April 30, 2008

Lawsuit over Pitch Counts

Overlawyered has a blog post today about the reports of a high school pitcher suing his school district because he wore out his arm throwing 140 pitches in a single game. Here is the gist of the story from the Seattle Times: Seven years ago, Plaintiff was pitching against a rival school. He had no plans to take himself out of the game. In the eighth inning his mother, assuming you believe her story, told coach, "He's at 117 pitches. He's done." (How many mothers out there are keeping exact pitch counts?) You know the rest of the story. The Plaintiff hurts his arm. He thinks he was the next coming of Roger Clemens... better make that Greg Maddux... and files suit claiming the coach should have pulled him out of the game.

Overlawyered and the Maryland Lawyer Blog agree that the possibility of a lawsuit causes people to act differently than they otherwise would. Where we disagree is whether, on balance, this is a good thing for society. For example, football coaches now know that depriving kids of water during practice is a bad thing and their doing so may expose the school to liability. In this area I think coaches already have proper incentive to do the right thing and this will only serve to exaggerate the risk of a "pitch count" lawsuit. Even if this is what I believe is the first lawsuit of its kind in this country. Obviously every baseball coach around the country is going to be talking about this and many are going to become worried about pitch counts.

Awareness of valid lawsuits properly encourages people (including doctors) to proceed with caution and to consider the risks that may cause harm. Frivolous lawsuits like this one have the opposite effect and are going to have some coaches - a small minority but still some - overreacting and limiting kids to ridiculously low pitch counts. But just as free speech requires us to tolerate hate speech, the search for justice requires us to tolerate some level of frivolous lawsuits. Whatever inertia this country has towards tort reform, it comes in no small measure from mainstream media and Internet reports (many of which are simply false) of ridiculous lawsuits.

I’m digressing from this story now, but one of the problems personal injury lawyers have in fighting back against the tort reform movement is their refusal to appreciate valid arguments made by reform advocates. For example, as a student of economics, no one will ever convince me that medical malpractice damage caps don’t decrease doctor’s insurance premiums. So why on earth do we keep arguing this?

I also think we have to concede that there is a “tort tax” and that litigation in pure economic terms is counterproductive. So is social security on many levels but the system stays because it brings about a greater good. According to the Consumer Product Safety Commission, every year about 4,500 deaths and 13.7 million injuries occur as a result of defective products in 15 different categories. Not included in these classifications are motor vehicles, drugs, medical devices, and toxic substances. It seems like the “wild west” with respect to consumer safety even with the risk of lawsuits. What would these numbers be like without tort litigation? The reality is tort litigation costs money but saves lives.

Of course, there is another argument against limiting plaintiffs’ tort recoveries. If you are injured as a result of the negligence of someone else, who should pay for those injuries, the innocent victim or the person responsible? Litigation provides some measure of justice. The problem with using the justice argument to fend off tort reform is that no one sees themselves as the tort victim until they are the tort victim. People who strongly support efforts to reduce jury awards rarely hesitate to file a claim or a lawsuit when they are seriously injured as a result of someone else’s negligence. I’ve represented many of these people. Are they greedy hypocrites? I don’t think so. I think they see the world differently when they step into shoes they never expected to be in and were statistically unlikely to wear: the serious injury victim. It changes the way they think and they no longer care about the “tort tax” but about fairness and justice and the lives saved by personal injury lawyers who help in the battle of keeping corporations focused on what almost everyone agrees should be their first priority: consumer safety.

April 9, 2008

Heparin Death Toll Rising

The FDA yesterday raised its current count of estimated heparin related deaths from 19 to 62. The FDA qualified its finding by pointing out that reports of allergic reactions or low blood pressure after the use of heparin do not necessarily mean heparin was a contributing cause to the death. I’m sure this is true. But the FDA puts this qualification in some context by noting that there were only three heparin allergic reaction deaths reported in 2006.

As I wrote earlier today, many people taking heparin have other health risks, but the number of heparin death cases calls we are receiving leads me to believe that, tragically, 62 reported deaths may be just the tip of the iceberg. (Hopefully, I'm wrong.)

Our Baxter heparin recall lawyers are accepting defective heparin cases throughout the country. Our law firm is handling only very serious injury and death cases. If you want to discuss your heparin case with one of our heparin contamination recall lawyers, call us for a free consultation at 800-553-8082 or click here for a free Internet consultation.

March 21, 2008

Heparin Contaminant Identified

The FDA announced Wednesday that it had identified the contaminant in Baxter heparin that has been linked to at least 21 deaths. The contaminant is a chemically altered form of the dietary supplement chondroitin sulfate, designed to mimic the active ingredient in heparin.

