Resolution Time: 2008

I make and try to keep resolutions.

For me it's been a year to remember: 2007 began with my decision to open my own law office. It was precipitated by a significant event at the end of 2006. This time last year my former "boss" tried to weasel out of a referral fee to another lawyer. It was a significant fee to be paid to a solo practitioner. When the owner of the firm demanded that I abide by the decision to - in essence - screw another lawyer, I told him would have none of it. That moment was one I will remember forever - I informed that I would resign that very moment if the referral fee was not paid. Ten minutes later I was told to leave, and told (yelled at, actually) that the fee would not be paid. Ninety days later, the Court ordered him to pay it. I have not looked back since, and have been happy with the decision. My 2007 resolution - Be transparent with any attorney who refers a case, provide regular updates and send a referral check promptly was met. Many times.

2008 will bring a list of more basic resolutions and courtesies:

1.When speaking with a person - client, attorney, etc. - I will not pick up my cell phone to see who it is. I will not check my blackberry while in a business setting.

2.My office will march forward to going paperless. We already move all FAX transmissions to our servers, and basic items such as Incident Reports and medical records are scanned. Next up: Other records and documents.

3.Use of IM and texting of clients: Angel Reyes uses texting to reach a client. We will as well. The use of IM in our offices works well, as we are spread out. Next is asking for the IM screen name of clients. I have found that nearly 60% of all clients use IM, even if only on a semi-regular basis.

4.Copying clients on case costs payments. In the old days, there would be sticker shock when a case resolved and the client saw for the first time the costs incurred in a case for matters such as expert witnesses, deposition transcript costs, and the like. Now, clients get all copies of letters showing payments to any entity (but they don't get a copy of the check). This will be a 100% rule in 2008.

5.Compliments: Seems like the law field is one area where compliments to staffers, fellow lawyers, etc. are rare. Not in my office. 2008 is the year of compliments and of 'well done' comments.

Retinopathy of Prematurity: Richard Shapiro and babyblindness.com

Preeminent Attorney Richard Shapiro has his site up and it is impressive. www.babyblindness.com is a site that addresses and explains Retinopathy of Prematurity.

"Retinopathy of Prematurity (R.O.P) is a potentially blinding eye disorder that primarily affects premature infants weighing approximately three pounds or less, born before 31 weeks of gestation (A full-term pregnancy has a gestation of 38–42 weeks). The smaller a baby is at birth, the more likely that baby will develop ROP. This condition is one of the most common causes of visual loss in childhood and can lead to lifelong vision impairment and blindness." There is a Resources page as well.

Richard spoke with me and said that he actually hopes to put himself out of business by addressing the root cause of this - to him - avoidable consequence of premature birth. With proper testing and procedures in place, preemies born with ROP should be diagnosed and treated in a way that the condition is almost unheard of in three to seven years.

The zones of the retina in R.O.P.:





Go to the site here.

30 Seconds of Ad Related Levity

DeNiro - not law related - responds to 'direction' when cutting an ad:

Avandia: Higher Risk of Heart Attacks and Death

Older people taking Avandia and Actos had a higher risk of heart attacks, failure and death than those taking other diabetes pills, says a study from Canada.

Diabetics over 65 on the drugs were 40 percent more likely to suffer heart attacks, according to a study in the Journal of the American Medical Association. Avandia increased the risks more than Actos did, possibly because smaller numbers of patients were prescribed the Takeda drug. The findings are similar to those in a May 21 New England Journal report by researchers at the Cleveland Clinic, which found Avandia increased heart attack risks by 43 percent.

You can find the article/study in JAMA .

Source: Here.

Vioxx Settlement Agreement Documents

You may find them at the Brown Greer site. The site informs: "BrownGreer PLC is the Claims Administrator for the Vioxx Settlement. The forms posted on this site may change, so be sure to check back often to get the most recent version. Also, legal developments and amendments to the Settlement Agreement may cause some of these documents to become outdated."

The documents (all in PDF)include:



Master Settlement Agreement (PDF) 2.7MB

Exhibit 1.1 - Registration Order (PDF) 208KB - Click Here for Required Registration Affidavit and Spreadsheet (Excel) 4.29MB

Exhibit 1.2.2.3 - Release (PDF) 700KB (Do not print this version of the Release to use for Enrollment. The Claims Administrator will provide a customized Release for each Registered Eligible Claimant upon receipt of the Registration Affidavit.)

Exhibit 1.3.1 - Required Medical (or PME) Records (PDF) 148KB

Exhibit 1.5 - Required Medical (or PME) Records Submissions Completeness Provisions (PDF) 272KB

Exhibit 2.2.1.1 - Injury Gate Criteria (PDF) 700KB

Exhibit 2.2.1.2 - Duration Gate Criteria (PDF) 116KB

Exhibit 2.2.1.3 - Proximity Gate Criteria (PDF) 32KB

Exhibit 2.2.2 - Evidence of Usage Confirmation Criteria (PDF) 108KB

Exhibit 2.7.3 - Future Evidence Stipulation (PDF) 96KB

Merck Seeks OTC Approval for Mevacor (Cholestrol Drug)

From Bloomberg.com:

Merck is asking the FDA to make Mevacor (a cholesterol-lowering medicine) available on drugstore shelves without a prescription.

Merck's try is its third in ten years. The FDA is unlikely to approve nonprescription Mevacor becuase of concerns raised by the 250,000-member American Medical Association.

The opposition makes sense. A consumer probably has not outward signs of high cholesterol unless diagnosed by a doctor. This is not a headache or joint pain.

