April 23, 2008

Heparin Litigation Update

The New York Times yesterday reported that the FDA has announced that the oversulfated chondroitin sulfate contaminant found in Chinese-made heparin, which has officially been linked to 81 deaths and will soon be linked to a lot more, has also been found in drug supplies in Australia, Canada, China, Denmark, France, Germany, Italy, Japan, the Netherlands, New Zealand and, of course, the United States. Somewhat incredibly, the Chinese maintain that the contaminant is not responsible for the deaths caused by allergic reaction to heparin.

The Times also reported that a GAO report found that the FDA will need an additional $56 million next year to conduct inspections of foreign manufacturing facilities of pharmaceutical drugs. This is incredibly convenient for the FDA because it creates the appearance that the problem was they did not have enough money to inspect the plants. But the failure to inspect the Chinese plant stemmed from the fact that they confused the names of the plants and thought that plant had already been inspected, not a lack of resources to inspect the plant in the first place. Classic pass the buck.

The FDA is also suggesting that had they inspected the plant they still would not have uncovered the contaminant. Maybe that is so, I really don’t know, but don’t you think that had the FDA rolled in, someone in that Chinese heparin manufacturing plant might have said, “Gee, maybe we should take the oversulfated chondroitin sulfate out of the heparin.”

In the end, however, Baxter is the one responsible for a safe heparin product. What was Baxter doing to test heparin to verify its safety? As I have written time and time again, there is nothing inherently wrong with making our pharmaceutical drugs and medical devices in China because it does lead to lower prices at home. But, be it China or Kathmandu, if you are going to go further away from your product you have to put systems in place to make sure the product is being safely manufactured, particularly if it is a life saving product for vulnerable patients, like heparin.

In other news, the Maryland Daily Record reports today that American Capital Strategies Ltd., which has as a 90% interest in one of the companies involved in the chain of distribution, is a Maryland-based company. This is interesting, but I don’t think their ownership interest will pierce the corporate veil and Baxter is the deep pocket with ultimate responsibility for the safety of their heparin product. I am quoted a few times in the article about the heparin class action litigation. (I would provide the link to the article but the Daily Record takes down the article after a day or so. But, if you go to the Maryland Daily Record website today, you will be able to find it.)

Bookmark:      Bookmark Heparin%20Litigation%20Update at del.icio.us      Digg Heparin%20Litigation%20Update at Digg.com      Bookmark Heparin%20Litigation%20Update at Spurl.net      Bookmark Heparin%20Litigation%20Update at Simpy.com      Bookmark Heparin%20Litigation%20Update at NewsVine      Blink this Heparin%20Litigation%20Update at blinklist.com      Bookmark Heparin%20Litigation%20Update at Furl.net      Bookmark Heparin%20Litigation%20Update at reddit.com      Fark Heparin%20Litigation%20Update at Fark.com      Bookmark Heparin%20Litigation%20Update at Yahoo! MyWeb

April 4, 2008

Let's Give the FDA More Work

A House committee this week approved legislation that would give the FDA new authority over the tobacco industry, giving the FDA the ability to regulate the sale and marketing of tobacco products such as flavored cigarettes and "light and low tar" products. A floor vote on the House of Representatives is expected soon.

Okay, the FDA is unable to inspect Chinese factories leading to the deaths of scores of people in the Baxter heparin recall debacle because it is under funded and stretched too thin. So our Supreme Court responds by making them the ultimate gatekeeper and the "great decider" as to whether drug companies are negligent (as opposed to the cute, yet silly, citizens of our country), and Congress responds by giving them even more work – regulating the behemoth this is big tobacco.

Now, incredibly, to complete the governmental insanity trifecta, we need President Bush to join in the fun. Who knew he would be the holdout? My guess is that he will find a way to oblige. He’s good like that. Maybe next week he will declare his plan that if the FDA approves a doctor – a one page Internet application by the doctor should do it - then no medical malpractice action can be brought against the doctor.

Bookmark:      Bookmark Let%27s%20Give%20the%20FDA%20More%20Work at del.icio.us      Digg Let%27s%20Give%20the%20FDA%20More%20Work at Digg.com      Bookmark Let%27s%20Give%20the%20FDA%20More%20Work at Spurl.net      Bookmark Let%27s%20Give%20the%20FDA%20More%20Work at Simpy.com      Bookmark Let%27s%20Give%20the%20FDA%20More%20Work at NewsVine      Blink this Let%27s%20Give%20the%20FDA%20More%20Work at blinklist.com      Bookmark Let%27s%20Give%20the%20FDA%20More%20Work at Furl.net      Bookmark Let%27s%20Give%20the%20FDA%20More%20Work at reddit.com      Fark Let%27s%20Give%20the%20FDA%20More%20Work at Fark.com      Bookmark Let%27s%20Give%20the%20FDA%20More%20Work at Yahoo! MyWeb

March 21, 2008

Gadolinium MRI Lawsuits

When I started practicing law, I spent most of my time defending a pharmaceutical company in AIDS/hemophilia cases, litigation involving approximately 10,000 completely innocent people who contracted HIV from the use of Factor VIII and Factor IX blood products. Regardless of how you viewed the liability of the involved drug companies, everyone agreed on the magnitude of the tragedy (which was very underreported in the media). My experience in those cases eventually lead me to becoming a plaintiffs’ lawyer because I quickly realized I would be far more energized by representing innocent victims who needed my help than large pharmaceutical companies. After I became a plaintiffs’ lawyer, I thought I would never be involved in a mass tort lawsuit with facts as tragic as the AIDS/hemophilia cases, but the gadolinium MRI contrast litigation, while on a thankfully smaller scale in terms of number of patients, is in the same league of suffering - a cruel, progressive disease that you contracted through absolutely no fault of your own.

