Pensacola Personal Injury Lawyer - Drug Products

Ketek Investigation Continues

Robert Blanchard — Wed, 30 Jan 2008 09:04:36 GMT

Democrats have now subpoenaed workers in the FDA to determine how in the world they approved Ketek despite scientific concerns over its safety. The new antibiotic ended up killing people from liver damage. Turns out the clinical trials were falsified and at least one doctor has gone to prison. Still no one at Aventis or the FDA has yet to be punished, so well intentioned lawmakers are at least looking into it. See full STORY.

By Mike Soraghan
Posted: 01/29/08 12:01 AM [ET]
Frustrated House Democrats will try to subpoena several Food and Drug Administration officials Tuesday as part of an investigation into whether FDA criminal investigators sought to prosecute a drug company in connection with a flawed drug that killed several people.
The House Oversight and Investigations Subcommittee is to vote on the subpoenas Tuesday, the latest development in an ongoing probe into FDA's approval of a respiratory illness treatment called Ketek.
Democrats on the subcommittee also want to look at the briefing book used by FDA Commissioner Andrew von Eschenbach to determine whether he was misled when he offered testimony last year about the approval process of the drug before Congress. After his testimony, several members raised questions about whether he had misled the subcommittee.

Originally posted at InjuryBoard by Robert Blanchard

New Ruling in Celebrex cases

Robert Blanchard — Wed, 28 Nov 2007 16:25:23 GMT

Judge Brier has just ruled in the Celebrex cases that the 200 milligram daily dosage
that was common for Celebrex has not been scientifically shown to cause heart attacks and strokes. You may recall that Celebrex is the Cox-2 inhibitor drug just like Vioxx that has
been subject to allegations that its use causes heart attacks and strokes, very much like Vioxx.
This may sound like very good news for the Pfizer company that made the drug but many people were prescribed more than the 200 milligram daily dose.

The Judge's ruling comes after months of legal battles regarding expert testimony that will be allowed in the Celebrex cases. Significantly Pfizer did not even move to exclude expert testimony that Celebrex is capable of causing heart attacks and strokes when a patient ingests 800 milligrams per day. There have been arguments, though, over how long someone would need to take this drug in order to have the adverse affects.

Despite hearing testimony from three experts that 200 milligram dosages were also capable of causing heart attacks and strokes, Judge Brier ruled that those opinions were not based upon good science. Judge Brier cited to the lack of randomized control trials involving this dosage. No word yet on whether Judge Brier wants the scientists to go forward with studies and give people the 200 milligram dosage under controlled conditions to see if they get a heart attack.

For more information on this subject, please refer to the section on Drugs, Medical Devices, and Implants.

Originally posted at InjuryBoard by Robert Blanchard

Vioxx Settlement Rattles Conservatives

Robert Blanchard — Sun, 25 Nov 2007 10:02:23 GMT

I watched in amazement as Neil Covuto failed to conceal his anguish and outrage as he interviewed a Vioxx trial lawyer about the recent announced settlement of Vioxx case litigation. Neil had no concern about the horrible things that the drug company was willing to do to make a profit, including hiding and distorting important safety data from the medical community and the FDA. Nor was Neil concerned about the thousands of heart attacks that medical scientist had determined resulted needless from patient exposure to Vioxx. Also not mentioned was the clear notice the company was under from the early days of the drugs development of the danger posed to patients. No, it seems Neil was only concerned that trial lawyers were going to make money off the deal. I am sure Neil works for free and puts everything at risk to go up against massive corporations to fight for the rights of those injured. Neil is that kind of guy. And he is a liar too, see link.

For more information on this subject, please refer to our section on Drugs, Medical Devices, and Implants.