For more, go here.

Avandia Dropped by Two Pharma Benefit Managers

Two dropped GlaxoSmithKline Plc's diabetes drug Avandia from their national formularies, based on concerns about safety.

Prime and HealthTrans- the managers- issued separate statements, which claimedthat each made a thorough analysis of the clinical literature examining the safety and efficacy of Avandia.

Go here for more.

Tim Tebow: Heisman Trophy Winner

I'm a Gator, having graduated from the University of Florida. Saturday night, Gator QB Tim Tebow won the Heisman Trophy:




It's not law related, but it is nonetheless fun to watch - unless you are a nole.

Prempro Verdict Tossed

A woman who claimed that Wyeth's hormone-replacement drug caused her breast cancer failed to prove, with have sufficient evidence, that Wyeth's Prempro caused her damage.

The opinion was written by Judge Ricardo C. Jackson. Four cases have gone to trial in Philly. Each time, a jury sided with the plaintiff only to have the judge reverse the verdict.

More than 5,000 women have filed suit.

FDA's Shortcomings Put American Lives "At Risk"

From Bloomberg:

American lives are at risk because the U.S. Food and Drug Administration lacks the funding to keep up with scientific advances, according to FDA advisers.

The FDA has an ``appallingly low'' rate of inspections and a lack of scientists who understand new technologies, a subcommittee of an outside panel said in the report, posted today on the FDA web site. The full panel, known as the Science Board, will discuss the findings today.

That the FDA is a mess is not news ... will it try to repair itself?

Go here for more.

Celebrex MDL: Breyer to Toss Out 200 mg dosage of Celebrex

The MDL Ruling from Judge Breyer came down mid-day today November 19, 2007. Based on Daubert, the science does not support claims of injury when a person took 200mg of Celebrex per day.

Stay tuned.

Vioxx and New Orleans: A Busy Week in December

December 10, 11 and 14 you won't be able to swing a dead cat in New Orleans without hitting a Plaintiff's lawyer.

On December 10 and 11, Mealey's will host a Plaintiff's Only National Settlement Conference chaired by my friend Tom Girardi, and which will cover among other things, the "View From the Bench" and the "Role of the Special Master."

On December 14, 2007 Judge Fallon will hear from counsel at its status conference.

Trasylol Pulled from Market b/c of Claimed Link to Kidney Problems

From AP, Reuters, Yahoo and others:

Bayer AG last week voluntarily stopped worldwide sales of its antibleeding drug Trasylol after a Canadian clinical study found it could be linked to a higher risk of death than other drugs.

Trasylol, also known as aprotinin, works by blocking enzymes that dissolve blood clots. It is designed to stem blood loss and enable patients receiving heart bypass surgery to avoid transfusions. The FDA approved Trasylol in the 90's. At least two studies found an alleged link between its use and kidney problems, heart attacks and strokes. There have been reports of renal failure tied to the drug's use. Stay tuned.

Friday Diversion: When Your Dogs Go Deaf

Two of my beloved labs (seen on the right) are getting up there in age. The oldest is nearly 14, and the black lab is nearly 11. The two of them are totally deaf, but happy. On cold mornings like the one today in Atlanta (cold for me at least, 33F) they refused to be awakened for a walk.

These four legged family members have heard me mutter about the law on walks, have listened to me practice my legal arguments, and have on my occasion wagged their tails furiously (surely in agreement) when I vented about the failures of the legal system.

It's new territory when what was once taught to help in field work - hand signals - now becomes the only way to communicate. Today I worked with them in total silence and realized how changes come whether you are ready or not. I vowed to spend more time with each, seeing how each still loves the attention.

I hope that when I'm that old someone will have remembered to go over hand signals with me.

Merck Announces Vioxx Settlement: $4.85 Billion

From everywhere:

Merck hasagreed to pay nearly $4.85 billion to settle a significant portion of the claims over injuries claimed to linked to Vioxx.

The drug maker said if certain conditions under the agreement are met, Merck will pay a fixed amount of $4.85 billion into a settlement fund for qualifying claims that enter into the resolution process.

The average plaintiff will receive just over $100,000 before legal fees and expenses according to one report. The settlement amount represents less than one year's profit for the company.

GTLA Blog: Washington State Voters Approve Pro-Consumer Insurance Bill

From gtlablog.com:

All eyes were on the state of Washington yesterday. Consumer advocates around the nation waited anxiously as voters turned out to voice their opinions by casting ballots on Referendum 67. It seems that Washington, like many other places, has had problems with insurance companies denying or delaying fair and just claims. The referendum allowed the people to decide what should happen.

Referendum 67 basically stated that if an insurer, acting in bad faith, unreasonably denies a legitimate claim, that insurer could be liable for up to triple the amount of damages.

Roughly 60% of voters approved Referendum 67. It would seem that unscrupulous business practices by insurance companies do indeed have consequences.

Report : Crestor Fails to Reduce Heart Failure Deaths

Crestor failed to cut down deaths in older people with heart failure in a recent study, a finding that suggests it won't be prescribed more widely in those patients.

The study was released at the yearly American Heart Association's meeting in Orlando, Florida. Source here.

According to the study, 11.4 percent of those on Crestor died or had a heart attack or stroke when compared with 12.3 percent given a placebo. All patients got aggressive drug therapy for the underlying heart failure.

The trial study had 5,011 patients tracked for an average of 2 1/2 half years. While Crestor didn't cut death rates in the study, the drug helped patients avoid hospitalizations and marginally lowered heart attack and stroke rates.

