Heparin: Quaid Testifies

Compelling video last week on Heparin.



Worth a look.

Spy on Your Friends

Or so says the WSJ in today's paper version. There are tools/sites to make it easier to "snoop."

The sites include:

Zabasearch.com: The site's tagline is: Telephone Numbers and Addresses Revealed Free

Wink.com:From the site - Wink People Search provides free people search across over 400 Million profiles from across the Internet - including Facebook, MySpace, LinkedIn, and all the other big social networks. You can search for people by name, location, work,and more

Spokeo.com: The site's main page says: Spokeo searches your friends' blogs and photos across 41 social networks so you don't have to visit hundreds of websites one by one.

Worth a look.

Tips: UpgradeYour Life

I'm not talking about learning CPR or adopting a child, just everyday upgrades. From Lifehacker:

A list that will help you start the handle the endless items each day that dog you. The list includes:

Hack 8: Consolidate Multiple Email Addresses with Gmail

Hack 12: Instantly Retrieve Files Stored on Your Hard Drive

Hack 21: Design Your Own Planner

Take the time to look at the post. It's the best 15 minutes you will spend this week.
Go here for more.

Walmart's $10 Meds

From the Walmart Releases:

Beginning today, Wal-Mart, Neighborhood Market and Sam's Club pharmacies will fill prescriptions for up to 350 generic medications at $10 for a 90-day supply. This option will give customers an additional choice and save them time and money without the hassle of purchasing or signing-up for a pharmacy discount card.


You can find the list of drugs here (PDF Alert).

.

Vioxx Deadline Extended: June 30, 2008

Merck report this week that more than ninety percent of eligible U.S. claimants have elected to participate in its $4.85 billion proposed Vioxx settlement, and the drugmaker extended the deadline to opt in.

Merck said that, while it was satisfied with signing up the vast majority of potential participants, it was extending by two months -- until June 30 -- the deadline for remaining eligible former users of its withdrawn arthritis drug to enroll in its proposed settlement.

Link here.

Total Body Formula Lawsuit Filed in Georgia

Today my office filed a lawsuit for a client who claims she was injured because of an unsafe supplement known as Total Body Formula.

You may view the first two pages of the Complaint here.

| View | Upload your own

The Total Body Formula product was sold in eight-ounce and 32-ounce plastic bottles. The Total Body Mega Formula is sold in 32-ounce plastic bottles. Both products are distributed by Total Body Essential Nutrition of Atlanta. The company is the sole distributor of the products and has voluntarily recalled Total Body Formula in the flavors of Tropical Orange and Peach Nectar and Total Body Mega Formula in Orange/Tangerine flavor.

The supplements were recalled, and the recalled Lots are: # 4016801, 4016802, 4024801, 4031801, 4031802 or 4031803.

The liquid dietary supplement products may cause severe adverse reactions, including nausea, vomiting and diarrhea, joint pain and fatigue. These symptoms can be followed by hair loss, nail brittleness and neurological abnormalities (such as numbness and other odd sensations in the hands, arms, legs or feet).

The FDA site informs:

The Florida Department of Health recently provided reports to the FDA on 23 individuals who experienced serious reactions to these products seven to 10 days after ingestion. In all cases, the reactions included significant hair loss, muscle cramps, diarrhea, joint pain and fatigue. The FDA subsequently learned and is investigating a report that some individuals in Tennessee using the same products have experienced similar reactions.

FDA laboratories are analyzing samples of the products to identify the cause of the reactions, including the possibility that the products contain excessive amounts of selenium, which is known to cause symptoms such as those described in the adverse events reported to the agency. Selenium, a trace mineral, is needed only in small amounts for good health.

The products have been distributed in Alabama, California, Florida, Georgia, Kentucky, Louisiana, Michigan, Missouri, New Jersey, North Carolina, Ohio, Pennsylvania, Tennessee, Texas and Virginia.

The FDA is advising consumers in all states to avoid using the products immediately and to discard the products by placing them in a trash receptacle outside of the home.

Source here.


On May 1, 2008, this news from the FDA:

FDA Completes Final Analysis of "Total Body Formula" and "Total Body Mega Formula" Products
Testing reveals high chromium levels in addition to selenium

The U.S. Food and Drug Administration’s final analysis of certain flavors of "Total Body Formula" and "Total Body Mega Formula” has detected hazardous amounts of chromium.

On April 9, 2008, the FDA reported the dietary supplement products contained hazardous amounts of selenium in samples of "Total Body Formula" in Tropical Orange and Peach Nectar flavors and "Total Body Mega Formula" in the Orange/Tangerine flavor. Further FDA analysis of the products found high levels of chromium as well. The samples contained up to 3,426 micrograms of chromium for the recommended serving (17 times the recommended intake). The recommended chromium intake for an adult ranges from 35 to 45 micrograms per day.

Excessive consumption of chromium can cause fatigue, muscle cramps, hyperactivity, hypoglycemia, renal failure and liver toxicity. Excessive chromium intake also can interfere with certain medications.

The new FDA finding comes as the U.S. Centers for Disease Control and Prevention (CDC) reports that the number of confirmed cases of adverse reactions in consumers using the products has climbed to at least 201 individuals in Alabama, Florida, Georgia, Kentucky, Michigan, New Jersey, North Carolina, Tennessee, Texas and Virginia.

Consumers were first cautioned March 27, 2008 not to purchase and to discontinue the use of "Total Body Formula" in Tropical Orange and Peach Nectar flavors and "Total Body Mega Formula" in the Orange/Tangerine flavor after receiving reports of adverse reactions. (http://www.fda.gov/bbs/topics/NEWS/2008/NEW01812.html).

The FDA continues to investigate how excessive amounts of selenium and chromium got into the products.

The sole distributor of the "Total Body Formula" and "Total Body Mega Formula" products has voluntarily recalled the affected products.

Central United Class Action

My friend and fellow attorney Joey James has asked me to post this about a pending class action and a proposed $650 payment to certain class members:


A national class action has been filed against Central United Life Insurance Company. Central United and the Class Representatives have agreed to enter into a settlement agreement in a state court in Alabama. Lawyers for Central United and lawyers for the two people that have brought this class action have negotiated a settlement between Central United and the Class Representatives.

