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.

Starcaps FDA Recall Notice

Balanced Health Products, Inc. Conducts Voluntary Urgent Nationwide Recall of Starcaps Dietary Supplement Capsules Found to Contain an Undeclared Drug Ingredient


FOR IMMEDIATE RELEASE -- November 26, 2008--- Balanced Health Products, Inc. is voluntarily recalling STARCAPS DIET SYSTEM DIETARY SUPPLEMENT, Lot 12/2011 – 84810, sold in 30 capsule plastic bottles.

The recall is effective immediately and is being undertaken because this lot of STARCAPS contains an undeclared drug ingredient- Bumetanide – a diuretic available by prescription only. Bumetanide is also not listed on the product label as an ingredient in this product.

Bumetanide is a diuretic indicated for the treatment of edema associated with congestive heart failure, hepatic and renal disease including nephrotic syndrome. Bumetanide has been detected in STARCAPS at a level of 0.8mg per capsule. Potential risks associated with the use of Bumetanide include serious and significant fluid and electrolyte loss and an elevation in uric acid concentrations. Consumers should not take Bumetanide if they are allergic to sulfonamides. Significant drug interactions with Bumetanide, such as with digoxin and lithium, may lead to an increase risk of toxicity. Patients may also be at an increased risk of hypotension (low blood pressure), fainting (syncope) and resultant injury if they have normal blood pressure or are already taking an antihypertensive medication and take STARCAPS with undeclared Bumetanide.

The company has received no reports of illness associated with this product.

To date, this recall only applies to Lot 12/2011 – 84810. The company is in the process of testing other lots and will notify the FDA of its results, as well as, if additional lots are to be recalled.

The recalled lot totaling just over 10,000 consumer-size bottles were distributed nationwide from August 2008 to October 30, 2008 through retail outlets and online sales.

Consumers who purchased STARCAPS Lot 12/2011 – 84810 should immediately discontinue their use and return it to Balanced Health Products, Inc at the address on the product label.

Consumers with questions may contact the company at (212) 794-9793 from 10:30am to 4pm EST Monday through Friday.

Consumers who experience adverse events with any lots of this product should seek immediate help from their physician or healthcare provider.

Retail stores are being notified by fax or registered mail to immediately stop all sales and return product to the company.

This recall is being made in cooperation with the US Food and Drug Administration.

Any adverse reactions experienced with the use of this product should 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, HF-410, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website at wwww.fda.gov/medwatch.

Vaginal Sling News-Mentor Ob Tape

Urinary stress incontinence is a common problem for women - some 13 million of them in this country alone - particularly after childbirth and as they age. There are diaper-like products on the market for such women, but many choose to medically correct the problem so they no longer have this inconvenient embarrassment in their life. Imagine their horror when the very procedure meant to help them ends up harming them far worse than the original incontinence. This is what has happened to many women who had the Mentor ObTape Vaginal Sling surgically inserted.

Mentor is a California company that manufactured an ObTape Vaginal Sling, an implanted device that is designed to replace eroded or weakened muscles in the urethra and support the bladder. The problems occur because the material the sling is made of doesn’t allow the tissue where the sling is attached to heal; the material itself prevents the needed nutrients and oxygen from reaching the tissue. Women have suffered infection, scarring, painful intercourse, vaginal discharge, pain, mesh extrusions, abscess, and return of the very condition meant to be rectified by this device – urinary stress incontinence. The complications from the Mentor ObTape Vaginal Sling often required patients to undergo surgery and, unfortunately, often serious and permanent injuries. Mentor’s ObTape Vagina Sling came on the market in 2003, and in less than 3 years was taken off the market. Mentor never stepped up and issued a recall; Mentor simply stopped marketing the Ob Tape in March, 2006, but it never actually recalled the product – Mentor just let it die a slow death.

In October, 2006, the Journal of Urology reported on a study which looked at 67 women who had been implanted with the Mentor ObTape Vaginal Sling. More than 13% developed vaginal extrusions. Others had chronic vaginal discharge, and one patient developed an abscess that led to complications. The most telling part of the study was that none of the control group of 56 women who used another type of vaginal sling experienced the complications seen with the Mentor ObTape Vaginal Sling.

This Mentor ObTape Vaginal Sling tried a new innovative design, which is commendable, but you cannot put a product on the market without adequate testing. Apparently, the ObTape Vaginal Sling pushed into and through the vaginal wall causing tearing, cutting, and sometimes permanent erosion of the vaginal tissues.

ObTape lawyers intend to argue that although Mentor won approval of ObTape from the FDA because it was "substantially equivalent" to slings already on the market, the ObTabe Sling is actually a very different product grounds ObTape was a new and unique product. But the Mentor ObTape Vaginal Sling was different because vaginal slings had historically been made with a mesh design, allowing the sling to breathe and get nutrients to the body’s tissue.

Mentor ObTape Vaginal Sling lawyers will argue to consolidate for discovery purposes the 22 filed Mentor ObTape Vaginal Sling lawsuits in an MDL (basically a class action for discovery purposes). Oral arguments will be held in late November in Charleston, South Carolina.

There are approximately 35,000 women used the Mentor ObTape Vaginal Sling between 2003 and 2006. This means that 7,000 women have potential OBTape Vaginal Sling lawsuits. Why only 22 ObTape lawsuits? Of course, many women have a hard time coming forward because this is such a private issue. There are 13 million women with this problem, yet many – between 50-70% in some studies – do not receive any treatment for urinary incontinence, most likely because of the privacy issues involved (and because they don’t realize how many others – including their friends and family - suffer from the same condition). But I also think many women do not realize that there are ObTape lawsuits pending around the country and there is a great possibility these women will receive the financial compensation they deserve for the Mentor ObTape Sling injuries.

