Vioxx Trial #3 Underway (Irvin)

The first trial before Judge Fallon in the MDL (in Houston, TX) involving Vioxx has begun. Jury selection has been completed, with the jury including two teachers (1 who teaches Algebra, 1 who teaches Science) and one engineer.

The Court expects the trial to be wrapped up in three short weeks.

Andy Birchfield handled the opening statements in the case for the Plaintiff.

Merck's lawyers blame Irvin's death on his age, weight, clogged arteries and family history, and they will argue that company researchers found a link between Vioxx and heart problems only among people who used it for 18 months or more.

Irvin's ``obesity and sedentary lifestyle caused his death -- much like they do each year for tens of thousands of American men in their 50s who have never taken Vioxx,'' Merck's attorneys said in court filings.

The usage by the deceased in the case was for less than ninety days.

Femara - Fertility Drug - increase in birth defects?

A drug used to increase a woman's chances of becoming pregnant may cause birth defects and miscarriages, according to Canadian health regulators.

Femara is approved to treat breast cancer in women who've undergone menopause. It is frequent prescribed "off-label" to prompt ovulation as part of fertility treatments.

Health Canada and Novartis have sent letters to Canadian doctors warning them about the off-label use of the drug.

Novartis will send a similar letter to U.S. fertility specialists to remind them that Femara is approved only as a breast cancer treatment.

Sources: Reuters, AP, Knight Ridder

Ortho Evra news

A number of doctors are no longer writing prescriptions for Johnson & Johnson's Ortho Evra contraceptive patch after FDA issued a warning earlier this month regarding possible health risks for women using the patch, according to multiple sources such as the WSJ, Yahoo, and Reuters.

The FDA issued a warning earlier this November that women who use the patch have a higher risk of experiencing blood clots and other side effects than previously stated because the patch exposes users to about 60% more estrogen than standard birth control pills.

For more news, go to FDA.org.

November this and that: On the road without a laptop

I took a trip during the holidays without a laptop. These are the items I brought, and you may want to add to your briefcase.

1.Sidekick II: It's bigger than a blackberry; the typing pad is easier to use IMO than a blackberry; you get both email and pretty decent web browsing with the SII; the cost for both totals $20 a month. It has a decent camera, no video.

2.Cellphone (Audiovox 9900):Small, fits in your pocket, has photo and video capability. I will never wear a phone on my belt, so this is just right.

3.Efax: I signed up for one. Easy to use, good viewer. Free, but for an area code specific number it's $12.95 a month.

4.Evoice: Similar to eFax. It's a web based phone number that is free (for now).

I am a big fan of the Sidekick II. It's $20 a month for unlimited email, the keyboard is bigger and easier to use than the blackberry device, the web browser is full color and runs graphics. Not too fond of the phone feature, and it does not have bluetooth capability.

Thankful

What are you thankful for? I'll be giving thanks this holiday weekend for many things. In my business I am thankful for:

Blogger.com: So that I can blod with little or no charge, as opposed to paying someone an ungodly sum of money to do the very same thing.

Bloggers: The up and coming new and/or first source for information - anything from where to find free, legally downloadable music, to case information, to recipes. I can only hope this remains as free form and independent as it can be.

I'm thankful for a court system that - despite billion dollar big business interests trying to make it hard to walk in the courthoue door- has rebuffed many conditions precedent to getting justice. The attack is on, however.

I'm thankful for people in my profession who are so willing to share documents, strategies, experts, and exhibits at no charge in the interests of justice.

I'm thankful for many other non law related things, and will think about them on my long drive this weekend.

Mass Torts, Round 2 notes

In addition to internet vendors I had the chance to learn a bit about specific types of drugs that may (or may not) be responsible for causing harm to consumers.

We discussed Serevent and how it worsens asthma attacks for those that take it for asthman related conditions. (See my blog, below).

I learned that the Plaintiff's attorney in the 2nd Vioxx case left a prosecutor on the jury. I also learned that he had three preemptory strikes remaining when the jury was seated. Why didn't he use them? I was taught- rightly or wrongly - to never leave any preemptories unused.

The Locks Firm has filed papers that address Merck's Motion to Dismiss non USA Plaintiffs, and that Motion is pending before Judge Higbee in NJ State Court.

Other seminar items included: Embracing your competition (which we already do here in Atlanta), handling Viagra blindness claims (our office is not investigating those), building your Firm's reputation through trials, and of course the internet and how it helps your practice.

