Friday, September 30, 2005
As defense counsel kept pressing, Humeston responded to a question with words to the effect that how could he (Plaintiff) be expected to remember vague facts as to a test more than twenty years ago, yet Merck's former research head (Ed Scolnick) could explain away forgetting the contents of a three year old email as to Vioxx causing deaths to patients in a clinical trial?
Those are the types of moments I live for in Court.
Thursday, September 29, 2005
Humeston testified how he went from feeling "bulletproof" to "unmanly" after he was stricken. He's working thru the testimony and points, and the jury appears interested.
Tuesday, September 27, 2005
Scolnick testified about two studies where Alzheimers-diagnosed patients ingested various dosages of Vioxx. In both studies, the clinical trial patients evidenced higher death rates than those in the control group who ingested only a placebo. The two studies were commenced to find if Vioxx would serve to delay the onset or worsening of the devastating effects of Alzheimer's.
Merck & Co. never notified physicians or its sales representatives of this result. He also admitted that the information regarding deaths among Alzheimer's patients was never mentioned or included in info cards that Merck sales reps used to answer potential queries by doctors.
Scolnick was asked to admit that the death data was important to doctors, and he said
"It's data the physician should know."
To access FDA information, go here. From that site:
In April 2002, FDA approved extensive labeling changes to reflect the findings from the VIGOR study. FDA also approved a rheumatoid arthritis indication at the 25 mg dose based on separate efficacy trials. The new label provided additional information to the Clinical Studies, Precautions, Drug Interactions and Dosage and Administration sections to reflect all that was known at the time about the potential risk of cardiovascular effects with Vioxx. These labeling changes included detailed information about the increase in risk of cardiovascular events relative to naproxen, including heart attack. It also included data from the ongoing placebo controlled Alzheimer's study at the 14 month time point which did not show an increase in CV risk. The new labeling change also noted that Vioxx 50 mg was not recommended for chronic use.
Monday, September 26, 2005
On the stand all morning (day 3 of his testimony) is David Anstice. He is the head of human health division. Anstice said that Merck was worried about the impact on Vioxx's sales if the cardiovascular data was included in the "Warning" section of its label.
Humeston's attorney showed him a document that addressed the CVE mention in the "Warnings" section could have cut Vioxx's sales by up to 50% per year.
Counsel also showed the jury several documents that showed that several members of an "independent panel" advising Merck on Vioxx's label had previously received been paid by Merck for work.
Week three continues.
"Merck's scientists believed in the safety and efficacy of Vioxx. Many, including the president of Merck's research labs, took Vioxx themselves. When Merck learned in the fall of 2004 of a small increased cardiovascular risk of Vioxx against placebo, seen only after long-term, continuous use in a trial, it promptly acted to remove the drug from the market.
These are not the actions of a company with something to hide."
My comment: For my comment, see the notes on my blog.
Thursday, September 22, 2005
Videotape testimony played: This week, a former Merck researcher Edward Scolnick, had his testimony played to the jury. He was questioned about emails he wrote raising concerns about the safety of Vioxx. "My worry quotient is high," was written in an April 2000 e-mail. He actually wrote: "I am actually in minor agony."
Scolnick also had concerns about the safety of Vioxx. He admitted that he wanted to work with a larger trial than had previously been done, but later concluded that the drug was safe.
One trial with 8,000 people in it, and whose results were published in March 2003 revealed 20/4,000 patients taking Vioxx suffered MIs, compared with 4 out of 4,000 who were taking naproxen.
Scolnick also admitted he was not happy when the FDA pushed to warn Vioxx users that the drug had a risk of MI's. Scolnick's opinion of FDA personnel wasn't very positive, to say the least. His internal email on FDA employees that evaluated the safety of drugs was the equal to "grade D high school students." (Ouch)
Not surprisingly, he suggested that Merck take an adversarial approach to the FDA.
"I have never seen being nice to the FDA, except on rare occasions, pay off," he wrote in an e-mail.
My comment: I think the term that describes this gentleman may be "bully?" Who coached this guy before his deposition?
