” Taxpayers have been footing the bill for the U.S. Environmental Protection Agency’s investigative and cleanup work in Libby, where the agency arrived in 1999. Expenses total $168 million and another $175 million in costs are likely, said Paul Peronard, EPA’s Libby project leader. Sen. Max Baucus, a Montana Democrat, called $250 million “a drop in the bucket compared to the destruction and pain our neighbors in Libby have been through.”

Asbestos came from the vermiculite mine and processing facilities, a few miles from Libby, that Grace owned and operated from 1963 until the site’s closure in 1990. Vermiculite was used in a variety of products and the asbestos was dispersed in a variety of ways. Workers carried it home on their clothing. Asbestos also ended up in the yards of homes where vermiculite was spread as a soil conditioner. Exposure in Libby has been blamed for lung-scarring asbestosis and for mesothelioma, a fast-moving cancer that attacks the lungs. “

While notable for it’s amount and the fact that at long last some measure of compensation and justice for the residents of the small Montana mining community is on the horizon, the facts of the Libby case and what still lies ahead really isn’t discussed in great detail in any of the news reports.  For perspective on what happened at Libby, the nature of this environmental and public health disaster we have turned to LBN’s Jan Schlichtmann, one of the nations leading environmental lawyers to discuss the case.

For today’s edition of Speaking of Justice, discussing the Libby Montana $250 million EPA settlement and what the future holds, click here.  

In today’s edition of Speaking of Justice host Scott Drake is joined by Civil Action lawyer Jan Schlichtmann as they discuss the news of the day concerning the Procrit and Aranesp and the potential cancer causing anemia drug issues. Since the fall of 2006 the medical, consumer and legal community have been closely watching the studies and investigations into these widely prescribed drugs for people on chemotherapy. 

Just today the ODAC committee of the FDA have now voted 13-1 that the drugs should stay available on the market and for use in cancer patients, but by a 12-2 vote that they should only be used in patients whose cancer is so far into it’s final stages that there is little hope for survival. Essentially they are baring it’s use in cases where there is early stage cancer or treatment so that the feared cancer accelerating aspects of these drugs are not a risk to patients. There are very few circumstances under which these drugs should be used if you or a family member have cancer and if you do use it you need to be in constant communication with your oncologist regarding it’s safety in your particular case.

Listen to the full podcast on anemia drugs, the FDA ruling and the future potential of any litigation as a result of the widely prescribed off label use of these drugs.  

Click here to listen to the podcast on mortgage foreclosures. 

Jan, one of the nations leading expects on environmental damage cases, gives his unique perspective on this case, it’s history and how it has moved through the courts. If you are interested in environmental law, the Exxon Valdez case or are just a Supreme Court watcher, this will be a fascinating podcast for you to listen in on.

Click here to listen to the entire podcast.

Many people and attorney’s are not aware there are still tobacco cases being brought against the firms that produce cigarettes for health and personal injury damage claims.  The West Virginia case centered on an argument to the US Supreme Court that a trial plan that cigarette makers claim will lead to unconstitutional awards of punitive damages had been crafted by the WV courts and they were calling for it to be striken. The US Supreme Court rejected this argument and cleared the way for sick smokers to seek millions, if not billions, of dollars in damages.

Learn more about this important ruling and it’s impact on the many individual smokers cases that are still pending in the court system by clicking here to hear the entire podcast.  

Later this week several of our other guest commentators will also cover this topic, with an eye toward the pending Warner-Lambert v. Kent as well as the Wyeth v. Levine cases that look at this same topic from the perspective of pharmaceutical litigation.

This is a major topic in mass torts and state law, as well as an issue of intense interest to Supreme Court watchers and constitutional law experts, so if you want to listen to a wide range of opinions and thoughts on preemption make sure you are getting our audio feeds or stealing our podcast widget so you can place it on your site.  

Click to hear the entire podcast here.  

The Thousand Oaks, CA location is Amgen’s headquarters and it, along with offices in Rhode Island, bore the brunt of the 1,500 layoffs.

In Washington, not only have workers started getting laid off, but plans for facility expansion have been postponed; just last year plans for expansion were underway, which could have doubled the workforce in WA, but the company has felt grave effects of the scrutiny over the ESAs.

Ventura County Star: “Layoffs at Amgen Begin”

Seattle Post-Intelligencer: “Amgen Lays Off 50 in Seattle, Bothell”

The Denver Post: “Amgen Lays Off 23 Colo. Workers”

As it stands now, CMS will only cover ESA treatment for cancer patients who suffer from chemotherapy-induced anemia when those patients’ hemoglobin (red blood cell) level is below 10g/dL because studies have shown that treatment at higher hemoglobin levels can increase the patients’ chances of suffering heart attacks, stroke, and premature death. Until new evidence is introduced to CMS, these guidelines will remain in place not only for cancer patients but also for those undergoing kidney dialysis treatment, of which it maintains similar reimbursement guidelines for ESA treatments.