For more, go here.

How Tech Affects Concerts

I had a chance to go back to my Homecoming at the University of Florida. Lynyrd Skynyrd played. When Freebird began, this was the view. Lighters have been replaced by cellphones and their lit screens. May not be perfect on this youtube.com video, but it was really something to see:

News from Legal Broadcast Network

My friends at LBN have news to report, and so I thought I would pass it along:

The Legal Broadcast Network (LBN) is an internet media company designed to leverage the powerful broadcasting medium of the internet to reach a very specific, high value audience of trial lawyers and other legal professionals announces key news. LBN's studios are located in Phoenix, Arizona and it provides 24/7 access for lawyers, paralegals, law schools, trial lawyer associations and others to draw on the expertise, knowledge and resources of professionals that have been successful in fighting for plaintiffs rights. LBN, co-founded by Jan R. Schlichtmann and Mark Wahlstrom, is the first online and podcast radio program specifically designed for trial lawyers, their clients and experts who help the community.



"The Miller Group and affiliated companies ("Miller") is the most ideal organization to assist the Company in developing and implementing its ultimate plan to broaden the scope of our successful LBN network," said Jan R. Schlichtmann. "Miller's successful Wall Street track record in working with emerging growth and middle-market companies, and their experience working with entrepreneurial management teams was a key factor in joining together."



Mark Wahlstrom stated, "We felt Miller's financial expertise along with their depth of media experience was a critical component in assisting LBN in taking the next step to building the Legal Broadcast Network into a premier internet and media company.



Rudy R. Miller, Chairman, President and Chief Executive Officer of Miller commented, "We are especially pleased to assist the founders and shareholders of LBN in executing a financial, business and media strategy. We look forward to a long and mutually rewarding partnership."





About The Miller Group



Miller, headquartered in Phoenix, in comprised of several affiliate companies including Miller Capital Corporation (MCC), which offers a broad spectrum of financial advisory and related services to both public and private middle-market companies located throughout the United States. MCC provides services in venture capital and private equity investing, management consulting and business valuations. Miller Capital Markets (MCM), a FINRA member firm, is a boutique investment bank that handles merger and acquisition transactions, private placement of equity and debt and public market advisory services. Miller Investments, Inc. and Miller Management Corporation are also a part of The Miller Group of affiliated companies.



A select group of past and present Miller clients include: America West Airlines, Inc., USAir Express, Capital Title Group, Inc., Global Entertainment Corporation, McMurry, Inc., REGENT Communications, Ritz Carlton magazine, Four Rivers Broadcasting, JACOR Communications and Wall Street Awareness Series, a nationally syndicated television program.




About LBN Founders



Jan R. Schlichtmann is a nationally recognized plaintiff attorney for his work that centers on consumer, environmental, product, toxic and mass tort litigation. He garnered international recognition for his representation in the 1980s of eight Woburn, Massachusetts families against W.R. Grace and Beatrice Foods for the contamination of the Woburn City Water supply. Today, Mr. Schlichtmann hosts his weekly show "Civil Action Radio" from Beverly, Massachusetts, which can be heard via podcast or from the continuous audio stream broadcast from the LBN Phoenix studios.



Mark Wahlstrom's firm, Wahlstrom & Associates, has 25 years experience in providing strategic advice in the development and design of structured annuities and settlement trusts. Mr. Wahlstrom is regarded in many legal circles as a leading expert in his field.

Prempro: Case Dismissed in MN

Wyeth won dismissal of a lawsuit in Minnesota linking its Premarin and Prempro drugs to breast cancer.

Judge George F. McGunnigle a State Court Judge in Minneapolis granted Wyeth’s motion to dismiss the action, ruling that a woman who blamed the drugs for her breast cancer had failed to offer any scientifically valid evidence supporting her claim.

Source: Here.

Imported Drugs Causing Problems for the FDA

From USA Today:

The FDA can't adequately inspect foreign drug manufacturers because its database is so outmoded it doesn't even know how many foreign firms are shipping drugs to the United States, according to testimony to Congress.

Marcia Crosse, director of health care at the Government Accountability Office, told a House hearing that without such basic data the FDA "cannot provide the assurance that the imported drugs are safe."

The FDA this year listed 3,249 foreign pharmaceutical manufacturers subject to its inspection — yet the agency cannot determine whether it has ever inspected 2,133 of them

A report by Congress a decade ago showed similar shortcomings, and that nothing had been done.

In my view, the FDA cannot possibly hope to keep up - it is a lost cause, and a new solution needs to be found.

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.

Crazy Pants Lawyer Loses His Job ?

From the WaPo blog, looks like the ALJ who lost his crazy pants lawsuit is about to be given the heave ho from his Administrative Law Judge position.

Go here to read more.

From that blog:

Meanwhile, at a fundraiser for the Chungs (dry cleaning defendants) last week, donors contributed more than $62,000 toward the legal fees the family incurred in their defense against the Pearson suit. Another $30,000-plus came in from Post readers and others who made contributions to a defense fund around the time of the trial in June.

Accutane Users Getting Pregnant

From the AP: More than 100 women became pregnant in the past year while taking an acne medicine that causes birth defects, even though each was enrolled in a program designed to prevent those pregnancies from happening.

If a woman becomes pregnant while taking Accutane her baby may be at risk to suffer brain and heart defects, mental retardation and other abnormalities, regardless of the dosage or duration. There may be a risk for 30 days after stopping the drug as well.