More later.

Pic update from NOLA

The band Nine Inch Nails (NIN) was in NOLA to hold a concert for the workers there, and their web site has unbelievable pics of that city that are recent. On the site, you can see a pic of the barge that compromised a levee causing flooding in the 9th Ward by going here. The other pics are posted here.

Notes from the Mass Torts Conference

I just returned. Here are a few thoughts on what I learned/saw:

Lawyers on the Net: I think for most attorneys their eyes glaze over when they hear about SEO, sponsored links, etc. I did agree with one speaker/vendor's statement that if you judged lawyer presence (advertising) on the web, it's a 5 on a scale of 1 to 100 - that is, it is in its infancy.

I was impressed in particular with Landon Harland from ejustice. While most vendors to lawyers simply say, "here is what we can do for you", and most lawyers say "how much and where do I send the check" Landon spent time talking what might be heresy to other net vendors. Among his suggestions/comments:

*Hire your own content person/administrator. This person in the long run will be much much cheaper than paying a vendor's writer. Also, you will get quicker response from an employee. To me, it's a no brainer suggestion.

*Sponsored links versus organic links. It was suggested that 80% of the people who see a blue top of the page sponsored link on Google (the blue link at the top of the page) will never click through. The other 20% makes it worthwhile. The sponsored links work much better than the sponsored links to the right of the google results page.

Landon also told me/us about Eyetools - Eyetools’ Greg Edwards has published a “heat map” of people’s eye movements on the typical Google results page, determining both organic results rank and paid placement rank are of paramount importance. Most site viewers’ eyeballs didn’t even pass over fourth or fifth items in the lists. Go here to see the results, or to Greg Edwards' blog here.

To me, this is critical stuff. There is even a study (for sale of course) that addresses this subject. According to a snippet online:

The study found that most viewers looked at results in an "F" shaped scan pattern, with the eye traveling vertically along the far left side of the results looking for visual cues (relevant words, brands, etc.) and then scanning to the right, as if something caught the participant's attention.

"The study showed that searchers react to organic results differently than they react to sponsored listings."

You can buy the eye tracking study here.

Blogs They actually talked about them. Not for long, but they did discuss them. I think the sum total of bloggers at this conference was 10 (of about 300) based on an informal poll.

Legal Broadcast Network: My friend Jan Schlictmann was there, interviewing the muckety mucks for his show. You can find his network here.

On the non lawyering front, I was able to see upclose and personal the Rolling Stones show on Friday night. Superb. The Wynn is as advertised.

More later.

Serevent and Asthma Warnings

This is from coreynahman.com


GSK: Lowering Advair/Serevent Sales, But Impact To EPS In '06/'07 Negligible:

On GlaxoSmithKline (GSK:$49.92; Underweight rated), just how the newly
announced potential Advair/Serevent labeling (recommending a change to second
line usage, from first line) will impact sales is difficult to forecast - any sales
decay will likely be gradual.

We are lowering our revenue forecasts modestly, but the impact to EPS in '06/'07
may be negligible given GSK's large revenue base. Following GSK's recent run-up
in share price, a pull-back may be warranted given these new concerns.

**Serevent (a long acting beta agonist, or LABA) is the product more clearly
"at risk" ... . Advair (combination of inhaled steroid and Serevent) should remain more resilient.


**SMART trial results first flagged potential safety issues in 2003 - why FDA
has just now requested a label change like this is unclear.

Attending the Mass Torts Conference in Vegas

I am off to the Mass Torts Conference in Las Vegas. At the conference we will hear about the 2nd Vioxx Trial in New Jersey (Humeston). Sort of an autopsy of the case. Also on tap are presentations by Geoffrey Feiger, Al Sharpton, Bob Woodward and others.


What do Shaprton and Woodward have to do with Mass Torts? I asked that same question. They are the luncheon speakers, and will probably at the very least be entertaining.

The competition:

One topic is "Welcome your competition by joining forces with them." It will be presented by my friend and fellow Atlanta attorney Andy Childers. My firm and his are considered competitors in the State of Georgia. We have, however, met on a regular basis, refer potential clients to each other (in the event of conflict, case outside our expertise, etc.), and work jointly on cases. Is this new? Not really, as we have been working together for more than four years.

