But now a group of federal lawmakers are stepping up to take on medical device manufacturers and the Food and Drug Administration, the gatekeeper for deciding if such devices go on the market.

A report from Safety Research & Strategies Inc. details how four members of Congress are attempting to tighten the rules that were eased during the Bush Administration to allow medical devices on the market with far less strict review. Some types of devices can now make it to market with no clinical testing or proof of efficacy.

The legislation is being pushed by by Reps. Edward J. Markey (D-Mass.), Henry A. Waxman (D-Calif.) and Jan Schakowsky (D-Ill.), who all sit on the House Committee on Energy and Commerce’s Subcommittee on Oversight and Investigations.. A fourth sponsor, Rep. Rosa DeLauro (D-Conn.), is a member the appropriations committee’s Subcommittee on Agriculture, Rural Development, the FDA and related agencies.

Meanwhile, Consumers Union has stepped up its efforts to prod Washington to boost oversight. This week, Consumers Union’s Safe Patient Project is bringing eight patient safety activists from around the country to the Capitol to meet with lawmakers in a bid for improvements to the Medical Device User Fee Act (MDUFA).  That act has been the subject of intense scrutiny as problems with various medical devices have continued to make headlines.

“Most Americans would be surprised to learn of the lax oversight of medical implants,” Lisa McGiffert, director of Consumers Union’s Safe Patient Project, said in a press release announcing the effort.  “Too many of these devices are allowed on the market without testing to determine whether they are safe and effective. Innovation is important but patient safety should be our first priority. A medical device isn’t innovative if it doesn’t work and hurts people.”

Astonishingly, 90 percent of medical devices do not require proof that they have been clinically tested and found to be safe and effective prior to being cleared by the FDA for distribution or sale, according to Consumers Union. The group is also pushing for a better system to monitor and track devices on the market so problems can be quickly identified and patients alerted.

Among the most notable problems have been among patients who received metal-on-metal replacement hips or hip resurfacing treatments. The group  US Drug Watchdog this week launched a campaign designed to  identify every US citizen, who is the recipient of any type of metal on metal  hip implant device since 2004.

A fact sheet on problems with medical device problems on Consumer Union’s web site also calls on changes so the FDA can to use its recall authority more effectively and for lawmakers to provide the agency with authority to require device makers to do long term post market studies, regardless of which process is used in the pre-market phase.

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The agreement to put Brius Healthcare in charge of operations at the facilities means a court-ordered injunction requiring compliance with the staffing levels no longer applies to those facilities. Under terms of the injunction, which was part of a settlement that reduced Skilled Healthcare’s liability to $62.8 million, the company is paying for a court-appointed monitor to ensure compliance. That injunction still applies to the other 17 Skilled Healthcare facilities covered by the verdict.

Tim Needham

Eureka attorney Tim Needham, one of the attorneys who represented residents of the Skilled Healthcare facilities in the class action suit, said he was not surprised by the maneuver to remove the Humboldt County facilities (four in Eureka and one in Fortuna) from the injunction, because the possibility was raised in the negotiations to reduce the jury’s $677 million verdict. “The deal was that if they transferred operations of the facilities to any type of entity affiliated with Skilled that the injunction would transfer as well,” Needham said. But if the new operator were unaffiliated with Skilled, then the injunction would not apply.

Needham said criticism of the part of the settlement that makes it possible for the facilities involved to be removed from the effects of the injunction doesn’t take into account the context of the negotiations. They took place while Skilled Healthcare officials were threatening to declare bankruptcy if the jury’s verdict were not modified. Not only would bankruptcy would have significantly reduced what the members of the class would have been able to collect, but Skilled would have been able to continue operating the facilities without an injunction requiring monitoring of staffing levels.

“You can say, in hindsight, was this bad [to remove the facilities from the injunction in the event of new operators], but I still don’t have any indication it was,” Needham said. “If they had come out of those negotiations saying, listen, we’re going to give those facilities to new operators, we would have been ecstatic. The fact that they are no longer operating five of them doesn’t hurt my heart. The way I felt when we were negotiating, it was good riddance if Skilled decided to get out.”

