Wednesday, April 26, 2006

Canada and the Infected Tissue/Bone Scandal

It is not just in Oklahoma City, or Atlanta, GA or on Long Island. News today shows that this is a problem for all of North America:

A Vancouver woman who found out that she may have received infected donor tissue during reconstructive eardrum surgery in 1994 is proceeding with what she thinks may be a class-action lawsuit against St. Paul's Hospital, the B.C. Ear Bank and a number of other defendants.

The lawsuit follows a Health Canada order three years ago to recall all unused tissue and bone distributed by the B.C. Ear Bank and notify all recipient institutions.

The scandal was reported by The Vancouver Sun in 2003. It was noted that St. Paul's Hospital officials acknowledged problems with the record-keeping and day-to-day operations of the B.C. Ear Bank, which had been housed in the hospital since 1995 but was shut down in 2002.

The ear bank, which collected, processed and stored bone and tissue, distributed 6,016 specimens to about 80 hospitals across North America for transplant and research purposes.

Source: Canada.com

Merck Article in Fortune

Good stuff on Fortune.com regarding Merck's "fight every case" strategy:

"Merck's defense of Vioxx is beginning to look ugly - and costing the company millions in legal fees and punitive damages. But make no mistake, the company's fight-every-case strategy is still its only rational option ...

For those of you keeping score at home, Merck has some 11,500 more cases to fight. So far, the company has faced six plaintiffs (in five trials) and prevailed against three of them. They're playing .500 ball.

In spite of some high-dollar jury awards, the company's general counsel, Ken Frazier says he's satisfied with the better-than-expected win-loss tally.

The key question before juries is: Did Vioxx cause this particular plaintiff's heart attack? So far, some jurors show a willingness to hear both sides and eliminate plaintiffs who appear to have invalid claims.

That's exactly the kind of consideration Merck needs. Despite what they say, Merck's lawyers don't really intend to fight every one of these 11,000 cases. The company's current strategy is a temporary one.

To most legal experts, it's the only legal strategy that makes sense. "What's the alternative?" asks Andrew Kaufman, a professor of law at Harvard University. "If you establish a settlement fund at this point, you're asking more people to file suit. A settlement in the absense of trials means inflated costs."

The only scenario in which they won't settle is if they win so much that all the plaintiffs go away. Based on the record so far, that isn't likely to happen."

Monday, April 24, 2006

Garza Vioxx Verdict: Trial Analysis

This case was tried only one week per month and as a result not easy to track. A member of the trial team provided the analysis below:

Leonel Garza was a 71 year old smoker with an extensive cardiac history - prior heart attack, bypass, stent placement. Retired military who worked as assistant County Auditor until he retired from that as well. Very active and careful since had previous heart problems. His wife testified that he had cut down his smoking from two packs a day to 3-4 cigarettes a day. Hypertension, hyperlipidemia, treated and well controlled.

Garza visited a cardiologist 3/27/01 complaining of arm pain. Doctor placed him on a seven day trial of an "anti-inflammatory" Only reference to Vioxx was a note made on billing sheet. Had a thallium scan performed which showed good perfusionand only mild abnormality in the region of previous mi. Dr Juan Posada (not his regular cardiologist) saw him in follow- up on 4/4/01 as Dr Evans was out. His notes reflect that he had arthritis symptoms which had "improved markedly" (because of the Vioxx)

Wife testified that Dr. Posada provided samples until his next visit (in a month) with Evans. His records reflected that he offered the "possibility" of a cath but garza wanted to discuss it with Evans. Posada agreed with the decision based on the absence of symptoms. Although Posada's records do not reflect that samples were provided, he testified that it was possible. Additionally, he said that it was more likely than not that a reasonable and prudent physician would continue medication that provided pain relief. Records also reflect that he was on 'optimal medical management"

On April 21, 2001, he was found dead beside his truck at his ranch. Autopsy revealed two fresh thrombotic occlusions. Case tried by David Hockema and Joe Escobedo from the firm of Hockema Tippett and Escobedo of Edinburg, and Kathy Snapka Turman& Waterhouse of Corpus Christi. Ms. Snapka provided this analysis.

Saturday, April 22, 2006

Bonescandal.com: Infected Bone and Tissue Site

We have put together a website that details the widening contaminated/infected bone and tissue scandal. Also this weekend, you can read about the Tainted Body Parts scandal in the south at ajc.com.

You can find it by going to www.bonescandal.com. It details the potential or alleged wrongdoers and provides information on what is happening now.

Texas Garza Vioxx Verdict: For Plaintiff

$32 million for the Estate, punitives awarded. More information to follow. Most who followed the case are surprised with the verdict.

Friday, April 21, 2006

Bone and Tissue Scandal: News hits in the U.K., Texas & OK

Recent articles in the Oklahoma City, OK newspaper as well as articles in Austin, Texas, Long Island, NY and Iowa newspapers tend to be more straightforward when detailing the infected/contaminated tissue and bone scandal. Not so in the U.K.

From the Observer's online edition, you can read the story that includes this text:


Every graveyard tells a story. The Maple Grove Cemetery in New York is no exception. Its tombs mirror the waves of immigration to this bustling corner of the city. Inscriptions on older stones, flecked with moss, are mostly Jewish or English. The newer ones, shiny and polished, bear Chinese names, or Indian, or Hispanic. Each grave is a full stop on an individual life: a point of final departure and no return. Except for one.


You can read more by going here.


You can also go to www.bonescandal.com for more information.

Thursday, April 20, 2006

Garza Trial: Attorney asks for $1B +

I just shake my head at tactcic like this. From Reuters:

In the Garza trial, the damage request includes $22 million for mental anguish and personal loss and $1 billion in punitive damages.

As was noted in my earlier post, punitive damages in that case have been capped at $750,000 under Texas law, meaning the Plaintiffs could collect no more than that even if the jury awarded the full $1 billion.

Florida: Battle rages over PIP

From various sources including the Miami Herald, the AFTL, the Bradenton paper, and the PB Post:

The Senate's no-fault auto insurance bill is picking up some steam, but it does not include many of the measures that insurers want. By way of background, the bill would extend the state's no-fault law to 2009, which is now set to expire in October. The designated October date is the "sunset" date.

On the House side, a companion bill will be heard today that extends Personal Injury Protection to 2012.

The bill gives $2.6 million to add 19 positions to the Department of Financial Services' Division of Insurance Fraud and provide pay raises for existing personnel. It also adds $750,000 to pay for six new assistant state attorneys to work solely on insurance fraud cases.

Florida is one of twelve states with no-fault auto insurance laws. Each driver must buy at least $10,000 in PIP coverage, which guarantees medical, disability and death benefits. In return, accident victims give up the right to sue for pain and suffering unless they have sustained a permanent injury.

For their part, most healthcare providers and attorneys would like to see the current law extended with no changes.

I'm licensd in Florida. When PIP-type coverage was done away with in Georgia the battle cry from the insurers was 'lower premiums' but that of course never materialized.

In the end, unpaid bills from auto wrecks were paid by ... guess who? If you said "taxpayers" you would be right. Many bills are now submitted to Georgia Medicaid which pays them and in return seeks some level of subrogation.

A Post Worth Reading: Duct Tape Marketing

John Jantsch at Duct Tape Marketing has a blog worth reading. Last week he wrote: Your Marketing Stinks and It's Your Fault.

While he writes for business, you may find his posts helpful if you run a law firm. He wrote last week:

The reason so many small businesses struggle is because they are unwilling to change. The marketing strategy, if there is one, is to do what everyone else in the industry seems to be doing. If that's your marketing reality, that little safe place, and it's not working, the first thing you have to come to grips with is that it is your fault... The only marketing strategy you need to worry about as a small business is to find a way to be unique.

Would this apply to law? It's worth looking to see what niche may work. The key is sticking to any marketing plan. For my law practice in Georgia one key component to our marketing plan: When it comes to a specific type of referral from a fellow lawyer, I pay that attorney/firm 50% of any legal fees derived, and when a case is successfully concluded, the client receives a letter directing him or her back to the originating firm. I don't keep that client in our database for any marketing purposes.

The problem I see is not so much having a unique marketing plan. The plan 'stinks' - fails - in the law business when there is insufficient execution of the plan.

Vioxx: Garza Trial (TX) Damages Capped

In the Texas State Court case involving Garza (a short term use case), yesterday the Court refused a Plaintiffs' request to ask jurors to decide during deliberations whether Merck had criminally caused the death of an elderly person.

What does the ruling mean? Merck, under Texas law, will now face at most a $750,000 capped award for punitive damages (if any). A ruling the other way would have taken all limits off.

The Plaintiff is Leonel Garza of Rio Grande City. He died of a heart attack in 2001 after taking Vioxx for no more than 24 days for arm pain. Merck has introduced evidence showing a 20+ year history of heart disease.


Sources:
This is from Reuters, Yahoo, the local TX papers.

Wednesday, April 19, 2006

Tequin (An Antiobiotic) News: Link to Diabetes?

Tequin (gatifloxacin), an antiobiotic is that widely prescribed, may be linked to diabetes and other blood sugar conditions and disorders.

The New England Journal of Medicine will publish a report shortly that shows Tequin users had 17 times greater risk of developing serious diabetes and 4 times greater risk of being hospitalized with low blood sugar complications than patients using other antibiotics.

Last month, the Canadian study released linked Tequin to diabetes and other blood sugar disorders. Dr. David Juurlink of the Sunnybrook and Women's College Health Sciences Center in Toronto asked the health industry if it would be perhaps in consumers' best interests to pull the drug. Go here to read the NEJM article in summary form.

This year FDA added a warning to the Tequin label. What is significant however is the report that problems can arise from short term usage of the medication.

NJ Vioxx Court Update, April 2006

From a recent case management conference:

Judge Higbee is concerned about a mass filing of cases on September 30,2006.
The Judge would prefer that cases a filed in smaller batches,
periodically between now and the September 30, 2006 SOL deadline.

