Tuesday, January 10, 2006

ADHD Drugs: Storm brewing? FDA involvement?

There have been reports of deaths, strokes, heart attacks and hypertension in children and adults who take drugs to treat ADHD disorders, and this has led to our trusted government's desire to dig deeper.

The FDA's reps have said it had received reports of "adverse events" -- including deaths -- when the drugs are used.

Health Canada pulled Adderall XR for six months in 2005 after they received reports of 20 sudden deaths and 12 strokes in adults and children using the drug. A number of the cases involved children with structural heart defects. (Health Canada site, here)

Now the FDA wants its Drug Safety and Risk Management advisory committee to look at how it may study cardiovascular risks of the drugs. Longer-term use of ADHD drugs provide little information on those risks that may exist.

Dr. Peter Gross is a committee chairman who has been quoted as comparing this potential problem to the issues revolving around Cox-2 painkillers like Vioxx and Bextra pulled from the market because of evidence they can raise the risk of a heart attack or stroke. The committee is to meet Feb. 9 and 10 in Gaithersburg, Md. (See various reports, including Yahoo reports and Reuters).


The FDA web site doesn't list the drugs by name. Popular ADHD drugs include Adderall XR and Ritalin.

My comment: I found this on the Reuters site to counter the concerns:

Drugs to treat attention deficit hyperactivity disorder (ADHD) are generally safe, some doctors said on Thursday after U.S. health officials announced a meeting to discuss possible heart risks.

"It's not a big deal for patients without a cardiac history," Dr. Adelaide Robb, a psychiatrist at Children's National Medical Center in Washington, told Reuters.


Stay tuned.

Avandia (diabetes drug) Warning Regarding Eye Swelling

There has been a warning from U.S. regulators diabetes drug Avandia to a few instance of swelling in the back of the eye as of last week.

The FDA issued a notice last week after GSK said it had received "very rare" reports of the swelling (macular oedema).

The warning also applies to Avandamet, a combination product (with the same active ingredient).

- From the FDA web site.

Monday, January 09, 2006

Disclaimer

1. Disclaimer

The hiring of a lawyer is an important decision that should not be based solely upon advertisements. This blog site is not intended to be an advertisement or solicitation. Material contained is for general information only and does not constitute legal advice or solicitation of legal services. Transmission of information from this site is not intended to create, and its receipt does not constitute, an attorney-client relationship between me and the reader. In the event that any information on this Web site does not conform fully with regulations in any jurisdiction, this law firm will not accept representation based on that information.

Friday, January 06, 2006

Vioxx: MDL Judge Fallon Frustrated

This week Judge Fallon has commented that he may stop (before he has even begun in earnest) trying any cases in New Orleans. During this week's monthly hearing Fallon
said he may ``shut down'' the consolidation if all the cases are being tried in state court before we get one tried in federal court.'

Fallon had said before Katrina struck that he wanted to try some Vioxx claims before starting settlement talks. By my count, at least six Vioxx suits are set for trial in state courts in New Jersey, Texas, Florida and California.

How to try them? The Judge commented from the bench that witnesses could not be located, lawyers were not available, and records and doctors could not be located. That is to say nothing of seating a jury in NOLA.

What will happen? IMHO they either get sent back to the state where the suit was filed (and tried in USDCT there), the MDL is moved permanently elsewhere, it is kept there but Judge Fallon sits by designation in other states (not likely), or the MDL is dismantled (not likely). Would the PSC and Merck Counsel agree to some sort of abeyance? With the two (2) year anniversary of the market withdrawal coming up, the closer that date is, the better idea Merck will have (in 2 year SOL states) how many claims are out there. My best guess is that the another trial will be held in NOLA but it may have to be set closer to late summer.

Merck should want them in one place, but given the strategy so far, the company may wish to have them splintered off, and it will result the death of the company by a thousand cuts.

Resolutions Part II: It's BLOG not BLAWG (a jargon rant)

I have firmly resolved from the top down in my office to rid it of jargon.

First to go: Blawg. No more emails or comments with it spelled that way. There are enough problems explanining what a web log is to someone over 40 as it is. No need to make it worse. It goes in the bin along with "scaleability" and other tech jarson insider foolishness. Speak english to me.

Second to go: Use of throw away words in pleadings. In Georgia it is common to begin a Complaint this way: "COMES NOW the Plaintiff and for his Complaint prays as follows against the stated Defendant" ... We use "Plaintiff sues Defendant and alleges ... ."

Third to go: "Please do not hesitate to contact the undersigned at your earliest convenience." I have never used it, but team members here let it creep in to form letters they write. We're not paid by the word, and last I checked plain ol' English works just fine - "Call me if you have any questions."