This settlement agreement has been reached without any trial or open hearings where others could tell what has happened to them. This settlement agreement will be binding on every Central United insured in this country if a person does not opt out and the trial court finally approves the settlement without appeal.


What does this mean? This means that if you do not opt out by June 3, 2008, and the trial court agrees with this settlement and it is not appealed, you will be stuck with whatever Central United has agreed to pay and there will be absolutely nothing you can do about it. So, if your cancer insurance is important to you, you must read the agreement and opt out if you do not want to be bound by it.

If you are unsure of what to do, call Bunch & James toll free at 1-877-882-0095 or email the office at joey@bunchandjames.com

Total Body Formula Recalled

A Supplement has been recalled because of an error in its preparation.

The Total Body Formula products were sold in eight-ounce and 32-ounce plastic bottles. The Total Body Mega Formula is sold in 32-ounce plastic bottles. Both products are distributed by Total Body Essential Nutrition of Atlanta. The company is the sole distributor of the products and has voluntarily recalled Total Body Formula in the flavors of Tropical Orange and Peach Nectar and Total Body Mega Formula in Orange/Tangerine flavor.


Recalled Lots are: # 4016801, 4016802, 4024801, 4031801, 4031802 or 4031803.

The liquid dietary supplement products may cause severe adverse reactions, including nausea, vomiting and diarrhea, joint pain and fatigue. These symptoms can be followed by hair loss, nail brittleness and neurological abnormalities (such as numbness and other odd sensations in the hands, arms, legs or feet).

Link, here.

Audio: Heparin Hearings on Capitol Hill (From NPR)

A report from NPR, with the requisite table pounding by a Congressman. FDA representative lectured because "you do not have the resources" to do the job the FDA is required to do. You can get the audio here on the NPR site. Most startling about the report? There is a claim that 80% of active ingredients in meds are produced overseas.


Good stuff, and dead on. The FDA is broken. (See ABC report, "FDA Is Broken, Endangers American Lives", link here). "The wheels are coming off. In fact, I would say they're off. They're already off" at the FDA (See link).

The FDA has no translators on staff, so when there is an inspection in another country, what does the FDA do? FDA reps rely on an interpreter at the plant or company to translate.

FDA Links Tainted Heparin to China

From various sites:

FDA reps said they have new evidence linking many serious adverse reactions and deaths among patients given the blood thinner heparin to a man-made contaminant introduced during production in China.

The FDA traces the contaminant to 12 different Chinese companies and has been found in heparin batches shipped to 11 nations, all of it from China.

Chinese rep blame a US company - saying allergic reactions could have been created by impurities introduced when the imported raw heparin was refined by Scientific Protein Laboratories (SPL) of Wisconsin and then prepared for distribution in New Jersey

Link here.

Trasylol MDL: West Palm Beach

Judge Donald Middlebrooks, judge for the United States District Court for the Southern District of Florida will oversee the Trasylol Multi District Litigation. He served as General counsel to the Governor of Florida from 1974 - 1977, and in in 1997 was appointed by President Bill Clinton to serve as a United States District Judge.

Judge Middlebrooks heard the Bush lawsuit back in 2000. From the NY Times:

"The federal judge selected at random to hear the Bush campaign's lawsuit seeking to block hand-counting of ballots in some counties in Florida is a lifelong Democrat who has long been active in liberal causes ... . The judge, Donald M. Middlebrooks, is also highly regarded by Democrats and Republicans, as well as prosecutors and criminal defense lawyers, who after working with him or appearing in his court widely agree that he is fair and thoughtful." Source here.

Trasylol or Aprotinin, is also referred to as a bovine pancreatic trypsin inhibitor, BPTI. Trasylol is used as medication administered by injection to reduce bleeding during complex surgery - typically heart or liver surgery.

What does it do? The goal is to slow down fibrinolysis, a process that leads to the breakdown of blood clots.

In late 2007, The FDA asked Bayer Pharmaceuticals to suspend marketing of the drug, pending a detailed review of preliminary results from a Canadian study that suggested an increased risk for death. From the FDA website:

The FDA requested the suspension in the interest of patient safety based on the serious nature of the outcomes suggested in the preliminary data. FDA has not yet received full study data but expects to act quickly with Bayer, the study's researchers at the Ottawa Health Research Institute, and other regulatory agencies to undertake a thorough analysis of data to better understand the risks and benefits of Trasylol.

There are not many treatment options for patients at risk for excessive bleeding during cardiac surgery. Thus, FDA is working with Bayer to phase Trasylol out of the marketplace in a way that does not cause shortages of other drugs used for this purpose.

Until FDA can review the data from the terminated study it is not possible to determine and identify a population of patients undergoing cardiac surgery for which the benefits of Trasylol outweigh the risks. Understanding that individual doctors may identify specific cases where benefit outweighs risk, FDA is committed to exploring ways for those doctors to have continued, limited access to Trasylol.

Source here.

Dangerous Plastic Bottles?

From Yahoo ...

A chemical in some plastic food and drink packaging including baby bottles may be tied to early puberty and prostate and breast cancer, the U.S. government said on Tuesday.

Based on draft findings by the National Toxicology Program, part of the U.S. National Institutes of Health, senior congressional Democrats asked the Food and Drug Administration to reconsider its view that the chemical bisphenol A is safe in products for use by infants and children.

The chemical, also called BPA, is used in many baby bottles and the plastic lining of cans of infant formula.

Go here for more.

Merck Hid Vioxx Dangers

Merck suppressed documents that Vioxx could harm patients, according to a recent report. What a surprise.

JAMA writers claim that Merck failed to disclose an internal analysis that found Alzheimer's patients taking Vioxx had a three times greater risk of death than patients taking a placebo.

The most damning charge? "If these findings had been reported publicly in April of 2001, it is likely that many fewer patients would have chosen to use Vioxx and probably many fewer would have been injured,"

A separate analysis suggests Merck recruited academic researchers to lend their names and credibility to company-written studies used to give evidence of the drug's safety and effectiveness.

Merck Response:

"Generally, these allegations, we believe, are not true," said Kent Jarrell, a crisis management expert and spokesman for the law firm representing Merck in litigation over Vioxx. Notice the lawyer speak - "generally."

The source is here.

JAMA online is here. It's free.

You can find the documents here.

