FDA Places Suicide Warnings on Antidepressants

"The U.S. Food and Drug Administration (FDA) today proposed that makers of all antidepressant medications update the existing black box warning on their products' labeling to include warnings about increased risks of suicidal thinking and behavior, known as suicidality, in young adults ages 18 to 24 during initial treatment (generally the first one to two months).

The proposed labeling changes also include language stating that scientific data did not show this increased risk in adults older than 24, and that adults ages 65 and older taking antidepressants have a decreased risk of suicidality. The proposed warning statements emphasize that depression and certain other serious psychiatric disorders are themselves the most important causes of suicide."

Read the FDA's full press release here.

Jury Awards $2.8 Million Against Allstate in Katrina Coverage Case

April 28, 2007,

"Attorneys say a federal jury that awarded more than $2.8 million to a man who lost his home to Hurricane Katrina sends a strong message to insurers who refused to pay thousands of other homeowners for damage from the storm.

"Insurers should worry about taking any case to a jury," said David Rossmiller, a Portland, Ore.-based attorney who writes a Web journal on Katrina insurance cases and other industry issues.

The U.S. District Court jury decided Monday that Allstate Insurance Co. did not pay Robert Weiss, of Slidell, enough money to cover the wind damage to his home.Allstate had claimed that most of the damage was due to storm surge, an event not covered in its policy."

Read the full article in the Boston Globe.

Texas Judge Threatens Viability of All State Vioxx Claims

April 24, 2007,

A recent ruling by Texas state court Judge Randy Wilson may be the end of nearly 1000 Texas Vioxx cases. The ruling was based on a recent FDA Administrative Rule which effectively preempts all state law failure to warn claims.

Read more at WSJ.com.

Welder Awarded $3 Million For Lung Damage

April 22, 2007,

The 6th Circuit Court of Appeals recently upheld a jury verdict of $3 million awarded to a welder injured by welding fumes.The focus of the appeal was expert testimony by Dr. Michael Houston, whostated that the plaintiff's pulmonary and respiratory problems were caused by inhaling welding fumes. The expert further testified that the plaintiff would need to be retrained to work a job in an irritant free environment.

This is one of the few welding fume cases that the plaintiff was successful. It is interesting to note that the plaintiff focused on exposure to welding fume chemicals other than manganese.

Read the full article at LexisOne.

Details of Doctor's Past Revealed

April 20, 2007,

Many state laws keep doctor histories safe from public review. This is especially the case when considering peer review reports. However, the sketchy past of an OB/GYN doctor in Texas was revealed after a long (and ongoing) court battle.As you read the following except from TheEagle.com, keep in mind that this doctor still practices.

According to Ellison's ruling, 16 of Benson's patient charts were reviewed by ACOG in 2001, and 'all 16 were rated unsatisfactory.' Eleven charts were found to be unsatisfactory in both documentation and management, the ruling states, while three others were found to be unsatisfactory only in documentation and two were cited solely for unsatisfactory management.

'Specifically, the ACOG report cited surgery that was not indicated, poor judgment in laparoscopic procedures, not anticipating complications, poor clinical management demonstrating substandard care that does not reflect ACOG's guidelines, poor management potentially exposing the mother and infant to [physician-induced] injury and questionable surgery performed in a patient with a presumed absence of her gynecological organs,' according to a footnote in the judge's ruling.

'The ACOG report concluded that Dr. Benson's charts exhibited a trend of 'grossly inadequate documentation' and that there were consistent indications of inadequate care,' the judge wrote. 'The ACOG report also concluded that Dr. Benson appeared to be 'unwilling or unable to accept peer review as an educational process.''

New York Jury Awards $35 Million in Asbestos Claim

April 18, 2007,

" Edward Martin, an insulator, and Robert Lettiere, a boilermaker/steam fitter, alleged that they were exposed to asbestos in powerhouses by the negligent conduct of Robert A. Keasbey. Lettiere originally filed a claim for asbestosis but amended his complaint after he was diagnosed with lung cancer in June 2005.