It was orginally printed in the Fulton County Daily Report which is published in Atlanta, GA. In emailing back and forth with Mr. Eustis, I asked if there was a specific group or organization to which I may donate, and he suggested among other the Louisiana State Bar. You can find more information and links for the LSB after this essay. It's very moving, and a piece that to me is unforgettable.
BATON ROUGE, La.—Every New Orleanian grows up steeped in water. It saturates the air on the city’s driest days. It laps at the shores of Lake Pontchartrain, where I sailed as a boy with my grandfather, father and uncles. And there is the Mississippi, the reason for the city, repository of American power and myth, carrying enormous freighter ships that pass level with the second story of my parents’ house two blocks away.
Water is our medium, our background music.
It is the backdrop against which most of our significant memories unfold: endless dinners of boiled seafood and Dixie beer at the lakefront, soggy Carnivals, stolen kisses on the levee with the river golden and scarlet in the fall evening, road trips to Pass Christian or Bay St. Louis to bathe in the Gulf and bask in the sun, football games in torrential afternoon thunderstorms. And always—always, always—the threat of The Hurricane. The one that would return our home to the waters. The one we always seemed to dodge.
To borrow a phrase from Norman Maclean’s novel “A River Runs Through It”: those who make their home in New Orleans are “haunted by waters.” The waters always lay in wait to claim their own. We knew it, and we laughed in their face, held parties in the shadow of fragile levees, named drinks after the natural disaster that would sink us one day.
My Last Visit
The last time I visited my home in New Orleans—two weeks ago—I barely spared it a glance. I was in a rush—in transit between a summer spent as a guide in the Wyoming backcountry and a fall semester at LSU that started far too soon. I stopped to spend the night at my parents’ house and eat a long breakfast with plenty of sweet rolls and chicory coffee. Then I raced west and north, cursing the heat and humidity. Why, I asked myself, hadn’t I just stayed in Jackson Hole?
On the Friday before the storm, I bypassed the city altogether as I made my way to east Tennessee to kayak the Ocoee River with friends. I assumed Katrina was another piddling Category 1 storm—the kind that always seems to knock out power in Mobile for six months but just affords my neighbors an opportunity for a hurricane party. After letting our frightened dog in for the night, my dad and brother would pour their usual tumblers of bourbon, light cigars and sit on our porch to watch the storm pass.
Thirty-three years of hurricane threats I had seen. Not one of them had ever landed a real blow. Of course, any riverboat gambler, any French Quarter casino sharpie, anyone who spent any time at the track at the Fairgrounds, could have told us that runs of luck like that don’t last.
When I finally turned on my cell phone late Saturday night, I intended to tell my parents that I would pass through New Orleans for a night on my way back to school in Baton Rouge. Instead I found message after message asking where I was and telling me that the storm looked horrendous.
A Call to Home
I called home immediately. The raucous raft guide party 50 yards away faded to a whisper.
“We’re going to Houston,” my mother said. “Your dad’s boarding up the house right now.”
My grandmother, aunts and uncles were going with them. My sister and her husband were fleeing to Atlanta.
If my father was leaving, this was serious. The Jim Bowie who died in the Alamo would have appreciated my father’s attitude to New Orleans.
Pop doesn’t like to venture farther than our place in Lafourche
Parish—about 80 miles away. He’d rather be home. Countless times my mother, grandmother and sister had fled for drier parts before a storm, while my dad stayed home, cooked a steak, watched a football game, and then cleaned up the yard and went to his law office the next morning.
“Some of us have work to do,” he said. My sister—also a lawyer—has adopted much of his attitude.
But this time he sensed the danger was for real. He and my mother now have an apartment in Houston. He refuses to unpack his suitcase. The Central Business District will have power soon, he reasons, and someone will have to get to work. He also checked out a satellite photo of our house Uptown. The deck is still in one piece, and the roof is still on, so he might as well go back.
He hasn’t yet. He can’t. No utilities yet, and there’s the threat of diseases that haven’t surfaced there since the 19th Century. Not even the courts are open yet—and there’s no telling when they will. The Fifth Circuit federal appeals court may be out of its magnificent New Orleans digs for a long time.
