ThePopTort

Health Care: Look Who’s Not Talking and Whose Job Is it Anyway?

So much focus of medical liability system “reformers” these days is about “communication.” Patients would be safer if doctors were more honest about their “mistakes,” the theory goes.  Hhmm. I’m not saying that couldn’t happen, but when you’re talking about “communication” in a hospital setting, the concerns of patients don't seem particularly urgent.

Take what’s happening in Wisconsin. There, the medical lobbies are pushing legislation to change state law to lessen what doctors must tell their patients. The standard now is “what a reasonable patient would want to know” but some lawmakers want to change the standard to “what a reasonable physician would tell a patient.”

“The last thing you want to do is roll back the way we get information and how much information we get,” said Martha “Meg” Gaines, director of the Center for Patient Partnerships and an associate dean at the University of Wisconsin Law School.

The proposal would move away from what patients want and need to know, she said, to what doctors think patients need to know.…

Informed consent should be what the patient wants to know - not what a physician thinks the patient should be told, she said.

In a hospital setting, patients are always at an enormous disadvantage when it comes to getting information about their own care let alone protecting themselves from getting hurt. There’s an effort now to burden patients with the responsibility of keeping doctors and nurses from infecting them.  Patients are supposed to keep asking health care providers if they’ve washed their hands. That’s because “healthcare workers comply only about half the time…and one in 20 patients will acquire an infection while in the hospital.”  So, it should be their job to ask this question, even though it is well-recognized that “speaking up for yourself in that setting is not an easy thing to do"?

“No one wants to be confrontational with the person you hope will save your life,” said Dr. Michael Bell, acting director of the division of healthcare quality promotion at the U.S. Centers for Disease Control and Prevention in Atlanta.

Plus, as one expert noted, “In some ways it says to patients, ‘This is your responsibility for us to do things safely for you, including hand hygiene. Why should it be the job of the patients or family members to make sure everybody cleans their hands? That’s the job of the system.” Ya think?

And not to mention that fact that sometimes, doctors (especially surgeons) can be, well, bullies. USA Today had a story last week about this problem:

Every workplace, like every schoolyard, has its bullies. But when the workplace is a doctor's office, hospital room or surgical suite — when doctors throw charts at nurses or nurses throw insults at trainees — it isn't just a workplace problem. It's a patient-safety issue, these experts say.

"The impact in health care is significant because you are dealing with patients' lives," says Peter Angood, CEO of the American College of Physician Executives in Tampa. Patients who experience or witness boorish behavior have every right to speak up ... because the quality of their medical care may depend upon it.

But who’s gonna do that? For example, should it have been patients' job to question the medical judgment of Dr. Faisal Albania, the St. Louis area neurosurgeon who apparently performed so many risky surgeries on spines, necks and brains, causing “permanent nerve damage, chronic pain and lost income” (and death) that he’s now “a defendant in about 50 lawsuits?  Meanwhile, Dr. Albania was allowed to keep practicing “even after the state’s highest court upheld key findings by the Missouri medical board against him.”

“I think he’s hurt a lot of people,” said Alvin Wolff Jr., a lawyer from Clayton who filed a suit last year on behalf of Gary Cotter of Pinckneyville, Ill., that accused Albania of performing an unnecessary surgery on his spine in 2010 that left him in permanent pain and hunched over. “Why do the hospitals let a guy like this on staff? Why do they let a guy like this stay on staff?”

Good question. Where was the hospital here? Where was the state medical board? (Indeed Missouri’s board is sadly typical – check out what’s going on in California.) They clearly weren’t asking the right questions or taking steps to save patients lives.  Reminds me of the hospitals featured in last night’s 60 Minutes, which had evidence they’d hired a serial killer nurse, told no one about it, and then gave him a "neutral" reference.

The Brutality of Wisconsin’s Nursing Home “Tort Reform” Law

There’s a song in the rock musical Hair called "Easy to Be Hard," and it goes like this:

How can people be so heartless
How can people be so cruel
Easy to be hard
Easy to be cold

These lyrics have been running around my head since reading the two-part series from the nonprofit Wisconsin Center for Investigative Journalism  about the impact of Wisconsin’s new nursing home “tort reform” law.  And when I say “impact,” I’m specifically talking about current and future nursing home residents who are abused and neglected.  (Pay close attention, Baby Boomers.) 