Gadolinium is the contrast given before a MRI (or MRA, magnetic resonance angiograph, although this practice was never FDA approved) to increase the contrast of blood vessels during an MRI procedure so that the reviewing radiologist can better diagnose abnormalities. While gadolinium did improve MRI diagnostics, nephrogenic systemic fibrosis or nephrogenic fibrosing dermopathy (NSF/NFD) resulted for many patients with kidney issues who received a gadolinium contrast MRI. NSF/NFD causes thickening or tightening of the skin and connective tissues, which severely limits a patient’s ability to move, and it also causes pain, muscle weakness, scarring of internal organs and difficulty bending joints. It seems that patients’ lives are potentially at risk because of the damage to their organs, and destroyed by their inability to move. What we can all hope for is that science will move quickly forward to find ways to make this NSF/NDF more manageable.

More than 215 cases of NSF/NFD have been documented in the last decade, but despite ongoing research, the etiology of the disease was originally unknown. Now, it is clear that use of gadolinium contrasting agents in patients with kidney failure is the culprit. In June 2006, the FDA first said that NSF/NFD can be caused by the use of gadolinium contrast MRI. Last year, on May 23, 2007, the FDA asked manufacturers to include a new boxed warning with gadolinium contrast informing health care providers that patients with severe kidney insufficiency who receive gadolinium contrast are at risk for developing NSF/NFD. Additionally, the warning states that patients with liver problems are also at risk for developing NSF/NFD if they are experiencing kidney problems.

The lawsuits against the five manufacturers of Gadolinium have a simple premise: these companies knew that gadolinium is toxic and, if misused, could lead to serious injury. Accordingly, these companies should have properly designed and tested the gadolinium MRI contrast and given more consideration to vulnerabilities of the different types of patients who would be using the contrast, in this case, patients with kidney disease or renal dysfunction.

I met recently with a confirmed NSF/NFD client here in Maryland. These cases are just absolutely heartbreaking. This client I met with is a wonderful woman who was struck down in the prime of her life by NSF/NFD. Thankfully, she is in better spirits than most people you meet.

The gadolinium MRI cases around the country have been consolidated in MDL-1909 in Ohio. Our gadolinium MRI NSF/NFD attorneys are investigating these cases throughout the country. If you or a loved one has been diagnosed with NSF/NFD, call one of our lawyers for a free consultation at 800-553-8082 or click here to discuss your gadolinium MRI case via the Internet.

Bookmark:      Bookmark Gadolinium%20MRI%20Lawsuits%20 at del.icio.us      Digg Gadolinium%20MRI%20Lawsuits%20 at Digg.com      Bookmark Gadolinium%20MRI%20Lawsuits%20 at Spurl.net      Bookmark Gadolinium%20MRI%20Lawsuits%20 at Simpy.com      Bookmark Gadolinium%20MRI%20Lawsuits%20 at NewsVine      Blink this Gadolinium%20MRI%20Lawsuits%20 at blinklist.com      Bookmark Gadolinium%20MRI%20Lawsuits%20 at Furl.net      Bookmark Gadolinium%20MRI%20Lawsuits%20 at reddit.com      Fark Gadolinium%20MRI%20Lawsuits%20 at Fark.com      Bookmark Gadolinium%20MRI%20Lawsuits%20 at Yahoo! MyWeb

March 10, 2008

MDL Panel Choice of Venue/Choice of Law

Alexandra D. Lahav, a law professor and editor of the Mass Tort Litigation Blog, has an interesting blog post on choice of law made by the MDL Panel in cases consolidated for discovery where the applicable law chosen may foretell the outcome of the case.

To receive certification by the MDL Panel, under Rule 23 you must have: (1) plaintiffs so numerous that joinder is impossible (numerosity); (2) class claims which present common questions of law or fact (commonality); (3) plaintiffs' claims that are typical of those of the class (typicality); and (4) plaintiffs who are adequate representatives of the putative class (adequacy).

This blog post addresses the third prong, commonality of law. In some cases, like the Michigan law at issue in Warner-Lambert v. Kent, with different statutes of limitations, the issue can be a case breaker for the plaintiffs. In MDL cases now, the MDL Panel determines which law will be applied by selecting where to send the case - wherever the case is sent, that forum's law applies. As Ms. Lahav's post points out, the MDL Panel is placed in a terrible situation when the outcome of the case is based on transfer and is already known in advance of the transfer.

Ms. Lahav's blog post, which she says will be the subject of an upcoming law review article, says the MDL panel should consider "transferring and centralizing the cases to several regional forums. I suggest two forums. Plaintiffs who filed within the regions covered by the preemption precedent would be consolidated in one court; plaintiffs who filed in the regions covered by the non-preemption precedent would be consolidated in another court. This would not lead to duplicative discovery because all the cases in region 1 would be dismissed, and all the cases in region 2 would proceed."

I do not appreciate the nuances of the law involving the seven judge MDL Panel's decision making process or the possible ramifications of Ms. Lahav's remedy. While this decision might hurt some plaintiffs who might be able to backdoor otherwise barred claims, I have to admit is appears to be a reasonably fair solution in cases where the choice of law is dispositive of the claim.

Bookmark:      Bookmark MDL%20Panel%20Choice%20of%20Venue%2FChoice%20of%20Law%20 at del.icio.us      Digg MDL%20Panel%20Choice%20of%20Venue%2FChoice%20of%20Law%20 at Digg.com      Bookmark MDL%20Panel%20Choice%20of%20Venue%2FChoice%20of%20Law%20 at Spurl.net      Bookmark MDL%20Panel%20Choice%20of%20Venue%2FChoice%20of%20Law%20 at Simpy.com      Bookmark MDL%20Panel%20Choice%20of%20Venue%2FChoice%20of%20Law%20 at NewsVine      Blink this MDL%20Panel%20Choice%20of%20Venue%2FChoice%20of%20Law%20 at blinklist.com      Bookmark MDL%20Panel%20Choice%20of%20Venue%2FChoice%20of%20Law%20 at Furl.net      Bookmark MDL%20Panel%20Choice%20of%20Venue%2FChoice%20of%20Law%20 at reddit.com      Fark MDL%20Panel%20Choice%20of%20Venue%2FChoice%20of%20Law%20 at Fark.com      Bookmark MDL%20Panel%20Choice%20of%20Venue%2FChoice%20of%20Law%20 at Yahoo! MyWeb

March 7, 2008

Yamaha Rhino ATV Lawsuits

Yamaha “Rhino” All-Terrain-Vehicle (ATV) litigation has drawn the interest of our lawyers. The Yamaha Rhino ATV appears to have design defects that make the Yamaha Rhino ATV unreasonably unsafe for its occupants. The big problem with the Yamaha Rhino ATV roll is that it will rollover during turns on flat surfaces, even at low speeds, because it has a center of gravity that it too high, too top heavy, and the tires are too small for the expected uses of the vehicle.

