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.

Blackbox Warning for Voltaren and other NSAIDS

The FDA is adding ‘black box’ warnings to all prescription and over-the-counter pain relievers – even to naproxen.

High doses of Advil (800 mg three times a day) and Voltaren (75 mg twice daily) were associated with rates of heart attack that were 51 percent and 63 percent higher than a placebo. An analysis of a large number of trials comparing COX-2 inhibitors to other NSAIDs found similar results – that Voltaren was estimated to increase vascular risk by about 70 percent over Aleve.

You can read more here.

Coming to Your MP3 Player: FDA Podcasts

The FDA is alerting health care professionals and consumers to the availability of audio broadcasts that provide emerging drug safety information.

The service is part of the agency's effort to speed up communications concerning the safety of marketed medications when unexpected adverse events are reported to FDA. You can subscribe to them for free at:

http://www.fda.gov/cder/drug/podcast/default.htm.

Vioxx News: Plunkett Seeks Trial #3

A woman whose husband died of a heart attack because of Vioxx (she claims) wants a retrial.

Evelyn Irvin Plunkett should get a third federal trial of her lawsuit claiming that the once-popular painkiller caused her first husband's fatal heart attack because a cardiologist who testified for manufacturer Merck & Co. did not reveal that his certification as a physician had lapsed. The first trial was a hung jury, and the second trial was a verdict for Merck.

For more, go here.

I'm In Love

Well, not in love, really. More like "I love this service." A company called Mediconnect, whose mission is stated on its site: "MediConnect offers secure online record retrieval using state-of-the art technology, a unique patented process, and individualized yet industry-leading service; all at minimal expense to you. "

I vowed in 2007 to use a records retrieval system like this, and generally had no complaints. Last week I had an urgent need to obtain a medical record from a hospital in another state. It was a rush item. One that if handled in office would likely take at least ten to fourteen days, multiple fax transmissions and multiple calls.

I used Mediconnect, ordered the records on a Thursday afternoon, and by Monday had the records in hand (via PDF to my email). Less than two business days. By Tuesday it was in the hands of an adjuster, and late yesterday the matter was resolved.

The best part about this service (and there are surely others) was: No staff complaining about having to go into crisis mode to obtain the records, less cost than staffing, no concerns by me over whether or not it was birddogged properly, and fast turn around. All for under $30 plus the costs of the records.

You owe it to yourself to give it a look, in my humble opinion.

Pergolide's Withdrawal Impacts 10,000 ...

Horses. Yes you read that right. An estimated 10,000 horses are currently prescribed pergolide in the United States.

The news that Pergolide (treats symptoms of Parkinson's disease) will be withdrawn from the market has a direct effect on ... horses.

Pergolide (Permax) is in a class of medications called dopamine agonists and is an important med used to control the symptoms of Cushing's disease, a pituitary disorder found in horses.

Current drug rules in the United States will not allow its import and use on animals. Nearly 10,000 horses are prescribed this drug.

Some may remember that the news regarding Hormone Replacement Therapy (HRT) also had an effect on horses. The horses were bred on Premarin farms, and when the HRT study showed a possible link between HRT drugs and certain cancers, many horses were put to death. Source here.

Sources include: Thehorse.com

14,000 Less Cases of Breast Cancer B/C of less HRT Use?

In 2002, Wyeth (maker of Prempro and Premarin) was hit with the news that claimed a link between breast cancer and the drugs it made for Hormone Replacement Therapy.

According to a recent study, as noted by among others Bloomberg, the rate of women diagnosed with breast tumors fell in 2003 and did not change in 2004, according to a report issued by researchers from M.D. Anderson Cancer Center in Houston.

Millions of menopausal women gave up on the HRT drugs affter the 2002 study was issued.

``The missing cancers, the ones that don't seem to have occurred, are the kinds that are responsive to hormone therapy,'' said the lead author, Peter Ravdin, an investigator at the cancer center, in a telephone interview. ``The decline was not a one-year wonder, a short-lived anomaly.''

Stopping hormone-replacement therapy may have led to 14,000 fewer breast cancers in 2003 than a year earlier, according to Donald Berry, head of quantitative sciences at M.D. Anderson.