Tech: ReQall - A "Memory" Tool

Playing around with ReQall now.

From their site:

"ReQall is the best memory tool you may ever have, connecting all the ways you communicate in one easy, seamless system. Best of all, reQall works with the technology you already use—nothing to buy, nothing to install."

Worth a look if you have time.

Thanks to Nicole Black, whose blog talked about ReQall here.

Duragesic: Justice in Chicago

My good friends at Heygood, Orr, Reyes, Pearson & Bartolomei received long due justice in a case involving a Duragesic pain patch for a client after a long trial in Chicago.

The story: Janice DiCosolo, 38, of Cicero died on Feb. 15, 2004, while using a Duragesic patch that her doctor prescribed to reduce pain caused by a neurological condition called reflex sympathetic dystrophy.

The mother of three died because the patch delivered a fatal dose of its main ingredient, the powerful narcotic pain reliever fentanyl, according to her family's lawyers.

The jury was told that fentanyl is a painkiller 100 times more powerful than morphine. The patches, prescribed for people combating chronic pain, are to be worn for 72 hours and then discarded. Janice DiCosolo was found wearing one when she died.

At least one lot of Duragesic patches in February 2004 was recalled, a day after DiCosolo died, because of improper sealing of the adhesive backing of the devices, defense lawyer David Sudzus wrote in a court filing. The patch worn by DiCosolo was from that lot, he said.

The jury forewoman, Peggy Rounsfull, 51, of Glenview, said, it was the fentanyl that appeared to have killed DiCosolo.

``There was no way of getting around the fact that she had too much fentanyl,'' Rounsfull said. (Link here)

The Johnson & Johnson units that make and sell the Duragesic pain-killing patch must now pay $16.6 million to the family of a Chicago-area woman.

Vehicle Tires: Time to Replace Them?

From my friend and fellow lawyer Rob Bunch, this article:


With all of the information contained on a tire’s sidewall, it’s no wonder the average consumer has difficulty deciphering it all. While most know how to tell a tire’s size and width, the manufacturer, and the maximum inflation pressure, the tire’s DOT serial numbering system may not be so easy to understand. A tire’s DOT number contains valuable information, especially when a tire was manufactured, but it was never meant to be very consumer friendly and was never meant to be decoded by the consumer. Having the means to tell when a tire was manufactured can mean the difference between safety and catastrophic results.

Some experts believe that tires have a shelf life and ignoring that could be fatal. Tires can sit on store shelves for years before they are sold; sometimes as long as five years; each can still be sold as new tires. There is no expiration date on tires, but research and tests show as tires get older, even if they haven’t even been driven a mile, the tires may begin to dry out, and the degradation process starts to take place.

After six years of age, tires can become unreliable or even dangerous. Tires may look great on the outside, but not much is known about what is going on inside the tire. After a time, tires begin to dry out and become less elastic even if they are not in use, making tread separation more likely even if they have plenty of tread depth and appear new. When a tire detreads at highway speeds, it becomes difficult if not impossible to retain control of a vehicle.

For decades, the tire industry has taught drivers to use the so-called “penny test” as a way to tell when a tire needed to be replaced. As late as last summer, they have recommended that the “penny test” is outdated, compromises safety, and should give way to the “quarter test.” Why not arm consumers with the knowledge of determining when their tires were manufactured by decoding the DOT serial number and then recommend that they replace them at a certain age, no matter what the tread depth? Or better yet, why not imprint an expiration date on the tires?


The U.S. tire industry has fought efforts to require an expiration date on tires. The industry says, given the improvements in tire production, age is not a key factor in a tire’s performance. However, the British Rubber Manufacturer’s Association issued a forceful warning to its British consumers stating “BRMA members strongly recommend that unused tires should not be put into service if they are over 6 years old . . .”. This is something that would come as news to most U.S. car owners, but seems to be known by everyone but the American consumer. In fact, the head of the U.S. Rubber Manufacturers Association has gone on record saying that there is no need for U.S. drivers to be given the same warning that British car owners have received.

U. S. car manufacturers have been warning their customers for years about the problems with aging tires. In fact, Ford Motor Company has asked the federal government to impose a 6 year age limit or expiration on tires.

So just how do you tell when your tires were manufactured? Begin by locating the DOT number on the sidewall of your tire. Up until last year, the DOT number was molded on the inside of tires, making it extremely difficult to locate. To read it, the consumer either had to put their vehicle on a lift or crawl under it with a flashlight to find it. Once you have located your DOT number, identify the 3 or 4 numbers at the very end of the serial number. If a tire has three numbers, it means that the tire was made prior to January 2000. If a tire has four numbers, it indicates that the tire was manufactured after January 1, 2000. The first two numbers in the date of manufacture indicate the week in which the tire was made.

I your tire has 036 as the last three digits of your DOT number, it indicates that the tire was manufactured in the third week of 1996. If your tire has 4604 as the last four digits of your DOT number, it indicates the tire was manufactured in the 46th week of 2004. Experts urge motorists to check their tires’ manufacturing date and replace them after six years of age.

Voluntary Recall of Potentially Oversized Tablets Expanded

From the medical news site www.medpagetoday.com:

ETHEX Corporation announced the voluntary recall of lots of five generic medications because they may contain more than the labeled amount of active ingredient, the FDA said.

The recall applies to 150-, 225-, and 300-mg propafenone HCl tablets, 30- and 60-mg isosorbide mononitrate extended-release tablets, 15-mg morphine sulfate extended-release tablets, 15- and 30-mg morphine sulfate immediate-release tablets, and 10-mg dextroamphetamine sulfate tablets.

