Articles Posted in Litigation

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It is hard to make sense of the Fresenius dialysis debacle. People have been hurt – the most vulnerable among us – and it could have been so easily prevented. What I try to do below is lay out what happened and explain what I believe the future of these lawsuits to be.

Fresenius Medical Care is the nation’s largest provider of dialysis treatments, with over 130,000 patients. Their dialysis facilities use GranuFlo and NaturaLyte acid dissolution products in treatments, which are products created by Fresenius. Countless non-Fresenius dialysis centers also use those products, which are sold by Fresenius. Defects in those products are terrifying not only because of the harm they could cause but because Fresenius has such a ridiculously high market share. This is not a product people want, it is a product they absolutely need.

Dialysis and Kidney Disorders: Background

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It is always an odd battle of brother v. brother when it comes to MDL fees. The plaintiffs’ MDL steering in most mass tort cases does most of the heavy lifting in getting the cases resolved. No one can argue with this. But the question is how much is that worth?

In the Avandia cases, the court decided that it is worth 6.25 percent of all settlements up to $143,750,000. Is that fair? It is hard to know. Hourly billing rates for common benefit attorneys ranged from $ 225 per hour to $ 595 per hour. No doubt, these are particularly easy to inflate and, let’s be honest, there is some bill padding that often goes on in these types of cases. But the Glaxo’s lawyers are billing out as high as $ 825 per hour. That is guaranteed money as opposed to the speculative work that plaintiffs’ lawyers do in an MDL. (Of course, the steering committee also gathers up individual cases in their travels to supplement their pay.)

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A New Jersey judge in the Aredia/Zometa state court cases found that a Zometa plaintiff’s lawsuit had been dismissed, applying Virginia’s statute of limitations.

The facts of this case are, like many of the other in the Aredia/Zometa cases, sad. Plaintiff, a resident of Virginia, developed osteonecrosis of the jaw after allegedly receiving infusions of Zometa.

Everyone agreed that Virginia’s substantive law applied. The court found that, if the substantive law of Virginia governs plaintiff’s damage claims, the defendant has the right to assert applicable affirmative defenses under Virginia law.

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Abnormal Use interviewed University of Maine School of Law professor Jennifer B. Wriggins in a blog post last week. Professor Wriggins is best known for her book “The Measure of Injury: Race, Gender, and Tort Law” which talks about how tort law does not provide full redress for injuries to women.

Professor Wriggins was asked by Abnormal Use, “What rule or concept in modern torts or products liability jurisprudence do you believe is the most outdated, and why?”

Now that is a really good question. My first answer would probably be contributory negligence which is also touched on in this interview. Professor Wriggins said she thought the most antiquated idea might be not telling the jury of the existence of liability insurance even though the likelihood is that most of them know or suspect the defendant has insurance:

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The Drug and Device Law Blog has an articulate rant about plaintiffs’ lawyers jerking around defendants on whether certain documents produced should be deemed confidential. The core of their argument is that plaintiffs’ interests in the battle over confidential documents is either for (1) sport, or (2) to shop documents obtained in discovery to the press.

There is some measure of truth to almost the entire post. But it is as if Tiger Woods told the following story: “I was looking forward to a nice Thanksgiving weekend with my family but on Sunday my wife just left. Didn’t say good-bye or anything.” That’s a true story.

Similarly, the Drug and Device Law Blog leaves out a little fact of the story: mass tort defense lawyers are the undisputed kings of making plaintiffs’ lawyers work for pure sport. Plaintiffs’ lawyers in drug and device cases largely just want to get from Point A to Point B as quickly as possible. I think this is a function both of the personality types attracted to these very different jobs (and I’ve done both) and fundamental economics: plaintiffs’ lawyers get paid for success while defense lawyers get paid for working, even if they are just creating work.

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According to the Maryland Intellectual Property Law Blog, Maryland has seen only 10 patent lawsuit in 2010. Incredibly, there have already been 265 patent lawsuits in Texas. There are not more patents in Texas. Maryland inventors received almost as many patents in the first half of 2010.
Drug companies, who are anti-lawsuits until they want to file one, are frequently parties in patent lawsuits involving one drug company accusing another of reverse engineering or copying of drugs.

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Ethics-Definition-05-25-10.jpgSean Wajert of the MassTortDefense Blog has a post on a court’s denial of a plaintiff’s ethics expert in an OBTape MDL pending in Georgia. We routinely disagree with Sean’s blog (we’re on different sides of the aisle, of course), but there isn’t much disagreement with this post.

Disclaimer: I haven’t been following the OBTape litigation too closely, so all my information is secondhand.

Plaintiffs hired a business ethicist, Professor Ann Buchholtz, to testify that the product manufacturer should have provided certain information about the product to physicians and consumers. This is essentially a failure to warn claim. The problem with hiring a business ethicist (who, apparently has no particular expertise in medical devices or medical ethics, which arguably could alter the analysis) is that she is unnecessary. A jury is tasked with determining whether a company failed to warn about specific dangers. Having an expert say what is “ethically” required is merely an attempt to substitute an expert’s opinion for that of the jury. And, the danger is that the opinion comes cloaked in the guise of expert testimony, so a jury might be more willing to accept the expert’s viewpoint.

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We previously blogged about the Fleet Oral Sodium Phosphate (laxative) cases, with about 1,200 now pending before the United States District Court for the Northern District of Ohio. This product was used by people before medical procedures, including colonoscopies. Plaintiffs allege that the product can cause kidney failure and chronic kidney damage. Some people needed dialysis, some needed kidney transplants, and other died.

The Fleet products at issue, Fleet Phospho-soda, Fleet Phospho-soda Accu-Prep and Fleet Phospho-soda EZ-Prep, were recalled in December, 2008.

It appears that both sides, plaintiffs and the manufacturer, C.B. Fleet, are close to working out a product liability settlement. Of course, as we wrote before, one of the Plaintiffs’ main contentions is that C.B. Fleet knew about the product dangers well before it actually warned or recalled the product. If the cases resolve, the first scheduled trial date of October 10, 2010 will be taken off the docket.

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A really nice Bloomberg article on whistleblowers “hit the stands” today. The authors, David Voreacos and Margaret Cronin Fisk did an excellent job of tracing the payouts and controversy surrounding corporate employees of drug companies who alert the DOJ to bad pharmaceutical practices. Essentially, the act of telling the DOJ gives the federal government the ability to recoup millions of dollars, a portion of which is given to the whistleblowers as an incentive payment. Without that payment, few whistleblowers would risk their jobs and peer ostracization to bring these bad practices to light. Some think the payments to whistleblowers are too high. I don’t have any problem with it–it may encourage others to report bad practices (and remember–not all whistleblowing cases are accepted, or result in multi-million dollar settlements).
See our prior Seroquel/Whistleblowing blog post.