Here is the series’ summary:

Families’ abilities to hold potentially negligent nursing facilities accountable have been diminished by a recent change in state law that bars records of abuse and neglect from use in the courts, the Wisconsin Center for Investigative Journalism has found. The Center’s investigation also shows that some long-term care facilities are failing to report deaths and injuries, as required by law.

Not that we’re surprised.  Under the leadership Governor Scott Walker and with the express assistance of that nasty gang-‘o-corporations, the American Legislative Exchange Council, the nursing home industry authored a bunch of provisions to make it difficult or impossible for families to sue on behalf of their abused or neglected (i.e., dead or injured) relative. For one, these laws make it virtually impossible for grossly negligent facilities to ever be liable for punitive damages.  For another - and the focus of the series- these laws prohibit families in these tragic situations from using any state investigation records as evidence in their lawsuit.  In the words of Milwaukee personal injury attorney Ann Jacobs, “When you’ve got these records that are part of the regulatory process, the idea that you wouldn’t be able to introduce them to the jury is just insane.  Why would we hold that information back?”  Indeed.

In one case profiled by the series, records of a four-month period of neglect that led to a bone-deep, E-coli infected bed sore on the backside of a 32-year-old brain-damaged and physically-disabled resident (he required horribly painful surgery and months on his stomach), could not be used in the family’s lawsuit. 

The impact of this law extends beyond the families who do sue:

Several attorneys said they have turned down meritorious cases because the new law makes it harder and more costly to sue nursing homes and other health care facilities.

“Even before this legislation, these were very difficult, expensive, time-consuming cases,” said Jason Studinski, a Stevens Point attorney who specializes in elder abuse lawsuits. “Frankly, once a victim knows what hurdles are in their path, some choose to go away, even if they have a legitimate claim.” …

And don’t think patient safety won’t suffer.  As Dane County Circuit Judge William Hanrahan, who prosecuted crimes against the elderly for 19 years as a district attorney and assistant attorney general, put it: 

“It’s very important that attorneys are able to take these cases and hold those who neglect and abuse the elderly accountable.  Some of the biggest changes come as a result of legal action.”

Heartless, cruel, hard, cold.  Mustn't forget dumb.  

Doctors and Apologies

How weird was it that around the same time Daniel Day Lewis was reciting the physicians’ Hippocratic Oath while accepting his Screen Actors Guild award, a bad case of medical negligence was happening over at PBS. That would be the death of Downton Abby’s Lady Sybil from pre-eclampsia, thanks to a misdiagnosis from a terribly pompous obstetrician, who even defied the local doctor who told him that Sybil needed to get to the hospital asap.

Notice the guy never apologized?  We’re pretty sure that wasn’t because he feared being sued a century ago in Britain. 

Also weird was the coincidental very long piece in the Boston Globe magazine by Darshak Sanghavi, the chief of pediatric cardiology at the University of Massachusetts Medical School in Worcester, titled, “Medical malpractice: Why is it so hard for doctors to apologize?” The case study in this article was another obstetric story, although this one was true and resulted in the death of a premature infant, whose mother was treated so poorly by hospital personnel who were covering up information, that she finally sought counsel and sued.

There were actually a few good points in this article aside from its ridiculous characterization of her attorneys – the only ones who eventually helped her, by the way. (“For patients seeking information, the only obvious recourse is to call a malpractice lawyer, whose livelihood depends on replacing a patient’s desire for comfort and understanding with a need for vengeance.” Vengeance? Take a look at the stories at the bottom of this page and let me know if you think “vengeance” was motivating any of them.)

Here are a few additional points. The authors say, “When a mistake is suspected, it may be unclear who from a team must step in to take responsibility.” Well, it’s worse than that actually. As we noted in this post, the U.S. Dept. of Health and Human Services published a study last year about hospitals' massive error “underreporting” problem because hospitals employees don’t seem to know what patient harm even is – and if they do, they think it’s someone else’s job to report it.