Needham said even though the new operators in Humboldt County won’t be monitored under the injunction, they’ll still face increased scrutiny as a result of last year’s verdict against Skilled Healthcare. “It’s our hope that they’ll play by the rules,” he said. “They’ve certainly been given every reason to understand that if they don’t play by the rules, we’ll go after them. I’m not going to jump in and prejudge these guys because it’s too easy to do so. I want to give them every chance to do a good job. And if they don’t, I’m going to be after them.”

Humboldt County native Brad Gibson, a health care industry veteran, is the Brius executive overseeing the facilities and is based in Eureka. “I’m in constant contact with Brad,” Needham said. “At least you know this much, the guy who’s responsible for the facilities now lives in our community, and you can pick up the phone and say, ‘Brad, what the hell are you doing?’ It makes a huge difference. [Skilled Healthcare senior management is based in Southern California.] He’s met with the [Humboldt County] district attorney, he’s met with me, he’s going around trying to improve their image in the community.

“At least from what I’ve seen so far there’s been pretty much a sea change [in the operation of the facilities]. I’m not upset by that.”

–J.G. Preston

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Dr. Stefan Konasiewicz, in a photo from the website of the South Texas Brain and Spine Center in Corpus Christi, where he now practices

In Texas, you call him a doctor who can practice medicine with no restrictions whatsoever.

In 2003 Texas voters approved, by a narrow margin, Proposition 12, amending the state constitution to allow the legislature to place caps on the amount juries can award as compensation to people who are injured by medical negligence, harmed through no fault of their own. The legislature promptly passed caps on liability for both non-economic damages (including loss of mobility, loss of fertility, severe disfigurement or ongoing chronic pain) and wrongful death.

If Texas voters were hoping these caps would attract more doctors to the state, perhaps they should have thought harder about what doctors would be attracted.

Stefan Konasiewicz, a neurosurgeon who had practiced at St. Luke’s Hospital in Duluth, Minn., was reprimanded by the Minnesota Board of Medical Practice on September 13, 2010. The board made reference to four of Konasiewicz’s patients in its reprimand, as summarized by the Duluth News Tribune:

In July 2007, Konasiewicz ordered an anesthesiologist to apply manual traction and placed a template into the surgical site, but noted a “sudden jerk’’ and movement of the cervical vertebrae. The patient was subsequently diagnosed with “persistent cervical quadriplegia.” Konasiewicz appeared before the board’s complaint review committee and admitted to movement of the patient’s spinal column during the procedure.

In February 2005, Konasiewicz performed lumbar spine surgery on a patient who died from cardiopulmonary arrest 12 hours after surgery. An autopsy revealed a perforation of the lumbar disc, with extension of the perforation into the wall of the aorta. The autopsy concluded that the patient’s death was caused by a surgically-induced defect (emphasis added).

In the fall of 2003, Konasiewicz recommended an epidural steroid injection to a patient with a history of chronic back problems and recent numbness in his right thigh. He injected a dye other than the one he intended to use. The injection caused muscle spasms, which resulted in fractures to three of the patient’s lumbar vertebrae.

On June 14, 2000, a patient fell off a ladder onto a landing at work, injuring his left hip and buttock. The patient claimed to have suffered a nerve root injury as the result of injections performed by Konasiewicz.

As part of the reprimand, the state board ordered Konasiewicz be observed performing surgeries by a board-approved supervising physician at least five times per quarter, with the supervising physician submitting quarterly reports to the board.

But Konasiewicz had already left Minnesota before the reprimand was issued, moving to Corpus Christi, Texas, where he is listed as a surgeon (the second one down) on the website of the South Texas Brain and Spine Center. Perhaps one reason for the move was that Minnesota does not limit the amount of compensation patients can be awarded for their medical injuries. Texas does. (Konasiewicz has been licensed in Texas since 1997 but did not move to the state until after damage caps were implemented.)

