Procrit, Aranesp and Epogen News: Congressman Says Stop the Ads

Congressman John Dingel has asked both Johnson & Johnson and Amgen Inc. to stop consumer advertising of their anemia medications for cancer patients until May 2007 or until the FDA wraps up an ongoing review.

Aranesp and Epogen (Amgen) and Procrit (J&J) have both been in the news over a recent clinical trial.

There is a planned May 10, 2007 FDA advisory panel meeting to determine among other things the black box warnings planned for the drugs. what, if any, additional measures need be taken to protect the public from unnecessary risks to human life from these products,'' Dingell said in the March 20 letters. His office confirmed the letters were sent today.

Procrit, Epogen and Aranesp are engineered versions of a protein called erythropoietin, or EPO. EPO promotes the production of red-blood cells, which carry oxygen through the blood. EPO has long been discussed in pro cycling circles. Go here for an article titled "Spinning in their Graves." Lance Armstrong had been given Epogen during his cancer battle.

The recent study suggested that blood clots, strokes and heart attacks may be linked to higher doses of these medications, a claim denied by the drugmakers.

Black Box Warnings for Procrit, Eopgen and Aranesp

From several sources:

Last week the the FDA issued a warning that using of an erythropoiesis-stimulating agent (ESA) also known as recombinant human erythropoietin to raise hemoglobin may be linked to serious and life-threatening side-effects or even death.

What is particularly noteworthy is that the FDA has stated there has never been any evidence to support claims made in direct-to-consumer advertising that treatment with darbepoetin (Aranesp), epoetin alfa (Epogen), or epoetin alfa (Procrit) might increase energy or ease fatigue in patients that face cancer therapy.

What does the warning say?

That persons taking any of the stated drugs use the lowest dose of Aranesp, Epogen, or Procrit that will gradually raise the hemoglobin concentration to the lowest level sufficient to avoid the need for blood transfusion

• Aranesp, Epogen, and Procrit and other erythropoiesis-stimulating agents increased the risk for death and for serious cardiovascular events when dosed to achieve a target a hemoglobin of greater than 12 g/dL.
• Use of erythropoiesis-stimulating agents to achieve a target hemoglobin of 12 g/dL or greater in cancer patients shortened the time to tumor progression in patients with advanced head and neck cancer receiving radiation therapy; shortened overall survival and increased deaths attributed to disease progression in patients with metastatic breast cancer receiving chemotherapy; and increased the risk of death in patients with active malignant disease not under treatment with chemotherapy or radiation therapy. Erythropoiesis-stimulating agents are not indicated for this patient population.
• Patients treated before surgery with epoetin alfa to reduce red blood cell transfusions had a higher incidence of deep vein thrombosis. Aranesp is not approved for this indication.

For more, go here.

Katrina: Gator Basketball Tours 9th Ward

From time to time I post about my alma mater, The University of Florida. This past weekend, the basketball team was in New Orleans, and the players and coaches toured the area devastated by the storm and its flooding.

One player, Joakim Noah, said this: "It was an experience I'll never forget." "It's been a year-and-a-half since Katrina, but in some areas, it looks like the hurricane hit just last week." He also commented, "It makes you wonder, 'Do we really care?' "

For more, go here. The link takes you to the Sunday 3/18/07 Orlando Sentinel article.

My comment: The answer to your last question is NO. America does not care. Many individuals, churches and volunteers, and I do, but the insurers, the politicians, the true titans of business do not. It may as well be Bosnia.

Shameful.

Vioxx Verdict: $20 Million in Humeston

In New Jersey, the Humeston case was retried, and today (3/12/07) the verdict came back: The jury concluded that Vioxx contributed to an Idaho postal worker Mike Humeston's heart attack, and awarded him and his wife $20 million in damages. The jurors awarded Humeston $18 million in compensatory damages and gave another $2 million to his wife, Mary.

The punitive damages phase begins this week.

My comment: Chris Seeger vowed that a retrial would vindicate his clients, and it has.

Actos (Diabetes Drug): Blamed for Broken Bones

Actos is a diabetes drug introduced in 1999. According to a recent study sponsored by Takeda, the drug's maker, it found incidences of fractures when comparing Actos to a placebo.

Women using Actos had about 1.9 broken bones for every 100 patient-years studied, compared with 1.1 broken bones for 100 patient-years in the other women. The data represented almost 12,000 patient-years for each group.

Most of the fractures involved the hands, wrists, forearms, feet, ankles and legs. Takeda said it doesn't know what caused these broken bones and is still evaluating the findings.

For more, go here.

Vioxx: Texas Garza Verdict Stands (For Now)

Leonel Garza's Vioxx verdict in Texas last year for $7.75 million will not be retried.

A State Court Judge did not rule on a pending Motion for New Trial filed by Merck. The Motion as a seventy five day time frame in which a Judge could rule on it. By not ruling, it has been effectively denied.

I am certain that there will be an appeal.

Seroquel and Zyprexa: Off Label Use Rampant?

Seroquel prescriptions for off-label use are growing. According to a recent report in Bloomberg,

Prescriptions for Seroquel and Zyprexa, generated more than fourteen billion dollars in total sales last year. According to doctors, the drugs have been prescribed to patients with Alzheimer's disease as well as to teenagers with emotional conditions.

Nearly half of Seroquel prescriptions last year were allegedly for disorders for which AstraZeneca has yet to gain regulatory approval. It is, however, legal for doctors to administer drugs for certain unapproved medical conditions. Companies are prohibited from marketing products to doctors for uses not yet cleared by the U.S. Food and Drug Administration in Washington or by regulators in other countries.

