Friday, June 30, 2006

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?

Thursday, June 29, 2006

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.

Wednesday, June 28, 2006

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.

Tuesday, June 27, 2006

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

Friday, June 23, 2006

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.

Thursday, June 22, 2006

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?

Wednesday, June 21, 2006

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.

Tuesday, June 20, 2006

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.

Monday, June 19, 2006

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.

Wednesday, June 14, 2006

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?

Friday, June 09, 2006

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.

Thursday, June 08, 2006

A 2nd Circuit Preemption Case

Reigel v. Medtronic, which you can find by going here, the Second Circuit Site, generally, or by going right to the PDF of the case, here

The Court tossed claims as to strict liability, breach of implied warranty, and negligent design, testing, inspection, distribution, labeling, marketing, and sale claims, each a device known as the Evergreen Balloon Catheter.


The Appellants' Brief can be found here.

You can read more about this device on the Medtronic page that houses its Annual Report, here. You can also read more about the device on the FDA site, here.

Doherty Trial Vioxx Update: Dr. Topol's Testimony

Cardiologist Eric Topol's testimony (via videotape) was heard on Wednesday. He is the doctor who criticized Merck & Co. over Vioxx in previous papers and trials. During opening statements, Merck's counsel suggested that dr. Topol had an ax to grind with Merck because it didn't fund his proposal.

A Merck lawyer picked at Topol's testimony that Merck failed to study the cardiovascular risks of Vioxx on patients with heart disease. Topol was asked about a claim that that that he and a colleague at the Cleveland Clinic sought funding from in 2001 to conduct a study on the drug's heart risks.

Dr. Topol testified that Merck failed to study heart risks flagged in several clinical trials before the drug's withdrawal. One study in 2000 found that Vioxx caused five times more heart attacks than another painkiller, naproxen.

The trial should take at least three more weeks.

Sources for this post include attorneys observing the trial, news repors at Yahoo.com and Google.com

Wednesday, June 07, 2006

Preemption: Another Read on the Paxil Litigation "Halted"

From Law.com, this report:

The widower of a woman who committed suicide after taking a generic version of the anti-depressant drug Paxil may not pursue product liability claims premised on an alleged failure to warn of suicide risks because the Food & Drug Administration strictly controls the content of such warnings and did not demand it at the time, a Pennsylvania federal judge has ruled.

The decision is Colacicco v. Apotex Inc.. Judge Michael M. Baylson found that the Plaintiffs' state law tort claims are pre-empted by the federal Food, Drug & Cosmetic Act.

Judge Baylson ruled that the defendants are entitled to dismissal of all claims against them because the FDA controls the content of warnings and because the Hatch-Waxman amendments to the FDCA explicitly require generic manufacturers to use the same labeling as approved for the drug's innovator.

Because the 3rd U.S. Circuit Court of Appeals has never squarely addressed the question, Baylson asked the FDA to submit an amicus brief.

In response, the FDA's lawyers filed a brief that urged Baylson to rule in favor of the manufacturers and dismiss the suit.

There is an Atlanta connection to this decision - GSK's lawyers include Thomas Bayman, Erica M. Long and S. Samuel Griffin of King & Spalding in Atlanta.


Baylson's ruling addresses the threshold issue of pre-emption, and "whether regulations of a federal agency, promulgated pursuant to a federal statute, and implementing that statute, require the court to dismiss this pharmaceutical products liability suit based on common law tort principles alleging that inadequate labeling of a prescription drug led to the suicide of plaintiff's wife." (See opinion).

Baylson answered "Yes." He did write that he found "many conflicting court decisions on this topic," but that a series of decisions from the U.S. Supreme Court "point this court in the direction of deference, and require dismissal of this case."

Baylson also found that the FDA's view, as expressed in its amicus brief, was "critical to this court's analysis" because U.S. Supreme Court precedent dictates that an agency's interpretation of the statute and regulations it administers is entitled to deference.

Tuesday, June 06, 2006

Forms: Preservation Letter

Here is the form of what my firm uses when it comes to a vehicle preservation letter. Remember, this is a form, not legal advice:

[ADDRESS]

Dear XXXXXXXX:

Our firm has been retained by XXXXXXXXXX to represent him in an accident which occurred on XXXXXXXX.

It is my understanding that the vehicle described above is currently in your possession and is being stored by you or a representative of yours. Because this vehicle may be evidence in a liability lawsuit, I ask that you safeguard this vehicle for that purpose and not make any repairs to this vehicle, remove any of its parts, make any modifications or change its condition in any manner.

If my request is inconvenient to safeguard the vehicle, please call me within the next twenty-four hours, so that I will know whether other arrangements need to be made. Should you decide to sell, strip, trade, or transfer the vehicle, please contact me. You are prohibited from taking any such action unless you have my express permission in writing to do so. In addition, if any insurance company notifies you concerning the disposal of the vehicle, please contact me immediately at the above number.