Our Baxter heparin lawyers are reviewing both individual and class action defective heparin recall cases throughout the country with an eye toward potential lawsuits related to the recall. If you want to discuss your heparin case with one of our Baxter heparin recall lawyers, call us for a free consultation at 800-553-8082 or click here for a free online consultation.

February 29, 2008

Heparin Recall Death Toll Rises to 21

The FDA reported yesterday that the number of deaths from Baxter's blood thinning drug Heparin had risen from 4 to 21. Approximately half of the country's supply of heparin has already been removed from distribution and an expanded recall is expected.

Our Baxter heparin recall lawyers are reviewing both individual and class action defective heparin recall cases throughout the country. If you want to discuss your case with one of our Baxter heparin recall lawyers, call us for a free consultation at 800-553-8082 or click here for a free Internet consultation.

January 14, 2008

Products' Liability Lawyers Handling Cases Involving a Chapin Sprayer

The Maryland Injury Lawyer Blog has a post today about the value of personal injury cases involving the loss of vision in one eye. We have a vision loss in one eye case now pending against Home Depot and Chapin International, a New York company that makes the Chapin Sprayer. We contend that our client lost vision in his eye as the result of a design defect in the Chapin Sprayer 2002. I’m writing this blog post because I would like to get into contact with any other Plaintiffs’ products liability lawyers who may have a similar design defect case against Chapin so that we can share information.

We think this model Chapin Sprayer 2002 is defective for a number of reasons. First, it is designed and manufactured with a nipple coming off the tank facing upward in a direction that would likely cause an eye injury. Other Chapin models such as the Spray and Go have the nipple designed to come off the side of the tank in a direction not pointed towards the user’s eye. Second, this model did not have a pressure relief valve, which is the safety feature contained in nearly every other Chapin model. Third, this model was packaged in such a way that the hose was not connected to the tank when it was delivered to the customer. Most of the Chapin sprayers and other sprayers have the hose attached to the tank by a metal crimp or by the factory so that the attachment is more secure than relying on the customer to make this attachment. Fourth, the nut to attach the hose to the tank was not provided to the purchaser. Finally, there were no warnings to indicate that the end user should not use this sprayer with dangerous chemicals, inadequately attached hoses, missing nuts, bib connection pointed toward the eye, and no pressure relief valve.

If you are a lawyer who has a design defect case involving the Chapin Sprayer 2002, give me a call. We have a great deal of information on this product to share and, hopefully, you will have some information for us as well on this Chapin Sprayer.

November 29, 2007

St. Jude Lead Wires: Following the Medtronic Path?

A recent editorial in Pacing and Clinical Electrophysiology reports findings of perforations in St. Jude Riata defibrillator leads. Coming on the heals of the recent Medtronic defibrillator lead recall, this editorial raises new manufacturing concerns about some of St. Jude’s newer and thinner leads. These perforations, coupled with their late presentation, pose a duel threat to patients. The lead perforation sometimes is not caught until it is “well beyond the right ventricular free wall” and protruding centimeters into surrounding tissue. This protrusion can lead to complications which can result in a lot of complications, including sudden death.

St. Jude has responded to these concerns by citing product analysis data showing that the perforation rate of St. Jude’s Riata lead wires is lower than the rates reported by similar leads. But, honestly, on the heals of the Medtronic recall, my confidence in reports from medical device companies about their safety and efficacy data is about the same as my confidence in Brittany Spears’ parenting skills.

November 13, 2007

Medtronic Class Action Suit

Two Kansas City men have filed separate class action lawsuits in the Medtronic defibrillator lead recall cases. Interesting, because Kansas City is in two states, the men have filed separate lawsuits in two different states.

Our Medtronic lead recall lawyers suspect all of these individual class actions will be consolidated in an MDL in one jurisdiction, most likely in Minnesota. Tomorrow, I will write about what the MDL is and how it will likely be applied in the Medtronic cases.

November 1, 2007

Medtronics Lead Recall

On October 30, 2007, the Wall Street Journal summarized the events leading up to the recall of the Medtronics Defibrillator Lead Recall. According to the article, Medtronics first became aware of the problems with the lead wires when problems with the Sprint Fidelis 6949 surfaced back in January. This was when doctors at the Minneapolis Heart Institute decided that they would no longer use the device, because six patients had come back to the Institute reporting that they were experiencing unnecessary shocks. However, it was not until after an October 7th meeting at Medtronics that the company stopped selling its malfunctioning product. The company also cited five deaths in the three years its product was on the market.

