Have A Safe 4th!

On June 11, 1776, the colonies’ Second Continental Congress, meeting in Philadelphia, formed a committee with the express purpose of drafting a document that would formally sever their ties with Great Britain. The committee included Thomas Jefferson, Benjamin Franklin, John Adams, Roger Sherman and Robert R. Livingston. The document was crafted by Jefferson, who was considered the strongest and most eloquent writer (nevertheless, a total of 86 changes were made to his draft!) The final version, the document that we know as the Declaration of Independence was officially adopted by the Continental Congress on July 4, although the resolution that led to the writing of the Declaration was actually approved two days earlier.

The following day, copies of the Declaration of Independence were distributed and, on July 6, The Pennsylvania Evening Post became the first newspaper to print the extraordinary document.

On July 8, 1776, the first public readings of the Declaration were held in Philadelphia’s Independence Square to the ringing of bells and band music.
All of this had occurred with some of the delegates to the Congress not even present; New York, for example, did not even vote on the resolution until July 9th. (Did you know that that not a single signature was appended to the Declaration on July 4th. While most of the fifty-six names were in place by early August, one signer, Thomas McKean, did not actually sign the Declaration until 1781.)

One year later, on July 4, 1777, Philadelphia marked Independence Day by adjourning Congress and celebrating with bonfires, bells and fireworks.

The custom eventually spread to other towns both large and small, where the day was marked with processions, oratory, picnics, contests, games, military displays and fireworks. Observations throughout the nation became even more common at the end of the War of 1812 with Great Britain.

On June 24, 1826, Thomas Jefferson sent a letter to Roger C. Weightman, declining an invitation to come to Washington, D.C., to help celebrate the 50th anniversary of the Declaration of Independence. It was the last letter, Jefferson, who was gravely ill, ever wrote. In it, Jefferson says of the document:

May it be to the world, what I believe it will be ... the signal of arousing men to burst the chains ... and to assume the blessings and security of self-government. That form, which we have substituted, restores the free right to the unbounded exercise of reason and freedom of opinion. All eyes are opened, or opening, to the rights of man. ... For ourselves, let the annual return of this day forever refresh our recollections of these rights, and an undiminished devotion to them.

In 1941, Congress declared July 4 a legal Federal holiday.

As Premption Kicks In, FDA Gets Soft

FDA enforcement actions targeting safety problems and misleading claims have fallen sharply even though violations have not, according to statistics released Monday by Rep. Henry A. Waxman. His report is titled "Prescription for Harm" and can be found here. (PDF alert).

In 2005, the FDA issued 535 warning letters to companies, a 54% decline from 1,154 such notices issued in 2000. Over that time, the number of violations reported by FDA inspectors in the field fell only 1% — from 6,334 to 6,268. In reply, an FDA talking head said that the stats did not take into account the agency's strategy of focusing scarce resources on big cases.

So let me make sure I can crystallize this: On the one hand, the FDA is doing the job it is required to do by statute when it approves New Drug Applications - applications that total say more two million pages for Ketek - and has plenty of intermediate investigations to address post approval drug safety problems, thereby allowing pre-emption to block the courthouse doors for people claiming a drug-related injury, but on the other hand, it does not have enough financial resources to investigate reported instances of alleged drug company wrongdoing. Waxman's report noted 138 cases in which headquarters did not take enforcement actions recommended by inspectors.

In the rarefied air of marble and granite courthouses where conservative judges cite scholarly articles to support tossing real life claims of unsafe drugs based on the FDA position, how will actual day to day facts affect the FDA's position on Preemption? Maybe the agency can take its scarce resources and check out alleged wrongdoers rather than spend time and money filing briefs in pending cases? Would that be a good start?

SCOTUS Gitmo Detainees' Decision

The Supreme Court ruled that Congress did not take away the Court's authority to rule on the military commissions' validity, and then ruled that President Bush did not have authority to set up the tribunals at Guantanamo Bay, Cuba, and found the commissions illegal under both military justice law and the Geneva Convention.

The opinion is worth reading. What is troubling? The early comments in medialand.

About five minutes after the decision was announced, a nationally syndicated radio host said that perhaps now is the time for President Bush to tell the Supremes that he just won't abide by this decision. Callers chimed in and - to my horror- resoundingly agreed. One said "it's time the President stick it to the Court" (word to that effect) to which the host gleefully agreed. Conservative blogs are saying likewise either in posts or in the comments.

What is next? A suggestion to go to war with SCOTUS?