If you need further information from this law firm, please do not hesitate to call me. I must tell you that it is very important that this vehicle be preserved in its present condition. Any changes to it may be deemed spoliation of that vehicle.

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

This letter usually gets the attention of the recipient.

Again, recall this form is one I use in Georgia. Please don't consider it legal advice. Thanks!

FDA preemption: June 30, 2006

That is the date of the FDA's position regarding Preemption of state law claims relating to unsafe drug litigation.

On SSRN, I found an article that is worth a read: "Discovering the Boundaries: Federal Preemption of Prescription Drug Labeling Product Liability Actions" which you can find by going here.

From SSRN, the article is described in this way:

The Food and Drug Administration (FDA) has promulgated a regulation which revises the format for prescription drug labeling, and, in the process, has taken the position that the regulation displaces, or preempts, state products liability laws that seek to assess liability on the manufacturer for a labelĂ‚’s warning adequacy. In the FDA'’s 100 year history, it has not taken the position that federal regulations preempt common law tort claims based on prescription drug labeling until now.

Also, in May there was the reported decision of Colacicco v. Apotex, Inc., -- F. Supp. 2d --, 2006 WL 1443357 (E.D. Pa.)

The Court ruled against a plaintiff whose wife committed suicide after taking Paxil. The Defendant relied on the FDA's recent Preamble taking the position, contrary to some earlier statements, that state-law failure to warn tort claims are preempted by the FDCA.

The court rejected specific state law claims, including a New York false advertising count. The court accepted the argument that, despite the existence of pervasive direct-to-consumer advertising, the learned intermediary doctrine precludes a prescription drug false advertising claim -- since only by fooling both doctor and patient can a drugmaker's false advertising succeed, and doctor-targeted ads aren't directed at consumers as the statute requires.

Today Mealey's will have a teleconference at 2PM Eastern on the subject. The cost is $299, and the title of the conference is: "Preemption, The FDA, & Pharmaceutical Drug Litigation." You can learn more by going here.

Adding Categories

I'm adding categories for my collected posts and you will be able to see them to the right as I work through them. Bear with me.

Monday, June 05, 2006

Ban Drug Samples?

From MSN:

Puget Sound Health Alliance directors voted to bar pharmaceutical sales representatives from pitching doctors and giving patients free drug samples.

"The Alliance encourages everyone to recognize pharmaceutical sales rep visits, free samples and other marketing items for what they are -- efforts to increase the sales of specific drugs," said Alliance Executive Director Margaret Stanley.

Read more here.

My comment: This is a common sense and refreshingly candid view on the practice of samples. It is long overdue.

Database of State Tort Reform Laws

I've read about this on several sites, so no link, other than here.

From the Social Science Research Network you will find, as the site says:

The dataset records state laws in all fifty states and the District of Columbia over the last several decades. For each reform we record the effective date, a short description of the reform, whether or not the jury is allowed to know about the reform, whether the reform was upheld or struck down by the states' supreme courts, as well as whether it was amended by the state legislator.

The author is Ronen Avraham from Northwestern U. Email Avraham a thank you if the paper helps.

Vioxx: Doherty Jury Chosen, Opening Statements 6/5/06

Opening Statements begin this morning in New Jersey in the case of Elaine Doherty who claims that Vioxx is the culprit surrounding her heart attack and subsequent double heart-bypass surgery in January 2004. The jury is made up of five women and five men; they were seated Friday.

Who's on the jury? A legislative aide, a person in retail sales, an air traffic control employee, a hotel concierge, a maintenance works, a housekeeper, a facilities technician and a dining room attendant are among them.

License Drug Representatives?

In Massachusetts, that state's Senate could make Massachusetts the first state in the nation to license drug company sales representatives. The law would also prohibit reps from providing entertainment, gifts, payments, or travel to doctors, healthcare facilities, or public officials.

Hairdressers and manicurists must be licensed, so so Pharmaceutical representatives who market prescription drugs and attempt to influence doctors to prescribe name-brand drugs should be as well.

For more, go here, which is the source of this post.

Friday, June 02, 2006

Doherty Jury Selection Begins Today (Vioxx Trial-NJ)

Doherty's trial is the first involving a female Vioxx user, and she just might be the best plaintiff yet. Add this punch to the second punch - new data released from Merck as to the Approve Study. Merck has released - twice - data from the clinical study that led it to pull Vioxx.

Several doctors have said to media outlets that the new data may suggest that heart attack and stroke risks went up after just four months of Vioxx use and lasted for at least a year after patients stopped taking the popular arthritis pill.