Opponents to the CMS guidelines include doctors, the American Society for Clincial Oncology (ASCO), the American Society of Hematology, US Oncology (cancer treatment center company), and other for-profit cancer and kidney treatment centers.

Reuters: “Medicare Seeks Evidence to Support Anemia Change”

Boston.com: “Medicare Unlikely to Reverse Cuts in Anemia Drug Payments”

Los Angeles Times: “Medicare to Keep Limits on Anemia Drugs”

“Medicare to Stand by Limits on Anemia Drugs Unless ‘New Evidence’ Is Submitted”

CNBC: “Medicare: We Want Proof On Anemia Drugs”

The panel’s implied target range is exactly the range that Amgen and Johnson & Johnson had hoped for. The two drug companies manufacture and market ESAs to treat kidney disease and cancer patients suffering from anemia. Amgen’s Epogen is used to treat most of the 350,000 U.S. kidney disease patients undergoing dialysis, while it’s Aranesp along with J&J’s Procrit are used to treat cancer patients as well as most of the 250,000 kidney disease patients who are not undergoing dialysis. For patients undergoing treatment with these ESAs, proper hemoglobin levels are vital to maintaining their health. Studies—for example the Normal Hematocrit Cardiac Trial and the Correction of Hemoglobin and Outcomes in Renal Insufficiency (CHOIR)—have shown that improper ESA dosages can increase hemoglobin levels in excess of 13 g/dL which has lead to death, heart attacks, strokes, heart failure and blood clots in patients. However, if prescribed properly, the ESAs can help patients maintain suitable hemoglobin levels which eliminate the need for risky and inconvenient blood transfusions. From these studies, the FDA has determined that 11 g/dL would be a proper hemoglobin level. Panelists, however, are reluctant to set an 11 g/dL target level because of testimony that it heard explaining that setting too high a limit could cause some patients to go under treated, which could result in their suffering from debilitating anemia or more blood transfusions.

Amgen and J&J are working together with the FDA to reach a consensus on which hemoglobin level (or range) is appropriate to place on new warning labels. The health risks that have come to light in the past few months have prompted the FDA to make changes on warning labels and, in determining which level should appear on the label, the FDA called this panel. Even though the FDA is not required to follow the advice of its panels, it generally does so. This could mean that a 10-12 g/dL range could be adopted by the FDA for its warning labels, which could affect both the way that doctors prescribe the ESAs as well as how the U.S. Medicare Insurance program reimburses the drugs. The Centers for Medicare & Medicaid Services has recently revised its reimbursement guidelines, which some private insurers are likely to follow. A change to the levels on warning labels could affect these guidelines.

Click the following links to read the full version of articles that contributed to this posting:

Associated Press (in Forbes): “FDA Panel: Widen Target for Anemia Drugs”

The Boston Globe: “Panel Says Anemia Drug Doses OK As Is”

Reuters: “Amgen Defends Anemia Drugs Before U.S. Panel”

AHC Media LLC: “FDA Panel Vote on Anemia Drugs Gets Mixed Reviews”

“Amgen and Ortho Biotech Breathe Collective Sigh of Relief After FDA Panel Vote”

“FDA Panel Votes Against Anemia Drug Restrictions”

Reuters: “US Panel Rejects Anemia Drug Limit in Non-Dialysis”

“FDA Hemoglobin Target for Amgen, J&J Anemia Drugs Too Narrow”

Reuters: “US Advisers Against Anemia Drug Restrictions”

The New York Times: “F.D.A. Advisory Panel Opposes Curb on Anemia Drugs”

The Wall Street Journal: “FDA Panel Vote Is a Win for Amgen, J&J”

The following are related articles:

“Amgen Bulls Running Wild”

Los Angeles Business Journal: “Panel Says Anemia Drug Dosage OK”

Vioxx was withdrawn from the market in 2004 because it was found that patients who had taken the drug for 18 months or more were suffering heart attacks. Scientists say that over 20 million Americans have taken Vioxx and that approximately 100,000 have suffered heart attacks. Merck said “it had adequately warned patients and doctors of Vioxx’s heart risks an that it never knowingly endangered patients.” However, counsel for the drug maker, Theodore V.H. Mayer, partner at Hughes Hubbard & Reed contends that there is not one case yet that he has tried where Vioxx caused a heart attack, simply because they are a very common occurrence. If Merck admitted that Vioxx can cause heart attacks, then why is it’s counsel against settling the cases?

So far over 45,000 claims have been filed against Merck, but less than 20 cases have actually made it to a jury. Most of the cases are in the pretrial discovery phase where Merck’s lawyers are investigating into the amount of Vioxx taken by the plaintiffs, how long they took it for, when they suffered a heart attack, how close to suffering the heart attack were they taking the drug, etc. Many plaintiffs’ lawyers are discouraged from pursuing their claims against Merck because of a lack of sufficient evidence regarding the taking of the medicine and the suffering of the heart attack. So far Merck has won most of the cases that have gone to trial and the ones it lost it has appealed.

