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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Texas has been the epicenter of so-called tort “reform” for decades, a land where an aggressive campaign on behalf of a corporate lobby bent on immunity from acts that cheat, maim, or kill has radically reshaped and deformed its civil justice system. The framers of the United States and Texas constitutions, who enshrined trial by jury as a fundamental right and believed in checks and balances, would not recognize the current Texas legal system, which perverts the rule of law into an instrument for the moneyed and powerful, as well as divorces it from any concept of justice.

The report says those who have seen their rights dangerously restricted include “patients, families, workers, homeowners, senior citizens, policyholders, and small business owners,” and says Perry’s reforms “have closed the courthouse door on many Texas families.”

The attacks on Texans’ rights began in 2003 with the implementation of a cap on compensation for non-economic damages caused by medical negligence, including such things as loss of mobility, loss of fertility, and loss of a parent or spouse. The fixed $250,000 cap is identical to what California has under its 1975 Medical Injury Compensation and Reform Act (or MICRA). The Texas Watch explanation of the impact of that cap fits California as well:

The noneconomic damages cap, which is not indexed to inflation and thus worth less each year, hits those without wages and economic damages particularly hard, making even the most clear-cut malpractice cases on behalf of the elderly, the young, the disabled, and stay-at-home parents financially impossible to pursue for many given the high cost of retaining medical experts, which comprise the bulk of litigation expenses. The merits of one’s case are far outweighed by their socioeconomic status. Under Texas law, the value of one’s life is essentially reduced to the value of their paycheck. You are what you make.

The report also details the consequences of the “loser pays” law the Texas legislature passed earlier this year, in which even Texans who have been harmed and win their cases could wind up paying:

…in the twisted reality of Texas jurisprudence, winners may actually be forced to pay under the arcane offer of settlement statute, which was bolstered in HB 274 to further tilt the scales against victims by potentially wiping out the entirety of a judgment awarded by a jury. In other words, a plaintiff could bring a valid claim, have a jury rule in their favor and award damages – only to be forced to pay the wrongdoer’s legal costs in the end, erasing their entire judgment in the process.

This is a tilted, one-way process where the defendant has the sole option of triggering this provision. It is intended to create even more risk for plaintiffs by forcing them to make a decision in the dark – before the extent of the defendant’s wrongdoing has been uncovered, a jury has been impaneled, or evidence has been presented. This introduces the prospect of additional financial harm if they refuse to accept hush money from the defendant in the form of a settlement offer. As a result, wrongdoers are able to forcibly purchase the silence of their victims, defeating public accountability and endangering other families in the process.

This type of fee-shifting is anathema to the open courts envisioned originally by our Founders and violates some of the deepest traditions in American law.

The report characterizes the “tort reform” efforts as offering “a false choice between jobs and justice” that has made the state “more dangerous for Texas families.”

–J.G. Preston

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The case before the court was Stinnett v. Tam, in which a jury found health care providers liable for the death of a young man and awarded his widow, Holly Stinnett, $6 million as compensation for loss of her spouse. Under MICRA, the jury’s award was reduced to $250,000, the maximum that can be awarded under the law for non-economic damages (such as loss of a spouse, loss of fertility, loss of mobility or severe disfigurement).

“Our argument was twofold,” said attorney Robert Peck of the Center for Constitutional Litigation in Washington, D.C., one of two attorneys who argued the case at the Court of Appeal on behalf of the plaintiff. “First, there is no longer a crisis affecting the medical malpractice insurance industry, as was alleged when the law was passed in 1975. The lack of a crisis no longer justifies a $250,000 cap on the most catastrophically injured individuals. And second, the right to jury trial means you get the benefit of the jury’s determination of damages. Any interference with that violates this inviolable right.”

In the trial court, the plaintiffs submitted an affidavit from former Missouri insurance commissioner Jay Angoff showing how California’s medical malpractice insurance industry is thriving, with high profits, record surpluses and a competitive marketplace. The trial court judge opined that the matter is one for the legislature to decide, not the courts.

But Peck argued that MICRA violates the equal protection clause of the state constitution by dividing a class of plaintiffs—people injured by medical negligence—and then discriminating against those who are catastrophically injured and thus do not get the full benefit awarded by a jury. Patients who suffer lesser injuries are not affected by the cap. Peck said the justification for the discrimination in 1975 was the malpractice “crisis,” a justification that was later upheld by the California Supreme Court, but he argued that if the crisis no longer exists, the discrimination cannot be allowed to continue.

“Equal protection means you have to have a rational basis for not treating groups equally,” Peck told the court. “We submit the rational basis for MICRA has evaporated.”

