ThePopTort

How Not to Mend a Broken Heart

CBS Sunday Morning is the top rated Sunday morning news show “in households, viewers and adults 25-54.” That’s a good thing, especially today.  (Although when they do a great piece like they did this morning, you kinda wish they had ratings like 60 Minutes - but we’ll take it. )  

Not to diminish in any way the wonderful segment on Patti Smith, but we’re mostly talking about the piece called “When Medical Implant Fail.”  (Video here.) This was as close to a video version of the Center for Justice & Democracy’s’ report, Heart Sick as we’ve ever seen.  (And I thought our post last week about Dick Cheney’s new heart was the best chance we’d get to discuss this topic!) 

As CJ&D reported back in 2009, each year, over 100,000 cardiac defibrillators are implanted in patients’ hearts to monitor irregular heartbeats and if necessary, deliver a 700 volt electric shock to restore a heart to proper rhythm.  Already scary.  But imagine yours was defective? Unfortunately, 21-year-old Joshua Oukrop can’t imagine that, because his malfunctioning Guidant defibrillator killed him.  Allan Gohde can’t either.  He had the same defibrillator as Joshua's. When his widow Kathleen bent over his coffin, a loud beeping starting coming from his chest.  This was the signal of a device malfunction.  Had it not started to beep, the family never would have known that the defect killed Allan.

When the U.S. Supreme Court decided the case Riegel v. Medtronic in 2008, it closed the courthouse door to these patients, telling victims and their families that they had no recourse or any opportunity to be compensated.  With that decision, the Court essentially placed blind faith trust in the FDA to protect the public.  We wish the CBS Sunday Morning piece had paid some attention to the "immunity problem."  But they get a pass for doing such a great job on the "FDA problem," and the agency’s regulatory megaflops over what are probably the most dangerous and recalled implants ever made.

CBS interviewed renowned cardiologist, Dr. Robert Hauser, who was Joshua’s doctor.  In 2005, he and another cardiologist went to the New York Times, which then broke the story about this Guidant defibrillator that was short-circuiting at a rate of about once a month. Three years earlier the company had changed its manufacturing process to correct the problem but never told doctors and continued to sell its defective inventory. Patients died and the FDA kept this information from the public for many months.  What’s more, this entire incident took place while the company was under special obligation to report device problems stemming from a 2003 plea agreement over its failure to disclose problems with defective aortic aneurysms stents. (See more in Heart Sick.) 

Meanwhile, subsequent litigation (that is, before the Supreme Court unceremoniously stripped patients of their legal rights) revealed documents like one doctor’s letter to Guidant: “I am not critical of Guidant’s device problems – these devices are so complex, issues are expected. I will not, however, work with a company that put profit and image in front of good patient care and honesty in device manufacturing.”

Meanwhile, according to the the medical device industry flack interviewed by CBS, Americans have nothing to fear because the safety duo of the FDA and the industry, "working together have an exemplary safety record” and besides, the approval process is too slow and needs to be speeded up.  Continues CBS:

But Dr. Hauser cautions that speeding up an already ineffective approval process could be dangerous, because there's also inadequate follow-up after a device hits the market - something called post-market surveillance.

"In the United States, there is no definite requirement for post-market surveillance for defibrillators and heart valves, artificial hearts and so forth," he said. "There's no absolute requirement. In other words, you wait for problems to be reported to you rather than actively seeking out problems, and there's a big difference."…

Last year, the Institutes of Medicine, an independent advisory group, issued a report stating that the FDA's current regulatory framework for most devices is so flawed it should be thrown out and replaced with a new system that "provides a reasonable assurance of safety and effectiveness.”

And here’s another idea.  Congress also needs to fix the horribly misguided Riegel decision.

Medical Implants – The Real Heart Breakers

You may have heard that Dick Cheney got a new heart this week.  Now, I’m not a professional comedian, but I do know that statement hardly needs a punchline.  That said, we wish him well because goodness knows, the guy’s had five heart attacks and has been implanted with so many bizarre medical devices that even Dr. Frankenstein would be impressed.  Did you see that battery operated heart pump contraption he’d been carrying around? 

Actually, the last time we covered the former VP was to mention his well-documented reliance on a pacemaker, a more common medical device that usually works, but sometimes shocks or even kills patients due to negligent design or manufacturing.  Since 2008, patients have had no legal recourse should that happen.  That's when the medical device industry got a little immunity present from the U.S. Supreme Court.

Speaking of which, since this industry received its immunity back in 2008, what do you think has happened to the safety of these devices?  A new study by the Minneapolis Heart Foundation and Abbott Northwestern Hospital Foundation tells one story.  This study of defective St. Jude Medical implanted defibrillators led Dr. Robert Hauser, the Minneapolis Heart Institute cardiologist who wrote the report, to say, “This is the most difficult and challenging device problem I've seen in 40 years … It's a very unique failure mode. It's never been seen before in a defibrillator or pacemaker lead. And it's very troubling because no one knows what the natural history of this will be.”  Oy.