Consequences for off-label scripts? Half a dozen states have filed suit against Eli Lilly, claiming in those lawsuit papers that the drugmaker (and others) failed to disclose the risks of side effects caused by the drug and promoted their use to treat conditions for which they were not approved.


For more, go here.

I Want Your Motion in Limine!

If you have a Motion in Limine that you are willing to share, would you send it to me? I would like any that you believe are helpful in your injury cases. Any Court. I plan to publish excerpts here, and any additional comment you may have regarding the contents of it.

My email is to the right. Any format. Are you willing?

Talk Like a Lawyer?

Trial attorneys and litigators of nearly every stripe will often tout how important it is to speak plainly, and how it is better to avoid legal jargon. Most unfortunately do not practice what is preached.

I'm reviewing a deposition transcript this morning and I'm getting a headache. Defense counsel has asked these gems: "Remembering that you are under oath, please describe the nature and permanency of the alleged personal injuries suffered by you in this negligence action." The reply was, "I don't understand what you just asked me."

Another: "What if any exacerbation of any pre-existing emotional condition are you claiming as a result of this negligence action?" His reply was that there was no "exasperation."

Have I described you?

Long ago I learned one basic question that I now always ask. Lefferts Mabie always began questioning with "tell us who you are." Better than, "please state your full legal name for the record."

Tamiflu: Side Effects Causing Concern?

The influenza drug Tamiflu may cause fatal side effects -- according to news from Japan. Two people who took it fell to their deaths in February of 2007.

The Health Ministry of Japan issued warnings that influenza patients may show psychiatric problems.

To the surprise of no one, Roche - the maker of the drug - denied a link between the medication and the deaths

For more, go here.

Bausch & Lomb recalls 1.5 million bottles of ReNu MultiPlus Lens Solution

B and L is recalling about 1.5 million bottles of ReNu MultiPlus because trace amounts of iron could cause the cleaner to lose effectiveness earlier than normal.

The optical products maker also reported a modest drop in fourth-quarter and full-year sales in 2006, citing sluggish contact lens sales amid a slower-than-expected recovery from last spring's recall of MoistureLoc, which was blamed for an outbreak of severe fungal eye infections.

No injuries have been reported, thankfully.

The recalled lots carry the expiration date “2008 – 03” on the bottle.

Not Legal: Post Secret

Frank Warren appears at themy alma mater the University of Florida this week. In case you don't know of him or his blog,Frank Warren is searching for the perfect secret, although he's not sure what it will look like. According to the press reports:

He spends about eight hours every day sorting through the 100 to
200 secrets that are delivered daily to his suburban home in
Germantown, Md.

Most come as postcards, usually in two 3-inch tall stacks. His
mail carrier, who knows Warren by name and face, fastens the stacks
neatly with two rubber bands, like ribbons on a gift. But others come
in more unusual packages - like the Starbucks Coffee cup that said
"I give decaf to customers who are rude to me."

Go here - http://postsecret.blogspot.com/ to check it out. Not legal - as in, this was not a post talking about legal issues or news.

Vioxx: Friday's Verdict News

In the cases jointly tried to conclusion last week, the jury found that that Merck was not negligent in the case of Brian Hermans of Waupaca, Wis., who died at age 44 after a September 2002 heart attack.

The jury did find that Merck violated New Jersey's consumer fraud law, so Hermans' family could recoup three times what he paid for Vioxx prescriptions. It also allows Hermans' family lawyer, Mark Lanier, to recoup his legal fees, which he estimates at $2 million.

In the second case, Mr. Humeston presented his case once more. Today the jury starts phase two, to determine whether the second plaintiff is entitled to damages. The jury found Friday that Merck was negligent in the case of Frederick "Mike" Humeston, 61, of Boise, Idaho, who survived a heart attack in September 2001, before the stronger warning. That case is considered a pre "warning change" case.

Jurors heard evidence about Merck's marketing of Vioxx and what it disclosed about increased risks of heart attack and stroke, which led Whitehouse Station, N.J.-based Merck to pull the blockbuster drug from the market in September 2004.

Tech: Gigasize.com & Jott

Gigasize.com allows you to share and send files up to 1.5GB. It's free . There is a 2.5 GB service for a small fee. Worth a look.

Jott.com is a telephone-based reminder system that sends your short message to your email (or another's email). Free. I like free a lot. I'm in the car a bunch, so it is much easier to call the toll free reminder and send a message than it is to write at 70 m.p.h.

Vioxx: Illinois State Court Trial Begins

In Madison County, a jury was selected to consider a widower's claims that Merck's drug is the culprit in his 52-year-old wife's fatal heart attack.

Patricia Schwaller is the deceased. She too Vioxx for more than 20 months before she died suddenly Aug. 8, 2003, her family's attorneys say. The woman had no previous heart attacks, strokes or symptoms of congestive heart disease according to her attorneys.

My opinion: For now the defense for Merck has been on limited fronts - the MDL, New Jersey, and California. Texas is plodding along. Illinois is another battleground now, and this case is one where the usage is more than the eighteen month period that Merck has said would be a floor in considering any possible causal link.

Stay tuned.

Liberty Mutual Insurance

Liberty Mutual Group Reports Fourth Quarter 2006 Results

My friend and fellow Georgia lawyer Mike Neff posted the news that Liberty Mutual Group (“LMG”) reported net income of $455 million and $1.626 billion for the three and twelve months ended December 31, 2006, respectively, an increase of $202 million and $599 million over the same periods in 2005.

Seems like LMG is doing rather well. Crisis? What crisis?