Fallout Continues over Vioxx/APPROVe Data and Corrections

As noted earlier this week, Merck said it made a mistake when it described the type of method of analysis used in the study released in 2004. The reference to treatment by-log-time interaction in the article should have referred to treatment by-linear-time-interaction, according to Merck representatives.

What does this mean for attorneys? Below you will see comments by attorneys already, but the new information needs to be fully assessed, documents reviewed and experts consulted. Several people much smarter than I are already weighing in. Steven Nissan, M.D., of the Cleveland clinic has again said that the initial studies were flawed and that with the correction in the data and conclusions of the study the misleading assumption of no risk inside of eighteen months has been exposed for what it was - an effort to to limit the claims of people alleging an injury caused by Vioxx.

According to the NEJM and to other reports on the web, an editor with the NEJM has said in looking at the 100-page data analysis plan there was no reference to using a linear method. The editor has suggested that one cannnot look at the data and then decide how to analyze it. By doing so, Merck would be suggesting that is permissible to change the data plan, which cannot be done. (See AP and Yahoo for sources).

From Merck:

The VIOXX cardiovascular data analysis plan called for numerous statistical and graphical methods to be used to assess whether the relative risk of VIOXX compared to placebo was constant over time or if it changed over time. The use of the variable, logarithm of time, was an element in the primary method specified. The reference to logarithm of time in the description of methods published in the NEJM was in error. The reference to treatment-by-log (time) interaction should have referred to treatment-by-linear-time interaction. The reported p-value = 0.01 came from that test using linear time, not logarithm of time. Recent tests show that the result using logarithm of time based on the final dataset has a p-value = 0.07. Results of diagnostic analyses indicate that a model using linear time is more representative of the data than one using logarithm of time. Thus, the linear time analysis is an appropriate method to assess the changes in relative risk over time.

As specified in the analysis plan, Merck used additional analytical and graphical methods to evaluate whether the relative risk changed over time. These methods included a Kaplan-Meier plot that showed similar curves for placebo and VIOXX during the first 18 months, which then began to separate at approximately 18 months. Relative risks were also calculated over successive six-month intervals in the study. Over the 36-month period of the study, the relative risk was lowest in the first three sets of six-month intervals and highest in the last three sets of six-month intervals, again demonstrating changing relative risk over time. The results of the linear time analysis, the Kaplan-Meier plot, and the interval relative risks together confirm that the relative risk changes over time. In the APPROVe base study, the increased relative risk was observed beginning after 18 months.

Chris Seeger, the attorney who lost the first NJ Trial didn't mince words, saying that Merck had been "lying" about the data it had. An attorney with Beasely Allen will now file a Motion in Judge Fallan's Court claiming a Fraud upon the Court.

FDA Approves First Treatment for Dementia of Parkinson’s Disease

While I spend much of my time investigating potentially unsafe pharmaceutical drugs, I do appreciate that many drugs work as promised and give much relief to those who take them.

Today's news from the FDA is Exelon (rivastigmine tartrate) has been approved to treat mild to moderate dementia (chronic loss or impairment of intellectual capacity) associated with Parkinson's disease, a disorder of the central nervous system. Exelon was previously approved for the treatment of mild to moderate dementia of the Alzheimer's type.

From the FDA site: "It's been recognized for almost a decade that the dementia of patients with Parkinson's disease differs from the dementia of patients with Alzheimer's," said Dr. Steven Galson, Director of FDA's Center for Drug Evaluation and Research, "but until now, there has been no treatment that has been shown to be effective specifically for the dementia associated with Parkinson's Disease. Today's approval of Exelon helps to fill this medical need."

Parkinson's disease is a chronic, progressive disorder of the central nervous system that belongs to a group of conditions called motor system disorders. Parkinson's is the direct result of the loss of cells in a section of the brain called the substantia nigra. Those cells produce dopamine, a chemical messenger responsible for transmitting signals within the brain. Loss of dopamine causes critical nerve cells in the brain, or neurons, to fire out of control, leaving patients unable to direct or control their movement in a normal manner. You can read more about this disease that primarily strikes those over 50 by going to http://www.michaeljfox.org/parkinsons/

I have an ill parent who suffers from moderate dementia associated with Parkinson's. I can assure you it is not something you would want to see for yourself. My parent will not get better, but this drug may help my parent and others cope a bit.

Vioxx: NEJM Corrects Risk Study

The Vioxx APPROVe study contained math errors that wrongly showed the risks changed over time, the New England Journal of Medicine has informed. The NDJM corrected the March 2005 study that led to the drug's withdrawal from the market to show the risks do not, as originally shown, greatly increase after 18 months.