According to the study,

Recalled St. Jude Medical Inc. heart device wires, still in use to connect life-saving implantable defibrillators in 79,000 patients, had multiple defects that led to melted conductors, electrical abnormalities and shocks.

Little Canada-based St. Jude stopped selling its Riata wires in December 2010 and recalled them last year on reports they could break through their insulation. Surgery to remove the leads may present higher risks than keeping them in, U.S. regulators have said.

“The problem with this whole defect is there is no easy way to pick it up until an event happens," said [Hauser]. "It's an all-or-nothing situation. We are trying to figure out how to manage these patients, or a way to monitor them safely and effectively.”

Double Oy.  By the way, so glad Dick Cheney had good health coverage.  Let’s hope the U.S. Supreme Court doesn't strip that away for the rest of us, too.

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.

Terror, Torture and Mixed Up Justice

There’s a large and uncomfortable amount of news this week about terror and torture victims trying to seek justice but not always ending up as they’d hoped.

The big US story is the wrongful death settlement by United Airlines and a security firm with the family of Mark Bavis, who was killed on 9/11 as a passenger on United Fl 175.  “The family was the lone holdout among the thousands that either accepted money from the $7 billion Victim Compensation Fund or settled their lawsuits.”  Read his brother Mike’s statement here, where he describes the devastating impact that federal preemption can have preventing litigants from getting answers in cases like this.  Yet the family did make progress.  He says,

Due to our family’s refusal to settle before this time, our attorneys at Motley Rice LLC have been able to conduct the most comprehensive investigation to date regarding how the airlines and airport security companies failed so miserably on 9/11 and in the days, weeks and months leading up to 9/11. Motley Rice’s attorneys have recovered ten times more information than the 9/11 Commission in regards to the failure of the aviation industry. 

On a somewhat similar note in Britain, it was announced that the government will compensate relatives of victims of 1972’s tragic “Bloody Sunday,” when “British troops fired without warning on unarmed demonstrators” and then were exonerated “amid unfounded accusations that the troops had been attacked by Irish republican terrorists.”  Fourteen people died that day, and 13 were wounded.  But “one family immediately announced its intention to refuse any restitution, saying there were no circumstances under which they would ‘ever accept money’ for the loss of their brother William, 19. The idea of taking money from the Defense Ministry, they said, was ‘repulsive.’”

Meanwhile, there won’t be any justice anytime soon for the Abu Ghraib prison victims, again thanks to federal preemption.  On Wednesday, the U.S. appeals court in Virginia dismissed lawsuits "claiming employees of two defense contractors conspired to torture and abuse Iraqis at the Abu Ghraib prison near Baghdad and at other locations. … One lawsuit was filed by 72 Iraqis while the other was brought by four Iraqis.”  Unfortunately, the court said the claims were pre-empted by U.S. national security and foreign policy law.

On the “suits recently filed” side of the ledger, Ernesto Zedillo, who was president of Mexico from 1994 to 2000, may have a bit of a problem at his new job teaching international studies at Yale as director of its Center for the Study of Globalization.

The Associated Press reports that Zedillo “has been sued in Connecticut for alleged crimes against humanity in connection with the 1997 killings of 45 people in a Mexican village, a lawsuit that he called slanderous.”  The lawsuit says that “Zedillo was responsible for the massacre by paramilitary groups in the village of Acteal, in the southern state of Chiapas, and tried to cover up the killings. The plaintiffs, who include people injured in the attack and relatives of some of the dead, are seeking total damages in the millions of dollars, one of their lawyers said.”

The case was “filed under the federal Alien Tort Claims Act, which allows people alleging violations of international law to sue in the United States, and the Torture Victims Protection Act, which permits damages for torture and illegal killings abroad.”

There are also reports that Iranian president Mahmoud Ahmadinejad has been sued for $10 billion in a class action lawsuit for “terror and torture ... on behalf of an Iranian woman living in Los Angeles whose brother was tortured to death by the regime of Muslim leaders in Iran."  Ahmadinejad apparently isn’t responding and “a default judgment would be the next step in the case, which was brought under the Alien Tort Claims Act and the Torture Victim Protection Act of 1991.”

What a world.

Damn the Regulations, Full Speed Ahead!

It’s official.  We are officially back to the Bush era!

One of our favorite PopTort themes is that consumers are kept safe from the havoc inflicted by corporate miscreants by both tough regulations and the deterrent effect of legal liability.  President George W. Bush did a great job turning federal regulatory agencies into apologists for corporate wrongdoing.  Take for example, the Occupational Safety and Health Administration (OSHA), which we covered in 2009  when the Washington Post wrote, “political appointees ordered the withdrawal of dozens of workplace health regulations, slow-rolled others, and altered the reach of its warnings and rules in response to industry pressure.… The result is a legacy of unregulation common to several health-protection agencies under Bush.”

