It’s now well established that tort “reformers” and hypocrisy go together like peanut butter and jelly.  Just think back to one of my favorite examples: alleged newsman and tort “reform” champion, John Stossel, who railed against frivolous lawsuits, but had no problem bringing one of his own. It was during one of his hard-hitting, investigative pieces about professional wrestling.  Poor John wanted to reveal the terrible secret about the sport–that it is fixed–even though the only person alive who was unaware of that seems to have been John. Nonetheless, he goaded one of the pros into bitch-slapping him (Stossel) upside the head during an interview, and promptly sued for “damages.”

But the hypocrisy takes on a deeper resonance when it comes from a physician tort “reformer” who specifically condemns “frivolous” medical malpractice suits, after having been a defendant in a meritorious action or two.  And here I’m talking about the GOP’s own Rep. Phil Gingrey, of California.  Injury Board shares the details in this recent post.  Yes, Dr. Gingrey and his colleagues treated an OB patient less than optimally, to put it charitably, and were responsible for allowing her fetus to die, and the patient to suffer a debilitating stroke.  So naturally, he would  sponsor a bill that would arbitrarily cap damages, restrict legal fees for lawyers handling medical malpractice cases, and bar the ability to obtain punitive damages against negligent drug and device makers when the product has been FDA-approved.

Those darned, frivolous medical malpractice suits can be such a bother–especially when your failures as a physician are what instigates them.  Thanks, Phil, and keep up the good work!

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Florida’s medical malpractice liability insurers have been profiting for the past 6 years. New liability companies apparently can’t wait to write medical malpractice “products” there.  Here is the News Press’s take on how robust Florida’s market for medical liability insurance has become.

And as Alan Belsky points out in in his firm’s blawg, Maryland Malpractice Lawyer, this comfort level for the insurance companies is not confined to Florida. In Pennsylvania, a physician-supported pool saw a 61% decline in claims, and there has been an exponential rise in liability insurers wanting to do business there.

Why do I point this out?  Because unfortunately, the AMA,insurance industry lobbyists,  and  politicians across this country, are continuing their urgent calls for tort “reform,” claiming that doctors are fleeing, or hanging it up altogether, due to the medical malpractice “crisis.”  But if that were true, who are the profitable medical liability companies profiting from?  And why are more of them opening up shop?  That’s right.  There are plenty of doctors around, and they all have to buy insurance.

And in medical-legal news, RF (radio frequency) tags are proving to be an excellent tool in the effort to decrease the leaving behind of surgical sponges in patients following surgery, according to OutpatientSurgery.  The RF tags embedded in the sponges  work like the anti-theft tags used in retail stores, and nurses need only pass an RF detection wand over patients to discover what the sponge count failed to account for.  Current studies claim there are also no false positives or negatives.  Lojack has arrived in the OR, and we are better off for it.

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You know, doctors don’t like to admit it, but even they turn to us trial lawyers now and then, as they have this week in California.  The reason? The Governator, a/k/a Arnold Schwarzenegger, exempted state hospitals from the requirement that an anesthesiologist be present when a nurse anesthetist administers anesthesia to a patient, without consulting the state’s medical board and board of nursing.  Pursuant to Medicare rules, he was requirerd to do so.

California’s medical societies have spun this as a patient safety issue, i.e., the supervision of an actual doctor prevents mistakes and injuries, and can better correct them if and when they occur.  But it is hard to ignore the fact that if doctors must be present in every case in which a trained, certified nurse anesthetist administers anesthesia, those doctors are going to make more money.

So who did the doctors call when they felt that their rights were being stomped on?  That’s right. Trial lawyers.  With their help, they have filed suit against Gov. Schwarzenegger.  Which is a little odd, since most of the time, when doctors or their medical societies use “trial lawyer” in a sentence, it is coupled with words like “greedy,” “evil,”  “opportunisitic,” and the like.

Of course, the reality is that trial lawyers may have saved your life, particularly if you were lusting after that cute little Ford Pinto some years back.  And even now, if you think Toyota is taking the action it is with regard to accelerator pedals on its own, you are probably in another galaxy.  It was trial lawyers, and the legitimate threat of lawsuits that would cost the company big money that was the ultimate motivator.

Perhaps if people had a natural tendency to take action to right wrongs they become aware of, we would not need us trial lawyers.  But history teaches us otherwise.  In yesterday’s NY Times, we learned some good news: that radiologists were finally taking the dangers of radiation therapy seriously by forming a safety task force and a central data base of errors that harmed patients.  But the disappointing news was this.  Such a step would never have been taken if the NY Times had not written two recent articles on the dangers of such therapy, and the lack of any safety systems that might help regulate such treatment.  You don’t think the radiologists envisioned a law suit or two, do you?

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In my last post, I addressed the dangers and senselessnes of FDA preemption in the wake of Riegel v. Medtronic, given the reality that some doctors continue to test and use medical devices in ways that can only be described as corrupt.  Combine that with the FDA’s well-documented history of poorly run trials that are hurriedly performed so that the product can be rushed to market, and you have untold disasters waiting to happen.

In today’s New York Times, reporters Barry Meier and Duff Wilson provide an update on one of the two fraudulent physicians discussed in my last post, Dr. Timothy R. Kuklo.  Dr. Kuklo, who happens to also be a lawyer, is the orthopedic surgeon who created a fraudulent study touting the benefits of one of Medtronic’s bone-growth products based on his treatment of severely injured U.S. soldiers at the Army’s Walter Reed Hospital.  Dr. Kuklo was a paid “consultant” for Medtronic at the time.  Once it was discovered that the had forged the signatures of four physicians on the study, and that the study included non-existent soldier-patients, the gig was up for Dr. Kuklo.

