FDA Conducting "Smear" Campaign vs. Avandia Critic

From ABC News:

The cardiologist who raised alarms about Avandia is saying a smear campaign has been organized against him by a top FDA rep.

Dr. Steven Nissen, chairman of Cardiovascular Medicine at the Cleveland Clinic, showed ABC News an e-mail sent to reporters by Douglas Arbesfeld, a senior communications consultant to the FDA.

According to the ABC report, the e-mail's title is "What are St. Steven's feet made of? Clay, perhaps?" It was forwarded to reporters with a critical news article which included an anonymous blog accusing Nissen of playing favorites among drug companies.

As I was reading the reply, I actually had an "LOL" moment as I read: "Arbesfeld, who is among the FDA's top spokesmen, acknowledged sending the e-mail to a handful of reporters but denied he was attempting to impugn Nissen's reputation. "

Riiiight. No, not at all. Let's see ... email allegedly sent from an FDA email account, a link to an anonymous blog post which has a drive by allegation of favoritism by Dr. Nissen (favoritism at the FDA perhaps??). No, the denial is most plausible. And I can sing tenor.

Source here.

Accutane Trial Verdict: $2.6 Million for Plaintiff

One of the first trials regarding the drug Accutane resulted in a Plaintiff's verdict in a New Jersey State Court.

The Plaintiff was Andrew McCarrell a software company employee. He was awarded $119,000 for past medical expenses and $2.5 million in compensatory damages to cover future medical costs, pain and suffering.

McCarrell took Accutane from June 1995 to October 1995 and suffered from achy knees and chapped lips while he was taking it. He later developed abdominal pain and was told her had inflammatory bowel disorder. He would later have his rectum and most of his colon removed.
After years using a colostomy bag, McCarrell had another surgery to connect the remains of the colon with the anus, resulting in permanent diarrhea because there is no colon to draw out excess water.

Three more trials are scheduled this year in Florida and Illinois.

My Interview on Legal Broadcast Network: Crazy Pants Lawsuit

About three weeks ago it seems that the $65 million dollar dry cleaning pants lawsuit was front and center everywhere - Fox, WaPo, AP, you name it. Last week Mark Wahlstrom from the Legal Broadcast Network interviewed me about this clearly frivolous lawsuit.

Catch Angel Reyes and Mark Cuban's blog posting about an attorney's response to the crazy pants lawsuit.

You can catch the podcast here.

AMO Contact Lens Solution Recalled

California-based Advanced Medical Optics (AMO) "immediately and voluntarily" recalled its Complete All-In-One MoisturePlus solution, which is sold across Canada and the United States.

The micro-organism causes acanthamoeba keratitis (AK), a serious corneal infection with symptoms that differ among patients. Symptoms range from redness and sensitivity to light to severe pain and possible vision loss. If left untreated, some patients may even require a corneal transplant.

The CDC interviewed 46 patients in the U.S. who had developed AK since January 2005. Thirty-nine of those patients wore soft contact lenses and 21 of them reported using Complete All-In-One MoisturePlus.

For the source, go here.

Majority of Medical Malpractice Claims Paid Zero?

From a site known as the insurancejournal.com:

The majority of medical malpractice claims in a study of seven states were closed without any compensation paid to those claiming a medical injury, the Justice Department's Bureau of Justice Statistics (BJS) reported. Go here for the abstract.

BJS conducted a study of medical malpractice insurance claims that were closed from 2000 through 2004 in Florida, Illinois, Maine, Massachusetts, Missouri, Nevada and Texas. These states were identified as having comprehensive medical malpractice insurance claims databases, some of which extended back to the early 1990s.

You can find the rest here.

Louisiana urged to make insurers pay up for $3B in shortfalls

From nola.com:

With federal officials hinting it is unlikely Washington will bail out Louisiana's Road Home program from a projected $3 billion shortfall, Gov. Kathleen Blanco and a top Louisiana Recovery Authority member are recommending the state seek more money from the group they claim caused about half the deficit -- insurers who underpaid homeowners for wind damage.