And it turned out several of Konasiewicz’s patients had been compensated for their injuries. The state board reprimand prompted News Tribune reporters Brandon Stahl and Mark Stodghill to launch a full-blown investigation into Konasiewicz’s medical career in Duluth, published May 29, 2011:

When he moved from Duluth about three years ago, Konasiewicz left behind two dead patients, one woman paralyzed from the neck down and six others who say his treatment caused them serious physical harm….

Multiple sources also show that between 2005 and 2008, St. Luke’s and Konasiewicz settled five malpractice suits for a total of at least $3.2 million.

Stahl and Stodghill talked to six doctors at St. Luke’s who told them “they had been gravely concerned about Konasiewicz’s ability and competence.” Neurosurgeon William Himango said, “The problems confronting this physician had — not only by me, but by others — been brought to the attention of the administration prior to some of these incidents.” And neurologist David McKee said, “The scope of the problem was evident from an early date. Information provided to the administration by physicians and nurses was not well-received.”

St. Luke’s responded to the News Tribune article with a statement expressing its full support of Konasiewicz. The hospital had already expressed its support financially, not just by paying settlements to injured patients but by paying Konasiewicz. The News Tribune found he had been the hospital’s highest-paid physician in 2005, earning $1.3 million, and was the second-highest-paid physician in 2008, with earnings of $1.6 million.

The first claim of malpractice against Konasiewicz came when he allegedly ruptured a woman’s aorta during spinal surgery within a year of his arrival in Duluth. A jury did not find Konasiewicz at fault, but a fellow St. Luke’s neurosurgeon testified against him.

Until recently, that was the only case against Konasiewicz to go to trial. But it was far from the last allegation of harm.

In 2001, a medical student who was treated by Konasiewicz for carpal tunnel syndrome lost the use of her right arm for several years and says her right hand is still numb. The News Tribune reported she sued Konasiewicz and St. Luke’s and settled for about $85,000.

The patient who suffered fractured vertebrae after being injected with the wrong dye in 2003 (one of the cases referred to in the state board reprimand above) settled for about $300,000.

In 2004 Konasiewicz operated on a 56-year-old woman to alleviate pain from a herniated disc. The woman got an infection from the procedure and was in progressively worse pain until she died at her home within a week of the operation. Her widower won a settlement of about $355,000.

In 2005 Konasiewicz cut the aorta of a 25-year-old mother of two during spinal surgery (another case referred to in the state board reprimand). But he apparently didn’t notice the hole in her artery, and she bled to death 12 hours later. Her family settled for $1.45 million.

And in 2007 a patient wound up paralyzed from the neck down after being improperly secured during neck surgery (also referred to in the reprimand). Her family settled for more than $1 million.

(The stories of all these injured patients are told in detail in the News Tribune.)

But when you look at Konasiewicz’s record on the website of the Texas Medical Board, you will find that, according to Konasiewicz, he has no reportable malpractice claims. No Texas patient who went to the state licensing authority for information about this doctor would have any clue that there had been more than $3 million in malpractice settlements resulting from his care.

The malpractice information on the Texas Medical Board website is reported by the physician him- or herself. News Tribune reporters Stahl and Stodghill talked to board spokeswoman Leigh Hopper:

Konasiewicz received his license from the Texas Medical Board in 1997 and is required to renew it every two years, Hopper said. She said the board is supposed to review a doctor’s malpractice and disciplinary action when it renews a license, but she couldn’t say if that happened with Konasiewicz.

“It’s actually possible that the board doesn’t know about all the medical malpractice cases in another state,” she said.

What might come as a shock is that the Texas Medical Board doesn’t go looking for malpractice information from outside sources. Again, from Stahl and Stodghill:

All state medical boards have full access to the National Practitioner Data Bank, which lists malpractice cases and disciplinary actions taken against doctors. But Hopper said that because the Data Bank charges for queries, it would cost the state of Texas too much — she estimated $160,000 a year — to check on every doctor licensed in the state.

“We might query it as part of an investigation, but it won’t be a source to start an investigation,” Hopper said.