There is reference to a new Massachusetts law “that, among other things, usually allows doctors to speak more openly to patients and families who were harmed, even apologize to them, without worry that their words will later be used against them in court.” Well, there’s actually much more to it than that. If the case does go to trial (there is a 6 month waiting period from the time the attorney notifies the provider of the case and the actual filing of the case), and the doctor deviates at all from what was told to the patient, whatever the doctor admitted to – including the apology itself– can indeed be used in court. It’s a check to make sure there is accurate and honest disclosure.

In terms of Mr. Boothman’s program at the University of Michigan Health System, hhmm. We’ve noted the problems with his system before.  While we were originally quite skeptical of the Massachusetts program, our further investigation makes us think it's far less problematic for patients than Michigan’s.

We do really like these points, however:

[T[here is a yawning chasm between physicians’ perception of malpractice costs and the reality of them [and] those annual bills for doctors haven’t been rising the way, say, the average person’s health insurance premiums have. On the contrary, a recent analysis showed that inflation-adjusted malpractice premiums actually fell from 1975 to 2005 for 96 percent of all Massachusetts physicians. (That didn’t stop the American Medical Association from declaring this a “crisis state.”)

As far as defensive medicine, says the author, “[s]tudies show that doctors order a lot of questionable testing and treatment even when malpractice risks are very low.” And, “Contrary to many doctors’ beliefs, there is no epidemic of frivolous lawsuits” and “when doctors make an actual mistake, the system is slightly biased in their favor.” And there’s more:

The misleading image of the doctor besieged by bogus lawsuits dangerously obscures an important fact: The vast majority of major medical errors never see the light of day. A classic 1991 study found that only about 2 percent of patients harmed by medical negligence filed a claim. According to a spreadsheet I was given, Harvard-affiliated hospitals were the target of only 90 malpractice claims relating to children between 2006 and 2010, a period when doctors racked up millions of patient encounters. The vast majority of the medical care at these hospitals is superb, to be sure, but it strains credibility to think that any major academic center makes a harmful mistake so rarely (especially when a 2010 study showed that 15 percent of all hospitalizations result in preventable harms).

The author also has good things to say about CRICO, insurer for the Harvard system, which focuses directly on reducing errors as the way to stop death, injuries, claims and lawsuits. The insurance industry could be playing a much larger loss prevention role than they are. See our earlier coverage here of the NY Presbyterian Hospital-Weill Cornell Medical Center program instigated by the hospital’s insurance carrier, MCIC Vermont.

And something needs to be done about doctors like Wisconsin’s Dr. David Almasy, who killed Nicole Johnston, a 35-year-old mother of four by giving her “at least 100 times too much epinephrine.” For this, “the Wisconsin Medical Examining Board in 2011 reprimanded Almasy, required him to take two classes and fined him $1,200.” 

Medical boards - where the coverup always ends up.

Don’t Fool with Consumer Watchdog, and Other Election Observations

If you’re one of the 18 to 29-year-olds who made up 19 percent of voters this year (a higher percentage youth vote than in 2008! Yay!), you are mostly likely unfamiliar with an annoying 1970s Chiffon Margarine TV commercial that goes “It’s Not Nice to Fool Mother Nature!”  But whether you’re 18 or 85, that universal “don’t fool with me” sentiment seems to have marked a number of election contests this year, even besides the obvious (i.e., women, gays and pot!) 

Let’s start with the California’s insurance industry. Don’t mess with the 1988 insurance reform initiative, Proposition 103, and the consumer group behind it, Consumer Watchdog. Billionaire Mercury Insurance Chairman George Joseph just wasted $17 million on his Proposition 33, which would have repealed Prop. 103’s provision preventing insurance companies from charging more to drivers who had a lapse in insurance coverage. This is about what Joseph spent almost exactly two years ago on basically the same ballot measure. Yet despite being outspent by Joseph 70 to 1 (the Consumer Watchdog coalition had only about $275,000), Prop 33 went down!  Next up for Consumer Watchdog: the health insurance industry! 

