Zicam

Zicam is a homeopathic cold remedy that you take through your nose.  Consumers are at risk for losing their sense of smell and taste.  The FDA is now involved and the maker has suspended shipments. This product should not have been marketed as an over the counter medicine. How did this come about? The litigation will answer many questions.

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Pharmacutical

The United States Supreme Court opened the door for legitimate litigation concerning unreasonably dangerous pharmacuticals when it rejected the preemption defense based on FDA approval. Several drugs are now involved in litigation. The following are a few:

1.  Fentanyl Patch is used for chronic pain but can easily be overdosed, causing death. It is critical to rule out misuse since this medicine is used by patients in significant pain. Misuse can be eating, injecting and smoking the medication. If an attorney is considering such a case he needs to locate the patch.This can be hard since it may have been taken off by EMS or in ER. Check the written report and photos in autopsy.

This litigation is not yet in an MDL

2.  Hydroxy cut is used for weight loss but can cause heart and liver damage. Since the drug is used by people who are over weight, it is important to rule out confounding variables before taking the case. Of course it isn't necessary to prove that this medicine is the sole cause of heart or liver damage.

3.  Fosmax is used for osteoprosis. Unfortunately it can cause osteonecrosis of the jaw. This basically bad blood flow to the bone. The risk is literally losing the jaw. The unusual danger is that the drug has a half life of ten years. This means that those who have taken the drug are at risk for many years. There is a MDL in New York.

4.  Kugal Mesh is a medical device used in hernia repair. The danger is two fold: The ring can spring loose causing internal damage. Also the adhesive side can become dislodged, adhering to organs.

5.  Prempro is used by menapause. It is derived from horse urine. The medication causes breast cancer. This risk should have been emphasis in a "black box" warning on the package. Wythe did not follow up on studies after it was introduced into the market so the black warning was not on the packaging until about five years ago. There is a MDL in Littlerock.

6.  Reglan is used for Acid Reflux. It cause a bazarre condition called Tardive Dyskinesia. It is important not to use the product for more than ninty days. Warnings have been totally inadequate. There is no MDL on this product.

7.  Avandia is used for Diabetes. It can cause heart attacks. It is in a MDL.

Nuremberg

I recently watched a 1961 movie called Judgment At Nuremberg. The cast was a “who’s who” of great actors. Spencer Tracy played the part of the presiding judge in a trial of four Nazi judges who participated in the judicial evils of Hitler’s Germany. The following is an excerpt from his finding of the defendants guilty of crimes that has caused me to consider the issues we face as a people today.

Janning's record and his fate...



illuminate the most shattering truth
that has emerged from this trial.



If he and all of the other defendants
had been degraded perverts...



if all of the leaders of the Third Reich...



had been sadistic monsters and maniacs...



then these events
would have no more moral significance...



than an earthquake,
or any other natural catastrophe.



But this trial has shown...



that under a national crisis...



ordinary, even able and extraordinary men...



can delude themselves
into the commission of crimes...



so vast and heinous
that they beggar the imagination.

*****

How easily it can happen.



There are those in our own country, too...



who today speak
of the protection of country...



of survival.



A decision must be made
in the life of every nation...



at the very moment
when the grasp of the enemy is at its throat.



Then it seems that the only way to survive
is to use the means of the enemy...



to rest survival upon what is expedient,
to look the other way.



The answer to that is: Survival as what?



A country isn't a rock.
It's not an extension of one's self.



It's what it stands for.



It's what it stands for when standing
for something is the most difficult.



Before the people of the world...



let it now be noted...



that here in our decision,
this is what we stand for:



Justice...



truth...



and the value of a single human being.
 

Dangerous equipment to change a tire

Many of the new cars are equiped with flimsy equipment for changing a spare tire. Ironically, the more likely the care is to be one you would give your daughter the more likely the handle the lug wrench is to be short. A lever that short just isn't going to loosen a lug nut that some idiot has tightened as tight as his air wrench will go. Someone is going to get hurt jumping up and down on the Matel-toy-looking lever. Even worse, your daughter might be stranded in a dangerous place. One would think that such a simple safety concern would have been addressed by car manufacturers. By the way, Toyota, that included the Prius I'm driving.

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General Motors Recall due to fire danger

General Motors Corp is recalling 1.5 million cars because of fire danger. Oil leaks in the 1997 Pontiac grand Prix,1997-2003 Buick Regal, 1998-2003 Chevrolet Lumina, Monte Carlo and Impala. have caused a fire hazard. Additional information can be found with the National Highway Traffic Safety Administration.

 

 

Yamaha Rhino 450 and 660 models

Yamaha Motor Corp. USA is recalling at the insistence of the Consumer Product Safety Commission  120,000 recreational vehicles. Two models were involved in 46 deaths and countless serious injuries.

The Consumer Product Safety Commission targeted the Rhino 450 and 660 models vehicles as unreasonably dangerous without significant alterations to the defects that caused the serious injuries and 46 deaths inflicted on consumers since fall of 2003.

Most of the injuries and deaths were due to rollovers. The design changes will  reduce the risk of rollovers,  improve handling and keep riders' limbs inside the vehicles.

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Sanatized juries

The right to trial by jury exists in the sixth and seventh amendment of the United States Constitution. It empowers the people in a way that did not exist in the countries from which our founders escaped. Thomas Jefferson said that he felt the right to trial by jury was even more important than the right to vote. The jury must be a jury of our peers for the system to work. If a citizen commits a felony or a misdemeanor theft, they lose their right to serve on a jury for life—no matter how good of a citizen they may later become.

