In today’s edition of Speaking of Justice the topic turns to the headline story of last week, the guilty plea of the “King of Torts”, Richard “Dickie” Scruggs.  In a week of amazing headlines regarding the likes of Eliot Spitzer or William Lerach, to our mind the most amazing story is this guilty plea of Scruggs to a charge of attempting to bribe a judge to rule in his favor during a legal dispute over attorney fees. 

In news from last week, the EPA announced on March 12, 2008 that WR Grace had agreed to pay $250 million to the EPA to fund the clean up of the town of Libby, MT., one of the most notorious environmental disasters of the last 25 years. You can read the entire AP news wire report by clicking here.

” 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.  

Civil Action Attorney Jan Schlichtmann joins Scott Drake on Speaking of Justice to discuss the huge surge in home foreclosures and the legal traps that are devastating thousands of homeowners nationally. In this very timely podcast lawyers and listeners can get a quick primer in the new reality of what happens in foreclosure or trust deed sales in the new banking economy.   There are huge traps for unaware or unrepresented homeowners regarding state laws on notification of property sales, legal notice and forced sale of property that are catching people of all levels of society unaware. If you are facing foreclosure, if you want to know what your legal rights are or what the pitfalls might be, this is a must listen podcast!

Click here to listen to the podcast on mortgage foreclosures. 

In today’s edition of Speaking of Justice, the daily podcast featured on The Legal Broadcast Network, Scott Drake is joined by Civil Action attorney Jan Schlichtmann to discuss on the landmark environmental damage cases, the Exxon Valdez oil spill. This infamous case is STILL being litigated, almost 20 years after the accident, as the argument of the punitive damages was heard before the Supreme Court earlier this week with a substantial risk that the entire amount could be tossed out. 

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.

In today’s edition of  “Speaking of Justice” LBN host Scott Drake is joined by famed Civil Action Attorney Jan Schlichtmann to discuss last weeks Supreme Court decision on the matter between the State of West Virginia and the tobacco companies. 

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.  

In the first of a series of podcasts on the important topic of preemption, Civil Action Attorney Jan Schlichtmann joins Scott Drake on Speaking of Justice to discuss the recent Supreme Court ruling in the Eiegel v. Medtronic case. This decision is going to be the first of two key cases addressing this contentious issue and Jan weighs in with his thoughts on where this decision could lead. 

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.  

In this video podcast Attorney Jan Schlichtmann sits down with Attorney Angel Reyes and his associate Attorney Jim Orr to discuss the recent Duragesic Patch verdict they returned. This area of product/mass tort litigation is of particular interest to trial lawyers and consumers who are interested in the FDA recent recall of even more of these potentially dangerous medicated patches. A great video to watch if you are a consumer or a trial lawyer.

Amgen, Inc., manufacturer of ESAs Epogen and Aranesp which help to treat chemotherapy-induced anemia in cancer patients by reducing the need for risky blood transfusions, has begun to lay off workers as part of its company restructuring in the wake of all the scrutiny that its top drugs have been under in 2007 after studies have shown that their over prescribing has led to heart attacks, strokes, blood clots, and premature death. Amgen, which employs over 20,000 workers worldwide, announced in August that it would have to cut 12-14% of its total workforce—roughly 2,600 jobs. Involuntary layoffs have begun in several locations: 675 of the 8,200 workers in Thousand Oaks, CA; 50 of the 1,100 workers in Bothell and Seattle, WA; and 23 of the 1,250 workers in Longmont and Boulder, CO. In addition to involuntary layoffs, roughly 700 workers worldwide accepted voluntary buyouts. Severance packages for laid off workers include cash (a minimum amount of 24 weeks of pay), company-paid health insurance through the end of 2008, and career transition services which offer workshops, a job bank and job fairs. A number of companies have expressed interest to Amgen in hiring laid off workers who have a certain level of expertise in their field.