Did Heparin Price Surge Increase Adulteration of the Drug?

Heparin contains a substance that is extracted from the intestines of pigs and is collected in slaughterhouses and on farms.

The main ingredient produced for Heparin in China had a price increase of nearly double to the prior year. This was less than six months before hundreds of American patients began having severe and sometimes fatal allergic reactions to the medication.

The unusual increase of the price should have been a red flag to drugmakers that something significant—and perhaps dangerous—was happening to the ingredient of a medication widely used in life-threatening situations. Heparin contains a substance that is extracted from the intestines of pigs and is collected in slaughterhouses and on farms.

The FDA found that that heparin made in China had been contaminated with inexpensive over-sulfated chondroitin, an altered version of a widely used dietary supplement.

According to the report, "the price of crude heparin exported from China went from $629 per kilogram in January 2007 to $1,507 per kilogram in December. The cost of refined heparin exported by China rose at about the same rate as that of raw heparin—strongly suggesting that the increase was driven by the price of the raw material rather than by processing problems."

This source informs that the price spike should have alerted the makers.

Exubera: Lung Cancer Risk?

Pfizer has report that clinical trials of the inhaled insulin Exubera found increased cases of lung cancer.

The lung-cancer news is a setback to Exubera, which held the promise of letting diabetics avoid needle sticks.

Pfizer has reported that six of the 4,740 Exubera-treated patients versus one of the 4,292 patients not treated with Exubera developed lung cancer. One lung cancer case was also found after Exubera reached the market.

Pfizer will update the product's labeling to include a warning with safety information about lung cancer cases found in patients who used Exubera, which U.S. regulators approved in January 2006.

The warning states all patients who developed lung cancer had a history of cigarette smoking, and that too few cases existed to determine whether the development of lung cancer is related to Exubera use.

Link and source here.

Heparin Update

From the FDA site more information:

The chart below shows numbers of deaths reported after heparin administration that occurred and were submitted to FDA over the last fifteen months (i.e., from January 1, 2007 through March 31, 2008).

* The reports are sorted according to the date of the medical event in the report, indicated in the first column. This date may be different than the date of death.

* The second column indicates the number of deaths reported after heparin administration, regardless of cause.

* The third column indicates the number of death reports that included one or more allergic symptom(s) or symptoms of hypotension (low blood pressure). These are the events that prompted a series of heparin recalls.

* There have been 103 reports of death since January 1, 2007; 91 were reported to FDA on or after January 1, 2008.

* Of the 62 reports of death that included one or more allergic symptom(s) or symptoms of hypotension, 56 were reported to FDA on or after January 1, 2008.

* The fact that allergic symptoms or hypotension was reported does not mean that these were the cause of death in all cases.

* FDA received reports of 41 patients who died without mention of allergy or hypotension. These patients died of a variety of causes.

The chart may be found here.

Drug Makers May Near Goal of a Legal Shield

The NYT has posted an insightful article about the realities of preemption, and specifically Johnson & Johnson and its Ortho Evra Patch. The shield is of course preemption.

From the article:

"For years, Johnson & Johnson obscured evidence that its popular Ortho Evra birth control patch delivered much more estrogen than standard birth control pills, potentially increasing the risk of blood clots and strokes, according to internal company documents.


More than 3,000 women and their families have sued Johnson & Johnson, asserting that users of the Ortho Evra patch suffered heart attacks, strokes and, in 40 cases, death. From 2002 to 2006, the food and drug agency received reports of at least 50 deaths associated with the drug.

Documents and e-mail messages from Johnson & Johnson, made public as part of the lawsuits against the company, show that even before the drug agency approved the product in 2001, the company’s own researchers found that the patch delivered far more estrogen each day than low-dose pills. When it reported the results publicly, the company reduced the numbers by 40 percent."

This IMHO is just another example of a drugmaker taking advantage of an overwhelmed system. The FDA is a mess in my view and is barely on top of 20th century advances, much less 21st century ones. In the rarefied air of academia or perhaps pro-business judicial chambers, the FDA works. Not in real life.

From a recent Bloomberg report:

Consumers are likely to die and suffer injuries because of an ``overwhelmed'' U.S. Food and Drug Administration that lacks enough funding, an adviser to the agency told lawmakers.

The FDA isn't inspecting enough manufacturers, has too few scientists who understand new technologies, and regulates a food supply that grows riskier every year, said Gail H. Cassell, an agency adviser who is a member of the FDA's Science Board, in written testimony today to a House subcommittee.

The Science Board adopted a report in December that said the FDA needs more money and better computer systems, and should be restructured to include a scientific leader. The agency, with a budget of more than $2 billion, regulates the sale of more than $1 trillion of products annually, including food, drugs, cosmetics and medical devices.

``Without immediate action, injuries and deaths from an overwhelmed regulatory system are certain, and the costs to our society will be far greater than any dollar figure upon which we can arrive,'' Cassell, vice president of scientific affairs at Eli Lilly & Co., told the investigative subcommittee of the House Energy and Commerce Committee.

The Science Board report described rapidly developing advances in areas such as genomics, wireless health-care devices and nanotechnology, and said the FDA fails to adequately monitor products because it can't keep up with the science. The FDA suffers ``serious scientific deficiencies,'' the report concluded.


For more go here, which is the source of the article, and here for the Blomberg story.

Annuale

You owe it to yourself to watch the spot on pharma spoof from the 4/5/08 SNL:



Disclaimers include:

Do not take Annuale if you plan to ever become pregnant, as it may turn your baby into a firemonster. In the days around your period, you may develop a leathery tail. Annuale may cause you to develop a second vagina.

Two Monitors Are Better Than One

At the recently completed GTLA Tech Seminar, my friends Landon Harlan and Dave Swanner were preaching the vitures of dual monitors. Why?

Studies show dual monitors increase productivity. "Survey after survey shows that whether you measure your productivity in facts researched, alien spaceships vaporized, or articles written, adding an extra monitor will give your output a considerable boost — 20 percent to 30 percent, according to a survey by Jon Peddie Research." Source.

Setup for me was easier, since I am the guinea pig in the office for this experiment. Rather than open up the PC, I bought a USB-based cable called external video adapter:



The external version is more expensive; changin out the internal video card is about $29 per PC. After five minutes I was ready to go.