The mistake was significant enough to change some of the conclusions of the trial -- including the eighteen month cutoff.

Sources include the NEJM site and Reuters.com

New Blog: Expert Witness Marketing

Expert Witness Marketing and Training is the title of this blog, which you can find by going to: http://www.expertcommunications.blogspot.com/.

Among the articles is: "Legal Blogs Can Provide a Wealth of Information for Expert Witnesses." It's found here.


The site is worth a look.

Vioxx Trial - California State Court (Grossberg)

Jury selection began L.A. in a lawsuit by a Southern California man who claims he suffered a heart attack after taking the painkiller Vioxx. The Plaintiff is Stewart Grossberg. Grossberg claims he took Vioxx for more than two years before he had a heart attack at 66.

His case is the first to go to trial in California and one of some two-thousand filed in the state and consolidated in Los Angeles Superior Court by Judge Victoria Chaney.

Playing around with Logo Design

A company from India solicited business from me regarding logo design. What do you think?

NSAIDs (Ibuprofen, Advil, Motrin) Pose Risk Post- Heart Attack?

A Danish look back study seems to suggest that all NSAIDS may increase the risk of death in heart attack survivors.

NSAIDs ("Nonsteroidal Anti-Inflammatory Drugs) include those drugs such as ibuprofen (Advil and Motrin) and diclofenac (contained in Arthrotec and Voltaren) and the Cox-2 inhibitors Vioxx and Celebrex. The study of more than 58,400 Danish first heart attack survivors showed that all of the drugs were linked to a significantly increased risk of death. Gunnar H. Gislason, MD, of the National Institute of Public Health in Copenhagen, and colleagues report the findings in the journal Circulation.

Aleve was not included in the study.

Ketek (Antibiotic): Senator says FDA Not Cooperating

As you read the Court decisions regarding preemption, many of the judges address the level of FDA review/involvement in the drug or medical product approval process in their analysis. Take a read of the Reigel decision (addressing a medical device and preemption of state law claims). Last week, however, Sen. Grassley tore the FDA a new one regarding Ketek.

Reports suggest the FDA may be trying to hide information about its review of a Sanofi-Aventis antibiotic known as Ketek that is linked to liver damage in some users.

From Reuters, you can read that "I smell a cover-up," Senate Finance Committee Chairman Charles Grassley said after the FDA failed to make available one of its criminal investigators for questions about his probe of fraud in a study of the drug, Ketek.

The Committee started a review of the FDA's approval of the antibiotic and subsequent monitoring of the drug's safety earlier this year.

Ketek was approved by the FDA approval in April 2004 to treat respiratory infections in adults, after the FDA twice rejected it for lacking safety information.

Several reports allege that some doctors in a Ketek study falsified data or did not keep proper records. One physician was jailed for fraud.

FDA: Triaminic Patch Warning - Risks to Children

From the FDA site:

The U.S. Food and Drug Administration (FDA)warns consumers not to use the Triaminic Vapor Patch marketed by Novartis Consumer Health because of reports of serious adverse events associated with accidental ingestion by children. Novartis Consumer Health also announced today that it is conducting a nationwide voluntary recall of all Triaminic Vapor Patch products.

FDA advises consumers who have used the product and have concerns or questions to contact their physician or health care practitioner. In addition, the company is advising consumers to either discard or return the product to their point of purchase for a refund.

Triaminic Vapor Patch contains camphor, eucalyptus oil, and menthol. The reported side effects from swallowing or chewing on products containing camphor or eucalyptus oils vary from minor symptoms, such as a burning sensation in the mouth, headache, nausea and vomiting, to more severe and life-threatening reactions, such as seizures.

For more information, go here.

From the Doherty Vioxx Trial

On Friday of last week, attorney Jim Pettit showed jurors a series of Merck documents indicating the company set up teams to "neutralize" nearly forty prominent doctors who publicly voiced concerns about risks of using Vioxx or who preferred prescribing competing painkillers.

Later in the day, documents stated many of the doctors had been "neutralized" by methods such as Merck indirectly paying them for serving on advisory boards, giving favorable speeches or participating in Merck research studies.

More later.

Georgia Malpractice Premium Cuts - None

From AP:


Despite promises that rising medical malpractice insurance
rates would be suppressed under new state laws, many of Georgia's insurers
have hiked their premiums since the sweeping reforms took effect last year,
according to an Associated Press analysis of state insurance records.

Six of the state's top insurers of doctors and dentists have
increased their liability rates - in some cases, by more than a third -
since new restrictions on malpractice cases became law in Feburary 2005,
according to state Department of Insurance records obtained by the AP
through an open records request.