The Court has proposed several measures to expedite future Vioxx
trials, including providing juries with: stipulated calendars and
summarizing key dates.

The Court has expressed interest in addressing stroke and GI-injury
cases on file.

The Court denied Merck's motion to stay the NJ litigation pending
appellate review of the Cona/McDarby decisions.

Bone and Tissue Scandal: Funeral Home Raided in Philly

From various sources including the Philadelphia paper online:

The D.A.'s office raided a funeral home located in Kensington, PA. The reason? Interviews are being conducted in an attempt to obtain informtino of the home in the developign body-parts scandal.

Philly investigators have talked to at least two former techs from Biomedical Tissue Services Inc. ("BTS"). Several now allege BTS removed bones, veins and tendons from corpses of deceased Philadelphians, according to sources close to the investigation. (Per the Philly papers)

The D.A.'s office is investigating how many Philly corpses were dissected, how much money was exchanged for the work, and how several funeral homes began a contractual relationship with BTS.

In PA, only corneas can be taken from corpses inside funeral homes.

You can read more at www.bonescandal.com. I know that my friend Steve Gacovino is also on the web at infectedtissueandbone.com.

Tuesday, April 18, 2006

Tech This N' That: Shorttext.com

Shorttext.com is a site where you can post any information and share it with others. Post your text below and we will save it and generate a URL for you. This URL is for you to distribute, print, post, so says that site.

It's a nifty little site that can help in a pinch. Today I was in another's office, and found a site that I thought I could use later. I didn't want to log in to my email, or have someone come over to the PC to show me a way to email the site. I went to shorttext.com, pasted the link, and emailed it from that site. It creates a URL to be emailed. Know that there are public and private URL linke you can create.


Hope you put the site to good use. Did I mention the site is free?

Fosamax News (Bone Loss Drug) - Merck's Next Litigation Problem?

Fosamax made the news last week.

Fosamax is a drug indicated for the treatment and prevention of osteoporosis (thinning of the bones) in men and women. A study recently linked the use of bisphosphonates, such as Fosamax with osteonecrosis of the jaw. It is frequently referred to as "jaw death." Merck makes this drug.

Osteonecrosis is a bone disease that few have heard of. Somewhere between 10,000 and 20,000 people are diagnosed with this disease each year in the United States alone. You can read more about the condition here.

The condition is associated with the interference of the blood supply to the bone and the consequential damage that occurs. Osteonecrosis of the jaw can be painful and could lead to infection, breakdown of the jawbone, and ulcerations in the lining of the mouth.

From the Online Journal:

The osteoporosis drug Fosamax has been on the market for a little over 10 years now. Drug maker Merck promoted it heavily by selling women the fear of a disabling hip fracture and the necessity of regular bone-density tests. Merck's initial TV advertising campaign featured a slim woman in her mid-40s, conveying the notion that testing was appropriate for women in this age group.

n a 2004 letter published in the Annals of Internal Medicine, researcher Susan Ott, MD, of the University of Washington wrote: "Many people believe that these drugs are 'bone builders,' but the evidence shows they are actually bone hardeners."

In a December 13, 2004, press release, doctors at Long Island Jewish (LIJ) Medical Center announced that they had discovered a link between a common chemotherapy drug and a serious bone disease called osteonecrosis of the jaw (ONJ).

The discovery, published in the Journal of Oral and Maxillofacial Surgeons, prompted both the FDA and Novartis to issue warnings to physicians and dentists about the risk for the potential adverse effect.

You can read more about the condition at that site.

Thursday, April 13, 2006

Vioxx Verdict in NJ: A Juror speaks

From AP, Newsday.com, and Yahoo!:

Carla Tennyson was one of the jurors in the McDarby case. She has been reported as saying, that Merck has "an obligation to tell us the facts and let us decide if the risk was worth taking," she said. "That's all it is. For me, it was right from the beginning the label. They could've gotten a new label in 30 days, as soon as they realized there was a problem. They didn't."

Also, it should be noted that in New Jersey the punitive damages award might result in a criminal probe. That state requires that punitive damages cases be referred to the county prosecutor and the state Attorney General's Office for investigation into whether a criminal act was committed.

The statute is 2A:15-5.17. "Record referred for criminal investigation" and provides "Upon the conclusion of any action in which punitive damages have been awarded, the court shall refer the record of that action to the prosecutor of the county in which the case was tried and to the Attorney General for investigation as to whether a criminal act has been committed by the defendant."

Tuesday, April 11, 2006

The Widening Scandal: Contaminated Bone and Tissue Implants

My office is investigating what to me are some of the most disturbing claims I have run across as an attorney. Patients have had implanted in them without their knowledge infected or contaminated bone and tissue parts while undergoing surgery for a back injury, a dental injury, or a fusion. Good hardworking people are now suddenly getting sick. Some have been diagnosed as having Hepatitis B or C, or worse. I wanted to jot down in a longer form what is happening to these folks to alert counsel across the country.


Bone and Tissue for Sale- How this scandal began

The practice of illegal trafficking in human organs, body parts, and tissue has made the news lately, and people have been indicted over the practice. Paitents who had bone or tissue implants placed in them without their knowledge are now getting sick and developing diseases like Hepatitis B and worse.

While the scandal of stealing bones from cadavers being falsely certified as clean continues to erupt in the headlines and the courtrooms, where did this mess all start? I can trace it back to UCLA’s Director of the Willed Body Program, Henry Reid. Reid was arrested and a criminal investigation launched several years ago.

The UCLA Medical Center investigation started in 1998. In March of 2004 Ernest Nelson was arrested - he claimed to have paid Director Reid hundreds of thousands of dollars for permission to enter the UCLA body freezer and and harvest body parts from hundreds of cadavers. You can read more here
about the arrest. The Los Angeles Times reported in 2004 that it was shown invoices on a UCLA letterhead indicating 496 cadavers were sold for a total of $704,600 between 1998 and 2003. One client was pharmaceutical giant Johnson & Johnson. Go here for the article.

Companies in the medical industry pay for a wide range of body parts including skin, scalps, teeth, skulls and bones, which are then used for among other things surgery. Heart valves can fetch $5,000 to $7,000 each. Skin, used to dress the wounds of burn victims, can go for $1,000 a square foot.If a single body could provide all its organs, the cadaver would be worth $150,000.

In 2004, Johnson & Johnson was named in court documents as having contracted with Nelson for human tissue. Later, a California law firm filed a class action.

The quest to have a class certified in that state failed. The California Court of Appeal issued a decision that may materially affect the ability to certify the matter. In Bennett v. The Regents of the University of California, 133 Cal.App.4th 347 (2005), the Court of Appeals, in dicta, implied that cases involving the mishandling of human remains do not generally lend themselves to class certification.

The Risk:

One of the risks associated with the illegal harvesting or snatching of body parts is that the ones who do it avoid screening and testing procedures set up and maintained to ensure recipients will not receive diseased or contaminated tissue, bone, or organs. With the possibility that many patients could receive tissue or bone from a single infected cadaver, the potential for a medical catastrophe cannot be minimized.

The FDA has issued reports on the harvesting, and in December of 2005 wrote on its website:

The Food and Drug Administration (FDA) is notifying the public of its investigation of human tissue recovered by Biomedical Tissue Services, Ltd (BTS) of Fort Lee, NJ and sent to tissue processors. Some of this tissue (e.g., human bone, skin, tendons) may have been implanted into patients from early 2004 to September 2005. The tissue was recovered by BTS from human donors who may not have met FDA donor eligibility requirements and who may not have been properly screened for certain infectious diseases.

Of special interest to periodontists are LifeCell Corporation, which produces Alloderm for BioHorizons, Inc., and Totugen Medical Inc, which produces Puros for Zimmer Dental. No adverse reactions related to these tissues have been reported at this time and the FDA and the Centers for Disease Control (CDC) believe the risk of infection from these tissues is low. It is important to determine whether the allograft material is from the recalled lots. Dentists and physicians who have obtained tissue affected by the recall should have been notified by now

You can find that information by going here. This news was preceeded by an October 2005 alert titled: FDA Provides Information on Investigation into Human Tissue for Transplantation, which can be found here.

In November, Medtronic informed the FDA that it had tracked 13,000 contaminated samples, and had 8,000 implanted.

News in 2006

In Brooklyn New York, more than one thousand bodies are part of the District Attorney’s investigations into the theft and sale of bones and other body parts removed from fresh corpses at several funeral homes, without permission. These were then sold to BioMedical Tissue Services, a Fort Lee, N.J., tissue recovery company run by Michael Mastromarino. There have been indictments issued, and they were handed down in February of this year. Go here for more information. The prosecutor has been quoted as saying that the case was "like something out of a cheap horror movie." Bones were replaced with everything from broomsticks and pipes to plumbing supplies. An AP photo can be found below showing just that:




BTS is not alone. Lifecell Inc. has issued a recall of certain products made from body parts acquired from BioMedical Tissue Services. They are AlloDerm, used for plastic surgery, burn and periodontal procedures; Repliform used for gynecological and urological surgical procedures; and GraftJacket, used for orthopedic applications and lower extremity wounds.

The Philadelphia Inquirer reported last month that more indictments are expected.

In addition, many medical facilities and hospitals have directly written to patients to notify them of the possibility that they may have contracted any one or more of a number of serious and even life-threatening diseases from the bone or tissue grafts they received.

For example, The North Shore-Long Island Jewish Health System has mailed letters to former patients alerting them that they may have been exposed to potentially contaminated body parts. The letters state the hospital had indirectly received human bone, skin and tendons from BioMedical Tissue Services, which may not have properly screened the items for infectious diseases.

Health officials are concerned that tens of thousands of people across the country, and possibly more on Long Island, may have been exposed by untested parts from BTS

BioMedical is already being sued by many who claim a relative’s body parts were stolen from the grave and sold to the New Jersey company. Hundreds are already being tested for various diseases. BTS supplied bone, skin and tendons to various processors, who in turn provided them to distributors.