Of the 122 pregnancies, 78 were taking the drug when they became pregnant. Another 10 were already pregnant when they started the drug including two who had a prescriber falsify pregnancy test results. The report didn't give a reason. Another eight became pregnant in the month after stopping the drug. The program couldn't provide details on the remaining pregnancies.

For more, go here the Wash. Post article.

Weekend Diversion: Personalizing Your Google Page

My home page started off as Google. Then along came iGoogle. What is that, you say? It's a personalized version of the plain as can be www.google.com.

I went online to see what folks had been doing to their iGoogle pages, and found some interesting reading (as always) on Lifehacker. An article on the subject may be found here: "Show us your iGoogle."

A clean one is right here:


Worth your time. I've added to my page a spellchecker, a to do list, and a quick link to my blog's email reader.

FDA Yanked Avandia Scientist After Concerns Voiced

A scientist with the FDA has told congressional investigators that the FDA had the scientis removed from working on Avandia after voicing concerns about the diabetes pill's safety, so say two Senators.

The FDA medical officer was once the primary reviewer for Avandia, according to a letter sent to the FDA by Senator Max Baucus Charles Grassley.

The scientist has believed that as far back as 2005 that there was enough evidence for a strong "black box" warning on Avandia about a risk of congestive heart failure according to the senators.

For more go the source of this blog post, here.

Europe: Agradil and Agreal Should be Withdrawn

The European Medicines Agency recommends the withdrawal of products containing veralipride for treating menopausal hot flushes, including Agreal or Agradil.

Veralipride was withdrawn from the Spanish market in 2005 because of reports of serious side effects affecting the nervous system.

The drug is associated with side effects, including depression, anxiety and tardive dyskinesia - both during and after treatment.

For more, go here.

DTA (Direct To Attorney Threats) Glaxo Warns Attorneys Re: Avandia Ads

In the pharma industry there is a shorthand phrase known as DTC or Direct To Consumer advertising. Here there is news that can best be described as a threat directly to attorneys:

Glaxo has sent letters to lawyers advertising for cases over the Avandia diabetes drug, demanding that they pull what the company contends are false or misleading ads.

``Lawyers have a right to advertise, but they have to play by the rules just like we do,'' Chris Viehbacher, president of Glaxo's U.S. unit, said - according to a Bloomberg.com post. It's worth your reading.

Blogs Turn 10

So says the Wall Street Journal. The article is a good, long read in print. Alas, you must be a subscriber of the paper to read it online. Cnet.com posted an article earlier this year on this milestone. You can read the article online here.

Hard to believe - for me at least - that blogs have been around for a decade. I consider myself tech savvy, and I didn't know much about them four years ago.

The contrarians out there who don't read blogs and think they are a waste of time - go ahead and think that way. For those in the law field that believe likewise, fine by me. One less competitor in the marketplace.

Injured Consumers and Lawyer Marketing

From the business information blog:


According to a recent study, more than ninety percent of all accident victims who make a medical malpractice or who seek legal redress for injuries caused by defective products, work site accidents, or harm caused by another are influenced in their choice of law firm by media advertising and the results of internet searches.

CEPAC, Inc. conducted the study.

Whether that percentage is high, close, or dead on (I would say 75% to 90%, so it's pretty much dead on), it shows that the way in which consumers choose a lawyer has long ago moved from the "referral" basis to what can best be described as the true consumer way ... much like buying detergent. a television, or a service.

At nearly every conference I attend there will be some older, 'seasoned' attorney who will speak on a topic, and suddenly careen into a diatribe about advertising attorneys. This speaker (typically over 60) will blather on and on, clueless that advertising attorneys are sitting in front of and listening to him or her. I heard one attorney call advertising attorneys "charlatans" and "a pox" on the profession. Alas, that attorney does not realize that many attorneys - of all stripes - now advertise on the web. Some advertise exclusively on the web.

When an aging lawyer complains about 'advertising attorneys' now, I will usually ask ... what type? T.V.? Radio? Yellow Pages? Daily Newspaper? Community Paper? Billboard? The Web- Google, Yahoo or MSN? Church Bulletin? Bumper Sticker? Direct Mail?

Some lawyers, like Richard Shapiro have evolved, his site is babyblindness.com and he has more sites that will showcase his talents.

Friday Diversion: Giant Banner Spell Checker

NASA's Space Shuttle Endeavour was brought to the pad, and they hoisted a banner.

Post #700 - The Arbitration Fairness Act of 2007

July 12, 2007 (Washington, DC)—Jon Haber, CEO of the American Association for Justice (AAJ), issued this statement upon today’s introduction of the Arbitration Fairness Act of 2007.

“We commend Senator Feingold and Rep. Johnson for introducing the Arbitration Fairness Act of 2007. Mandatory arbitration prevents people from having a fair chance to receive justice through the legal system when they are injured by the negligence or misconduct of others. Increasingly, corporations and their CEOs are using mandatory arbitration clauses to weaken basic legal protections and further stack the deck against Americans. Though voluntary arbitration is an effective method to resolve disputes efficiently, unsuspecting consumers should not be forced into it through typically indecipherable fine print buried on the back pages of an agreement.

AAJ supports strong consumer protection laws that level the playing field so that deserving individuals can get justice and wrongdoers are held accountable. The introduction of this bill is an important milestone in our continuing fight for justice.”

Arbitration Fairness Act of 2007

The Arbitration Fairness Act of 2007 – introduced by Senator Feingold (D- WI) – and Congressman Hank Johnson (D-GA) would prohibit the use of pre-dispute arbitration in consumer, employment and franchise agreements.