What do you see? This image shows what it is like:



I'm able to keep open my office database on one monitor, and work on the other. Already I am seeing a difference in output.

USDCT Denies Pfizer Attempt to Subpoena Journal Documents

A federal district court in Chicago dened a Pfizer subpoena that would have "threatened the integrity of [the journals'] peer-review process," as Journal of the American Medical Association (JAMA) editor Dr Catherine D DeAngelis writes in JAMA.

Magistrate Judge Arlander Keys ruled that the journals were not compelled to provide Pfizer with documents regarding how manuscripts are accepted/rejected, or hand over copies of rejected manuscripts, identities of peer reviewers and the manuscripts they reviewed, and comments by and among peer reviewers and editors. Pfizer had requested the documents as part of a broad request for information it hoped to use in its defense against more than 3000 lawsuits pertaining to how celecoxib and valdecoxib were advertised and marketed.

The editorial explains that JAMA and the Archives journals have always deliberately kept the names of peer reviewers confidential and have a policy of not disclosing the topics of papers ultimately not accepted for publication. "This promise to reviewers and authors allows the peer-review process to work in an unrestrained environment. Producing any of these documents, with or without names, would seriously compromise the process and the trusting relationship among the editors, authors, and reviewers."
Confidentiality Upheld

In her ruling, Judge Keys agreed with the journal editors that this information could be kept confidential from Pfizer and the public and that any information Pfizer's lawyers might need could be obtained from published articles.

For more go here.

Report: Auto Accidents - Workers on Cellphones Cost Employers

It should not surprise anyone that cellphones are a menace in the hands of some drivers. In my short commute to work, I see drivers backing up while on a cellphone, texting while driving more than 70 mph, and worse. In one congested intersection manned by police officers, even they are typically on cellphones.


In my Atlanta paper, this report on cellphone use:

"Cellphones have spurred fantastic advances in business productivity and employee availability, allowing workers and bosses to stay in constant contact. A 2007 study says three-quarters of Americans use cellphones while driving. And a good percentage of them are surely doing company business.

But for all the work-related benefits, the devices also allow personal-injury attorneys to reach into companies' deep pockets.

In December, McGrogan's employer, International Paper, agreed to pay $5.2 million to settle an accident in which a woman's car was forced off the road and her arm was later amputated ...

Recent settlements such as these and other big-money cases nationwide have caused companies to move to protect themselves from financial liability. With increasing frequency, businesses are mandating that workers not use cellphones when driving or at least employ hands-free sets."

Interesting reading from the AJC, and you can find the rest of the article here.

This will get worse, not better.

The Growing Vytorin Problem

Vytorin, developed and marketed jointly by Merck and Schering-Plough, is a combination of cholesterol-lowering Zetia and the statin Zocor. Statins like Zocor reduce the amount of cholesterol produced by the liver, while Zetia lessens the amount of cholesterol in food that is absorbed in the intestines. High cholesterol levels put a person at risk of developing clogged arteries. It was thought that by using Vytorin to reduce both sources of cholesterol, the amount of artery clogging plaque would also be reduced.


Congress is investigating whether the makers of Vytorin withheld data that would have hurt sales. This week, there was a release of new evidence supporting the suspicions.


The Senate's committee has said that the researcher who led a crucial study of the drug accused Vytorin makers Merck & Co. and partner Schering-Plough Corp. actually withheld.

A letter from the committee's ranking Republican, Sen. Chuck Grassley of Iowa, states that delaying the results affected medical decisions and put financial burdens on patients and the federal government, which has paid hundreds of millions of dollars for Vytorin since the study ended nearly 2 years ago.

For more go here.

Celebrex a Risk at Higher Doses (400 mg+)

If you type in Celebrex at the top of this blog and hit enter, you'll find a number of posts on that drug.

From pharmalot.com and other sites, this 'news' which has been discussed for more than two years:

Patients taking the largest dose of 400 mg twice a day tripled their chance of a heart attack or stroke, compared with people taking a placebo, according to a study presented today at the American College of Cardiology meeting. The study confirms earlier concerns that prompted the FDA three years ago to warn that Celebrex and other painkillers, including ibuprofen and naproxen, should be prescribed at the lowest dose possible.

The 200 milligram dosage is the most commonly prescribe dose of the medication.

Posts are collected here.

Total Body Formula Recall - Information You Can Use

Total Body Formula has been recalled. The liquid dietary supplement products may cause severe adverse reactions, including nausea, vomiting and diarrhea, joint pain and fatigue. These symptoms can be followed by hair loss, nail brittleness and neurological abnormalities (such as numbness and other odd sensations in the hands, arms, legs or feet).

Read more below; if you have concerns or questions, call me at Toll Free 866-755-LAWS, or email me at ageorgialawyer@yahoo.com.


Consumers are being told not to buy or use Total Body Formula in Tropical Orange and Peach Nectar flavors and Total Body Mega Formula in Orange/Tangerine flavor. These products are available in 32-ounce plastic bottles and are distributed by Total Body Essential Nutrition of Atlanta.

The products have been distributed in: Alabama, California, Florida, Georgia, Kentucky, Louisiana, Michigan, Missouri, New Jersey, North Carolina, Ohio, Pennsylvania, Tennessee, Texas and Virginia.

Lot numbers include: 4016801, 4016802, 4024801, 4031801, 4031802 and 4031803.

From the FDA:

The FDA notified healthcare professionals and patients that it has found hazardous levels of selenium in samples of certain flavors of the dietary supplement products "Total Body Formula" and "Total Body Mega Formula." Analyses of samples by FDA have found most of the samples contain extremely high levels of selenium -- up to 200 times the amount of selenium indicated on the labels of the products.

The FDA has received 43 reports of persons from nine states who experienced serious adverse reactions using these products. The adverse reactions generally occurred after five to 10 days of daily ingestion of the product, and included significant hair loss, muscle cramps, diarrhea, joint pain, deformed fingernails, and fatigue. Consumers should stop taking the products and consult their healthcare professional if they experience any adverse events associated with the use of the products.