Recognizing the problem, Yamaha agreed last summer to install doors and additional passenger handholds on all Yamaha Rhino ATVs manufactured in the last 4 years to protect passengers from a rollover, but they stopped short of issuing a recalling, or even ceasing production of the Rhino ATV.

Yamaha has also issued a new product warning label for the Yamaha Rhino ATV that acknowledges the risk of rollover accidents and alerts users that the Rhino can rollover even while being operated over flat, open areas.

I have to assume that Yamaha’s calculus is that the injuries sustained in these cases are such that the sale of the Yamaha Rhino ATVs creates revenues sufficient to sustain the legal costs, settlements and verdicts that Yamaha will undoubtedly endure. Regrettably, as we learned years ago in the Ford Pinto cases, companies with high selling and profitable products make these cost/benefit decisions all of the time, just like this one.

The reports of injuries in these cases are largely similar: slow speed turns where the Yamaha Rhino ATV rolls over and, because there are no doors to protect the passengers, people fall out of the Rhino and are crushed.

If you or someone you love has suffered a serious rollover injury or death in a Yamaha Rhino ATV, we want to help you. Our lawyers are handling Yamaha Rhino ATV rollover cases in serious injury and death cases across the country. Call us for a free consultation at 800-553-8082 or click here for a free Internet consultation.

Bookmark:      Bookmark Yamaha%20Rhino%20ATV%20Lawsuits at del.icio.us      Digg Yamaha%20Rhino%20ATV%20Lawsuits at Digg.com      Bookmark Yamaha%20Rhino%20ATV%20Lawsuits at Spurl.net      Bookmark Yamaha%20Rhino%20ATV%20Lawsuits at Simpy.com      Bookmark Yamaha%20Rhino%20ATV%20Lawsuits at NewsVine      Blink this Yamaha%20Rhino%20ATV%20Lawsuits at blinklist.com      Bookmark Yamaha%20Rhino%20ATV%20Lawsuits at Furl.net      Bookmark Yamaha%20Rhino%20ATV%20Lawsuits at reddit.com      Fark Yamaha%20Rhino%20ATV%20Lawsuits at Fark.com      Bookmark Yamaha%20Rhino%20ATV%20Lawsuits at Yahoo! MyWeb

February 26, 2008

Do We Trust Juries?

According to a recent poll on jury duty, the answer is yes. Fifty-eight percent of those surveyed believe that a jury is fair and impartial all or most all of the time. Even more interestingly, half of those surveyed said they would expect a jury to give a fair verdict as opposed to a judge. Only 23% selected a judge over a jury (27% were unsure). In other words, by a margin of more than 2 to 1, we trust juries more than judges. Only 18% of African-Americans and 19% of Hispanics chose a judge.

Maybe our founding fathers were on to something with this whole “jury of our peers” thing. But I don’t think this is a knock on our judges. Instead, I think people would prefer to be judged by regular everyday people like themselves who are outside of the process.

In light of the recent Medtronic ruling and drug preemption cases pending before the Supreme Court, I would like to add one more question to the survey: Do you think a jury or the FDA is more likely to protect you and your family from a defectively designed pharmaceutical drug or medical device? Someone do this survey and send the results to the Supreme Court.

Thanks to the Florida Jury Selection Blog for the link to the study.

Bookmark:      Bookmark Do%20We%20Trust%20Juries%3F at del.icio.us      Digg Do%20We%20Trust%20Juries%3F at Digg.com      Bookmark Do%20We%20Trust%20Juries%3F at Spurl.net      Bookmark Do%20We%20Trust%20Juries%3F at Simpy.com      Bookmark Do%20We%20Trust%20Juries%3F at NewsVine      Blink this Do%20We%20Trust%20Juries%3F at blinklist.com      Bookmark Do%20We%20Trust%20Juries%3F at Furl.net      Bookmark Do%20We%20Trust%20Juries%3F at reddit.com      Fark Do%20We%20Trust%20Juries%3F at Fark.com      Bookmark Do%20We%20Trust%20Juries%3F at Yahoo! MyWeb

January 28, 2008

Stryker Trident Hip Implant Problems: Class Action Lawsuit on the Way?

Medical device maker Stryker said last week that it will voluntarily recall the hip implant surgery products Trident PSL and Hemispherical Acetabular Cups.

This recall comes on the heels of a warning from the FDA to fix a host of long-standing problems, primarily the failure to function and poor fixation with its hip implant components and in its manufacturing of hip replacement parts. These defective Stryker products have led to numerous complaints and forced some artificial hip implant patients to have additional surgeries. In fact, the FDA told Stryker that it was aware that Stryker had received complaints about the improper fitting of hip implants that caused bone fractures in some patients three years ago.

The following Stryker products were named in the FDA investigation for containing manufacturing defects that are potentially harmful to hip and joint replacement patients:


• Hip Implants with ceramic components

• Solar Plasma Purefix HA Shoulder Stems

• Trident PSL Acetabular Shells

• Duracon Total Knee Modular Femoral Component

• Global Modular Hip Stems

• Trident PSL HA Solid Black 52 MM

• ReUnion Plasma Spray Humeral Stem

• Trident Hemispherical Cluster 50 MM

Almost all products liability cases against medical device manufacturers are design defect cases. In these Stryker Trident hip implant defects cases, the negligence appears to be in the manufacturing process rather than a problem associated with the way the Stryker products were originally designed.

