Trasylol Lawsuit filed in N.Y.

Trasylol, also known as aprotinin has been alleged to increase the risk of heart attack, stroke and kidney failure. The drug is commonly used to prevent excessive blood loss during heart surgery. Trasylol is given to patients intravenously along with other medicines so that most people do not even know that they are receiving it. Doctors do not need special permission to administer it.

A NY lawsuit filed claims that the drug an eight-month hospitalization and death. According to the source, Doctors at Stony Brook University Medical Center said the man's complications were serious side effects from the drug, Trasylol, which is used to control bleeding during heart surgery (according to the lawsuit).

The drug allegedly caused kidney failure in the 52-year-old man, and set off a chain reaction that forced Randone to have both his legs amputated, require a tracheotomy and be put on a ventilator to breathe.

$134.5 M Verdict in Prempro: Wyeth Execs knew of Cancer Dangers since the 1970's

In a just completed trial, there is information that several researchers allegedly warned Wyeth reps as early as 1976 that the company's menopause drugs could be tied to increased risks of breast cancer but that the company chose not to study the issue, at least according to the lawyer for the Plaintiffs Arlene Rowatt, Jeraldine Scofield and Pamela Forrester.

Their cases all have a common claim: That hormone- replacement medicines, including Prempro and Premarin, caused their breast cancers.

Closing arguments were held on 10/8/07.

Verdict: A jury in Reno, Nev., decided Wyeth should pay $134.5 million to three women who claimed their breast cancer was caused by company-made drugs used in their hormone-replacement therapy. Source is the WSJ: here.

Merck Wins Another Vioxx Case: FL State Court

From various sources listed below:

In in a Florida State Court (Hillsborough County Circut Court) a jury ruled in favor of Merck in the defense of a Vioxx case.

Refik Kozic was the plaintiff in that action. He was known for his major league soccer career, playing for the Tampa Bay Rowdies. According to most reports, Kozic had atherosclerosis and coronary artery disease Kozic had high cholesterol and other risk factors that contributed to the progression of his disease over a long period of time.

Florida Circuit Court Judge William P. Levens presided over the case. This was the first VIOXX case in Florida to go to trial.

Lawyer Advertising: What Not To Do

Driving through a southern state this weekend I heard a radio ad for a law firm. The 30 second informed that the Firm handled injury cases as well as divorce cases.

What was missing? In the short span of the ad, the telephone number was mentioned once - about fifteen seconds in -but not mentioned again. The Law Firm's name was mentioned only once, and the name was not easy to pronounce much less remember. There was no website reference. There was one mention of the street address.

Why waste your money on this?

In my experience, any radio ad must mention the phone number at least three times. A website reference (at least twice) is critical, especially if the Law Firm name it not easy to recall.

At a minimum, if a firm has a toll free number the .com can be just that ... "our number is the same as our website: 877-80 DRUGS , 87780drugs.com"

Lawyers: Is Your Web Site Lacking?

Lacking a way to reach you that is ... .

Yesterday I was seeking out attorneys in a western city and state to discuss a possible referral. At 8 p.m. from one of my websites I received an email from a person with a potential case. We spoke the same night. Immediately I went looking for an attorney, only to have little success. It took me nearly a half hour to find one attorney.

Where did this happen? A city that is the state capitol of said state. When I found a site for a firm/attorney with potential, I looked for a way to contact or email the attorney right away. Nothing. No email listed, no "Contact Us" box. Just a phone number which of course went to a recorded voice mail. By the time the office opens, it will be 11 a.m. Eastern here in my city, and the chance to possibly work on a significant case is gone forever.

Ok, no problem I thought. Next attorney site, same problem. Next attorney site, nothing. Finally, at lawyer website number four, an email listing. I emailed that attorney and have a reply this morning at 8:30 a.m. Eastern. The attorney in that city is already up and working before the sun has risen in his town. He has my attention.

For the others who missed the chance, how can this be?

One thing I've always remembered is a saying from a fellow lawyer many years ago: People just don't need a lawyer during business hours. The same is true on the web. To think that any firm or attorney would not even list a way to be reached other than by telephone when putting up a website just made me wonder ... how many potential clients are being missed? How many - like me - simply moved on to the next attorney?

Does your site miss such a vital piece? Check your site right now, today. Because if I need your assistance and the only way to reach you is by phone after hours, I'm moving on to your competitor.

FDA Warns Hand Sanitizer Maker Re: Claims It Prevents Colds

Procter & Gamble Co makes a hand sanitizer called Vicks Early Defense Foaming Hand Sanitizer that the company has claimed could prevent colds among school children and fight germs for up to three hours.

