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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St. Jude Medical Center in Fullerton was fined $75,000 after a patient there died of a morphine overdose — ten times what the physician had intended — administered by a recently-hired nurse. The patient had gone to the emergency room after an accidental overdose of medication to treat high blood pressure. The nurse misunderstood a statement by the doctor, who apparently for some reason was describing the morphine dose that could be used in palliative care, and changed the dosage administered by the patient’s morphine pump to that higher amount. The nurse also failed to get a second nurse to verify the dosage change as required.

Within an hour, the patient was dead of acute morphine intoxication. The nurse who administered the overdose resigned.

Two deaths involved elderly patients who died of pneumonia even though they had been vaccinated against it at the Kaiser Foundation Hospital in South San Francisco. The vaccines they received had been compromised by being improperly stored at below-freezing temperatures. Several other patients were hospitalized with pneumonia after receiving the ineffective vaccine.

The pneumonia vaccine was one of several medications stored together at improperly-cold temperatures over a 32-month period; those drugs were administered to nearly 5,000 patients. Katharine Mieszkowski reported in The Bay Citizen that an engineer who was supposed to schedule preventive maintenance checks on the refrigerator in question every three months had instead scheduled them for every three years, and the hospital’s pharmacy director admitted to state investigators that no one was responsible for monitoring the refrigerator’s temperature, allowing the problem to continue for such a long time.

The Department of Public Health also criticized the hospital for not notifying all the patients who had received the compromised medications about the error. Instead the hospital notified only those patients it thought were at high risk. One of the patients who died was not told of the need to be re-vaccinated.

Another medication error resulted in a patient needing kidney dialysis. The patient at the Henry Mayo Newhall Memorial Hospital in Valencia was administered six overdoses — each three times the amount the doctor intended — of an intravenous antibiotic and suffered acute kidney failure. State investigators determined the doctor’s instructions were unclear.

And yet another medication error affected a newborn at Lucile Packard Children’s Hospital at Stanford. After the newborn had surgery to repair a congenital heart defect, intravenous medication was not properly diluted by the hospital pharmacy technician and pharmacist. The newborn wound up getting more than 13 times the amount of ammonium chloride per dose, resulting in seizures. The child required intubation for several days as a result of the error.

Half of the fines involved items that were left in patients after surgery:

Fresno Surgical Hospital: A woman who had a hysterectomy continued to suffer from pain and infections after she was sent home; after eight months on various antibiotics she collapsed at home, was hospitalized and placed on intravenous antibiotics for 11 days. Two days after she was sent home, she started to feel terrible again and underwent surgery at a different hospital that found a surgical sponge that had been left in her after the hysterectomy. “I feel like I have been robbed of my life having to live with this,” she told investigators, and says she still suffers from a weak bladder and incontinence as a result.

LAC+USC Medical Center, Los Angeles: A patient who had an appendectomy wound up back in the emergency room and was diagnosed with small bowel obstruction resulting from adhesions from surgery. Checking a radiograph after surgery to break the adhesions found a sponge that had been left inside during the appendectomy, requiring yet another surgery to remove it.

Mission Hospital Regional Medical Center, Mission Viejo: A 71-year-old woman had back surgery to place a mental implant, but a metal breakaway tab from the cross-link was left inside her. The tab was found on a X-ray and she had a second surgery that night to remove it.

Scripps Memorial Hospital, La Jolla: During spine surgery, a one-inch pin used to stabilize the spine was left inside the patient. Afterward the patient complained of discomfort; she first said something was stuck in her throat, then said she felt something moving in her neck, then reported difficulty breathing, An X-ray found the pin, and a second surgery was required to remove it. The pin had been seen in an earlier X-ray but it wasn’t believed to be a foreign object. (This was the sixth penalty Scripps has received since the DPH started issuing them in 2007. Only Southwest Healthcare System in Riverside County has received more, seven.)

Sutter Solano Medical Center, Vallejo: A new mother discharged from the hospital after a caesarian section returned to the ER with severe abdominal pain. Surgery found a sponge that had been left in her after the C-section.

Torrance Memorial Medical Center: A patient underwent surgery for esophageal cancer, then a later X-ray found a sponge had been left in the patient’s abdomen, requiring a second procedure to remove the sponge.

Ventura County Medical Center, Ventura: Two weeks after abdominal surgery to close a colostomy, the patient went to the emergency room with abdominal pain and swelling, nausea and vomiting. A second surgery found a thin surgical towel had been left in the abdomen during the first surgery.

