Monday, June 11, 2007

Criminal Law: A Taser's A "Calming" Device?

I don't usually write about matters relating to criminal law, but when I heard this today I had to shake my head and wonder, "what the ... ??? "

"Nuggets reserve forward DerMarr Johnson was charged with resisting arrest and interfering with police during a disturbance outside a nightclub. Police said they used a Taser on him to calm him." Source here.

A Taser fires small dart-like electrodes with attached metal wires that connect to the gun, propelled by small gas charges. A Taser 's burst of voltage is often 50,000 volts.

When I hear or use the word calm, it's usually in the context that conjures up images of a quiet beach, or the stillness of the moments before sunrise. It's NOT the word I'd use to describe what happens here:







Friday, June 08, 2007

Friday Diversion: The Surfrider Foundation



I grew up in Florida and water is a way of life for me even now. Ocean, gulf, river or lake, it does not matter to me . The Surfrider Foundation is active in preserving beach access to the general public, fill protests, and more.

Their page informs:

Surfrider Foundation's Beach Access initiative promotes the right of low-impact, free and open access to the world's waves and beaches for all people.

In nearly every state, some portion of the beach is public land, which means that all members of the public have the right to use that portion of the beach. Because much of the land between where people can park and where they can enjoy the beach is privately owned, their ability to enjoy beaches often depends on the quality and availability of access between roads and parking lots and the beach. It is simply not equitable for only some people to have access to the ocean and beaches, which are public resources.

Thursday, June 07, 2007

Best Buy Defense Counsel Admits Altering Documents

From seattlepi.com:


A lawyer for Best Buy Co. has admitted that he falsified e-mails and a memo before turning them over to plaintiffs in a nationwide class-action lawsuit.

The pending case has been stayed while Best Buy looks to hire new litigation counsel. The lawyer works for Robins, Kaplan, Miller and Ciresi, and that firm has filed a Motion to Withdraw.

The altered documents are supposedly "limited" to two e-mails and one memo, and as of yet the documents have not been publicly released.

Will this make it to page one anwyhere? Fox News? The crazy pants lawyer's lawsuit makes it around the world, another attorney has TB and while his condition has nothing to do with his profession, he even gets more headlines play than Paris Hilton (at least for 3-5 days), so can people expect the same from this news? I won't hold my breath on it.

The FDA: Who's Guarding the Guards?

Juvenal was a Roman poet active in the late first and early second centuries. Juvenal is credited with the creation of the phrase, Quis custodiet ipsos custodes? It has been translated as "Who will guard the guards?" or "Who watches the watchmen?"

That phrase comes to the fore when I read today's most recent FDA-related news. Once again - in another Congressional hearing held this week - several lawmakers rebuked the FDA for failing to protect consumers. Congressman Henry Waxman says that despite warnings, the FDA never required the drug maker to conduct a thorough post-market study of heart risks . Source
here.

When will it end? The FDA is broken. It's going to take a generation to repair.

Actos (Diabetes Drug) To Add Boxed Warning

Actos - the rival drug to Avandia - made by Takeda, will have added to its package insert a black box warning. The warning will increase awareness of risk of congestive heart failure. There are reports that the FDA asked to have the warning added. Source here.

From philly.com:

An FDA commissioner told Congress on 6/6/07 hat the FDA was ordering GlaxoSmithKline and Takeda Pharmaceutical Co. Ltd. to add "black box" warnings to their diabetes drugs Avandia and Actos, strengthening existing warnings about heart failure, a condition where the heart does not adequately pump blood.

Congestive heart failure (CHF), or heart failure, is a condition in which the heart can't pump enough blood to the body's other organs. This can result from
  • narrowed arteries that supply blood to the heart muscle — coronary artery disease
  • past heart attack, or myocardial infarction, with scar tissue that interferes with the heart muscle's normal work
  • high blood pressure
  • heart valve disease due to past rheumatic fever or other causes
  • primary disease of the heart muscle itself, called cardiomyopathy.
  • heart defects present at birth — congenital heart defects.
  • infection of the heart valves and/or heart muscle itself — endocarditis and/or myocarditis

Source: Here.