From the news developing, many of the body parts used on Long Island were purchased from BioMedical by a Florida tissue bank responsible for testing and sterilizing every body part it buys. Regeneration Technologies, based in Gainesville has or will be inmplicated.


Based upon the revelations so far, the scandal involving body parts, tissue, and bones promises to be major news for the next eighteen months or more.

Sources include:
nypress.comas well as articles on newsinferno and the daily news, and the FDA or at www.bonescandal.com

McDarby Vioxx Trial: $9 Million in Punitives

You can read more at Yahoo and Reuters.

Print from your computer to any Kinko's anywhere

"Print anywhere in the world" is the title of a post you can find at The Practice Blog. When I'm on a trip I carry a list of Kinko's that are near my hotel or meeting, because you just never know when a web connection will fail, or you need something that you may have forgotten. This post to me is golden, and I repost it in full ...


This link will bring you to Kinkos. You can download and install software. When you are ready to print a document, you click on this, and off it goes. You can have it bound, hole punched, or enlarged.

So many uses for this. You can print a document to the Kinko's nearest a client and then the client can just pick it up. A virtual law clerk could research and write a memo and then have the attorney pick up a printed version. Law students could use this to print out papers and save the hassle of printing it at home, especially late at night the day before it is due when printers have a habit of breaking.

This is a great little program that you can use.

Many thanks, Jonathan and Terry!

Ban Xenical, Public Citizen urges

Public Citizen petitioned the U.S. Food and Drug Administration to remove from the market the prescription version of Xenical (orlistat, made by Roche Pharmaceuticals) because the obesity treatment has been known to cause a significant increase in aberrant crypt foci (ACF), which are widely believed to be a precursor to colon cancer.

Last week, the FDA sent an “approvable” letter concerning the over-the-counter (OTC) version of orlistat to GlaxoSmithKline, which has applied to market this version. Despite safety concerns, if GlaxoSmithKline meets the conditions set by the FDA – conditions that have not been made public – this would make the drug eligible for final approval for OTC sales.

For more information, go here.

Monday, April 10, 2006

HIPAA Preemption Analysis by State

Thanks to the folks at the HIPAA blog for the link:

HIPAA Preemption Analysis of State Privacy and Security Laws: You can find it
here, at the site National Association of Chain Drug Stores Foundation.

For example, for Georgia you can find this:

Are there any statutes or regulations governing the privacy of a customer’s personal information used or disclosed by a retail pharmacy?

Yes, in Georgia there are privacy-related statutory and regulatory requirements in the following areas:

· Confidential Information
· Disclosure
· Pharmacist-Patient Privilege
· HIV/AIDS

In addition, there are information-related statutory and regulatory requirements in the following areas:

· Record Maintenance
· Records of Dispensing
· Automated Data Processing Systems
· Transmission of Prescriptions
· Transfer of Prescriptions

McDarby: Court denies Motion to Dismiss Punitives

Read more here

Friday, April 07, 2006

Vioxx: Gilmartin on the stand

It's the first testimony in any trial setting by Merck's former chief, Raymond Gilmartin. He testified in the punitive damages phase of the McDarby trial.

You can read much more by going to the Forbes site, here.


From the Philly paper:

Gilmartin appeared to be taken off-guard once when attorney Mark Lanier showed him an e-mail from his onetime chief scientist that appeared to question Gilmartin's leadership. Edward Scolnick wrote an email to new CEO Peter Kim, expressing hope for a "reborn" Merck under a "new CEO" who would not restrict Kim's freedom as Scolnick's had been restricted "in recent years."

Gilmartin, was shown that email after he had finished testifying that Scolnick was a great scientist dedicated to safety. He paused when the email was discussed.

Go here for more.

From the Forbes article:

During the hearing, Lanier showed jurors an internal analysis Merck performed in October 2000. It pooled data from clinical studies and allegedly indicated that Vioxx users suffered more than twice as many heart attacks as those on comparison drugs used in the studies.

The attorney declared that the analysis was never given to the U.S. Food and Drug Administration. "So you are telling us it was important enough to do the study but not important enough to send to the FDA?" Lanier asked him.

"No, I'm not telling you that at all," the AP quoted Gilmartin as snapping back.

Thursday, April 06, 2006

On the Cona Verdict - Attorneys' Fees Award

For those out there that think that Mark Lanier will only earn a contingency fee from the $135 dollar verdict ... he will seek substantially more.

The NJ statute dealing with consumer fraud allows for an application of attorneys' fees. Each case had a consumer fraud count which was ruled on in favor of the Plaintiff.

You can surely expect that in Lanier's application for fees, he may seek more than $400,000.

Vioxx Verdicts: For Plaintiffs

Well, sort of. By now most are digesting the impact of the verdicts yesterday in New Jersey. The McDarby case verdict exceeded $4 million, while the Cona case essentially was a zero (a jury award of $45, trebled to $135).

As they say in the South, the verdicts makes the claims against Merck "clear as mud."

A few thoughts:

* Merck now knows that there are two firms that can beat the Company in trial.

* Will Mark Lanier's fiery Texas style litigation work in New Jersey? It didn't work on the Cona case. He has an office now in New York, so he is in for the long haul.

* Did the N.Y. Firm of Weitz & Luxenburg have an East Coast style that plays better?

* Causation: Lanier took the approach that the marketing of the drug was the key part of fault here. That worked in his Texas verdict, but here the question was one of causation, as it should be.

The punitive damages phase on the McDarby case starts this morning, and as a result the damages could top $20 million.

Mr. McDarby is quite ill from all reports. He had a heart attack on April 15, 2004, at home in Park Ridge, N.J. McDarby said he took Vioxx daily for four years for arthritis. He is now confined to a wheelchair. He spent 34 days in the hospital and 69 days in a rehabilitation center before coming home. He cannot get up out of a chair, he can't get out of bed on his own, he can't dress himself and hHe needs assistance going to the bathroom.

What is signficant is that Mr. McDarby had significant risk factors when placed on Vioxx - his age, diabetes, high blood pressure, and clogged arteries. In December of 2004 many attorneys would have possibly turned down his case because of the risk factors. I saw a claim involving risk factors as one where Vioxx was in essence throwing gasonline on a fire. You can read the definitive study on risk factors in the Framingham Study.

The News: Once again lazy reporting on many TV outlets. Most reasonable attorneys would not see a $45 verdict as a "W." On a news report here in Atlanta last evenign, the sixty second blurb about the verdict included a teaser about two jury verdicts against Merck. The report said that Merck lost two cases in a State Court in New Jersy, including one verdict for more than four million dollars.

The real verdict on this litigation? Too early to tell. Mike Galpern is up next.

More later.

Tuesday, April 04, 2006

Vioxx Trial: Desperate Executives?

Plaintiff's Attorney Mark Lanier captivated the courtroom yesterday in closing argument on the Cona case.

Lanier presented his 70-minute closing statement to the jury in the form of a TV series he called 'Desperate Executives' - a takeon the popular series "Desperate Housewives." Lanier's fictional series consisted of four episodes: "Shoot for the Moon"; "Trouble in Paradise"; "The Cover Up"; and "Game Over."

The story, Lanier said, began with the desire to make money from Vioxx, progressed through a series of evasions and denials that the drug caused heart attacks, and ended with Vioxx being criticized by a number of scientific reports.

Great stuff. Read more here.

Monday, April 03, 2006

Vioxx: Cona closing arguments

Closing arguments begin today:

A Merck lawyer told the jury in the Cona joint trial that there was no evidence in the latest Vioxx trial that the painkiller caused the heart attacks of two men who have sued the drug maker.

Christy Jones said the two men had coronary artery disease, and one of them had diabetes, a risk factor for heart disease. Jones also said Merck acted responsibly in studying Vioxx's risks and warned of the risks in the drug's label.

Jones walked jurors through a timeline of studies of Vioxx since it was launched in the U.S. in 1999. Merck followed up on studies suggesting Vioxx had risks, and submitted all data to the FDA. The FDA itself approved additional uses for Vioxx even with these risks, which were added to the drug's prescription label, Jones said. Plaintiffs' attorneys are set to make closing statements later Monday, after which the case will go to the jury.

Wednesday, March 29, 2006

Plaintiff's Motion in Limine (form)

(From last year)

I file a Motion in Limine on general issues early so that I can set the tone for depositions and other discovery issues that crop up during a case. Almost always, I file an extensive MIL within sixty days of service of an Answer. The MIL is lengthy, but I have won every single point, or had defense counsel agree to them in advance.

FIRST MOTION IN LIMINE

Plaintiff files this Motion in Limine and moves this Court for an Order prohibiting counsel for the Defense from making any comment, directly or indirectly, in any manner whatsoever, concerning any of the matters set forth:

1.APPROACH THE BENCH: Plaintiff requests that Defense counsel first approach the Bench and obtain a ruling of the Court outside the presence and hearing of all prospective jurors, or jurors ultimately selected in this case, in regard to any alleged theory of such matters contained herein, at trial and mentioned to jury at Voir Dire.

2. INFORM WITNESSES: Plaintiff moves the Court for an Order directing counsel to inform any and all defense witnesses of the Court order regarding these matters, and to instruct any and all such witnesses to refrain from mentioning any such matters in the presence and hearing of all prospective jurors or jurors ultimately selected in this case until defense counsel has obtained a ruling in compliance with this order that such matters would be admissible as evidence in this case.