A Changed Baton Rouge
I returned to Baton Rouge on Tuesday, running backroads to escape the Interstates rumored to be impassable. I drove through ditches and over logs to get through. The side of the road was lined with people dragging salvaged belongings, or those who had run out of gas. The radio crackled with spotty AM stations desperately conveying what little information they had to whomever had survived and could listen.
Highway 90 in Mississippi, the conduit to so many spring weekends on the gulf shores: gone. Not just impassable. Not there. As if nature had tired of it and decided to erase it forever. The owners of convenience stores stood in their doorways with shotguns.
Working in a Shelter
The next day I started work as a medic in the evacuee shelter at the River Center in downtown Baton Rouge. My cable was out, so no TV or Internet news prepared me for the crowds: The young, the sick, the hurt, the scared, the old.
My medical training is as a Wilderness First Responder; I can dress wounds, splint breaks, reduce dislocations, wrap the hypothermic and immobilize spinal injuries. But I was dealing with diabetes, with heart conditions, sores and ailments brought on by filthy water, people so sick and scared and traumatized we hardly knew what to do with them. All of them had spiritual hurts I could do nothing about.
One seven-foot giant of a man arrived barely sentient, able to do nothing but cradle his face in his hands and weep. He had been trapped in the Superdome, and could not locate his wife and five children. One woman, once a nurse, had suffered a stroke, and refused to be parted from her husband to receive the care she needed. We had at least a dozen children whose parents were missing.
The first days were terrible—barely organized, supplies short, and hurts deep. Without the few doctors and exhausted nurses who kept the clinic running, the body count already would be much higher than it is.
Since then things have improved. A team of doctors has set up in the clinic, and we have plenty of supplies. My cousin, a displaced Tulane medical student, is coordinating the efforts of medical students nationwide from her new room in my apartment.
The offers of help have been huge—not only in material, but for morale.
We haven’t been forgotten.
Things Have Changed
But a million things have changed—some of which I notice, some of which I have chosen not to think about. There is no part of my life this storm hasn’t touched. In Baton Rouge groceries and gas are in short supply, as is space on the streets and in our homes. There’s no place to park, no point in trying to drive. Starting this weekend, my apartment, luxurious for one, will have five people in it—including my three-month-old niece. We don’t know when they will go home—or where that home will be. Materials I wanted for school are at my parents’ house. These are little things, of course. We’re lucky.
My sister’s firm is looking for office space. It might be in Baton Rouge. Or it might just continue with its Lafayette office. Or maybe Houston. My brother-in-law is looking for a teaching job. They don’t know if there is anything for them to return to in New Orleans—whether their new house of six months survived the storm. My father wants to get back to work—and presumably to his partners.
I am back in class, studying literary theory. I have never been so convinced of the inadequacy of language. As a favor for a professor unable to return to Baton Rouge yet, I have agreed to lead his graduate seminar: “New Orleans and the Arts.” We’re beginning with Walker Percy’s “Lancelot”, a work suffused in tragedy and loss, in which some horrible things happen during a hurricane. I honestly don’t know how to begin.
Next is a book by Percy’s Uncle Will—the classic “Lanterns on the Levee”. Then John Kennedy Toole’s “Confederacy of Dunces”.
I have forsaken television news. I turned on the TV when power returned, only to find people bickering over politics while my neighbors drowned, starved, dehydrated, preyed on each other, rotted in the flooded streets an hour away from me. I nearly vomited.
If they like, I can assign blame for them; it’s the blame that lies at the heart of all such disasters: some combination of man’s breathtaking folly and nature’s rage. Nature, as Edward Abbey said, always bats last.
I hate everything about this disaster. I hate the glimpse of humanity it has given me—how quickly people can become beasts. But as New Orleans Mayor Ray Nagin said a few days ago: there’s a ray of light. The Quarter survived, as it always does, along with parts of Uptown. The rest is draining slowly. There are stories of great bravery, tenderness, selflessness, to counter the nightmarish brutality we’ve witnessed in the storm’s wake. Signs that civilization may hold.
