Austin Personal Injury Lawyer - FDA & Prescription Drugs

Pregnant (Or Think You Might Be)?: Beware Birth Defects Caused By Psychotropic Drugs (Lamictal, Paxil, Zoloft & Prozac)

Mark Perlmutter — Mon, 29 Jun 2009 13:34:52 GMT

The same medication helping you could be hurting your baby, as recent studies of psychotropic drug use show. The drugs Lamictal, Paxil, Zoloft, and Prozac have now all been linked to birth defects in unborn children. There are a large number of women that are currently prescribed psychotropic drugs, with many others taking these medications without a prescription. While some psychotropic drugs may be taken safely during pregnancy, others have been found to create negative and sometimes fatal effects to your child in utero. Although psychological disorders left untreated can have negative impacts on the fetus, before starting a regimen of any medication, an expecting woman should first consult her physician to ensure a safe pregnancy.

Lamictal, an anticonvulsant drug used in the treatment of epilepsy, has been shown to increase the risk of cleft lip or palate in infants when taken in the first trimester of pregnancy. The FDA released this alert after a study by the North American Antieleptic Drug Pregnancy Registry showed that 5 cleft lip and palate cases occurred out of 564 women on Lamictal during pregnancy. Women who are currently taking, or have taken, Lamictal during pregnancy should inform their physician to make certain of the health and safety of their unborn child.

Paxil, Zoloft, and Prozac, are all drugs labeled SSRIs, or selective serotonin reuptake inhibitors. SSRIs are used to treat bulimia nervosa, panic, depressive disorders and obsessive compulsive disorder, among many others. The FDA released a warning on July 19, 2006 that infants are more prone to lung and pulmonary problems after being exposed to SSRIs during pregnancy.

Although SSRIs have not been directly linked to a substantial increase in any birth defects, studies are beginning to show an increase in incidence of birth defects due to their use. If you or anyone you know is taking an SSRI during pregnancy, or had been taking it before learning of their pregnancy, please contact your physician or healthcare professional. With proper medical treatment and care, we can ensure that our nation’s children don’t just have a fighting chance, but that they are destined to succeed.

Originally posted at InjuryBoard by Mark Perlmutter

Chalk One Up For The Good Guys; US Supreme Court Rejects Preemption

Brooks Schuelke — Wed, 04 Mar 2009 11:32:16 GMT

I spent a good part of last October writing about federal preemption of state tort claims, including talking about the case of Wyeth v Levine. In that case, Wyeth was asking the U.S. Supreme Court to reverse a $6.7 million judgment awarded to a musician who lost her arm after using a Wyeth medication.

Moments ago, the U.S. Supreme Court released a 6-3 decision upholding the jury's verdict. I haven't had time to analyze the opinion. But whatever it says, congratulations are in order to Ms. Levine and her attorneys.

Originally posted at InjuryBoard by Brooks Schuelke

Is The FDA Even Opposed To Complete Immunity Preemption?

Brooks Schuelke — Thu, 30 Oct 2008 11:54:40 GMT

Regular readers know that we've been looking at complete immunity preemption issues this month. In looking at these preemption issues, we've already seen how doctors are opposed to FDA preemption of drug litigation. But now it appears that even the FDA may be opposed to preemption.

Yesterday, a congressional report on preemption was released, and included among report were several memos from senior FDA officials who opposed preemption. John Jenkins, the top official in the FDA drug approval sections, wrote about preemption in 2003:

Much of the argument for why we are proposing to invoke pre-emption seems to be based on a false assumption that the FDA approved labeling is fully accurate and up-to-date in a real time basis.

Regular readers will recognize that this is one of my (many) complaints against preemption. I have argued here and here that regulators aren't nimble enough to provide up-to-date protections for consumers.

The report that included the preemption memos concludes:

FDA has an obligation to ensure the safety and effectiveness of drugs. In this case, however, the internal documents indicate that the Bush Administration weakened important drug safety regulations to shield manufacturers from liability. This is a serious abuse of the agency’s publich health authorities.

One other story notes that the memos were forwarded to the FDA’s chief counsel, who is now the general counsel for pharmaceutical giant Glaxo-Smith-Kline. That type of close relationship between the regulating body and the industry being regulated, which is all too common, should give us all pause.

Originally posted at InjuryBoard by Brooks Schuelke

Even Doctors Are Against Complete Immunity Preemption

Brooks Schuelke — Thu, 23 Oct 2008 15:22:31 GMT

With the Wyeth v. Levine case slated to be argued soon, preemption continues to stay in the news, and one of the biggest stories came out earlier this week when the Journal of the American Medical Association announced that they were opposing the pharmaceutical industry and the government in the preemption fight.