The ultimate responsibility of disclosing malpractice cases is on the doctor, Hopper said.

“If the doctor doesn’t want to tell us and is not truthful when he renews his license, then we’re not going to find out about it, either,” she said.

Konasiewicz’s page on the Texas Medical Board website does include this information:

Disciplinary Actions By Other State Medical Boards

The physician has reported the following:

Description: DISCIPLINARY ACTION TAKEN BY THE MN BOARD OF MEDICAL PRACTICE REQUIRING MENTORING OF CASES AND REPORTING TO THE MN BOARD.

But there is no information about the nature of that disciplinary action. And the requirement for a supervising physician to monitor Konasiewicz’s surgeries and file quarterly reports is not being observed in Texas, according to the News Tribune:

If a doctor relocates to Texas, that state’s medical board typically adopts the disciplinary actions and sanctions imposed by a previous state, said [Hopper].

However, she said, as far as Texas is concerned, Konasiewicz has a clear medical license with no restrictions.

“And I don’t know why that is,” she said.

…Minnesota has no obligation or authority to require Konasiewicz to follow the discipline order, said Ruth Martinez, the complaint review unit supervisor for the Minnesota medical board.

After the News Tribune published its initial investigation into Konasiewicz, the reporters heard from more of his former patients and told the stories of four of them in an article published August 1. That same day, a report by Stahl focused on “the efforts of Konasiewicz’s former colleagues to warn the St. Luke’s administration about his practice, and the hospital’s response.”

Konasieweicz is now back in court in Minnesota, facing another malpractice allegation. Alan Meinershagen says he has been unable to walk since a cerebral hemorrhage caused by a brain biopsy performed by Konasiewicz in 2006. The trial was moved 150 miles from Duluth to suburban St. Paul at the request of Konasiewicz’s attorneys “because of concerns about jurors being prejudiced by previous news coverage,” according to Meinershagen’s attorney. (UPDATE: Konasieweicz was found to be not negligent in a verdict returned on August 10.)

Meanwhile, news of Konasiewicz’s history of malpractice has reached Corpus Christi, where he now practices. And a patient who said he’s having difficulty recovering from a recent spinal fusion surgery performed by Konasiewicz “says he feels deceived because he even tried searching the Texas Medical Board website for complaints against Dr. Konasiewicz and nothing turned up,” according to a report from KRIS-TV.

–J.G. Preston

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It’s hard to say what brings tears to Kathy Olsen’s eyes faster – talking about her son’s past, or the young man’s future.

Steven Olsen was a mischievous two year-old in 1992, the kind of kid happy to lead his 3-year-old sister into trouble on a regular basis. His response when mom put up a gate to keep the kids from climbing the stairs? No problem – Steven would turn a laundry basket into a step; up and over they’d go. And when dad blocked off the ladder to the backyard slide? Steven turned a tricycle into a step stool.

“He figured this all out,” she says. “He was really quite intelligent.”

That all changed in late February 1992, when a freak injury followed by a downward spiral of medical errors left the boy severely brain-damaged. This tragic series of events turned the Olsens into forceful advocates in the battle to roll back California’s medical malpractice caps, set in place by the watershed Medical Injury Compensation Reform Act of 1975. MICRA’s $250,000 cap on human suffering, the Olsens argue, led to an inadequate financial settlement and didn’t allow the family to fully hold accountable the people responsible for destroying their son’s life.

The Olsen’s ordeal began during a visit to a relative’s mountain cabin outside San Diego, where Steven tripped while running and fell face-first onto a sharp stick that penetrated deep into the right front part of his mouth, face and sinus cavity. Surgeons at Children’s Hospital of San Diego repaired the damage and took cultures to test for infections as a precaution, then sent the family home.

A few days later, Kathy and her husband, Scott Olsen, noticed that Steven was becoming lethargic. A fever spiked. The Olsens brought him back to the hospital. As the medical teams tried to figure out what was happening, the couple suggested the face-impalement may have caused additional problems and asked for a brain scan. The medical team rejected the request and  diagnosed meningitis, the first in a series of errors that eventually sent Steven into a two-week-long medically induced coma.