3.COLLATERAL SOURCE PAYMENTS/BENEFITS: Any reference or suggestion that Plaintiff has received, has been entitled to receive, will receive, or will become entitled to receive, benefits of any kind or character from a collateral source, including, but not limited to, the following: (A) Benefits from collateral insurance coverage; (B) Services furnished without charge; (C) Compensation for time not actually worked; (D) Social Security or pensions; (E) Workers' compensation benefits; (F) Medicaid or Medicare. See Denton v. Conway Express, Inc., 261 Ga. 41 (1991); Georgia Power Co. v. Flagan, 261 Ga. 41 (1991); Bennett v. Haley, 132 Ga. App. 512, 525 (1974). See also Warren v. Ballard, 266 Ga. 408 (2), 467 S.E.2d 891 (1996); Worthy v. Kendall, 222 Ga. App. 324, 474 S.E.2d 627 (1996).

4.OTHER COMPENSATION. That the plaintiff, by reason of age, infirmity, or otherwise, is now or may be entitled in the future to receive any compensation or benefits by reason of the Social Security Law of the United States or from any governmental agency such as the veterans' Administration, Medicare, or sources of this nature.

5. ATTACKS ON PLAINTIFF'S TRIAL COUNSEL BY DEFENSE ATTORNEYS. Any reference or suggestion as a personal attack and uncivil comments about plaintiff's trial counsel by the defendant or their attorneys. Personal attacks on adversarial counsel has no place with the truth-seeking context of litigation.

6. ADVERTISEMENT BY PLAINTIFF'S ATTORNEY. Any reference or suggestion to the advertisement or the fact that plaintiff's attorney advertises. This includes slogans, jingles, or reference to the yellow pages, television or any media. The issue of how attorneys obtain business should not become an issue in the case. The fact that plaintiff's counsel advertises to obtain clients is no more relevant that the practice by defense attorneys to join exclusive organizations in which to wine and dine insurance adjusters and corporate clients for business, in order to obtain business.

7.FINANCIAL STATUS OF ATTORNEY OR MEDICAL PROVIDER. Any reference or suggestion to the income or financial status of the plaintiff’s attorney or the treating physicians. The issue of the wealth or income of the attorneys or treating physicians should not become an issue in the case. On at least one occasion, defense counsel has argued in other cases that plaintiff's attorneys advertised and stated to jury "how do you think these attorneys and these doctors can afford such expensive advertisement and have nice offices".

8.AMERICAN TORT SYSTEM OR PLAINTIFF'S LAWYERS IN GENERAL. Any reference or suggestion or the introduction of any evidence by the defense counsel directly or indirectly attacking the American Court System or plaintiffs attorneys or recent tort reform campaigns.
Neither the American tort system or plaintiffs attorneys in general are on trial in this case. The trial of this case should not be an opportunity for defense counsel to voice opinion regarding tort reform. The injuries sustained by the plaintiff are a result of the defendant’s negligence and the defense should not be permitted to ignore the issues in this case and attack the tort system in general.

The debate surrounding tort reform is irrelevant to this case and would serve only to inflame and prejudice the jury. These references would poison this case with anti-lawsuit and anti-lawyer bias, which has been highlighted in recent corporate, media campaign and emotional propaganda. The only thing to be gained in allowing defense counsel to discuss these issues would be a concealment of the truth. This subject applies to Trial only and not Voir Dire.

9.UNRELATED CLAIMS. Any reference or suggestion that Plaintiff has had unrelated, prior or subsequent claims, suits or settlements or the amounts thereof. See O.C.G.A. §24-2-1 and §24-2-2; Goforth v. Wigley, 178 Ga. App. 558, 559-60 (1986). Further, no mention should be made concerning any injuries to the defendant(s), that they did not bring a claim or suit for.

10. UNRELATED ACCIDENTS AND INJURIES. Any reference or suggestion that Plaintiff has any other unrelated injuries, diseases, conditions, or illness, or the effects thereof, which are wholly disassociated from and do not relate to or serve as a "sole cause" defense to his/her present claims, and which Defendant cannot medically associate and relate to plaintiff's injuries for which compensatory damages are claimed in this case. See O.C.G.A. §24-2-1 and §24-2-2; Goforth v. Wigley, 1788 Ga. App. 558, 559-60 (1986); United Motor Freight Terminal Company Inc. v. Hixon, 76 Ga. App. 653, 655 (1948); Barnes v. Cornett, 134 Ga. App. 120, 122 (1975). Further, No mention should be made about the plaintiffs having previously filed claims or lawsuits.

11.FINANCIAL CONSEQUENCES OF JUDGMENT AGAINST DEFENDANT. Any reference or suggestion that Defendant is uninsured as to Plaintiff's claims, including, but not limited to, any reference as to Defendant as a little person, or small or struggling, or any other such reference which would tend to convey to the jury the impression that Defendant is a party of modest means who cannot afford to pay a substantial judgment. See O.C.G.A. §24-2-1; Adams v. Camp Harmony Association, 190 Ga. App. 506, 508, (1989); Denton v. Conway Express, Inc., 261 Ga. 41 (1991); Georgia Power Company v. Flagan, 261 Ga. 41 (1991); Northwestern University v. Crisp, 211 Ga. 636, 641 (1955); Brunswick & Western Railroad Co. v. Wiggins, 113 Ga. 842, 850 (1901); Higgins v. The Cherokee Railroad, 73 Ga., 149 (3) (1984); Bennett v. Haley, 132 Ga. App. 512, 525 (1974); See also Georgia State Bar Rules, DR 7-102(A)(3), (4) and (5); DR 7-106(C) (1); Rule 4-102(d) Standard 45 and O.C.G.A. § 9-10-185.

12.PAYMENT OF JUDGMENT. Any indication of any kind that Defendant driver personally will have to pay any judgment that may be entered in this case, especially since Defendant is insured against liability. See O.C.G.A. §24-2-1; Adams v. Camp Harmony Association, 190 Ga. App. 506, 508 (1989); Denton v. Conway Express, Inc., 261 Ga. 41 (1991); Northwestern University v. Crisp, 211 Ga. 636, 641 (1955); Brunswick & Western Railroad Co. v. Wiggins, 113 Ga. 149 (3) (1884); Bennett v. Haley, 132 Ga. App. 512, 525 (1974). See also Georgia State Bar Rules, DR 7-102(A)(3), (4) and (5); DR 7-106(C) (1); Rule 4-102(d) Standard 45 and O.C.G.A. §9-10-185.

13.PLAINTIFF'S USE OF AWARD. Any reference or suggestion as to what Plaintiff will or might do with any award of damages Plaintiff might receive. See O.C.G.A. §24-2-1 and §24-2-2; Gusky v. Candler General Hospital, 192 Ga. App. 521 (3) (1989). See also Hall v. Chicago & Northwestern Railway Co., 125 N.E.2d 77, 86 (Ill.1955); and Law note at 28 ATLA Law Reporter 101 (April 1985).


14.MONEY WILL NOT UNDO DAMAGE. Any reference or suggestion to the effect that "money won't undo the injury and damage the plaintiff may have sustained", because such a suggestion is an improper appeal for jury sympathy toward Defendant. and invites the jury to disregard it's duty to apply the legal measure of damages which the evidence shows have been caused by Defendant's misconduct and instead to base a verdict on improper considerations. See O.C.G.A. §24-2-1; Gielow v. Strickland, 185 Ga. App. 85, 86 (1987) (jury cannot be urged to use some other measure of damages than that prescribed by law); Central of Georgia Railway v. Swindle, 260 Ga. 685, 687 (1990) (trial should not be invaded by improper considerations); Adams v. Camp Harmony Association, 190 Ga. App. 506, 508 (1989) (effect of verdict an improper consideration).

15.DEFENDANT IS “SORRY” OR “APOLOGIZES.” Any reference or suggestion that Defendant is sorry or regrets the occurrence in question, because such a suggestion is an improper appeal for jury sympathy toward Defendant, and invites the jury to disregard it's duty to apply the legal measure of damages by awarding such damages as the evidence shows have been caused by such defendant's misconduct and base a verdict on improper considerations. O.C.G.A. §24-2-1; Adams v. Camp Harmony Association, 190 Ga. App. 506, 508 (1989); Gielow v. Strickland, 185 Ga. App. 85, 86 (1987) (jury cannot be urged to use some other measure of damages than that prescribed by law); Central of Georgia Railway v. Swindle, 260 Ga. 685, 687 (1990) (trial should not be invaded by improper considerations).


16.TAXATION OF RECOVERY. Any reference or suggestion that any recovery by Plaintiff either would or would not be subject to federal or state income tax or any other form of taxation. See O.C.G.A. §24-2-1. Also, that any recovery by Plaintiff would not be subject to federal income taxation or any other form of taxation. Atlantic Coast Line R. Co. v. Brown, 93 GA. App. 805, 807 (1956).

17.EMPLOYMENT OF COUNSEL/FEES. Any reference or suggestion regarding the time or circumstances under which Plaintiff employed any of her attorneys. O.C.G.A. §24-9-21(2). Any reference or suggestion regarding the existence of a contingent fee arrangement between Plaintiff and her counsel. See O.C.G.A. §24-2-1; Stoner v. Eden, 199 Ga. App. 135 (1991).

18.FAILURE TO CALL EQUALLY AVAILABLE WITNESSES. Any reference or suggestion that Plaintiff has not called to testify any witness equally available to both parties in this case. See O.C.G.A. § 24-4-22; Bank of Emmanuel v. Smith, 32 Ga. App. 606 (1924); Bradford v. Parrish, 111 Ga. App. 167 (1965).

19.VOUCHING FOR DEFENSE WITNESSES. Any reference or suggestion as to whether or not Plaintiff or any of Plaintiff's witnesses believe that any of the defense witnesses are honorable or otherwise worthy of belief. O.C.G.A. §24-2-1.

20.PERSONAL BELIEF OF COUNSEL. Any reference or suggestion by defense counsel as to his or her personal belief concerning the credibility of any witnesses, or as to the merits of Plaintiff's claims, injuries, or damages. Manning v. State, 123 Ga. App. 844, 845-6 (6) (1971); Georgia State Bar Rules, DR 7-106 (C) (4); EC 7-24.