Fourth to go: No more mini Miranda warnings at the bottom of all of emails. You know, the one that mentions that the email is confidential and that you are to destroy it, or send it back, or print it and mail it back at my expense, or print it and make a paper airplane out of it. There's a toggle bar on the email, use it! I asked a friend if he was going to dinner, and in the midst of 1 and 2 word emails, there was the confidential language.

Thursday, January 05, 2006

2006 Resolutions?

I always make them both as to personal and as to business. Here is my business list, are any of these yours?

1. Revisit office form letters: Our office handles a number of cases where certain letters are simply not redone each case. It's worth it to review the key ones although I have undertaken reviewing nearly all of them. In particular, my letter of representation (LOR) is worth a second look, and I have had to unfortunately make one change - I have added a line that states "Unless or until you have received from this office a written notice that the Firm is no longer working for [client name], do not contact [client name] under any circumstances. Also, our letter to a health insurance company regarding any claim of reimbursement can evolve considering the litigation surrounding this issue.


2.Analyze your tech needs and wants: After more years than I care to admit, I finally was able to decide on a flat screen monitor. I added another product to carry (Sidekick II). We are considering scanning all documents and attaching them to the current database and moving quickly to paperless.

With technology changing, it simply does not make sense to sit back and not analyze. Another attorney, a sole practitioner in his 50's who is on the same floor as our offices visited me yesterday and asked me to convert a Word document to Wordperfect 4.0. Now realize that the product in use by attorneys is WP 12, and that it likely means his software if probably ten or more years old ... . Why not upgrade?

3.Web presence: I recently visited a website of a firm that had a photo and bio of an attorney that had left the firm more than a year ago. I went to our site and found deficiencies. It's addressed and is also being tweaked. It's the little things that matter - having your Firm name, address, contact email and telephone number on each page; having a decent form to fill out with as few required fields as possible (we deleted the "retype your email" line).

4.Staff issues: Mike Papantonio's well written book, In Search of Atticus Finch (you can buy it here)
mentioned a decent problem solving requirement that we implemented now system wide: If there is an issue or problem facing an office team member, it is required that the team member: 1)reduce the problem to a one sentence issue and 2)not come into my office or another employee's office unless that team member has one suggested solution. It works wonders. It ends the practice of an employee walking in and simply handing off a problem.

That's part of my list - what are you resolving to do?

Tuesday, January 03, 2006

Georgia has a new Pro Hac Admission Process: $200 per case

Georgia has a new Uniform Rule of Superior Court, Rule 4.4 which has been revised and is now effective.

The rule sets forth a detailed process for applying for and obtaining pro hac vice admission in the State Courts of Georgia. A fee of $200 for each application must be paid to the State Bar of Georgia and the State Bar General Counsel's Office has the authority to object to a lawyer's proposed pro hac vice admission.

Go here for the text of the Rule.

My comment: Looks like the State Bar is trying to centralize and watch out of state lawyers who should likely be licensed here. Florida has been battling this demon as well.

Accutane Registry Established

From various sites including the FDA's own:

A national registry began accepting names of Americans who take the anti-acne drug Accutane. This is done as part of a federal effort to limit use of the birth-defect-causing drug by pregnant women.

The Food and Drug Administration has tried to limit the exposure of fetuses to the drug, prescribed to about 100,000 people each month. If a woman uses Accutane during pregnancy or becomes pregnant shortly after taking the drug the baby runs a risk of brain and heart defects or mental defects.

The registry is known as iPledge and can be found at https://www.ipledgeprogram.com/

A Maritime Blog - Worth a Look

Dwayne Clark in Jacksonville, Florida has an interesting blog which can be found here.

It's called Lawboat. It has a good set of links to Maritime subjects including the Coast Guard safety site. Worth a read and it's a good addition to your RSS reader.

Thanks Dwayne!

Monday, December 19, 2005

Canada Bans Bextra

From various sources, including Reuters and Canada sites:

Canada banned Pfizer Inc.'s arthritis drug Bextra this December of 2005 because of risks of heart attacks and strokes. Bextra sales in Canada had been suspended by Pfizer in April at the government's request.

"Following a review of safety information, Health Canada is informing the public that Bextra, an anti-inflammatory drug used to treat arthritis and pain, will not return to the market," the government said in a statement.

Friday, December 16, 2005

Verdict: Vioxx Merck Mistrial was a business "L"

Is the mistrial in the last Vioxx trial bad news for Merck? Some said no, at least initially. Now though, it looks like from the business side, it's a yes to me.

The mistrial leaves Merck's record at 1-1 in state courts and unresolved in federal court. Merck's own lawyers had described the case as a sure win for Merck because of the short-term use. Of course that did not happen.

Merck IMHO needed another victory to start to put the squeeze on claims numbering at least 6,400. While some have said that said a mistrial was better than an outright defeat, Wall Street has hit Merck.

Merck's stock closed down 72 cents, or about 2.5 percent, to $28.41. That price is more than 36 percent below Merck's pre-recall level Sept. 30, 2004.