The internet

One segment of the conference addresses the Internet. From the materials, it does not look like blogs will be discussed at all. Shame on the speaker if that is the case. I find much useful information as to unsafe drugs now on blogs, and in fact spend most of my time searching blogs first for cutting edge news. Does a blog result in calls? It has to my office.

I may be a contrarian in that I do not believe that internet advertising (solely or as the bulk of advertising) as to unsafe drugs or medical devices makes financial sense when compared to other media. It works for traditional personal injury practice, however.

I have heard an attorney at a national firm boast of results of an internet campaign as to an unsafe drug. When I asked the ratio of spending to actual calls (then distilled to potential claims), I was astonished at the high cost of the campaign. It was nearly $5000 per potential case. That to me makes zero sense. I did not tell the attorney that, however.

Value

The most significant value to the conference will be the sharing of ideas and strategies. Plaintiffs' attorneys have always teamed up for the better. Mass tort claims are no different.

More later

Bad News for the Ortho Evra Contraceptive Patch?

Ortho-McNeil (a subsidiary of Johnson & Johnson) has finally acknowledged the fact that women who use the Ortho Evra patch are at greater risk of developing blood clots, stroke, and death than woman who use other forms of oral contraceptives.

Women using the patch may receive 60% more estrogen than they would be exposed to if they were taking a birth control pill instead.

CBS News broadcasted a story from Austin, Texas, concerning documents produced in the course of a pending lawsuit involving a young mother who was paralyzed by a stroke only 12 days after she began using the patch.

The report noted that there were 4x as many strokes in women using the patch as in women using an oral contraceptive.

Ortho Evra, like the other hormonal contraceptives, has a black box warning about an increased risk of cardiovascular adverse reactions in older women who smoke. This type of warning is the strongest that the FDA can request.

In a pending case, an internal memo shows that the company in 2003 would not agree to pay for a study that compared its patch to its own Ortho-Cyclen pill because of concerns there was ‘too high a chance that study may not produce a positive result for Evra’ and there was a ‘risk that Ortho Evra may be the same or worse than Ortho-Cyclen.’”


Ortho Evra was approved by the Food and Drug Administration (FDA) in November 2001 and is the first contraceptive product to be approved as a skin patch. In 2004, the drug accounted for more than 9.9 million prescriptions with sales topping $411 million.

The abel warns that Ortho-Evra should not be used by those that have:

* A history of heart attack or stroke
* Blood clots in the legs (thrombophlebitis), lungs (pulmonary embolism), or eyes
* A history of blood clots in the deep veins of your legs
* Chest pain (angina pectoris)
* Known or suspected breast cancer or cancer of the lining of the uterus, cervix or vagina
* Unexplained vaginal bleeding (until your doctor reaches a diagnosis)
* Hepatitis or yellowing of the whites of your eyes or of the skin (jaundice) during pregnancy or during previous use of hormonal contraceptives such as ORTHO EVRA, NORPLANT [levonorgestrel], or the birth control pill
* Liver tumor (benign or cancerous)
* Known or suspected pregnancy
* Severe high blood pressure
* Diabetes with complications of the kidneys, eyes, nerves, or blood vessels
* Headaches with neurological symptoms
* Use of oral contraceptives (birth control pills)
* Disease of heart valves with complications
* Need for a prolonged period of bed rest following major surgery
* An allergic reaction to any of the components of Ortho Evra


More later.

Where have you met a client?

I ask many attorneys that question and expect an answer that will include someplace other than an office or home. I spend my time working for injured people only.

Last evening I met a person who works the night shift in a small guard shack in rural West Georgia. He does not have very dependable wheels and would not drive seventy miles to meet with me. So there I was: Sitting on a milk crate, in a guard shack not quite as large as an outhouse on a windy clear night. After 30 minutes and a few cigarettes being smoked by the other person, I was able to leave knowing we could help him. He kept saying that his coworkers would not believe that an attorney would take to time to sit where we sat. (At 9:00 p.m.)

Other places? I have sat on the hood of a car in a not so great part of town to talk business with a potential client.

I have had more than one cup of coffee at a Waffle House with a potential client.

I've met a potential client at a truck stop, an airport, a gas station, a Steak and Shake. I have been to houses where the people were so poor, the windows were covered with clear plastic, no glass.

Meeting these folks where they live and work hasn't been a problem. In fact, it's been humbling. One meeting involved me coming to a home whereupon more than a dozen neighbors came walking in, sat and listened.