Wednesday, June 06, 2007

Avandia (Diabetes Drug): FDA Hearing on 7/30

July 30th is the day that GSK's Avandia is in the spotlight before the FDA.

The FDA said it would gather members from its advisory committees on endocrine and metabolic drugs and on drug safety and risk management. The advisory panel will discuss the cardiovascular risks of the class known as thiazolidinediones, "with a focus on rosiglitazone, as presented by FDA and GlaxoSmithKline," the FDA said.

Stay tuned.



FDA Hot Topics Website

Worth a look, go here.

http://www.fda.gov/oc/opacom/hottopics/default.htm

Tuesday, June 05, 2007

20 Sure-Fire Ways to Come up with Great Ideas

Reading the nonbillable hour, there's a link to "20 Sure-Fire Ways to Come up with Great Ideas" which can be found here.

Several of the items make sense. One of the ideas (to me) is not a good one to practice:

"1. Carry a notebook.

Have a little notebook that you carry around with you wherever you go, including to bed. I like Moleskine notebooks, but any pocket-sized one will do. When you get an idea, write it down — right away. Even if you have to stop the car in order to do so. Ideas are fleeting, and you must write them down before they’re gone again. "


There is one, however, that I cringe when I read anywhere or have told to me:

"5. Exercise.

Running, for example, is a great way to come up with ideas. First of all, exercise gets your blood circulating, which seems to stimulate your mind. Second, you’ve got some quiet time to think. And finally, the peaceful scenes of nature that you pass when you’re running seem to inspire great ideas. Any kind of exercise will do, though."

To me this is always a bad idea. Running (my exercise of choice) is the time to get away from thinking. Yes you read that right. For me (and certainly for others) the day is jammed with pressure, meetings, calls - work. I leave all of that behind for the sometimes too short times when I run. I turn the music on loud and forget - forget bills, calls, tirades, bad news, good news, people.

The ad which has caught my eye recently is the one for Propel water, referred to as the Propel Stress Monster (the one where the "boss" meets his demise during the ad:




Other than that, the list is a good place to start.






FDA Seizes Shelhigh Patches and Valves

From the FDA's site:

The Food and Drug Administration seized all implantable medical devices from Shelhigh, Inc., Union, N.J., after finding significant deficiencies in the company's manufacturing processes. The deficiencies may compromise the safety and effectiveness of the products, particularly their sterility.

The products include pediatric heart valves and conduits (tube-like devices for blood flow), surgical patches, dural patches (to aid in tissue recovery after neurosurgery), annuloplasty rings (to help repair heart valves) and arterial grafts. The tissue-based devices are used in many surgical settings, including open heart surgery in adults, children and infants, and to repair soft tissue during neurosurgery and abdominal, pelvic and thoracic surgery. Critically ill patients, pediatric patients and immuno-compromised patients may be at greatest risk from the use of these devices.

All medical device companies must follow current good manufacturing practice, a set of requirements that help to ensure the safety and effectiveness of all medical products. Shelhigh's violations include: manufacturing products in a facility with a poorly constructed and poorly maintained clean room where sterilized devices are further processed; failing to adequately monitor critical manufacturing environments for possible microbial contamination; failing to properly test products for sterility and fever-causing contaminants; and failing to scientifically support product expiration dates.

Physicians should consider using alternative devices. Physicians should also monitor patients with a Shelhigh implant for infections and proper device functioning over the expected lifetime of the device. Patients who think they may have received a Shelhigh device during surgery should contact their physician for more information. FDA will issue a Preliminary Public Health Notification to physicians and other health care professionals and a Preliminary Advice for Patients shortly with more information; those documents will be posted to FDA's Web site.

The seizure follows an FDA inspection of the Shelhigh manufacturing facility last fall, as well as meetings with the company at which FDA warned Shelhigh that failure to correct its violations could result in an enforcement action. FDA also alerted the company to its manufacturing deficiencies and other violations in two warning letters.