Attorney Daniel U. Smith

“Now, 36 years after MICRA was passed, times have changed,” said attorney Daniel U. Smith, who also argued the plaintiffs’ case before the Court of Appeal. “The conditions in the insurance market and in health care are completely different than they were in 1975. There is no crisis. Medical malpractice insurers are profitable. Mr. Angoff’s affidavit showed that by every measure their profits exceed the national average, and we showed that health care is not at all at risk. Doctors have their choice of malpractice insurance carriers, new carriers are moving into California to take advantage of this market, and premiums are declining. On that basis we suggested to the court that there is no rational basis for continuing discrimination against the most severely injured plaintiffs.”

“We’re not here to litigate whether there was a true crisis in the mid-1970s,” said Stewart Tabak, who represented Ms. Stinnett at trial. “But there is no evidence whatsoever—none—to suggest a crisis currently exists. And if there’s no crisis, there’s no rational basis to claim that MICRA has any life left in it. We have Proposition 103 [enacted in 1988] in place now to regulate malpractice insurance premiums and ensure insurance companies get a fair return and health care providers are not overcharged.”

Smith made the analogy during his argument before the court that MICRA is like a cast put on a broken leg. Just as a cast is used to help heal an injury, MICRA was used to help treat what was thought to be an insurance crisis. But once the leg heals, there’s no rational basis to keep the cast on, and Smith argued now that the crisis is over, there is no reason to keep MICRA.

The defense was represented at the Court of Appeal by Kenneth Pedroza, on behalf of the health care providers involved; Todd Chayett, on behalf of the California Medical Association, California Hospital Association and American Medical Association, among others; and Fred Hiestand, on behalf of the Civil Justice Association of California, the big-business-backed group that works to reduce citizen access to the courts.

“The arguments that were made by the other side were, one, this is really something for the legislature to do and no court has the authority; the court seemed to look down on that argument pretty much,” Peck said. “The second was that because of the way the evidence came in at trial on the current lack of a crisis, in the affidavit from Mr. Angoff that was submitted late in the process, maybe it’s necessary to have a full-fledged evidentiary hearing and do it differently.”

Pedroza said during his argument in court, “They [plaintiffs] argue it’s Proposition 103 that has kept malpractice insurance rates reasonable. We say, no, it’s MICRA that has kept rates reasonable….I don’t think this is an appropriate function of the court to determine who’s keeping rates stable.”

He went on to add, “Proposition 103 does nothing to control premium increases based on claims, it just guarantees insurers a fair rate of return. It won’t help doctors with premium increases after a $7 million case.”

Pedroza also said the analysis in the Angoff brief claiming medical malpractice insurers paid out too low a percentage of their premiums in claims did not take into account the cost of defending the cases.

“There are going to be good years and bad years [for insurance companies based on the amount paid in claims],” he told the court. “The point of MICRA is to provide stability, so companies can continue providing insurance and doctors can continue to practice….There continues to be a rational basis for MICRA.”

Chayett countered Smith’s cast analogy with an analogy of his own, saying enacting MICRA in response to an insurance crisis was more like a dam built in response to a flood. Remove the dam, he said, and the flood will come back. “We think we would revert to a medical malpractice crisis [without MICRA],” Chayett told the court. “We think there would be problems retaining physicians.”

Peck later referred to a California Medical Association report that cited the reason for doctors leaving the state as the penetration of managed care and noted there was nothing in that report about medical malpractice premiums.

Chayett pointed out the state Supreme Court’s 1985 ruling in Fein v. Permanent Medical Group that there was an insurance crisis that created a rational basis for MICRA. “Are we stuck with that forever?” asked Justice Dennis Cornell. “On that basis there would still be Japanese-Americans interned. Aren’t there constitutional issues that can be investigated by a trial court?”

The question was aimed at defense arguments that only the legislature has the power to change MICRA since it is a statute. Peck later pointed out that when the state of Texas implemented caps on damage awards to malpractice victims, it did so through an amendment to the state constitution granting the legislature the power to enact a cap.

In his final remarks, Peck said, “The [malpractice insurance] crisis doesn’t exist, therefore the rational basis [for MICRA] doesn’t exist. We think the court has full authority to declare MICRA unconstitutional based on changed circumstances.”

In addition to Justices Cornell, Justices Betty Dawson and Gene Gomes heard the case for the Court of Appeal and must issue a decision by mid-November. The justices, especially Justices Cornell and Dawson, extensively questioned all the attorneys who presented, and at the conclusion Justice Cornell said the case was “very well argued.” Cornell had started the proceedings by saying it is “an amazingly interesting case.”

–J.G. Preston

Here is a video report on this story:

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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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