ThePopTort

Get Out of our Bodies, Johnson & Johnson

Yesterday, a New Jersey jury ruled in the first of about 1,800 vaginal mesh cases pending in that state against Johnson & Johnson and its subsidiary, Ethicon.  The jury could not have been more clear: $3.35 to a South Dakota nurse, who was surgically implanted with a Gynecare Prolift vaginal mesh.  This device injured her so severely that she’s already undergone 18 operations to try to repair the damage. From our earlier coverage of vaginal meshes: 

The FDA approved surgical meshes for procedures like abdominal surgery.  But J&J began marketing them for use in a women’s vaginal area, treating problems like incontinence.  Subsequently, hundreds of women became severely injured and some died as the meshes began disintegrating, growing into tissue and becoming impossible to remove.

Meanwhile, the company’s Securities and Exchange Commission filing revealed last Friday that the United States attorney’s office in Massachusetts and the civil division of the Justice Department are investigating J&J's marketing of its its ASR hip replacements.  That’s the Frankensteinian device that J&J finally recalled in 2010 even though it apparently knew the device was failing and releasing high levels of metallic ions, and which it is now defending in a bunch of lawsuits. See some of our previous coverage here. 

And also last Friday, the U.S. Food and Drug Administration said it has “notified healthcare professionals of a Class I recall, the most serious type,” of J&J’s LPS Diaphyseal Sleeve, used in reconstructive knee surgery.  Apparently, says the FDA, this device as the “potential for fractures” and the FDA has already received 10 reports of the device malfunctioning: 

A fracture in the sleeve at the joint of it could lead to loss of function or loss of limb, infection, compromised soft tissue or death, the FDA said.

From now on, Johnson & Johnson needs to stick to cotton swabs.  The outer ear is as far inside the body we would like J&J products to go, thank you very much.

Finally Getting Hip to J&J’s Cover-Up

On March 4, 2009, in its 6-3 decision, Wyeth v. Levine, the U.S. Supreme Court said one of the smartest things the Robert’s Court has ever said about civil lawsuits. (OK, maybe the only smart thing.):

Congress did not provide a federal remedy for consumers harmed by unsafe or ineffective drugs … Evidently, it determined that widely available state rights of action provided appropriate relief for injured consumers.  It may also have recognized that state-law remedies further consumer protection by motivating manufacturers to produce safe and effective drugs and to give adequate warnings...

State tort suits uncover unknown drug hazards and provide incentives for drug manufacturers to disclose safety risks promptly.

Promptly?  Hhmm.  That's really a term of art when it come to drug companies.  Perhaps the Court could have more accurately said,"state tort suits uncover unknown drug hazards and prevent drug manufacturers from covering up what they already know about safety risks." 

Take our “friends” Johnson & Johnson, whose recent litany of wrongdoing was highlighted in this post last June, like the time it endangered babies with cancer-causing chemicals in its signature Baby Shampoo line.  But for the adults folks out there more likely to be thinking about “hip implants,” you will be happy to know that thanks to litigation against this company, we have learned the following:

An internal analysis conducted by Johnson & Johnson in 2011 not long after it recalled a troubled hip implant estimated that the all-metal device would fail within five years in nearly 40 percent of patients who received it, newly disclosed court records show.

Johnson & Johnson never released those projections for the device, the Articular Surface Replacement, or A.S.R., which the company recalled in mid-2010. But at the same time that the medical products giant was performing that analysis, it was publicly playing down similar findings from a British implant registry about the device’s early failure rate.

The company’s analysis also suggests that the implant is likely to fail prematurely over the next few years in thousands more patients in addition to those who have already had painful and costly procedures to replace it.

Writes Bloomberg,

The failure-rate estimate came in pretrial testimony of Paul Voorhorst, a biostatistician for J&J’s DePuy unit, which made the hips. A plaintiff’s lawyer, Brian J. Devine, asked Voorhorst about a graph showing the company’s review of 554 implanted hips through September 2011, and how many would fail, requiring follow-up replacement surgery known as revisions.

“That means that 37 percent are expected to fail at 4.57 years, correct?” Devine asked Voorhorst.

“The estimated revision rate at that time would be 37 percent,” Voorhorst said. “That’s correct.”

And there’s more.  Writes the New York Times,

In other pretrial testimony released Friday, a DePuy engineer stated that company officials were aware in 2008 of reports by an English surgeon that the resurfacing version of the A.S.R. was releasing high levels of metallic ions, particularly in women. As a result of the reports, company officials felt they had to move quickly to redesign the implant. 

But J&J didn’t pull 93,000 of these Frankensteinian things from the market until 2010, citing “U.K. joint registry data showing that more than 12 percent failed within five years.”  It now turns out – thanks to this litigation disclosure - that the failure rate was triple that!

