Georgialawyer's 09 Resolutions

I make them every year. Each helps guide me, focus my office, and serve as a component of the office Business Plan. In no particular order, here they are:

1. Each employee will have two monitors. I have used two monitors, and I can tell you that productivity increased. Having two monitors gives me access to the firm database as well as to the current project I may be working on, and cuts down on constant switches to other programs.




2. Go completely paperless. From the moment mail comes in, to the moment we turn the lights off at the end of the business day/night. We are almost there now.

3.Declutter. From excessive cables at a desk, to 'Mt. Paper' around the office. Seems like simple resolution, but this one will be the most difficult.

4.Remember who we work for, always: I have this habit of telling a client, "You're my boss" when a contract is signed. I mean it, but sometimes in the daily grind not all who work for any one person may. This year we reinforce this basic premise every day. I so see lawyers who tout their skills or speak of a result as if the client was nothing more than an asterisk to the story being told. I don't like it, and plan to also point it out to those who forget.

5.Tech: Figure out what Social Media is, how it relates to the people we work for, and determine the value of it. Not sure about this one, but I plan to figure it out. Stay tuned, as this subject looks to be one front and center on this blog.

Do you make any resolutions?

From the Blog Drug & Device Law 10 "Worst" Decisions of 08

The Drug and Device Law Blog is a must read for me. This month, the folks there compiled a list of "worst" court decisions. Why are these the worst? Read on ... and read the complete list by going here:


"1. Conte v. Wyeth, Inc., 85 Cal. Rptr.3d 299 (Cal. App. 2008). It’s only an intermediate appellate court decision, but the implications are staggering. The court held that the manufacturer of a pioneer (name-brand) drug can be liable for the inadequate warnings on a competing generic product. The mere label (“misrepresentation”) on the cause of action throws out 50 years of justifying product liability on the basis that the party profiting from the product should bear the burden of compensating product-related injuries.

2. In re Zyprexa Products Liability Litigation, 253 F.R.D. 69 (E.D.N.Y. 2008). It’s Judge Weinstein. It’s a class action. That means that the result favors the plaintiffs, and the certification order is accompanied by a plausibly reasoned (if you think all class actions should be certified) opinion that goes on forever. Having had class certifications shot down by the appellate courts on market share, nuisance, and consumer fraud, this time Judge Weinstein tries non-reliance RICO. So it’s off to the Second Circuit again.

3. Hyman & Armstrong, P.S.C. v. Gunderson, ___ S.W.3d ___, 2008 WL 1849798 (Ky. April 24, 2008). In federal court, Parlodel stroke cases have almost always been thrown out on Daubert grounds - no scientific basis for causation. In Kentucky, they go to the jury and produce eight-figure verdicts – and they get affirmed by the Kentucky Supreme Court on the basis that you can prove causation with a dog and pony show featuring a bit of this and a bit of that, when none of the bits are valid science in and of themselves. "

Those are three of the ten. Biting commentary included. I'm not an attorney who advocates class actions cases, and find them particularly troubling in cases involving unsafe/recalled drugs. In fact, I despise them generally speaking. The other cases mentioned are worth a read of each opinion. Otherwise, you're essentially stuck with reading a movie review only of each case.

Happy reading!

FDA News: Recall of a Medical Device: "Vibe"

The Food and Drug Administration has issued a recall notice for a device made by a Colorado man that some claim cures cancer and other diseases. The FDA says the "Vibe" has not been shown to be safe and effective at curing or treating diseases.

Source here.

Social Media for Lawyers

I've been reading/catching up on Social Media for Lawyers. One site list the top myths regarding it, and here is one highlight:

Myth: Social media tactics are too time consuming.

Truth: Social media tactics could take hours and days, but they do not have to take that much time to be effective. The simple solution is to allot a certain amount of time each day for social media efforts. Set aside an hour or so and blog on Monday, network using LinkedIn or Facebook on Tuesday, use twitter when you have some down time, etc. Remember to go your own pace and plan what works best according to your personal preferences and goals. If you decide you do not want to take on the responsibilities yourself, hire someone in-house to or outsource your social media campaign to a marketing company.

Source here, from Tom Foster.