Overdoses of all four of the drugs can have serious and life-threatening complications, according to an FDA press release announcing the recall.

These include arrhythmias and low blood pressure with propafenone HCl, fainting and low blood pressure with isosorbide mononitrate, respiratory depression and low blood pressure with morphine sulfate, and rapid heart rate and high blood pressure with dextroamphetamine sulfate, the agency said.

Earlier this year, the drug maker voluntarily withdrew three lots of 5-mg dextroamphetamine sulfate tablets and 60-mg morphine sulfate extended-release tablets. (See: Dextroamphetamine Sulfate Tablets Recalled)

The following lots are involved in the current recall and were shipped before May 22:

* 150-mg propafenone HCl tablets (73761, 78184, 79373, 81240, 81241, 81242, 83470, 84357, 90525, and 90526 with expiration dates ranging from 3/2009 to 3/2011)
* 225-mg propafenone HCl tablets (71720, 74831, 76014-15, 81243-45, 89731, 90527-29, and 90657 with expiration dates ranging from 3/2009 to 2/2011)
* 300-mg propafenone HCl tablets (72834, 76016-18, 81246, 89092, 89732, 90530, 90532, and 91641-42 with expiration dates ranging from 6/2009 to 3/2011)
* 30-mg isosorbide mononitrate extended-release tablets (62355, 66423, and 68102 with expiration dates ranging from 11/2008 to 8/2009)
* 60-mg isosorbide mononitrate extended-release tablets (63466, 66034, 67351, and 67354 with expiration dates ranging from 12/2008 to 11/2009)
* 15-mg morphine sulfate extended-release tablets (81175, 82514-16, 89660, 89664, 89667, 90249-51, and 91687 with expiration dates ranging from 12/2008 to 2/2010)
* 15-mg morphine sulfate immediate-release tablets (77852-54, 81746, 82519-20, 84113, and 90276-78 with expiration dates ranging from 9/2009 to 1/2011)
* 30-mg morphine sulfate immediate-release tablets (75093, 77855-57, 82297, 82521-22, 87239, 88925, and 90288-98 with expiration dates ranging from 8/2009 to 3/2011)
* 10-mg dextroamphetamine sulfate tablets (73934, 75892, 77945, 81137, 86320 with expiration dates ranging from 6/2009 to 5/2011)

Source here.

The Internet, Clients and My Law Office

This recent report caught my eye:

A report, released in August, says 40% of people 50 to 64 years old and 27% of adults 65 and older are getting information online every day, compared to about 55% of those 18 to 49. The study surveyed 2,251 adults 18 and older from April 8 to May 11 of this year. Source here.

Does your law office make an extra effort to gather your clients' emails? We have done so, aggressively, this year. The result? I am now seeing a decrease in postage and copy costs. I filed a lawsuit for a client, and when we received a "Notice of Removal" on the matter, simply emailed it to her. No need to copy and send 125 pages. We explained it in detail in an email PDF letter, asked her to call, and spoke at length. In that one case, we probably saved the client $20 just on one mailing. Now, multiply that over a typical caseload, and you have substantial (to me) savings to the client.

I've sent settlement papers, updates and other papers to client over the age of 65. All appreciate the ease of email. Informally, nearly 2/3rds of our clients over the age of 50 in our office now have and use email.

Are you doing all you can to gather your client's emails?

Relion Syringe Recall

From the FDA:

FDA is urging patients and health care professionals to check packaging carefully for syringes labeled as 100 units for use with U-100 insulin from lot number 813900.

The recall applies to the following product information:
-- ReliOn 1cc, 31-gauge, 100 units


The syringes were distributed by Can-Am Care and sold only at Wal-Mart stores and Sam's Clubs.

Recalled syringes should be returned to a local Wal-Mart or Sam's Club pharmacy for a replacement.

Consumers and health care professionals who suspect they have the recalled product are asked to call toll-free at (866) 780-5436 or go to www.relion.com/recall.

The Tyco Healthcare Group LP (Covidien) is recalling ReliOn brand syringes because they may lead to patients receiving an overdose of as much as 2.5 times the intended dose. An overdose of insulin can lead to hypoglycemia, serious health consequences, and even death.

My Law Partner's Verdict For The Little Guy: $2.298Million

One of my law partners just completed a retaliatory discharge case in Alabama involving Dollar General.

A retaliatory discharge claim against an employer is generally allowed where an employee has been fired for exercising a right under state law, or the discharge of the employee violate public policy.

The former employee was allegedly fired from Dollar General after she reported an injury. Joey James said: "My client proved that Dollar General has a company policy that fines its’ managers $7500 for every employee injury reported from their store. The money comes straight out of the manager’s yearly bonus check.”

The former Dollar General employee hurt her hand on the cash drawer. It then became infected and her arm had to be amputated. Dollar General denied her worker's compensation claim three days after her arm was amuptated.

The jury deliberated less than three hours before reaching the $2,298,000 verdict.

This to me is a clear victory for all working men and women.

Preemption Before U.S. Supreme Court

A good piece on the WSJ Law Blog regarding the Levine v. Wyeth case, which is front and center on the preemption issue.

Preemption simply stated is the position that FDA approval of a drug supercedes state law claims challenging safety, efficacy, or labeling. Drugmakers and the FDA argue preemption exists by maintaining the agency’s actions are the final word on safety and effectiveness. The court’s decision, therefore, is being closely watched because its ruling will determine whether patients can sue a drugmaker through state law when a product has already been approved by the FDA.