The legislation would not prohibit arbitration. Instead, it would ensure that the decision to arbitrate is truly voluntary and that the rights and remedies provided for by our judicial system are not waived under coercion. Under the bill, pre-dispute mandatory arbitration would be allowed to continue in most business-to-business agreements. The legislation would not apply to collective bargaining agreements.

Tech: Create A Branded, Custom Toolbar

From Conduit.com, I've been playing around with it -

It’s a toolbar that is similar to the Google toolbar. It has a Google-based search function, allows you to integrate (if you have it) your blog’s RSS, and lets you display news and messages. There is a nifty feature that permits feedback from your blog readers - all through the custom toolbar you design. There is a scrolling news feature as well. Best of all, you are able to link in bold face or via logo your own website.

The cost? Free.

My office now uses it on all computers, and others are kicking the tires on it as well.

Rocephin (Antibiotic) Warning

Rocephin, also known as ceftriaxone sodium, is prescribed to treat lower respiratory infections, urinary tract infections, gonorrhea and other infections.

Last week the FDA warned doctors of new risks to newborn babies, including death, associated with combining the drug with certain other treatments.

Rocephin should not be combined with calcium or calcium-containing products, following reports of an unspecified number of cases of fatal reactions in the lungs and kidneys of newborns.

The FDA issued the warning on the "MedWatch" section on its website. Also posted is a letter to doctors dated June 2007 describing the drug's updated prescribing information.

Source: Here.

Xolair (Asthma Drug) Gets Black Box Warning

The FDA finalized a strong new label warning patients and doctors about a potentially deadly allergic reaction from the asthma drug Xolair.

Xolair, given as an injection and known generically as omalizumab, is approved to treat for moderate to severe asthma (12 and older).

The previous label warned that anaphylaxis, a dangerous inflammatory reaction marked by shortness of breath, rash, wheezing and low blood pressure, occurs in about one in 1,000 patients taking the medication.

The new label, prompted by patient reports following the drug's June 2003, notes that cases of anaphylaxis were seen in roughly two out of 1,000 patients.

Source: FDA, Reuters, APand Yahoo.

"Lost-pants lawsuit for $67 million defeated in a triumph of common sense"

From the Morningjournal.com:

"Score one for the little guy. A welcome dose of reality was injected into the legal system yesterday when a judge shot down that out-of-control $67 million lawsuit against a family-owned dry cleaner for allegedly losing a customer's pair of pants.

The man who sued now has to pay the dry cleaner's court costs of about $1,000. A request to have the loser pay the dry cleaner's attorney bills also is under consideration. The judge should make the loser pay every penny of the ''tens of thousands of dollars'' it cost the Chung family to defend itself.

After all, the loser isn't some know-nothing who pulled a ridiculously high dollar figure out of the air. The loser is an administrative law judge in Washington, D.C., named Roy L. Pearson.

That's the other problem. Anybody who could file such a stunningly outlandish and abusive lawsuit over something as trivial as a pair of pants has no business making decisions involving questions of justice.

During the pants lawsuit trial last week, Pearson reportedly broke down in tears when describing his problem. At one point in his dispute with the dry cleaner, Pearson had even demanded money so he could rent a car to travel to another shop. Another leg in Pearson's case was his claim that the dry cleaner violated consumer protection laws because the shop had a ''Satisfaction Guaranteed'' sign, yet failed to satisfy Pearson."

The judge also wrote, ''A reasonable consumer would not interpret ÔSatisfaction Guaranteed' to mean that a merchant is required to satisfy a customer's unreasonable demands'' or accept demands that he could reasonably be expected to dispute.

That refreshing, common sense ruling in the pants lawsuit came from Judge Judith Bartnoff in District of Columbia Superior Court. Good for her.

GTLA Responds to the Crazy Pants Zero Verdict

From the Georgia Trial Lawyers:

The administrative law judge, Roy Pearson of Washington DC, who sued a drycleaners over a pair of pants lost in court today.

This news comes to no surprise to the President of the Georgia Trial Lawyers Association (GTLA), Joe Watkins. “Just as we anticipated, the Civil Justice System worked today. The Judge presiding over the case ruled in favor of the drycleaners—and against the man at the center of this ridiculous business dispute.” Court costs will be assessed again Pearson

Pearson filed suit against the drycleaners for $54 million after alleging that they lost a pair of his pants. “The suit itself was ludicrous. As an attorney for 30 years I am aware of the dangers that this type of sensationalism can generate. The general public cannot help but be engrossed in its details. Now that the decision has been reached, the general public can bask in what is just another example of the Civil Justice System accurately and fairly working for us all,” said Watkins.

The attorney representing the drycleaners was Chris Manning, a member of the American Association for Justice (AAJ), the national affiliate of GTLA. AAJ has been sharply critical of Judge Pearson’s lawsuit. In April, AAJ CEO Jon Haber called on the District of Columbia Bar Association to conduct a disciplinary investigation of Judge Pearson for his conduct in this matter. Haber and AAJ President Lewis “Mike” Eidson pledged to support the defendant’s defense fund and encouraged the AAJ membership to also contribute.

“It is our hope that the resolution of this case garners as much media attention as it did when it was filed. The public deserves to know the how the Civil Justice System works on their behalf,” said Watkins

The System Works: Crazy Pants Verdict: Zero ($0.00)

The attorney who sought millions for a pair of lost pants rolled a zero in Court. For now it appears the alleged shakedown by this attorney failed.

