Wednesday, April 30, 2008

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

Sunday, April 27, 2008

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.

Thursday, April 24, 2008

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.

Wednesday, April 23, 2008

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.

Sunday, April 20, 2008

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.

Wednesday, April 16, 2008

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.

Tuesday, April 15, 2008

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.

Monday, April 14, 2008

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.

Wednesday, April 09, 2008

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.

Tuesday, April 08, 2008

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.

Monday, April 07, 2008


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.

Friday, April 04, 2008

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.

Wednesday, April 02, 2008

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.