In part from the WSJ Blog:

"At the center of the case is the delivery technique for an antihistamine called Phenergan. Diana Levine, the plaintiff, sought treatment for nausea. Clinicians administered Phenergan using a delivery technique called “IV push,” as opposed to “IV drip.” As a result, Levine, a guitar player, developed gangrene in her arm, which eventually required its amputation. Both Wyeth and the FDA were aware that the “IV push” risked inadvertent arterial injection and gangrene, but the FDA nevertheless approved labeling for Phenergan that warned against – but did not prohibit – IV push administration. (For more background, go to Scotus blog.) Superior court in Vermont had instructed a jury that the label’s compliance with FDA regulations did not establish its adequacy when considering Wyeth’s negligance. The jury awarded Levine more than $6 million in damages. "

Go here for more.

From various sources, it looks like the justices took issue with Wyeth’s argument that it couldn’t update its label to add stronger warnings without first getting FDA approval. “Wyeth could have gone back to the FDA anytime” to update the label, Justice David Souter said. “And it simply didn’t do it.” Source.


You can also read the transcript of the argument here.

Avandia Update: Consumer Group Seeks Ban of Drug

The government should ban the diabetes drug Avandia because of a wide variety of life-threatening risks, including heart and liver damage, a consumer group said Thursday.

The consumer group, Public Citizen, filed a petition with the Food and Drug Administration to have Avandia taken off the market.

"The FDA is in possession of clear, unequivocal evidence that (Avandia) causes a wide variety of toxicities," Public Citizen said in its petition. "Many of these are life-threatening, such as heart attacks, heart failure (and) liver failure.

Links: Here and here.

Fen Phen Verdict - Primary Pulmonary Hypertension

From Bloomberg.com:

A recent verdict regarding Wyeth's Pondimin drug resulted in a decision that the cause of Gloria Stribling's primary pulmonary hypertension was caused by Fen Phen. The trial loss was Wyeth's first in four years in a case involving the often-fatal illness.

Wyeth sought to resolve most fen-phen users' claims through a $3.75 billion national settlement program. The accord didn't cover people stricken with the fatal lung disease.

For more, go here.

1 Million Cribs Recalled

The recall announced by the U.S. Consumer Product Safety Commission involved older cribs that are no longer on the market but are often reused by families or sold at resale shops and online at sites such as Craigslist. The recall covered cribs sold in the U.S. from 1995 to 2007 by Delta Enterprise, the largest distributor of cribs in the world.


Delta is recalling all cribs with the “Crib Trigger Lock with Safety Peg” drop side hardware design. When the safety pegs are missing from the lower track, the crib locks can disengage and detach if lowered below the peg hole, creating a hazardous gap which can lead to entrapment and suffocation.

The model numbers for the recalled Delta cribs with the "Crib Trigger Lock with Safety Peg" drop side hardware are: 4320, 4340, 4500, 4520, 4530, 4532, 4540, 4542, 4550, 4551, 4580, 4600, 4620, 4624 (production dates 01/06 through 11/07), 4640, 4660, 4720, 4735, 4742, 4750 (production dates 01/95 through 12/00), 4760, 4770, 4780, 4790, 4820, 4840, 4850, 4860, 4880, 4890, 4892, 4900, 4910, 4920, 4925-2, 4925-6, 4930, 4940, 4943, 4944, 4947, 4948, 4949, 4950, 4958, 4963, 4968, 4969, and 4980.

The recalled cribs have date codes ranging from 1995 though December 2005; one model (4624) was made in 2007. The model numbers are located on the top of the mattress support board. The cribs, made in Taiwan and Indonesia, were sold at major retailers, including WalMart, Kmart, and Target.com from January 1995 through September 2007 for about $100 and may also have been sold secondhand.

Go to the Delta site for more.
http://www.cribrecallcenter.com/

Total Body Formula Litigation: MDL is in AL

In the Total Body Formula lawsuits, the MDL for all of the litigation, including the Total Body Class Action, will be Birmingham, Alabama. Judge Proctor drew the cases.

The Transfer Order may be found here. (PDF Alert)

Expect an initial hearing in Birmingham soon.

New Blog: Georgia Justice Blog

You may find it here. http://georgiajustice.blogspot.com/

What is it? It's the blog from the Georgia Trial Lawyers Assoc. The most recent post starts with a recap of this:

A Great Escape and a Great Man
The Georgia Trial Lawyers Association honors Judge Anthony A. Alaimo

Atlanta, GA—Hailed as what will be the largest gathering of judges and attorneys in the history of the state of Georgia, the Georgia Trial Lawyers Association [GTLA] is hosting The Height of Excellence—an event honoring excellence in Georgia’s judiciary and where Judge Anthony A. Alaimo, a Senior United States District Court Judge of the Southern District of Georgia, will be the first recipient of the inaugural Anthony A. Alaimo Award for Judicial Excellence.

“It is very appropriate that the first award given by the members of GTLA for judicial excellence carries the name of Judge Anthony A. Alaimo and that he will be the very first recipient,” said GTLA President Fred Orr. “Judge Alaimo, at age 88, remains one of the hardest working judges in the entire country. He is among the most beloved and respected judges of the federal judiciary. He is a true American Hero.” More on their site.

It's worth reading, and worth adding to a blogroll.

Pfizer Settles Bextra and Celebrex

From various sources:

Pfizer has announced that is has offered a total of $894 million to settle heart attacks, strokes, and other damages caused by its painkillers Bextra and Celebrex.

According to Pfizer, the settlement ends about 90 percent of the 7,000 personal injury lawsuits brought by those who were allegedly hurt by the painkillers.