The owners of Custom Cleaners did not violate the city's Consumer Protection Act by failing to live up to Roy L. Pearson's expectations of the "Satisfaction Guaranteed" sign that was once placed in the store window, District of Columbia Superior Court Judge Judith Bartnoff ruled. Bartnoff ordered Pearson to pay the court costs of defendants Soo Chung, Jin Nam Chung and Ki Y. Chung.

Source here.

More later. I hope that the 'costs' will/may include an assessment of fees. Will he lose his ALJ position as well?

Avandia Lawsuit Filed in Texas

From various sources, including Yahoo and others:

GlaxoSmithKline has been sued, with the Plaintiff claiming that that the anti-diabetes drug Avandia contributed to the death of a 60-year-old man.

Larry Stanford died May 21, 2007. That was the date of publication of a report in The New England Journal of Medicine claiming that Avandia may increase patients' risk for a heart attack. The lawsuit claims Glaxo knew of the dangers of the drug and continued to sell it to patients, including Stanford, who died of a heart attack.

The lawsuit was filed in the United States District Court for the Eastern District of Texas. Stephen Drinnon of the Drinnon Law Firm filed the suit.

Stay tuned.

Friday Diversion: Tech That Helps You Leave the Office This Summer

I know what you're thinking: It's the first weekend of the summer, and why am I here at my desk when the beach/lake/mountain/circus beckons. Well, you have to work sometime and an article from the Huffington Post gives guidance on how you can take work with you on your boat/plane/SUV/minivan:

*Thanks to Tim Ferriss, the HP's write who authored the information, which you can find in full here.

"1. No more mail:
First, we need to cut out the crap -- reduce volume. Have your mail forwarded to special processing centers, where it is all scanned and emailed to you. One popular service is called Remote Control Mail, and there are two big benefits to the time-focused and mobile-minded: relevant postal mail is funneled into e-mail, so you can check both email and postal mail at once ("batching" both at the same time); you can travel freely whenever and wherever without ever missing a letter.

2. No more answering the phone:
Use a service like GrandCentral to listen to voicemail as they're being left. Each caller is required to announce their name before the call is dialed, and you are able to preview the name and send them to voicemail, where you can listen to their message as they leave it. If you want to speak with them, you can jump in. If not, let them leave a voicemail and -- at the set times when you batch -- go to step 2.

3. No more voicemail:
Get your voicemail delivered to your e-mail inbox, which then serves as your single communications "funnel." This would be our single "bucket" in the parlance of David Allen, and our remote control postal mail joins the voicemail here: e-mail, postal mail, and voicemail all in one place. GrandCentral can e-mail audio files, but for those who want text, Simulscribe is a popular option with near 90 percent transcription accuracy. Stop managing separate inputs from office phone voicemail, cell phone voicemail, and multiple email accounts. Consolidate. To further encourage all people to communicate with you via e-mail, there are two approaches that I've used effectively: indicate in your voicemail greeting that people must leave their e-mail address, and respond to them via e-mail; use Jott to send a voice message to them as an e-mail.

3. No more returning calls:
Pinger enables you to send voicemail to people without calling them. Why would you want to do that? From their website:

We've all been there -- you make a call and think to yourself, "please don't pick up," or you call and think "I hope I'm not interrupting..." With Pinger you leave the message at your convenience, and they get it at their convenience. Unlike voicemail, there is no ringing, no annoying prompts, no lengthy greetings -- just your message."

From me ... I use Simulscribe and Jott; just signed up for Pinger.

Site With Useful Law Practice Forms

At myshingle.com, the lawyer has compiled a great resource - she calls it "SOLOFORMANIA! A Cornucopia of Forms for the Busy Solo. "

You can find it here. She writes:

"What is SOLOFORMANIA? It's a cornucopia of forms for the busy solo - ranging from FREE sample practice guides, fee agreements and retainer letters, to court forms for all 50 states (some free, some fee) to general form files on the Internet. " Links include one to the Georgia State Bar's online forms.

Well done!

Use this now: Simulscribe

I attended a seminar this past week and learned of a service/product that's worth my while, and probably yours. It's called Simulscribe. From the site:

SimulScribe converts your voicemail messages into text. "We deliver your transcribed voicemail, along with the original audio, to your mobile phone, PDA, and/or email account."

The site also has:

Benefits

Read voicemail on your mobile phone, portable device and/or e-mail

Whether you are in a meeting, traveling, or on the golf course, you can instantly see who called, what they said, and you won't have to listen to all of your messages to find out about an important missed call

Use the SimulScribe online user interface to search, sort, archive and delete voicemail like email

You won't have to write down the information from a voicemail; important numbers, names and addresses are easy to find, easy to access and will never get lost

Respond in text or forward the message to another person

Delivering voicemails as text when you are roaming saves you money

If a message is inaudible, you can still listen to the message as an audio file that is sent direct to your e-mail or dial in to the voicemail system

Keep the same voicemail functionality that you are used to; all dial-in voicemail functionality stays the same.

I'm using it. It's worth the $10 a month.

Congressional Panel to Consider FDA Drug Safety Bill

Happens today. According to reports, a U.S. House of Representatives subcommittee will take up legislation that gives teeth to the FDA's ability to monitor prescription drug side effects post drug approval.

A draft of the bill includes parts that are tougher than those passed in a similar Senate bill. One section limits consumer drug advertisements and symbols on newly approved medications to alert patients.

Source here.

Accompli (Obesity Drug): To Be Released Drug - FDA Report

The obesity drug made by Sanofi-Aventis (Acomplia) may trigger suicidal behavior and other psychological side effects in some patients. The FDA posted on its site its review. There is a meeting on June 13, 2007 wehre experts will vote on whether it should be approved.