Speaking of the insurance industry, seems like they’re a little nervous that their influence-peddling in Congress may be in need of some new targets. Reports the National Underwriter’s website,

Rep. Judy Biggert, R-Ill., was defeated for re-election, a victim of redistricting. She headed the Subcommittee on Insurance, Housing and Community Opportunity of the House Financial Services Committee, and was expected to be a big player on insurance issues. She shepherded the [National Flood Insurance Program] bill through its tortuous, five-year path to a long-term extension. The bill was finally enacted in July. It is unclear who will succeed her as chair of the insurance subcommittee. Biggert was also expected to be a key player on regulatory issues as well as in gaining passage of A Terrorism Risk Insurance Act extension.  Joel Wood, senior vice president of congressional affairs of the Council of Insurance Agents and Brokers, called Biggert's defeat, “extremely disappointing to the insurance industry.”

I can see why they’re anxious.  Between escaping payment for climate-related floods and getting bailed out for terrorist attack losses, this industry clearly needs some friends.  

And speaking of elections, here are a few other interesting outcomes:

• The U.S. Chamber of Commerce finally got their wish in West Virginia, ousting consumer-friendly AG Darrell McGraw who had held office for 20 years, “perhaps marking the start of major changes to West Virginia consumer protection litigation… [McGraw] has won the state more than $2 billion in consumer protection lawsuit settlements against pharmaceutical, coal and tobacco companies and unscrupulous lenders, according to his office.”
• They also got supermajorities in states like Indiana, Wyoming and Tennessee (both Houses), North Carolina (one House plus Governor) and won back majorities in states like Wisconsin. (See more here and here.) But the good news is that state houses flipped the other way in Colorado, New York, Maine, Minnesota, and Oregon (where there had been a tie), with apparent supermajorities in California and Illinois!  And that awful New Hampshire Speaker who pushed through that horrendous anti-patient medical malpractice bill (which we covered here) is no longer speaker since the Democrats took over!  Let’s hope a repeal is on the way!

As far as Supreme Court races, here’s some of what we know:

• Three Florida Supreme Court justices retained their seats in retention votes despite organized campaigns by conservative organizations to oust them.
• Iowa retained Justice David Wiggins, the Supreme Court Justice who had ruled on same-sex marriage with a 54% retention rate.  (This is in counter to two years ago when 3 of Wiggins’ colleagues were thrown out by voters.)
• In North Carolina, incumbent Supreme Court Justice Paul Newby won over appellate Judge Sam “Jimmy” Ervin IV thanks to an unprecedented and disturbing amount of outside money from business interests and conservative groups. 
• In Mississippi, attorney Josiah Dennis Coleman won over pro-consumer attorney Richard Phillips due to nasty outside money:  "The out-of-state special interest group Law Enforcement Alliance of America ran advertising in north Mississippi blasting Phillips as a trial lawyer who had filed a lot of lawsuits against business. …Phillips said the Virginia-based LEAA was trying to buy a seat on the court. He said such groups can put out negative ads that distort the truth without disclosing who are the individuals paying for the ads."

It’s not nice to fool Mother Nature, or with the truth.

The Delusion of Drug Safety Testing

When it comes finding new ways for state lawmakers to protect negligent pharmaceutical companies, we find that the American Legislative Exchange Council (here, here) can be so accommodating!  For example, ALEC provides three - count ‘em three – ALEC-approved choices to assist any state lawmaker bent on further subsidizing this industry: option 1, complete immunity for marketing unsafe FDA-approved drugs (only one state – Michigan - has had the nerve to do this, although states like Wisconsin are trying); option 2, shifting the standard of proof entirely in the drug company’s favor (some North Carolina lawmakers are hot to trot on this idea); and finally, immunity from punitive damages for FDA-approved drugs.  (Actually, option 3 is an old idea, even popping up in congressional bills like the federal “medical malpractice” bill H.R. 5, which has passed the U.S. House of Representatives and yet remains in a state of perpetual mark up.)

So interesting that these anti-government folks think the FDA gets it right every time when it comes to drug safety.  Perhaps today’s news will dampen their pro-government enthusiasm?  Nah, probably not.

The Institute of Medicine has come out with study finding that the agency isn’t protecting the public from safety problems that arise once a drug is on the market.  Who would have thought? IOM concludes, “the FDA’s current approach to drug oversight in the postmarket setting is not sufficiently systematic and does not ensure that it assesses the benefits and risks of drugs consistently over the drug’s life cycle.”  IOM is calling on the FDA to “review drugs on a regular basis for as long as they are on the market in order to catch any new safety issues.”

