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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You can read more about the problem at Safety Research and Strategies Inc.

 The latest report follows numerous developments as lawsuits have moved forward against Toyota.

 In a related case, a man accused of manslaughter after his Toyota careened out of control was released from prison when authorities became convinced the true culprit was unintended acceleration. See the ABC News story below.

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Quaid has produced a documentary film springing from his own experiences with medicine gone wrong: The nearly fatal overdose of medication administered to his newborn twins in 2007.

In a recent interview with the Associated Press following a speech to the National Press Club in Washington, Quaid said, “There were 41 hours where their lives were in the balance.” He said it was the most frightening day of his life and left him and his wife, Kimberly, in “shock, anger and confusion.”

In the documentary, “Chasing Zero: Winning the War on Healthcare Harm,” slated to run April 24 on Discovery Channel, Quaid details the toil of medical mistakes on society. He appeared this past week at the National Press Club in Washington to talk about the nation’s medical malpractice epidemic, and in a TV interview talked about how the 98,000 preventable deaths due to medical error each year in America make such mistakes the third leading killer in the nation.

Quaid, 56, is no stranger to taking a stand. CBC 60 Minutes has done a piece on the twins’ medical travails. In 2008, just months after his twins — Thomas and Zoe — recovered from an overdose of the blood thinner heparin, Quaid spoke to Congress about his concerns with mounting medical malpractice and with the limits on legal challenges established in California and other states. In written testimony Quaid said:

I have also learned a lot about the legal system – and it was surprising, I have to tell you. Like many Americans, I believed that a big problem in our country was frivolous lawsuits. But now I know that the courts are often the only path to justice for families that are harmed by the pharmaceutical industry and medical errors. Yet the law is stacked against ordinary people.  For instance, in my home state of California, a 1975 law caps compensation to malpractice victims. The cap has never been raised for inflation. The practical effect is that people without the wealth to pay legal fees up front are unable to get their cases before a judge or jury.

Now we face something with potential to be even more sweeping and even more unjust: federal preemption. The Supreme Court is about to decide whether to bar most lawsuits over drugs and their labeling, as long as the drug was approved for marketing by the FDA. After many years of rejecting arguments that FDA actions should preempt lawsuits involving injuries from products regulated by the FDA, White House appointees at the FDA reversed that position in 2002, and now argue that FDA approval immunizes the manufacturers of dangerous products from liability for the deaths and injuries they cause.

We sued Baxter Healthcare Corporation in November 2007. Baxter has filed a motion to dismiss the case, relying on the same preemption argument that the drug industry and the FDA has made before the Supreme Court – that when the FDA allowed its Heparin drug onto the market, it gave Baxter the government’s seal of approval – a “get out of jail free” card that denies us the right to hold the company accountable. (Of course, Baxter never mentions the FDA regulations that encourage and sometimes require manufacturers to fix their drug labels immediately, without getting the FDA’s permission first.) So, says Baxter, our suit may not be heard by a judge or jury.

It is hard for me to imagine that this is what Congress intended. You tell me, Mr. Chairman: When it passed the Food, Drug, and Cosmetic Act in 1938, did Congress intend to give appointed bureaucrats at the FDA the right to protect a drug company from liability, even when the company cuts corners and jeopardizes our safety? A federal ban on lawsuits against drug companies would not just deny victims compensation for the harm they experience. It would also relieve drug companies of their responsibility to make products as safe as possible, and especially to correct drug problems when they are most often discovered – years after their drugs are on the market.

Permitting bureaucrats who are under pressure from their bosses and the drug companies themselves to yank our access to the courts is incomprehensible. We have all heard about understaffing and backlogs at the FDA, and about drug-safety scrutiny that is patchy at best. If the Supreme Court rules in favor of the drug companies, it will eliminate one of the most effective deterrents to letting the bottom line win out over public health and safety.

We can hope that the Supreme Court will not put more barriers in front of patients who are harmed by drug companies. But if the Court goes along with the FDA and rules for the drug companies, I respectfully ask this Congress to pass corrective legislation on an emergency basis, just as it should do immediately to correct the recent Supreme Court decision immunizing the makers of defective and mislabled medical devices. We Americans need some balance on the scales of justice in our country.

–Eric Bailey

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It turns out there is.  RAND’s report “investigates the relationship between safety outcomes in hospitals and malpractice claiming against providers, using data for California hospitals and insurers from 2001 through 2005,” in the words of the researchers.  They analyzed more than 365,000 “in-hospital events and complications with potential to harm patients” over the five-year period from such things as post-surgical problems to infections originating in a hospital.  The researchers also examined a database of about 27,000 claims from four of the largest medical malpractice insurers in the state.