At trial, Keasbey argued that the men’s lung cancers were cigarette smoking-related and that they were not exposed to significant enough doses of asbestos to cause lung cancer.
But on March 22, after phase I of the reverse-bifurcated trial, the jury returned an $11 million award for Robert Lettiere for pain and suffering.

At the same time, the jury returned $26 million for Edward Martin and his wife, Bonita, including $18 million for pain and suffering; $942,850 in economic damages to Bonita Martin; $9,063 in economic damages to Edward Martin, and a loss of consortium award of $7 million."

Read the full article at LexisOne.

Judge Rules FDA Preempts State Law in Thimerosal Claims

April 16, 2007,

A federal judge in Pennsylvania recently ruled on a Thimerosal case that may have disastrous effects on those harmed by the vaccine preservative. The ruling essentially states that the FDA is the law of the land on drugs, preempting all state consumer protection laws.Considering the track record of the FDA in protecting Americans over the last 5 years, that is a frightening thought.

"The defendants raised two preemption arguments, one of express preemption under the Vaccine Act and a second of conflict preemption under the Food and Drug Administration’s position expressed Jan. 24, 2006, as the Preamble to the Final Rule. Judge Stengel disagreed with the express preemption argument, but said the legislative history of the Vaccine Act as set forth in Blackmon v. Am. Home Prods. Corp (328 F. Supp. 2d 659, 663-66 [S.D. Tex. 2004]) shows that Congress intended to preempt claims asserting strict liability and design defect based on negligence, but not failure to warn.
However, the judge ruled that failure to warn on all products is conflict preempted by the FDA’s Preamble/Final Rule, which says state laws requiring stronger or different labels conflict with the FDA’s authority over the contents of drug labels."

Read the full article at LexisOne.

Physicians and Pharma Closely Intertwined

April 14, 2007,

A recent article in Forbes magazine brings light just how embeded the pharmaceutical industry is in the medical profession.

"The ties between doctors and drug manufacturers are close indeed, with virtually all doctors reporting some kind of relationship with industry, even if it's as seemingly innocuous as accepting free food and beverage, a new study has found.
But the relationships vary depending on the kind of medical practice and specialty, the patient mix and the professional activities of the physician, according to the study, published in the April 26 issue of the New England Journal of Medicine.

Over the past two decades, physician-industry relationships have attracted increasing scrutiny. One review found that, on average, physicians meet with industry representatives four times a month, and medical residents accept six gifts annually from industry representatives."

Merck Wins First Illinois Vioxx Trial

April 12, 2007,

"The high-profile trial over Vioxx late last month in Madison County was just an early skirmish in what could be years of litigation here and elsewhere over Merck & Co.'s once highly touted painkiller.

The jury, after a month-long trial, rejected pleas to slap Merck with tens of millions of dollars in damages for the 2003 death of a Granite City woman who spent 20 months on Vioxx.

Though the drugmaker's lawyers celebrated their win in a county with a reputation for being unfriendly to corporate defendants, they'll be back soon for the next Vioxx trial in Madison County, scheduled for September.

Two Vioxx trials are also set for December in the county, according to Merck's trial calendar, but those would probably be pushed off. A fourth was slated to face a jury in October but was transferred to Chicago."

Read the full article in the St. Louis Dispatch.

IBS Drug Zelnorm Taking Off the Market

April 10, 2007,

"The Food and Drug Administration (FDA) has requested that Novartis Pharmaceuticals Corporation of East Hanover, New Jersey, voluntarily discontinue marketing of Zelnorm (tegaserod) based on the recently identified finding of an increased risk of serious cardiovascular adverse events (heart problems) associated with use of the drug. Novartis has agreed to voluntarily suspend marketing of the drug in the United States.
Zelnorm is a prescription medicine approved in July 2002 for short-term treatment of women with irritable bowel syndrome whose primary symptom is constipation. It was subsequently approved in August 2004 for treatment of chronic constipation for men and women under age 65. Zelnorm is marketed in 55 countries."