By the time the nightmare stabilized, Steven was severely brain-damaged from an undiagnosed and ruptured abscess inside his skull caused by the impalement. That unseen damage would have been discovered had the doctors heeded the Olsens’ request for a scan. And it likely would have been treated even sooner had the medical team checked the lab results on the cultures that had been taken during the first hospital visit.

Steven (right) with his brother and sister. © Consumer Attorneys of California

The fallout of that missed diagnosis of a treatable infection was horrific: The bright and creative problem-solving toddler was left severely brain-damaged, blind and incapable of all but the most basic tasks. As his parents look to the future, they fear for how his later years will play out, in part because MICRA had capped a jury verdict of $7.1 million in pain and suffering damages at $250,000.

The Olsens did receive $4.1 million in economic damages from the jury and a pre-trial settlement with some of the defendants. That total immediately shrank by a quarter for lawyers’ fees, and by another $115,000 for the expert witnesses who testified in the trial. Other expenses, including nursing care and a private school for the disabled that helped Steven regain some of his speech and coordination, also have accounted for more than $100,000 in costs.

Steven also receives $718 a month disability support from Social Security, which was cut in May from $908 a month. The Olsens say a conservator controls the money on Steven’s behalf, but they fear it will run out. “I don’t think his money will last as long as he will,” Kathy Olsen says, tears again streaming down her cheeks. Yet she also thinks her son is lucky that they’ve been able to advocate for him. “We’re survivors in a system that isn’t really set up to help somebody,” she says.

Most of the young man’s medical costs have been covered by health insurance through Scott Olsen’s job as an automotive technical writer, but he will soon age out of that coverage. They fear that once they pass on, responsibility for Steven’s care will ultimately fall to government programs rather than to the people most responsible for his condition – the medical team that made the critical and avoidable errors when the boy was two.

Steven’s medical problems have transformed the Olsen’s family life. When he was injured, the family had four pre-teen children living and sharing bedrooms in a two-story house in suburban San Diego. Kathy Olsen quit her career as a store manager for Sears to become Steven’s primary care-giver rather than hiring aides to cover the hours when she otherwise would be working. Scott Olsen believes his career as a technical writer has suffered because of his repeated and extended absences during Steven’s many medical crises – including 23 surgeries.

Steven's mother Kathy became his primary caregiver. Photo by Lori Shepler © Consumer Attorneys of California

“Everyone’s been good,” he says, adding that he has appreciated the support and understanding from bosses and co-workers. “But it doesn’t help when they ask, ‘Can everyone come in tomorrow?’ and I say I can’t because my kid’s in the hospital.”

The Olsens had to move from their two story home into a nearby ranch house because Steven could no longer navigate the stairs he used to scramble up like a monkey. They also needed more room – because of the constant need for care, Steven could no longer  share a room with a sibling. Through the conservatorship, Steven owns half of the house, which underwent renovations to make it easier for him to maneuver, and to add a full access bathroom off his bedroom.

Out back, the yard has a play set and a swimming pool where Steven, despite having limited control of his motion (the brain injury caused cerebral palsy), likes to swim, and gets regular exercise. Steven’s a generally happy young man despite his disabilities, though he has trouble sometimes controlling emotions and impulses because of the areas of the brain that have been damaged. At the start of the interview for this story, he said he was interested in talking but after insisting on showing me his bedroom and how his favorite toys worked (we walked down the hall together, Steven kissing my shoulder most of the way until his mother persuaded him to stop) he decided he no longer wanted to talk.

Steven requires near-constant supervision after his accident. Photo by Lori Shepler © Consumer Attorneys of California

He requires near-constant supervision, and help. He can tend to most of his bathroom needs during the day but has to be diapered at night. For his own safety, his room – outfitted like a young boy’s – has a locking door with an alarm in his parents’ bedroom to keep him from wandering around at night. Leg braces help him stand and he has limited abilities to use a cane for walking around.