It appears hard to argue that Stryker, a Michigan based company that before this news came out was having a great run of profitability, has done something wrong here. In the FDA’s letter stemming from its inspection of Stryker’s Mahwah, New Jersey manufacturing plant, complaints were that Stryker failed to correct their manufacturing procedures that led to complaints about their hip replacement products in the first place. It says one thing about Stryker when the FDA notes manufacturing deficiencies in the first place. It says quite another thing about Stryker when they fail to fix the defects that have been previously brought to their attention.

A lot of lawyers will be looking at these cases very closely to see whether there are enough injuries for a class action lawsuit against Stryker for these defective hip replacement products. Whether class litigation will be viable will depend on the number of reported injuries and the severity of those injuries.

Our lawyers are currently reviewing cases. If you want to discuss your case with one of our Stryker defective hip replacement lawyers, call us for a free consultation at 800-553-8082 or click here for a free Internet consultation.

Bookmark:      Bookmark Stryker%20Trident%20Hip%20Implant%20Problems%3A%20Class%20Action%20Lawsuit%20on%20the%20Way%3F at del.icio.us      Digg Stryker%20Trident%20Hip%20Implant%20Problems%3A%20Class%20Action%20Lawsuit%20on%20the%20Way%3F at Digg.com      Bookmark Stryker%20Trident%20Hip%20Implant%20Problems%3A%20Class%20Action%20Lawsuit%20on%20the%20Way%3F at Spurl.net      Bookmark Stryker%20Trident%20Hip%20Implant%20Problems%3A%20Class%20Action%20Lawsuit%20on%20the%20Way%3F at Simpy.com      Bookmark Stryker%20Trident%20Hip%20Implant%20Problems%3A%20Class%20Action%20Lawsuit%20on%20the%20Way%3F at NewsVine      Blink this Stryker%20Trident%20Hip%20Implant%20Problems%3A%20Class%20Action%20Lawsuit%20on%20the%20Way%3F at blinklist.com      Bookmark Stryker%20Trident%20Hip%20Implant%20Problems%3A%20Class%20Action%20Lawsuit%20on%20the%20Way%3F at Furl.net      Bookmark Stryker%20Trident%20Hip%20Implant%20Problems%3A%20Class%20Action%20Lawsuit%20on%20the%20Way%3F at reddit.com      Fark Stryker%20Trident%20Hip%20Implant%20Problems%3A%20Class%20Action%20Lawsuit%20on%20the%20Way%3F at Fark.com      Bookmark Stryker%20Trident%20Hip%20Implant%20Problems%3A%20Class%20Action%20Lawsuit%20on%20the%20Way%3F at Yahoo! MyWeb

January 14, 2008

Loss of Vision in One Eye: Case Values in Maryland, Virginia, and Washington D.C.

Metro Verdicts Monthly has a graph in this month’s issue that reflects the median verdicts and settlements when the injury victim loses vision in one eye in Washington, D.C., Maryland, and Virginia. The median for the loss of vision in one eye in Maryland is $231,000. You could drive a truck through the gap between Washington, D.C. and Virginia’s median settlements in verdicts with loss of vision in one eye cases: Washington, D.C.’s median is $162,500; Virginia’s is $320,000. If you read graphs regularly, you would expect Washington, D.C. and Virginia to be reversed because Virginia as a whole typically has more conservative verdicts.

These numbers are a bit misleading I think because most loss of vision cases are products liability cases. Many products liability cases have questionable liability which decreases the average and median recoveries. If liability is not an issue, the values of these cases are much higher.

On the Maryland Lawyer Blog today, I discuss one of our products' cases against Home Depot and Chapin International involving one of Chapin's sprayers.

Bookmark:      Bookmark Loss%20of%20Vision%20in%20One%20Eye%3A%20Case%20Values%20in%20Maryland%2C%20Virginia%2C%20and%20Washington%20D.C.%20 at del.icio.us      Digg Loss%20of%20Vision%20in%20One%20Eye%3A%20Case%20Values%20in%20Maryland%2C%20Virginia%2C%20and%20Washington%20D.C.%20 at Digg.com      Bookmark Loss%20of%20Vision%20in%20One%20Eye%3A%20Case%20Values%20in%20Maryland%2C%20Virginia%2C%20and%20Washington%20D.C.%20 at Spurl.net      Bookmark Loss%20of%20Vision%20in%20One%20Eye%3A%20Case%20Values%20in%20Maryland%2C%20Virginia%2C%20and%20Washington%20D.C.%20 at Simpy.com      Bookmark Loss%20of%20Vision%20in%20One%20Eye%3A%20Case%20Values%20in%20Maryland%2C%20Virginia%2C%20and%20Washington%20D.C.%20 at NewsVine      Blink this Loss%20of%20Vision%20in%20One%20Eye%3A%20Case%20Values%20in%20Maryland%2C%20Virginia%2C%20and%20Washington%20D.C.%20 at blinklist.com      Bookmark Loss%20of%20Vision%20in%20One%20Eye%3A%20Case%20Values%20in%20Maryland%2C%20Virginia%2C%20and%20Washington%20D.C.%20 at Furl.net      Bookmark Loss%20of%20Vision%20in%20One%20Eye%3A%20Case%20Values%20in%20Maryland%2C%20Virginia%2C%20and%20Washington%20D.C.%20 at reddit.com      Fark Loss%20of%20Vision%20in%20One%20Eye%3A%20Case%20Values%20in%20Maryland%2C%20Virginia%2C%20and%20Washington%20D.C.%20 at Fark.com      Bookmark Loss%20of%20Vision%20in%20One%20Eye%3A%20Case%20Values%20in%20Maryland%2C%20Virginia%2C%20and%20Washington%20D.C.%20 at Yahoo! MyWeb

December 4, 2007

Riegel v. Medtronic: The FDA Preemption Super Bowl

Today, the Supreme Court will hear argument in Riegel v. Medtronic Inc. The issue is whether the Food, Drug and Cosmetic Act forecloses state law personal injury lawsuits for injuries from the design, manufacture and labeling of a Medtronic medical device that was granted pre-market approval by the Food and Drug Administration. This case is a product defect case involving a Medtronic balloon catheter that killed the patient but, this case could have ramifications for the Medtronic lead recall lawsuits that are being filed all over the country. While technically this case focuses on a specific statutory provision, no one would be surprised if the Supreme Court’s holding provides a comprehensive framework for preemption that would apply to all drug and medical device cases.