Writes U.S. News and World Report,

The U.S. Food and Drug Administration approves new drugs based on clinical trial evidence that their benefits outweigh their risks. However, the full range of a medication's effects may not become apparent until it is used by a larger, more diverse population over a long period of time, the FDA-sponsored report noted.

A number of drugs approved by the FDA were later found to have problems, including the pain reliever Vioxx, the diabetes drug Avandia and the cholesterol-lowering drug Crestor.

As Reuters notes,

"It's impossible to know all the risks and benefits of a drug before approval," said Dr. Ruth Faden, co-chair of the IOM committee. The IOM called on the FDA to monitor drug safety at regular intervals over time.…

Currently, the FDA must only check for new safety issues after the drug has been sold for 18 months, or after it has been used by 10,000 patients, whichever is later. It relies upon reports of side effects submitted by the drugmaker, doctors or patients.…

Dr. Faden, who is also director of the Johns Hopkins Berman Institute of Bioethics, said extensive post-approval monitoring is critical because safety concerns with a drug may only become apparent once it has been used for many years, and by thousands of patients.

And backing all of this up is a new study in Journal of the American Medical Association, “an analysis of over 40,000 clinical trials registered in a government database, [where] researchers found that many of those studies -- looking at the effects of drugs, devices or behavioral interventions -- were small and of inconsistent quality. … The majority of those trials -- 62 percent -- reported recruiting 100 or fewer patients. Two-thirds were conducted at a single research site.”

Of course, none of this really should surprise anyone given how under-resourced the FDA is, how lax our regulatory laws are, and how conflicts of interest routinely interfere with this agency’s safety role.  Check out last Sunday’s editorial in the New York Times.

Honestly, how much more evidence do we need that FDA-approval is barely a minimum standard for drug safety and clearly shouldn’t become a “get out of jail free” card for the drug industry?

Workplace Safety Goes Missing

The other day, Newt Gingrich called child labor laws “stupid.”  We report this not to make a statement about presidential politics, but to show where some people are when it comes to workplace priorities these days.  (Or as David Letterman’s put it, "this is the man we need to lead us into the 18th century.")  

Safety isn’t much of priority for many firms, which makes Newt’s idea especially wacky.  In fact, let’s “Span the World” of OSHA highlights this week (And yes, somebody got hurt.)

For the sixth time, OSHA (that is, the U.S. Department of Labor’s Occupational Safety and Health Administration) has cited a Wisconsin Rapids carbon steel foundry “for overexposing workers to crystalline silica, a known hazardous material.”

In upstate New York, OSHA cited the Wisconsin-based Briggs & Stratton Power Products Group,

for alleged repeat and serious violations of workplace safety standards at its Munnsville manufacturing plant. The lawnmower manufacturer faces a total of $125,000 in proposed penalties, chiefly for mechanical, electrical and fall hazards identified during an inspection begun in June by OSHA's Syracuse Area Office.

The sizable fines proposed in this case reflect both the gravity of these hazards and the fact that several are substantially similar to conditions cited in an earlier OSHA inspection," said Christopher Adams, OSHA's area director for central New York. "It's imperative that this employer not only corrects these latest hazards but also takes effective steps to ensure that they are corrected once and for all."

Down in Hot Lanta, OSHA cited Midsouth Steel Inc., "a general contractor performing steel fabrication and roof decking ... for four safety violations following an inspection that found workers exposed to fall hazards,” specifically, “allowing them to work at heights of 35 feet in an aerial lift without requiring the use of fall protection, exceeding an aerial lift's load capacity and failing to provide fall protection for employees working on a steep pitched roof.”  Three of these violations were “willful,” that is, “committed with intentional knowing or voluntary disregard for the law's requirements, or with plain indifference to worker safety and health."

In Illinois, OSHA cited “Igor Jerema Construction Co. in Buffalo Grove for four willful safety violations after a worker applying stucco at a home under construction in Burr Ridge fell off a scaffold and sustained a fatal head injury in May.”

In Texas, OSHA cited "Houston, Texas-based oil and gas drilling contractor Nabors Drilling USA LP for two alleged workplace safety violations after a worker was electrocuted at a Williston job site in May.”