And there are signs that the city’s peculiar magic realist grace will persist. There is the woman we treated, who broke into the boxing gym across from her submerged house and floated to safety with her infant son on a boxing ring. There is the man I saw who swears he was led by a flight of butterflies to the empty skiff that saved his family.
The nation will pay late and large for what it should have paid for early. One day, there will be someplace to live in the crescent of the river south of Lake Pontchartrain. Someplace, we hope, that’s worth salvaging. But I wonder whether the New Orleans flair, its Creole, Mediterranean comfort and glee in the face of death, will ever return.
I loved that city. I wonder if I’ll feel the same about the place that will bear its name.
To donate, go here: The Louisiana State Bar
Tuesday, September 20, 2005
At the Humeston trial, more powerful testimony that can't bode well for Merck: A day's use of the painkiller could be enough to cause a heart attack, Dr. Luchessi testified Monday.
Vioxx breaks takes nearly four days (he said on the stand 85 hours) to leave the blood system, according to Dr. Lucchesi. He also said that based on the information at the time of its release, there was reason to believe that a single dose OR multiple doses , could lead to an adverse event such as an MI or stroke.
The Food and Drug Administration issued a non-approvable letter for parecoxib sodium, an injectable COX-2 inhibitor. Parecoxib sodium is marketed by Pfizer under the brand name Dynastat.
It is to be administered for short periods of time under the supervision of a health-care professional.
Monday, September 19, 2005
The first MDL trial - Irvin - will be held at the United States District Court for the Southern District of Texas, 515 Rusk Street, Houston, Texas 77002, on November 28, 2005.
The September Hearing will also be hel in Houston on September 29, 2005 at 2:30 P.M.
"Besides the large number of rescuers, there was another key reason for the success of rescue efforts. The nature of the flooding differed from the scenarios that would have resulted in 10 to 25 thousand dead. Worst case models projected a storm surge that overtopped the levies by 10 feet, destroying them and creating an instant flood at or near the time a Cat 5 hurricane leveled 80 percent of the structures in the city and environs.
That only happened in parts of the city, eastern New Orleans. It is clear from video footage that even there much of the housing survived, at least insofar as it provided a few days of refuge from flood waters. The flooding elsewhere was extensive, but not always rapid--in many areas the rise was six inches to a foot per hour, easily evaded by a moderately fit adult or child.
Flooding didn't crest until Sept. 2, giving rescuers a five-day window in which to prioritize operations for the most desperate. Even then, few homes were overtopped and submerged."
Thank you Mr. Dolinar.
Judge Higbee does not allow jurors to hearg about an FDA memo issued in 2005 that said cardiovascular risks are associated with Celebrex, Bextra, ibuprofen and naproxen & not just Vioxx.
Higbee rips Merck's lead attorney, Diane Sullivan, for commenting on the Plaintiff's lawyers in her opening statements which violated the Pretrial Order.
2 docs' testimony didn't help. Humeston's doctor (Gregory Lewer) tells jurors Humeston was an active nonsmoker with no history of heart disease who was stricken two months after he started taking the drug to relieve pain from an old war wound.
Dr. Benedict Lucchesi, fights back tears on the stand. He said, "they're putting profits before lives," Lucchesi told the jury.
"Based on my medical knowledge, there is a good probability that Vioxx does pose a risk to patients with underlying disorders," Lucchesi testified on behalf of Humeston. (This quote was obtained from several sources, including Yahoo and AP).
Luchhesi sais that there was a very high chance that Vioxx and other Cox-2 inhibitors, but mostly Vioxx, could lead to the development of thrombo-embolic events.
This from one of Merck's doctors early in the process.
Friday, September 16, 2005
More information can be found here: Link.
Wednesday, September 14, 2005
"Why did we have no hurricane levee failures but five separate places with floodwall failures?" asked Joseph Suhayda, a retired LSU coastal engineer who examined the breaches last week. "That suggests there may be something about floodwalls that makes them more susceptible to failure. Did [the storm] exceed design conditions? What were the conditions? What about the construction?"