21.FUTURE INCOME, ETC. OF PLAINTIFF. Any reference or suggestion as to the future income or employment benefits of Plaintiff.

22.UNDISCLOSED PHOTOGRAPHS. Any reference or suggestion as to the existence or contents of any document, photograph, motion picture film or videotape which has not previously been disclosed in the pretrial order until the same has been tendered to the Court and Plaintiff's counsel, outside the presence of the jury, and shown or exhibited to determine its relevance and suitability for introduction into evidence. See O.C.G.A. §24-2-

23.EFFECT OF CLAIMS ON INSURANCE RATES. Any reference or suggestion regarding the effect or results of a claim, suit of judgment upon insurance rates, premiums, or charges, either generally or as particularly applied to Defendant in this case as a result of this or any other lawsuit or claim. See O.C.G.A. §24-2-1 and §24-2-2.

24.EFFECT OF CLAIMS ON INDUSTRY. Any reference or suggestion that damage awards may drive up the price of products, put manufacturers out of business, or cause jobs to be lost. See O.C.G.A. §24-2-1 and 24-2-2.

25.REQUESTS FOR PLAINTIFF'S FILE MATERIALS. Any demands or requests by defense counsel before the jury for matters found or contained in Plaintiff's or her counsel's files, which would include statements, pleadings, photographs, and other documents directed to the Plaintiff or Plaintiff's counsel during the course of the trial and in the presence of the jury.

26.REQUEST FOR INDEPENDENT OR COMPULSORY MEDICAL EXAMINATION DURING THE COURSE OF TRIAL. During the course of the trial, any demands or requests by Defendant or defense counsel for additional medical examination, physical demonstrations, or other similar requests directed to the Plaintiff or Plaintiff's counsel and in the presence of the jury. See O.C.G.A. § 24-2-1.

27.REQUESTS FOR PHYSICAL DEMONSTRATIONS. Any requests for Plaintiff or any of Plaintiff's witnesses to participate in or assist defense counsel with any physical or other demonstration. See O.C.G.A. §24-2-1.

28.SUPERSEDED PLEADINGS. Any reference or suggestion as to the contents of any pleadings which have been superseded by the current pleadings or the pretrial order on file in this case.

29.EX PARTE STATEMENTS. Any reference or suggestion as to the contents of, or tender of any ex parte statement or report of any person not then and there present in the Court to testify and to be cross-examined by counsel for Plaintiff.

30.TESTIMONY OF UNAVAILABLE WITNESS. Any reference or suggestion as to the probable testimony of a witness available to Defendant who is not called to testify in this case.

31.NOTICE TO DEFENDANT OF SUIT. Any reference or suggestion that no notice of the claim was given to Defendant(s) until the suit was filed in this case, since none is required to be given.

32.SPECIAL EFFORTS REQUIRED BY JURY. Any reference or suggestion that the jury must extend special efforts to be fair and impartial to the defendant.

33.SEAT BELTS. Any reference or suggestion that Plaintiff may not have been wearing a seat belt at the time of the collision made the basis of this suit. O.C.G.A. §40-8-76.2.

34.PRIOR TRAFFIC RECORD. Any reference or suggestion as to any prior moving traffic violations or any prior automobile collisions that Plaintiff may have had in the past. See O.C.G.A. §24-2-1 and 24-2-2; Myers v. Barnard, 180 Ga. App. 192 (1986); Underwood v. Butler, 166 Ga. App 527, 529 (1983). See also Green, Georgia Law of Evidence, 3rd Ed., §§68, 70 and 71 (Harrison Co., 1991 Supp.).

35.CRIMES INVOLVING FIRST OFFENDER STATUS. Any reference or suggestion as to any crimes involving first offender status. O.C.G.A. § 42-8-65(a) obligates the clerk to ensure that such information is disclosed only to those persons authorized to receive it. Witcher v. Pender, 260 Ga. 248 June 8, 1990, held that the first offender record of an adverse witness in a civil case is not admissible for the purpose of impeaching the witness for a crime of moral turpitude. In Georgia, the rule is that a witness may be impeached by proof of a conviction of a crime involving moral turpitude. Hall v. Hall, 261 Ga. 181 (402 S.E. 2d 726)(1991).

The use of the term moral turpitude has been "restricted to the gravest offenses consisting of felonies, infamous crimes and those that are malum in se and disclose a depraved mind", Lewis v. State, 243 Ga. 443, 444 (254 S.E. 2d 830)(1979). Under that definition it is apparent that a misdemeanor conviction for possession of less than an ounce of marijuana, a conviction equivalent to a misdemeanor conviction for DUI. See Hall v. Hall supra, it is not a crime of moral turpitude. It does not suggest an "insensibility to the obligation of an oath". Lewis supra, at 446.

Tuesday, March 28, 2006

No Go for Sparlon to treat ADHD

A Cephalon Inc. drug to treat attention deficit hyperactivity disorder in children is not acceptably safe and needs more study according to the FDA.

A Food and Drug Administration panel of advisers said that Cephalon's data on the stimulant Sparlon, sold as Provigil for sleep disorders, showed that it was effective, but that questions about the drug's safety outweighed its benefit for ADHD.

The panel's 12-1 vote against recommending approval based on safety concerns was a huge blow to the Frazer biotech. Cephalon sells four drugs and was hoping to take advantage of the large market for ADHD medications taken by millions of children.

Another Conference: Unsafe Drugs

I am headed to Miami to attend a conference that will discuss in detail the soup to nuts approach in a Vioxx Trial. It's limited to Plaintiffs' counsel. Since most of the Eastern U.S. is under cloudy skies and cool temps, I imagine that sunny days and 80F weather may lead to a big crowd for this one.

Other drugs to be discussed include Ortho Evra and Bextra. If you'd like to hear about it, read more here next week.

Morgan Stanley Analyst Predicts Vioxx Verdict

From Yahoo.com:

Jami Rubin, a Morgan Stanley analyst, said there is a "decent chance" the jury will find for either of the two plaintiffs who are suing Merck and whose cases are being heard in a single trial. She said the judge's actions indicate a pro-plaintiff tilt and said she believed the jury isn't as educated as the panel in an earlier New Jersey trial who absolved Merck from any responsibility in the heart attack of man who blamed Vioxx for his affliction.

In the current case, Rubin predicted pain and suffering damages in the $1 million to $2 million range but sees no reason for the jury to award punitive damages because there is no evidence of Merck acting recklessly.

My comment: Mr. Cona is one plaintiff. He still plays golf post heart attack, and plays more than thirty times a year. If there is a verdict the range may be $500,00 to $3,000,000.

Read more here.

Monday, March 27, 2006

The Vioxx War Room

On the CBS News site there is a decent article on the Plaintiff's War Room in the Cona trial. We've used the war room concept in our office and most recently for a six week trial in another city. Here are excerpts from the article, which you can read by going to the link below:

"For the legal eagles hunkered down in Room 3628 at the Borgata Hotel Casino & Spa gambling isn't on the docket. For weeks, lawyer Mark Lanier and his associates, paralegals and support staff have been spending nights in this hotel suite _ plotting strategy, guessing at the enemy's next move, looking behind to look ahead.

They call it the war room.

Lanier represents heart attack victim Thomas Cona, 59, of Cherry Hill, a businessman suing drug maker Merck & Co. of Whitehouse Station, N.J., over its troubled arthritis drug Vioxx.

Five days a week, when the trial day wraps up in Courtroom 3A ... it's up to Room 3628 for the war room ritual, one practiced by trial lawyers of all stripes when they're trying cases.

"War rooms are near and dear to us," said Larry S. Pozner, a former past president of the National Association of Criminal Defense Lawyers who also does civil litigation. "There are so many things that happen in each day of trial, you need to bounce it off other people. `Did the witness really say that?' `What's the significance of the judge's ruling?' `How does this affect our presentation of the evidence?"

Merck's legal team has its war room, too. Eight of them, in fact.

Across town, at the Sheraton Atlantic City Convention Center Hotel, lead counsel Christy Jones and three other Merck lawyers work out of seven hotel rooms that have had the beds and dressers removed. The eighth is a conference room used for group meetings.

"Every evening after court, we have a trial team meeting in that conference room," said Chuck Harrell, a spokesman for the team. "We discuss the events of the day, what we need to do in planning for the following days and even a day or two beyond that."

For Lanier's gang, the war room is set up in an elegant suite that has been converted into an office _ with boxes and boxes of documents stacked along the walls, computers and FAX machines sitting atop tables and a big easel and pad on one side.

The article is worth read ... find it here.

Friday, March 24, 2006

Blogs are a Curse!

(this isn't a law related post)

They are. Just ask the General Manager of the NBA's Portland Trailblazers. At least he thinks so, according to a quote in the March 27, 2006 edition of Sports Illustrated. The G.M. laments the instant news, the spin, the knuckleheads that write about his team.

My question to him is, "are you that stupid?" In the early 1990's the management of professional sports teams (and college athletic directors)lamented the growth of sports talk on radio. Many complained that the medium was loaded with lunatics. They didn't embrace radio. It was only recently (since 2003 or so) that sports teams saw the value (and money) in radio. Heck, even former Braves President Stan Kasten has radio time now.

After radio came the internet. If you think management hated sports talk radio, you know what the reaction was to the web. Forums, fansites (like gatocoutnry.com), and "suck" sites had these guys buying Tums by the truckload. Did they embrace it? No. Only after a half decade are you seeing them buy in. Tiger Woods breaks news on his own site now.

Well, it looks like blogs are the latest whipping boy. Rather than again embracing it and in true business form controlling/manipulating it to a team or player's benefit, it's more crying. Will it take these guys five years to realize that blogs are not going away? In this Google Generation, everything is instant.

Will these guys ever get it?



For a guy who manages a half billion dollar business, he seems to be lacking vision and smarts about the future.

