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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In a recent NY Times article, reporter Barry Meier discussed Medtronic’s acknowledgment that some 13 deaths have been attributed to malfunctions of a device it manufactured –a small cable, known as the Sprint Fidelis, that connects an implanted defibrillator to the patient’s heart.  Apparently, Medtronic knew the device was failing shortly after it reached the market in 2004, according to the FDA’s investigation into the product’s failures.  Yet the device was not recalled until 2007.  Where was the FDA “oversight” that should have protected such patients?

The NY Times article provides a meaningful introduction for an article published the next day by The New England Journal of Medicine, entitled “A To-Do List for the New FDA Commissioner.”  Susan Okie, M.D., one of the NEJM’s national correspondents, provides some well-thought-out suggestions for how to fix the dysfunctional government entity.  For starters, the new commissioner needs to take a bipartisan approach to securing increased federal funding, as new employees must be recruited and trained.  Additionally,  the agency’s information-technology system is obsolete, and must be replaced.

The new commissioner must restore credibility to the FDA, and this means attaining increased transparency immediately.  This will be a challenge, as the agency has long maintained an insular culture that frowned on dissent.

The food-safety operations at the FDA must be streamlined and centralized.  At present, food regulation is handled by three different departments of the agency, and more than eleven additional federal agencies take part.  Dr. Okie notes that the fallout from the recent outbreak of salmonella prompted President Obama to make a review of food-safety operations at the FDA a priority.

The agency’s process for approving medical devices needs attention as well.  As Dr. Okie points out, “the 1976 law granting the agency authority to regulate medical devices allows it to approve certain new devices without clinical testing of safety and efficacy, provided they are deemed substantially equivalent to devices already on the market.  Despite 1990 legislation ordering the agency to begin requiring more extensive clinical studies of class III devices (those implanted in the body) before approval, most are still approved with minimal testing.”  This has resulted in exactly the type of problem discussed in the NY Times article on Medtronic’s Sprint Fidelis device.

Lastly, the agency must act immediately to share developing concerns about the safety of drugs with doctors and the public.

Is President Obama’s nominee for commissioner, Dr. Margaret Hamburg, up to the task?  After six years as New York City’s Health Commissioner, I’m betting that she is.

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In early February, I posted about West Virginia physician, John A. King, who had managed to generate 124 medical malpractice lawsuits during the short time he was on staff at Putnam General Hospital.

It turns out that Dr. King also generated considerable, and illegal fees for himself, courtesy of the medical device makers whose products Dr. King installed into patients during surgeries.  On this blog, we call those fees “kickbacks.”  The Charleston Gazette reports that several of the 124 lawsuits named as codefendants Wright Medical Technology, Inc. and EBI, Inc., both of which supplied devices used by King during the suspect surgeries.  Wright’s bone-fusion compound had not even worked in animals, nor had EBI’s vertebral spacers.  The patients were never informed they were being treated with experimental devices.

Of course, it gets worse.  Dr. King filed for bankruptcy once he saw the legal writing on the wall.  Then, he defrauded the Bankruptcy Court by claiming, in December, 2007, that he had no checking or savings accounts, no firearms, clothing furs, jewelry or monthly income.  All he had to his name, he said, was the value of of 1993 Volvo.  Now, a bankruptcy judge who caught on to Dr. King’s scheme of hiding his actual assets from the court has denied Dr. King the benefits of his bankruptcy filing.  It turns out that Dr. King had been making regular deposits into his mother’s bank account, and had secreted hundreds of thousands of his own dollars into “The Bonemaker Trust” (yes, that is its true name).

Meantime, the State of Virginia has a dark secret that is secret no longer.  It fails to adequately discipline its physicians.  The poster boy for Virginia’s broken system is Dr. Stephen Plotnick, a rheumatologist who specialized in pain management.  10 of his patients have died since 2004, and it took 5 years before he was forced to surrender his license for 2 years.

If you’re headed south to Florida in the near future, do yourself a favor and fly there.  If you must drive, don’t stop in Virginia or West Virginia, if you know what’s good for you.

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