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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By NANCY WRIDE

Mayra Fornos had big dreams, and they’d all come true by age 24. Newly married to a handsome USC student, Fornos lived across the street from the sands of Manhattan Beach, he a surfer bound for law school, she the tall and stunning fashionista. The future seemed set: He would become a lawyer; she would launch a career in apparel marketing.  She was already one of three top models in Los Angeles that shaped Guess and other brands in the $2 billion jeans industry. She’d already been a Rams Cheerleader.

Then, it all cratered, with the break of a wave.

Attorney Mayra Fornos at her law firm in Los Angeles. Photos: Lori Shepler

On that day in 1979, six months before graduating USC, Ralph Fornos walked into the waves with his board, and had to be carried out.  Perhaps a wall of water slammed him to the ocean floor, or he hit a sandbar. He floated to the surface alive, but unmoving, a quadriplegic.

In the years that followed, her husband’s life in a wheelchair drastically changed hers.  “After my husband was injured, he said ‘that’s it. We have to change the world,’ ” Fornos recalls proudly. It started with Fornos turning the pages of his law books. Immersing herself to help him with classes at University of West Los Angeles School of Law, Fornos decided to become a lawyer herself, and practiced with her husband until his death in 2002.

She views the Americans with Disabilities Act as the greatest civil rights law passed since the Civil Rights Act itself.

Today, it’s fair to say that Mayra Fornos is the only lawyer in Southern California whose entire workforce is either paraplegic or quadriplegic.  She is one of the best-known Los Angeles attorneys specializing in Americans with Disabilities Act claims, and a widely respected advocate for the profoundly injured.

Working tirelessly both in and out of court, she has changed access policies, she has changed bicycle safety routes, she has changed hospital protocols. Friends say she never focuses on the money, but the cause. She has helped found two charities for the disabled.

She has done it, say her colleagues, with an approach that is blissfully ego free in a profession that typically is not. Steve Heimberg, a Los Angeles medical malpractice attorney and physician who works frequently with Fornos, put it this way: “She has fairy dust.”

And a firm resolve. When defense firms see Fornos is on the case, Heimberg said, they bring in their biggest guns for the battle. Even those who have jousted with Fornos in court respect her – and her devotion to the rights of the disabled.

“She’s an excellent lawyer, but even more impressive than her legal skills is her passion for the ADA and her pursuit to preserve the true intent behind the ADA,” said Kathleen Hunt, a Los Angeles lawyer who has sat opposite from Fornos.

Fornos isn’t after technical violations, added Hunt. “Her concern is to really make people aware that those with physical disabilities can and should have access and equal enjoyment to properties, places, just like anyone else.”

That devotion carries into her Century City office with the team she has assembled. Three of her associates are paraplegic. Two are quadriplegics. That they are impressive goes without saying – but their manner says something about Fornos, as well.

Across the street from Fornos’ Century City practice, she and associate attorney Mark Willits, 29, of Woodland Hills, talked about how he was paralyzed from the lower neck down. He breathed through a ventilator as an assistant fed him.

He had just turned 16, and was helping unload a semi-trailer on his family’s small town Iowa farm, 1,200 acres of corn, soybeans and a 100-cow herd.  A bunch of wood fell on top of him, causing catastrophic C2 and C3 injury.

“Think about it: he can’t breathe on his own but since his injury, he has graduated UCLA law school, he has gotten married, he holds a job and he’s bought a house,” Fornos said. “What people can do if given a chance – there it is.”

Willits would not minimize the staggering degree of mental trauma one lives through with this kind of tragedy. But neither does he dwell, allotting just a couple of sentences to define his fate.

“I wanted to die. But I eventually realized that I had to move on with life, and I had a very strong family to support me,” he said. Earning his law degree and passing the California bar were big turning points. His role is to recruit clients who seem in need of legal or life help, and to screen the cases for the firm. “Mayra is empathetic and passionate about helping people,” Willits said simply.

