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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The Wall Street Journal’s Law Blog shines a light on something that is more than just medical malpractice.  It is criminal enterprise. This story concerns a physician and snake-oil saleswoman, all in the same person, who took advantage of the desperation of patients with advanced cancer by selling them an expensive “herbal remedy” that she surely knew would work only to line her pockets with cash.

The WSJ Law Blog also reports on the big dust up in south Florida over a new website called “whocanisue.com.” Many find it crass and distasteful, perhaps because of the ads on billboards and bus shelters promoting it, which feature a lawyer slipping on a banana peel.  The name of the site does not exactly inspire love and respect, either.  And, according to WSJ and a local Florida paper referenced in its post, some of the people most offended by the site are other Florida lawyers who feel that it degrades the entire profession.

One of the issues addressed in the WSJ post is that the site is not subject to attorney discipline, since it is only a “referral” service.  And that’s a valid point.  But my concern is, given how successful the site is in drawing in business, according to the press about it, shouldn’t there be some vetting of the firms that advertise on the site?  For instance, checking that the attorney: is licensed in the state; has not been the subject of repeated disciplinary action by the state bar; does not have a history of misrepresenting his services to potential clients (i.e., the lawyer promises his individual attention to your case, but hands it off for a percentage of the anticipated fee as soon as he signs you up); and actually has experience in the specialty area he claims expertise in.

Getting back to the more ennobling aspects of lawyering, my Twitter friend, Bill Marler (@bmarler if you want to follow him, which I recommend)  delivered shirts emblazoned with the phrase “Put a Trial Lawyer Out of Business” to the Senate earlier this week in an effort to call attention to the need for better food safety regulations, according to the Mass Tort Litigation Blog.  Bill was prominently featured in last week’s New York Times article on the devestating effects of E. coli on a children’s dance instructor who ate contaminated hamburger meat.  She is now paralyzed from the waist down as a result.

And yes, you can thank a “trial lawyer” like Bill Marler for forcing the hamburger manufacturers to do what they should have been doing all along with regard to food safety, since such arcane concepts as “caring enough not to poison those who eat your product” seem so elusive to such companies, until they stand to lose profits to a lawsuit.

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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 today’s NY Times, Gardiner Harris reports on renewed interest by federal prosecutors in going after doctors who accept illegal kickbacks from drug and device manufacturers in return for using their products.  The Department of Health and Human Services is concerned about “marketing tactics that enrich doctors but increase health care costs and sometimes endanger patients,” according to Mr. Harris.  Doctors could face loss of their licenses, fines and jail time for violations.

The federal prosecutors vow to bring greater transparency to the public about the nature of consulting relationships between doctors and drug and device companies, which will not only curb illegal agreements enriching doctors, but will (hopefully) restore the public’s trust in such relationships, and the products produced as a result of them.

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Today’s NY Times discusses the good and the potentially bad when it comes to conducting trials of new drugs outside of the United States.   Subjects in developing countries may be rushing to sign up and disregarding their own safety.  Populations in some other countries may be so physically different from Americans that results of testing may not apply to us.  And some testing is done in Canada and Sweden, with populations similar to Americans physically, and financially.

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