The statement echoes my concerns that the government tests aren't adequate to protect the public. The doctors write:

...clinical trials don't identify the full risks and complete safety profile of new drugs...the drug and device regulation process is at best an inexact and incomplete science. Until these deficiencies in the system are remedied, some patients inevitably will continue to experience harm from the use of newly marketed products as well as from use of other approved medications...

They also recognize that the tort system plays an integral part in protecting patients. They write, "...until the system of approving drugs and monitoring their safety improves markedly...patients will need legal recourse against pharmaceutical makers..." If the Supreme Court sides with Wyeth, "patients will lose an irreplaceable method for seeking remedies for injuries resulting from pharmaceutical agents that were approved by the FDA."

Interestingly, this isn't the first statement from the medical industry opposing complete immunity preemption. The New England Journal of Medicine filed an amicus brief in the case opposing preemption.

Now if we can only get them to consider the same issues on tort reform....

Originally posted at InjuryBoard by Brooks Schuelke

The Other Side of Preemption

Brooks Schuelke — Tue, 21 Oct 2008 20:39:00 GMT

Those of us at Injuryboard have been doing a series on the dangers of complete immunity preemption, and we've been talking about the dangers of preemption. In order to be fair, I wanted to highlight a press release from Wyeth, who has a highly publicized preemption case coming before the Supreme Court, in which they attempt to describe the benefits of preemption. (Hat tip to Pharmalot for the link.)

In the release, Wyeth argues:

The public health is better served by having a single expert regulatory body making decisions about risks, benefits, and warnings - rather than an ad hoc system that could produce hundreds of conflicting results that would be impossible for manufacturers, physicians, and patients to reconcile or interpret. Such a system would undermine the careful balance struck by the FDA when making approval decisions.

This reminds me of my first appellate argument where one of the three judges on the Austin Court of Appeals told me, "Frankly, Mr. Schuelke, I've read your brief, and I don't buy it." I have the same reaction to Wyeth's pro-preemption arguments. First, there hasn't been the "careful balance" historically. Until the Bush administration came along, the FDA and other regulatory agencies went forward with their regulations knowing that the federal regulations and the state tort system "regulation" worked in concert with one another. Federal safety regulations were not meant to be the end all, be all word on safety. Attempting to use those regulations in such a manner now does not properly protect the public.

Second, federal regulatory agencies clearly aren't nimble enough to protect the public. With today's science and technology, we are always discovering new risks of drugs, finding safer ways to make products, or discovering new dangers from materials (plastic baby bottles anyone?). Changing federal regulations can take years; on the other hand, allowing regulation through tort law means that these standards can be incorporated on an on-going basis, and more citizens are protected.

Finally, the federal government just doesn't have the resources to be the "great guarantor of safety." In the last year, we've seen story after story where the FDA doesn't have resources to properly test new drugs or inspect drugs or food arriving from China or other countries or stories where the Consumer Product Safety Commission doesn't have the resources to inspect imported toys. We just can't rely on the federal government to make sure that our country is safe. That responsibility has to fall on the states and the tort systems as well.

Originally posted at InjuryBoard by Brooks Schuelke

Did Merck Ghostwrite Vioxx Studies For Doctors? And Why Is That Important To Personal Injury Lawyers?

Schuelke Schuelke — Wed, 16 Apr 2008 09:58:30 GMT

According to an article published yesterday by the Journal of American Medical Association, Merck was ghostwriting Vioxx studies for doctors. The study's authors reviewed over 20,000 pages of drafts reports of studies and came to the conclusion that:

When publishing their own clinical trials (designed, conducted,and sponsored by Merck), documents were found describing Merckscientists often working to prepare manuscripts and subsequentlyrecruiting external, academically affiliated investigators tocollaborate on the manuscript as guest authors.

But the authors state that Merck may not be alone in this practice:

We cannot determineif the authorship pattern we observed for clinical trial andreview articles related to rofecoxib also would be observedin articles describing other Merck products or the productsof other pharmaceutical companies. However, given the reportedprevalence of guest authorship and ghostwriting among the mostprestigious medical journals and that similar authorshippatterns were identified using documents produced during litigationsurrounding both gabapentin and sertraline, iit is reasonableto expect that the authorship practices observed in this casestudy may be used by other pharmaceutical companies as well.

On its face, this conduct is unacceptable. The World Association of Medical Editors has described this type of conduct as dishonest and unacceptable and stated that it erodes the ethical foundation of medicine and medical research.

But I think this story is significant to personal injury victims and trial lawyers for at least two non-obvious reasons. First, this study demonstrates the value of litigation, not only as regulation, but also as a check on unsubstantiated assertions of wrongdoers. The study was based on a review of studies and drafts of studies that were produced in the various Vioxx cases. In the absence of pharmaceutical litigation, these studies would never have been scrutinized and this type of story would never come to light. As the authors of the study wrote:

Nevertheless,access to industry documents through litigation presents a rareopportunity to explore the relationship between the medicalprofession and the pharmaceutical industry and has providedvaluable insights and findings in the past.