The FDA reported that it had sent P and G a warning letter about the "unlawful" marketing claims. The FDA claimed that this amounted to an unapproved drug because it did not contain proper instructions for use and carried the unsupported claims that the product could effectively fight germs that cause colds.

The FDA letter states: "Under sections 301(d) and 505(a) of the Act (21 U.S.C. §§ 331(d) and 35 5(a)), a new drug may not be introduced or delivered for introduction into interstate commerce unless an FDA approved application is in effect for it. Vicks Early Defense Foaming Hand Sanitizer does not have an approved application, and its introduction and delivery for introduction into interstate commerce violates these provisions of the Act."

Also, "the product claims to be effective in fighting the "germs" that cause colds. We are not aware of sufficient evidence to show that that the product is generally recognized as safe and effective in preventing individuals from becoming infected with colds, a condition caused by viruses."

Alas, the FDA gives P and G 15 working days to take steps to take action, or more as needed. How long will it take? Stay tuned ... .

Trucking Interrogatories

Over at the Trial Lawyer Blog, Brian Parker posted his version of trucking Interrogatories. Brian works in my office now, and he is a hard working young litigator with great skills.

Go here to get the discovery. Here is a sample:

GENERAL

1. What is Defendant’s document retention policy?

WRECK

2. Was driver within course and scope of his employment at the time of the collision?

3. If anyone on behalf of Defendant went to the collision scene please answer the following: Who on behalf of Defendant photographed or video graphed the scene, vehicles or both?Who on behalf of Defendant measured the collision scene?
   

Free Software Worth a Look

I am a fan of free software mostly because of the price. A recent blog post noted several that may be of some value in your practice. I am using:

1.Foxit Reader. A replacement for an Adobe reader. Faster and easier to use. Go here to find it.
The site says: "Are you tired of waiting for your PDF to load? Look no further, Foxit Software is the answer! Foxit Software specializes in core PDF technologies and provides a true and complete PDF solution. These affordable high quality solutions range from generic PDF desktop products to customized PDF applications and software development kits for various platforms."

2.Irfan View. In a nutshell, it is a simple graphic viewer. You get with it email, the ability to change color, and a thumbnail/preview option. Go here to find it.

3.Shorttext.com. While not freeware, it is a handy little webpage to use when you are on a public computer or another PC. The vanilla site informs:

ShortText.com is a simple tool to post text online, with minimum fuss. No sign ups, no sign in, just instant web presence for your information.

"Don't have a website? Don't want a blog? Want to share a piece of code...perhaps an article? Just paste your text below and click 'Create URL'! ShortText.com now supports direct linking to your images and video. "

I've used it as a reminder to myself and as a short note to a fellow lawyer.

Each is worth a go.

NYC Debuts 9/11 Health Website

Today marks the debut of http://www.nyc.gov/html/doh/wtc/html/home/home.shtml, which the City proclaims to be "a single source for information about the health effects of 9/11. It consolidates the latest information about scientific research and services, including where those affected can go for free treatment and medicine."

The website includes easily accessible research findings and treatment options for the different groups of affected people - rescue and recovery workers, residents, children, and city employees.

Several interesting facts gleaned from various websites:

The World Trade Center Health Registry monitors the long-term health of people who were exposed to the World Trade Center disaster. They now reside in all 50 states.

The Registry recently released findings about rescue and recovery workers, some of whom were suffering from asthma and post-traumatic disorder as a result of the disaster.

One in eight rescue and recovery workers had post-traumatic stress disorder when they were interviewed in 2003 and 2004. Rates were highest among volunteer workers and lowest among police officers.

As you go about your day, how will you remember 9/11?

FDA Panel: Trasylol Hearing 9/12

An advisory panel of the FDA takes another look at the safety of Trasylol on Wednesday, just after new data came just days after another FDA advisory panel met last year over the drug's safety.

That first advisory panel found that Trasylol, used to stem bleeding and the need for blood transfusions during surgery, was acceptable for some patients undergoing heart surgery.

According to Reuters, the FDA staffers wrote that the totality of three recent studies support the risk of renal failure and dysfunction, and noted a "mortality disadvantage detected" in one Bayer study. Link.

The FDA may conclude that indeed the drug increases the risk of kidney failure and death. In my view, however, patients may not even be aware they were injected with Trasylol during heart surgery. To be truly practical, the FDA should require any hospital patients who were given Trasylol to be informed by letter from the medical provider who may have had it injected.

Regulating the Drug Pushers

That title comes from an article on the Motley Fool website. It's nice to know what M.F.
has to say. In the article, there is this comment: "The FDA hasn't been completely negligent when it comes to advertisements."