The proposed settlement also would ends lawsuits filed by insurers and patients looking for reimbursement for the money they spent on Bextra and Celebrex, as well as claims by state attorneys general over Pfizer’s improper promotion of Bextra.

The AP link is here.

FDA Regulators Missing Deadlines

From Reuters:

Several U.S. deadlines for reviewing new drugs have come and gone without a decision from the FDA. Here is a partial list:

Prasugrel, a blood thinner from Eli Lilly and Daiichi Sankyo. A decision was due Sept. 26. The application remains pending.

Promacta, a drug for a clotting disorder. The deadline was Sept. 19. No decision has been made.

For more go here.

FOIAs Reveal How Bush Administration Made Complete Immunity for Negligent Corporations a Top Priority

From the AAJ:

"In a stealth effort coordinated at the highest levels of the Bush administration, multiple federal agencies were repeatedly ordered to usurp state law and undermine consumer protections, according to documents obtained through repeated FOIA requests by the American Association for Justice (AAJ). The documents released today detail how helping corporations escape accountability for dangerous products has been the administration’s top priority.

“This is the real Bush legacy,” said AAJ President Les Weisbrod. “In effect the Bush administration made the safety of Americans secondary to corporate profits.”

The FOIA documents detail a Bush regulatory strategy called preemption. In short, the Bush administration has decided that federal rules should usurp – or preempt – the rights of states to protect their citizens with stricter safety standards. In turn, consumers can no longer use the state protections when harmed by negligence or misconduct, giving total immunity to corporations instead.

AAJ has tracked how the administration’s first attempts to preempt states rights utilized friend-of-the-court briefs on behalf of corporations in civil justice cases. After only mixed success, the administration then shifted strategies, targeting instead regulatory agencies in charge of product safety oversight. Beginning in 2005, carbon copy statements claiming that federal agency rules preempt state law began surfacing in the “preambles” of regulation issued by the federal government, and in some cases in the body of the final rules themselves. Because the courts have not yet conclusively determined whether preambles carry the full weight of law, corporations have a new legal theory on which they can argue in product liability cases.

“Unelected federal regulators are now claiming that states can’t protect their own citizens with stronger consumer protections,” Weisbrod added. In an upcoming Supreme Court case, 47 state attorneys general filed a brief arguing the FDA is breaking with historical precedent. In fact, in their brief they urge the U.S. Supreme Court to uphold a Vermont Supreme Court ruling that state law forces a drug manufacturer to pay $6.8 million to a Diana Levine, whose arm had to be amputated after she was injected with an improperly-labeled Wyeth drug.

Since 2005, seven federal agencies have issued over 60 proposed or final rules with preemption language in the preamble. During the past year, AAJ submitted numerous FOIA requests that prove the Office of Management and Budget (OMB) had direct involvement in the placement of the “complete immunity” preemption language. In an earlier request, OMB responded that there were no documents. However, emails recently obtained from the individual agencies prove that OMB did indeed discuss preemption with agencies, and in some instances OMB officials wrote the language.

Given this discrepancy, AAJ submitted an expanded request for OMB documents. On September 26, 2008, OMB responded it had identified 146 documents, but refused to release any of them, saying that “the disclosure of these documents would not be in the public interest.”

In piecing together the emails from the FOIAs, AAJ uncovered the cozy relationship between federal officials and the industries they regulate. For example, the pharmaceutical industry intensified its efforts to influence the FDA in the months leading up to the physician labeling rule’s release on January 24, 2006. Much of the lobbying efforts were aimed at Sheldon Bradshaw, who had succeeded Daniel Troy as FDA chief counsel in April 2005.

AAJ obtained emails that list attendees of a meeting between Bradshaw and the Pharmaceutical Research and Manufacturers of America (PhRMA) revealing the FDA chief counsel met with legal representatives from Pfizer, Wyeth, Eli Lilly, Berlex, Organon, Abbott Laboratories, Takeda, Sanofi-Aventis, Serono, AstraZeneca, Cephalon, Millenium, Eisai, Amgen, Astellas, GlaxoSmithKline, Bristol Myers Squibb, Johnson & Johnson, Novartis, Merck, and 3M.

Less than six months after this meeting, the agency would release its final physician labeling rule with complete immunity preemption language in the preamble, a complete about-face from the language in the proposed rule that specifically said the agency did not intend to preempt state law with the rule.

“Big business lobbyists have been on a crusade to destroy state consumer protection laws, and further stack the deck against American consumers,” said Weisbrod."

Vioxx Study: Heart Risks Last Nearly One Year

From various sites:

A long-term analysis of people who took the arthritis drug Vioxx confirms it doubles the risk of strokes and heart attacks. The risk seems to decline a year after people stop taking it. And other drugs in the same class of painkillers known as Cox-2 inhibitors may cause similar harm. Link here. The study may be found in the journal known as The Lancet. Vioxx articles are linked here.

Price Gouging Update: GA does nothing, FL getting results

Just after Hurricanes Gustav and Ike wreaked havoc, I posted on price gouging going on in Florida and Georgia.

It's been about a month. What has happened?

Florida:

A Florida gas station accused of price gouging after Hurricane Ike has agreed to reimburse anyone with a receipt who was overcharged for gasoline, under a settlement with the state attorney general.

Kelly Junior #9, a gas station in Quincy, Fla., will also pay the American Red Cross $2,000 under terms of the agreement and pay the costs of the state's investigation into the price gouging.

The price of unleaded gasoline at Kelly Junior #9, individually owned by S and K of Quincy, Inc., increased twice on September 12, starting at $3.99 and ending at $4.29.