Thursday, March 23, 2006

Vioxx Trial Update: 3/23/06 - Merck's turn; Jury Question

Merck served up the first witness in defense of the pending action. Dr. Briggs Morrison is a VP at Merck Labs.

During cross, Mark Lanier said Merck's Vioxx drug application consisted of enough documents to fill more than 120 boxes, suggesting that Merck purposely data that showed Vioxx made users more susceptible to heart attacks.

Lanier asked the doctor if he thought that the FDA was able to zone in on one paper out of 127 boxes.

Lanier also introduced an internal review document through Morrison that was a response to a 2001 paper summarizing clinical study data on cardiovascular risk. Merck's memo concluded there was no evidence Vioxx caused heart attacks. Dr. Morrison testified that it was wishful thinking to conclude that, and that he felt the paper interpreted the data to support a preconceived notion.

When asked if that paper was given to the FDA, Morrison said no, that it was an internal review never shared with FDA.

Juror asks a question:

During his testimony, a juror posed a question. Dr. Morrison told the jury that during the time he worked on the Vioxx development team at Merck, the company did not do a clinical study specifically aimed at determining whether Vioxx caused heart attacks.

Should that question worry Merck? How about the answer?

Sources for this post include attorneys in the courtroom, news reports on sites including google news, AP, and Reuters.

Wednesday, March 22, 2006

FDA Hearings Today (3/22) on ADHD Drugs

The FDA's Drug Safety and Risk Management advisory committee last month voted to recommend adding "black-box" warnings to stimulants used to treat ADHD, alerting doctors and patients of the risks these drugs have on the cardiovascular system.

The FDA is not required to follow the recommendations of its advisory committees, but usually does.

The latest reviews show that psychosis or mania can occur in some juvenile patients at normal doses of any ADHD drug. The reviews included roughly 90 studies of the drugs as well as reports from doctors, parents and others.


You can read more by going here.

Tuesday, March 21, 2006

British Drug Trial: What Went Wrong

Detailed article on the web explaining how the British medical community tries to find the cause of the catastrophic immune response of the six ill drug trial volunteers earlier this month.


Go here to read more.

Monday, March 20, 2006

Lawyers on the air: Would you say this?

I'm listening to a radio show today. Attorneys are guests and each is taking questions. In response to one caller's question, Attorney #1 comments that a lawsuit may be difficult because of the potential application of the "statute of repose." Attorney #1 does not explain of what that means. The caller says thanks and hangs up.

Attorney #2 mentions in response to a question that the issues "therein" can be complicated.

Why must attorneys use this terminology when dealing with sane, rational people? I just shake my head when I hear lawyers on the air sometimes.

Baycol Class Approved

A state court judge approved a class action settlement that would reimburse unions, employers and health plans for money spent on the recalled cholesterol drug Baycol.

The judge in the Philadelphia Court of Common Pleas gave preliminary approval to the national class action settlement.

The attorney for the Plaintiffs' group is Stewart Cohen. Cohen's original clients included a Philadelphia firefighters' union. He works with my Chris Placitella in PA. Go here for their website. My firm works with Placitella on cases involving Vioxx.

FDA: Cephalon's Sparlon (ADHD drug) News

Cephalon’s Sparlon was associated with 31 cases of suicidality, aggression or psychosis in clinical trials for attention deficit hyperactivity disorder in children, FDA reported in a summary for its Pediatric Advisory Committee, which is set to meet on this week, on March 22, 2006.

An analysis provided by Cephalon as part of its response to FDA’s Oct. 20 “approvable” letter for the ADHD indication found four suicidal events, two events of psychosis/mania and nine aggression events in the double blind clinical studies of Sparlon (modafinil).

You can read more on the FDA site here.

Thursday, March 16, 2006

Auto: Passenger/Driver Joint Representation Auth.

For the GTLA folks (and others): A question was posed regarding the ability to represent a driver (who is not at fault) and passenger in that driver's vehicle. While we do not have any set policy regarding it, when the situation arises we send the passenger the following letter:
****************

Authorization For Joint Representation
(For the Passenger)

I, MG, ask that Firm represent me in my claim for injuries received in an automobile accident which occurred in April, 2006. I also know that Firm may or will represent the driver of the vehicle I was in connection with injuries he sustained in that same accident.

Firm has explained to me that since I was a passenger in the car driven by Ss, I may have a claim against Ss if he was in any way at fault in this accident. I understand that if Ss failed to act or react as a reasonable prudent person would act or react under the same circumstances, he could be found to have caused the collision or contributed to the collision, in which event a jury could find him totally or partially at fault. This finding will likely adversely affect my right to either a full recovery or a partial recovery for my injuries. ________ (Initial)

I understand that Firm can represent the driver, Ss only if I waive any claim that I may have against the driver. ______________ Initial and date

I have been told that I should not waive any claims. I understand that if I do waive my claims against Ss, and if a jury should then determine that such person was in fact at fault in the accident, I may have waived my right of recovery against the driver for injuries and be totally unable to recover any damages for my injuries. I understand that I have an absolute right to maintain my claim against Ss and to insist that Ss find separate counsel and that Firm has told me that it is in my best interest to require that person to obtain separate counsel.

Nonetheless, understanding all of the above, I desire Firm to represent both driver and me, and for that purpose I waive any claim I may have against the driver. I have been told to read this Authorization twice and have been given the chance to do so.

This __________ day of _____________________, 200_.


Signature: _________________________

Print: _________________________

ADD & ADHD Drugs: Stronger Warnings needed

Drugs children take for attention deficit hyperactivity disorder should carry stronger warnings about the risk of side effects like hallucinations and paranoia, the FDA states.

The agency since 2000 has received more than 500 reports of psychosis in children 10 and younger who took attention drugs such as Adderall, Strattera, and Ritalin.

``Signs and symptoms of psychosis or mania, particularly hallucinations, can occur in some patients with no identifiable risk factors,'' an agency review dated March 3 said. The documents were posted on the FDA Web site in advance of a panel meeting next week.


For more information, go to Bloomberg or to the FDA site here (PDF).

Vioxx MDL: FDA's Dr. Graham to testify

From Newsday as well as those following the MDL Vioxx litigation:

The FDA whistleblower who has addressed the agency's handling of Vioxx will be deposed and may present evidence that could help the pending lawsuits.

Judge Fallon denied a Motion to Quash the subpoena of drug reviewer Dr. David Graham, who testified at a 2004 Congressional hearing that the Merck & Co. drug caused as many as 160,000 heart attacks and strokes. The Motion was filed and argued by attorneys for the FDA.

Fallon said it was vitally important that plaintiffs know the truth about Vioxx including what the FDA knew about the drug, when the agency knew it, if it had all the facts and whether the FDA concealed anything from the public.

Wednesday, March 15, 2006

Branding

Continuing on the subject of branding ... . I saw first hand how branding works for the attorney whom I visited with last week. Still seeking more information on the subject, I had a chance to go to a blog by Patrick Lamb. He has a segment of his blog devoted to Branding and Sales. Worth a read is his post titled, "Branding? Yes!" which you can find about 2/3's of the way down in that category. He commented on branding in the context of the use of a Firm logo. He wrote:

Logos by themselves probably mean very little. That said, however, logos in the context of a meaningful branding program probably means a great deal. Well said, Mr. Lamb.

In my view, a logo in the context of a well thought out plan should be seriously considered. Once again the trick is to avoid being caught up in things like cost and style, and vague policy statements used by the designer you hire. A number of logo designers that have helped me and my business partners can deliver a logo for less than $3,000. That's the cost of two doctor depositions in a typical case. A logo may even contain the messsage, such as "we treat you the way you want to be treated." Combine it with a vanity number such as 1-800-JUSTICE or 800-444-4444, and it adds up to the complete image and brand you wish to convey.

I continued reading Mr. Lamb's useful blog and found that he linked to Dan Hull, who had posted his comments on the use of a logo: "Law Firm Logos are Goofy, Useless, and a Waste of Time and Money ...I would add that if you have a logo, don't change it--but if you don't have a logo, don't bother to develop one." You can read that here.

Here is the logo that works for the Levin,Papantonio firm:




If you walk into Mike Papantonio's office, you will see a column found in the logo on each side of the door. Does that logo convey the fact that "Pap" has a $100+ million dollar verdict to his credit? Or that the firm is nationally recognized? Probably not, but the way it is used among a certain set of attorneys conveys the instant message of who that firm is, when the big picture of the LP brand is considered.

I hope many of my competitors in my area of the law - representing injured consumers - follow those who advise that the creation of a logo is "goofy." Keep to the basic letterhead, the white paper, the tombstone yellow pages ads. Keep the tag line, "no recovery unless we win." The last thing I need is an innovative competitor (or two or three) in my area of the law. If others read that a logo can be had for about 10% of what some contribute to political campaigns on a yearly basis, then everyone may have one, right?


Does your firm have a logo? Grant Morain does here in Georgia. If you navigate his site, the arrow in the logo leads you to that page, a nifty little trick:

Tuesday, March 14, 2006

Miss Wang, the 21st Century is on Line 1

I read Lifehacker.com each and every day. It's a site that has daily 'hacks' that can help both at work and at home. (With links to things like online coloring books.)

One of today's snippets is titled, "How Business Gurus Work." You can find it here.

You can read more in the link, but what struck me as odd was a set of comments attributed to Vera Wang who is known for her wedding gown collections among other specialties in fashion.

Lifehacker noted that, "Designer Vera Wang doesn’t use email at all." It also noted that Wang "hate[s] phones... . if I were to go near e-mail, there would be even more obligations, and I would be in Bellevue with a white jacket on."

What? Is this view possible from a titan in any business much less hers? It brought to mind a comment made by a law partner twelve years ago. That attorney scoffed at computers on the desk of lawyers, and said "those things are for secretaries." If you take a look at her site, it's well done and flashy. I would add "ecommerce" to her list of things she "hates" as you can't buy any of her products online at her site.

Someone please mail her the memo.