Good advice. Will lawyers listen? At the end of the day, a lawyer has to wan to go online and post to a blog, use LinkedIn, or use Twitter. I remember the first six months of this blog - I was certain no one was reading it. That has changed, and it has taken "only" two years to have folks ergularly comment on or reply to posts.

FDA Recalls Custom Stryker Cranial Implant Kits

Stryker has had an interesting 2008. Pain pumps made by that company have been the subject of litigation. (The Stryker Pain Pumps are infusion devices designed to deliver controlled amounts of local anesthetics to the patient for post-operative pain management. Medication is delivered directly to the surgical wound site or in close proximity to the nerves associated with the surgical area. The pump infuses the medication at an hourly flow rate or combination of an hourly flow rate and controlled bolus doses.)

It also made news because of it was claimed to have been been running illegal YouTube.com ads that a group alleged violated some U.S. Food and Drug Administration (FDA) requirements. Source here.

Now there is this news: The FDA has issued a class 1 recall for Stryker Custom Cranial Implant Kits, manufactured by Stryker Leibinger USA, because of lack of assurance of sterility and risk for infection, according to an alert sent today from MedWatch, the FDA's safety information and adverse event reporting program. Class 1 recalls warn of situations in which there is a reasonable probability that use of the recalled products will cause serious injury or death.

The recall affects all sizes of the cranial implant kit distributed from November 5, 2007, through October 23, 2008. These custom implants are individually designed to correct patient-specific trauma-related and/or other defects of the lower jaw (mandibular), upper jaw, and face (maxillofacial), or the cranium and the face (craniofacial bone).

A letter dated October 24, 2008, notified sales representatives, risk managers, implanting surgeons, and other appropriate healthcare professionals of the recall, stating that sterility could not be assured and that there was a risk for serious infections. In addition, clinicians were advised to follow up with patients for infections for at least 6 months after surgery, and instructions were provided for identifying and returning any remaining implant kits.

Source here.

Season's Greetings

It's in the air here in Atlanta today: High 20's, steel gray sky, moderate winds. As I ran this morning with gloves, hat - anything to keep me warm - I kept my mind on the reason for the season.

Have a safe and happy holiday. I'd ask Santa for snow, but it looks like the forecast for us is a day in the low 60's. I can always dream, right?

I'm On Twitter

Look for me there: ageorgialawyer would be me. Go figure. Thought I'd give it a spin, see what the buzz is about. While at that site, found this from David Barrett:

9 Reasons You Need Social Media Marketing in 2009. Among those are:

4. More Social = more Search.
More Search = More Customers.
More customers = More business.


Duh. The web is more de-centralized than ever. After we do our initial searches through the Google, we start looking for communities of likeminded people. Your best customers are the ones that are passionate and want to have a conversation about you, your product, or something related (news, pictures, whatever). You need to be there to have the conversation WITH your customers. Otherwise, they will have it behind your back. You might not be able to rank right away on search engines anymore, but you can get to the top of a news or industry specific site for a few days with good content.

also this gem:


8. Your website is only a billboard

You can have the most beautiful website in the world, and without traffic, it might as well be a billboard in the middle of a cornfield in Iowa. Just ask all those big corporations who paid millions to have their beautiful flash sites built, and forgot to hire a SEO. You launched your site, and now you need traffic, or it’s been there for a long time, and you need MORE traffic and exposure. You listened to the search engines, and created great content! (after all, content is king!) But you still don’t seem to have much traction, and only your Aunt Frita, Uncle Merv, and 6 other people are visiting your site every day.

OK, I'm in. Follow me?

ObTape Vaginal Sling: MDL in GA

Between 2003 and 2006, approximately 35,000 women who underwent a transobturator surgical procedure to treat stress incontinence and bladder leakage received a defectively designed ObTape vaginal sling manufactured by Mentor. Estimates have suggested that 17% to 18% of these women could suffer severe and debilitating complications, including infection, vaginal extrusions and urinary tract erosions.

Problems include:

* Vaginal or Pelvic Pain
* Chronic Infections
* Severe Pain in the Back, Hips and Legs
* Cellulitis
* Vaginal Extrusions
* Urinary Tract Erosions


The United States Judicial Panel on Multidistrict Litigation has ordered that all federal lawsuits involving the Mentor ObTape Transobturator Sling be consolidated in the U.S. District Court for the Middle District of Georgia for pretrial proceedings as part of an MDL, or Multidistrict Litigation.