The reforms passed by the Georgia Legislature last year included a
$350,000 limit on jury awards for malpractice victims' pain and suffering,
tougher standards for expert witnesses in malpractice trials, and new
incentives for patients to settle out of court.

Doctors and hospitals contended the measures, dubbed "civil justice
reform," would curb malpractice insurance rates and help lure more doctors
to Georgia. Business lobbies, too, threw their weight behind the legislation
because it encourages speedy out-of-court settlements and penalizes parties
who make frivolous claims.

But trial lawyers and patient advocacy groups argued that limiting
damage awards puts an arbitrary price on a victim's life, and that the
state's medical insurers have fostered a false crisis by driving up premiums
in a market with little competition.

"Our worst fears have come true," said Allie Wall, the director of
consumer group Georgia Watch, which vigorously opposed the new laws.

Insurance Commissioner John Oxendine, who supported the reforms that
backers vowed would help cut costs for medical providers, said ways must be
found to entice more competition in the state's malpractice insurance
market. Providers of malpractice insurance in Georgia typically seek the
insurance commissioner's approval of any planned rate increases, even though
they are not required to do so.

The six other companies that increased rates in the past 15 months
represent only about 15 percent of the state's malpractice market. The
largest of that group, The Medical Protective Company, underwrites roughly
$23 million in medical malpractice claims while MAG Mutual writes $162
million in Georgia.

The biggest increases were by Birmingham, Ala.-based Medical
Assurance Co. and Jacksonville, Fla.-based First Professional Insurance Co.
Both companies requested rate increases of 64 percent but settled with the
state on hikes of 35 percent. Medical Assurance's increase was approved last
April, while First Professional's rate jump was brokered with the state just
days after the reforms were approved by lawmakers.

Officials at both companies didn't immediately return telephone
messages seeking comment on why they requeste the increases.

Rate increases among the four other insurers ranged from 2 percent
to 15 percent.

To doctors who were squeamish about the law's impact, the premium
boosts validated their fears.

Dr. Kelly Thrasher, who practices internal medicine in Sandy
Springs, was skeptical of the legislation during last year's debate. Since
the bill was signed into law by Gov. Sonny Perdue, he's seen his malpractice
rates nearly double from $9,000 last year to about $17,000 this year.

"I feel like I've been duped," Thrasher said. "(The debate) pitted
doctors against lawyers because I think there's a natural rivalry, but a lot
of my colleagues were hoodwinked."

Fentanyl Patch Abuse Results in Death

An adult male may have died from biting down on a Fentanyl patch, instantly releasing three days' worth of a drug more powerful than morphine. He was dead before he even got to the hospital.

Fentanyl, a synthetic narcotic, was introduced in the 1960s, but it was not until the early 1990s that it became available in patch form. Last year, the first generic versions of the patch hit the market.

Emergency-room visits by people misusing fentanyl rose to 8,000 nationwide between 2000 and 2004, according to the U.S. Department of Health and Human Services.

The first fentanyl patch was Duragesic, made by Johnson & Johnson. Sales more than tripled from 2000 to 2004, according to the Pacific Law Center in La Jolla, Calif. Worldwide sales were more than $2 billion in 2004, and half of that was in the U.S., according to the J&J's Web site.

You can read more by going here.

This is the revision to my standard letter regarding ERISA in light of Sereboff. The ATLA CLE may yield more information next week:

Opening/address:


This acknowledges receipt of your letter informing of a potential subrogation or right of reimbursement regarding the contract of health insurance between our client and yours.

Please provide me with a copy of the plan summary as well as the express language that allows you, as the agent for the fiduciary health insurer in this instance, to make a subrogation or right of reimbursement claim. Please inform me in writing if it is your intention to assert subrogation or a right of reimbursement, and whether such claim(s) may be based on Section 502(a) of E.R.I.S.A.

At this time, we acknowledge your correspondence and potential claim. Please note, however, that I cannot make a determination as to the validity of the fiduciary’s right to recover–if any– unless or until a copy of the plan is provided.

First: I ask for written documentation from the Health Plan that confirms any right to make a claim on behalf of the Plan.

Second: Please do not make the mistake of responding to this letter by stating that your entity is not the plan administrator and my request for a copy of the relevant documents is to be made to the plan. You are clearly acting as an agent for the health insurer. You have made a request/demand for information and reimbursement and I seek documentation that supports such a claim as it relates to the contract for health benefits.