Continues the New York Times,

The episode represents one of the biggest medical device failures in recent decades and the forthcoming trial is expected to shed light on what officials of Johnson & Johnson’s DePuy Orthopaedics division knew about the device’s problem before its recall and the actions they took or did not take.

Apparently this new information “represent[s] only a tiny fraction of the information that will become public if the trial proceeds.”  We can’t wait.  10,000 people have sued.  And opening statements in the California case are this Friday. 

Time and again, pharmaceutical companies have violated the public’s trust with devastating results for patients.  The FDA is basically useless in these scenarios.  Only through litigation has the public learned anything. 

Meningitis Cases – No Preemption Problem Here!

Let’s hear it for the FDA’s failure to regulate the New England Compounding Center!  (You know, the source of the fungal meningitis outbreak that’s already killed over a dozen people.)  Don’t worry, we haven’t been hacked.  Let us explain.

As we noted earlier this week, compounding pharmacies are not regulated by the FDA.  Now, it’s possible the New England Compounding Center was acting more like a drug manufacturer than a compounding center in this case.  Members of the U.S. House and Senate are currently demanding investigations over those allegations, including whether a crime may have been committed, and Massachusetts Governor Deval Patrick said the Center “may have misled regulators and done work beyond the scope of its state license.”  That all may be true, but for the victims of this tragedy, the fact that there was no FDA oversight, while decidedly unhelpful to their health, may be very helpful to their quest for justice.

First, note that the first case has now been filed.  It was filed today in Minnesota by a woman who was given a steroid injection for back pain and “has experienced symptoms consistent with meningitis.”  As these cases move forward, it will no doubt come up that this company’s owners have some history of negligence and have forced victims to settle confidentially in the past.  USA Today reported yesterday,

Long before the current rash of fungal meningitis, the compounding pharmacy suspected in the outbreak settled a lawsuit alleging it produced a tainted shot that caused a man's death in 2004.. …

A 2004 lawsuit filed in upstate New York's Monroe County claimed New England Compounding Center produced a tainted shot that caused William Koch to contract bacterial meningitis at Rochester General Hospital on July 17, 2002. Koch died Feb. 28, 2004, at the age of 83. …

The compounding pharmacy reached a settlement with Koch's widow in 2007 before the case went to trial, according to her lawyer Mark S. Nunn. He declined to elaborate Wednesday because the terms were confidential.

That said, it is important to note the following. Had the contaminated steroid been regulated by the FDA and you happen to live in Michigan, no lawsuit would be possible – at all.  Had the case involved a misleading label on a generic drug, and the brand name version has been approved by the FDA, no lawsuit would be possible – at all.   Had the case involved a Class III medical device approved by the FDA (as opposed to an injected steroid), no lawsuit would be possible – at all.  And had the contaminated steroid been regulated by the FDA, and H.R. 5 (the federal medical malpractice/drug immunity bill) were law, a lawsuit might be possible, but the Center might not be liable for any punitive damages - despite how many were sickened and killed.  (I only say “might not” because the bill exempts "knowing misrepresentations" to the FDA, which may or may not be provable in this case.) 

That’s all to say, while FDA regulation is certainly preferable to no regulation, history shows that many FDA-approved drugs and devices have caused some of the most serious injuries and death.  Yet, the fact that a drug or device is regulated, no matter how unsafe, might present legal defenses that could prevent a patient’s legal case from going forward - at all.  This legal doctrine is known as “preemption" and fortunately, they don’t apply here.

ALEC Hearts Immunity - Read All About It!

Some important updates on a few stories we’ve been following:

First comes breaking news that George Zimmerman will be charged with Travyon Martin’s murder today, which we assume means he won’t be able to take advantage of the civil immunity provision in Florida’s Stand Your Ground laws.

And on the related ALEC front, kudos to Minnesota Governor Mark Dayton for vetoing yet another ALEC bill (see our coverage of some of his other vetoes). This legislation would have protected the asbestos industry and successor companies from liability, greatly harming asbestos victims.  Meanwhile, Wendy’s joined the list of other high-profile ALEC corporate members disassociating itself from that organization.  And now, shareholders may be joining anti-ALEC efforts, as well. 

Following up on our coverage of the struggles of a severely injured former Pennsylvania student, Ashley Zauflik, to overcome a Draconian $500,000 cap on the school district’s liability, today her lawyers went back to court.  They are arguing that not only is the cap unconstitutional, but also that “the district should face sanctions [because it] withheld the existence of a $10 million insurance policy until after the trial.” 