So, while the rest of the TV media merely concludes that the "levees failed" there is more to this story.
Plaintiff's counsel likes this jury. Stay tuned.
Tuesday, September 13, 2005
Do you believe punitive damages are a good way of holding companies accountable for their misdeeds? How would you describe your political orientation?
Two of the more than 75 questions the approximately 325 prospective jurors are expected to answer in voir dire.
Monday, September 12, 2005
At least one Plaintiff has named Walgreens in its Complaint. Now the company wants to be dismissed. The alelgations against Walgreens is negligence because it sold a defective product and breach of warranty.
Walgreens asserts that both state and federal courts in Illinois have held pharmacists and pharmacies are not strictly liable under product liability theories of failure to warn or the “unreasonably dangerous” condition of prescription medication if the medicine in question is dispensed as ordered by the prescribing physician.
An Order is expected soon.
My comment: Should the pharmacy be named in the Complaints? Wouldn't the testimony of a pharmacist help in some form?
Friday, September 09, 2005
My comment: Will this case settle? With this development, it to me looks like it may - after jury selection.
From columnist Chris Rose of The Times-Picayune www.nola.com
I suppose we should introduce ourselves: We're South Louisiana.
We have arrived on your doorstep on short notice and we apologize for that, but we never were much for waiting around for invitations. We're not much on formalities like that.
And we might be staying around your town for a while, enrolling in your schools and looking for jobs, so we wanted to tell you a few things about us. We know you didn't ask for this and neither did we, so we're just going to have to make the best of it.
First of all, we thank you. For your money, your water, your food, your prayers, your boats and buses and the men and women of your National Guards, fire departments, hospitals and everyone else who has come to our rescue.
We're a fiercely proud and independent people, and we don't cotton much to outside interference, but we're not ashamed to accept help when we need it. And right now, we need it.
Just don't get carried away. For instance, once we get around to fishing again, don't try to tell us what kind of lures work best in your waters.
We're not going to listen. We're stubborn that way.
You probably already know that we talk funny and listen to strange music and eat things you'd probably hire an exterminator to get out of your yard.
We dance even if there's no radio. We drink at funerals. We talk too much and laugh too loud and live too large and, frankly, we're suspicious of others who don't.
But we'll try not to judge you while we're in your town.
Everybody loves their home, we know that. But we love South Louisiana with a ferocity that borders on the pathological. Sometimes we bury our dead in LSU sweatshirts.
Often we don't make sense. You may wonder why, for instance - if we could only carry one small bag of belongings with us on our journey to your state - why in God's name did we bring a pair of shrimp boots?
We can't really explain that. It is what it is.
You've probably heard that many of us stayed behind. As bad as it is, many of us cannot fathom a life outside of our border, out in that place we call Elsewhere.
The only way you could understand that is if you have been there, and so many of you have. So you realize that when you strip away all the craziness and bars and parades and music and architecture and all that hooey, really, the best thing about where we come from is us.
We are what made this place a national treasure. We're good people. And don't be afraid to ask us how to pronounce our names. It happens all the time.
When you meet us now and you look into our eyes, you will see the saddest story ever told. Our hearts are broken into a thousand pieces.
But don't pity us. We're gonna make it. We're resilient. After all, we've been rooting for the Saints for 35 years. That's got to count for something.
OK, maybe something else you should know is that we make jokes at inappropriate times.
But what the hell.
And one more thing: In our part of the country, we're used to having visitors. It's our way of life.
So when all this is over and we move back home, we will repay to you the hospitality and generosity of spirit you offer to us in this season of our despair.
That is our promise. That is our faith.
Chris Rose can be reached at email@example.com
Judge Breyer has a brother who many know is on a higher court - Justice Breyer.
Hoffman is a philosophy professor who head the Center for Business Ethics at Bentley College in Waltham, Mass. He was expected to testify that Merck did not meet the standards of its own code of ethics when it began receiving data regarding adverse events associated with Vioxx.