We were hoping this would not also be the legacy of our new President, but it looks like the U.S. Chamber of Commerce has finally had its way with him.  Today, the President took to the pages of the Wall Street Journal  announcing his new Executive Order that will lead to eliminating regulations whenever possible, it seems - like, for example, if businesses can argue that health and safety regulations will cost jobs.  Salon writes:

The argument for less regulation reads somewhat antithetically. Obama is quick to point out how regulation places "unreasonable burdens on business — burdens that have stifled innovation and have had a chilling effect on growth and jobs." His executive order promises to eliminate "absurd and unnecessary paperwork requirements that waste time and money" as well as "avoid excessive, inconsistent and redundant regulation."

But in the same breath, he recognizes how a lack of government oversight nearly caused the next Great Depression.

But I know, everything IS about jobs now (thanks to a ruined economy caused by lack of regulation).  And if you don’t think jobs will be used as any excuse to endanger the public’s health and safety, take a look at the title for Thursday’s House Judiciary Committee hearing: Oversight Hearing on "Medical Liability Reform - Cutting Costs, Spurring Investment, Creating Jobs"  (Center for Justice & Democracy’s Ex. Dir. Joanne Doroshow will be testifying as the only witness for the D’s, by the way!)

I guess one could make the argument that a weakened tort system, which leads to more dangerous hospitals, will create the need for more prosthetics manufactures, physical therapists and round the clock nursing care.  But I’d rather not go there.

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.

Spin, Sweat and Tone at Your Own Risk

Check out the web site for Powerhouse Gym, the self-described “fastest growing gym licensing organization in the world  … distinguished by our unsurpassed motivating atmosphere, knowledgeable staff and premier exercise equipment, which supports our members in meeting their individual fitness goals.”

Beautiful fitness instructors? Check.  Yummy health café? Check.  All kinds of exciting classes? Check.  Happy kids? Check.  Defective bikes that seriously hurt their members?  Defective bikes?  Anyone?

No, you won’t see those mentioned on Powerhouse Gym promos.  This would include the bike that apparently hurt Gina Stelluti less than an hour after she purchased a membership at a New Jersey Powerhouse club.  According to her lawsuit, which was thrown out of court yesterday, the handlebars on her spin class bike “dislodged as she was instructed to stand on the pedals. Stelluti’s feet remained strapped into the pedals as she fell forward, causing her to suffer chronic neck and back pain, as well as a cracked tooth, according to court papers.”

It’s not that the bike wasn’t defective and caused her injury.  It’s that to join the gym, like most gyms, she had to sign a liability waiver.  This actually included a release of liability by the gym for "the sudden and unforeseen malfunctioning of any equipment."

Somehow, I doubt their “membership specialists” point that out when persuading potential new members to hand over their credit cards.  This is not OK.  And that most gyms force members to sign these waivers shouldn’t make it legally OK, either. In fact, other courts have found these waivers to be against public policy.  (See this 2009 Connecticut decision.)  But the reality is, people unwilling to submit to this immunity would never get a gym membership. 

Of course, this raises a much bigger issue, similar to another one we’ve discussed before (here, here, here) in the context of mandatory binding arbitration clauses, which have become standard in credit card and real estate contracts, applications for bank loans and leasing cars, employment contracts and even HMO policies.  Like arbitration clauses, liability waivers are nothing more than corporate end runs around the civil justice system.  Where Big Business and their political allies have failed to legislatively eliminate the civil jury, they have accomplished exactly the same objective here -- abolishing jury trials and eliminating the American public’s right to sue and hold accountable corporations that cause injuries.  

We couldn’t have put it better than dissenting judge Justice Barry T. Albin, who said,

[T]he court has abandoned its traditional role as the steward of the common law. For the first time in its modern history, the court upholds a contract of adhesion with an exculpatory clause that will allow a commercial, profit-making company to operate negligently — injuring, maiming, and perhaps killing one of its consumer-patrons — without consequence.

Huff Post Repost: America Wakes Up to the Importance of Liability and the Stupidity of “Caps”

Teachable moments can come almost anytime, from anywhere. The recent history of corporate and professional breakdowns and mess-ups should provide a number of them. Bob Herbert raised the issue in a stinging New York Times column recently when he asked, "Will we learn anything from this disaster ...?" BP was his focus but also on his mind was "how the giant financial firms almost destroyed the American economy" and the "devastating mine explosion in West Virginia -- at a mine run by a company with its own hideous safety record ..."