The FDA, which has come under fire from Congress and others for not more closely monitoring medical device manufacturers, will no doubt receive increased criticism for its failure to move more quickly to take this product off the market. Dr. Daniel Schultz, Director of the FDA, is quoted as saying that despite having information about the malfunctioning device, “there was nothing we could point to specifically to say this is a violative product that needs to come off the market.” The article discussed the speculation that the FDA did not require that this product have pre-market clinical trials or post-market studies, because it was similar in design to earlier products.

As I have written elsewhere, the problem in the vast majority of the cases is not the timing – even if flawed – of the recall, because this is not a recall. In most cases, these Sprint Fidelis lead wires cannot be recalled anyway because they cannot safely be taken out of a patient. For people that had wires implanted between January and October, the delay is a real issue. But for the majority of the over 250,000 people who have these leads, the negligence claim against Medtronics will focus primarily on the fact that the Sprint leads were on the market in the first place.

First and foremost, if the reports are true that there were no clinical trials, because the new leads were similar in designs to the old leads, Medtronics and the FDA completely ignored patient safety. The Medtronics Sprint Fidelis leads are almost half the size of traditional leads. This is not a similar product, it is a technological innovation and Medtronics marketed these leads as such. But when you have a new product, as these defibrillator leads were, you have to adequately test the product to be sure it is safe, especially before you allow a quarter of a million of them to go on the market for insertion into people’s chests to monitor their hearts. It really is as simple as that.

The second problem is the failure of adequate post market studies. This is a Medtronics fault, of course, but is also a systematic flaw in the FDA itself. Safety and speed have been called the yin and yang of the regulation of drugs and medical devices and there is some measure of truth to this. We all want safe medical devices that have been tested, but, particularly with serious medical conditions, we want immediate access to breakthrough drugs.

In 1992, it was possible that the pendulum had swung too far toward safety. The most notable example was the slow speed with which new AIDS medications were being brought to the market. The Prescription Drug User Fee Act in 1992 represented a deal between the FDA and the drug industry. Pharmaceutical companies agreed to pay millions of dollars in fees, and the FDA guaranteed that drug and medical device reviews would be completed within a year for fast track drugs.

But all of this new FDA money was for clinical trials and other pre-market efforts. The pharmaceutical companies made no investment into the post-market safety once the drug or medical device was on the market. So what happened at the FDA? The agency became a pseudo private agency and the influence of the pharmaceutical companies rose dramatically. At FDA advisory committee meetings, they begin by asking the doctors to put on the record their conflicts of interest. Today, it seems 90% of any panel has some tie in with a pharmaceutical company. While the FDA still looked at drugs and medical devices after they were put on the market, this branch of the FDA became the black sheep with insufficient funding, which obviously led to those post-market people at the FDA being overworked and underappreciated. You know how the story goes from here.

This is exactly what has happened in the Medtronics defibrillator lead recall cases, which should soon be certified as a class action. This will likely cost Medtronics over a billion dollars in lost revenues, litigation costs, and payouts in settlements and verdicts in a class action and individual lawsuits.

If you are looking for a Medtronics recall lawyer to assist you in your defibrillator recall claim, our lawyers are representing patients with these Medtronic defibrillators with defective leads throughout the United States and Canada. Fill out this brief form if you need additional information or would like us to review you case, or call us at 800-553-8082. You can also click here for answer to questions about the Medtronics defibrillator recall that many of our clients are asking.

October 24, 2007

Topps Meat Recall

Federal regulators are pointing the finger directly at Topps Meat claiming that a Topps Meat factory neglected critical safety measures in a rush to fulfill orders. As a result, thousands of frozen hamburger patties contaminated with E. coli were put in the marketplace. This Topps meat recall, which was the second largest recall in our nation's history, and a spate of recent recalls like it have raised questions as to whether the food industry has been given too much freedom to regulate itself.

Nothwithstanding the debacle of the meat recall, there is some logic to allowing the food industry to largely police itself. In contrast to the pharmaceutical industry where defective drugs and medical devices seem to be an acceptable cost of doing business, given the high profit margins of pharmaceutical drugs, there does seem to be a greater backlash against food companies for putting unsafe food into the marketplace. Topps Meat essentially went from being one of the leading meat producers in the world to going out of business as a result of this meat recall. Certainly, every other food producer will take notice.

October 23, 2007

Medtronics Defibrillator Lead Recall: Where Was the FDA?

The Medtronics defibrillator lead failures have again raised the issue of whether the FDA’s testing procedures are sound. A congressional oversight committee will review the FDA’s testing procedures for the Medtronics recalled wire component of its defibrillator, which has been linked to at least five patient deaths.