That's one of 4,000 being investigated.

Georgia:

Nearly 150 Georgia gas stations are having to defend why they charged inflated prices after Hurricanes Gustav and Ike made fuel scarce over the past month.

The state has subpoenaed sales records from businesses following complaints from 1,500 customers angry over what they were paying at the pump. State officials received reports of gas as high as $9.99 a gallon for regular unleaded, said Bill Cloud, spokesman for the Governor's Office of Consumer Affairs.

He said his office is still getting a few dozen calls a day about gas prices.

One station in Cobb County was charging $8.82 a gallon, and a Houston County gas station was asking customers to pay $7 per gallon, Cloud said.

Source here.

How many will ultimately be found to have gouged GA consumers? Does it really take a month to figure out that charging $9.99 is gouging?

Eli Lilly to pay $62 million in Zyprexa settlement

From Reuters:

Lilly, has settled Zyprexa claims for $62 million. Zyprexa is Lilly's biggest product, with global sales of $4.76 billion in 2007.

The settlement with 32 states and the District of Columbia ends an 18-month investigation of the Indianapolis-based company, which had been accused of promoting the drug for unapproved off-label uses and of playing down side effects such as weight gain, which can increase the risk for diabetes.

Source here.

Total Body Formula Lawsuit: State Court Hearing 10/13/08

On Monday October 13, 2008 at 9:00 a.m. in Decatur, GA Judge A. Wong will hold the first hearing on cases involving folks who claim they were injured by a supplement known as Total Body Formula and Total Body Mega Formula.

I and others will attend. Judge Wong will consider a proposed Case Management Order on the currently filed cases.

Stay tuned.

Raptiva Brain Link?

From Bloomberg:

A patient taking its drug for chronic psoriasis, Raptiva, has developed a rare brain infection.

The infection, progressive multifocal leukoencephalopathy, or PML, was linked to a 70-year-old who received Raptiva for more than four years.

For more go here.

More Misleading Pharma Ads (FDA sez)

The FDA sent letters to Lilly, J&J, Novartis, Shire, and Covidien' Mallinckrodt with complaints about certain promotions.

Shire drew objections for a webpage and video testimonial posted on YouTube featuring television celebrity designer Ty Pennington. Both overstated the efficacy of Adderall XR, and the video left out important risk information, the FDA said.

Go here for the source.

FDA Analysis Shows Cholesterol Lowering Medications Do Not Increase the Risk of "Lou Gehrig's Disease"

From the FDA site:

A U.S. Food and Drug Administration's analysis provides new evidence that the use of statins does not increase incidence of amyotrophic lateral sclerosis (ALS), a neurodegenerative disease often referred to as "Lou Gehrig's Disease." The analysis was reported on Monday, Sept. 29, 2008 in Pharmacoepidemiology and Drug Safety.

"The FDA's review, which began in 2007, is an example of the agency working to analyze products - throughout their lifecycle - to keep health care professionals and patients informed of new and emerging safety data," said Mark Avigan, M.D., director, Division of Pharmacovigilance I, Center for Drug Evaluation and Research, FDA.

The FDA analysis, undertaken after the agency received a higher than expected number of Adverse Event Reporting System reports of ALS in patients on statins, is based on data from 41 long-term controlled clinical trials. The results showed no increased incidence of the disease in patients treated with a statin compared with placebo.

Statins -- HMG-CoA-reductase inhibitors -- are the most commonly-prescribed medications to treat elevated cholesterol levels in the United States. ALS is a fatal neurodegenerative condition with an overall annual incidence of 1 to 2 per 100,000 people in the general population. The incidence of ALS increases with age.

Statins have also been shown to reduce the risk of heart disease in a wide variety of patients. Based on currently available information, health care professionals should not change their prescribing practices for statins and patients should not change their use of statins.

More here.

Georgia Federal Court: Recent Daubert Ruling

You can see it by going to Slideshare.net. The nutshell version: Daubert should only apply to junk science.

Daubert Order GA Law

View SlideShare document or Upload your own. (tags: georgia law)

Zimmer Hip Cup Recall

Zimmer Holdings, the largest producer of orthopedic devices in the United States, recently halted sales of a hip replacement implant which has been failing in unacceptably high numbers. The Durom Cup hip socket implant, introduced by Zimmer in 2006, has been implanted in over 13,000 patients across the nation. Of those, doctors say that hundreds will most likely need to undergo more expensive and painful surgery to replace the replacement.

Over 5% of patients implanted with the Zimmer Durom Cup hip replacement experience serious problems, according to research conducted by the company and orthopedic surgeons. In these patients, the metal hip implant fails to bond properly with the existing bone structure. Instead, the metal socket loosens and separates, grinding painfully against bone as it moves.

Although Zimmer Holdings was alerted to problems with its Durom Cup hip replacement as early as 2007, it did not launch an investigation until April 2008, and did not cease its sales of the defective device until July 2008. Because of the company’s delay, even more unsuspecting patients were implanted with the faulty Durom Cup hip replacement. Each may need hip replacement surgery, which is a lengthy and expensive procedure, costing anywhere from $30,000 to $40,000.

The Zimmer Durom Cup Hip Implant – A Timeline

2006 – The Zimmer Durom Cup hip implant is introduced. A metal hip socket replacement originally designed for a 15- to 20-year lifespan to accommodate young, active patients, the Durom Cup implant begins to show signs of trouble not long after its debut.