Go here for more. Also, thanks to the folks at ITP for noting that when it came to insurer payments in LA,

1. Insurers paid only 61% of total insured damages, including the flood program, while the state expected 76%.

2. Only 23% of policyholders got 100 cents on the dollar.

3. 37% of policyholders received less than 50 cents on the dollar, including flood.

4. About 8% received less than 10 cents on the dollar. Source.

Expect lawsuits before the upcoming 2 year SOL.

Avanaia (Diabetes Drug) and Claimed Link to Heart Attack Risk

From the upcoming NEJM comes a report that after an analysis of previous studies, patients on Avandia were reportedly more than forty percent likely to have a heart attack. The researchers also found a trend toward high death rates. Avandia is taken by 1 million Americans and generated sales of $3 billion in 2006. Source here.

The accompanying NEJM editorial hammered the drug's maker. While noting there were flaws in the study, “in view of the potential cardiovascular risks... the rationale for prescribing [Avandia] is unclear.”Assuming its findings are valid, they indicate “a major failure” of drug monitoring in the U.S., the editorial said. NEJM here.

I hope the impact of that clearly damning statement makes its way to Joe Citizen.

Congressmen John Dingell Bart Stupack have said they would launch an inquiry into what they called the failure of the manufacturer as well as the FDA to warn diabetics about possible risks associated with the drug.

The FDA's newly issued safety alert states:

“Patients who are taking Avandia, especially those who are known to have underlying heart disease or who are at high risk of heart attack, should talk to their doctor about this new information as they evaluate the available treatment options for their type 2 diabetes,”

The quote can be found in an article in the Congressional Quarterly with the title "FDA Under Fire for Handling of Diabetes Drug Risks." Here.

Can it get any worse for the FDA? My best is yes. It has not yet hit rock bottom.

Eli Lilly Sued by the State of Utah

Utah filed a lawsuit against Eli Lilly as to Zyprexa, claiming that the state was misled about risks to patients who received the drug through Medicaid.

"Utah has paid millions of dollars for inappropriate and medically unnecessary doses of Zyprexa. As a result, Lilly has been illegally enriched at the expense of the state," the lawsuit said.

The source for the quote and this article: Here.

Medicare Suggests Limits on Anemia Drug Coverage

More bad news for ESA drugs like Epogen:

From the Medicare site:

The Centers for Medicare & Medicaid Services (CMS) announced today its proposed decision to limit coverage of erythropoiesis stimulating agent (ESA) treatment for beneficiaries with certain cancers and related neoplastic conditions, either because of a deleterious effect of the ESA on the beneficiaries’ underlying disease or because the underlying disease increases their risk of adverse effects related to ESA use.

The proposed national coverage decision (NCD) was made in response to a Food and Drug Administration (FDA) black box warning regarding the use of ESAs. FDA recently announced concerns about the use of ESAs by adding Black Box warnings to all ESA labels.

This led CMS to open a National Coverage Analysis (NCA), on March 14, 2007, on the use of ESAs for conditions other than end-stage renal disease (ESRD), which was the first step toward issuing this proposed NCD.

FDA also conducted an Oncologic Drug Advisory Committee meeting on May 10, 2007 that raised concerns about the use of ESAs in oncology patients.

“We pay close attention to FDA black box warnings because the safety of our Medicare beneficiaries is paramount,” said CMS Acting Administrator Leslie V. Norwalk, Esq. “We have carefully examined the evidence surrounding these labeling changes and have issued this proposed decision to protect our beneficiaries.”

CMS proposes that ESA treatment is only reasonable and necessary under specified conditions for the treatment of anemia in certain cancers.

CMS is seeking public comments on this proposed decision. The public comments period is open until June 13. Medicare local contractors have the discretion to make reasonable and necessary determinations for all uses of ESA therapy for beneficiaries with cancer whose condition is not addressed in the proposed decision memorandum.

“Because there is a preponderance of emerging data for ESA use in the oncology setting, we have narrowed the focus of the national coverage analysis to ESA use in cancer and related neoplastic conditions,” said Barry M. Straube M.D., Chief Medical Officer for CMS and Director of the Agency’s Office of Clinical Standards and Quality.