If you haven't had the chance to do so, consider it. It may open your eyes to how folks we work for live.

Random Notes: Vioxx Trial #2

Observers have opined that the counsel for Plaintiff overstepped how Mr. Humeston was portrayed, that is -- having good health and no or very little problems.

According to those who watched the trial, Humeston was teaching whitewater rafting shortly after his heart attack occurred that he claimed that was caused by Vioxx. There was a evidence of a video of Humeston in a rafting class that was taken as part of an unrelated Workers' Compensation file. Also, Mr. Humeston had obtained psychological and medical care because of the troubles he was having at work at the post office.

Vioxx Report: Judge Higbee's Hearing of 11/7

While the news of a Merck verdict reverberated throughout the country, the realities of litigating in front of a State Court Judge in New Jersey moved apace.

Yesterday at a hearing before Judge Higbee, those in attendance learned that of the approximately 2000 cases pending, nearly 60% of them involve an alleged injury together with 18+ months usage of the drug.

The next ten trials will all have a Plaintiff who took Vioxx for at least 18 months.

My comment: After the verdict last week, Merck reps told anyone and everyone that Merck had and has "a good story to tell." We will see, now that the next ten trials in New Jersey will tell the story of a drug pulled from the market after the VIGOR study suggested an increase in the chance of an injury when Vioxx was taken for 18 months or more.

Chris Placitella weighs in on the Vioxx Verdict

From the Placitella Firm:

Although Merck & Co. won a victory in the second VIOXX trial today, in New Jersey, the decision does not have anynegative implications for other plaintiffs. According to Christopher Placitella of Cohen, Placitella & Roth, P.C., one of the attorneys involved in the Texas trial case, where there was a $250 million verdict, the loss is not a setback for the 6,400 other lawsuits that have been filed against Merck."

"Everyone knew from the beginning that this was a difficult medical case
and that Merck would present a vigorous and well orchestrated defense focusing
on the plaintiff," Placitella said following the verdict. "There will be wins
and losses during the course of this litigation for both sides, depending upon
the facts as presented in individual cases."

Citing the early lawsuits for asbestos health issues, Placitella pointed out that first six asbestos cases were lost before the asbestos companies' conduct was fully explained and revealed. "That is not the case here. One jury has already found the drug maker's conduct so reprehensible that they awarded $250 million," he emphasized. "The liability evidence introduced was compelling."

Placitella, who has been conducting national liability discovery against
Merck, which he says has yet to be used in a trial against the drug maker,
stated, "Discovery of new evidence in the VIOXX cases continues and new
evidence will surface in every case we try over the next year."

He added, "Our trial team, which comprises not only the lawyers who won
the case in Texas, but also some of the best law firms in the United States,
looks forward to trying the next case against Merck."

Texas paper's article on Vioxx Trial #2

From the Houston Chronicle.com:

Among other things, the article notes:

This lawyer didn't make marketing and Merck's deceptions on science the center of the case," said Lanier, whose client in August won the $253 million wrongful death suit against Merck after a jury blamed Vioxx for the death of her husband. "And that was a mistake because that's the most compelling part."

Lanier said the lawyer instead chose to focus too much on medical problems experienced by the plaintiff.

"I think first you have to educate the jury about the drug, what Merck knew, when Merck knew it, what Merck did with its knowledge," Lanier said.

A majority of the jurors in the Angleton trial said Merck's aggressive marketing of Vioxx led to their decision to award Lanier's client, Carol Ernst.

Lanier is scheduled in January to begin yet another Vioxx trial, this time in New Jersey, where he will employ that strategy. He said Thursday's decision won't help Merck in appealing the Ernst case.

"Texans are fiercely independent," he said. "We don't have appellate judges that are going to change their minds because of what some unknown jurors did in Atlantic City, N.J."

One thing most legal experts agree on is that Merck's victory Thursday staves off the flood of new Vioxx filings that would have followed a finding against the drugmaker. Personal-injury cases against large corporations are usually done on a contingency-fee basis, in which a lawyer collects a percentage of any award. If the case is lost, the attorney doesn't get paid and has to eat any upfront costs, such as fees for court filings, expert witnesses and hotels.

A veteran New Jersey personal-injury lawyer who was close to the Humeston case estimated Seeger's firm spent $4 million to $5 million to prepare for and conduct the seven-week trial.