Meanwhile, medical device manufacturer St. Jude lost its efforts to force a retraction by the medical journal that published devastating research, led by renowned cardiologist Dr. Robert Hauser, about the horrendous defects in its implanted heart defibrillators.  Writes the New York Times, “the journal’s editor, Dr. Douglas P. Zipes, said in an interview late Monday that the publication had looked at St. Jude’s complaint and did not plan to pull back the article, which had undergone review by experts associated with the journal before its online publication two weeks ago.”  This is all part of St. Jude’s (backfiring) “scorched earth” attack on its critics.  

Now this next one isn’t exactly an update, but the irony is just too good: the exceedingly pro-tort reform, anti-litigation Koch brothers are filing another suit against the Cato Institute, which sponsors the exceedingly pro-tort reform, anti-litigation blog, Overlawyered.com. Oh my. Talk amongst yourselves.

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.

Food, Drugs and the FDA Breakdown

Today, the U.S. House of Representatives is debating whether to impose its contaminated political judgment on every local judge and jury in America.  Well, not every local judge and jury, but certainly any deciding a lawsuit against the health care industry.  And not just medical malpractice cases, mind you.  The bill they are debating today, H.R. 5, would limit the liability of the pharmaceutical and medical device industries, nursing homes, and even insurance companies and HMOs that refuse to pay legitimate claims.

Singled out for extra special protection are drug companies with FDA-approved drugs. Proponents of this bill - generally the "anti-federal government" crowd - apparently trust the federal government to get it right every time when it comes to the safety of drugs and medical devices. Does this strike anyone as odd?

Well, there are four stories out today that highlight big problems with this notion.  What they show is that the FDA continues to fall down on the job, and when left to their own devices, manufacturers will cut safety corners and often harm the public.  When it comes to some of our country’s most dangerous products, lawsuits are often the only way to prevent the wholesale destruction of public safety.

First, there’s a front page New York Times story about how a U.S. Supreme Court decision last year has blocked thousands of injury lawsuits against generic drug companies.  This is an issue that could be fixed by either Congress or the FDA.  Given what’s happening on the House floor today, no sane person could possibly expect this Congress to restore rights to drug injury victims.  However, the FDA could.  But so far, it won’t.  As the Times writes:

Public Citizen, a consumer advocacy group, has petitioned the Food and Drug Administration to give generic companies greater control over their labels, a rule change that could allow users of generic drugs to sue, but the agency said earlier this month that it needed more time to decide. “Congress can make this problem go away, and the F.D.A. could, too,” said Allison Zieve, the director of Public Citizen Litigation Group. “But we haven’t seen signs that either of them is paying much attention.” A spokeswoman for the F.D.A. declined to comment.

Moving on.  The FDA has a special rule –510(k) of the Federal Food, Drug, and Cosmetic Act – whereby drugs and devices that are “substantially equivalent” to a device already on the market are not required to go through more rigorous FDA approval.  This allows companies to market dangerous products for uses never really "approved" by the FDA, yet with the stamp of FDA approval!  This is just what Johnson & Johnson did according to a story from Bloomberg today about vaginal meshes.  The FDA approved surgical meshes for procedures like abdominal surgery.  But J&J began marketing them for use in a women’s vaginal area, treating problems like incontinence.  Subsequently, hundreds of women became severely injured and some died as the meshes began disintegrating, growing into tissue and becoming impossible to remove.  Over 500 women have now sued and finally, after J&J marketed the device for three years, the FDA is saying that the company should not have used 510(k) to fastrack these.  Not exactly quick work by the agency.  And had H.R. 5 been on the books, J&J might be immune from any punitive damages for what they did.

If you are still not convinced that when given the choice to help patients or make money, the drug industry’s priorities are completely screwed up, consider another article in the New York Times today.  This article is about a generic drug called tranexamic acid, which slows bleeding and could be saving lives.  And it’s cheap!  But, writes the Times,

[I]ts very inexpensiveness has slowed its entry into American emergency rooms, where it might save the lives of bleeding victims of car crashes, shootings and stabbings — up to 4,000 Americans a year, according to a recent study.  Because there is so little profit in it, the companies that make it do not champion it. …

The slowness of American hospitals is due to “inertia,” said Dr. Ian Roberts, clinical trials director for the London School of Hygiene and Tropical Medicine and leader of the 2010 trial, which was called Crash-2. “The people who do the urging and the talking about new drugs are the pharmaceutical companies, and if they’re not interested, it’s not done.”

Finally, we certainly don’t want to ignore the FDA’s other main regulatory area - food.  While food lawsuits may not be covered by the drug and device industry protections in H.R. 5, the FDA’s failures to regulate in both these areas are quite similar.  Today, the Center for Justice & Democracy at New York Law School is releasing a new study called Our Fatal Food Attraction:  Regulatory Failures and the Civil Justice System.  This study,

[F]inds that the regulation of food safety, particularly by the Food and Drug Administration (FDA), is inadequate to keep Americans safe and properly informed of foodborne illness dangers.  The study explores the dangerous impact of both privatization of key government functions and the lack of transparency by government agencies.  It also recognizes the important role that lawsuits play in protecting Americans, providing both a critical layer of food industry oversight and disseminating key public safety information to the public.