What is notable in the article is this: Incidences of breast cancer rose about 0.5 percent a year throughout the 1990s according to the researchers. The last two years? A decline of more than 8 percent.

Motion in Limine: Low/Minor Impact Complaint - Exclude Photographs

Body of the Motion:

The evidence of the extent or amount of property damage is irrelevant.


Because the fact of the collision and the damage to the vehicles involved are not at issue in this case, photographs of the vehicles, property damage invoices, or other evidence regarding the extent or amount of property damage is not relevant. Georgia Rule of Evidence O.C.G.A. §24-2-1 defines relevant evidence as “evidence that relates to the questions being tried by the jury and bear upon them either directly or indirectly. Evidence that fails to meet that definition is irrelevant and is inadmissible. O.C.G.A. §24-2-1.

The Defendant has admitted causing the collision. Additionally, neither party has made a claim for property damage in this suit. Because neither the fact of the collision nor the amount of damage to the vehicles is at issue in this case, evidence discussing such issues does not make any fact of consequence more or less probable.

The extent or amount of property damage lacks the requisite foundation and testimony.

Because the fact of the collision and the damage to the vehicles are not issues in this case, the only conceivable purpose for evidence of the extent or amount of property damage is to invite the jury to speculate on the issue of causation (or absence thereof). To prove or disprove causation, however, the party must present competent evidence through competent witnesses after a proper foundation has been laid for the witnesses’ testimony.

The defense has not designated any expert witnesses to testify as to causation or lack thereof. Instead, the defense will simply refer to the photographs or repair invoices for the vehicles and argue that the jury use their “common sense” and find that Plaintiff’s injuries could not have been caused in this collision. Georgia courts require testimony, not argument, to prove or disprove causation and damages.


Use of evidence of property damage in this manner requires a proper foundation be laid through an expert witness. Interpreting the force of an impact from vehicle photographs and then assessing the likelihood of injury from such impact are tasks that can only be attempted by experts. Such matters are not within jurors’ realm of common sense.

For example, the issue of determining the force of the impact in a two-vehicle collision has been debated in scientific literature for years.Determining how much energy was transferred from the object vehicle to the target vehicle alone is extremely difficult to accomplish because most of the vehicle crash tests are conducted with a vehicle and fixed object (rather than between two vehicles).

Furthermore, most of the crash tests are performed at speeds exceeding 30 m.p.h., therefore, making it virtually impossible to extrapolate the crush values to lower speed collisions. Lastly, vehicles vary considerably in their ability to absorb certain impacts without showing damage. In fact, the same vehicle may show little damage after one type of impact, but extensive damage from another type of impact.


Even if it were possible to determine how much energy was transferred from one car to another, it is usually impossible to then ascertain exactly how much energy was transferred to the occupant of the target vehicle (as opposed to how much energy was absorbed by the vehicle). Assuming we could compute how much energy from the object vehicle reached the occupant, we would then need to know how it caused the occupant to move. To calculate this, we would need to know things like how the occupant was seated, their head position relative to the head rest and whether their head was turned. These computations can only be made by a biomechanical expert or someone with biomechanical training.

Discovery has closed, and there has not been a designation of an expert on this issue. Many are correctly finding that such evidence is not admissible when it is not accompanied by supporting expert testimony to establish an adequate foundation. See Davis v. Maute, 770 A.2d 36 (Del. 2001) (reversible error to admit evidence of property damage and allow counsel to argue serious injuries could not have resulted from “minor” collision).

The Davis court correctly found: As a general rule, a party in a personal injury case may not directly argue that the seriousness of personal injuries from a car accident correlates to the extent of the damage to the cars, unless the party can produce competent expert testimony on the issue. Absent such testimony, any inference by the jury that minimal damage to the Plaintiff’s car translates into minimal personal injuries to the Plaintiff would necessarily amount to unguided speculation. Davis, 770 A.2d at 42. The Davis holding was reaffirmed by the Delaware Supreme Court in the case of Eskin v Carden, 842 A. 2d 1222 (Del. 2004). See also, Brenman v. Demello, 383 N.J.Super. 521, 892 A.2d 741 (N.J.Super.A.D.,2006).

Thanks to Glenn Loewenthal, Esq.