Mentor Corp. currently faces at least 22 ObTape lawsuits pending in 12 different Courts. The cases have been filed by women who have suffered severe complications allegedly caused by a defective design in a vaginal bladder sling previously sold by Mentor to treat stress urinary incontinence.

The Mentor ObTape Sling contains a “nonwoven” design, which has been found to block essential nutrients and oxygen, potentially resulting in severe pain, vaginal extrusions, urinary tract erosion or infection.

In October 2008, Mentor filed a petition with the Panel on Multidistrict Litigation to consolidate all of the ObTape lawsuits that are currently pending or may be filed in the future. They asked that all of the cases be centralized before one judge for coordinated pretrial litigation in the Western District of Oklahoma or, in the alternative, in the Northern District of Oklahoma or Northern District of Ohio.

At a hearing on the petition November 20, 2008, attorneys representing women who have filed these lawsuits opposed the formation of an MDL, arguing that the litigation only involves one defendant and there are currently only a limited number of ObTape law firms investigating cases. However, they asked that if an MDL was formed, that the cases be transferred to the Middle District of Georgia, where the most cases are currently pending and the first ObTape lawsuit was filed.

Gadolinium Lawsuits Line Up

Lawyers for the plaintiffs and lawyers for the manufacturers of gadolinium based MRI contract agents have filed a joint list of 193 NSF lawsuits which are eligible to be among the first cases prepared for trial in the consolidated federal litigation.

There are over 350 NSF lawsuits that have been filed in federal and state courts throughout the United States alleging that the manufacturers of five different gadolinium MRI contrast agents failed to adequately test their products or warn that they could cause a progressive and potentially fatal condition associated with the hardening and thickening of the skin, severely restricting movement.

All of the federal cases have been consolidated in an MDL, or Multidistrict Litigation, in the United States District Court for the Northern District of Ohio, where they are being handled by Judge Dan Polster for pretrial litigation.

The 193 cases consist of those lawsuits where the parties have agreed that there has been a “good faith substantiation” of which of the five different gadolinium contrast agents were used and where the plaintiff alleges that they have been diagnosed with Nephrogenic Systemic Fibrosis (NSF). The list was narrowed down from over 250 cases which have been consolidated in the MDL.

From various sources, including lawyer colleagues,

Tainted Weight Loss Pills

he FDA warned consumers Monday to neither consume nor purchase a slate of more than 25 different weight-loss products. Each may contain "undeclared, active pharmaceutical ingredients that may put consumers' health at risk," the FDA said in a release.

The drugs the FDA warns could be tainted:

# 2 Day Diet
# 3x Slimming Power
# 3 Day Diet
# 5x Imelda Perfect Slimming
# 7 Day Herbal Slim
# 7 Diet Day/Night Formula
# 8 Factor Diet
# 999 Fitness Essence
# Extrim Plus
# Fatloss Slimming
# GMP
# Imelda Perfect Slim
# Japan Lingzhi 24 Hours Diet
# Lida DaiDaihua
# Miaozi Slim Capsules
# Perfect Slim
# Perfect Slim 5x
# Phyto Shape
# ProSlim Plus
# Royal Slimming Formula
# Slim 3 in 1
# Slim Express 360
# Slimtech
# Somotrim
# Superslim
# TripleSlim
# Venom Hyperdrive 3.0
# Zhen de Shou

The FDA warning comes after an analysis found that the "undeclared active pharmaceutical ingredients" in some of the products contained a controlled substance, a drug not approved for marketing in the United States and a suspected cancer-causing agent.

According to the FDA:

These weight loss products, some of which are marketed as “dietary supplements,” are promoted and sold on various Web sites and in some retail stores. Some of the products claim to be “natural” or to contain only “herbal” ingredients, but actually contain potentially harmful ingredients not listed on the product labels or in promotional advertisements. These products have not been approved by the FDA, are illegal and may be potentially harmful to unsuspecting consumers.

The FDA advises consumers who have used any of these products to stop taking them and consult their healthcare professional immediately. The FDA encourages consumers to seek guidance from a healthcare professional before purchasing weight loss products.

Source here.

2008 Resolution Recap

Sitting in the South on a rainy weekend, I'm taking stock of some of my resolutions (those posted here), seeing how I did:

Back about this time last year, I resolved these:

1.When speaking with a person - client, attorney, etc. - I will not pick up my cell phone to see who it is. I will not check my blackberry while in a business setting.