Chrondylosis and Pain Pumps (PAGCL)

Medical experts have reported that if you think you may have developed Postarthroscopic glenohumeral chondrolysis, (PAGCL), a painful condition caused by the deterioration of cartilage (a dense connective tissue that, among other things, allows movement in joints) around the shoulder area, there are several things you should do. Here’s what they recommend:
See your doctor

While this is always the obligatory first step and fairly obvious to most, it’s important to see your doctor right away as he or she can take an x-ray to determine how much, if any, cartilage has deteriorated in your shoulder. From there, your doctor can recommend whether prescribing anti-inflammatory medications will help or if further surgery is a viable option.

In some cases, patients must undergo a procedure known as arthoplasty which reconstructs the shoulder using metal and plastic parts to replace the damaged shoulder joint. However, this option is obviously major surgery and may require a great deal of recovery time.

Understand your symptoms

As any medical professional will tell you, shoulder pain can be the result of a variety of factors including bursitis, arthritis, rotator cuff tear, tendonitis – and the list goes on and on. To determine if you have PAGCL, consider whether you have any of these symptoms:

Shoulder pain whether in motion or at rest

A narrowing of the joint space in the shoulder area (which will be detected on an x-ray)

Clicking, popping or grinding of the shoulder (called Crepitus)

Shoulder stiffness or weakness

Decreased range of motion

Medical experts who understand PAGCL say that these symptoms generally occur between three months to a year after someone has had shoulder surgery and used a pain pump directly afterwards to manage the pain during recovery.

Multiple sources all over the web.

ING Georgia: 1/2 Marathon

Sunday I ran in the ING Georgia 1/2 Marathon, and did it on a cold, windy, wet, miserable day. Ran it for a friend in the military, and ran it carrying a flag of the USA for the whole race. Came in at just about 2 hours.

Thanks to those who wished me luck; today will be an aspirin day.

The Public Library of Law

From their site, which you can find here:

"Welcome to the world's largest free law library.

Searching the Web is easy. Why should searching the law be any different? That's why Fastcase has created the Public Library of Law -- to make it easy to find the law online. PLoL is the largest free law library in the world, because we assemble law available for free scattered across many different sites -- all in one place. PLoL is the best starting place to find law on the Web.
What is available on PLoL?

* Cases from the U.S. Supreme Court and Courts of Appeals
* Cases from all 50 states back to 1997
* Federal statutory law and codes from all 50 states
* Regulations, court rules, constitutions, and more."

It's free and worth a look.

More Bad News for Heparin?

Another maker of the blood thinner Heparin has announced a recall, warning that the drug may be contaminated. B. Braun Medical Inc. has recalled 23 lots of Heparin but said in a press release that there had been no reports of adverse events.

Last month, Baxter International Inc. on at least a temporary basis stopped making multiple-dose vials of the injectable blood-thinning drug Heparin because of reports of serious allergic reactions and hypotension (low blood pressure) in patients who receive high "bolus" doses of the drug.

For more information on Braun, go here.

Florida Justice TV

I'm a member of the Florida Justice Association, the FJS has launched Florida Justice TV.

From the site:

2008 Session Week 3 Update

An update from Frank Petosa on the events of week 3 of the legislative session in Tallahassee.

Georgia Technology CLE: 3/26/08

If you'd like to see the information from this seminar, let me know. email me at ageorgialawyer@yahoo.com

Philly Judge: No Preemption in a Paxil Case

Collins adv. Glaxo, which you may find here.

A Philadelphia State Court Judge has denied a defense MSJ which would have served to dismiss the state law claims of a family whose husband and father committed suicide while taking Paxil, in Collins v. SmithKline Beecham, d/b/a GlaxoSmithKline.

A few highlights:

“Defendant's position is clearly not sustainable. Federal law in question unquestionably places the duty upon the manufacturer and does not preempt a State's ability to allow one of its citizens to inquire into whether the manufacturer breached that duty.” (Order at p. 9)

More later.

LawProse: Video of Interviews with Suprem Court Justices

Compelling stuff, much of it is unvarnished. Enjoyable video footage:

From the site:

In 2006-2007, Bryan Garner interviewed eight of the nine Justices about legal writing and advocacy. These are the complete interviews. Because the files are large, the videos may take a few moments to start playing.

LawProse is making these interviews available as a public service. Anyone may freely use these videos for educational purposes, with appropriate attribution to Bryan Garner or LawProse.

For more go here:

A New Website for Documents: JD Supra

Worth a look. Not sure if it will ultimately succeed, as many organizations (such as a Georgia Trial Lawyers Association) have sites where documents are shared/stored. The site is new - and I hope it does well:

http://www.jdsupra.com/

From their site:

For anyone in the legal community - lawyers, law firms, law schools, law professors & their students, public interest groups - JD Supra is not just a resource, it’s also a showcase:

* As a legal professional, you post your court filings, decisions, forms and/or articles to JD Supra’s database, a free tool for legal research. You also create an in-depth professional profile that is freely available simply by browsing or keyword searching, or via link from any of your posted documents.
* Consumers use JD Supra to find lawyers who have worked on cases similar to theirs, or to research a legal issue or a prospective lawyer’s filings, decisions, and articles.
* Journalists use the documents and profiles to build story ideas and find credible contacts. (In fact, we encourage you to flag your most interesting and "hot" documents for listing in our Scoop section, which we created with the media in mind.)
* Your peers and colleagues use JD Supra as a robust research tool, both for their own practices and to find like-minded colleagues and referrals.
* Anyone can search JD Supra for free, and so the benefits to you are enormous.


IMHO - "benefits to you are enormous?" Well, I'd be happy with even a modest benefit.

Zyprexa Litigation News

In the news at the end of last week, the NYT reported that a Lilly executive had encouraged the promotion of its schizophrenia drug Zyprexa for a use not approved by federal regulators.

The report said John Lechleiter, set to become chief executive in April, wrote an e-mail in 2003 discussing the use of Zyprexa by children and teenagers, although it is only approved for adults with schizophrenia or bipolar disorder.

The state of Connecticut has sued Lilly accusing it of illegally marketing and concealing its serious side effects. It faces similar accusations in Alaska as well.

For more, go here.

Imported Heparin to be Tested

Today the FDA ordered the detention of all imported supplies of heparin blood-thinner products so they could be tested for possible contamination. Heparin is derived from pig intestines, and used in dialysis and heart procedures, among other surgeries, to avoid blood clots.