2007 – Prominent orthopedic surgeon Dr. Lawrence Dorr, alerts Zimmer Holdings, the implant’s manufacturer, after noticing that the Zimmer hip replacement implant has an abnormally high failure rate. Dorr states that many of his patients return to his office complaining of extreme pain only months after undergoing hip replacement surgery. Despite Dorr’s extensive experience, Zimmer Holdings blames the implant failures on Dorr’s surgical technique and brushes the warning aside.

2008 – In April, Dr. Dorr goes public with his concerns, warning other orthopedic surgeons against using the Durom Cup hip implant. Zimmer responds by launching an investigation, but refuses to take any further action for months. In July 2008, after its own investigation reveals an implant failure rate of over 5%, Zimmer suspends sales of the device but promises to resume business after doctors are trained to ‘properly’ install the implant.

Ex-Medtronic Lawyer: Company took Docs to Strip Club

From the Minneapolis paper:

'A whistleblower lawsuit against Medtronic Inc. that highlighted perks allegedly paid to doctors was filed by one of the company's lawyers, according to a report today in the Wall Street Journal. The legal action was ultimately settled in 2006 for $40 million.'

The suit, filed by former senior legal counsel Ami P. Kelley, claimed that the company lavished spine surgeons with a variety of incentives to use its products, including regular entertainment at a Memphis strip club, trips to Alaska and patent royalties on inventions they played no part in.

Link.

OK, so why does this matter? Senator Grassley has been investigating such activities to determine if the perks offered by Medtronic to doctors induce them to use the company's spine products in "off-label" ways not approved by the Food and Drug Administration (FDA). The FDA has warned that surgeons' off-label use of a Medtronic bone graft called Infuse has led to potentially life-threatening side effects in dozens of patients.

The Infuse Bone Graft has been claimed to cause complications when used in surgeries on the cervical spine, or the area around the neck. The bone protein is approved for use in a variety of spinal, oral and dental graft procedures, but the paper reported that Infuse has been linked to complications when used in "off-label" procedures, or operations for which is has not specifically been approved.

Earlier this summer, the FDA warned doctors that it could cause dangerous complications when used in neck surgeries. The complications included swelling that caused difficulty in swallowing, breathing and speaking, which in some cases lead to tracheotomies and further surgeries. Source here.

Spirivia and Atrovent Slammed by JAMA

So says Medline Plus. You can access the JAMA abstract here.

The drugs Spirivia and Atrovent are prescribed for chronic obstructive pulmonary disease (COPD), and according to a recent report, each is associated with an increased risk of heart attack, stroke and other cardiovascular problems.

Spiriva and Atrovent are the most commonly prescribed once a day drug for treatment for COPD.

Chronic obstructive pulmonary disease (COPD) is a lung disease in which the lungs are damaged, making it hard to breathe. In COPD, the airways—the tubes that carry air in and out of your lungs—are partly obstructed, making it difficult to get air in and out.

Cigarette smoking is the most common cause of COPD. Most people with COPD are smokers or former smokers. Breathing in other kinds of lung irritants, like pollution, dust, or chemicals, over a long period of time may also cause or contribute to COPD.

The airways branch out like an upside-down tree, and at the end of each branch are many small, balloon-like air sacs called alveoli (al-VEE-uhl-EYE). In healthy people, each airway is clear and open. The air sacs are small and dainty, and both the airways and air sacs are elastic and springy. When you breathe in, each air sac fills up with air like a small balloon; when you breathe out, the balloon deflates and the air goes out. (See the How the Lungs Work section for details.) In COPD, the airways and air sacs lose their shape and become floppy. Less air gets in and less air goes out because:

* The airways and air sacs lose their elasticity (like an old rubber band).
* The walls between many of the air sacs are destroyed.
* The walls of the airways become thick and inflamed (swollen).
* Cells in the airways make more mucus (sputum) than usual, which tends to clog the airways.

Source.


There was a 58 percent increased risk of cardiac death, heart attack or stroke in people taking these drugs according to Dr. Sonal Singh, assistant professor of internal medicine at Wake Forest University Baptist Medical Center in Winston-Salem, N.C. Singh was lead author of a paper published in the Sept. 24 issue of the Journal of the American Medical Association.

Medline Plus link is here.

Total Body Formula Update: MDL Hearing in Boston 9/25

Our office is investigating claims of people who were hurt by a recalled dietary supplement called Total Body Formula.

On September 25, 2008, one of my law partners will be attending a Federal Court hearing in Boston that will address a request to centralize the USDCT court cases in one court. The process is referred to as Multidistrict Litigation, or "MDL."


Multidistrict litigation is a procedure utilized in the federal court system to transfer to one federal judge all pending civil cases of a similar type filed throughout the United States. The decision whether cases should be transferred is made by a panel of seven federal judges appointed by the Chief Justice of the United States Supreme Court. The Judicial Panel on Multidistrict Litigation meets periodically to review requests that cases be consolidated for pretrial matters pursuant to 28 U.S.C. § 1407

Some folks I have spoken with have asked if the MDL Court is the same as a class action - it is not.

Although class actions may be transferred to an MDL consolidation in the same manner as single plaintiff cases. For cases to be treated as proper for an MDL, however, consolidation the Panel must find they one or more common questions of fact. Since commonality is also an required element for a class action, class actions are frequently litigated in MDL proceedings.

As to the Total Body Formula litigation, each Defendant would like the cases heard in Alabama. Others have asked for an MDL Court in FL or LA.

Stay tuned.

Tarceva: Two Deaths from Hepatorenal Syndrome

The FDA has reported that the makers of the cancer drug erlotinib (Tarceva) have reported two deaths -- one from hepatorenal syndrome and one from rapidly progressing liver failure -- among patients taking the agent.