From that article:

"The FDA plans to run a study to see whether positive images and statements are causing viewers to ignore the warnings about potential side effects. It needs to run a study to figure this out? Of course happy families frolicking in the park are helping viewers to ignore the fast-talking guy at the end of the advertisement."

Also ...

"The announcement follows a New England Journal of Medicine study published last week, suggesting that FDA regulation of the advertisements is on the decline ... it seems more likely that the FDA is understaffed for the increasing number of direct-to-consumer (DTC) advertisements. Spending on DTC ads increased 330% from 1996 to 2005."

Go here for more.

G.T.L.A. Blog Debuts

The Georgia Trial Lawyers Association has a Blog that is worth a look. Go here to check it out.

FDA Panel To Review Trasylol Safety

The folks at the FDA have scheduled a meeting to review the safety of Trasylol, which has been under government scrutiny for more than a year.

Trasylol was approved for U.S. marketing in 1993 to reduce the need for blood transfusions in bypass surgeries.

On September 12, 2007 the FDA will review documents that may show Trasylol can cause kidney damage, heart failure and even death.

More information here.

NYT Article Regarding Vioxx

From the article:

"None of the 45,000 people who have sued Merck, contending that they or their loved ones suffered heart attacks or strokes after taking Vioxx, have received payments from the company. "

The article goes on to note:

"Promising to contest every case, Merck has spent more than $1 billion over the last three years in legal fees. It has refused, at least publicly, to consider even the possibility of an overall settlement to resolve all the lawsuits at once."

Link here.

Avandia and Actos Get Blackbox

Avandia and Actos will carry U.S. regulators' strictest warning on the risk of heart failure.

The drugmakers agreed to a black box warning on prescribing information.

An analysis of existing research published last month in the journal Diabetes Care found that Avandia and Actos doubled the risk of heart failure in diabetics. Use of Avandia and Actos may increase the likelihood by causing fluid retention or swelling, which can make the heart work harder. The study found that a quarter of heart-failure cases occur in people younger than 60.

``Despite the warnings and information already listed in the drug labels, these drugs are still being prescribed to patients without careful monitoring for signs of heart failure,'' said Steven Galson, director of the FDA's Center for Drug Evaluation and Research. Source here.

Canada Yanks Permax as of August 30, 2007

Health Canada is ordering a drug used for treatment of Parkinson's disease off the market. HC claims that it has told distributor Eli Lilly that sales of the drug Permax (pergolide mesylate) must cease as of Aug. 30.

Source here.

Blawgworld 2007?

At legalunderground there is a link to the free PDF of a document known as BlawgWorld 2007 , which reduced to a plain description features essays from the legal blog world. The TechchnoLawyer touts it as a new way for law firms to find answers to management and technology questions.

Me? I love Eric Goldman's description of this endeavor:

"77 blogger chose their favorite posts, which were compiled into an e-book. The compilation turns out to be a great way to get noisy [bloggers] to promote their brilliant contributions to the e-book, which generates traffic and link love for the publisher, which in turn creates a nice delivery vehicle for sponsored content/advertising."

At the Trial Lawyer Blog: Trucking Request for Production

Just added to the Trial Lawyer Resource Blog, a one hundred plus subject production request:

Go here for more. You will see among others, these:

FMCSR

61. Any “out of service” stickers ever issued to the defendant from any governmental or regulatory agency of the United States or any state.
62. A copy of the periodic inspection report as required by 49 C.F.R. & 396.21
63. Any documents containing information as to any investigative inquires concerning the defendant driver as required by 49 C.R.F. & 391.23.
64. All safety management controls (as defined by 49 C.R.F. & 385.3) which the Defendant had in effect during 2004.
65. All Safety ratings (as defined by 49 C.R.F. Section 385.11) issued to the Defendant by any state or federal government agency for the last 5 years.

From Forbes: Unsafe at the FDA

From Forbes.com, this scathing assessment over the Avandia hearings last week:

"The biggest damage from the proceedings [as to Avandia] may be to the FDA itself." During the process of the meetings, "the agency displayed its weaknesses on drug safety and the wounds that have been caused by years of controversy, giving the agency's critics more ammunition."

First there was the conflict: David Graham, a drug safety reviewer who played a key role in the mounting criticisms of Vioxx, told the advisory panel that Avandia should be pulled off the market. His boss, Gerald Dal Pan, head of the FDA's Office of Surveillance and Epidemiology, backed him up. But Robert Meyer, a top official in the office that approves drugs, took a more tempered stance, admitting there were fundamental disagreements at the FDA about what to do with Avandia."

Good work by David Graham. Once again, shame on the FDA.

For more, go here.

Friday Diversion: Credit Card Sized Survival Tool

Can opener, saw blade, wrench. And? $5 bucks. Find it here.