Five companies have agreed to test for the contaminant, which is a chemical similar to heparin, FDA officials said. The agency would not name the companies or say where they are located, but said they represented the majority of the U.S. heparin market.

Source and more here.


Heparin chronology:

On January 17, 2008, Baxter International, Inc., initiated a recall of nine lots of its heparin sodium injection. This recall was initiated after Baxter noticed a severe spike in the reporting of adverse events. The initial recall focused only on multi-dose vials in two sizes: 1000 units/mL 10 mL vials and 1000 unit/mL 30 mL vials. The recall noted that Baxter had not observed significant increases in adverse events to its other heparin products.

-On February 11, 2008, Baxter issued an update on its recall of its heparin products. The update noted that since the initial recall, Baxter was notified of reactions related to lots of heparin sodium injection other than the nine lots recalled (same size as nine lots and different sizes). The update announced that Baxter decided (after discussion with the FDA) to not recall further lots of heparin due to market needs for heparin. While Baxter suspended the manufacture of additional vials, Baxter continued to distribute its existing products. Healthcare professionals were advised to balance the need for heparin with the increased possibility of reaction.

-On February 14th and 15th of 2008, the Wall Street Journal reported that the active ingredient in Baxter's heparin was supplied by a company known as Scientific Protein Laboratories (SPL). SPL maintains facilities in Wisconsin and China. The active ingredient in Baxter’s heparin is manufactured at both facilities. The facility in China was not inspected by the FDA prior to the reported increases in adverse events. The articles did not explicitly link the adverse events to problems with the facility in China.

-On February 28, 2008, Baxter expanded its recall of all remaining lots of all sizes of its multi-dose vials of Heparin Sodium injection, as well as single dose vials, and its heparin lock flush products. The recall notes that Baxter expanded the product removal as a precautionary measure after the FDA confirmed adequate market supply of heparin without Baxter’s presence. The recall notes that despite the expanded recall, the vast majority of adverse reactions reported occurred with Baxter’s multi-dose products. Baxter did not recall its heparin IV bag solutions in this recall.

-On March 5th, 2008, the FDA briefed the media on the Baxter heparin situation. The FDA announced that it discovered a "heparin-like molecule" in the active ingredient in heparin manufactured by Scientific Protein Laboratories (SPL), and supplied to Baxter to make its heparin. This molecule appears similar to heparin, but is considered a contaminant of the heparin. The molecule’s presence was confirmed in both samples of crude heparin (active ingredient only) and in end-product heparin. Because of the molecule's similarity to heparin, routine tests did not detect its presence. The details as to how the molecule found its way into SPL's product are currently unknown. FDA scientists have found that the molecule accounts for 5-20% of the mass of samples tested. According to the FDA, there is an association between the molecule and the severe reactions recently experienced by those taking Baxter heparin. However, the FDA has not yet established a direct causal link. The FDA is continuing to study Baxter heparin and the contamination with this heparin-similar molecule.

Jargon and Tech: Speak English for Cryin' Out Loud

This is a message (or plea) to those in the Tech World: Speak English.

I know it's hard. I know you get caught up using words like scalability, GIGO, WYSYWYG -- pronounced "wizz ee wig")and modularization. It makes you feel special. For me though, when you when you use tech jargon, I feel like I'm being bamboozled.

I'm pretty tech savvy, but when you tell me that my order hasn't been completed "through provisioning" I have to ask you to speak English to me, and now you've lost my confidence and likely my repeat business.

Pharma in bed with Democrats?

From WaPo.com:

The pharmaceutical industry is now saddling up to the Democratic Party, and it has worked to block Democrats top prescription-drug initiatives.

From the article:

"In the year since they took over on Capitol Hill, Democratic leaders have been unable to pass either a bill allowing reimportation of drugs from Canada or a measure requiring negotiation of drug prices under Medicare. Neither is likely to reach the president's desk this year. Lawmakers on both sides of these issues say the primary reason is the influence, now redirected, of the drug lobby.

Drug companies have gone on a hiring binge, retaining Democratic lobbyists in dozens of major firms. This strategy, which K Streeters call "clogging the system," prevents adversaries from hiring anyone from those consultancies."

For more, go here:

Tech Tip: Buy a .com With Your Telephone Number

With domain names becoming somewhat scarce, one easy .com buy is: Buy your office telephone number.

Attorney Bill Harrell has already done this, and it's a no brainer. The firm website is www.forjustice.com, and their number is 251-1111.com. Surely it is simply redirected to the main site.

A good friend who advertises in various media adds the tagline, "our website's the same as our number ...."

Online File Sharing from EatLime.com

EatLime speeds up online file sharing by allowing a recipient to begin downloading the file as soon as you start uploading it. So, no more waiting for the file to finish uploading before the download starts. File size up to 1GB will work.

Thanks to Lifehacker.com.

From the site:

EatLime is an easy-to-use free service that allows anyone, anywhere to transfer large files over the Web, Email, or Instant Messenger (IM).

EatLime offers an improved file transfer technology (patent-pending) with the vision to be the premier destination for direct data delivery.

Joseph Wambaugh's "Hollywood Crows" In My Inbox

Just arrived, so expect a book review in short order. I get to it after wrapping up "The French Quarter: An Informal History of the New Orleans Underworld."


The Synopsis:


When LAPD cops Hollywood Nate and Bix Rumstead find themselves caught up with bombshell Margot Aziz, they think they're just having some fun. But in Hollywood, nothing is ever what it seems. To them, Margot is a harmless socialite, stuck in the middle of an ugly divorce from the nefarious nightclub-owner Ali Aziz. What Nate and Bix don't know is that Margot's no helpless victim: the femme fatale is setting them both up. But Ms. Aziz isn't the only one with a deadly plan.
In HOLLYWOOD CROWS, Wambaugh returns once again to the beat he knows best, taking readers on a tightly plotted and darkly funny ride-along through Los Angeles with a cast of flawed cops and eccentric lowlifes they won't soon forget.

I'm a Wambaugh fan, so I hope it's worth the read ... .

CT Sues Lilly Over Zyprexa

Connecticut is joining at least nine other states suing drug maker Eli Lilly and Co. over the antipsychotic drug Zyprexa.