From Reuters, Michael Galpern - Doherty's Attorney - was quoted as saying: "It debases Merck's stock defense that you needed to be on the drug 18 months before you had increased risk," he said, and the "high-school level statistical error" Merck just disclosed undercuts its credibility."

Galpern will certainly argue that senior citizens with risk factors are the very group that Merck targeted its ads.

Thursday, June 01, 2006

Alabama Attorney Abduction: Victim Randomly Selected

From Al.com:

Dedrick Griham was being held at the Birmingham Jail as of today. No charges had been filed late Wednesday night. Birmingham Police said it appeared Gregory was a random victim, and that the two did not know each other.

After reading this online , I tuned in to the Nancy Grace show on CNN. Ms. Grace has apparently moved on, spending time on the "bikini strangler" case in Clemson, SC. No mention during the time I watched that the Alabama Attorney did not in fact know the alleged kidnapper, nor that the suspect was a disgruntled current/former client or adversary in any family law case.

Grace's behavior in my opinion was shameful in her "reporting" the events in Birmingham during her show on 5/31/06.

USA Today Article on Congressmen who Blog

Well, sort of. USA Today's News section has a decent write up on blogging. While I don't usually blog about blogging, you can read more about it here.

It's interesting if for no other reason than to note these comments:

"Blogs are supposed to be personal online journals but few lawmakers write their own. Pence typed part of his recent travel blog on a laptop while flying between Baghdad and Ankara, Turkey, but says he usually writes less than 15% of entries. Patrick Leahy jots ideas into his BlackBerry; aides "fill in the facts" before posting it on his blog.

Blogs must be constantly updated to draw a following but that's "extremely taxing on staff," says Will Adams, the press aide who ran the blog of Rep. Tom Tancredo, R-Colo."

To me the key distinction in blogging is who writes the blog. If I am not the author of the content or commentary, is it really a blog? I would probably not waste my time reading a blog if I knew, for example, that an injury law blog was written not by an attorney, but perhaps by his marketing guy. Ghost author, if you will.

Vioxx: Grandma's Case is Next

Elain Doherty, a 68 year old grandmother, is next up for trial in State Court in Atlantic City before Judge Higbee. She blames Vioxx for her 2004 heart attack.

Doherty alleges she used Vioxx daily for three years to treat pain from arthritis of the hands and knees. Michael Galpern is lead counsel for Doherty.

Information indicates that Doherty had atherosclerosis disease, cholesterol, high blood pressure and diabetes.

Is CNN's Nancy Grace Despicable?

Network and Cable News outlets were breathlessly reporting yesterday evening the news that a Birmingham, AL attorney was abducted and thankfully found alive several hours later. Nancy Grace on her CNN show had live "reports" from Alabama journalists. She solicited opinions from attorneys and even one psychotherapist during the show. In nearly every report, the victim was classified as a "divorce attorney."

Also on the show was Paul Finebaum, who has a well regarded sports show on the radio in Alabama. A curious choice as a "local" voice on this news item.

My commentary primarily relates to Grace's seat of the pants opinions ostensibly asserted as as facts. Grace repeatedly made mention that the alleged abductor was "probably" a disgruntled current or former client of the abducted attorney, or that perhaps it was a husband on the "losing" end of a divorce/custody battle.

For most of the show, it was a near certain conclusion that this alleged kidnapper was linked somehow to Ms. Gregory, the victim. Only once did anyone mention that perhaps it was too early to tell, and that it may have been a crime of opportunity (this comment was from the psychotherapist). This early conclusion by a guest on the show was nearly shouted down by Grace. What is significant that as of the airing of the show, the suspect's name was not even known.

Why are media outlets now running breathless comments by newslebrities who suggest or comment that a report is a fact? At any point is Ms. Grace going to admit she was wrong when it is later determined that this was simply a crime involving chance between suspect and victim? I don't think that will happen.

As an attorney with a national show, to me it is irresponsible for Grace to suggest loudly and repeatedly that this was a client-attorney related crime, or one where the two had some type of connection. Grace also made unfair and snide comments about family law in general (and I don't practice in that area). When it was mentioned that the attorney had been planning to attend a family law seminar titled "Divorce on the Beach" in Destin, Ms. Grace said with a sneer, "don't even get me started" on that ... .

Let's see what develops in a story where not even the name of the suspect is public at this time. Will it simply be a case where the suspect was watching an ATM for an opportunity? Given that there were three stops at ATMs, that the attorney's SUV was left abandoned in a housing project in that city, and that the attorney was held in a local Birmingham-area hotel, my early guess is that there may not be a link.

To discount all possiblities surrounding the kidnapping during a one hour national program is irresponsible, in my opinion. Unfortunately, this is the price being paid now in the always on era. She's wrong, and the facts will show it.