Today’s article reveals that Iowa’s Senator Charles E. Grassley, who is the ranking Republican on the Senate Finance Committee, has opened an inquiry into Dr. Kuklo’s conduct.  This will not be good public relations for Medtronic, according to Meier and Wilson, who report that “since late last year, Senator Grassley and, separately, the Justice Department have been investigating whether the company [Medtronic] illegally promoted uses of Infuse [the bone-growth product] that were not approved by the Food and Drug Administration–by paying doctors, among other alleged measures.”

So, let’s review.  Medtronic is the type of company that now enjoys the huge benefits of federal preemption.  Medtronic pays physicians to come up with the results Medtronic wants, so that Medtronic can sell more of its products.  The studies are not only biased, but out and out fraudulent.  The patients on the receiving end of this profit-not- patient- driven medicine are returning soldiers with life-changing orthopedic injuries, who may or may not benefit from Medtronic’s product because a fraud like Dr. Kuklo cannot be relied upon to have used it properly while his eyes were on his consultancy fees only.  And certainly, the results of the fraudulent study funded by Medtronic will not benefit the medical/surgical community.

And, this case is one of the known cases.  Chances are, this kind of fraud has happened, is happening, and will continue to happen.  But wounded veterans who find themselves injured by such tainted products will not be able to sue, due to the Feres Doctrine.  And civilian recipients of such products that got through the FDA’s approval process who are injured or killed by them are equally without recourse.

Come on, folks in Washington, DC.  It’s past time to right the wrong of federal preemption, and the sooner, the better.  What’s going on now is just un-American, and an outright disgrace.

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Today, we revisit the story of a West Virginia orthopedist who has injured and killed numerous residents of his state with his unmatched incompetence.  ChicagoTribune.com reports that Biomet, Inc., parent company of EBI, the manufacturer of bone stimulators used by Dr. John King during many failed surgeries, has settled 24 out of 27 claims by plaintiffs.  Based on a regulatory filing by Biomet, it expects to pay out $39 million dollars on the claims.  EBI has denied that it improperly marketed its devices through an illegal kickback scheme centering on Dr. King, which scheme was also alleged to have defraued federal healthcare programs.

Of course, this is not the first time Dr. King has been covered by this blog.  I wrote about the kickbacks he seemingly enjoyed from the makers of devices he implanted here.   And before that, I wrote, in awe, about how a man facing 124 medical malpractice suits still had the time and the chutzpah to sue the good lawyers who had defended him in court.

Meanwhile, in yesterday’s NY Times, we learned that an Army surgeon at Walter Reed Medical Center who was a paid “consultant” for Medtronic, concocted a fraudulent study, using nonexistent subjects, to support his glowing praise for Medtronic’s bone-growth product.  He even forged the signatures of four other Walter Reed doctors when submitting his study for publication in a British medical journal, which has since retracted the related article at the Army’s request.  And this is where it almost gets personal.  Dr. Timothy Kuklo, the doctor who masterminded this fraud, is also a lawyer, having graduated from Georgetown University’s Law School.  Ethics? Professional Responsibility? Differences between right and wrong?  Are these no longer part of the law school curriculum?  Do they really have to be?

But the bigger problem here is, because these physician-criminals have so bastardized the process of using medical devices and products, they have effectively muddied the waters surrounding their quality.  We cannot know how effective these devices are, since they were used in a manner dictated not by what was best for the patient, but what was best for the pocketbook.

And, the unfortunate victims of these scams will never be able to seek redress in the courts when these products fail, due to the federal preemption doctrine.  Ironically, the federal preemption case that enabled big business to avoid its responsibilities to the medical consumer involved this very company, Medtronic (Riegel v. Medtronic).

Let’s hope that the current efforts in Washington to undo that ill-advised decision will bear fruit, and quickly.

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An editorial in today’s New England Journal of Medicine laments the result of the Riegel v. Medtronic decision, based mostly on the NEJM’s concern that “preemption will result in medical devices that are less safe for the American people.”  The editors point to the most recent example of preemption in action, in which a district court judge in Minnesota dismissed over 1000 cases that had been filed against Medtronic for injuries resulting from failures of its Sprint Fidelis implantable carioverter-defibrillator lead (see my March 15, 2009 post for details).

In addition to the disadvantages that Riegel imposes on American consumers of healthcare needing medical devices, the NEJM notes that in light of the more recent decision in Wyeth v. Levine, there has been created an unnecessary and ill-advised conflict: preemption for medical device makers; but not for drug companies with insufficient warning labels on their products, despite FDA approval.

The solution?  The Medical Device Safety Act of 2009. This bill would essentially nullify the Riegel ruling, and allow patients to seek redress when FDA-approved medical devices injure them.  The NEJM editors are not only compassionate in the way doctors should be toward their patients, but their suggestion would resolve a legal conflict that makes little sense.

And of course, their argument gains additional traction when each news cycle reminds us of how little reliance we consumers of medical care can realistically place on FDA approval.  In today’s ABA Journal, we learn: (a) that a study of the anti-psychotic drug Seroquel revealed risks of weight gain and diabetes for patients; (b) the study was disclosed to the FDA, but not to doctors or the public; and (c) the FDA nonetheless approved Seroquel as safe and effective, even though the study itself was supect due to the number of subjects who dropped out before its completion.

Here’s hoping that the new FDA, under new leadership, can do better.

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