You can go here to read the notes in either PDF or HTML format.

From the report:

Although the literature is unclear with respect to the relationship between weight loss and depression, increased rates of psychiatric events, including depression, have been reported with weight loss agents in their package inserts: orlistat (Xenical) (depression: 3.4% versus 2.5% at Year 2) and sibutramine (Meridia) (depression: 4.3% versus 2.5%, and emotional liability: 1.3% versus 0.6%) for active drug versus placebo, respectively.

Stay tuned. The vote won't be close; my crystal ball says the vote will be for approval.

Criminal Law: A Taser's A "Calming" Device?

I don't usually write about matters relating to criminal law, but when I heard this today I had to shake my head and wonder, "what the ... ??? "

"Nuggets reserve forward DerMarr Johnson was charged with resisting arrest and interfering with police during a disturbance outside a nightclub. Police said they used a Taser on him to calm him." Source here.

A Taser fires small dart-like electrodes with attached metal wires that connect to the gun, propelled by small gas charges. A Taser 's burst of voltage is often 50,000 volts.

When I hear or use the word calm, it's usually in the context that conjures up images of a quiet beach, or the stillness of the moments before sunrise. It's NOT the word I'd use to describe what happens here:

Friday Diversion: The Surfrider Foundation

I grew up in Florida and water is a way of life for me even now. Ocean, gulf, river or lake, it does not matter to me . The Surfrider Foundation is active in preserving beach access to the general public, fill protests, and more.

Their page informs:

Surfrider Foundation's Beach Access initiative promotes the right of low-impact, free and open access to the world's waves and beaches for all people.

In nearly every state, some portion of the beach is public land, which means that all members of the public have the right to use that portion of the beach. Because much of the land between where people can park and where they can enjoy the beach is privately owned, their ability to enjoy beaches often depends on the quality and availability of access between roads and parking lots and the beach. It is simply not equitable for only some people to have access to the ocean and beaches, which are public resources.

Best Buy Defense Counsel Admits Altering Documents

From seattlepi.com:

A lawyer for Best Buy Co. has admitted that he falsified e-mails and a memo before turning them over to plaintiffs in a nationwide class-action lawsuit.

The pending case has been stayed while Best Buy looks to hire new litigation counsel. The lawyer works for Robins, Kaplan, Miller and Ciresi, and that firm has filed a Motion to Withdraw.

The altered documents are supposedly "limited" to two e-mails and one memo, and as of yet the documents have not been publicly released.

Will this make it to page one anwyhere? Fox News? The crazy pants lawyer's lawsuit makes it around the world, another attorney has TB and while his condition has nothing to do with his profession, he even gets more headlines play than Paris Hilton (at least for 3-5 days), so can people expect the same from this news? I won't hold my breath on it.

The FDA: Who's Guarding the Guards?

Juvenal was a Roman poet active in the late first and early second centuries. Juvenal is credited with the creation of the phrase, Quis custodiet ipsos custodes? It has been translated as "Who will guard the guards?" or "Who watches the watchmen?"

That phrase comes to the fore when I read today's most recent FDA-related news. Once again - in another Congressional hearing held this week - several lawmakers rebuked the FDA for failing to protect consumers. Congressman Henry Waxman says that despite warnings, the FDA never required the drug maker to conduct a thorough post-market study of heart risks . Source
here.

When will it end? The FDA is broken. It's going to take a generation to repair.

Actos (Diabetes Drug) To Add Boxed Warning

Actos - the rival drug to Avandia - made by Takeda, will have added to its package insert a black box warning. The warning will increase awareness of risk of congestive heart failure. There are reports that the FDA asked to have the warning added. Source here.

From philly.com:

An FDA commissioner told Congress on 6/6/07 hat the FDA was ordering GlaxoSmithKline and Takeda Pharmaceutical Co. Ltd. to add "black box" warnings to their diabetes drugs Avandia and Actos, strengthening existing warnings about heart failure, a condition where the heart does not adequately pump blood.

Congestive heart failure (CHF), or heart failure, is a condition in which the heart can't pump enough blood to the body's other organs. This can result from

• narrowed arteries that supply blood to the heart muscle — coronary artery disease
• past heart attack, or myocardial infarction, with scar tissue that interferes with the heart muscle's normal work
• high blood pressure
• heart valve disease due to past rheumatic fever or other causes
• primary disease of the heart muscle itself, called cardiomyopathy.
• heart defects present at birth — congenital heart defects.
• infection of the heart valves and/or heart muscle itself — endocarditis and/or myocarditis

Source: Here.

Avandia (Diabetes Drug): FDA Hearing on 7/30

July 30th is the day that GSK's Avandia is in the spotlight before the FDA.

The FDA said it would gather members from its advisory committees on endocrine and metabolic drugs and on drug safety and risk management. The advisory panel will discuss the cardiovascular risks of the class known as thiazolidinediones, "with a focus on rosiglitazone, as presented by FDA and GlaxoSmithKline," the FDA said.

Stay tuned.

FDA Hot Topics Website

Worth a look, go here.

http://www.fda.gov/oc/opacom/hottopics/default.htm

20 Sure-Fire Ways to Come up with Great Ideas

Reading the nonbillable hour, there's a link to "20 Sure-Fire Ways to Come up with Great Ideas" which can be found here.

Several of the items make sense. One of the ideas (to me) is not a good one to practice:

"1. Carry a notebook.