Then of course, there’s retaliation against whistleblowers who report safety violations:

[OSHA] filed a lawsuit against the Angels With Paws animal shelter in Lakewood on behalf of an employee who was terminated in violation of the whistleblower provisions of the Occupational Safety and Health Act. The employee had complained about safety and health hazards to the animal shelter's management before filing a formal complaint about the hazards with OSHA. The employee was later discharged and then filed a whistleblower complaint with OSHA alleging retaliation by the defendants in violation of Section 11(c) of the OSH Act. OSHA's Whistleblower Protection Program conducted an investigation and determined the former employee's allegations had merit.

Mix that all up with a little bit of anthrax in the workplace (the federal government just settled with the family of Robert Stevens, a tabloid photo editor in Florida who was killed after receiving an anthrax letter in 2001), and voila!  A perfect place to send the kids!

Here’s the whole Letterman monologue. (As we’ve said before, we take no position on this election, but sometimes, well, we just can't resist the comedy.)

Wisconsin Immunity for Killer Propofol (And Other Unsafe Drugs and Devices)?

You might be happy to know that the FDA just approved Teva's new antipsychotic drug called Olanzapine, otherwise known as the generic Zyprexa.  Let’s just hope the FDA knows what it’s doing.  Zyprexa, you may know, has serious side-effects that can lead to  diabetes and its manufacturer, Eli Lilly, has been sued by tens of thousands of ill Zyprexa users, telling salespeople to downplay these side effects.  You can read more about this in the Center for Justice & Democracy’s new study, Repeating a Tragic Blunder, about a disastrous drug and medical device immunity bill now being considered in Wisconsin.  (Read more here.)

Actually, if you live in Wisconsin or Michigan for that matter, you had really better hope the FDA knows what it’s doing.  As the CJ&D study explains, Michigan's law – and the Wisconsin bill – would completely immunize drug companies like Teva (not to mention Eli Lilly) for marketing unsafe government-approved drugs that kill or injure patients.  

It’s not like there isn’t reason to be very concerned about a company like Teva.  As Bloomberg reports, Nevada juries have recently imposed punitive damages three times against Teva and two other drug companies for selling the anesthetic Propofol to doctors in bottles so large that they needed to be reused, leading colonoscopy patients to develop Hepatitis C, which can be lethal.  (Yes, THAT Propofol.  Between this and what we’re learning about Propofol in the Michael Jackson case, like MJ’s nurse who just testified “nobody who cares or has your best interests at heart will give you Propofol,” it’s hard to imagine a more maligned drug in the news right now!) 

When Michigan passed its drug immunity law in the 1990s, the drug companies immediately skipped town and all those promised jobs were lost.  Meanwhile, the pharmaceutical industry has had a “get out of jail free” card there ever since while sick and injured patients are kicked to the curb.  Beats us as to why anyone would support such a thing.

Unless, of course, you happen to be a venture capitalist who, as the New York Times reports today, is dumping boatloads of money on politicians with the goal of weakening FDA regulation even further. Writes the Times,

As Congress considers reauthorizing a law that sets the fees for medical device makers, venture capitalists are emerging as a rich and influential ally of device companies eager to remove what they say are regulatory roadblocks in the approval process. The push has alarmed patient advocates and some doctors, who have been calling on the F.D.A. to intensify its oversight of devices, particularly in light of some all-metal artificial hips that are failing prematurely at an unusually high rate.

“They have this unwritten assumption that every new device is innovative,” Dr. Rita Redberg, who is the editor of the Archives of Internal Medicine, said, referring to the venture capital funds. But some devices, she said, “are killing people or causing significant harm.”

What a time to be throwing immunity into the mix.

Immunity That The Good Wife Never Saw Coming

Did you happen to catch the TV show The Good Wife over the weekend? (Full episode here.) “Straight from the headlines” doesn’t half describe it, and I’m not even talking about the listeria-outbreak subplot given what’s gong on with cantaloupes these days (although this story dealt with processed cheese, which seems somehow more fitting for show about food poisoning.) 