The upshot: A correlation between better health care and fewer malpractice lawsuits. The authos say that a county with a decrease of 10 adverse events would see 3.7 fewer malpractice claims. Similary, an increase of 10 events would suggest 3.7 more malpractice claims. 

Rand researchers say their study is the first to suggest that efforts to improve patient safety could contribute to fewer medical malpractice claims.

The report concludes by yanking the bandage off wounds left by the state’s long-running tort wars: 

“Arguments about the merits of statutory tort intervention will surely continue in the future,
but to the extent that improved safety performance can be shown to have a demonstrable
impact on malpractice claims, that offers another focal point for policymakers in seeking to
address the malpractice crisis. Based on the results of the current study, we would suggest that that focal point may be more immediately relevant than has previously been recognized.”

That’s a nice, academic way of saying something simple: Fewer medical errors, fewer lawsuits.

–J.G. Preston

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The decision comes as the auto giant continues to grapple with a separate slate of troubles with its vehicle fleet involving sudden unintended accelleration that prompted a massive recall and government investigations.

The latest blow involved a single vehicle, the high-end Lexus GX 460 SUV. The consumer watchdog organization reported in an article posted on its website that the SUV would swerve badly while attempting to slow heading into a corner during routine tests at the magazine’s testing facility in Connecticut. For only the second time in a decade, Consumer Reports issued a “don’t buy” warning to its readers. 

In a video that accompanies the article, the SUV can been seen with its rear end swerving badly during the cornering manuever involving the driver lifting off the accelerator to reduce speed heading into a turn. The magazines editors say that in a real-world situation, such as a driver entering a freeway exit ramp at too high a speed, that sort of performance could lead to a potential rollover accident. Consumer Reports has notified the National Highway Traffic Safety Administration about the problem.

The “don’t buy” designation marked the first time since 2001 that the magazine has issued such a warning to consumers. The last car to be hit by that black mark was the 2001 Mitsubishi Montero Limited.

Toyota initially responded to the magazine’s report with an on-line statement expressing concern over the results of the test, but saying their engineers never encountered the problem when conducting similar tests. The statement said the auto giant would try to duplicate the test, quickly evaluate the results and “determine if appropriate steps need to be taken.”

In the meantime, the company statement said, “please keep in mind that the 2010 GX 460 meets or exceeds all federal government testing requirements.  Customer safety and satisfaction remain our highest priorities.  We take the Consumer Reports’ test results seriously and appreciate Consumer Reports bringing it to our attention.”

But later in the day, as a firestorm of media attention and cutomer complaints began to grow, Toyota took further action and pulled the SUV from the market until tests can confirm what changes might need to be made to ensure the safety of the vehicle.

“At this time we have asked our dealers to temporarily suspend sales of the 2010 GX 460,” Mark Templin, the group vice president and general manager, told the New York Times.

–Eric Bailey

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This column appeared on July 17, 2009 in the Daily Journal. It is reprinted with permission of the Daily Journal.

By Dean A. Hanley

Each year, 3,000 Americans develop asbestos cancer, known as mesothelioma, a very rare and rapidly fatal cancer of the lining of the lungs, heart, abdomen or testicles, caused only by asbestos. Nearly all victims of asbestos cancer will die within six to 18 months of diagnosis. Typically their asbestos exposure occurred on the job where they worked around construction materials that contained small amounts of asbestos.

They came into contact with asbestos from insulation aboard ships and in industrial refining facilities, or from wallboard finishing compounds and sprays, fireproofing, brake linings, cement pipe and gaskets and packings commonly used in valves and pumps, automobile engines, refrigeration and air compressors. It was even used in ordinary lawnmowers.

The workers themselves are invariably without fault in their own demise. Never warned, usually unaware that the materials they were handling contained asbestos, they unwittingly poisoned themselves by breathing invisible and odorless asbestos. Often they brought these invisible fibers home on their clothes, hair and shoes. In so doing, they exposed their wives and children to asbestos, some of whom develop asbestos cancer 20-40 years later.

Asbestos victims have recourse in California if they can prove that they were exposed in California. Many who now live throughout the United States served their country in naval shipyards located in California where they and their families suffered exposure to asbestos. When that victim can satisfy a judge and jury that a defendant’s products or actions were a substantial factor in contributing to his risk of developing asbestos cancer, he may hold the company liable for its proportion of fault in causing his disease.

To the extent his economic damages are not offset by settlements secured from responsible bankruptcy trusts or other defendants, he can hold the defendant responsible for the remainder of his out-of-pocket losses incurred because of his asbestos cancer. Since his life expectancy is measured in months rather than years, California affords him an opportunity to have his day in court before he dies. The jury must determine all of the entities at fault for causing the asbestos cancer and attribute to the remaining defendant its appropriate share of that fault.