There’s some wild stuff in here that everyone should know.  And as they say, everything’s connected.  So don’t forget to call your member of Congress today (1-888-291-9824 to reach the U.S. Capitol switchboard), and ask them to oppose H.R. 5.  Today’s the day.  Speak up, loud and strong. 

Medical Malpractice and Congressional Fairy Tales

Would you believe that there's been a recent flood of Snow White movies, with not one but two coming soon to theaters near you?  There’s Snow White and the Huntsman with Charlize Theron as the evil queen.  And there’s Mirror Mirror starring Julia Roberts as the evil queen.  That title, of course, references her famous magic mirror, to whom she constantly asks, “Mirror mirror on the wall, who’s the fairest of them all?”  And the mirror always lies and says, "You, my queen, are fairest of all."  This goes on for awhile, but eventually, the mirror tells the truth and things don’t end up too well for the queen.  House leadership, take note.

For some reason, the House leadership has suddenly decided to push for a vote on H.R. 5, the anti-patient (and anti-women) medical malpractice/drug and medical device/nursing home bill.  The bill’s biggest proponent who keeps egging this on (the magic mirror himself!) was a malpracticing doctor.  That should tell you something.   You can follow the process today, including the introduction of a bunch of amendments, at the House Rules Committee site here. 

I say suddenly because, while the bill was on a very fast track at first, it ran into fierce opposition from some unlikely suspects.  Specifically, Tea Party conservatives.  (See, e.g., here, here )

Now, of course, the likely suspects are also vehemently opposed to the bill.  See, e.g., the consumer and patient group letter sent to Congress yesterday which explains why the bill is anti-patient and especially anti-women.  But I can’t say that the House leadership cares too much about them, or about women, or nursing home patients, or victims of pharmaceutical industry misconduct, or insurance bad faith victims.  Otherwise, there wouldn't be an H.R. 5.

But they are supposed to care about the Constitution.  So right now, a lot of folks in the conservative base are telling the House leadership to throw away those magic mirrors and get a reality check.  We shall see.

Regs Schmegs. Who Needs Consumer Protection Anyway?

The constant drumbeat of the attacks on consumer protection laws by big business and their friends on the editorial board of the Wall Street Journal is making me think, wouldn’t it just be easier to just let corporate miscreants do what they want?  So what that the giant medical device industry keeps paying off doctors to implant dangerous heart devices into patients.  Some measly DOJ fine isn’t gonna stop that, right?

If you’re with me, I want to tell you that there are some great things happening around the country.  In fact, speaking of hearts, in Ohio, the Cleveland Plain Dealer reports,

While we're in the middle of one of the busiest shopping seasons of the year, the Ohio House is preparing to tear up the Consumer Sales Practices Act as a little gift to the state's auto dealers [with] a change that would make it easier for companies that cheat consumers to wriggle out of serious consequences. … It wouldn't do away with the law wholesale. Instead it surgically removes the law’s heart.

Make more sense than giving this law a defective pacemaker.  Then in New Jersey, Sy Larson, President of AARP New Jersey writes in the Daily Record,

Some of the regulations that currently protect all of us, as consumers, may no longer be enforced if some new rules being considered by the New Jersey Division of Consumer Affairs are implemented.

Indeed, these new rules being considered by the division actually would allow businesses, in some cases, to ignore established laws that protect consumers — without notifying the public of the act. …

Consumer protections such as The Used Car Lemon Law and The Telemarketers Do Not Call Act are just two of the many consumer protections that could be rendered essentially worthless.

Look, you know you’re absolutely dying for more telemarketers in your life.  Don’t you lie to me!

Now let’s turn to the property/casualty insurance industry, who were skewered pretty badly by a Huffington Post piece today:

Because of their protective role in the lives of ordinary citizens, insurers have long operated as semi-public trusts. But since the mid-1990s, a new profit-hungry model, combined with weak regulation, has upended that ancient social contract.

Weak regulation?  That's just silly.  It's no regulation, more like it.  In New York, writes the Buffalo News:

Insurers in New York no longer have to file their rates with regulators and obtain approval before issuing commercial insurance policies to companies, nonprofits or government agencies that are considered large and sophisticated.

Ooh, sophisticated!  So in other words, just let the insurance industry regulate itself cause the "free market" works so well when it comes to insurance. 

Actually, that’s a little tease.  Stay tuned tomorrow – we’ll have a lot more on that!  Promise.

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.