Medical devices manufactured by Shelhigh include:

  • Shelhigh Pericardial Patch
  • Shelhigh No-React Pericardial Patch
  • Shelhigh No-React PneumoPledgets
  • Shelhigh No-React VascuPatch
  • Shelhigh No-React Tissue Repair Patch/UroPatch
  • Shelhigh Pulmonic Valve Conduit No-React Treated
  • Shelhigh No-React Dura Shield
  • Shelhigh BioRing (annuloplasty ring)
  • Shelhigh No-React EnCuff Patch
  • Shelhigh No-React Stentless Valve Conduit
  • Shelhigh Internal Mammary Artery
  • Shelhigh Gold perforated patches
  • Shelhigh Pre Curved Aortic Patch (Open)
  • Shelhigh NR2000 SemiStented aortic tricuspid valve
  • Shelhigh BioConduit stentless valve
  • Shelhigh NR900A tricuspid valve
  • Shelhigh MitroFast Mitral Valve Repair System
  • Shelhigh BioMitral tricuspid valve
  • Shelhigh Injectable Pulmonic Valve System
FDA.org is the source.

The Story Behind Ketek

From the St. Pete Times: A detailed article that sheds light on a system that can best be categorized as a mess.

The paper notes how Dr. Anne Kirkman Campbell, a family practice doctor in Gadsden, Ala., signed up 400 patients at $400 a pop to enrol in a Ketek study. When at least one patient withdrew, the doctor forged a consent form and faked the data. The drug's maker however didn't inform the FDA of the action, according to reports. The drug maker just included the faulty data in the reports on the drug.

The paper notes that as FDA's drug approval division checked out the Ketek data, its inspectors were conducting routine audits of the biggest study sites. Their first stop was Campbell's office, where they found violations and called in the FDA's criminal investigators.

You can read the whole story at the St. Pete Times site, or posted on a blog here.

In my opinion, this is more of the same from the FDA. Created to protect consumers, it instead acts to betray the public's trust. Having read "Dispensing with the Truth" (a book detailing the rise and fall of the drug Fen-Phen) this unfortunately does not come as a surprise.

The web has legions of articles on Ketek and the congressional fallout, as well as the worldwide scandal .

Iowa's Senator Charles Grassley's sub-committee heard the testimony that one of the doctors used in the drug's safety study had falsified results, and that FDA managers hid that fact from the FDA panel that recommended the drug, and that the FDA then used unscientific foreign reports of the drug's side effects to claim it was safe. And when cases of death and injury began to appear, the testimony alleges the FDA did not issue an adequate new warning label for at least a year. (Link)

You'll see more to this, and this scandal will not be the last.

Monday, June 04, 2007

Trade Center Dust Deemed Cause of an Attorney's Death

From CNN.com

"The death of U.S. Department of Education attorney Felicia Dunn-Jones, 42, five months after she became trapped in dust caused by the collapse of the first World Trade Center tower, is now being considered a homicide and her name has been added to the official list of World Trade Center victims."

Dr. Charles S. Hirsch, the city's Chief Medical Examiner, notified Dunn-Jones' family attorney, Richard H. Bennett two weeks ago. "Accumulating evidence indicates that in some persons exposure to WTC dust has caused sarcoidosis or an inflammatory reaction indistinguishable from sarcoidosis ... " and "it is likely, with certainty beyond a reasonable doubt, that exposure to WTC dust...was contributory to (Dunn-Jones') death."

Link here.

The medical examiner came to this conclusion nearly six years after Dunn-Jones' death. It's surprising to learn that this is the first time the city of New York has officially declared that exposure to World Trade Center toxins following the 9/11 attacks contributed to a person's death.



Januvia (Type II Diabetes Drug) - Group Says Wait Before Usinig

From Public Citizen: Januvia (scientific name sitagliptin), a new drug designed to improve blood sugar control in patients with type 2 diabetes, should not be used because the drug’s long-term safety is still unknown.

Clinical study patients who were given Januvia experienced an increase in the chemical creatinine, which is found in the blood. Increases in creatinine are often an early indicator of kidney problems. Because the drug is new, more serious adverse effects may not become apparent until the drug is used by a large number of patients. Public Citizen advises consumers not to take the drug until after it has been on the market for seven years – in this case, until 2014 – without exhibiting significant health risks.

What is notable is that P.C. suggests that people with Type 2 Diabetes should wait seven years before taking Januvia.