Third: I consider your company a fiduciary of the plan. If you disagree, please let me know why, doing so in writing.

My obligation in my contract rests solely with my client, a person injured through no fault of his own. As of the date of this letter, there is no recovery of any nature. When or if there is a recovery, I will consult my client. I will not provide you with updates of her treatment or her care. Do not contact my client. If the client agrees, I will be happy to contact you once my client’s care has ended and if or when an offer is made by the at fault party or any insurer.

I may assert the common fund doctrine at some point relative to the claim you make. Please inform me if you intend to take the position that the common fund doctrine does not apply. Of course, I request that if your company takes such a position that you support it in writing. It is our firm’s legal conclusion that if the common fund doctrine applies, it does so regardless of the settlement offer(s) ultimately made.

I have read the Sereboff decision. As you know, in Sereboff a fiduciary made claims against a participant for reimbursement of plan-paid medical expenses. My client expressly reserves the right to advance any own claims he may have against the plan fiduciary.

Is it this Firm’s conclusion that the Plan may impose a constructive trust or equitable lien only on that specific portion of the settlement that was equal to the amount of benefits paid, as opposed to the entire settlement funds. If you disagree with this conclusion, please explain why in writing.

Finally, unless or until you are informed in writing that our legal representation has come to an end at any point, always know that we are the insured’s attorneys. If it is your position that either our law firm or the plan participant is required by contract to update your or the Plan, please provide me with the language on that point.

Feel free to call me if you wish further explanation. I do need the documentation requested so that I may fully explain to my client the nature and validity of the claim asserted. I must have those documents no later than thirty days from the date of receipt of this letter.

*******************************************

Federal Government Employee Sharing Tissue Sample with a Pharma Co.?

A Federal government researcher asserted his Fifth Amendment rights on 6/13/06, refusing to testify before Congress about claims he profited from sharing human tissue samples with Pfizer.

Dr. Trey Sunderland appeared before members of a House subcommittee. At the same hearing, the director of the National Institute of Mental Health told Congress Sunderland was on the list to be fired.

House Energy and Commerce Committee personnel claim that Dr. Sunderland shared human tissue samples with Pfizer Inc. and made more than $250K from that work.

You can read more about this in the WSJ online or in print today.

New Orleans Note

I have written many times about my favorite city, New Orleans. My last visit was during Jazz Fest, and it was an event all should consider.

This post is just one minor - and I do mean minor - tidbit. It looks like Arena Football, an indoor phenomenon (bastardization?) of American Football will host the 2007 Championship Game in NOLA. The game was held in Vegas this year, and generated a fair amoutn of revenue for that city. Some expect it to generate $5-10M for NOLA during its short weekend.

News should not come out officially for several weeks.

June's Litigation Rantin' and Ravin'

After several days of depositions and Court matters, thought I would comment on the sorry state of lawyer civility:

Motion Practice: I have set Motions as many others have, and typically (always) when it is a Motion I have filed, logic would suggest that I speak to the Motion first when a Hearing begins. You would too, I surmise. You'd be wrong.

I am seeing a disturbing trend among defense counsel. When the Judge calls the matter to be heard, Defense counsel immediately begins talking/dissecting the Motion before "the Movant" (yours truly) can utter a word. The primary culprit in these shenanigans tends to fit this profile: 1)Male; 2)Over 40 and typically older than 55; 3)Loaded up with grey hair or alternatively no hair; 4)Bad suit; 5)Two other associates sitting with said counsel and 6)Almost always from a firm with more than 50 attorneys.

Finally a Judge told opposing counsel to "pipe down" until I had a chance to discuss the matter with the Court, or "at least tell me who he is."

I clerked for a US District Court Judge, and I can assure you that this does not happen in Federal Court, at least more than once. I see it happening more rather than less. I am not sure how to correct it, other than to ignore it.

Short Deadlines: More and more often, I receive letters - these typically are authored by younger/less experienced litigators on the defense side - that ask me to respond to some type of request, give me forty eight ("48" being typed next to it in parens), and suggest that if I do not object in writing in or to that time frame, the acton will be taken by defense counsel or agreed to by me. Yesterday I simply scrawled "I object" on the letter and sent it back via FAX, after leaving a message on VM.

FAX transmissions of more than twenty pages. Yes, I still get these - do you? The worst offender is an in town Firm that has sent a telecopier transmission of more than forty eight (48) pages. The Firm is five miles away.

What drives you crazy?

Two Blogs:

Sui Generis--a New York law blog, by Nicole Black. Worth a look.

Go here for it.

Martime law blog: Go here for it. Worth a look.