ESAs are anti-anemia biologics, distributed as Epogen and Aranesp and as Procrit. They are manmade versions of erythropoietin, a hormone that is produced in the kidney, and stimulate the bone marrow to make more red blood cells.

ESAs are FDA-approved to treat anemia in patients with ESRD and reduce the need for blood transfusions in patients with ESRD and chronic kidney failure, as well as in cancer patients whose anemia is caused by chemotherapy. Epogen and Procrit are also approved for some patients scheduled for major surgery to reduce potential blood transfusions, and for the treatment of anemia due to zidovudine therapy in patients with human immunodeficiency virus (HIV).

This proposed decision is the latest step in CMS’ efforts to closely review the use of ESAs in the Medicare population. In addition to this proposed NCD, CMS continues to review its monitoring policy for the use of ESAs in the ESRD setting.

“Medicare beneficiaries with cancer and renal disease are among our most vulnerable patients, and we are dedicated to ensuring that they are receiving appropriate care,” said Dr. Straube.

For national coverage decisions, the Medicare Modernization Act of 2003 requires CMS provide a 30-day period for public comment on the proposed decision and make a final decision no later than 60 days after the conclusion of the public comment period.

Taken from this site.

FDA: Bad news for Aranesp

At the FDA last week the Oncology Drugs Advisory committee voted 15-2 to add additional restrictions to the Aranesp label and voted 12-5 to restrict certain tumor types from the drug's label. The panel was concerned about the lack of large, randomized trials of the EPO drugs and limited survival data. The FDA is not required to follow an advisory panel's advice, but it often does.

The committee voted 15-2 in favor of having further marketing authorization of the drugs be contingent upon adding additional restrictions to the drugs' labels. It also unanimously recommended further marketing of the drugs should be contingent on the companies conducting additional clinical studies.

These types of drugs are "injectables" known as erythropoiesis-stimulating agents, or ESAs, and act by stimulating the production of red blood cells in the body.

Story sources include: Marketwatch.com and the FDA site.

Pergolide and Horses: An update and how you can help

In my email, I've received a number of messages regarding the Pergolide withdrawal and its effect on horses.

I wanted to let folks know about a site worth reading: www.peroglideaction.blogspot.com.

The author notes that on 3/29/07, the FDA announced a withdrawal of the drug pergolide from the market. This action placed the health and well being of all horses diagnosed with Equine Cushing's Disease in jeopardy.

Dr. Kellon on her site also notes that there is no present viable alternative to pergolide to control Cushing's, or to stave off debilitating and life threatening side effect of the disease in horses.

There is a link on page one of the site to a petition. I signed it. Will you?

O.J. & his Attorney: Lawsuit for kicking OJ out of Restaurant?

O.J. Simpson, who is guilty (according to a civil jury verdict) of the wrongful death of Nicole Brown Simpson and Ron Goldman, was asked to leave a restaurant last week. "I didn't want to serve him because of my convictions of what he's done to those families," Jeff Ruby said in a telephone interview Tuesday. "The way he continues to torture the lives of those families ... with his behavior, attitude and conduct." Source here.

It looks like many who have heard about or read about this story side with the restaurant owner. On CNN last night Ruby mentioned on air that he had received many supportive emails.
O.J.'s attorney, however, sees it differently. Alas, he let his emotions get in the way of rational thought. According to published stories, Yale Galanter (Simpson's lawyer), said the incident was about race, and he intended to pursue the matter and possibly go after the restaurant's liquor license. Oh by the way ... Michael Jordan, walked in five minutes after Simpson left and got a table. He stayed, ate, paid his bill, and left.

"He screwed with the wrong guy, he really did," Galanter said by telephone Tuesday night. Source same as above.

Really? Let me think this through a bit. Kentucky like most states has a public accommodations statute. Is it likely that it was violated by the restaurant owner? IMHO, probably not. Let's presume though that on some level it was.

What happens next? Suing the restaurant? If I'm the restaurant attorney, I am thinking about a jury in Kentucky considering a case brought by someone found (in a civil court) of killing two people, the chances he would have in that state, and the likelihood that if he succeeds the money goes to satisfy the verdict against him in the wrongful death case. wqn

As an old law professor once said to me about a potential case, "Son, if I were you I wouldn't file that case."