Possible Bad News for Tricor (Triglyceride Drug)

Yesterday (June 3, 2007) there was a report in Barron's which said several cardiologists and nephrologists raised questions about the safety TriCor. The drug helps lower triglycerides.
The doctors raised concerns that fenofibrate (TriCor) may cause decline in kidney functions.


Sources include Reuters and Barron's online. You'll need to login to read the rest.

Friday, June 01, 2007

Friday Diversion: An Atlanta Blog


The Majestice Diner on Ponce.

Isawitonponce.com

The site informs that it is "Dedicated to all of the unbelievable sights that can only be witnessed along historic Ponce De Leon Avenue in the heart of Atlanta, Georgia."

If you are ever in Atlanta, there is a distinct part of the city that has as its main artery Ponce De Leon Avenue. It's away from Buckhead, or trendy Midtown. To quote the blogger, mentioned in the local weekly known as Creative Loafing: It is a street that is
"rich with character ... because it is the border dividing several distinct pocket neighborhoods – Midtown, Old Fourth Ward, Virginia-Highland, Druid Hills, Candler Park, Decatur. It divides neighborhoods that are almost different worlds.

The blog shows you the highlights of what 'the locals' like me get to enjoy. Events like the Decatur Arts Festival, and restaurants like Watershed. Give it a look.

Wednesday, May 30, 2007

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.


Tuesday, May 29, 2007

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.

Tuesday, May 22, 2007

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.


Monday, May 21, 2007

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.

Tuesday, May 15, 2007

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.



Monday, May 14, 2007

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.

Thursday, May 10, 2007

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."




Tuesday, May 08, 2007

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.



Monday, May 07, 2007

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.

Thursday, May 03, 2007

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.

Wednesday, May 02, 2007

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.

Tuesday, May 01, 2007

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.






Sunday, April 29, 2007

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.

Thursday, April 26, 2007

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.

Monday, April 23, 2007

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

Wednesday, April 18, 2007

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.

Epogen Study: Drug was a Profit Center?

From Forbes and JAMA:

Kidney dialysis centers run as for profit businesses (such as Davita) administered significantly more of the anti-anemia drug Epogen than did not-for-profit dialysis centers, according to JAMA in a recent article.

The authors of the JAMA article ("Dialysis Facility Ownership and Epoetin Dosing in Patients Receiving Hemodialysis") reviewed Medicare claims data to examine Epogen dosage for nearly 160,000 dialysis patients in December 2004. The authors found that the for profit centers used an average dose of Epogen, also known as epoetin, that was 20,838 units per week--16% higher than the average dose at nonprofit facilities.

Recently the FDA issued an advisory warning that epoetin and darbepoetin (erythropoiesis-stimulating agents [ESAs]) result in an increased number of deaths and of non-fatal heart attacks, strokes, heart failure, and blood clots when ESAs were adjusted to maintain hemoglobin at a certain rate.

In the same JAMA issue, there is an editorial that notes the 2004 Medicare reimbursement rate of $10 per 1,000 units of Epogen resulted in a $1,700 a year per patient higher expense for the higher average dose.

What to me is significant is that JAMA appears to have found problems with Medicare reimbursement for dialysis treatment. According to the data, a large portion of the 335,000 kidney failure patients here who receive dialysis are covered by Medicare. One source is here.

Medicare will reimburses dialysis centers directly for this treatment at a fixed amount. But reimbursement for the use of Epogen is not capped; instead, it is based on the amount of the drug that is used. Medicare spends more money on Epogen--nearly $2 billion--than on any other drug.

According to Forbes and others, a Morgan Stanley report estimated that dialysis chains made 25% of their profits on the Epogen spread.

Sunday, April 15, 2007

Gov. Corzine: Not Buckled

The gothamist.com has a well done graphic showing layout of the SUV in which New Jersey Governor Corzine was a front seat, unbuckled passenger. By now most know that Corzine suffered severe injuries in a car wreck last week. No seatbelt. What was he thinking?


Friday, April 13, 2007

Listerine Recalls 4 million bottles of mouthwash

Late yesterday, Johnson and Johnson recalled four million bottles of its Listerine agent Cool Blue mouthwash. This applies to the "glacier mint" and "bubble blast" flavors.