Read the full FDA news release here.

Doctor Admits 'Greed Subverts Healthcare'

April 8, 2007,

It is likely known by all doctors, but very few will admit: Greed subverts healthcare.The following is an article in the Portsmouth Herald Local News about a brave doctor who is telling it like it is.

"Dr. Terry Bennett, the controversial and opinionated Rochester physician who has traveled the world practicing medicine -- including a stint as physician to the Saudi royal family -- does not have high hopes that a fix can be found for the country's broken health care system.
The reason, he contends, is that the amount of money involved in the system brings out one of the more negative human attributes -- greed.

"Unless and until these extraordinary costs unique to the United States are squashed into manageability, there is too much greed and too little control of greed being exercised," said Bennett, a Harvard Medical School graduate, who operates a practice that bases its fees on the ability of his patients to pay. "It does not matter what politician suggests what plan --- Republican or Democratic, that plan will fail."

There are four primary reasons for Bennett's pessimism: the educational debt carried by new doctors; the practice of hospitals "owning" the physicians who are affiliated with them; extraordinarily high prescription drug costs; and the advent of health management organizations, which have assumed a middleman position between patients, health care providers, pharmaceutical companies and hospitals."

Campaigning For Medical Error Disclosure

April 6, 2007,

Believe it or not, some state laws forbid the disclosure of medical errors.Below is an article from a Colorado woman seeking disclosure of medical mistakes:

"GOLDEN - The loss of her only son still a sharp wound, Patty Skolnik is determined to make Colorado the 16th state to publicize malpractice judgments against doctors.
Skolnik, of Centennial, appeared at a news conference Tuesday where Health Grades announced it has gone online with the first national data base with information on malpractice settlements against doctors. Information on malpractice judgments, settlements and arbitration awards against doctors from 15 states is available at .

Health Grades, which bills itself as the nation's largest independent health-care rating company, can only make available the information if the states don't shield it, said Sara Loughran, executive vice president."

Read the full article in the Rocky Mountain News.

Illinois Jury Awards $144 Million in HMO Fraud Case

April 4, 2007,

"A onetime Illinois HMO was hammered with a $334 million judgment Tuesday, the largest of its kind ever in northern Illinois and an amount almost equal to the company's profits since it was founded.
U.S. District Judge Harry Leinenweber added a $190 million penalty on top of an October $144 million jury verdict against Amerigroup Illinois and Amerigroup Corp. for purposely not insuring "unhealthies" and women in late-term pregnancies."

Read the full article in the Chicago Sun-Times.

News Media Vessel for Hospital Propaganda

April 2, 2007,

This is an interesting article written in the Philadelphia Evening Bulletin, addressing the problem with hospitals getting in bed with the news media:

"Local television stations are now making deals with hospitals to air their propaganda disguised as news. Frankly, I don't understand this new development, as based on over 30 years of closely observing the local television scene, local stations have often run the propaganda of hospitals disguised as news. Here's how that long-standing scenario works: The local medical reporter gets cozy with the hospitals who feed the station what the hospital would like to think are the latest medical advances or other medical news of interest. The hospital comes up with the happy patients, the doctors who treated them and the hospital backdrop for shooting the story. The reporter puts the hospital's sales pitch on the air, and everyone is happy. The reporter gets a flow of medical stories that are easy to shoot and produce and the hospital gets free advertising."

New Study Confirms Insurance 'Crisis' is Unrelated to Malpractice Claims

March 30, 2007,

"Americans for Insurance Reform (AIR) announced today the release of Stable Losses/Unstable Rates 2007, a new study that examines fresh insurance industry data to determine what caused the most recent medical malpractice insurance crisis for doctors.The study by AIR, a coalition of over 100 consumer and public interest groups representing more than 50 million people, finds that the insurance crisis that hit doctors between 2001 and 2004 was not caused by claims, payouts or legal system excesses as the insurance industry claimed."

Continue reading "New Study Confirms Insurance 'Crisis' is Unrelated to Malpractice Claims" »