We'll add to that list the Toyota debacle, drug companies marketing contaminated childrens' medications, builders who pushed defective Chinese drywall into thousands of homes, Delaware doctors who covered-up a pedophile pediatrician who raped children, not to mention more and more dangerous hospitals everywhere. What a couple of months.

Keep reading.

Guidant Defribillators - Corporate Crime in the Immunity Age

In 2005, at the encouragement of two well-respected cardiologists Dr. Robert G. Hauser and Dr. Barry J. Maron, New York Times reporter Barry Meier broke the story about a Guidant implanted defibrillator that was short-circuiting at a rate of about once a month.  Three years earlier, the company had changed its manufacturing process to correct the problem but never told doctors and continued to sell its defective inventory.  Patients died and the FDA kept this information from the public for many months.  Somebody made these corporate decisions.  (You can read a lot more about this in the Center for Justice & Democracy’s study, Heart Sick.)

Meier, Hauser and Maron never took their eye off Guidant (now part of Boston Scientific) and today, the Times reports a new story “raising a fundamental question about medical safety and the law: who should be held accountable when a company sells a flawed product that can injure or kill patients? Is it the company or the people who run it?”

Drs. Hauser and Maron are objecting to a Justice Department plea agreement “in which the company would plead guilty to two criminal misdemeanors and pay a $296 million fine.”  Even though this is “the largest ever paid by a medical device maker,” Hauser and Maron’s point is that  “Nobody is being held accountable."  But as Meir points out, “corporate executives rarely face criminal charges in such actions.”

The reason?  According to one drug and device attorney quoted in the piece, “’Prosecutors want the money … And at least in the big money settlements they have had in pharma cases, it appears that prosecutors are willing to settle even if it means forgoing prosecutions against individuals.”

What an unbelievable point.  The government wants its cut.  Understandable.  But meanwhile, the legal system’s deterrent function becomes largely nonfunctional – first by the failure to criminally prosecute individuals responsible for corporate crime, and second, because no civil case can go forward – at all!  Actual patient-victims of this corporate crime, who should have recourse in the civil courts, have been left out in the frigid cold. That’s because in the 2008 case Riegel v. Medtronic, the U.S. Supreme Court immunized from liability companies that manufacture defective heart devices. This decision leaves heart patients with no legal recourse should they be injured, and removed the most significant and effective financial consequence to a company for choosing to keep a dangerous heart device on the market.

Legislation to remedy this situation is currently before Congress, called the Medical Device Safety Act.    What more is it going to take to get this law passed?!

UPDATE:  The judge has rejected this plea agreement. 

Happy as a Pig Farm in Slop

That silly “lipstick on a pig” brouhaha during the 2008 presidential election campaign came to mind today when we read about a Missouri jury verdict yesterday.  The jury awarded around $11 million to folks living near an 80,000-head hog farm run by industrial food giant Premium Standard Farms, now owned by Smithfield Foods and the state's largest hog producer, over the operation’s stifling and intolerable odors. The awards weren’t huge: “$825,000 for each of the 13 plaintiffs. A 14th plaintiff was awarded $250,000, and the 15th got $75,000” and included no punitive damages.

The company is appealing, calling it a “gang trial” and a “gang verdict.” They also believe it was unfair because the company complied with government regulations – an argument we’ve heard before and one that the U.S. Supreme Court isn’t too fond of.

Mostly what the families want is odor abatement.  Their attorney said, "’If we sit down and talk, we can include more than money,’ ... ‘It's common sense. Nobody wants to live across the street from 80,000 hogs.’”

Premium Standards Farms has itself had its own problems.  Last month, 1,500 northern Missouri residents met with the state Attorney General because of an upcoming deadline for the company to comply with a 1999 court order to implement “$25 million in pollution-reducing equipment” – the deadline has been expanded since “and is still being implemented.”  Meanwhile, “In January, the U.S. Justice Department also reached a $900,000 settlement with Smithfield Foods Inc. and Premium Standard Farms over premerger rule violations.”  (here)

Missouri, it turns out, has a strong history of trying to get local control over operation of these huge corporate hog farms.  The Wall Street Journal wrote:

As livestock operations have grown more industrialized, residents across rural America have banded together to try to keep them out. They say the bigger farms are wreaking havoc on their communities, polluting waterways with manure that can kill fish and sicken people. A popular tool has been county-level "local control" ordinances that govern where a large farm can locate.

While many states have retained authority over the siting of livestock farms, Missouri has a staunch local-control movement that took root in the early 1990s as corporate-controlled hog processors moved in. In 1999, the Missouri Court of Appeals held that a county can implement an ordinance governing livestock farms, including where they are located, if it is rooted in concerns over public health. Today, more than a dozen of Missouri's 114 counties have the ordinances.

Another thing lipstick clearly can’t mask – the smell of rotten eggs.