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”

According to Reuters, CMS (the Centers for Medicare and Medicaid Services) sent a letter to doctors and others who were trying to pressure it into reviewing its newly revised strict reimbursement guidelines for Amgen’s Aranesp and Epogen and Johnson & Johnson’s Procrit used to treat chemotherapy-induced anemia in cancer patients, which stated firmly that in the absence of scientific evidence to the contrary, it felt that its new reimbursement guidelines for ESAs are in the best interest of the patients and founded upon the results of clinical studies. Amgen, along with a coalition of doctors, organizations and health centers, contends that the new reimbursement guidelines compromise the quality of care that doctors can offer their patients. Arguing that CMS’s guidelines have no scientific basis, opponents claim that the guidelines could in fact hurt patients by making hemoglobin levels to drop to dangerously low levels before allowing treatment coverage. CMS denies the claims made by the opposition and says that unless it gets some questions answered within the next 30 days, its reimbursement guidelines will remain as they are. Two specific questions that CMS wants answered are: (1) is it a requirement that chemotherapy patients’ hemoglobin levels are above 10g/dL? and (2) is ESA treatment a superior alternative to blood transfusions in order to maintain the 10g/dL level?

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”

On September 11, 2007 the U.S. Food and Drug Administration heard from an advisory panel of 19 on the question of whether or not to limit the hemoglobin (red blood cell) level of kidney-failure patients (both those who are and who are not undergoing dialysis) to not exceed 11 grams per deciliter [g/dL]. In a 14 to 5 split, the panel voted against setting a specific target level of 11 g/dL, stating that it was uncomfortable with setting a specific target in the absence of evidence proving that a level of 11 g/dL was safer than 12 g/dL. The panel explained that it was more in favor of leaving it up to the doctor’s discretion about how to treat each individual patient, and felt more comfortable with advising the FDA that a range of 10-12 g/dL was more appropriate since doctors could treat patients up to 12 g/dL (even though 9 out of 19 panelists were in favor of an 11-11.5 g/dL maximum).

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”

 

Merck & Company, the third-largest drug maker in the United States, is escaping liability for the adverse side effects that Vioxx caused thousands of patients. As published in The New York Times, Merck has forced every claim to be tried on a case-by-case basis, not allowing for plaintiffs to aggregate their claims. So far courts have agreed with Merck that because each plaintiff’s claim is based on a separate set of facts (specific to that particular plaintiff), the claims should not be aggregated. However, how fair is this to the plaintiffs?

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”

Many news sources have published articles regarding Amgen’s recent announcement that it will undergo restructuring due to declining sales of two of its blockbuster drugs, anemia drugs Aranesp and Epogen. Included in the restructuring is, first, a 12% to 14% cut in the company’s workforce of 20,000, which is a loss of 2,200 to 2,600 employees. Next, capital expenditures will be reduced by about $1.9 million between 2007 and 2008. Further, certain operations facilities will be closed down while others will be reduced in size for efficiency purposes. Also, the adjusted earnings per share guidance has been lowered to between $4.13 and $4.23 per share from previously estimated $4.28 per share. Restructuring pre tax charges are estimated between $600 million and $700 million for 2007 and 2008, but the restructuring plans implemented by Amgen are estimated to save the company between $1 billion and $1.3 billion next year.

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”

A recent article in The Boston Globe highlights some developments with the Danversport Trust, started on June 1, 2007 when it was approved by Judge John Casey. The trust has been established as a means for those who were effected by the November 2006 warehouse explosion  (occupied by CAI, Inc. and Arnel Co.) to “negotiate a group settlement against any party found responsible.” The explosion caused over $20 million in damage and displaced many families whose homes were either severely damaged or destroyed.

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”

 

 Last week on Civil Action Radio guest host, Attorney Roberta Ashkin of the Ashkin Law Office, was joined by the trial lawyer team that won the nationally publicized verdict in the first Federal Fentanyl Patch case. Roberta is a frequent guest and commentator on The Legal Broadcast Network and her commentary on legal issues and areas of interest to trial lawyers can be found exclusively on LBN channels and podcasts.