Met. In fact, I now ask those who (like a true addict) start nervously peering down to a PDA/blackberry or cell phone while talking to me about a business matter to STOP and pay attention. I now leave my phone in the car or turned off. There are exceptions, but they are rare.


2.My office will march forward to going paperless. We already move all FAX transmissions to our servers, and basic items such as Incident Reports and medical records are scanned. Next up: Other records and documents.

Met in a big way. Thanks to the Scansnap and a high powered copier/scanner, my office is far ahead of where I thought I'd be. I attended a day long mediation last week and had a portable hard drive with me of a key litigation matter. I was able to have access to thousands of pages that were sitting in my office, while I was in another state.

3.Use of IM and texting of clients: Angel Reyes uses texting to reach a client. We will as well. The use of IM in our offices works well, as we are spread out. Next is asking for the IM screen name of clients. I have found that nearly 60% of all clients use IM, even if only on a semi-regular basis.

Met. Maybe a little too much. Clients now routinely IM me, so much so that I have moved to another username, and my office monitors the main IM.

4.Copying clients on case costs payments. In the old days, there would be sticker shock when a case resolved and the client saw for the first time the costs incurred in a case for matters such as expert witnesses, deposition transcript costs, and the like. Now, clients get all copies of letters showing payments to any entity (but they don't get a copy of the check). This will be a 100% rule in 2008.

Wow, I really posted that? Didn't get to 100%, but closer to 75% now.

5.Compliments: Seems like the law field is one area where compliments to staffers, fellow lawyers, etc. are rare. Not in my office. 2008 is the year of compliments and of 'well done' comments.

I am handing them out, but there is always room for improvement here. Funny how the toughest one - this last resolution - is free, yet was harder to implement, since it required human capital.

Coming soon: 2009 Resolutions.

FDA News: Antiepileptic Medications Must Carry Suicide Warnings

News today from the FDA:

The U.S. Food and Drug Administration has announced it will require the manufacturers of antiepileptic drugs to add to these products' prescribing information, or labeling, a warning that their use increases risk of suicidal thoughts and behaviors (suicidality). The action includes all antiepileptic drugs including those used to treat psychiatric disorders, migraine headaches and other conditions, as well as epilepsy.

The FDA is also requiring the manufacturers to submit for each of these products a Risk Evaluation and Mitigation Strategy, including a Medication Guide for patients. Medication Guides are manufacturer-developed handouts that are given to patients, their families and caregivers when a medicine is dispensed. The guides will contain FDA-approved information about the risks of suicidal thoughts and behaviors associated with the class of antiepileptic medications.

"Patients being treated with antiepileptic drugs for any indication should be monitored for the emergence or worsening of depression, suicidal thoughts or behavior, or any unusual changes in mood or behavior,” said Russell Katz, M.D., director of the Division of Neurology Products in the FDA's Center for Drug Evaluation and Research. “ Patients who are currently taking an antiepileptic medicine should not make any treatment changes without talking to their health care professional.”

The FDA today also disseminated information to the public about the risks associated with antiepileptic medications by issuing a public health advisory and an information alert to health care professionals. Health care professionals should notify patients, their families, and caregivers of the potential for an increase in the risk of suicidal thoughts or behaviors so that patients may be closely observed.

The FDA's actions are based on the agency's review of 199 clinical trials of 11 antiepileptic drugs which showed that patients receiving antiepileptic drugs had almost twice the risk of suicidal behavior or thoughts (0.43 percent) compared to patients receiving a placebo (0.24 percent). This difference was about one additional case of suicidal thoughts or behaviors for every 500 patients treated with antiepileptic drugs instead of placebo.

Four of the patients who were randomized to receive one of the antiepileptic drugs committed suicide, whereas none of the patients in the placebo group did. Results were insufficient for any conclusion to be drawn about the drugs' effects on completed suicides. The biological reasons for the increase in the risk for suicidal thoughts and behavior observed in patients being treated with antiepileptic drugs are unknown.