Have a little notebook that you carry around with you wherever you go, including to bed. I like Moleskine notebooks, but any pocket-sized one will do. When you get an idea, write it down — right away. Even if you have to stop the car in order to do so. Ideas are fleeting, and you must write them down before they’re gone again. "

There is one, however, that I cringe when I read anywhere or have told to me:

"5. Exercise.

Running, for example, is a great way to come up with ideas. First of all, exercise gets your blood circulating, which seems to stimulate your mind. Second, you’ve got some quiet time to think. And finally, the peaceful scenes of nature that you pass when you’re running seem to inspire great ideas. Any kind of exercise will do, though."

To me this is always a bad idea. Running (my exercise of choice) is the time to get away from thinking. Yes you read that right. For me (and certainly for others) the day is jammed with pressure, meetings, calls - work. I leave all of that behind for the sometimes too short times when I run. I turn the music on loud and forget - forget bills, calls, tirades, bad news, good news, people.

The ad which has caught my eye recently is the one for Propel water, referred to as the Propel Stress Monster (the one where the "boss" meets his demise during the ad:




Other than that, the list is a good place to start.

FDA Seizes Shelhigh Patches and Valves

From the FDA's site:

The Food and Drug Administration seized all implantable medical devices from Shelhigh, Inc., Union, N.J., after finding significant deficiencies in the company's manufacturing processes. The deficiencies may compromise the safety and effectiveness of the products, particularly their sterility.

The products include pediatric heart valves and conduits (tube-like devices for blood flow), surgical patches, dural patches (to aid in tissue recovery after neurosurgery), annuloplasty rings (to help repair heart valves) and arterial grafts. The tissue-based devices are used in many surgical settings, including open heart surgery in adults, children and infants, and to repair soft tissue during neurosurgery and abdominal, pelvic and thoracic surgery. Critically ill patients, pediatric patients and immuno-compromised patients may be at greatest risk from the use of these devices.

All medical device companies must follow current good manufacturing practice, a set of requirements that help to ensure the safety and effectiveness of all medical products. Shelhigh's violations include: manufacturing products in a facility with a poorly constructed and poorly maintained clean room where sterilized devices are further processed; failing to adequately monitor critical manufacturing environments for possible microbial contamination; failing to properly test products for sterility and fever-causing contaminants; and failing to scientifically support product expiration dates.

Physicians should consider using alternative devices. Physicians should also monitor patients with a Shelhigh implant for infections and proper device functioning over the expected lifetime of the device. Patients who think they may have received a Shelhigh device during surgery should contact their physician for more information. FDA will issue a Preliminary Public Health Notification to physicians and other health care professionals and a Preliminary Advice for Patients shortly with more information; those documents will be posted to FDA's Web site.

The seizure follows an FDA inspection of the Shelhigh manufacturing facility last fall, as well as meetings with the company at which FDA warned Shelhigh that failure to correct its violations could result in an enforcement action. FDA also alerted the company to its manufacturing deficiencies and other violations in two warning letters.

Medical devices manufactured by Shelhigh include:

• Shelhigh Pericardial Patch
• Shelhigh No-React Pericardial Patch
• Shelhigh No-React PneumoPledgets
• Shelhigh No-React VascuPatch
• Shelhigh No-React Tissue Repair Patch/UroPatch
• Shelhigh Pulmonic Valve Conduit No-React Treated
• Shelhigh No-React Dura Shield
• Shelhigh BioRing (annuloplasty ring)
• Shelhigh No-React EnCuff Patch
• Shelhigh No-React Stentless Valve Conduit
• Shelhigh Internal Mammary Artery
• Shelhigh Gold perforated patches
• Shelhigh Pre Curved Aortic Patch (Open)
• Shelhigh NR2000 SemiStented aortic tricuspid valve
• Shelhigh BioConduit stentless valve
• Shelhigh NR900A tricuspid valve
• Shelhigh MitroFast Mitral Valve Repair System
• Shelhigh BioMitral tricuspid valve
• Shelhigh Injectable Pulmonic Valve System

FDA.org is the source.

The Story Behind Ketek

From the St. Pete Times: A detailed article that sheds light on a system that can best be categorized as a mess.

The paper notes how Dr. Anne Kirkman Campbell, a family practice doctor in Gadsden, Ala., signed up 400 patients at $400 a pop to enrol in a Ketek study. When at least one patient withdrew, the doctor forged a consent form and faked the data. The drug's maker however didn't inform the FDA of the action, according to reports. The drug maker just included the faulty data in the reports on the drug.

The paper notes that as FDA's drug approval division checked out the Ketek data, its inspectors were conducting routine audits of the biggest study sites. Their first stop was Campbell's office, where they found violations and called in the FDA's criminal investigators.

You can read the whole story at the St. Pete Times site, or posted on a blog here.

In my opinion, this is more of the same from the FDA. Created to protect consumers, it instead acts to betray the public's trust. Having read "Dispensing with the Truth" (a book detailing the rise and fall of the drug Fen-Phen) this unfortunately does not come as a surprise.

The web has legions of articles on Ketek and the congressional fallout, as well as the worldwide scandal .

Iowa's Senator Charles Grassley's sub-committee heard the testimony that one of the doctors used in the drug's safety study had falsified results, and that FDA managers hid that fact from the FDA panel that recommended the drug, and that the FDA then used unscientific foreign reports of the drug's side effects to claim it was safe. And when cases of death and injury began to appear, the testimony alleges the FDA did not issue an adequate new warning label for at least a year. (Link)

You'll see more to this, and this scandal will not be the last.