The company says tests showed it is contaminated with microorganisms. This could make some people sick who have weakened immune systems. However, there have been no reports of sickness so far.

For more, go the website: www.agentcoolblue.com.

Wednesday, April 11, 2007

Adolor's Bowel Drug "Entereg" also linked to Heart Disease

In the wake of last week's news regarding Zelnorm and the decision to voluntarily yank it from the market, GlaxoSmithKline and Adolor Corp. have said that the experimental drug Adolor to treat constipation due to opioid painkillers was linked to higher risk of heart attacks and other serious heart problems, fractures and skin cancers in a late-stage trial.

The companies said the negative findings came from a year-long Phase III study of Entereg involving 805 patients experiencing bowel dysfunction as a result of taking opioids for treatment of chronic non-cancer pain.

For more, go here.

Tuesday, April 10, 2007

Do you use the term "corpus" daily?

As the Anna Nicole Smith baby daddy issue flogs humanity from every available media outlet today (DNA results released) , I heard an exchange on a local Atlanta station. The newsman on that station mentioned the DNA results, then turned to the station's "go to" legal expert for comment.

The legal eagle was asked words to the effect of, "what does this mean for the [Anna Nicole Smith] baby's finances in the future?" The lawyer's reply? He said, "the corpus may be encroached upon by application" in the future for the child's benefit. A cutaway to the weather followed.

75% of the listeners just said "huh?" Apparently it's too much to ask an attorney to speak plainly now on air.

Blogging: Heavy Handed, Self Appointed Blog Cop Wants Rules

I had to laugh as I read the news that Tim O'Reilly - a person the average man on the street couldn't tell you one thing about - has decided that blogs and bloggers must be muzzled.

Nonsense. The self important snob forgets that the import of anonymous speech rises geometrically in proportion to the growth of big government. Those who seek to control such speech are in my humble opinion dangerous to the very foundation of free speech.

From various sites:

Last week, Tim O’Reilly, a conference promoter and book publisher who is credited with coining the term Web 2.0, began working with Jimmy Wales, creator of the communal online encyclopedia Wikipedia, to create a set of guidelines to shape online discussion and debate.

Chief among the recommendations is that bloggers consider banning anonymous comments left by visitors to their pages and be able to delete threatening or libelous comments without facing cries of censorship. (Source, here).


Take a look around, Tim. In fact, why not take a moment to check out the history of our nation's leaders? If you bothered to do so, you would know Abraham Lincoln and Benjamin Franklin both published anonymous letters for political purposes. In fact, Franklin used anonymous letters for political purposes up to his death. (Source here).

This self important but likely well meaning attempt to muzzle bloggers should cease.

Monday, April 09, 2007

FDA: Zellnorm Withdrawn

Just a week or so ago, the FDA asked that the marketing of Zelnorm end, based on findings suggesting increased risks of serious cardiovascular adverse events (heart problems) associated with that drug. The drug was voluntarily withdrawn.

The drug was often used to treat IBS and significant abdominal pain, Zelnorm is the only FDA-approved therapy for the constipation-causing form of the ailment.

For more, go here.

Sen. Grassley: Show me the Zyprexa documents

The Republican Senator from Iowa wants Eli Lilly to produce documents that may suggest Lilly didn't play fair in touting Zyprexa, often used to treat schizophrenia and bipolar disorder.

Senator Grassley wants Lilly to provide "e-mails, letters, reports" and other internal documents relating to Zyprexa. Earlier this year, a USDCT judge ruled on the dissemination of documents that were the focus of New York Times articles reporting that Lilly knowingly understated the risks of its drug, and touted it for unapproved uses. You can find the NYT article here.

From the NYT: "Lilly’s own published data, which it told its sales representatives to play down in conversations with doctors, has shown that 30 percent of patients taking Zyprexa gain 22 pounds or more after a year on the drug, and some patients have reported gaining 100 pounds or more. But Lilly was concerned that Zyprexa’s sales would be hurt if the company was more forthright about the fact that the drug might cause unmanageable weight gain or diabetes, according to the documents, which cover the period 1995 to 2004."