Merck’s tactics are discouraging to plaintiffs because most of them will never see their day in court. There are no settlement opportunities available to the plaintiffs and because of the sheer volume of cases, many of the plaintiffs will probably die before their case is heard. One attorney, Mr. Lanier, who represented Carol Ernst in a case against Merck in 2005, says, “Merck’s goal is to manipulate the legal system to deprive justice to tens of thousands of people whose cases can never be heard.” That seems to be just what Merck is doing. Even though Ernst won her case against Merck and was awarded $253.5 million, the drug maker appealed the ruling and had the damages lowered to $26.1 million.

In total, Merck has spent over $1 billion in the last three years in legal fees which, unfortunately enough for the plaintiffs, has seemed to help Merck out tremendously. Not only are the number of claims against Merck decreasing, but so too is the total amount of liability, down to $5 billion from a previously estimated $25 billion. The victims in this whole scheme are the plaintiffs who not only suffered adverse effects from taking Vioxx, but who—for the majority—will never get a chance to face Merck in court. For those few who might bring their case and win, such as Ernst, victory is bittersweet because it will be years before any compensation is even paid out (it is estimated that the earliest Ernst might see any compensation is in 2008).

To read the full New York Times article, click on the link below:

“Plaintiffs Find Payday Elusive in Vioxx Cases”

Amgen, founded in 1980, has seen a steady increase in sales and profits since Epogen was introduced into the market in 1989. This plan for restructuring is the first one of its kind that Amgen has experienced in its 27-year history as a biotechnology company. The company has grown to employ 20,000 employees worldwide, with 11 of its facilities located in some of the biggest cities in the U.S., including San Francisco, CA; Cambridge, MA; and Seattle, WA. The restructuring plans come in the wake of “payment limits by insurers and safety warnings from U.S. regulators.” FDA approved labels for Amgen’s drugs have undergone changes including the inclusion of a “black box” warning. These warnings coupled with numerous studies into the safety of the drugs have adversely affected Amgen’s anemia drug sales, which have, in turn, caused the company’s restructuring.

Click on the following links to read the full version of the articles which have contributed to this post:

Associated Press (in Forbes): “Amgen to Cut Up to 2,600 Jobs”

Bloomberg: “Amgen Will Cut 2,200 to 2,600 Jobs, Saving $1 Billion”

The New York Times: “Amgen to Cut Jobs, a First for the Biotech Giant”

The Benton Crier: “Amgen to cut up to 2,600 jobs”

Associated Content: “Biotech Firm Amgen Announces Layoffs”

So far, authorities have not found either CAI or Arnel responsible for the explosion. According to officials, the explosion was most likely caused by the ignition of chemical vapors from an unknown source. Final reports have not yet been made available. Some members of the community, however, are planning to band together and hire their own team of experts to find out what really happened. One possibility is the presence of natural gas in the building structure; however, there is not yet any evidence of that.

Jan Schlichtmann, the attorney representing The Danversport Trust, says that once findings are released concerning the cause of the explosion the trust will then have a better idea of who to approach regarding settlement negotiations. “If a settlement is reached, the money would be paid into the trust” and the beneficiaries of that trust would be the property owners whose property was effected by the explosion. The trust is also accepting private donations which, thus far, exceed $7,000. Based upon the needs of each beneficiary (so far there are over 200, including minor children), the money in the trust will be distributed under a benefits plan, with some money also being used “for the long-term improvement of Danversport.”

While some property owners have already reached monetary settlements with their insurance companies, a great number of them have yet to return to their homes and businesses. Out of 70 homes and businesses that were severely damaged or destroyed by the explosion, more than half of them are still being repaired and/or rebuilt.

The Boston Globe: “Victims form trust for settlement”

Over at The Settlement Channel, our associate Mark Wahlstrom was joined last week by Attorney Robert Wood for the first edition of his featured commentary for the Legal Broadcast Network. This commentary is sponsored by ATG Trust Company of Chicago, IL, and will be a regular monthly feature on LBN channels each month. You can learn more about Robert Wood by clicking here to his web site and get a wide range of resources, articles and commentary authored by this nationally respected expert on the tax issues related to taxable and non-taxable damages.

Todays podcast is about the recent Murphy vs IRS opinion, which came out July 3, 2007 and reversed the prior decision which appeared to open up a wide range of taxable cases to potentially falling under the tax free umbrella of section 104(a)(2). You can find the entire Murphy opinion by clicking here.

This podcast, while lengthy at 25 minutes, covers a wide range of topics as to taxable damage cases, what the impact is for trial lawyers and plaintiffs, and some of the issues for litigants in sexual abuse cases among others will now be facing given the wording and reasoning behind the Murphy vs IRS opinion.

With the recent Los Angeles Archdiocese settlement in the news, this discussion of the most recent tax opinion on what is a taxable, and what is a tax free, damage claim couldn’t be more timely and it’s something every trial lawyer needs to be aware of in their practice.  

The Settlement Channel is doing a three part blog series specifically on the impact of Murphy v IRS so I want to make sure you know where to find this featured podcast to get more back ground information on this vitally important decision for trial lawyers and settlement professionals.

Listen to the podcast by clicking here.