A circle of friends and relatives have pitched in to give the Olsens some time for themselves (a cousin stayed with Steven during the interview), but caring for their son has become the focal point of their lives. Steven has regular preventive appointments with a pediatrician, a neurologist/neurosurgeon, an orthopedic surgeon, an ear/nose/throat specialist, schedules that pick up when he encounters unexpected  problems. A physical therapist the couple pays for privately visits the house three or four times a week to help keep Steven’s limbs, over which he has limited control, as functional as possible.

“He is highly maintained,” Kathy Olsen says. “We go every six months. I don’t want anything else to happen to him.”

Yet Steven is not coddled. “He needs to know what he can do for himself,” the mother says. “Getting in our van, I put his foot there and say, ‘Now, plant your foot and get your butt up on that seat.’ He has learned what I think are some of the independent skills that he has to learn. He has to function.”

The Olsens’ experience with the legal system, and their frustration with the MICRA cap, turned them into reluctant activists. They have taken part in rallies, spoken at conferences on the issue and testified before Congress on how the MICRA cap has affected their lives. They are particularly galled by pronouncements and political spin by proponent of the caps.

The Olsens have been active fighting MICRA.© Consumer Attorneys of California

“We probably wouldn’t have done anything, but then we kept hearing from insurance companies and the other side about how this cap is helpful to people like us,” Scott Olsen says. “If they would have just shut up, we probably would never have done anything.”

The Olsens are particularly irked by the Californians Aligned for Patient Protection (CAPP) group, which is supported by doctors, hospitals and other medical care providers, and whose board of directors is composed of leaders of for-profit medical groups.

“They don’t protect patients at all,” Scott Olsen says. “Their whole premise seems to be that this is helpful to the person that’s been injured by malpractice.  They can collect the award faster, they settle much quicker. This isn’t right. If they would just say, ‘We don’t want to pay for it,’ that’s fine. Just be honest about it.”

The couple also occasionally fields calls from people who have been similarly affected by medical malpractice, but – particularly those involving the death of a child – can’t find lawyers to take on the cases because the cost of going to trial exceeds the possible judgment.

“Unfortunately, if you kill a child, there’s no economic damages,” Scott Olsen says. “Or it’s someone with no income that it happens to.” The MICRA cap, the couple says, effectively bars those families from seeking redress through the courts.

Scott Olsen says dismissive attitudes by defenders of the caps also galvanized them. He cites a comment by then-U.S. Rep. Christopher Cox (R-Newport Beach) in the mid-1990s that referred to pain-and suffering awards as “feelings” damages. “That,” Olsen says as his now-adult son struggles nearby to eat lunch without help, “just set me off.”

California’s MICRA law has been used as a blueprint for similar laws in other states, and in pushes for federal legislation – efforts that also brought the Olsens to witness chairs in legislative hearings, and rallies fighting the measures. They’ve appeared on national television talk shows and news programs, from the old “Phil Donahue Show” to NBC’s “Today” show. They also are active with Consumer Watchdog (Kathy Olsen sits on the board) and the Center for Justice and Democracy, and have worked on projects with the Consumer Attorneys of California.

“There were so many things that were not right that you have to do what you can,” Kathy Olsen says, arguing that the issue is not a face-off between doctors and lawyers, but between insurance companies and doctors and their patients. She sees the MICRA cap as part of the broad power the insurance companies have amassed, which now extends to dictating to doctors how they treat patients.

For all the broad policy elements of medical malpractice caps, the full impact is on the micro level. Over the course of a nearly two-hour interview, the Olsens’ dug into two decades of memories to detail the dizzying litany of treatments, complications and medical crises that their son has endured due to the medical negligence of his doctors. Finally, memory spent, Kathy Olsen went off to the family computer to print out a list.

She returned a few minutes later with four stapled sheets holding 56 separate entries listing all of Steven’s serious medical encounters, from the first emergency room visit through November 2009, the last time she had updated it.

“People who are 21,” she says, “shouldn’t have a medical history like this.”

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