More importantly, this story is important in the tort "reform" debate. I have written about it time and time again, but this revelation is another indictment of the current administration's continued push for preemption of state laws. It is the administration's position that any drug that is approved by the FDA (or product approved by the CPSC, etc) should not be subject to lawsuits based on state law. At a time when articles are coming out weekly about the FDA's (or other governmental entity's) inability to regulate all of the drugs or products and with this revelation that pharmaceutical companies are likely misleading the government, it makes no sense to me to continue pushing for preemption.

For more on this story, you can read:

NYT: Merck Wrote Drug Studies For Doctors

Merck Press Release: Merck Responds to JAMA

Pharmalot: Vioxx Studies --- Ghostwriters and Merck Sponsorship

Oklahoma City Injuryboard: JAMA Editorial Blows Whistle On Drug Companies

WSJ Health Blog: Ghost of Vioxx Still Haunts Merck

UPDATE: Since my post, the following have posted good articles on this story:

Injuryboard national desk

Ethics for the Real World

Public Citizen's Citizen Vox

Originally posted at InjuryBoard by Schuelke Schuelke

Singulair May Be Linked To Suicide

Brooks Schuelke — Sun, 30 Mar 2008 13:47:01 GMT

Some warnings hit home. The FDA has now issued warnings that the popular asthma drug Singulair may be linked to suicidal thoughts. This is particularly disconcerting because Singulair is a popular prescription with children (including one of my own).

If you or your child takes Singulair, please discuss these risks with your doctor.

For more information from my Injuryboard brethren, you might check these blogs out:

Injuryboard
Houston personal injury lawyer Bob Binstock
El Dorado personal injury lawyer

Originally posted at InjuryBoard by Brooks Schuelke

The Problem With Preemption

Brooks Schuelke — Tue, 29 Jan 2008 11:45:13 GMT

The Bush Administration has long supported a policy of federal government rules and regulations preempting state court causes of action. For example, in December, the administration argued that pharmaceutical companies should not be liable to consumers for their defective products if the products were approved by the FDA.

But the problem is that the FDA is not well-suited to handle the responsibility. Today, the New York Times ran an article detailing the problems with the FDA. The article cites a recent General Accounting Office study that finds that the agency is understaffed and underfunded to properly do its role. A former FDA lawyer expected to testify for Congress in the upcoming weeks stated, "This is a fundamentally broken agency, and it needs to be repaired."

But the problem only continues to get worse. According to the article, the FDA's budget has been shrinking as its responsibilities have increased:

In the last 14 years, the drug agency has lost 1,311 employees and nearly $300 million in appropriations to inflation while Congress has passed more than 100 laws defining or expanding its regulatory responsibilities. The agency now regulates about $1 trillion worth of goods, or 25 cents of every dollar spent by consumers.

It is amazing in the face of these difficulties that the Bush Administration keeps pushing for preemption. Isn't it apparent to everyone that the FDA hasn't been equipped to handle the responsibilities shoved upon it? Isn't it apparent that simply because a drug or device has been approved by the FDA that it's not necessarily a safe drug or product? I would hope that most of us see that, but apparently some are still blind.

Originally posted at InjuryBoard by Brooks Schuelke

Biggest Drug Recalls of 2007

Brooks Schuelke — Tue, 04 Dec 2007 09:03:53 GMT

In a year of massive drug recalls, the FiercePharma blog has a report on the top 10 drug recalls of 2007. The list includes:

1. Antidepressants - Various companies

2. Epogen/Aranesp - Amgen

3. Zyprexa - Lilly

4. Avandia - Glaxo

5. Actos - Takeda

6. Provigil - Cephalon

7. Zelnorm - Novartis

8. Byetta - Amylin

9. Xolair - Genentech

10. Fentora - Cephalon

Apparently, the list is based on 2006 world wide sales, which explains a little deviation from what you might expect.

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

Originally posted at InjuryBoard by Brooks Schuelke

Ethical Duties on the Vioxx Settlement

Brooks Schuelke — Sat, 17 Nov 2007 08:00:04 GMT

Under the recently announced settlement, lawyers participating in the agreement must recommend to all of his or her clients that they participate in the settlement, and if they don't agree to participate, the attorney must take steps to withdraw from the representation. That provision is causing many attorneys to consider whether participation in the agreement requires them to violate any of their ethical obligations. This issue is addressed in detail in a recent Texas Lawyer article on the Vioxx settlement.

I don't know enough about the settlement to have a real opinion on this, but as an attorney that prosecutes legal malpractice claims, we will be following this story.

Originally posted at InjuryBoard by Brooks Schuelke