Two penalties were surgery-related. A woman received a partial mastectomy instead of a full mastectomy at San Francisco General Hospital. The patient changed her mind after first signing a consent form for a partial and later signed a second consent form for the full. While preparing the patient for surgery, a nurse failed to confirm the procedure that was to be done. Later the patient expressed concern to a second nurse about having signed two consent forms and said she wanted a full mastectomy; that nurse saw two conflicting consent forms but did not follow up, instead telling the patient to talk to surgeon, but the surgeon did not see the atient until after she was under anesthesia.

In the other case, at UCSF Medical Center in San Francisco, a surgeon made an incision near the wrong eye of a patient who was having surgery to relieve blocked tear ducts. After making the incision, the surgeon realized the mistake and performed the proper procedure. This is the sixth penalty UCSF has received from the DPH.

The other penalty handed down was not related to medical negligence but rather for lax security leading to the abduction of an infant from Santa Barbara Cottage Hospital by a woman posing as a nurse. The woman was arrested at her home a few hours later and is now serving a sentence in state prison. The child was returned to its parents unharmed.

–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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Details are in their report “Health Care Can Hurt You” published June 27 as the first part of a series about Las Vegas hospital care titled “Do No Harm.”  Sun editor Brian Greenspun writes:

…as far as we can tell, no one else—not government, not the hospital industry, not any other media—has done the kind of hospital-by-hospital analysis that Marshall and Alex are writing about today, examining how patients run the risk of being harmed by the very hospitals they turn to for healing.  That patients fall ill, are injured or are seriously infected while in a hospital flies in the face of a fundamental principle for health care providers:  First, do no harm.

Here are some of the cases Allen and Richards expand on in their report:

Rosie Powell’s surgeon removed a mass from the 74-year-old’s abdomen, thinking it was a cancerous tumor.  It was a healthy kidney.

Donna Wendt’s windpipe was torn during insertion of a breathing tube.  Oxygen was pumped into her chest cavity instead of her lungs, bloating her.  She couldn’t be saved.

Tyrone Bush developed gaping, bone-deep bedsores on his buttocks and heels while recovering from heart surgery.  Two years later, he can barely walk.

Morry Janovitz was a day from being released from the hospital when he was found on the floor of his room with a broken neck.  He suffered for months from the complications before dying.

Allen and Richards found a total of 475 cases of bloodstream infections involving central-line catheters…in just a 731-day period.  There were 79 cases of a patient developing advanced-stage pressure sores and 21 cases where a foreign object was left in a body after surgery.

Since no comparative data exists, it’s impossible to accurately evaluate whether Las Vegas hospitals are below average or not.  But Allen and Richards reached this conclusion:

Hospital insiders tell the Sun that a dangerous culture of mediocrity has become the status quo.  Profits, they say, come before patients.

Those who feel there are too many medical negligence lawsuits should know the easiest way to reduce the number of those suits is to reduce the amount of medical negligence.  The Las Vegas Sun report underscores how much work needs to be done in that regard.

(The Sun series brings to mind Hearst Newspapers’ extensive report that ran last year, “Dead By Mistake,” that told tale after tale of preventable hospital errors with tragic results.)

–J.G. Preston

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But apparently the California Board of Registered Nursing hadn’t been bothering with that bit of obvious due diligence, which is as easy as matching names to a database maintained by the National Council of State Boards of Nursing. As a result, some 3,500 nurses who have been disciplined in other states have been licensed to nurse in California, including several hundred who have lost their licenses elsewhere, according to this report by Pro Publica, via the Los Angeles Times.

The board finally checked its 376,000 license holders against the database after an earlier report by Pro Publica reporters Tracy Weber and Charles Ornstein (both former colleagues of mine at the Times). From their new story story:

California’s nursing board has historically done little to check whether its nurses were running into trouble anywhere. Until late 2008, the state did not require nurses, when renewing their licenses, to reveal whether they’d been disciplined elsewhere. The board checked their records against the national council’s database of disciplinary actions only when they initially applied for a California license. Board President Ann Boynton said the board now plans to pay the national council to run checks of California nurses on a quarterly basis.The risks of not checking can be serious. The Times/ProPublica investigation detailed cases in which nurses sanctioned in another state moved to California and were later accused of misconduct.

Nurse Beverley Cathey, for instance, came to California after being put on probation in North Carolina in November 2006 for failing to account for drugs she’d signed out, falsifying records and providing negligent care. Four Los Angeles-area hospitals filed six complaints against her in August and September of 2007, according to records from a temporary staffing firm that hired Cathey.

The California board did not file a public accusation against her license until August 2009, nearly two years after North Carolina indefinitely suspended her.

Regulators not regulating. Again.

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