Fresenius Dialysis Lawsuits: Real Information for Victims

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

Patients who are in kidney (renal) failure must go through a process called hemodialysis. Dialysis is the process of removing harmful products from the body, including excess waste, acid, and water. A dialysis patient’s kidney doctor (nephrologist) will set the parameters for dialysis, including how often the patient must go and solution flow rates. Dialysis patients typically go to a center about three times per week, with each treatment lasting about three to four hours.

GranuFlo and NaturaLyte are acid concentrates, which are important for dialysis. They are used to remove excess acid from the blood by helping the body to create bicarbonate, an acid neutralizer.
Defective GranuFlo & NaturaLyte Dialysis Drugs
Just as too much acid is dangerous to the body, so is too much bicarbonate. Acid dissolution solutions are supposed to help the body make more bicarbonate. The problem with GranuFlo and NaturaLyte is that some of the ingredients can be converted into bicarbonate—if the prescribing physician or technician doesn’t take this into account, the patient’s body might create too much bicarbonate, which can cause a number of injuries:

  • low blood pressure
  • hypoxemia (low levels of oxygen in the blood)
  • cardiac arrhythmia (irregular heartbeat)
  • hypercapnia (excessive carbon dioxide in the blood)
  • cardiopulmonary arrest (heart attack)

Some studies are showing that patients using GranuFlo or NaturaLyte are four to six times as likely to suffer a heart attack within 48 hours of dialysis treatment. In 2010, there were 941 Fresenius patients who had heart attacks while at Fresenius dialysis clinics. There were certainly many more who were getting treatment at other dialysis centers.
What Fresenius Did Wrong
Where to begin? Fresenius knew about these problems, but decided to keep it quiet for far too long. When they realized there was a potential problem, they warned doctors at their own clinics, but didn’t tell any of the countless other clinics who use Fresenius products. It would be hard to find a more tailor-made “profits over people” example.

In fact, the way the FDA and other clinics found out was when an internal Fresenius memo was leaked. Fresenius then sent an official warning to those other clinics four months later. As a result, in June 2012 the FDA instituted a Class-I recall of NaturaLyte and GranuFlo. This is the highest level of recall, reserved for products which pose a serious concern of health problems or death.
Status of Fresenius Lawsuits
Our product liability lawyers are investigating potential Fresenius dialysis lawsuits. The most serious cases are those where patients have had a heart attack or death within two days of a dialysis treatment. Remember—patients treated at non-Fresenius dialysis centers may be at risk because other centers use Fresenius products.
Contact Us
If you or a family member is on dialysis, and believe you may have been treated with GranuFlo or NaturaLyte, contact our product liability lawyers at 1.800.553.8082, or send us some information about your case for a no charge, internet evaluation.

MDL Fees

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.)

Zometa Case Lost on Statute of Limitations

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.

At no additional charge, the court threw in a little lecture for plaintiffs:

Statutes of limitations are enacted to provide certainty for litigants and to prevent the litigation of stale claims. Judicial cherry picking whereby a litigant argues simultaneously in favor of two separate states’ period of limitations, as [plaintiff does] in this case, threatens to render statutes of limitations meaningless.

You can find the court’s opinion here.

Juries and Insurance

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:

One rule that strikes me as possibly outdated is the rule that juries are not allowed to learn about liability insurance policies. Even when a case involves an auto accident, and auto insurance is mandatory in a state (as it is in almost all states), so that jurors who are car-owners (probably most jurors) know that there is likely to be insurance, jurors are not supposed to know about insurance. I understand that it is important for the liability and damages issues not to be affected by the presence or absence of insurance, but I think it is very likely that jurors think about insurance anyway. I would want to think about this more before advocating it, but perhaps we should just give jurors the insurance information and tell them it should be kept separate from the liability and damages determinations. If they are hypothesizing about insurance and taking it into account anyway, then giving them accurate information should not hurt the process. I can see both sides of this, but I think we are probably deluding ourselves if we pretend jurors don’t know and aren’t thinking about the existence of liability insurance.

Jurors’ first question after a trial is often, “What’s the deal, didn’t this guy have insurance?” Jurors expect people to have insurance but they also expect information. If after a weeklong trial no one has mentioned insurance, jurors can easily begin to conclude that there is something special about the case and the defendant might not have insurance.
I think I agree with Professor Wriggins’ premise – which even she does not seem 100% sure about – but I have not given it a lot of thought. Why? The fact that we don’t tell juries about insurance always seemed like my poor vertical leap: something I accepted and never thought would change.

Pot Calling the Kettle Black

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.
The Drug and Device Law Blog freely admits that defendants do designate too many documents as confidential because “it’s hard to analyze the confidentiality of millions of documents and get every call exactly right.” (Y’all do this on privileged documents too, a practice that usually goes by unchecked.) So, their thinking goes, “if one errs on the side of over-designation, the documents can be de-designated and nobody is hurt.” So it is a hassle to do the job right the first time even though you billed the client $85 gazillion dollars for the document review. And the court’s order didn’t say, “Hey, when it doubt, just mark it confidential, we will put the burden on plaintiffs’ lawyers to have to run back to me to get it straight.”
Moreover, making documents public that show what drug companies are actually doing may serve plaintiffs’ lawyers’ interests but it also serves the public good. If you are taking a drug and the manufacturer has documents showing they are burying studies that reveal the drug has risks not fully disclosed, isn’t it a good thing if the patient and the doctor read about this in The Washington Post? The fact that the documents show you are misleading patients and their doctors is not confidential. The blog post suggests the problem is that drug companies don’t properly answer the charges in the media. Okay. But you can’t suggest the public does not have the right to know because you don’t have the time, energy, inclination or PR staff to respond.
I would have been far more okay with this blog post if after it was done suggesting plaintiffs’ lawyers sadistically are creating work, it would have had something thrown in there about the fact that defense lawyers are far more guilty of this than plaintiffs’ lawyers. Because, believe me, it is undeniable.

Patent Lawsuits on the Rise

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.

Ethics Experts In Product Liability Cases

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.
I don’t know if the plaintiffs hired FDA experts, but that’s really the approach to take. It is important to show that the company had knowledge of specific product problems, defects or dangers that rose the level of requiring the company to report those problems to the FDA, and likely require the company to issue a better warning. That’s the expert opinion testimony needed in a case like this.
Ethics are important, but they are not rules. It’s not something that should be testified to by an expert in most cases. The jury should determine whether or not they apply in any particular case, and what the standard should be.

Fleet Phospho-Soda Settlement

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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.

More On Whistleblowing

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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.