Naturally, the Bush administration has lined up squarely behind the pharmaceutical companies. This is ironic because there is a strong presumption against preemption, particularly in cases where the issue involves the individual states’ power to protect public safety and health. The Supreme Court has consistently found that preemption of state law does not apply unless “the nature of the regulated subject matter permits no other conclusion” or “the Congress has unmistakably so ordained.” Chicago & N.W.Transp. Co. v. Kalo Brick & Tile Co., 450 U.S. 311, 317(1981) (quoting Florida Lime & Avocado Growers, Inc. v. Paul, 373 U.S. 132, 142 (1963)).

Preemption limits the states’ ability to protect its own citizens. The requirement that express preemption provisions be unambiguous follows this administration’s line of thinking: the states should be allowed to decide what is best for its citizens whenever possible, accordingly we should err on the side of states’ rights unless the preemption provisions are crystal clear. Yet, in this case, this administration supports usurping the states’ power even when it is clear that there is no express legislative intent for preemption.

The Bush administration is a big proponent of states rights. The President clearly believes that if the state of Kentucky finds that all of its citizens should be permitted to walk into shopping malls with AK-47s, it is all good and the federal government should just stay out of it. Yet all of this high minded capital “F” Founding Fathers and Federalism gets trumped because pharmaceutical and medical device companies do not want to be held accountable for their own negligence. The lesson, as always, is that protecting big business prevails over all, even at the expense of deeply held core values.

Bookmark:      Bookmark Riegel%20v.%20Medtronic%3A%20The%20FDA%20Preemption%20Super%20Bowl%20 at del.icio.us      Digg Riegel%20v.%20Medtronic%3A%20The%20FDA%20Preemption%20Super%20Bowl%20 at Digg.com      Bookmark Riegel%20v.%20Medtronic%3A%20The%20FDA%20Preemption%20Super%20Bowl%20 at Spurl.net      Bookmark Riegel%20v.%20Medtronic%3A%20The%20FDA%20Preemption%20Super%20Bowl%20 at Simpy.com      Bookmark Riegel%20v.%20Medtronic%3A%20The%20FDA%20Preemption%20Super%20Bowl%20 at NewsVine      Blink this Riegel%20v.%20Medtronic%3A%20The%20FDA%20Preemption%20Super%20Bowl%20 at blinklist.com      Bookmark Riegel%20v.%20Medtronic%3A%20The%20FDA%20Preemption%20Super%20Bowl%20 at Furl.net      Bookmark Riegel%20v.%20Medtronic%3A%20The%20FDA%20Preemption%20Super%20Bowl%20 at reddit.com      Fark Riegel%20v.%20Medtronic%3A%20The%20FDA%20Preemption%20Super%20Bowl%20 at Fark.com      Bookmark Riegel%20v.%20Medtronic%3A%20The%20FDA%20Preemption%20Super%20Bowl%20 at Yahoo! MyWeb

October 19, 2007

Medtronics Lead Recall Lawyers File Class Action Lawsuit

Plaintiffs in the Medtronic defibrillator litigation are seeking class action certification against Medtronic for their defective implantable defibrillators. Five deaths have already been attributed to broken wires in the leads of these Medtronic defibrillators. Regrettably, more are expected given that 235,000 Americans have the four Sprint Fidelis lead wires that even Medtronic concedes are failing. Medtronic estimates that four to five thousand patients with the Sprint Fidelis lead will experience a lead fracture within 30 months of implantation. (You cannot help but assume this is low.) Medtronic is asking the 235,000 people with these defective electrical leads to have their physician evaluate whether their lead has developed a fracture. Certainly, you should contact your doctor if you do not know whether you have a Medtronic defibrillator - many people do not know the brand of their defibrillator, much less details as to the component parts (although most patients have a wallet card that will specify the manufacturer of their defibrillator leads). The Sprint Fidelis leads that have been recalled have the model numbers 6949, 6948, 6931 and 6930.

Obviously, lead recalls are particularly serious given the difficulty to replace them. Should a defective Medtronic defibrillator be replaced if there is no evidence of a fracture? This is an issue that can and should be addressed with your doctor.

While Medtronic has not disclosed the precise mechanism of how these Sprint Fidelis lead fracture failures have failed, it appears that the defect is caused by the small diameter of the coil and conductors in the lead. Because of this, the lead is subject to stress damage both during and after the defibrillator is implanted. A lead fracture occurs when the conductor is critically overstressed. While only five deaths have been reported, many people are reporting repeated electrical shocks due to their lead having fractured.

Medtronic appears to be trying to do the right thing after the damage has been done. Medtronic deserves credit for this. But the problem with Medtronic and these other medical device companies selling defibrillators is that because defibrillators are so lucrative, in an effort to sell more product than the competition, companies rush out new defibrillators, supposedly technologically superior to older defibrillators, but with no proven history of safety and reliability.

Our lawyers are representing patients with these Medtronic defibrillators with defective leads not only in Maryland but around the country. 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 a question and answer of the issues in the defibrillator lead recall class action.

Bookmark:      Bookmark Medtronics%20Lead%20Recall%20Lawyers%20File%20Class%20Action%20Lawsuit at del.icio.us      Digg Medtronics%20Lead%20Recall%20Lawyers%20File%20Class%20Action%20Lawsuit at Digg.com      Bookmark Medtronics%20Lead%20Recall%20Lawyers%20File%20Class%20Action%20Lawsuit at Spurl.net      Bookmark Medtronics%20Lead%20Recall%20Lawyers%20File%20Class%20Action%20Lawsuit at Simpy.com      Bookmark Medtronics%20Lead%20Recall%20Lawyers%20File%20Class%20Action%20Lawsuit at NewsVine      Blink this Medtronics%20Lead%20Recall%20Lawyers%20File%20Class%20Action%20Lawsuit at blinklist.com      Bookmark Medtronics%20Lead%20Recall%20Lawyers%20File%20Class%20Action%20Lawsuit at Furl.net      Bookmark Medtronics%20Lead%20Recall%20Lawyers%20File%20Class%20Action%20Lawsuit at reddit.com      Fark Medtronics%20Lead%20Recall%20Lawyers%20File%20Class%20Action%20Lawsuit at Fark.com      Bookmark Medtronics%20Lead%20Recall%20Lawyers%20File%20Class%20Action%20Lawsuit at Yahoo! MyWeb

September 25, 2007

Topps Meat Recall Lawyers

On September 25, 2007, Topps Meat Company ordered a recall of over 21 million pounds of ground beef products. This is the third largest recall in U.S.D.A history. Reports of at least 28 cases of illness caused by suspected E. coli bacteria led to the recall. Ten persons are known to have been hospitalized in this outbreak.