Chronicle reporter John C. Roper and the Associated Press contributed to this story.
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Vioxx Trial #2 Verdict

If you had to do a quick analysis of the result:

The ten lawyer supergroup who are going off on their own - nothing changes.

The next trial is late November in Houston.

10:45 A.M. Merck: Defense Verdict in Humeston Trial

More later in the day.

Drug Company suggests that FDA Pre-approve all drug ads

From multiple sources, including Yahoo, Reuters, and the drug company's info sites:

AstraZeneca has suggested a mandatory requirement for pharmaceutical companies to submit all direct-to-consumer advertising to the U.S. Food and Drug Administration for review prior to its use.

AstraZeneca - maker of Crestor - will accept guidelines on direct-to-consumer advertisements, and the principles are reflected in its new ads, including those for Nexium.

My comment: Smart. Very smart. I don't think other drug companies will agree with this approach, however.

FDA's new online "PDR-ish" database

You can find it by going to the link below. What is a nifty feature - if it works - is that label changes will be added to this site within 24 hours of changes being made.

Go here for more information.

According to the FDA announcement:

"These new electronic product labels will be the key element and primary source of medication information for "DailyMed" -- a new interagency online health information clearinghouse that will provide the most up-to-date medication information free to consumers, healthcare providers and healthcare information providers. This information can be accessed through the National Library of Medicine at http://dailymed.nlm.nih.gov.

In the future, this new product information will also be provided through facts@fda.gov, a comprehensive internet resource designed to give one-stop access for information about all FDA-regulated products."

Vioxx Plaintiff's Closing: Is this too trite?

The attorney for Humeston has said in his closing that Merck is wrong for implying in their closing argument Mr. Humeston -- was lying.

"I believe in him. I believe in his wife. I believe in this cause," Seeger said.

I may be too harsh, but that sure sounds hokey.

Vioxx Trial Closing Argument: Merck Atty in trouble again

Judge Higbee scolded Merck lawyer Diane Sullivan for breaking an agreement on what can be said in the courtroom. Higbee told Sullivan that Sullivan's objection to a reference made by plaintiff's attorney Christopher Seeger during his closing statement was improper.

The issue related to the lack of witness testimony from FDA personnel.

My comment: If counsel ever gets to finish, the jury verdict could be in by Thursday morning.

Salmeterol/Serevent - information burying?

Does salmeterol (Serevent) (known as Advair when combined with the steroid fluticasone) cause paradoxical bronchoconstriction? A trial conducted three years ago suggested it did, but has yet to see the light of day. Why is that?
Salmetrol is compared to Serevent and Advair. Paradoxical bronchoconstriction is a rare complication of bronchodilator therapy. Although theories have been proposed about components of albuterol solutions and preservatives as causative agents, the true mechanism of the phenomenon remains unknown. See here.

Glaxo Smith Kline tried to bury the findings. Did it also deceive the FDA by muddling up the figures from the trial, omitting the more damning data?.

Incredibly an article/editorial in the Lancet says that there is no pressure from the FDA.

In 1996 the company conducted a trial comparing salmeterol to a placebo. The results have never been published.


The Salmeterol Multicenter Asthma Research Trial (SMART) was designed to study 60 000 asthma patients to either salmeterol or a placebo. The study duration was 28 weeks, with patients examined about every 4 weeks. Investigators were also asked to report (but not actively seek out) any serious adverse event that occurred within 6 months after the patient completed the trial.

The primary outcome was combined respiratory-related deaths and life-threatening experiences; secondary outcomes included asthma-related deaths, asthma-related deaths or life-threatening experiences, and all-cause deaths.


GSK submitted its SMART data at a 2003 meeting of the American College of Chest Physicians. Based on the interim data, on Aug 11, 2003, the FDA modified the labelling for both Serevent and Advair to include a black box warning of a “small but significant increase in asthma-related deaths”.

In July of 2005 the Advisory Committee meeting asked that the company add to its label for both Serevent and Advair that those who used either would be encouraged to also use an inhaled corticosteroid use.

The SMART study was terminated nearly three years ago. Why the delay in publication?

Zevalin: Severe Skin Reactions w/ usage

Severe and sometimes fatal skin reactions have been reported in patients treated with Biogen lymphoma drug Zevalin, the U.S. Food and Drug Administration reported.

The reactions were reported in patients treated with the approved Zevalin regimen, which includes Rituxan.

From various sources, including Biogen's site.