The FDA alerted health care professionals in January 2008 that clinical trials of drugs to treat epilepsy showed increased risk of suicidal thoughts and actions. In July 2008, the FDA held a public meeting to discuss the data with a committee of independent advisors. At that meeting the committee agreed with the FDA's findings that there is an increased risk of suicidality with the analyzed antiepileptic drugs, and that appropriate warnings should extend to the whole class of medications. The panel also considered whether the drugs should be labeled with a boxed warning, the FDA's strongest warning. The advisers recommended against a boxed warning and instead recommended that a warning of a different type be added to the labeling and that a Medication Guide be developed.

Acting under the authorities of the Food and Drug Administration Amendments Act of 2007 (FDAAA), the FDA is requiring manufacturers of antiepileptic drugs to submit to the agency new labeling within 30 days, or provide a reason why they do not believe such labeling changes are necessary. In cases of non-compliance, FDAAA provides strict timelines for resolving the issue and allows the agency to initiate an enforcement action if necessary.

The following antiepileptic drugs are required to add warnings about the risk of suicidality:

Carbamazepine (marketed as Carbatrol, Equetro, Tegretol, Tegretol XR)
Clonazepam (marketed as Klonopin)
Clorazepate (marketed as Tranxene)
Divalproex sodium (marketed as Depakote, Depakote ER, Depakene)
Ethosuximide (marketed as Zarontin)
Ethotoin (marketed as Peganone)
Felbamate (marketed as Felbatol)
Gabapentin (marketed as Neurontin)
Lamotrigine (marketed as Lamictal)
Lacosamide (marketed as Vimpat)
Levetiracetam (marketed as Keppra)
Mephenytoin (marketed as Mesantoin)
Methosuximide (marketed as Celontin)
Oxcarbazepine (marketed as Trileptal) Phenytoin (marketed as Dilantin Suspension)
Pregabalin (marketed as Lyrica)
Primidone (marketed as Mysoline)
Tiagabine (marketed as Gabitril)
Topiramate (marketed as Topamax)
Trimethadione (marketed as Tridione)
Zonisamide (marketed as Zonegran)
Some of these medications are also available as generics.

Health care professionals and consumers may report serious adverse events or product quality problems with the use of this product to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail, fax or phone.



-- Online : www.fda.gov/MedWatch/report.htm

-- Regular Mail : use postage-paid FDA form 3500 available at: www.fda.gov/MedWatch/getforms.htm
and mail to MedWatch, 5600 Fishers Lane , Rockville , MD 20852-9787

Study: Hormone Use Increases Cancer Risk

From Yahoo News:

Taking menopause hormones for five years doubles the risk for breast cancer, according to a new analysis of a big federal study that reveals the most dramatic evidence yet of the dangers of these still-popular pills.

Even women who took estrogen and progestin pills for as little as a couple of years had a greater chance of getting cancer. And when they stopped taking them, their odds quickly improved, returning to a normal risk level roughly two years after quitting.

Collectively, these new findings are likely to end any doubt that the risks outweigh the benefits for most women.

Link here.

You can read more about a recent Prempro verdict here. The article discusses a four-week trial in which a jury said Premarin, an estrogen replacement, and Prempro, a combination of estrogen and progestin, were defective products and found Wyeth was negligent in producing, marketing and selling the drugs.

Did Wyeth Pay to have Journal Articles Written?

A US Senator claims that Wyeth paid a company to ghostwrite medical journal articles about its hormone therapy products and seek academic scientists to sign them as authors.

According to papers from lawsuits suggest the drugmaker hired DesignWrite Inc. of Princeton, New Jersey, to draft manuscripts related to the Wyeth products and breast cancer risks, according to letters released today from Senator Charles Grassley of Iowa to the companies. Wyeth makes the hormone replacement drugs Prempro and Premarin.

For more, including the Wyeth response, go to the Bloomberg article here.

Weekend Post: First Christmas Without My Lab

I tend to post simply about things that interest me: News regarding pharmaceutical litigation, tech items of interest. What most folks comment on in emails? The pictures of the dogs - to the right on this blog.

This year, along with the happiness of the season, there is some sadness in my home. My 14 year old yellow lab named Pudge won't be around. He died earlier this fall. If you aren't a dog person, it's hard to explain. If you are ...

Pudge was the biggest and most rambunctious pup of the litter. He - like me - could be headstrong, aggravatingly persistent, funny, and high energy (all at the same time). He loved water (like his dad) - from a hose, a dirty puddle, even a half empty creek.