Monday, March 13, 2006

An "Amen" to Dennis Kennedy Re: Attorney Websites &

and the information displayed.

Dennis Kennedy wrote recently about attorney internet sites and where a site may come up short. I've ranted about the inability to find a phone number and/or email address often on my blog. Here is what Kennedy writes:

1. Not Considering Likely Usage. Many times, I go to a law firm website simply to get contact information for a lawyer or the firm (phone number, mailing address , email address). I have to believe that this a common reason people go to websites. It surprises me how many websites do not have the office mailing addresss and main phone number on the front page. It shocks me, though, how difficult some sites make it to find that information. As an another example, it can take a trip to several pages and a search box or two to find lawyer bios, some of which still do not include phone numbers and email addresses. It's almost impossible to put standard contact info in too many places on a website.

Bravo and well said. I strongly believe that a Firm must have the office telephone number and address on each page of the Firm site. Andy Childers' Firm does it. It matters because sometimes a person gets a page served up by a search engine that may be in the middle of a site.

Attorney Advertising and Branding

I spent the day with Attorney Eddie Farah in Jacksonville, Florida last week, and he is a walking primer about advertising and branding a Plaintiffs' Firm.

Farah has twenty-three attorneys on staff and more than eighty employees in five offices throughout Jacksonville and North Florida. He is everywhere - television, billboards, the web - but before you quickly conclude (or dismiss) the firm is a typical "TV Lawyer" Firm, a bit of background:

The Farah and Farah Firm tries cases to verdicts. The Firm's attorneys have tried to conclusion two jury verdicts with one exceeding $3.3 million dollars and another in excess of $5.8 million. The latter was a claim based on the FTCA. Eddie Farah himself tried a wrongful death case in a rural county where the top offer was $10,000 and the jury awarded $750,000.

Branding: There are quite literally thousands of attorneys and law firms advertising. Some have a clear strategy, others are in my opinion scattershot in their methods. Farah's office first and foremost has in mind branding. In many of the ads, the tag line includes "Call me Eddie." Nearly all the ads include the statement that, "We treat you the way you want to be treated." Amidst the clutter of cookie cutter ads, the talking heads, the bookshelf background, the term "no fee unless we win," his ads stand out.

It's the name - Eddie Farah - and the message. From the hold music that has a voice message, to the Internet. Consistency in the message, much like the theme in a trial. When we went to dinner in this city of more than one million it was almost surreal - people walking up to him to shake his hand, to say "thanks" and in one instance to ask for an autograph. He's been in that part of Florida for more than twenty-five years, and grew from a two attorney office to where he is now.

Advertising: His strategy has multiple components, and is viewed by Farah much like the strategy in a war. The "Air Campaign" involves (of course) television and radio. The Florida Bar has many restrictions on what can be said and how it can be said.

Farah has taken the TV ad to another level. In addition to thirty second ads - which he says are becoming more rare at least for him - he has fifteen second, ten second, and five second ads. The five second TV spot is known as an adlet. It may be simply a recorded five second spot as that leads in to local weather: "This weather is brought to you by the Law Offices of Eddie Farah, 396-XXXX." The ten second spot he considers to be a ten second "video billboard." All ads are produced on film and not videotape. He says (and I agree) that film projects a much warmer image.

Radio and the Internet: Ten and fifteen second spots are the norm for Farah in radio. He preaches that all spots are to be recorded. When it comes to the web, he is a risk taker. He sponsors legal headlines on at least one local news source on the web, and has created specific stand alone websites for different types of cases, such as securities law and arbitration.

On the Internet his site there is a wealth of information. He has multiple links, multiple sites, and he watches closely SEO.

Farah is also ahead of others in that he has his own weekly radio call-in show. It is called "The Consumer Law Hour" and airs on Saturday mornings. He pays for the full hour and of course puts his spots on during the show. Before you think that this may not work, know that the last Arbitron book had his show as the #1 rated show during the weekends and not just on that station, but as to the entire region. In fact, he has had to tell the station not to sell other lawyers' ads on his hour. There is talk of national syndication. I've been a guest on the show several times and it's a lively and informative hour. He gets the callers as well.

Phone Books and Billboards: In Atlanta attorney billboard advertising is not a particularly competitive market. You just don't see that many here, relatively speaking. In Jacksonville one of the first things you notice are the lawyer billboards. I won't address whether or not they are a good thing. I do know that the Farah billboards are "wrapped" with a photo quality skin. High production and gloss. They - to me - standout when compared to others. Several competing attorneys have simple painted on messages on billboards, some with a photograph of an attorney that can best be described as a mugshot. Not Farah's. His photograph (if there is one) is not an after thought but well made. His message is short and simple and the telephone number can be easily read.

I suggest that if you are considering a billboard, avoid the grim face. Avoid standing there with arms crossed and staff standing behind you. Keep the message short - I can't read that your Firm handles Bankruptcy, Divorce, Real Estate, Wills, Criminal Law, Injury, Wrongful Death, and Trucking Cases in the few seconds it takes for me to pass your billboard. Stick with one or two and your number. While the multiple message billboard may work in small towns, it's just a jumble of text in bigger cities, in my opinion. Perhaps a group think mentality compels firms to put them up.

When it comes to the yellow pages Farah seems to spend money to keep his position in the community viable. I part company with him on some of his strategy, but it works for his office. Farah's office includes a mix of YP spines, full page ads, back covers, quarter page ads, and more creative spots throughout the books. Once again he has a strategy mapped out first, and he keeps to it. It works.

Phone numbers: Farah is a big believer in a simple toll free "vanity" number. He uses 1-800-JUSTICE in most of his advertising. He had used another number, but found that those who were injured through no fault of their own had one underling concern: Getting justice. So for Eddie, the choice of a number was easy. I believe that a vanity number by far is the best way to go when it comes to conveying a unified message.

The Ground Campaign
: Farah's term for other ways to keep the brand out front. It has a components non-traditional ways to let the public knows about the Firm's services. Whether it is sponsoring sopecific events, or attending on a regular basis both high and low profile events throughout the community, Farah has a plan.

What is significant is what he has told me: There are many events where he is the only attorney advertising or present. Understand the significance of that last statement - Eddie Farah is there. Not a paralegal, or a young attorney, or a firm employee. I won't give away where he goes, but know that if you sit down with a a community calendar on a regular basis, you will see opportunities to not only project your brand, but you will see in those events the chance for people to know that you are a dad (or mom), a volunteer, a a member of your community. I'm not talking about Chamber of Commerce, but for smaller communities that may be a start.

I learned from his this past week, hopefully some of this will be helpful to you.

Friday, March 10, 2006

Upcoming: Advertising Pointers

I'm in Florida now with attorneys who have something in common with my offices: We advertise in traditional mediums such as television, and we look for innovative ways to help injured clients.

Next week there will be notes on what may or may not work in our own experiences.

Wednesday, March 08, 2006

Henry Blodget (Formerly of ML) has a Blog

Heny Blodget, formerly of Merrill Lynch - whose email comment was waved in many securities arbitrations in the past three years, has a blog.

Blodget according the the NY AG allegedly helped manipulate stock ratings to mislead investors. In internal documents and emails, Blodget has been quoted as calling stocks "crap", "toast" and "POS" ("piece of shit") while simultaneously having "Buy" recommendations on them.

He has blog called internetoutsider, which can be found here. Regardless of his past dealings, it is certainly worth a look. He leans a bit heavily towards Google posts.

Update on the N.J. Vioxx Trial 3.8.06

Mark Lanier is pressing on with the trial of Mr. Cona before State Couourt Judge Higbee. This week the jury saw e-mail messages, internal documents and other materials that showed how Merck was concerned about the the MI danger of Vioxx.

New for the Vioxx litigation: The jury saw a short video not previously shown in other trial. Called the "V Squad," it's not an Oscar worthy flick. It is a 12-minute sales-training video played that had two Merck salespeople dressed as superheroes -- each in a black suit with a giant orange V on it. In the video the salesmen fought off human obstacles who represented questions from doctors to whom the company pitched its blockbuster arthritis drug.

Other documents introduced at the trial:

Also shown:

*An internal memorandum where Merck executives indicated it would cost Merck $611 million in sales if rival Celebrex beat Vioxx to market. (It did)

*An e-mail from a Merck employee which said the only essential study needed for Vioxx was a "CV outcomes" study whose lone purpose was assessing whether Vioxx caused heart attacks and strokes. Merck didn't do the study.

*A letter to Merck's CEO at the time (Raymond Gilmartin) sent by the FDA. In that letter, the FDA told Merck it was misrepresenting Vioxx's safety profile and misleading doctors.

This information comes from those at the trial as well as news reports on Yahoo and Reuters.

Tuesday, March 07, 2006

NJ Supreme Court Ethics Op.- Disclaimers on Attorney Internet Ads

This comes from W. Horsnby's blog regarding NJ attorney advertising:

New Jersey Supreme Court’s Committee on Attorney Advertising issued an ethics opinion that limits the use of the Internet for client development. Opinion 36, issued January 2, 2006, states that lawyers who pays a flat fee for an online listing and receives an exclusive listing for a county for a particular field of practice “must ensure that the listing or advertisement contains a prominently and unmistakably displayed disclaimer, in a presentation at least equal to the largest and most prominent font and type on the site, declaring that “all attorney listings are a paid attorney advertisement, and do not in any way constitute a referral or endorsement by an approved or authorized lawyer referral service.”

Hornsby wrote: "Usually ethics opinions are presented as sources of direction that fall short of legal authority. But this opinion states that a lawyer “must” ensure that the advertiser provide this specific disclaimer. Some might conclude that this should be the role of the court itself and, if important enough, the court should change its rule to provide such a requirement."

I checked a few of the more well known sites that use this type of format, and as of today none of the ones I checked that listed a NJ attorney had this disclaimer. Is anyone paying attention?