What is next? A New Jersey State Court case with a person who took the drug for at least eighteen months - which is the time frame minimum that Merck admits may lead to an increase in an adverse event. The lawyer for the Plaintiff? The team will include Mark Lanier who has recorded the first Vioxx verdict.

Wednesday, December 14, 2005

December Tech: I like it

This from the BBC.com site: SMS text messages that 'self destruct' about a minute after they are received/read:

Londoners have subscribed to a self-destruct text message service which started on Sunday in the UK. The commercial service allows sensitive messages to be destroyed 40 seconds after being read. It's called StealthText.

"The technology behind StealthText is derived from military technology, so the comparisons with Mission Impossible are justified," said Carole Barnum, chief executive of Staellium UK.

"The ability to send a self-destruct message has massive benefits for people from all walks of life, from everyday mobile users through to celebrities and business people," she said.

People interested in using the service to send messages have to register and download a small program onto their mobile phone.

Once a message has been sent, the recipient receives a text notification showing the sender's name and a link to the message.

After they have opened it, the message disappears after 40 seconds.

Despite the fact the message will be removed from phones, users cannot entirely avoid a data trail. For legal reasons, a log of the message will remain on a secure server to which they have no access.

Aha. So it's not really gone. But, thanks for letting a guy like me know what to ask for in discovery now.

My E.R.I.S.A. Letter of Rep.

In my office we receive on personal injury cases a typical "Notice" letter from either a health insurer of its collections agency. Unfortunately it is typically the collection agent (such as Rawlings, HRI, etc.) that sends computer generated letters each month.

As such, we send out this letter - if you can use it go ahead!


[SALUTATION]

This acknowledges receipt of your letter informing of a potential subrogation claim or right of reimbursement regarding the contract of health insurance between our client and yours. I request that you provide us with a copy of the plan summary as well as the 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. I must have compliance with this request within thirty days of the date of this letter.

At this time, I acknowledge your correspondence and the potential claim asserted. 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.

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 are making a request/demand for information and reimbursement and I am asking for documentation to support such a claim as it relates to the contract for health benefits.

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

My obligation 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 potential for 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.

I may assert the common fund doctrine at some point. 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 and quote all relevant state or decisional law that applies. 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.

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.

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.

Monday, December 12, 2005

Vioxx Trial #3: Mistrial 12/12/05

This will be reported shortly - Judge Fallon declared a mistrial in the pending case. Public comments earlier this morning by the Court were in substance that the jury was to have a sufficient amount of time to decide, and that time had run. From the information I have, it was less than three full days of deliberations.



Why the mistrial? Could it be that the newly discovered allegations of wrongdoing, as editorialized in the New England Journal of Medicine, may have weighed on the Court's mind? More later.

For Attorneys who advertise: Record your spots

Our office advertises and finds that pre-recorded fifteen second spots on radio, either before or after traffic updates, work well. Be careful, however, when a station or ad buyer tries to sell you "live" lead ins. Always insist on recorded. Why?

Today on the way in to work, I heard a live spot for an injury attorney on the sports station. The sports jocks were laughing it up for the segment prior, and as they went to the attorney, this is what I & thousands of others heard: "It's the holidays, and attorney {XXX XXX} wants you to watch out for the meatheads out on the road this season... ." The radio personality then gave the number, amongst background laughter.

Yes, "meatheads." I am pretty certain that this attorney (who I know) strives to be taken seriously and works very hard on his image. The traffic spot I heard was a waste of money, and more importantly showed to me that this advertiser was not being taking seriously by the station.

Take the time to record your spot, or you may suffer the same fate. It's hard enough to convey a dignified image, it's worse when someone is yukking it up.

Friday, December 09, 2005

Merck hid data in Vioxx study! Wow what a surprise

Please excuse my lack of surprise over the news/bombshell late in the day:


Merck withheld information about heart problems suffered by patients taking the company's painkiller Vioxx from the manuscript of a journal article published in 2000, the New England Journal of Medicine just reported.

The journal said relevant and dare I say important information about the problems had been deleted from the manuscript, and the article's authors -- two Merck employees among them -- did not reveal information about three heart attacks, though they knew about the incidents at least four months before publication.

This from USA Today:

"Pharmaceutical giant Merck was accused ... of knowingly withholding data on three heart attacks related to its controversial painkiller Vioxx in an influential medical study in 2000.

Shameful? Of course. Despicable? Probably. Surprising? Not in the least.

Wednesday, December 07, 2005

Merck: Vioxx trouble brewing in China

Crom cri.com.

Merck has a worldwide problem on its hands, if they didn't know that already:

A Beijing-based law firm will file a collective lawsuit against US pharmaceutical company Merck & Co Inc next year, and is looking for Chinese users of the pain relief drug Vioxx who have suffered from side effects.