Dangerous Food: Joint Update: FDA/USDA Finds Contaminated Poultry

The USDA and the FDA) have learned that byproducts from pet food manufactured with contaminated wheat gluten imported from China have been used in chicken feed on some farms in the state of Indiana. This information came to light as part of the continuing investigation into imported rice protein concentrate and wheat gluten that have been found to contain melamine and melamine-related compounds.

At this time, the investigation indicates that approximately 30 broiler poultry farms and eight breeder poultry farms in Indiana received contaminated feed in early February and fed it to poultry within days of receiving it. All of the broilers believed to have been fed contaminated product have since been processed. The breeders that were fed the contaminated product are under voluntary hold by the flock owners.

Source: FDA.

My comment: This is just the beginning of what may be an epidemic and years long series of instances involving contaminated food. Reports will become more common (and incidents more widespread) , rather than less common.

Anemia Drug in Japan Blamed for Death of Patient

A U.S. patient died of liver failure in Japan after taking an anemia med that is considered experimental. The patient was taking ten other medications and was over 70.

The drug is known now as FG-2216. It is part 2 of a three stage of patient study usually needed for approval in the U.S. It aims to help patients with chronic kidney disease and cancer increase levels of a protein called erythropoietin that stimulates production of red-blood cells, which carry oxygen through the blood.

The drug was to used orally, and would be an alternative to Epogen, Procrit and Aranesp . Recently each of those made news because of alleged links side effects, including strokes and heart attacks, in patients with chronic kidney failure. Epogen is also the biggest drug expense for the U.S. health insurance program.

The source is Bloomberg.

ACE Inhibitors May Cut Dementia Risk

The news isn't always bad when it comes to pharmaceuticals. If you have a loved one, family member or friend who is battling the onset of dementia, here's hopeful news:

Certain types ACE inhibitor hypertension drugs may help cut the risk of dementia in older adults, according to the Wake Forest University School of Medicine. According to WaPo, centrally acting ACE (angiotensin-converting enzyme) inhibitors may help reduce inflammation that might contribute to dementia.

People who took centrally acting ACE inhibitors, they had a 50 percent lower rate of mental decline than people taking other kinds of hypertension drugs.

Centrally active ACEIs, such as captropril (Capoten), fosinopril (Monopril), lisinopril (Prinivil or Zestril), perindopril (Aceon), ramipril (Altace), and trandolapril (Mavik), cross the blood-brain barrier. Previous animal studies suggest that centrally active ACEIs protect against dementia not only by controlling hypertension, but also by decreasing oxidative stress and reducing inflammation in the brain. (Source: Medscape).



The article may be found here.

Crazy Pants Lawsuit: A Reply

Many thanks to fellow Georgia attorney Jamie Bendall, the author of this fine piece:

I have a confession to make. I am serial changer of dry cleaners. Maybe
I'll change because I don't like the way my shirts are starched. Once it
was because the clean clothes smelled too much like chemicals. The worst
was when I had to change because I had thought they lost a pair of my
pants. Oh I was sure they'd lost them and man were those pants
comfortable. It turns out the pants were not lost, simply in the back of
the closet. As sorry as I am to admit it, I thought it easier to change
dry cleaners than let them know I'd found my pants.

You can imagine then why I was drawn to this story about the person who is
suing his dry cleaner for more than $65 million dollars over a lost pair of
pants. Now I know what you are thinking, obviously these pants had a
winning lottery ticket in the back pocket when they were lost. That's not
exactly the case. Instead, it's a basic dispute between a business and a
customer that has spiraled out of control. It's my guess that there are
only a handful of reasons why you may have heard about this lawsuit at all.
The first is that person who is suing the dry cleaner is a lawyer, and even
better than that, a Judge. The second is the amount of money, because
let's face it, that is one shocking amount to claim in damages. The third
is it's been a slow news period. The President and Congress are fighting
about to how best end our engagement in Iraq; a woman's right to choose is
being incrementally restricted; it will be at least another two weeks
before John Edwards needs another haircut, and Sanjaya is gone from
American Idol, so there's not much there to capture the imagination between
commercials for all-steel buildings and gold funds.