Attorney General Richard Blumenthal says Connecticut's lawsuit seeks to recover more than $190 million that the state's medical assistance program spent on Zyprexa over more than a decade. The charges: Lilly ran an illegal marketing campaign to promote Zyprexa for unapproved off-label uses, including treating children.

For more go here.

Kmart and $1 OTC Meds

Kmart Pharmacy has announced that it would offer its customers a choice of ten over-the-counter medications from the chain's American Fare brand for $1 with every prescription purchase. The medications will be offered through the company's new American Fare Dollar Program.

Kmart said the medications include aspirin, ibuprofen, children's pain reliever, baby aspirin, nasal decongestant, cough suppressant, anti-diarrhea medication and cold and allergy tablets.

Source here.

A smart approach. Well done Kmart.

Former NFL Player Challenges TX Malpractice Caps

Former Dallas Cowboy football player Ron Spring has been in a coma since late 2007 after having surgery to remove a cyst; he is one of several plaintiffs challenging Texas' medical malpractice cap in a lawsuit filed at the end of February.

In Springs' case, the claim is that anesthesiologist Joyce Abraham and plastic surgeon David Godat were negligent in a 2007 cyst removal procedure in which Springs suffered a severe reaction to anesthesia, resulting in cardiac arrest.

The lawsuit challenges the 2003 Medical Malpractice and Tort Reform Act that limits awards in Texas. The lawsuit asks the court to declare the cap unconstitutional. In 2003 the Texas Legislature passed the Medical Malpractice and Tort Reform Act, which set an award limit of $250,000 per plaintiff in cases where medical malpractice had been proved.



Source: The International Herald Tribune.

Hormone Replacement Therapy: Cancer Risk Stays

Menopausal women who took estrogen and progesterone do risk cancer for more than two years after the drug ingestion ended, according to the most recent results of a government study that has revealed a series of sobering findings about the once-popular hormone therapy.

The study of more than 15,000 women who took the hormones for more than five years found that the chance of developing cancer remained elevated well after they quit, which many did after an earlier stage of the study showed that the risks outweighed the benefits.

For more go to the WaPo report here.

Pfizer Pulls Lipitor Ads featuring DR. Jarvik

Pfizer announced it is voluntarily withdrawing Lipitor advertising and promotion featuring Dr. Robert Jarvik.

For more, go here.

Vioxx Update for February, 2008

Lawyers will have an extra month to send in paperwork for people who want early payment from a $4.85 billion federal court settlement involving the painkiller Vioxx.

February 29th is the deadline for "enrolling" people to get the early payments from Merck & Co., which sold the drug until September 2004. Several lawyers are having difficulty gathering the required paperwork, so the deadline for that has been moved to March 30, 2008.

Those who have submitted their names and Social Security numbers by Feb. 29 and their medical and other supporting paperwork by March 30 could get partial payments by late summer. As of now, the 'census' of registrants is 58,000 people as interested in the settlement; more than 13,200 are formally enrolled.

According to various reports and to lawyers I am working with, there may be as many as 27,000 potential enrollees who claim that Vioxx cased a heart attack or stroke.

At the hearing yesterday, my friend Woody Wilner asked Judge Fallon to allow approximately 230 of his clients to be added to the list of those eligible for the settlement. According to Wilner, there were agreements with the committee of lawyers set up to represent plaintiffs in the federal litigation before Fallon, and the agreements had been in place before the settlement had been announced. The 230 had not had their individual cases filed before November 9, 2007 because the Florida SOL had not yet run and Wilner and other attorneys had no way to know the settlement's limits because Fallon had ordered secret negotiations.

Merck and the PSC committee disagreed with Wilner's argument. Stay tuned.

What A Doctor Employed by the FDA said about the FDA

Continuing on the Riegel set of posts, it seems that those applauding the decision conclude that if the FDA can just get funded properly, we'll be fine.

I wanted to see what someone within the FDA thinks of the FDA, and I found:
Dr. David Graham, Associate Director for Science and Medicine in FDA's Office of Drug Safety. He provided testimony to a Senate Committee on the FDA's failures. Compelling stuff.

On one website, you can read this, among other things (and remember this is from someone within the FDA): "I would argue that the FDA, as currently configured, is incapable of protecting America against another Vioxx. We are virtually defenseless."

More:

It is important that this Committee and the American people understand that what has happened with Vioxx is really a symptom of something far more dangerous to the safety of the American people. Simply put, FDA and its Center for Drug Evaluation and Research are broken.

In 1938, Congress enacted the Food, Drug and Cosmetic Act, basically creating the FDA, in response to an unfortunate incident in which about 100 children were killed by elixir of sulfanilamide, a medication that was formulated using anti-freeze. This Act required that animal toxicity testing be performed and safety information be submitted to FDA prior to approval of a drug.

In 1962, Congress enacted the Kefauver-Harris Amendments to the FD&C Act, in response to the thalidomide disaster in Europe.

In my opinion, the FDA has let the American people down (addressing the Vioxx debacle), and sadly, betrayed a public trust. I believe there are at least 3 broad categories of systemic problems that contributed to the Vioxx catastrophe and to a long line of other drug safety failures in the past 10 years.

Read more here.

A Riegel View From a Nonlawyer?

Some serious gloating (and teeth gnashing) going on all over the net today as a result of Reigel. At a blog discussing drugs and devices, there is commentary on blog posts today.

You can find a good roundup of posts on the New York Personal Injury Law Blog.

Back to the device blog -- taking one set of comments at face value, this poster (with a reference to the Pharmalot blog) writes:


"Everything we have learned about industry, FDA, and their relationship over the past decade (and much longer) tells us that they will not step up to the plate. On the FDA side, they simply do not have the means to do the kind of job you describe.

I believe it a certainty, therefore, that disaster will occur, and it will be on a scale much larger and more devastating than anything we have seen because most of it will happen in the dark. When the levee breaks, it will entail more than burying the bodies and hoping for a Congressional fix. Trust in the FDA and the industry will be shattered for a very, very long time. And that itself will result in both economic and public health disaster. We will have a lot of dead people. And a lot of dead companies. So I agree - the situation will be profoundly worse for the industry, and all of us, than it is now.

That is one reason I have been arguing for several years that preemption has never been in industry’s interest. Entirely, the opposite. And the disapproval rates one sees now will be looked back upon as very good days compared to what is to come.