The 25 minute podcast featured Attorney Jim Orr of Dallas, TX and a partner in Heygood, Orr, Reyes & Bartolomei, and Attorney Ike Gulas of Birmingham, AL and a partner in the firm of Gulas & Stuckey. This podcast is a bit longer then our typical 15 minute editions but this case has been reported in virtually every major national publication and legal magazine and this interview with two key members of the trial team will give you an inside glimpse into the facts and issues that brought this verdict in for the plaintiffs.
 

 Jim Orr focuses his practice on complex business litigation and personal injury matters and over the course of his career he has represented both plaintiffs and defendants in a variety of civil litigation matters and has tried over 60 cases to verdict. He is AV rated by Martindale Hubbell and has been voted several times by his peers one of the “Super Lawyers” in the State of Texas. Also representing the client for Heygood, Orr, Reyes and Bartolomei in this case were Attorney Angel Reyes and Charles Miller as part of the trial team and you can find their bio’s and more information about the firm by clicking the link above.

 

 

 Ike Gulas has built an impressive reputation in mass tort litigation and class action suits brought against the pharmaceutical manufacturers of Rezulin, Fen-Phen, Serzone and Baycol. His firm is known through out the south as one of the premier mass tort trial firms and this verdict in a difficult federal case will only further cement that reputation.  

The podcast discusses the $5.5 million wrongful death verdict against two subsidiaries, Janssen Pharmaceutical Products, LP and ALAZ Corp, of pharmaceutical giant Johnson & Johnson in the nations first federal court trial involving the patch form of the narcotic painkiller fentanyl, also known and sold under the name “Duragesic patch”.  In this particular case the plaintiffs were the estate of the late Adam Hendelson who died on December 17, 2003 as a result of the leakage of the patch which put fatal levels of fentanyl into his system, killing him at home.

This is a significant verdict and fascinating case that will be of interest to trial lawyers nationally and settlement professionals who have clients that work in pharmaceutical litigation.

You can listen to the entire podcast by clicking here. 

Reuters and the NY Times published articles in which U.S. District Court Judge Eldon Fallon denied Merck’s motion for summary judgment in two Vioxx cases. Merck’s argument that the cases should be thrown out on the grounds of preemption did not persuade Judge Fallon. Merck argued that an FDA’s rule preempts the ability to file a products liability lawsuit, but the court ruled that the plaintiffs’ claims did not violate federal law and therefore the plaintiffs’ claims are still valid.

Reuters article- Judge denies Merck motion to discard Vioxx cases

NY Times article- Judge Rejects Merck’s View on F.D.A. Issue

 

The U.S. District Court’s ruling is also discussed on the FDA Law Blog webpage. The published article cites specific rulings made by the court (see the end of the article).

Supreme Court to Hear Case Involving Scope of the Preemption Provision of the Medical Device Amendments

 

In a short article published by The Salem News, the Salem Superior Court has approved the Danversport Trust. The Trust was established to pool the claims of one hundred fifty home and business owners affected by the Nov. 22 explosion. The Trust was created on June 8, 2007 and has 259 beneficiaries.

Click here to see the article.

 The American Association for Justice (AAJ), formerly the Association of Trial Lawyers of America, was named in an article published by The Hill in Washington, D.C., for including its own provisions in the draft of an FDA bill. The AAJ wants included in the bill the provision that drug and device companies cannot use FDA approvals as a shield to block state lawsuits. The AAJ opposes the notion that the drug companies are protected under the legal standard of federal preemption against claims in state courts. When these companies market “unsafe or mislabeled products” they should be held accountable for the harm that it causes those who take FDA-approved drugs. The AAJ is not looking to reverse the standard of federal preemption; more appropriately it wants drug and device companies to recognize that an FDA-approval will no longer be sufficient to protect it from claims brought in state court.

Trial lawyers’ win on suit provision threatens FDA bill