But the main plot dealt was something equally timely, and kudos to them for tackling it - i.e., the FDA’s highly controversial 510(k) process, which allows manufacturers to put certain medical devices on the market if they submit evidence that the device is “substantially equivalent” to a device already on the market   (See Public Citizen’s study on this.) In the show, a spinal cord stimulator – a medical device used to ease chronic pain - was implanted in a patient, a young mother.  Turns out that the manufacturer and inventor of the device was the patient’s doctor and he made boatloads of money every time he implanted one.  Are these writers clairvoyant or what?  Just last week, the Wall St. Journal published a large investigative piece about spine surgeons who do this very thing, writing:

Rather than use spinal implants from third-party manufacturers, scores of surgeons have started their own device makers to churn out similar designs, putting themselves in a position to benefit financially from the hardware they insert into patients. 

And just like real life, this Good Wife doctor never put the device through the more rigorous FDA approval process (with clinical trial data) because he paid some “experts” to say the device was “substantially equivalent” to a device already on the market.  Writes the WSJ:

The Food and Drug Administration has a less stringent approval process for medical devices nearly identical to ones on the market. Surgeons only have to submit mechanical-testing data attesting that their implants are "substantially equivalent" to existing ones. The FDA usually gives its green light within 90 days.

But like many of these 510(k) devices, this one was defective, it malfunctioned and as a result, the patient was permanently injured.  And she sued.

Ironically and as we’ve pointed out many times (here, here ), had the device actually gone through a pre-market approval process, this lawsuit probably would have been impossible.  Device manufacturer are completely immune from all responsibility for putting unsafe Class III (i.e. high-risk) devices on the market (yes, plenty of unsafe devices are FDA-approved) and the writers would have had to come up with a whole different storyline.

Actually, here is one new storyline that’s not so different.  Wisconsin Governor Scott Walker, not satisfied just with targeting abused and neglected nursing home residents, now wants to do to his residents what Michigan politicians did to theirs almost two decades ago (and which no other state has since replicated).  They want to prevent any Wisconsin citizen who is injured by any FDA-approved unsafe drug or device, from ever getting compensated by the negligent drug company.  As The Cap Times wrote:

For 15 years Michigan residents and families of loved ones who have been injured or killed by drugs like Rezulin, Accutane and Vioxx have tried to get their day in court. But they've largely been stymied by a state law that shields drug makers from legal liability.

Even the state itself, seeking to recover millions in Medicaid dollars spent on ailments caused by Vioxx, was prevented from doing so by its own appeals court.

Michigan passed the law in 1995, and it remains the only state in the nation with such sweeping legal immunity for drug makers.

But Wisconsin Republicans want to enact similar legislation that would shield drug makers from lawsuits over FDA-approved drugs. And the proposal here would go further, including immunity for makers of FDA-approved medical devices like automatic external defibrillators, heart valves and artificial hips. They also would be granted immunity from lawsuits if their products had inadequate warnings.

"If this becomes law, all of those people who are injured, or the families of people who die, will just be SOL," says Mike End, the president of the trial lawyers group Wisconsin Association for Justice.

Even the conservative U.S. Supreme Court has said that immunizing drug companies is a very bad idea  All I have to say is, we once warned Hollywood about great legal class action storylines drying up because of the way our class action system is being decimated.  They had better start paying attention to this one, too.

Wisconsin’s New Fantasy Governor

This week, Wisconsin’s new Governor Scott Walker laid out the details of his first bills to get the economy moving in Wisconsin and bring jobs back to the state.  Number one on the list? Take away the legal rights of injured people!   Wow, that should really get the economic recovery going! 

In fact, in keeping with the spirit of Wisconsin’s new state government (which flipped from Democratic to Republican this last election), I have a song recommendation.  It’s Radiohead's “In Limbo” (listen here), which has one very predominant lyric: “You're living in a fantasy.” As in:

I'm lost at sea
Don't bother me
I've lost my way
I've lost my way
You're living in a fantasy

Here’s what I mean.  His idea is to bring jobs to Wisconsin by making sure that if your mom or grandma is abused or neglected in a nursing home, your ability to be compensated is severely limited and the nursing home is less accountable. 

Other proposals weaken the accountability of the worst of the worst corporate wrongdoers in Wisconsin– the ones who should be liable for punitive damages, but no longer will be thanks to the Governor’s plan.