Pudge heard countless closing arguments from me while on our runs together. If I put on my running shoes, he knew what it meant: Running and talking. LOTS of talking.

He spent weekends sleeping and snoring away at the office as I prepared for trials. His favorite spot was always next to my chair as I would sit, dictating away. When I mean next to me, it was quite literally next to me, with his rump touching my leg. Pudge would look up from time to time as I worked, and the "thump thump thump" of his heavy tail hitting the floor seemed to say that he knew that my drivel was directed towards him. I cannot tell you how many times a dictated transcript would include (upon its return) a sentence like "Plaintiff deposed witness "B Smith" who ... Pudge lie down, get out of the trash can .... " as he happily distracted me.

Christmas time usually meant his tail wagging around the tree with a crash, followed by an ornament breaking for all to hear. No wine glass was safe on the coffee table when he was in the house. If there was a fire going in the fireplace, you would have to step over his content body as he quite literally spread out in front of it.

As Pudge aged, the runs ended; the walks became shorter, the car rides less frequent. We went from closing arguments on our walks to opening statements. Towards the end, he was totally deaf and partially blind. We communicated with hand signals more often than not. His tail still wagged furiously, though, even when he was ill.

Through it all, Pudge made me and then my family laugh. He was as much my law partner, the silent one we lawyers all dream about, and the one who never argues about strategy or long hours, as he was my friend. This Christmas won't be the same without him at our house.

As I go about my end of the year tasks at the office, there is one less confidant in my life. I hope Santa rectifies that this year with another dog to add to the menagerie in our home. It won't be the same, but I hope that if a dog needs rescuing, love, and care, I know Pudge will be there in spirit and memory.

FDA Panel Hearing Regarding Asthma Drugs

FDA staffers who police drugs after approval spoke before an advisory panel this week. What did the FDA panel hear? That none of the medicines known as long-acting beta-agonists (LABAs) should be given to children with asthma.

It was also argued that two Serevent and Foradil, should not be used by asthma patients of any age.

"We now know with high certainty that LABAs increase asthma mortality. Do the health benefits justify that?" asked FDA drug safety reviewer David Graham, who has been outspoken on medication risks and criticized the FDA's ability to manage them.

Graham said the answer clearly was no, as he saw little improvement among asthma patients treated with LABAs, particularly children. He estimated that as many as 14,000 deaths could be attributed to LABAs since 1994.

For more, go here.

Hospira Recall News

Hospira Issues Voluntary Recall of One Lot of 20meq Potassium Chloride in 5% Dextrose and 0.45% Sodium Chloride Injection, USP Due to Incorrect Bar Code Label

Media Contact:
Dan Rosenberg
(224) 212-3366

FOR IMMEDIATE RELEASE -- LAKE FOREST, Ill., Dec. 8, 2008 -- Hospira, Inc., a global specialty pharmaceutical and medication delivery company, is following up on a nationwide voluntary recall issued Sept. 18 of one lot (lot number 65-620-FW, expiration date May 1, 2010, NDC 0409-7902-09) of 20 mEq Potassium Chloride in 5% Dextrose and 0.45% Sodium Chloride Injection, USP in 1000 mL flexible plastic containers because a small number of the containers may be incorrectly labeled with a bar code for 5% Dextrose Injection, USP (NDC 0409-7922-09). The incorrect bar code could lead to a medication error resulting in the wrong drug being delivered to a patient if a bar code system is used to confirm the medication. Potential adverse events related to an error of this type include electrolyte imbalance, cardiac dysfunction, gastrointestinal disturbances, paresthesia and mental confusion.

The product contains 20 mEq Potassium Chloride in 5% Dextrose and 0.45% Sodium Chloride. The product name and National Drug Code (NDC) number printed on the container are correct. The affected lot was shipped to U.S. customers between July 2008 and September 2008. No other lots are affected by this recall.

Hospira has not received any reports of adverse health events in connection with the recalled lot. Hospira has identified the root cause of the error and taken action to prevent its recurrence.

Anyone with an existing inventory should quarantine the product immediately and call Hospira Customer Care at 1-877-946-7747 for instructions on how to return it. Customers who have medical questions should contact Hospira Medical Communications at 1-800-615-0187. This recall is being conducted with the knowledge of the U.S. Food and Drug Administration (FDA).