Hoffman recently made the news when he began teaching a class titled: "The Organizational Life Cycle: The Boston Beer Company -- Brewer of Sam Adams Boston Lager."
My comment: The testimony would not have been understood by the jury.
Thursday, September 08, 2005
The pharmaceutical company filed its Motion asking Judge Higbee to refuse a request by the Court TV cable network to broadcast from inside the courtroom during the trial.
"The risks from broadcasting are particularly acute when -- as here -- there has already been significant media attention to a case," Merck said in court papers.
My comment: She will not allow cameras. If she does, look for the case to settle after jury selection.
Wednesday, September 07, 2005
Hundreds of firefighters who volunteered to help rescue victims of Hurricane Katrina have instead been playing cards, taking classes on FEMA's history, and lounging at a local hotel as they wait for days for deployment orders.
Throughout the hotel, a sea of burly firefighters wearing navy blue shirts loafed on couches Tuesday. A few sat outside in the gentle August breeze, enjoying boxed meals.
For more, read: http://aolsvc.news.aol.com/news/article.adp?id=20050907055509990007
What in the world is FEMA doing?
Ffederal lawsuits over Merck & Co.'s withdrawn painkiller Vioxx are being moved to Houston from New Orleans, at least temporarily, because of Hurricane Katrina.
U.S. District Court Judge Eldon E. Fallon several of his clerks and staffer have already moved into temporary quarters in the federal courthouse in Houston.
Can the judge legally cannot hold trials there? My conclusion is no.
The person became unemployed because hurricane of Katrina, and while his house in New Orleans is liveable he can't live there for obvious reasons.
He calls the IRS to find out the status of his tax refund and was told that the check was mailed to his New Orleans address August 26. That means that the check is sitting in some post office somewhere, undeliverable.
It seems like the obvious thing for the post office to do is to return the checks to the IRS which can then make alternative arrangements to send them to taxpayer's new addresses, right?
He was just told by the IRS representative that the Post Office is going to turn the checks over to FEMA, which will establish pick up centers where people will go in person to pick up their refund checks. Where these locations will be no one knows yet, but given the fact that people are scattered to the four corners of the country this method makes little sense .
He and I called FEMA at their designated disaster relief number 1-800- FEMA to try to get an answer. Instead, I reached a recording saying that they are overwhelmed with calls and cannot respond. Then the recording said "your call will now be disconnected." Then they disconnected me.
FEMA's performance is an ongoing disaster in and of itself.
Tuesday, September 06, 2005
Donate Office Space
Many lawyers and firms have been displaced in the wake of Hurricane Katrina. The ABA is gathering information from companies and firms who have space they are willing to share with businesses and lawyers.
Good work by the ABA.
The link is : http://www.abanet.org/katrina/
Thursday, September 01, 2005
Look for a decision on what happens to the MDL today or by the early part of next week. I would not be surprised if it is moved to Pensacola, Florida to Houston. Factors to consider would include the Judge's ability to administer the matters, the accessibility of the courthouse, the ability of the city to handle the number of attorneys and staffers, and the ability to hold trials in the new location.
A trial was set for the end of November, 2005 before Judge Fallon; you can expect it will not be held, unless it is sent back right away to Florida.
I'm in Atlanta, and have offered her full run of my office and materials. Money helps of course, so we are donating to the Red Cross. I humbly suggest that any attorney - if you have space - offer it at least for a short time. You'd be surprised how many attorneys are hunkering down here or there.
Here is the email:
< style="font-weight: bold;">Thanks for the many e-mails, calls and other inquiries about my sister ... . They left New Orleans on Friday morning before the storm’s path was evident, so they didn’t take any of the things they WISH they had taken with them….stuff like family heirlooms, jewelry, important papers, baby pics, etc.. They thought it was probably another false alarm like the other two times they have evacuated this year. They were wrong. >
All indications are at present that they have lost everything…their house, car, all of their possessions and even two beloved cats. As you can imagine, this is devastating for them. They have no idea when they will be able to return to see if anything is salvageable.
We are at a loss as to help them thru this.
Call your Bar association in your state and ask if they are offering temporary relocation to any attorneys.