Each of her half dozen workers is devoid of self-pity, willing to share how they came to be permanently injured, well moved-on from the dark days of wanting to die or hide from the weight of their own thoughts about the future.

Brianna Walker of Anaheim was a former dancer and legal secretary when she crashed her car in a sleep-deprived state and was paralyzed. Her life in a wheelchair is as full as it ever was – she practices law with Fornos and, along with Willits, helps run the charities Ralph and Mayra established.

Left to right: Mark A. Willits, Briana Walker, Mayra M. Fornos, Anthony R. Orefice III and Robert Rohan. Photos by Lori Shepler.

Walker and her co-workers share a matter-of-fact confidence about their capabilities and no self-doubt about their standing at the firm. There, Fornos and her team have represented cases of malpractice and discrimination and won damages and access for the disabled into places where barriers once stood – schools, amusement parks, workplaces, public spaces.

But the case she’s really arguing is the rights of her clients to have a life.

It sounds so simple, and yet it never is, and nobody knows this better than Fornos, part of why she is so effective in cases she fights herself and those she works on with other lawyers, some at big firms with the resources to power the lengthier battles. She has teamed with some of the top personal injury and medical malpractice lawyers in Los Angeles, among them longtime CAOC leaders Bruce Broillet and Heimberg.

“Her own view of what is important and which of her cases are the biggest is different than a lot of attorneys,” Heimberg said. “They are not the money cases they’re the cause cases – and virtually every case of hers that I am aware of is a cause case.” In the hard-knock legal world, Fornos operates “on the goodness method.”

“I think she is quite unique in the country,” said Heimberg – and he isn’t just talking about her team of lawyers in wheelchairs.

During her years of marriage, Fornos became well aware of what it actually means for a wheelchair-bound person to not be able to use a public restroom. It is not just the indignity or potential humiliation – it’s a potential health hazard. Robbed of a place to relieve themselves, they can experience extreme high blood pressure and a risk in some cases of dying.

In her first semester at law school, Fornos took a course in constitutional law from a professor that would become the most influential person in her professional life: the late California Appellate Justice Bernard Jefferson. He was also president of the law school.

Jefferson, who authored the California Evidence Benchbook, took Ralph Fornos under his wing – and the university did likewise, making its campus more accessible to he and other disabled students. Fornos was inspired to apply her experience as the wife of a quadriplegic living a full life.

“It was perfect timing and meant to be,” said Fornos. “The ADA passed in 1990, and went into effect in 1992. We passed the bar in 1993. We were maybe among the first lawyers to really focus on it.”

In those days, people who worked with the couple said their palpable romance and connection was evidence of what life could be for the wheelchair-bound.

“I met Mayra and her late husband many years ago. I think it was at a disabilities expo, and they were shopping for new vans and wheelchairs,” said Tommy Hollenstein, 49, an advocate and former client of Fornos. She won a discrimination case on his behalf. He is now an artist beloved in the disabled community. Hollenstein can’t use his hands, instead drizzling paint as his electronic wheelchair moves on canvas. He then rides through with his wheels to complete the picture. He became a minor celebrity for doing this with his dying guide dog, whose paw prints cut a path through the paint alongside his wheels.

Hollenstein was 24 when he rode his mountain bike off a dirt hill in a San Fernando Valley accident in 1985 and landed in a trench. He does a lot of volunteer work today in one of two charities Fornos founded or helped create. Ralph’s Riders, named after Fornos’ husband, is a support group where the disabled can learn everything from resources and product information to how to go on a first date in a wheelchair.

“They were an amazing couple,” Hollenstein said of Mayra and Ralph. “They clearly loved each other.”

Mayra and Ralph Fornos

In disability parlance, it’s called “not seeing the chair.”

