Not safer

According to FDA rules, a manufacturer must seek clearance for a new model if it includes changes that "could significantly affect the safety or effectiveness of the device."

The TJF-Q180V duodenoscope, used to check out ducts in the gastrointestinal system, includes a modification to the exact part of the device that's been implicated in the superbug outbreaks.

With this new model, Olympus sealed up that part of the device, known as the elevator channel, hoping to make it more impervious to infection.

"The company clearly made these modifications to make the device safer, but it seems to be that it wasn't safer," Riley said.

Last year, at the FDA's request, Olympus applied for permission to sell the scope. That application is still pending.

Riley emphasized that duodenoscope procedures can be lifesaving, so the agency doesn't want to take them off the market.

"More than 500,000 of these procedures are done every year in the U.S., and the risk of bacterial transmission is actually really very, very low," she said. "We believe the risks outweigh the benefits."

Riley noted that the other two duodenoscope manufacturers, Pentax and Fujifilm, did apply for and were granted clearance to market models similar to Olympus' TJF-Q180V.

Not clean enough

Now the FDA is asking all three companies to submit evidence that the scopes can be thoroughly cleaned -- and so far it's not going well.

Riley said twice the companies have submitted data that failed to show that cleaning could get rid of 99.9999% of all microbes on the scope -- the FDA's standard for disinfection.

"We're still working with them to get good data," she said.

Riley said she doesn't know if the FDA will penalize Olympus for selling the device without permission.

Diana Zuckerman, a device safety expert (National Center for Health Research), said they should.

"It's like with kids. How do you teach your children to behave if there are no consequences when they misbehave?" she said.

http://www.cnn.com/2015/03/04/us/superbug-endoscope-no-permission/

$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

Conflict of Intere$t: Medical Leader$ are Conflicted!

Public Health & Policy

Following the Money: Gold in Ivory Towers

Published: Apr 1, 2014

By John Fauber, Reporter, Milwaukee Journal Sentinel/MedPage Today

Academics who moonlight for drug companies have faced intense scrutiny in recent years, but new research suggests much larger sums of money are being paid to their bosses -- the leaders of medical schools and hospitals who serve on drug company boards.

Looking at the world's 50 largest drug companies, researchers found that 40% had at least one board member who held a leadership position at a U.S. academic medical center -- including medical school deans, chief executive officers, department chairs, and university presidents.

The average annual compensation from the drug companies was $313,000, according to the paper published today in the Journal of the American Medical Association.

"These relationships present potentially far-reaching consequences beyond those created when individual physicians consult with industry or receive gifts," the researchers wrote.

Big Jobs, Big Bucks

Others who were not involved in the study said such lucrative moonlighting for drug companies with vested interests simply should not be done by university leaders who oversee independent research and the instruction of medical professionals.

"I don't know how they can manage a conflict like that," said Susan Chimonas, PhD, who frequently writes and lectures on conflicts of interest in medicine. "My gosh, there is so much money they are making for a little side job."

Serving in dual roles raises so many potential conflicts that it would be wiser to eliminate them, said Chimonas, associate director of research for Columbia University's Center on Medicine as a Profession.

Unlike faculty or staff, top leaders of academic medical institutions are involved in business decisions and corporate partnerships, said Paul Levy, the former president and CEO of Beth Israel Deaconess Medical Center in Boston, which is affiliated with Harvard University.

Those decisions and partnerships could include performing clinical trials for drug companies, allowing drug samples to be given out in hospitals and clinics, allowing doctors to engage in drug company promotional speaking, endorsing and offering drug company funded continuing medical education (CME), and deciding what drugs to allow on a hospital's formulary, said Levy, who headed Beth Israel Deaconess from 2002 to 2011.

"You cannot serve two masters, even if you are highly intelligent," said Levy, who now blogs about the health industry and serves as senior adviser at Lax Sebenius, of Concord, Mass. "In fact, if you are highly intelligent, you will rationalize the problems away by saying that you cannot be personally corrupted."

By the Numbers

The JAMA paper did not list individuals, though it did name medical schools, universities, and academic hospitals whose officials served on drug company boards of directors. It also named drug companies, including Pfizer, Merck, GlaxoSmithKline and Johnson & Johnson.

For the study, the researchers only looked at the year 2012.

The Journal Sentinel and MedPage Today used proxy statements filed by the companies to identify some of the board members and find out how much they were paid.

From the Yale School of Medicine in New Haven, Conn., to the David Geffen School of Medicine at UCLA in Los Angeles, the institutions include some of the most prominent academic medical centers in America.

For instance, Robert Alpern, MD, dean of the Yale School of Medicine received $259,000 in total compensation serving on the Abbott Laboratories board of directors in 2013, according to the company's proxy statement.

As of Jan. 1, 2014, he also held 11,656 shares of restricted Abbott stock.

In its proxy, Abbott said Alpern's relationship did not impair his independence.

In an email, Karen Peart, a spokeswoman for Yale, said Alpern would have no role in any of the above decisions such as clinical trials, drug samples or drug formularies.

"If ever he had the opportunity to be involved in a decision affecting Abbott, he would recuse himself," she said.

She said the university encourages its faculty to consult widely and to engage in activities that may benefit the university and the public.

A. Eugene Washington, MD, dean of the UCLA School of Medicine, joined the Johnson & Johnson board of directors in November 2012. In 2013, he was paid $261,000 in total compensation by the company, according to its proxy statement. As of Feb. 25, 2014, he was listed as the beneficial owner of 5,129 shares.

In an email, a spokesman for Washington said UCLA does not allow drug companies to provide samples and prohibits faculty from promoting drugs.

"Dr. Washington manages any potential conflict of interest in accordance with university policies and makes no decisions regarding the purchase of pharmaceutical products or clinical trials," Dale Triber Tate, a UCLA spokesman said.

Mary Sue Coleman, president of the University of Michigan, also serves on the Johnson & Johnson board and was paid $276,000 in total compensation in 2013, according its proxy statement. As of Feb. 25, 2014, she was listed as the beneficial owner of 34,465 shares. That stock was worth nearly $3.4 million at Tuesday's price of about $98 per share.

In an email, Kelly Cunningham, a spokeswoman for the university, said the university already has banned drug company funded doctor education and drug samples from all companies.

She said Coleman is not involved in decisions involving Johnson & Johnson purchases or investments.

"The University of Michigan does not see President Coleman's service on the Johnson & Johnson board as a conflict of interest," Cunningham said.

In its proxy statement, Johnson & Johnson said it sells healthcare products and services to both UCLA and the University of Michigan. It also listed research grants and consulting fees with Michigan. It said neither of its board members from those institutions had any "direct business relationships" with the company.

The company also said its board determined that neither of the relationships conflicted with the interests of the company or impaired "the relevant nonemployee director's independence or judgment."

"It is a potential conflict of interest that is not often discussed," said senior author Walid Gellad, MD, with the VA Pittsburgh Healthcare System and an assistant professor of medicine at the University of Pittsburgh. "If a pen or a $150 dinner presents a conflict for a doctor, what does it mean if you get $300,000?"

Gellad noted that the research only involved drug companies. It did not include medical device companies and health insurance firms.

"I would say this is just the tip of the iceberg," he said.