Originally posted at InjuryBoard by Robert Blanchard

Heart ByPass Drug Recalled

Robert Blanchard — Mon, 05 Nov 2007 12:06:53 GMT

If you are soon to receive a heart bypass, at least you won't face the propsect ohf being given the medication known as Trasylol. After consultation with agencies in the U.S., Canada, and Germany, the drug manufacturer has announced that it is wiithdrawing the drug worldwide. See Article. The FDA approved the drug in 1993 and started re-evaluating the drug's side effects after the publication in January 2006 of two studies that associated the drug's use to serious injuries, most significantly, kidney problems, heart attacks and strokes.
Newer studies indicate the drug also raises the risk of death. One of those studies previously was withheld by Bayer from the FDA, a common practice among pharmaceutiical companies that put profits over safety. The company claimed the withholding was due to a "regrettable human error." What is regrettable is their complete lack of ethics.

For more information on this subject, please refer to the section on Drugs, Medical Devices, and Implants.

Originally posted at InjuryBoard by Robert Blanchard

FDA Panel Votes to Withdraw Youth Cold Meds

Courtney Mills — Mon, 22 Oct 2007 14:36:53 GMT

An FDA panel took a vote last week to ban cough and cold products for children under six years of age. According to the experts who testified before the panel, these cough and cold medicines are wholly ineffective in the treatment of cough and colds and have far more risks than benefits.

This recommendation comes just a few weeks after drug companies pulled pediatric formulations of cough and cold medicines for children two years and younger from drugstore shelves, citing some evidence of dangerous side effects and serious harm in youngsters.

The cough and cold medicines for children 5 and younger, which have been used by parents for years to treat common colds, will be cleared from shelves if the FDA acts on the petition from the advisory panel. Some of the more popular brands include Robitussin and Dimetapp Elixir. The removal of these medicines from drugstore shelves will radically change the way parents treat common colds in their children.

For more information on this subject, please refer to the section on Drugs, Medical Devices, and Implants.

Originally posted at InjuryBoard by Courtney Mills

Preemption Attack on Your Rights

Robert Blanchard — Mon, 25 Jun 2007 16:56:07 GMT

One way the big manufacturers were going to avoid any liability for their actions was to stack the courts to rule that State courts could not interfere (with jury verdicts) in areas where the Feds have regulated. Unfortunately for their diabolic plans, some of the conservatives put on the Supreme Court actually believe in keeping the Feds out where the States can do a better job of protecting the public. While Bush's appointments tend to be corporate lapdogs who will do whatever the largerst corporation wants in a given case, I expect diehards like Scalia to stand by their principles and stop this whole "preemption" nonsense. Note the latest move by the Supreme Court:

The U.S. Supreme Court agreed to consider giving patients the right to press product-liability lawsuits against Medtronic Inc. and other medical-device makers.
The justices today agreed to hear an appeal by a New York man who says he suffered permanent injury when a Medtronic-made catheter burst during an angioplasty. A lower court said Medtronic couldn't be sued because its product was cleared for sale by the U.S. Food and Drug Administration.
The issue has arisen in scores of lawsuits against Fridley-based Medtronic and other medical-device makers, with most lower courts shielding the companies from suit.
Injured consumers are now "without any remedy in many parts of the country," patient Charles R. Riegel and his wife, Donna, argued in their appeal, filed in Washington.
The Bush administration's top courtroom lawyer, U.S. Solicitor General Paul Clement, told the justices they shouldn't take up the appeal. He said suits challenging an FDA-approved medical device "would undermine the regulatory scheme established by Congress."
Medtronic similarly urged the high court not to get involved, saying the New York-based 2nd U.S. Circuit Court of Appeals reached the right conclusion. The Supreme Court had rejected five similar patient appeals since 2001.
Charles Riegel underwent an angioplasty to dilate his coronary artery in 1996. When the device burst, he lost consciousness and developed a complete blockage, forcing emergency bypass surgery.
Medtronic says the surgeon failed to follow guidance on the device's FDA-approved label not to use the catheter on patients with calcified arteries.
The legal question is when the "pre-emption" provision in the 1976 Medical Device Amendments kicks in to bar state-law suits that claim a product is defective or that a manufacturer failed to warn of risks. The federal law says pre-emption applies when the U.S. government imposes a "requirement," though it doesn't specify whether that term includes FDA approval.
In 1996 a divided Supreme Court permitted a suit against Medtronic over a pacemaker lead that was approved under the FDA's more streamlined "grandfather" rules. That process provides for fast-track review of new devices that are similar to those already on the market.
The Riegel case involved "pre-market approval," a more extensive FDA procedure that typically takes years.
The justices will hear arguments in the nine-month term that starts in October.

