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 Also, legal developments and amendments to the Settlement Agreement may cause some of these documents to become outdated."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.