Attorney Hao Junbo from Beijing Limin Lawyer's Office said he thought China has a large number of Vioxx users, Beijing Youth Daily reported yesterday.

Hao said his firm is seeking Chinese patients to show their prescription and medical records when using Vioxx, in a bid to prepare for compensation claims in the United States.


Beijing Youth Daily quoted Hao as saying that there are more than 4,200 civil cases in the US filed against the New Jersey-based company, and an American lawyer helped a Texas widow win a US$253 million verdict in the first Vioxx trial, held on August 19 this year.

"The winning is quite conducive to future court rulings," he said, adding that his firm would be acting on a no-win no-fee basis.

Tuesday, December 06, 2005

COX 2 inhibitors may not be safer for the stomach

British scientists last week they had found no evidence that prescription painkillers such as Celebrex, Vioxx and Bextra protected against stomach bleeding any better than older drugs.

Julia Hippisley-Cox had found no proof that these painkillers, known as COX-2 inhibitors, were less likely to cause gastrointestinal bleeding than aspirin or other treatments called non-steroidal anti-inflammatory drugs (NSAIDS).

In the four-year observational study, Hippisley-Cox and her team studied more than 9,000 patients in Britain who had been diagnosed with a stomach ulcer or bleeding and compared each case with up to 10 control patients.

Forty-five percent of the patients with a stomach ailment had been prescribed an NSAIDS in the previous three years and 10 percent had taken a COX-2 inhibitor. This compared with 33 percent and 6 percent in the control group.

The researchers said the risk of a stomach problem associated with using NSAIDS was lower in patients who were also taking drugs to heal ulcers.


You can find the article here.

(from varioud sources including yahoo, brit pages).

BCBS Opens a Bank

From various sources, including yahoo:

BCBS said this week that its board of directors approved the development of Blue Healthcare Bank. The aim is to simplify the administration of health savings accounts and other similar plans offered by Blue Cross insurers throughout the U.S.

Health Savings Accounts (HSAs) would be able to be established by those with HI plans that have a significant deductible. Employers and employees would be able to deposit money into the accounts. The accounts would grow tax-free.

According to the reports:

"The move into the financial services arena could prove to be a lucrative one for Blue Cross. By 2010, HSA accounts could be holding as much as $75 billion in assets, according to a report by DiamondCluster International Inc., a management consulting firm. As a result, financial institutions could stand to collect up to $3.5 billion from asset management and account fees, according to the report." (See the yahoo article).

Thursday, December 01, 2005

Trial Attorneys: Doing business with advertising attorneys

My office is one of those that advertises. We advertise in every medium you can think of: the Web, phone books, radio, TV (including local, state, regional and national), and once in a blue moon newspapers.

With a vast caseload we cannot litigate each case in house so I have spent a great deal of time cultivating capable counsel to help us try cases.

My question to trial attorneys: When is the last time you either wrote, emailed or even cold called an advertising attorney in your state? I am not asking you to think city only. Think the statewide advertisers.

If you have not considered this, the time to do so is now.

Who calls me? I have been impressed with trial attorneys in their thirties and forties who call me quite literally out of the blue. We talk about cases, what they work on, and results. I have not seen any more senior attorneys reach out, however.

Some tips for those who would or should consider going this route to obtain more business:

Due Diligence. Get a read on the type of office that he or she may have. Number of offices, types of attorneys, etc.


Have a plan.
We generate cases from the tip of Florida, to the edges of Eastern Alabama, all of Georgia, South Carolina, Tennessee, and North Carolina - the border states. That's a lot of territory.

If you seek to assist on cases, be specific as to geography. I had a discussion with a small office who said they would "go anywhere." Help stand out and choose certain areas. If you have a specific metro area, inform.

Tell us about the tougher cases you may want to bring to trial. Mark Link from the firm of Hertz, Link and Smith has created a niche handling civil DUI cases all over Georgia. He also seeks out cases with a severe injury but liability issues. They have superb results.

Another attorney has somewhat boldly says he will only want to talk to me about slip and falls with fractures of the leg or lower body.

Another pushes very hard to be allowed to review one car wrecks involving death or serious injury.

What not to do: I have plenty of people in my office who are happy to litigate catastrophic cases with million dollar limits. Some will call and say they only want to look at serious injury cases with clear liability and high insurance limits. Riiight.

Talk about fees early on. My office actually uses a sliding scale (higher if settled early in litigation, downward when certain milestones are reached).


Most trial attorneys who talk with me are surprised by what I ask for in return: If they have cases they believe are "too small" for their offices, send those to me. One attorney from another state looks at cases with values in excess of $100,000 only. I have been able to assist on more than a dozen cases in the range lower than that. I won't expect to get cases back, but I do ask.

Well? Are you willing to make that first contact? That first call? You will never know until you ask.