Her personal experiences quite obviously color everything Fornos does in the courtroom and in her law practice. It is difficult to include all that Fornos involves herself with, the scope of her impact, because it is widely recognized as ridiculously surpassing the law. While she’s known in the legal world for her disability rights work, Fornos sees herself more broadly. On top of winning settlements and justice for her clients, she seeks help and support for them.

“I want to be helping the whole person, from the time they are injured to getting them resources and support,” Fornos said.

She would be the first to point out that there are attorneys out there filing bogus claims about disability discrimination that are out for the money, and she is particularly sensitive to the small business person’s frequent complaint that they can be shaken down for minor technical violations of the complex law. She is, after all, a small business owner herself with a small staff of six.

Said opposing counsel Hunt, “she’s really for the cause more than just a quick settlement.”

Fornos said she couldn’t help but be changed by her husband’s accident and her life with him as a quadriplegic. “Yes, you can win people a lot of money, but now what? You have to help people with that. I wake up every morning with the joy of that. Asking, how can I get them to change their mind today, and see this differently, at a job or a government office? Had I not gone through the pain, really, I’d just be a lawyer.”

Nancy Wride is a journalist and local editor reporting news for the Long Beach website, Belmontshore.patch.com

All photos: Lori Shepler

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Published reports say the chamber is launching its new, more aggressive legal stand as election day nears in a race that some pundits predict could end with chamber-allied Republicans gaining control of the House of Representatives.

“Litigation is one of our most powerful tools for making sure that federal agencies follow the law and are held accountable,” said Thomas Donohue, the chamber’s president and chief executive.

Reuters reported that two senior Democratic congressional officials said their view was that the chamber was effectively operating as an arm of the Republican Party during the current campaign. But the Democratic officials said they did not want quotes attributed to them for fear of unduly antagonizing the chamber.

The biggest outcry was by the chamber’s traditional critics. The American Assn. of Justice, the umbrella group for the nation’s trial lawyers, roared on its Twitter account that the chamber was engaging in bald hypocrisy by suddenly embracing litigation as its best weapon, immediately after chamber president Donahue complained about lawsuits.

“Hypocrites at chamber now LOVING lawsuits,” the AAJ said on Twitter. “Don’t they always whine about ‘frivolous litigation.’?”

– Eric Bailey

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In the end, front groups for the oil, insurance, health care and pharmaceutical industries that want to see consumers and attorneys take it below the belt instead got walloped in the polls. And they spent a whole heap of money along the way.

Among the biggest losers? The Civil Justice Assn. of California and its board of corporate giants that includes BP, AIG, the California Building Industry Assn., Dow Chemical, Pfizer, State Farm Insurance and lots more.

Here’s a look at the numbers.

$60 million

(That’s how much Mercury Insurance and PG&E spent while failing to pass Propositions 16 and 17).

$2.5 million

(What anti-tort groups CJAC and Californians Allied for Patient Protection poured into showdown races).

684

(The vote lead progressive Democrat Mary Salas holds over corporation-backed candidate Juan Vargas, an insurance executive, in the 40^th Senate District primary).

10

(The number of races targeted by the Consumer Attorneys of California).

10

(The number of targeted races in which candidates supported by the Consumer Attorneys of California either won or hold the lead).

0

(The number of targeted races won by candidates supported by CJAC and CAPP).

The outcome of this election makes it clear that voters are getting canny about corporate-backed candidates and causes. In an era of BP oil spills and runaway Toyotas, the public has grown wise to the reality that corporate candidates are bent on undercutting the civil justice system to help boost the profits reaped by corporations and their billionaire leaders. The common man and woman can make a difference simply by stepping into the voting booth and making wise choices.

–Eric Bailey

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In a nutshell, Marcinkowski, a lawyer and former congressional candidate, argues that corporate and medical proponents of tort reform are really just trying to shift responsibility for their business actions to consumers, or to government. It’s a gambit to reduce the cost of doing business by passing along the responsibility for, in essence, cleaning up their messes. It’s like a kid trying to get the whole street to pay for a window he broke.