Wednesday, April 04, 2007

Practicing Law: My New Office

Posting has been a bit light for me lately, as I have left my prior firm and have now opened my own office. Extricating myself from one firm has had issues typical to most, as well as several that are a bit less standard.

Change can come quickly as I have seen. I am quite happy now, more so than I thought possible. I will be writing a bit more as time permits.

Ortho Evra: Drug's Maker Buys "Negative" Domain Names

From Bloomberg:

Johnson & Johnson bought domain names Orthoevrakills.com and Deathbypatch.com according to documents released today in a New Jersey lawsuit. Ortho Evra is a birth control patch currently on the market.

One document from Johnson & Johnson document refers to the purchase of domain names, monitoring blogs and bidding on key search terms about the patch on search engines.

I went to both site, but nothing is up on either one. Perhaps J and J should direct them to a news page inside their main domain?

Friday, March 23, 2007

Procrit, Aranesp and Epogen News: Congressman Says Stop the Ads

Congressman John Dingel has asked both Johnson & Johnson and Amgen Inc. to stop consumer advertising of their anemia medications for cancer patients until May 2007 or until the FDA wraps up an ongoing review.

Aranesp and Epogen (Amgen) and Procrit (J&J) have both been in the news over a recent clinical trial.

There is a planned May 10, 2007 FDA advisory panel meeting to determine among other things the black box warnings planned for the drugs. what, if any, additional measures need be taken to protect the public from unnecessary risks to human life from these products,'' Dingell said in the March 20 letters. His office confirmed the letters were sent today.

Procrit, Epogen and Aranesp are engineered versions of a protein called erythropoietin, or EPO. EPO promotes the production of red-blood cells, which carry oxygen through the blood. EPO has long been discussed in pro cycling circles. Go here for an article titled "Spinning in their Graves." Lance Armstrong had been given Epogen during his cancer battle.

The recent study suggested that blood clots, strokes and heart attacks may be linked to higher doses of these medications, a claim denied by the drugmakers.

Wednesday, March 21, 2007

Black Box Warnings for Procrit, Eopgen and Aranesp

From several sources:

Last week the the FDA issued a warning that using of an erythropoiesis-stimulating agent (ESA) also known as recombinant human erythropoietin to raise hemoglobin may be linked to serious and life-threatening side-effects or even death.

What is particularly noteworthy is that the FDA has stated there has never been any evidence to support claims made in direct-to-consumer advertising that treatment with darbepoetin (Aranesp), epoetin alfa (Epogen), or epoetin alfa (Procrit) might increase energy or ease fatigue in patients that face cancer therapy.

What does the warning say?

That persons taking any of the stated drugs use the lowest dose of Aranesp, Epogen, or Procrit that will gradually raise the hemoglobin concentration to the lowest level sufficient to avoid the need for blood transfusion
  • Aranesp, Epogen, and Procrit and other erythropoiesis-stimulating agents increased the risk for death and for serious cardiovascular events when dosed to achieve a target a hemoglobin of greater than 12 g/dL.
  • Use of erythropoiesis-stimulating agents to achieve a target hemoglobin of 12 g/dL or greater in cancer patients shortened the time to tumor progression in patients with advanced head and neck cancer receiving radiation therapy; shortened overall survival and increased deaths attributed to disease progression in patients with metastatic breast cancer receiving chemotherapy; and increased the risk of death in patients with active malignant disease not under treatment with chemotherapy or radiation therapy. Erythropoiesis-stimulating agents are not indicated for this patient population.
  • Patients treated before surgery with epoetin alfa to reduce red blood cell transfusions had a higher incidence of deep vein thrombosis. Aranesp is not approved for this indication.
For more, go here.

Sunday, March 18, 2007

Katrina: Gator Basketball Tours 9th Ward

From time to time I post about my alma mater, The University of Florida. This past weekend, the basketball team was in New Orleans, and the players and coaches toured the area devastated by the storm and its flooding.

One player, Joakim Noah, said this: "It was an experience I'll never forget." "It's been a year-and-a-half since Katrina, but in some areas, it looks like the hurricane hit just last week." He also commented, "It makes you wonder, 'Do we really care?' "

For more, go here. The link takes you to the Sunday 3/18/07 Orlando Sentinel article.

