TorteDeForm

Kia Franklin

Civil Justice: The Cure for a Broken Heart (Defibrillator)

Whether you're talking about poisonous pot pies and pop corn, defective defibrillators, tainted toys, or some other alliteration, recent newspaper headlines provide countless examples of the clear link between inadequate government regulation, the abuse of corporate power, and the need for individual citizens and vulnerable communities to access the civil justice system to protect their rights. Two cases in point pop from today's headlines:

First, the LA Times reflects upon the pot pie debacle, asking why it took ConAgra days to pull the pies from store shelves despite mounting evidence that keeping them on the market was a recipe for disaster. The article points out that:

...ConAgra Foods Inc.'s delay in recalling potpies linked to a nationwide salmonella outbreak increased the chance that more people would become sick, opened up the company to greater liability and exposed a key weakness in the nation's food safety system: voluntary recalls.

"It's clear that this recall wasn't well handled, and the outbreak may well grow," said Caroline Smith DeWaal, director of the Center for Science in the Public Interest's food safety division.

ConAgra issued a health alert Tuesday afternoon and asked stores nationwide to stop selling Banquet and store-brand chicken and turkey potpies, but the company didn't recall the pies until Thursday evening. The company and federal officials warned customers not to eat the potpies and to throw them away, and ConAgra is offering refunds.

Not a good look for you, ConAgra.

Second, to contrast, yesterday Medtronic announced it was stopping sales of its malfunctioning defibrillators and taking measures to ensure that patients who already have the device get tested and get it replaced if there are any problems with it. The company's stocks suffered today, but, as one FDA official said: “Pulling this device from the market is the right thing to do.” Not alerting the public to this problem would cause more deaths and serious health crises, and likely, legal liability.

Perhaps the company can't bear any more bad press (like this or this). Or perhaps the combination of bad press and financial hits from litigation finally clued them in to the lesson that's at the heart of the matter: the public's safety is more important than profits. And if that moral isn't enough, well, when the public's health is undervalued in the pursuit of profit, this bad decision will eventually send the bottom line into cardiac arrest.

Medtronic hopes its actions in this instance (the company's no angel but you got to give them credit here) will be a model, in contrast to the actions of competitors that failed to disclose serious risks to the public. From the Times:

Whatever happens, Medtronic is hoping to contrast its response with that of Guidant three years ago, when deadly defects were discovered in some of its defibrillators. Guidant, which Boston Scientific acquired in 2006, angered doctors and regulators by failing to quickly disclose the problems.

Since then, the Heart Rhythm Society, the professional group for doctors who implant defibrillators, has developed guidelines for handling product safety problems.

Dr. Schultz at the F.D.A. said the company’s actions were an indicator of how much the industry had learned from the mistakes made in handling the Guidant malfunction. Dr. Hauser, the Guidant whistle-blower, agreed. “I think that in the old days, this lead could have continued on the market for a long time, maybe forever,” he said.

When people mischaracterize the civil justice system as clogged and in need of tort deform, we should ask how inadequate governmental regulation and irresponsible/immoral corporate behavior—the very factors that create a need for the checking power of the civil legal system in the first place—come into play. Civil justice impacts regular Americans’ access to safety, economic justice, consumer protection, civil rights, and environmental justice. It’s not about the right to sue, it’s about being able to enforce important rights via the court system. And it's about impacting the way businesses are run by making it clear that there are consequences for bad decisions that harm the public.

***UPDATE*** Thanks to a Tort Deform commenter for pointing out that actually we should be a little more stingy with the credit we give Medtronic for pulling its device. Unfortunately, according to this source Medtronic did not exactly jump at the opportunity to act in the public's interest. It took them months to take action:

The Medtronic implantable defibrillator analysis is not the first time that the Sprint Fidelis lead has caused concerns. Earlier this year, another study published by the Minneapolis Heart Institute found that a significant number of patients with the component had experienced painful shocks when the defibrillator fired unnecessarily. Medtronic was made aware of the Minneapolis study’s findings, but did not believe that there was enough evidence to reach any conclusions about the performance of the Sprint Fidelis lead. However, in March, the company did send doctors a letter outlining concerns with the defibrillators.

Well, there goes voluntary regulation as the cure for a broken heart (defibrillator). It looks like the Civil Justice system remains one of the few remaining avenues for recourse.

Kia Franklin: Author Bio | Other Posts
Posted at 9:04 AM, Oct 16, 2007 in FDA | Health Care | Under-regulation
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Comments

Yes- Medtronic DID do the right thing- however they HAVE known about this problem since at least March 2007 and are just NOW recalling it. I am one of the many with this device and I was shocked numerous times inappropriately and let me tell you- it was the MOST horrifying thing that has ever happened to me!

Posted by: KT | October 15, 2007 3:19 PM

Wow. So basically this angle--wanting to be a model for other companies in terms of putting patient safety first--is just a spin-game. Lovely how that little detail was omitted in the papers.

Here's more on this on newsinferno: click here I'll update the post accordingly.

Thanks for your comment.

Posted by: Kia Franklin | October 15, 2007 6:13 PM

All safety enhancement comes from technology and business competition. The self-dealing, masking ideology of the tort lawyer misleads. The lawyer has deterred potentially useful and safer technology. The effect of torts is the opposite of its declared goal.

Posted by: Supremacy Claus | October 16, 2007 11:55 AM

I agree that competition inspires innovation. But why aren't these companies that are all "health centered" in name not competing over who can be the best at providing products that actually pursue the public's health? This would really increase profits for them. A true socially responsible pharmeceutical company or medical device company, for example, if left able to thrive without the threat of bullying by other co's who file frivolous patent lawsuits to stop innovation and stop competition, but to preserve their profits--they would make a killing without killing anyone.

Failure to innovate should not be rewarded by excessive profits. The market is not the testing lab--figure that stuff out BEFORE you distribute it on the market, and DISCLOSE important data SOONER rather than LATER.

Posted by: Kia | October 16, 2007 6:08 PM