Jim Marcinkowski

Some of Marcinkowski’s points can be quibbled with. For instance, the argument that lawsuits have driven up medical costs is a canard because “research has shown that over the course of the last decade, both the number of cases filed and the total amount of compensation paid out in medical malpractice have declined.” Well, maybe. But malpractice premiums have increased, which has a direct effect on doctors’ costs of doing business — and the rates they set for providing care.

But for tort-reform advocates to blame that on lawsuits is a classic game of blaming the victim. There undoubtedly have been cases in which people have tried to game the system, making claims for injuries that didn’t happen. But, as Marcinkowski points out, the legal system has a mechanism in place to weed those lawsuits out, and they form a sliver of the overall number of court cases. (And you have to wonder how often businesses file “frivolous” claims to try to gain an advantage. California has a SLAPP law for a reason.) Legal challenges forcing proper, responsible behavior by businesses is a market mechanism that punishes bad behavior and rewards good behavior — the same tools good parents use to raise their children to do right.

In a lot of ways, the tort-reform argument is like saying because some people abuse the social-service system, no one should receive help, no matter how badly he or she needs it. Those are political positions in search of proof, and you can prove just about anything with selective use of anecdotes. Go stand on a beach and look out to sea. That world looks pretty flat doesn’t it?

Marcinkowski’s strongest point is his summation of who bears the responsibility for an injury caused by a product or service:

The person or entity found responsible for the loss in a legal proceeding pays the person suffering the loss. In the case of a business, this may be looked at as the “cost of doing business,” where the cost of the accident is paid by the business, which in turn spreads those costs to its customers by raising the price of its product or service. In such a “mini-free market” system, lawsuits punish an irresponsible party, forcing either higher prices or even market exit, while simultaneously rewarding a more responsible competitor who, without a lawsuit, can keeps its prices low.

Now, what’s so unfair about that?

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The report carved out the top 15 special interest groups who together spent more than $1 billion trying to influence policy over the decade. The top two heavy spenders were labor groups whose members’ wages depend on state spending, the California Teachers Association and the California State Council of Service Employees. They spent a combined $319 million. But that was dwarfed by the $545 million spent by six corporations — led by the Pharmaceutical Research and Manufacturers of America‘s $105 million — and four business associations. The other three big spenders in the top 15 were Native American tribes, who laid out $202 million.

Incidentally, the Consumer Attorneys of California (members of which help support the nonprofit behind this blog) spent about $21 million over the decade, earning it 25th place on the FPPC’s list. Though the folks at the Civil Justice Association of America (which seeks to limit lawsuits) are trying to argue that plaintiffs’ attorneys spent $35 million since 1999. The problem is that figure includes individual lawyer’s donations to state officials and candidates, an expression of individual political choice that the FPPC more wisely left out of its lobbying tabulations.

And the CJAC, incidentally, didn’t contrast the lawyers’ individual political contributions with those by corporate executives, Chamber of Commerce members, doctors, or even against the total amount of all campaign contributions. And as we all know, numbers without context are just numbers.

This is the FPPC’s “Billion Dollar Club,” the top 15 that spent a combined $1 billion over the past decade:

1. California Teachers Association     $211,849,298
2. California State Council of Service Employees     $107,467,272
3. Pharmaceutical Research and Manufacturers of America     $104,912,997
4. Morongo Band of Mission Indians     $83,600,438
5. Pechange Band of Luiseno Indians     $69,298,909
6. Pacific Gas & Electric Co.     $69,240,759
7. Chevron Corp.     $66,257,132
8. AT&T, Inc.     $59,619,677
9. Philip Morris USA     $50,756,360
10. Agua Caliente Band of Cahuilla Indians     $49,078,448
11. Southern California Edison     $43,412,031
12. California Hospital Association     $43,281,456
13. California Chamber of Commerce     $39,065,861
14. Western States Petroleum Association     $35,214,325
15. Aera Energy LLC     $34,671,163

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