Incredibly, according to an e-mail from an employee at the USDA, tests confirmed the presence of the E. coli bacteria strain O157:H7 in Topps Meat Company hamburgers on September 7th. This is the point where they knew for sure there was a problem. Yet they waited another 17 days to recall this meat.

The ground beef products being recalled have a "sell by date" or a "best if used by date" between September 25, 2007, and September 25, 2008. All these recalled Topps Meat Company products will have a U.S. Department of Agriculture establishment number of EST 9748. Topps Meat has asked that consumers who find the products at home cut off the UPC code and return it to Topps for a full refund, then dispose of the product immediately. In Topps’ defense, it is worth noting that they have seemed to handle this well, at least as of September 25, 2007. But there is still a great deal of investigating that needs to be done to determine who knew what and when.

E. coli bacteria is found in the intestines of both humans and animals. E. coli contamination can occur with negligent food preparation. Symptoms of E. coli exposure usually begin within a few days of exposure and can last for up to ten days. Symptoms include diarrhea with or without blood, severe stomach cramps, and fever. Some exposures to E. coli can lead to kidney failure and death.

Our Topps Meat recall lawyers are investigating any claims in all 50 states and the District of Columbia that might stem from exposure to this contaminated meat. If you have been exposed to Topps Meat with a "sell by date" or a "best if used by date" between September 25, 2007, and September 25, 2008, and believe you may have been exposed, call our Topps meat recall lawyers at 1-800-553-8082 or click here.

Bookmark:      Bookmark Topps%20Meat%20Recall%20Lawyers at del.icio.us      Digg Topps%20Meat%20Recall%20Lawyers at Digg.com      Bookmark Topps%20Meat%20Recall%20Lawyers at Spurl.net      Bookmark Topps%20Meat%20Recall%20Lawyers at Simpy.com      Bookmark Topps%20Meat%20Recall%20Lawyers at NewsVine      Blink this Topps%20Meat%20Recall%20Lawyers at blinklist.com      Bookmark Topps%20Meat%20Recall%20Lawyers at Furl.net      Bookmark Topps%20Meat%20Recall%20Lawyers at reddit.com      Fark Topps%20Meat%20Recall%20Lawyers at Fark.com      Bookmark Topps%20Meat%20Recall%20Lawyers at Yahoo! MyWeb

August 14, 2007

Mattel Recall

Speaking of the perils of the exposure of children to lead based paint, Mattel has announced its second recall in the last two weeks, this time of more than 9 million "made in China" toys because of injury and health risks posed by lead paint and reports of choking and intestinal damage that can occur from children swallowing the small magnets on some of these toys. The recall is the second initiated by Mattel in the last two weeks, and both recalls involve toys that were made in China. They are:

"Sarge" Die-Cast Toy Cars (from the Pixar movie “Cars”)

Polly Pocket Play Sets

"Doggie Day Care" Magnetic Toys

"Barbie and Tanner" Magnetic Toy Sets

"Sarge" Die-Cast Toy Cars

Batman Magnetic Action Figure Sets

With respect to the "Sarge" Die-Cast Toy Cars, it is worth nothing that the cars marked “Thailand” are not included in the recall. Chinese manufacturing and the acceptance of their goods here is taking yet another tumble. Apparently, days after Mattel identified his company as the manufacturer most implicated in the recall, the owner of the Chinese toy factory committed suicide.

While the risks associated with exposure to lead paint are extraordinary, these toys are likely not leading to the kind of exposure that would cause even mild brain injury. Mattel is appropriately being extra cautious on this front. But with respect to the magnets' risk, the fears are even more well-founded. In 2006, there was a similar recall for 3.8 million "Magnetix" sets. The sets consisted of tiny magnets that, if swallowed, caused intestinal perforation that can cause serious injury or death. There were 34 reported incidents involving the magnets, including one death and four serious injuries. As I wrote in my blog last year, this probably represents 3400 incidents because of underreporting. Before this recall, a 20-month-old boy tragically died after he swallowed pieces of a magnet that twisted his small intestine and created a blockage.

With pet food, toothpaste, seafood, and toys, this has been a bad year for Chinese manufacturers with respect to their credibility with the American public. These products are certainly cheap. The question now is are they safe?

Bookmark:      Bookmark Mattel%20Recall at del.icio.us      Digg Mattel%20Recall at Digg.com      Bookmark Mattel%20Recall at Spurl.net      Bookmark Mattel%20Recall at Simpy.com      Bookmark Mattel%20Recall at NewsVine      Blink this Mattel%20Recall at blinklist.com      Bookmark Mattel%20Recall at Furl.net      Bookmark Mattel%20Recall at reddit.com      Fark Mattel%20Recall at Fark.com      Bookmark Mattel%20Recall at Yahoo! MyWeb

June 11, 2007

Avandia Backlash

GlaxoSmithKline's stock price has fallen approximately 10% since a study published in the New England Journal of Medicine in May showed an increased risk of heart attack and other adverse cardiac events for patients taking the diabetes drug Avandia. Now shareholders are fighting back. A class action lawsuit has been filed against GlaxoSmithKline in the US claiming the company issued a series of "false and misleading statements" regarding Avandia, the group's blockbuster diabetes drug.