Thankfully, this story fits perfectly in to established story lines many
people have about the legal system. Even though the most recent studies
have shown that jury trials have been become more and more scarce, people
are still willing to believe that our civil justice system is on the brink
of disaster. The fact that this person, a citizen, can walk right in to
the courthouse, file a lawsuit, and claim that amount of money for a lost
pair of pants, well something simply has to be done about that. That this
person is a lawyer? That just dots the old "i" and crosses the old "t," on
the point that if we don't do something today, like cap damages or abolish
joint and several liability, or grant broad immunity for certain classes of
wrong-doers, then have failed the founders of this country.

Now it's probably time to let you know, if you hadn't guessed, that I am a
lawyer. I'm reading about what lawyers need to do, if anything, to counter the
discussion surrounding some guy who couldn't work it out with his dry
cleaner. It's a pretty sad state of affairs, when such a negative bill of
goods has been sold on an entire portion of a profession that this isolated lawsuit is seen as proof positive of system run amok.

Here is my suggestion, and believe me it's radical. Let the system work.
The person who was missing his pants and the dry cleaner tried to work it
out between themselves and for whatever reason, and whatever we may think
about that, could not. One recourse was to take legal action, and that is
what this person did. What he claimed as damages, and in what amounts,
appear to comply with what is permitted under the law. He has asked,
through the legal system, for the help of his community in the form of a
jury trial, to resolve this matter. Maybe, just maybe, we'll find that he
won't actually get awarded $65 million dollars. I am guessing our system
can handle this one, let's just be patient.

I want to end this a flourish. Perhaps I could mention that the Judge in this case will likely evaluate this case like most of us get dressed in the morning; one leg at a time. I thought I
might suggest that without knowing more about the case, my opinion would likely be hemmed in by what I knew. I also was going to attempt to include a reference to the pleatings in the case, but thought it was too much of a reach, though it seemed tailor-made at first. Instead, I will simply end by alluding to that famous story about the Emperor's new clothes, and
believe that this person, like the Emperor, may soon find that his claims
are wearing no pants.


Jamie Bendall
Bendall & Mednick

12 Important U.S. Laws Every Blogger Needs to Know

That is, according to the folks at http://www.avivadirectory.com/blogger-law/

The 12 include:

"Whether to Disclose Paid Posts:

Over the last five years bloggers have begun to displace traditional media outlets as individuals’ source for reliable information and recommendations. This development has created big opportunities for advertisers to get bloggers to endorse a product or service, primarily through posts or affiliate links. But as the practice and influence of bloggers has grown, US law has come to govern this area."

They then layout a thumbnail sketch of the law, and close with:

"How to stay out of trouble:

1. NEVER claim that you are an objective, unbiased source if you are being paid to provide information.
2. ALWAYS make it easy for your readers to distinguish between advertising and editorial content ... ."

It's worth the twenty minute read.

Witness Interviews: A Quick Way to Record/Transcribe

I'm a fan of Speakwrite, and lawyer Dave Swanner (South Carolina Trial Law Blog) has this: Use SpeakWrite to record witness interviews.

Dave tells us:

1. Call the witness on the phone. 2. Using conference calling, add www.Speak-Write.com as a "third" caller.

By setting up a conference call with Speak-Write, you eliminate the need to for having the equipment to digitally record the conversation yourself and you eliminate the need to hiring your investigator to take the statement. You also eliminate the cost of the investigator.

You can also use this to take a recorded statement from your client. You can put the phone on speaker and call Speak-Write. You will get a transcribed copy of the interview and also the digital recording in the client's own voice.

Good work Dave.

Katrina: Insurers Settle with Homeowners

From UPI:

Attorney Zach Scruggs announced that his office helped homeowners resolve 227 claims with Nationwide Mutual Insurance Co. on behalf of Mississippi's . In January of this year, State Farm Fire and Casualty Co. settled with 640 of Scruggs' clients for $80 million. There are another 34 that have settled. Still pending are 470 cases with State Farm.

Finding contractors to do the work for the insured homeowners is the next headache.