My comment: The answer to your last question is NO. America does not care. Many individuals, churches and volunteers, and I do, but the insurers, the politicians, the true titans of business do not. It may as well be Bosnia.

Shameful.

Monday, March 12, 2007

Vioxx Verdict: $20 Million in Humeston

In New Jersey, the Humeston case was retried, and today (3/12/07) the verdict came back: The jury concluded that Vioxx contributed to an Idaho postal worker Mike Humeston's heart attack, and awarded him and his wife $20 million in damages. The jurors awarded Humeston $18 million in compensatory damages and gave another $2 million to his wife, Mary.

The punitive damages phase begins this week.

My comment: Chris Seeger vowed that a retrial would vindicate his clients, and it has.

Actos (Diabetes Drug): Blamed for Broken Bones

Actos is a diabetes drug introduced in 1999. According to a recent study sponsored by Takeda, the drug's maker, it found incidences of fractures when comparing Actos to a placebo.

Women using Actos had about 1.9 broken bones for every 100 patient-years studied, compared with 1.1 broken bones for 100 patient-years in the other women. The data represented almost 12,000 patient-years for each group.

Most of the fractures involved the hands, wrists, forearms, feet, ankles and legs. Takeda said it doesn't know what caused these broken bones and is still evaluating the findings.

For more, go here.

Vioxx: Texas Garza Verdict Stands (For Now)

Leonel Garza's Vioxx verdict in Texas last year for $7.75 million will not be retried.


A State Court Judge did not rule on a pending Motion for New Trial filed by Merck. The Motion as a seventy five day time frame in which a Judge could rule on it. By not ruling, it has been effectively denied.

I am certain that there will be an appeal.

Seroquel and Zyprexa: Off Label Use Rampant?

Seroquel prescriptions for off-label use are growing. According to a recent report in Bloomberg,

Prescriptions for Seroquel and Zyprexa, generated more than fourteen billion dollars in total sales last year. According to doctors, the drugs have been prescribed to patients with Alzheimer's disease as well as to teenagers with emotional conditions.

Nearly half of Seroquel prescriptions last year were allegedly for disorders for which AstraZeneca has yet to gain regulatory approval. It is, however, legal for doctors to administer drugs for certain unapproved medical conditions. Companies are prohibited from marketing products to doctors for uses not yet cleared by the U.S. Food and Drug Administration in Washington or by regulators in other countries.

Consequences for off-label scripts? Half a dozen states have filed suit against Eli Lilly, claiming in those lawsuit papers that the drugmaker (and others) failed to disclose the risks of side effects caused by the drug and promoted their use to treat conditions for which they were not approved.


For more, go here.

Friday, March 09, 2007

I Want Your Motion in Limine!

If you have a Motion in Limine that you are willing to share, would you send it to me? I would like any that you believe are helpful in your injury cases. Any Court. I plan to publish excerpts here, and any additional comment you may have regarding the contents of it.

My email is to the right. Any format. Are you willing?

Talk Like a Lawyer?

Trial attorneys and litigators of nearly every stripe will often tout how important it is to speak plainly, and how it is better to avoid legal jargon. Most unfortunately do not practice what is preached.

I'm reviewing a deposition transcript this morning and I'm getting a headache. Defense counsel has asked these gems: "Remembering that you are under oath, please describe the nature and permanency of the alleged personal injuries suffered by you in this negligence action." The reply was, "I don't understand what you just asked me."

Another: "What if any exacerbation of any pre-existing emotional condition are you claiming as a result of this negligence action?" His reply was that there was no "exasperation."

Have I described you?

Long ago I learned one basic question that I now always ask. Lefferts Mabie always began questioning with "tell us who you are." Better than, "please state your full legal name for the record."

Thursday, March 08, 2007

Tamiflu: Side Effects Causing Concern?

The influenza drug Tamiflu may cause fatal side effects -- according to news from Japan. Two people who took it fell to their deaths in February of 2007.

The Health Ministry of Japan issued warnings that influenza patients may show psychiatric problems.