Originally posted at InjuryBoard by Robert Blanchard

Beware Phony Botox

Robert Blanchard — Thu, 14 Jun 2007 12:06:11 GMT

A more hellish scenario is hard to imagine: you go in for cosmetic Botox injections and find yourself unable to speak or breathe. Eric Kaplan spent months trapped in his own body after the couple were injected with a "homemade brew" of Botox. The selling of phony and low grade Botox is not an isolated problem, there are reports of low grade Botox being for as little as 10$ for an injection size dose that is then resold by the doctor for as much as $1200. With this kind of profit incentive, consumers will have to be ever vigilant. Don't count on the FDA, they want be able to keep up with the profit takers.
What does this mean for the victims? As Mr. Kaplan desribed it, "I mean literally, I was trapped inside my body. I mean imagine not being able to open your eyes, not being able to talk, not being able to communicate, and then having to learn to do these things again..."

Originally posted at InjuryBoard by Robert Blanchard

Another Contact Lens Solution Causes Injuries

Robert Blanchard — Tue, 29 May 2007 17:31:34 GMT

As we looked at injury cases from the Bosch and Lomb Renu with MoisturLoc contact lens solution, we noticed a number of cases of Acanthamoeba infection. This is different from the fusarium fungal infection that had been most widely cited in relation to the Renu product, so predictably Bosch and Lomb denied any relationship between its product an Acanthamoeba infections. As if it it just couldn't be related! Now we know from a new recall that it certainly could be related. In the face of FDA pressure, Advanced Medical Optics recalled its Complete MoisturePlus contact lens solution after the Centers for Disease Control and Prevention (CDC) in Atlanta linked the product to a rare but serious eye infection known as Acanthamoeba keratitis. Caused by a parasite, Acanthamoeba keratitis causes blindness and corneal transplants, and the treatment to avoid these problems is an excruciating nightmare. The problem with these products is simple quality control. The solution reaching customers does not have sufficient antibacterial ingredients.

Originally posted at InjuryBoard by Robert Blanchard

Antibiotic Ketek - How Many Must Die?

Robert Blanchard — Wed, 25 Apr 2007 18:43:46 GMT

It has been over 9 months since Dr. David Graham, an FDA safety official stated in his June 16, 2006 memo that Ketek should be withdrawn. He said approval of the drug was a "mistake" and contended that "every principle concerning the review and approval of new drugs was abandoned or suspended where [Ketek] is concerned."
Dr. Graham believes the benefits of Ketek are outweighed by the risk of serious liver problems.
Dr. Graham may not be alone in believing that Ketek should be recalled. Dr. Charles Cooper, Dr. David Ross and Dr. Rosemary Johann-Liang all have expressed serious doubts about the safety of Ketek.

Originally posted at InjuryBoard by Robert Blanchard

Pensacola Personal Injury Lawyer - Drug Products

Ketek Investigation Continues

More Heparin Problems

New Ruling in Celebrex cases

Vioxx Settlement Rattles Conservatives

Heart ByPass Drug Recalled

FDA Panel Votes to Withdraw Youth Cold Meds

Preemption Attack on Your Rights

Beware Phony Botox

Another Contact Lens Solution Causes Injuries

Antibiotic Ketek - How Many Must Die?