Fairly often two of our courts have what has become known as “dollar and a day”. Possibly 50-100 people who wrote a hot check are lined up. They are offered a dollar find and pretty steep court costs if they will plead guilty. Some of the offenders need punishment because they are just thieves. Others are single mothers who didn’t have enough money to cover the check for diapers they bought. For the rest of their lives they must admit to their conviction and can not serve on a jury. A sixty year old woman, who was herded through “dollar and a day” at age eighteen for a $25 check, still is disqualified from serving on a jury.

This system is designed merely for the poor and sanitizes the jury panel of peers for a poor citizen seeking a fair trial.

 

Death of Fed preemption for FDA

The United States Supreme Court just handed down a decision in Wyeth v. Levine throwing out the fiction created by the Bush Administration.  The spurious argument that pharmaceutical companies can dupe the under manned FDA into approving a drug or its labeling and thereby avoid civil liabilities. In a sweeping 6-3 opinion it declared such nonsense unpersuasive, reviving the rights of states to make and enforce their own civil laws and the right of citizens to seek redress in the court system. This is a banner day.

 

 

 

 

For more information on pharmaceutical litigation in Texas see www.bailey-law.com

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Federal preemption

I know I have been railing about federal preemption when it has no legitimate legal justification and amounts to a violation of the reserved rights of states set out in the Constitution. But things keep getting worse. A few years ago the Supreme Court affirmed a preemption for injuries at extrahazardous railroad crossings because the government fronted the cost for luminus paint for cross buck signs--with no thought that this would cause all intersections to be safe.

I keep arguing that big pharmacutical companies, which bully FDA to approve medicine not proved to be safe just to get it on the market at break-neck speed, are at the brink of blanket immunity on the frivilous theory of federal preemption.  More evidence keeps piling up that the FDA simply is not equiped to make such decisions. To use the guize of FDA approval to preempt the right of hundreds of thousands of consumers who rely upon the expertise and good faith of the manufactures and subsequently suffer serious conditions and death, is unconstitutional and unethical.

The AP (1/12) reports, "An internal watchdog finds that financial conflicts involving outside researchers who test experimental drugs often remain hidden," and "missing information, loopholes, and weak oversight hamper efforts to uncover financial conflicts involving researchers who test experimental drugs before companies seek government approval." The Health and Human Services inspector general's office's report said, "We found a number of limitations in" the Food and Drug Administration's (FDA) "oversight, leaving FDA unable to determine whether [drug companies] submit financial information for all clinical investigators." According to the AP, "because scientists can be tempted by profits, the government requires disclosure of possible conflicts involving clinical researchers who review medications before drug companies seek FDA approval."

        The FDA "does almost nothing to police the financial conflicts of doctors who conduct clinical trials of drugs and medical devices in human subjects, government investigators are reporting," the New York Times (1/12, A10, Harris) adds. Noted was that, "in percent of clinical trials, the agency did not receive forms disclosing doctors' financial conflicts and did nothing about the problem, according to the investigation, which was conducted by the inspector general of the Department of Health and Human Services and whose results were scheduled to be made public Monday." Another study "by the inspector general last year found that the National Institutes of Health did almost nothing to police the financial conflicts of university professors who received federal money."

Please let me know your feelings. B

good samaritan law

Read about the lawsuit against a rescuer in California. Both women were out drinking and had an accident. The passenger feared the car would catch on fire (the photos show it didn't).

Story of plaintiff: She was dazed and was having trouble getting the door open. The passenger came around and "jerked me out like a rag doll" and dropped her on a hard surface. She alleges that this caused her to be a paraplegic and suffer liver laceration.

Story of defendant: She thought she heard an explosion when they hit (no evidence of an explosion from the photos I saw). 

Arguments of Defendant: She thought she was doing the right thing for her friend and "medical care providers" are immuned by statute from negligent medical care in an attempt to rescue in an emergency.

Arguments of Plaintiff: If the defendant was worried about a fire why didn't she carry her away from the car to protect her from a potential  fire. But for being jerked from the car at an angle and dropped to the ground she would have survived the car wreck without suffering paraplegia. Defendant was not a trained health care provider rendering medical treatment so is not covered by the California statute referring to emergency medical care.
 
Ruling of the court: The statute relied upon by the Defendant does not provide immunity except for medical care and defendant was not a medical care provider providing medical care.
My thoughts: It is interesting that health care providers are immuned but not the everyday untrained person, (possibly the lobbyists were less concerned about the liability of those who were not paying their salaries). I personally am glad that people may hesitate jerking me from a car and dropping me to the concrete after an accident unless my car is actually on fire and they exercise as much caution as possible to keep from adding to my injuries. 
The jury must find that the defendant acted differently than a prudent person would have acted under same or similar circumstances. If the jury felt that there was reasonable evidence that the plaintiff was in eminent danger of the car catching on fire and the defendant was reasonable in the manner she pulled her friend from the wreck--and that there is a foreseeable connecting link between the actions by defendant and the paraplegia--then the jury will rule for the defendant. Remember, the plaintiff has the burden of proof. I suspect presenting credible medical proof that the paraplegia is related to the rescue attempt rather than the crash will be problematic.
I personally came up on an accident in which the driver was still strapped in a car with the side ripped off of it. There was steam coming from the engine and what I thought was smoke. Rather than unbuckling her and risking further injury I stood ready to do so until the paramedics arrived. Threat of lawsuit or not, I hope that rescuers will act in the same manner if I were in that situation.