To the surprise of no one, Roche - the maker of the drug - denied a link between the medication and the deaths

For more, go here.



Wednesday, March 07, 2007

Bausch & Lomb recalls 1.5 million bottles of ReNu MultiPlus Lens Solution

B and L is recalling about 1.5 million bottles of ReNu MultiPlus because trace amounts of iron could cause the cleaner to lose effectiveness earlier than normal.

The optical products maker also reported a modest drop in fourth-quarter and full-year sales in 2006, citing sluggish contact lens sales amid a slower-than-expected recovery from last spring's recall of MoistureLoc, which was blamed for an outbreak of severe fungal eye infections.

No injuries have been reported, thankfully.

The recalled lots carry the expiration date “2008 – 03” on the bottle.



Tuesday, March 06, 2007

Not Legal: Post Secret

Frank Warren appears at themy alma mater the University of Florida this week. In case you don't know of him or his blog,Frank Warren is searching for the perfect secret, although he's not sure what it will look like. According to the press reports:

He spends about eight hours every day sorting through the 100 to
200 secrets that are delivered daily to his suburban home in
Germantown, Md.

Most come as postcards, usually in two 3-inch tall stacks. His
mail carrier, who knows Warren by name and face, fastens the stacks
neatly with two rubber bands, like ribbons on a gift. But others come
in more unusual packages - like the Starbucks Coffee cup that said
"I give decaf to customers who are rude to me."

Go here - http://postsecret.blogspot.com/ to check it out. Not legal - as in, this was not a post talking about legal issues or news.

Vioxx: Friday's Verdict News

In the cases jointly tried to conclusion last week, the jury found that that Merck was not negligent in the case of Brian Hermans of Waupaca, Wis., who died at age 44 after a September 2002 heart attack.

The jury did find that Merck violated New Jersey's consumer fraud law, so Hermans' family could recoup three times what he paid for Vioxx prescriptions. It also allows Hermans' family lawyer, Mark Lanier, to recoup his legal fees, which he estimates at $2 million.

In the second case, Mr. Humeston presented his case once more. Today the jury starts phase two, to determine whether the second plaintiff is entitled to damages. The jury found Friday that Merck was negligent in the case of Frederick "Mike" Humeston, 61, of Boise, Idaho, who survived a heart attack in September 2001, before the stronger warning. That case is considered a pre "warning change" case.

Jurors heard evidence about Merck's marketing of Vioxx and what it disclosed about increased risks of heart attack and stroke, which led Whitehouse Station, N.J.-based Merck to pull the blockbuster drug from the market in September 2004.




Saturday, March 03, 2007

Tech: Gigasize.com & Jott

Gigasize.com allows you to share and send files up to 1.5GB. It's free . There is a 2.5 GB service for a small fee. Worth a look.

Jott.com is a telephone-based reminder system that sends your short message to your email (or another's email). Free. I like free a lot. I'm in the car a bunch, so it is much easier to call the toll free reminder and send a message than it is to write at 70 m.p.h.

Thursday, March 01, 2007

Vioxx: Illinois State Court Trial Begins

In Madison County, a jury was selected to consider a widower's claims that Merck's drug is the culprit in his 52-year-old wife's fatal heart attack.

Patricia Schwaller is the deceased. She too Vioxx for more than 20 months before she died suddenly Aug. 8, 2003, her family's attorneys say. The woman had no previous heart attacks, strokes or symptoms of congestive heart disease according to her attorneys.

My opinion: For now the defense for Merck has been on limited fronts - the MDL, New Jersey, and California. Texas is plodding along. Illinois is another battleground now, and this case is one where the usage is more than the eighteen month period that Merck has said would be a floor in considering any possible causal link.

Stay tuned.

Liberty Mutual Insurance

Liberty Mutual Group Reports Fourth Quarter 2006 Results

My friend and fellow Georgia lawyer Mike Neff posted the news that Liberty Mutual Group (“LMG”) reported net income of $455 million and $1.626 billion for the three and twelve months ended December 31, 2006, respectively, an increase of $202 million and $599 million over the same periods in 2005.

Seems like LMG is doing rather well. Crisis? What crisis?