USA: Per Capita Drug Spending: $885

This Press Release from researchandmarkets.com:

With a population approaching 300 million, the USA is the third largest country in the world, behind China and India. The largest state is California, with a population of 36 million.

The USA is the world's largest and wealthiest pharmaceutical market, accounting for around 48% of the world total. Per capita expenditure on drugs is $885 in 2005, nearly double the level found in the rest of the world.

Go here for more.

Monday, March 06, 2006

New Warnings for Serevent and Advair (asthma meds)

GlaxoSmithKline will update the product label for Advair with a new warning that tells doctors to limit the use of the drug only to patients who are not controlled on other asthma drugs, or have such severe cases.

This follows a 26,000 patient study that found a higher death rate in patients treated with salmeterol, one of the ingredients in Advair. The death data were already in the label in a black-box warning, but now the label also includes tells doctors to restrict use of the powerful combination asthma drug to patients who really need it.

"[S]almeterol] one of the active ingredients in ADVAIR DISKUS may increase the risk of asthma-related death. Therefore, when treating patients with asthma, physicians should only prescribe ADVAIR DISKUS for patients not adequately controlled on other asthma controller medications…or whose disease severity clearly warrants initiation of treatments with two maintenance therapies," is on the label now.

There is also a new label for Serevent.

You can go to the FDA site or to the GSK site for more information, and you can read more on the web, including at Yahoo and Forbes.

Medicine Patches more dangerous when combined with heat?

From the Philadelphia Inquirer:

Medicated patches used by more than ten million people in the USA may become unsafe when heated by exercise, soaking in a hot tub, or even a high fever. Medicated patches include the Duragesic Patch, Ortho Evra's birth control patch, and others.

The FDA said last week it would investigate. The FDA nvestigation comes nearly one year after the agency announced a probe into 120 deaths linked to fentanyl patches such as the ones marketed under the Duragesic brand used for chronic pain. In November, the agency issued a warning about the Orth Evra birth-control patches after a study showed that women who wore the patch had 60 percent more estrogen in their blood than those on the pill.

The problem is most evident with the fentanyl patch, which is 100 times more potent than morphine. Since it was introduced in 1990, the drug has been linked to 120 deaths.

In 2004, patches overall were cited as the primary cause of death in eight cases, including two teens on birth-control patches per the P.I. In 2003, three people died, including a 45-year-old man and a 58-year-old woman on fentanyl pain patches.


Studies as early as 1986 showed that heat can double the rate at which the body absorbs medication, but there were no public warnings until 1994.

There is a PA case that involved a death where a patch was blamed. Kurt Hophan was given a fentanyl pain patch after a back injury. He went to his bedroom at his mother's house in Glenside and fell asleep with a heating pad and an electric blanket.

"When the heat from the pad and the electric blanket came into contact with the patch, the amount of fentanyl released into Mr. Hophan's bloodstream was approximately one hundred (100) times greater than the amount prescribed," according to the judge's ruling in a lawsuit filed against the drug's manufacturer by his mother, Elaine Hophan. He died on March 4, 1994.

In 2001, a jury awarded his mother $5 million in compensatory damages.

FL Med. Assoc. Seeks to Limit Non-FL experts

The Florida Medical Association is actively involved in the agenda setting in that state. In its lists of goals, a bit of disturbing news:

There is a proposal to require xpert witness certification for out-of-state doctors in malpractice cases. In reality this is nothing more than an attempt to eliminate out of state expert witnesses because many know that that doctors licensed in Florida don't like to go toe to toe with any of their own.

You can find the FMA by going here.

You can also read more about the FMA agenda here and here.

Thursday, March 02, 2006

New Vioxx Revelations

More disturbing news about what Merck may or may not have revealed in its Vioxx studies, according to the New England Journal of Medicine's release last week.

NEJM wrote: "The information we have indicates that the Vigor article...did not contain relevant safety data available to the [Merck] authors more than four months before publication."

On its site, NEJM has a table from a July 2000 internal Merck memo analyzing the risk to the heart for patients taking Vioxx during the trial. The table is found in a Merck memorandum and notes the three heart attacks that were not included in the medical journal.

Merck developed a plan to analyze cardiovascular events only late in the trial. But instead of selecting the same cutoff date for cardiovascular problems, as it did for stomach side effects, Merck picked a cardiovascular cutoff date one month earlier, in effect excluding heart attacks that occurred in the final weeks of the trial. This part of the trial "inevitably skewed the results," per the NEJM.

A Secret End Date?: Merck didn't tell ELEVEN other academic researchers working on the paper. The 11 academic co-authors of the paper have told NEJM that each was "unaware" of this cutoff date--Feb. 10, 2000. The company says that it did this to give it time to analyze the heart-attack data, and that the cutoff was appropriate. Go here for the PDF.

Clotting Adverse Events: Among data available to Merck before the article was published but apparently not included in the NEJM release was information that a half dozen people who took Vioxx developed clots in the arms and legs during the trial -- compared with only one on naproxen.

A key question for doctors was whether Vioxx benefits to the stomach outweighed any risk of increased heart attacks. VIGOR suggests that there was indeed a benefit. Looking at the July 5, 2000 memorandum however, those who took Vioxx had 27 more "thromboembolic events" such as heart attacks and strokes than those on naproxen.

Merck, to the surprise of no one, denies it all.

You can go to Forbes as well as the NEJM to read more. The NEJM is released 3/16/06.

Vioxx: Jury seated in the Cona trial in N.J.

A 10-person jury was seated yesterday in the Cona case being tried by Attorney Mark Lanier, and five of the jurors are casino-hotel workers. It's a six person jury before Juge Higbee.

Interesting shenanigans during Voir Dire? During jury selecton Plaintiff's counsel asked the Court to address strikes by Merck's lawyers, claiming that race played a role in certain strikes. Merck struck three potential jurors, two of whom were African American. (What we call -- at least here in Georgia -- a Batson challenge). The Judge allowed the strikes.

After the issue was addressed, a Merck rep. denied that race played a role in striking two of the three black potential jurors. In various reports on the web, the Merck rep said "Merck would never do that" Riiiight.

The eight-woman, two-man jury now seated has one African American on the panel.

Wednesday, March 01, 2006

CA proposes "No More Vioxx" Legislation

From CALPIRG:

No-More-Vioxx Legislation Introduced


SACRAMENTO—Responding to public outcry over recent prescription drug scandals, CALPIRG and Senator Jack Scott (D-Altadena) have introduced legislation in Sacramento to make sure that drug companies finally come clean about the safety of the medicines. The bill, SB 1683, requires drug companies to publicly disclose the results of all their clinical trials for each drug they sell in California.

“No one would expect consumers to buy a car without knowing the gas mileage or how it would hold up in an accident,” said Emily Clayton, CALPIRG’s Health Care Advocate. “Yet, when it comes to lifesaving medicines, current law allows the pharmaceutical industry to keep much of this safety and effectiveness information from us. That’s wrong and it’s time for California to fix the problem.”

While many states have considered legislation regarding clinical trials, SB 1683 is broader and stronger than existing bills. Because it applies to all FDA-approved medicines sold in California, SB 1683 would give everyone with an internet connection unprecedented access to the results for virtually every pharmaceutical industry-sponsored clinical trial conducted over the past several decades.

“For many years, I have been concerned that consumers simply do not have enough access to information regarding pharmaceutical drugs and their testing history. Recently, we have seen the effects of a lack of information. The goal of this legislation is to keep Californians healthy and safe,” said Scott. “This is also the least costly and most direct way to provide information to our citizens.”

In addition to addressing safety concerns, the legislation also tackles the problem of overpriced and underperforming medicines. Because researchers, doctors and the general public will have access to all of the health and effectiveness studies conducted by manufacturers, they will finally be able to clearly compare medicines in the light of day.

Once accurate comparisons can be made on issues of safety and effectiveness, drug companies may have a much harder time convincing doctors and patients that expensive brand-name drugs are worth two or three or ten times the price of equally safe and effective generic drugs.

“The drug companies like to talk the talk about competition in a free marketplace,” said Clayton. “But a free market demands a free flow of information. Let doctors and patients be the judge of which drugs are worth the price based on complete information—not just the information the drug companies want us to know.”

Will this serve as a model for other states?

First Celebrex Trial in June of 2006

Going to bat first in litigation over Celebrex is Beasly, Allen whose lawyers lost last the first MDL Vioxx Trial.

The Plaintiff is Rosie Ware. She claims that Celebrex was to blame for a stroke she suffered a year ago at age 53. She alleges that Pfizer and companies it has since purchased understated the risks of the drug and failed to warn consumers of possible side effects.

The case has been set for trial on June 6, 2006 at the Circuit Court of Barbour County in Alabama. This is basically the home turf of the Beasly Firm. There are two Courthouses in that county, and one of them is in Eufaula. It's an idyllic place - it conjures up images of To Kill a Mockingbird combined with a beautiful lake area.

By the way, Eufaula is the hometown of Tom Methvin, the managing partner of Beasly, Allen, Crow, Methvin, Portis and Miles. He and I were classmates together in law school. He is today probably one of the most 'famous' people to call Eufaula home.

I'm sure Pfizer will get a fair trial there.

Stay tuned.

P.C.: Ban Darvon (Prescription Painkiller)

Public Citizen is asking that Darvon and its generic versions be banned, since they have been linked to thousands of deaths.

Public Citizen asked the FDA to ban propoxyphene which is sold by Xanodyne Pharmaceuticals under the brand Darvon. P.C. claims that Darvon contributed to 2,110 deaths between 1981 and 1999.

In 2005 a British agency announced a phased withdrawal.

FDA spokeswoman Laura Alvey confirmed that the agency received the petition and would review it carefully but could not comment further.

Twenty-three million propoxyphene-based U.S. prescriptions were filled in 2004, making it the 12th top-selling generic drug with $291 million in sales, according to the petition.

Sources: Public Citizen, internet everywhere.