For those of us living in the real world, here’s an important thing to remember.  If corporate wrongdoers can’t be sued, they’ll become more dangerous.  That’s what happens.  Laws like this won’t bring back jobs or even keep them.  Just look at Michigan. Several years ago Michigan decided to completely immunize drug companies that produce unsafe drugs.  The business lobbies argued they needed the law to encourage drug companies to stay in Michigan.  No other state has such a law.  No sooner did the law pass than pharmaceutical jobs started leaving Michigan by the hundreds.

In 2005, the Economic Policy Institute (“EPI”) released a study debunking common myths about the costs of the legal system and its burden on consumers. According to EPI,

There is no historical correlation between the inflated estimates of the costs of the tort system and corporate profits, product quality, productivity, or research and development (R&D) spending. Evidence suggests that the tort system, without the proposed restrictions, has actually been beneficial to the economy in all these areas. … [Moreover], significant tort law change would be more likely to slow employment growth than to promote it. Endlessly repeating that so-called ‘tort reform’ will create jobs does not make it true.

Except, of course, if you’re living in a fantasy.

Sprinkles of Civil Justice (With a Post Election Flavor)

So what do the civil courts have in store for us, post mid-term elections?  Looks like a dash of new state hurdles here, a pinch of federal obstruction there.  Let’s take a look at a few smidgens!

First, Oklahoma's new Attorney General-elect, Scott Pruitt, apparently accepted thousands of dollars in campaign donations from poultry industry employees, for which he was heavily criticized – and for good reason.  As soon as he was elected, he announced that he would consider stopping the state’s lawsuit against the poultry industry for causing “widespread pollution” even though the state “has spent millions of dollars arguing the case, and it is awaiting a judge's ruling.”

Also, in an article earlier this week, New York Times reports that the new Governor-elect of Wisconsin, Scott Walker, said “he planned to remove all ‘litigation, regulation, excessive cost’ barriers to businesses (declaring Wisconsin, on election night, ‘open for business!’)."  In other words, no accountability for wrongdoing whatsoever!  How attractive!  (Hope you’re paying attention toxic polluters, makers of unsafe children’s products, dangerous commercial truckers and hazardous equipment manufacturers.)

On the federal judiciary front, Ann Woolner writes for Bloomberg, 

Republicans have managed to stall more than a score of President Obama’s nominees to the bench so far, although they number only 41 senators, barely enough to keep a filibuster going.

With six more Republican senators narrowing the gap in January, the minority party in the Senate will have more muscle to use against the president’s choices...

Republicans have been loading the federal bench with as many conservatives as they can, while blocking as many Democratic nominees as possible.

Yes, I said Democratic nominees instead of liberal. The current list of 23 stalled Obama nominees includes 17 approved by the Senate Judiciary Committee without a whiff of controversy or even a no vote against them.

And when it comes to one of the hottest environmental issues today – greenhouse gases - a new study by “DB Climate Change Advisors (DBCCA), a New York-based eco-investment advisory unit of Deutsche Bank Group” concluded that:

The failure of federal cap and trade, the return of Republican control in the U.S. House and California's plans to move forward on that state's greenhouse gas law will probably inspire a new wave of lawsuits moving the climate change battle to the courts,

"It is probably inevitable that people are turning to litigation to fill the void left by the lack of legislation, and it is possible that the threat of court action will in some cases galvanize legislators to take action where before they had simply avoided the issue," DBCCA analysts say in the report, titled "Growth of U.S. Climate Change Litigation: Trends and Consequences."

And finally, the decision as to who will be Alaska's next Senator moves to the courts, with Tea Party trial lawyer Joe Miller now suing to invalidate a lot of Sen. Lisa Murkowski’s write-in ballots. 

Whoa, back up a minute.  Did we say "Tea Party trial lawyer"?  You betcha we did!  Specializing in all kinds of accidents including medical malpractice cases, Mr. Miller writes on his web site:

Have you been injured? If you have suffered serious injury as a result of an accident, you have probably been contacted by an insurance adjustor. Remember, insurance adjustors are in the business of saving insurance companies money, not helping you. Insurance adjustors are very skilled in what they do...

Every day, Insurance Companies convince accident victims that their injuries are insignificant and deserve little compensation. You should always contact an attorney before resolving your case.

Couldn't have said it better ourselves, Joe.