I am sorry to be so negative. Trust me, this is not a political statement. And it is precisely the opposite of anti-industry. It is looking a policy in the face - the policy of preemption - and simply saying what cannot be blinked away: it is logically, practically, and ethically bankrupt. It is a preemptive strike that will cost more, in both lives and treasure, than the preemptive strike on Iraq. It is an avoidable disaster (in the drug arena), but one that will almost certainly not be avoided.

And, sad to say, those who are on the inside of the industry know this best of all. And many of them have told me this, just as I am sure, in one way or another, they have told you. "

Source here.

I'd like to welcome back to reality anyone who rationally thinks that the FDA is doing a good job now.

SCOTUS Riegel Opinion: Preemption as to Medical Devices

The U.S. Supreme Court issued its opinion in Reigel. You may find it here.

The ruling will affect the medical devices most frequently targeted in lawsuits, cutting-edge products such as bone screws and defibrillator wires that undergo the FDA'S pre-market approval process. Because that process typically takes almost a year, companies use it relatively sparingly, filing only 43 new applications with the FDA in 2005.

From one blog:

"The medical device industry, or at least the most innovative part of it, received major relief from product liability litigation yesterday in Riegel v. Medtronic (now online at 2008 WL 440744)." As the blogger posted: "As long as [device makers] with PMA-approved devices comply with federal law, [device makers are] not going to be subject to much in the way of product liability." Source here.

For more news, go here.

Wyeth Wins a Thimerosal Case

There are claims that Thimerosal is linked to Autism. Jude Stuart R. Berger of the Circuit Court for Baltimore City in Baltimore, Maryland, granted in a Thimerosal case Wyeth's motion for summary judgment. The case was Blackwell v. Sigma Aldrich, Inc., and the claim related to the drug. The Complaint alleged that Jamarr Blackwell's exposure to thimerosal-containing vaccines caused him to become autistic.

For more, go here.

Jury Verdict for My Friend Angel Reyes and His Firm

My friends at Heygood, Orr, Reyes, Pearson & Bartolomei pass along news of a great jury verdict for their client, Tony Alardin, in a partnership dispute regarding the development, manufacture and sale of wireless video surveillance trailer systems.

In 2001, Mr. Alardin, along with his company Remote Monitoring Technologies, entered into a partnership with Dallas businessman Gregg Hoss and his company, Hoss Equipment Company, to perfect the technology and further develop and market wireless video surveillance trailer systems. In March 2005, as the technology was being perfected and as the market became poised for growth, Mr. Hoss barred Mr. Alardin from the premises of the partnership. Hoss Equipment Company continued developing and marketing the wireless video surveillance trailer systems and subsequently generated approximately $2 million in revenue. Mr. Hoss denied the existence of any legal partnership with Mr. Alardin and took the position that his relationship with Mr. Alardin was, at best, a marketing partnership and as a result, he was fully within his rights to do what he did.

In January 2006, Mr. Hoss and Hoss Equipment Co., brought suit against Mr. Alardin seeking, among other things, repayment of the money put into the wireless video surveillance trailer systems prior to the lock-out. Mr. Hoss claimed the money had not been capital contributions to a legal partnership but instead loans to Mr. Alardin and his company that were never repaid.

Mr. Alardin approached Heygood, Orr, Reyes, Pearson & Bartolomei to defend him against the allegations brought against him and to pursue counterclaims against Gregg Hoss, including breach of fiduciary duty. The case was tried in Dallas County before Judge Jim Jordan. After a week and a half trial and two days of deliberation, the jury returned its verdict and found that Mr. Hoss had breached his fiduciary duty to Mr. Alardin. The jury awarded Mr. Alardin $3 million.

Michael Heygood, Partner of HORP&B, was the lead trial attorney for Tony Alardin, and was assisted at trial by Ryan Browne. Mr. Heygood commented, “At the end of the day, as is often the case, the jury was able to understand what was really going on.” According to Mr. Heygood, “Even though there was no written partnership agreement, the jury recognized the partnership between Mr. Hoss and Mr. Alardin and agreed that Mr. Hoss failed to treat Mr. Alardin fairly or justly."

Well done.

Another Fentanyl Recall (Actavis and Abrika)

Fentanyl patches were recalled for the second time in a week because of a problem that could cause patients or caregivers to overdose on the potent drug inside.

Sold in the United States by Actavis South Atlantic, the newly recalled patches have both this name and the company's former name, Abrika Pharmaceuticals, on their packaging. The old name is on the pouches that contain the patches and the new name is on the outer carton.

This recall includes 25-microgram-per-hour, 50-microgram-per-hour, 75 microgram-per-hour and 100 microgram-per-hour patches with expiration dates of May through August 2009.

What's wrong with the patches?

Several of the patches may have a defect that can cause them to leak. This would put both patients and caregivers at risk of coming into direct contact with the powerful drug inside the patch. This could result in difficulty breathing and a potentially fatal overdose.

Could Drugmakers Use Journals to Promote Off Label Use?

From Bloomberg.com:

Drug and medical-device makers would be allowed to use medical journal articles to promote unapproved uses of their products under a U.S. proposal that drew immediate criticism on Capitol Hill.

The Food and Drug Administration issued draft guidelines today explaining the circumstances in which companies could distribute ``truthful and non-misleading'' articles to health- care providers.

Makers of drugs and devices aren't permitted to promote their products for conditions not approved by the FDA, although doctors are free to prescribe such ``off-label'' uses. Representative Henry Waxman, a California Democrat, said the FDA's proposal ``caters to the industry's desire'' to market products without enough testing or review.

Source here.

60 Minutes and Trasylol

From CBS:

"This is the story of a drug that was on the market for 14 years and may have contributed to the deaths of thousands of patients. Trasylol, made by Bayer, is given in the operating room to control bleeding. It was a big money maker.

As correspondent Scott Pelley reports, Bayer marketed Trasylol aggressively until it was used in about one third of all cardiac bypass operations in America.

But then, in 2006, a study showed widespread death associated with Trasylol, and as it turns out there was concern long before that.

How much did Bayer know? And why did it take Bayer and the U.S. Food and Drug Administration nearly two years to take the drug off the market after major studies revealed the danger? Two years - during which it's estimated Trasylol was contributing to the loss of one thousand lives a month. "

Video link here.