In an letter to FDA Commissioner Andrew von Eschenbach, Henry Waxman (D-CA) requested a thorough timeline of the recall and an overview of how FDA approves so-called "supplemental" parts of medical devices. "Please describe the process by which FDA approves all defibrillator leads," Congressman Waxman's letter states. "Specifically, please explain whether FDA would approve a defibrillator lead under a distinct (pre-market approval) or as a supplement to a PMA for another device." Waxman also cited reports that the FDA did not require Medtronic to submit clinical trial data on these recalled leads and requested an explanation for the FDA's failure to do so.

Certainly, the FDA needs to do its part in analyzing the safety efficacy data on these products. But it the end, the burden lies with Medtronics to do all that it can to make a safe product. The race to get these products on the market is furious. Medtronics and other medical device companies selling defibrillators rush out new defibrillators that may be technologically superior, but with no proven history of safety and reliability, because they want more market share. The FDA does not have time, energy, manpower, whatever, to properly evaluate the safety of the product. Yet at trial, you can bet that Medtronics defibrillator recall lawyers that are representing the victims will hear one defense theme over and over: “FDA approved.” The solution to this problem would be to exclude evidence of the FDA approval; it is of limited probative value to demonstrate safety of the product, and it is likely to mislead the jury, because they may incorrectly assume the FDA approval process is more vigorous than it really is. I think this is a reasonable solution to this unfair hurdle that plaintiffs’ pharmaceutical lawyers must face in every case.

October 16, 2007

Prempro Verdict

Yesterday, a Nevada jury awarded $99 million in punitive damages to three women who claimed their breast cancer was caused by Wyeth’s hormone replacement drugs Premarin and Prempro. The jury had originally awarded $134.5 million, which was reduced to $35 million after the jury indicated that the original verdict had also included punitive damages. So in the punitive damages phase, the jury tacked back on the $99 million.

These are 3 of the more than 5,000 lawsuits that have been filed around the country involving Premarin and Prempro, which are hormone replacement drugs intended to ease the symptoms of menopause.

A national study of hormone replacement therapy that had been conducted by the Women's Health Initative in 2002, found that Prempro increased the risk of a number of ailments, including stroke, heart disease, and breast cancer. Incredibly, these drugs remain on the market.

October 1, 2007

Topps Meat Recall Lawyers

The Maryland Injury Lawyer Blog posted detail last week on the Topps Meat recall. You can click here for more information.

July 18, 2007

Minnesota Seat Belt Law

The Minnesota Supreme Court released an opinion last week, stating that an exception to Minnesota’s seat belt gag rule permitted a three year-old child to sue his parents for not properly buckling his seat belt. The suit contended that the parents failed to discover and remove a coin from the buckle mechanism of the child’s car seat. The suit was brought on behalf of the child by his grandparents, presumably with their consent and encouragement.

The facts of this case are unimaginable. This boy’s seatbelt came off when the SUV his father was driving was struck by an uninsured motorist. Their SUV flipped and the boy’s car seat became unbuckled. The boy is now a quadriplegic confined to a wheelchair and will require 24-hour care for the rest of his life. It is not easy to conjure up a greater tragedy.

Minnesota has a law that makes the Plaintiff’s failure to wear a seat belt inadmissible at trial. As I have written in the past, Maryland has a similar law on seat belt use admissibility at trial. A claim was brought and settled against the parents and the manufacturer of the restraint system, based on the Minnesota seat belt statute’s gag rule allowing claims for “an action…for defectively designed, manufactured, installed or operating seat belt restraint systems.” Progressive Insurance made the argument that the plain meaning language of the seat belt gag rule statute made clear that the exception was intended to apply to manufacturers of car seats or seat belts, and not to those who may have negligently buckled or maintained a seat belt.

The majority of the Minnesota Supreme Court disagreed, construing the word “an action” to mean, as defined by another statute, “any proceeding in any court in the state.” The court further noted that while the word “defective” is associated with products liability actions, the word defect has many different meanings.

Another other than a lawyer reading the case would find bizarre the court’s description of Progressive’s contentions as arguments the “Harrisons” were making. As a personal injury lawyer who reads cases regularly, even I found odd the text that, on its face, leads the reader to believe the parents were making arguments against their quadriplegic child. (I guess if I’m made up of 10 lbs of lawyer, I’m about 180 lbs of parent.)

This case has little practical meaning to this boy and his family. Progressive is required to fork over another $100,000.00 - chump change in the treatment this boy needs. Progressive has every right to make its arguments, and, in this case, I think their argument had some merit, even if the Minnesota Supreme Court didn’t agree. Still, I can’t imagine that if they had prevailed, they would have gone home skipping, thinking they had made the world a better place. This is why I hated defense work and why I enjoy being a personal injury lawyer. Being a personal injury lawyer is not exactly the same as working in the Peace Corp, I fully realize this, but it is a joy to try to help people receive compensation for their suffering.