Any adverse reactions experienced with the use of these products, and/or quality problems may also be reported to the FDA's MedWatch Program by phone at 1-800-FDA-1088, by Fax at 1-800-FDA-0178, by mail at MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website at www.fda.gov/medwatch.

FDA: Asthma Drugs Serevent, Symbicort and Foradil Subject of Hearing

The FDA has informed that three popular asthma medicines may increase risks of hospitalization and death in some asthma patients.

The safety of the drugs - Serevent, manufactured by GlaxoSmithKline P.L.C.; Symbicort, made by AstraZeneca P.L.C.; and Foradil, from Novartis AG - will be reviewed by outside medical advisers to the FDA at a two-day hearing next week in Rockville, Md.


A fourth drug, Advair made by GlaxoSmithKline, had no increased risk of respiratory complications, FDA staff said. Advair has about $4 billion in annual sales and is Glaxo's biggest product.

Medical experts will consider the potential risks of all LABAs, including Advair, at the two-day hearing Wednesday and Thursday, will hear presentations by the drugmakers, and will make recommendations. The drugs already carry strong warnings, but the findings next week could lead to more specific instructions for patients.

Souurce here.

FDA: Drugmaker Suggested Off Label Use for Seroquel

Seroquel is indicated for the treatment of both depressive episodes associated with bipolar disorder acute manic episodes associated with bipolar I disorder as either monotherapy or adjunct therapy to lithium or divalproex as well for the treatment of schizophrenia. Seroquel XR is indicated for the treatment of schizophrenia.

The FDA issued a warning letter to AstraZeneca, Seroquel's maker, claiming that a company sales rep recommended or suggested to a healthcare professional an off-label use for Seroquel and Seroquel XR.

The comments, according to the agency, created a new "intended use" for Seroquel and Seroquel XR for which the products lack adequate directions. The FDA said that in addition to the reps oral comments, AstraZeneca sent a mailing to the same health care professional regarding unapproved uses for Seroquel. The agency said these promotional activities and materials misbrand the drugs in violation of the Federal Food, Drug, and Cosmetic Act.

Source here.

Will Preemption Rules be Introduced?

The clock is ticking for lawyers specializing in consumer safety litigation as they wait to see what "midnight regulations" the Bush administration squeaks through before leaving office in January.


There are dozens of rules now under review by the administration that affect everything from prescription drug labeling to water quality to auto roof safety, according to the Office of the Federal Register, the government's official daily publication for rules, proposed rules and notices of federal agencies.

Midnight regulations are last-minute federal rules and regulations that a president issues before leaving office, usually in the last three months of his term.


Defense counsel are counting on the Bush administration to leave behind regulations that offer greater liability protection to manufacturers and less regulation. The plaintiffs' bar fears just that, warning that as many as 21 possible regulations could be a nightmare for consumer safety and the environment.



Pre-emption is front and center. What may show up in the last days of the current President's term:



• A proposed regulation that would require auto manufacturers - for the first time in 35 years - to increase the strength of vehicle roofs. Plaintiffs' lawyers say the roof strength standards are still too low, and that automakers that meet that rule will be granted complete immunity from all lawsuits, according to the AAJ.



• A proposed rule by the U.S. Food and Drug Administration (FDA) to revise warning labels regarding the use of prescription drugs during pregnancy and breast-feeding, and to update them with more detailed information, including clinical trial results.

This rule includes a pre-emption clause, which the AAJ fears will offer drug makers blanket immunity and give injured women no recourse.


• A proposed FDA rule that would shield companies from liability for potentially harmful over-the-counter drug ingredients. The proposed rule changes the status of some ingredients used in over-the-counter drugs, making them subject to additional FDA approval. Once they were approved, manufacturers no longer could be held accountable should the ingredients cause harm, according to the AAJ.

Stay tuned.

Source: Fulton Daily Report.

Is Rieperdal A Concern when used by Kids?

From the WSJ Health Blog:

Concerns about Risperdal use by kids:

One particularly troubling side effect is the growth of breasts in some male patients taking Risperdal. The alleged problem stems from prolactin, a hormone involved in lactation, that can be elevated in males and females who take the medicine. Two minors currently involved in a lawsuit required mastectomies to get rid of their bosoms.

Source here.