For many people like Jim Morrison, the California system works to help compensate that which can never truly be compensated. Having never smoked a cigarette in his life, at the age of 54 he was diagnosed with cancer from asbestos and given only months to live. His primary goal was to live long enough to see his engaged daughter marry later in the year.

With nearly $2 million in lost earnings as the owner of his own plumbing business and more than $500,000 in medical bills, he sued the three dozen companies that caused his cancer. His doctors opined that from a medical and scientific perspective, the cause of his cancer was clear: the totality of all of the asbestos he was exposed to during his working life. Virtually all of the exposure occurred in very small doses, scraping some gaskets here and there, sweeping up debris, wiping down his workbench and wearing work clothes that were never truly free of asbestos even after going through the washer and dryer.

While Jim never saw it coming, many of the companies he sued did. One of those companies declared in a 1966 memo that “people who made a good living working with asbestos may as well die from it. They have to die from something.” Others demonstrated their disregard for human safety by continuing to sell the asbestos Jim was exposed to into the late 1980s when it was well understood that exposure to the smallest amounts of asbestos will cause cancer in some people. The jury found that defendant Copeland Inc. was negligent for failing to recall or retrofit dangerous products still on the market and in the field today. In that regard, Jim’s personal lawsuit served a larger good.

By contrast, overly aggressive defense of these lawsuits harms society. Defense experts have peppered the scientific literature with false and unscientific conclusions in an effort to create medical defenses that would not otherwise be available. These “experts” have manufactured an argument that 95 percent of the asbestos historically used in the United States does not cause asbestos cancer – in direct conflict with the findings of every U.S. and intergovernmental agency, regulatory body and disinterested scientific organization that has studied the issue. Busy physicians glancing through abstracts of articles created by those companies and their “experts” are often understandably unaware that they need to consider the source of that information – a source often undisclosed.

When a company manufacturing equipment with asbestos components considers itself “unfairly targeted,” we should question what is unfair. Surely there is nothing unfair about holding a company responsible for its share of the fault in causing an injury. Is joint and several liability unfair? Joint and several liability for economic damages is a policy judgment made by the people of California that applies to all cases, not just asbestos cases.

If a company that had a substantial hand in causing the injury cannot be held responsible for such damages, who should be? Are we prepared to advocate for a system in which an injured victim has no recourse against the culpable company that hurt him or his family? Should asbestos victims instead look to public assistance programs when their livelihood has been taken from them or their families?

The idea that the source of the industry’s problem is lawyers from outside California is likewise untenable. If the companies weren’t killing Californians in such high numbers, there wouldn’t be such work for those lawyers and the world would be a better place.

Many asbestos victims spent a working lifetime repairing equipment covered with asbestos insulation on the outside and asbestos gaskets and seals on the inside. Despite that the equipment manufacturers specified and often supplied the asbestos and knew the deadly consequences of handling asbestos when performing ordinary maintenance and repairs on their equipment, their own repair manuals were silent about the hazards and simple precautions – masks, ventilation and wetting the material – that would have prevented the harm.

Now, the lawyers for many of these asbestos-laden pump, boiler and turbine makers shrug in feigned disbelief that their clients are being sued for this conduct. These companies could and should have played an important role in preventing the asbestos public health disaster, but they too, like their counterparts in the asbestos insulation business, chose the pursuit of profits over workers’ lives. They belong in court to answer for their inexcusable conduct.

Way back in the 1930s, scientists understood that asbestos caused fatal disease. By the 1940s, California was regulating asbestos. If those regulations had been followed, little disease would have occurred and alternatives to asbestos would have been found. By the 1950s, asbestos was established as a carcinogen. By 1961, researchers found that exceedingly low amounts cause asbestos cancer, and that the risk extended to families of people who worked around asbestos and lived near factories where it was used.

There was a time when many asbestos companies mocked victims by saying they had to “die from something” anyway. As recently as the 1970s, when Union Carbide salesmen selling raw asbestos fiber to great profit and promoting its use in a wide variety of products throughout the United States, including in our homes and schools, triumphantly proclaimed in memos that an unsuspecting customer “didn’t even know it was asbestos” that he was buying.

Now that the devastation of disease that asbestos companies have caused is leaving its true legacy in this country by its rising death toll, they should not complain how the civil justice system is unfair to them. What’s unfair is that they promoted asbestos and concealed its danger.