Avandia is still on the market, pending further research. The FDA has said it will issue a "black box" warning on Avandia,which means that studies indicate the drug carries a significant risk of serious or even life-threatening adverse effects. This warning and the media frenzy around Avandia is going to decrease sales and, of course, declining profits. This lawsuit alleges that Glaxo not only ignored its duty to Avandia users, it also ignored Glaxo shareholders.

Bookmark:      Bookmark Avandia%20Backlash at del.icio.us      Digg Avandia%20Backlash at Digg.com      Bookmark Avandia%20Backlash at Spurl.net      Bookmark Avandia%20Backlash at Simpy.com      Bookmark Avandia%20Backlash at NewsVine      Blink this Avandia%20Backlash at blinklist.com      Bookmark Avandia%20Backlash at Furl.net      Bookmark Avandia%20Backlash at reddit.com      Fark Avandia%20Backlash at Fark.com      Bookmark Avandia%20Backlash at Yahoo! MyWeb

April 20, 2007

Study Highlights General Motors' Vehicle Death Rates

The Insurance Journal reported today on an Insurance Institute for Highway Safety study that found that General Motors' vehicles had both the highest and lowest death rates in the period between 2002 and 2005. Chevrolet Blazers built from 2001 to 2004 had 232 driver deaths per million registered vehicles during the four-year span, the highest of any vehicle. The Acura RSX had the second-highest rate with 202 driver deaths followed by the Nissan 350Z, which registered 193 deaths. The rate represents the reported number of driver deaths divided by the model's number of registered years.

In contrast, the Chevrolet Astro minivan had the lowest rate with only seven deaths per million registered vehicles. It was followed by the Infiniti G35, BMW 7 Series and the Toyota 4Runner. Ironically, Chevy no longer makes the Blazer or the Astro.

My guess is that the Chevy Astro is not 33 times safer than a Chevy Blazer. Certainly, the demographics in terms of risk taking behaviors are different for the purchaser of a mini van than a sporty SUV because the study did not consider driver behavior or how the vehicles are used. Still, there are still meaningful conclusions that can be drawn from this study about which vehicles are the safest and least save to drive. The profile on the driver a Chevy Blazers cannot be that different from the drivers of Toyota 4-Runners.

The good news is they are making cars safer than they used to make them. These rates have gone down about 30 percent since the mid-1990s. The study also confirms our lawyers' experience that heavier vehicles such as SUVs and pickups have lower death rates. The message here underscores a theme I have discussed before on the Maryland Personal Injury Lawyer Blog: for all of the shouting about the need to decrease our dependence on foreign oil - which I agree with completely - the death toll on our highways will increase if we become a nation of Yugo drivers.

Bookmark:      Bookmark Study%20Highlights%20General%20Motors%27%20Vehicle%20Death%20Rates%20 at del.icio.us      Digg Study%20Highlights%20General%20Motors%27%20Vehicle%20Death%20Rates%20 at Digg.com      Bookmark Study%20Highlights%20General%20Motors%27%20Vehicle%20Death%20Rates%20 at Spurl.net      Bookmark Study%20Highlights%20General%20Motors%27%20Vehicle%20Death%20Rates%20 at Simpy.com      Bookmark Study%20Highlights%20General%20Motors%27%20Vehicle%20Death%20Rates%20 at NewsVine      Blink this Study%20Highlights%20General%20Motors%27%20Vehicle%20Death%20Rates%20 at blinklist.com      Bookmark Study%20Highlights%20General%20Motors%27%20Vehicle%20Death%20Rates%20 at Furl.net      Bookmark Study%20Highlights%20General%20Motors%27%20Vehicle%20Death%20Rates%20 at reddit.com      Fark Study%20Highlights%20General%20Motors%27%20Vehicle%20Death%20Rates%20 at Fark.com      Bookmark Study%20Highlights%20General%20Motors%27%20Vehicle%20Death%20Rates%20 at Yahoo! MyWeb

April 12, 2007

Ford Recall Escape SUVs

The New York Times reported today that Ford is recalling more than 500,000 Escape sport-utility vehicles after 50 reports of engine fires caused by corroded brakes. Ford notified dealers of the recall this week for Escapes, covering the 2001 to 2004 model years. Ford will also contact the truck owners directly in the near future. The decision follows a National Highway Traffic Safety Administration investigation last year. The recall impacts only conventional gasoline-powered Escapes.

Ford surely does not enjoy fire being associated with its vehicles. Although time has erased most of the taint, Ford has an unpleasant history with its vehicles and fires. In the early 70s, it became clear that the Ford Pinto's design made the care susceptible to leakage and fire in moderate and even low speed rear end collisions (rear end auto accidents the most common type of vehicle accident). In April, 1974, the Center for Auto Safety petitioned the National Highway Traffic Safety Administration to recall Ford Pintos due to this defect. It took over four years and a ridiculous number of wrongful death and catastrophic injury lawsuits - including a $125 million punitive damage award that was later reduced - before Ford agreed to recall the 1.5 million Ford Pinto that were still on the market.

Ford also had a more recent brush with engine fires when 3.8 million Ford vehicles were recalled for engine fires just a few years ago.

The impression I have is that the risk associated with these fires pale in comparison to the risk associated with the Ford Pinto. Accordingly, I do not think that products liability lawyers in Maryland should expect to see a lot of cases. Still, when you are talking about fire and cars, there is always risk. If you have an Escape implicated in the recall, you should contact your Ford dealer immediately. If the engine of your Escape has caught fire and you have been injured, you should call a plaintiffs' products liability lawyer to investigate your case.

Bookmark:      Bookmark Ford%20Recall%20Escape%20SUVs at del.icio.us      Digg Ford%20Recall%20Escape%20SUVs at Digg.com      Bookmark Ford%20Recall%20Escape%20SUVs at Spurl.net      Bookmark Ford%20Recall%20Escape%20SUVs at Simpy.com      Bookmark Ford%20Recall%20Escape%20SUVs at NewsVine      Blink this Ford%20Recall%20Escape%20SUVs at blinklist.com      Bookmark Ford%20Recall%20Escape%20SUVs at Furl.net      Bookmark Ford%20Recall%20Escape%20SUVs at reddit.com      Fark Ford%20Recall%20Escape%20SUVs at Fark.com      Bookmark Ford%20Recall%20Escape%20SUVs at Yahoo! MyWeb

January 28, 2007

Lucentis May Increase Risk of Stroke

The New York Times reported on Saturday that Genentech posted a letter on its Web site warning eye specialists of its new eye drug Lucentis, which may increase the risk of stroke for those on Lucentis. Genentech found that patients taking their marketed dose of Lucentis were much more likely to suffer a stroke than patients taking a lower dose.