Dean Hanley has represented asbestos plaintiffs in California for 17 years and is a founding partner of Paul & Hanley with offices in Los Angeles and Berkeley.

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(c) 2009 Daily Journal Corporation. All rights reserved.

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Many victims are military veterans and naval shipyard workers who became exposed to the deadly fibers while protecting our nation. They never saw the disease coming, but corporate executives who became rich off asbestos knew well the dangers.

Documents that have become public largely because of asbestos-related litigation prove that captains of the asbestos industry knew about the hazards in the 1930s. Some cynical executives shrugged off the dangers as late as the 1960s. By the 1970s, documents show, industry leaders were coaching people about how to allay public concerns.

In the 1930s and 1940s, Sumner Simpson was president of Raybestos Manhattan, Inc., a prominent manufacturing company based on Connecticut that used asbestos in its products. The company’s history calls Sumner a visionary.

Letters, studies and other documents he wrote, received and stowed have been dubbed the Sumner Simpson Papers, and likened to the Pentagon Papers of the asbestos industry. They prove knowledge about the dangers of asbestos at the highest levels dating back eight decades.

The editor of an occupational journal sent Sumner a letter dated Sept. 25, 1935, seeking permission to publish an article about the hazards of asbestos.

“Always you have requested that for certain obvious reasons we publish nothing and naturally your wishes have been respected.”

On Oct. 1, 1935, Simpson wrote a note to his colleague Vandiver Brown, secretary of Johns-Manville Corp., the preeminent asbestos miner, manufacturer, seller and distributor in the Western world between the 1930s and the 1970s.

“I think the less said about asbestos the better off we are … “

Brown replied two days later, Oct. 3, 1935:

“I quite agree with you that our interests are best served by having asbestosis receive the minimum publicity.”

Brown went on to suggest that if an article were to appear that it use “American data rather than English.” The reason was clear: The American study was sponsored by Raybestos, Manville, and Metropolitan Life Insurance Company, the insurance carrier for the asbestos giants, and drew far less alarming conclusions than British studies.

Edward Ames wrote an infamous memo dated Jan. 7, 1942. Ames was in marketing for  Owens-Corning Fiberglas Corp.  In the 1940′s, Owens-Corning sought to compete with asbestos insulation makers by selling fiberglass-based insulation.  In his memo, produced in discovery during a lawsuit in the early 1980′s, Ames urges that his firm compete with the asbestos industry by pointing out the dangers of asbestos.

“The following plan is suggested: 1) Gather as a weapon-in-reserve an impressive file of photostats of medical literature on asbestosis … This file would cover five or six hundred pages, which can be microphotographed in the library of the Surgeon General in Washington or in some other medical library.”

Tragically, Owens-Corning decided in about 1952 to make and sell asbestos containing insulation, and became Johns-Manville’s main competitor in most of the U.S. from the mid-1950′s into the mid-1970′s.

Twenty years later, the cognoscenti knew of the dangers even as they expanded the uses of asbestos while keeping workers in the dark. Asbestos was used extensively in braking and clutch systems for cars, trucks and industrial machinery.  Bendix was a major manufacturer in this area through the 1990′s. 

By the mid-1960s, some consumers and sellers became concerned about the health implications of asbestos fibers. Ed A. Martin was a Bendix officer, who wrote to a major supplier of the asbestos fiber in Bendix’ products in this letter, dated Sept. 12, 1966:

“My answer to the problem is: if you have enjoyed a good life while working with asbestos products why not die from it. There’s got to be some cause.”

By 1971, industry executives started taking a different tact. A Union Carbide letter dated Dec. 31, 1971, describes one of its products, Calidria, and says of the customer:

“He did not even realize Calidria was asbestos!” 

“I chose not to rock the boat with any warnings or suggestions.”

As more people started asking questions, industry executives started taking a different tact. In June 1972, executives suggested a script for sales persons who might be confronted by worried customers:

“Set the mood. Controlling the conversation is paramount.”

The letter goes on to urge that if customers become irate

“A certain amount of aggressiveness may be effective.”

Asbestos’ cancer-causing potential is well-known, and described by the National Cancer Institute here. The onset of illness can come decades after their exposure.

Asbestos’ toll continues to mount, in lives and dollars. One jury in Washington state recently awarded $10 million toHenry Barabin, a retired Crown Zellerbach Paper Mill, and his wife, Geraldine. 

In a study released in 2009, the Centers for Disease Control found that 18,068 people died from malignant mesothelioma in a seven-year period ending in 2005, and that the number of deaths is rising, from 2,482 in 1999 to 2,704 in 2005. Here is a link to the study, and a link to a news article about the study. Here is a list of products compiled by the EPA that contain asbestos.

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