Some doctors remain undeterred. “Right now, it will have no impact on my use of Lucentis,” a doctor at the Palmer Eye Institute of the University of Miami, wrote to the New York Times in an e-mail message. “When given a choice between a high likelihood of blindness or a 1 percent risk of stroke, I think most patients will choose their vision.”

I don't know enough about Lucentis to say whether I think this doctor is correct. The problem is, I don't think Lucentis' manufacturer knows either.

Bookmark:      Bookmark Lucentis%20May%20Increase%20Risk%20of%20Stroke at del.icio.us      Digg Lucentis%20May%20Increase%20Risk%20of%20Stroke at Digg.com      Bookmark Lucentis%20May%20Increase%20Risk%20of%20Stroke at Spurl.net      Bookmark Lucentis%20May%20Increase%20Risk%20of%20Stroke at Simpy.com      Bookmark Lucentis%20May%20Increase%20Risk%20of%20Stroke at NewsVine      Blink this Lucentis%20May%20Increase%20Risk%20of%20Stroke at blinklist.com      Bookmark Lucentis%20May%20Increase%20Risk%20of%20Stroke at Furl.net      Bookmark Lucentis%20May%20Increase%20Risk%20of%20Stroke at reddit.com      Fark Lucentis%20May%20Increase%20Risk%20of%20Stroke at Fark.com      Bookmark Lucentis%20May%20Increase%20Risk%20of%20Stroke at Yahoo! MyWeb

January 27, 2007

Prempro Verdict

A Philadelphia jury found that Wyeth's hormone replacement therapy Prempro was the cause of an Arkansas woman's breast cancer and awarded the victim's family $1.5 million. The jury found that Wyeth was negligent in failing to provide adequate warnings about the risk of breast cancer associated with the use of Prempro.

The jury is expected to return this week with a decision on punitive damages. In Maryland, under Owens-Illinois, Inc. v. Zenobia, 325 Md. 420 (1992), a landmark Maryland Court of Appeals' opinion, punitive damages in this case against Wyeth for failing to warn about the risks of Prempro would have to be supported by a showing that the conduct of Wyeth was malicious, or the result of evil motive, or ill will. There are no such allegations in the Prempro litigation.

Bookmark:      Bookmark Prempro%20Verdict at del.icio.us      Digg Prempro%20Verdict at Digg.com      Bookmark Prempro%20Verdict at Spurl.net      Bookmark Prempro%20Verdict at Simpy.com      Bookmark Prempro%20Verdict at NewsVine      Blink this Prempro%20Verdict at blinklist.com      Bookmark Prempro%20Verdict at Furl.net      Bookmark Prempro%20Verdict at reddit.com      Fark Prempro%20Verdict at Fark.com      Bookmark Prempro%20Verdict at Yahoo! MyWeb

January 19, 2007

Consumer Reports Retracts Article on "Failed" Car Seats

Last week, I wrote about the Consumer Reports article on failed infant car seats. As I wrote the post, my wife was spending a few hundred dollars on new car seats for our 3 month-old twins. Sure enough, Consumer Reports retracted the article this week after receiving data from the National Highway Traffic Safety Administration who reported the car seats did quite well at the correct impact speed.

In their tests, Consumer Reports simulated impacts at more than 70 miles an hour when they were supposed to simulate an impact at 38 miles an hour. At the time, I thought it was probably silly to buy new car seats particularly given the data that was offered on the side impact risk to infants. But how can you argue against taking the safest possible course for your kids? You can’t. Now, if you are a lawyer out there considering a class action against Consumer Reports, you have your first client. I'm kidding, that would be a completely frivolous lawsuit, in my opinion. But do not be surprised to see one.

Speaking of frivolous lawsuits, a personal injury attorney announced in news conference in California that the he was filing a wrongful death case on behalf of the family of a 28 year-old woman who died in a water drinking contest on a radio show. The attorney said the wrongful death suit would name the radio station as the defendant, presumably for holding the contest in the first place. I do not think this is a meritorious case nor do I think it helps the cause of personal injury lawyers and their clients. I will offer more thoughts on this case this weekend.

Bookmark:      Bookmark Consumer%20Reports%20Retracts%20Article%20on%20%22Failed%22%20Car%20Seats%20%20 at del.icio.us      Digg Consumer%20Reports%20Retracts%20Article%20on%20%22Failed%22%20Car%20Seats%20%20 at Digg.com      Bookmark Consumer%20Reports%20Retracts%20Article%20on%20%22Failed%22%20Car%20Seats%20%20 at Spurl.net      Bookmark Consumer%20Reports%20Retracts%20Article%20on%20%22Failed%22%20Car%20Seats%20%20 at Simpy.com      Bookmark Consumer%20Reports%20Retracts%20Article%20on%20%22Failed%22%20Car%20Seats%20%20 at NewsVine      Blink this Consumer%20Reports%20Retracts%20Article%20on%20%22Failed%22%20Car%20Seats%20%20 at blinklist.com      Bookmark Consumer%20Reports%20Retracts%20Article%20on%20%22Failed%22%20Car%20Seats%20%20 at Furl.net      Bookmark Consumer%20Reports%20Retracts%20Article%20on%20%22Failed%22%20Car%20Seats%20%20 at reddit.com      Fark Consumer%20Reports%20Retracts%20Article%20on%20%22Failed%22%20Car%20Seats%20%20 at Fark.com      Bookmark Consumer%20Reports%20Retracts%20Article%20on%20%22Failed%22%20Car%20Seats%20%20 at Yahoo! MyWeb