As a result of the deaths, OSI Pharmaceuticals and Genentech, the makers of the epidermal growth factor receptor inhibitor, are revising the label to include new warnings about both liver and kidney risks.

They added a warning about the need for extra caution when using the drug in patients with hepatic impairments (total bilirubin less than upper limit of normal or Child-Pugh A, B, and C).

The label will recommend stopping the drug if "changes in liver function are severe such as doubling of total bilirubin and/or tripling of transaminases in the setting of pretreatment values outside normal range."

Additionally, the precaution about hepatoxicity has been updated and moved to the warnings section from the precaution section of the label. Now it will state that erlotinib dosing should be interrupted or discontinued is total bilirubin is greater than three times the upper limit of normal and/or transaminases are greater than five times the upper limit of normal in the setting of normal pretreatment values.

And a precaution about renal failure was also moved to the warnings section and has been updated to include a warning about hepatorenal syndrome.


Erlotinib is approved for monotherapy of locally advanced or metastatic non-small-cell lung cancer. It is also approved in combination with gemcitabine (Gemzar) for first-line treatment of locally advanced, unresectable, or metastatic pancreatic cancer.

Source here.

Tech: Using Rocket Dock

Rocket Dock is a free Mac dock "clone" that anyone is able to use on a Windows-based PC or notebook. Most desktops including mine are loaded up with junk. The Rocketdock I now use has just a few icons - Mozilla, a database icon, an icon for my WP system.

It's free and easy to use. Go here to get it.

You can also view the video how to here.


RocketDock 1.3.0 Final! - Watch more amazing videos here

FDA News: Rituxan

From the FDA:

Genentech has informed healthcare professionals of revisions to prescribing information for Rituxan regarding a case of progressive multifocal leukoencephalopathy (PML) leading to death in a patient with rheumatoid arthritis who received Rituxan in a long-term safety extension clinical study. PML is a brain infection and had already been noted on Rituxan's label as a possible risk.

The patient developed a JC virus infection with resultant PML and death 18 months after taking the last dose of Rituxan.

Healthcare professionals treating patients with Rituxan should consider PML in any patient presenting with new onset neurologic manifestations. Additionally, consultation with a neurologist, brain MRI and lumbar puncture should be considered as clinically indicated.

You can find the Dear Doctor letter here. (PDF)

Atrovent News: Increased Risk for Cardiovascular Death

In patients with COPD, an anticholinergic drug used to prevent bronchospasm, ipratropium bromide (Atrovent)increased the risk of cardiovascular death, researchers here reported.


A nested case control study found that ipratropium use was associated with a 34% increase in risk of cardiovascular death (OR 1.34, 95% CI 1.22 to 1.47), according to Todd A. Lee, Pharm.D., of Hines VA Hospital in Hines, Ill., and colleagues.

Additionally, theophylline exposure was associated "with a statistically significant increase in respiratory deaths compared with the unexposed group (OR 1.71, 95% CI 1.46 to 2.00)," they wrote in the Sept. 16 issue of Annals of Internal Medicine

For more, go to this Link

Gas Prices: Gouging in Hurricane's Wake?

In Georgia as in many parts of the country people saw a run on prices for gasoline. In turn, many of us (including yours truly) were angered by what seemed to be gouging at the pumps. It's not just me; even a County Sheriff thinks so.


In Florida:

Florida’s agriculture and consumer services commissioner said Monday that he is issuing subpoenas for financial information from 16 major oil terminals in Florida. The subpoenas, which were being hand-delivered to the terminals on Tuesday, seek records to determine whether any of them illegally increased the wholesale prices that were passed on to retail gas stations and, ultimately, customers. Link.

In Georgia, will a GOP Governor take any action? From a TV station's website:

"The [Georgia] Governor's Office of Consumer Affairs reported they have had 140 official complaints about price gouging of gasoline, and 48 businesses have been put on notice that they will be investigated.

The GOCA is are faxing out these warnings of Georgia law to businesses.

In my neighborhood, 1 station went from $3.69 to $4.29 in five hours. In another Atlanta suburb station, the price jumped to nearly $6. No, that's not gouging is it.

Officials say their phones have been busy all day taking complaints, but they are urging Georgians who think they have been the victim of price gouging to report violators. Dougherty County's Sheriff thinks price gouging has happened, and his deputies are keeping records."

Note to the Georgia Governor: We're watching. Florida will punish those who clearly gouged --- will Georgia hold those who did accountable?

Tech: Secure Instant Messaging for a Law Office

In my office we rely on technology in many areas, including Instant Messaging ("IM"). What is it? IM is a text-based computer conference over the Internet between two or more people who must be online at the same time; Unlike email instant messaging software allows you to 'talk' to someone in real time by typing and receiving messages.

Why do we use it? I have two offices with multiple folks assisting on various projects and files. It's too cumbersome to read 100+ emails a day. Also, phone calls back up, and intercom use is too disruptive. Thus, IM.

For many, IM has been through AOL or Yahoo. I wanted to have control over IM, have it occur in a closed environment, and I wanted it to be either cheap or free. I may have found the solution.






24im.com is what we are trying. From their site, you will see the service provides:



Enterprise Instant Messaging

Presence Management

Project management

Department directories

Guest user access

Broadcast messaging

Group activity feed

Web-based or desktop access and

Role based administration

The messaging is encrypted. I like it a lot, and will test it fully for bugs and ease of use. Stay tuned.

9/11/08: Voices To Bring 9/11 Museum Relics To Life

As I sit down to write this blog post, I noticed that coincidentally this is post 911 on my blog ....

From CBS.com:

The artifacts awaiting their place in the Sept. 11 museum sit in storage - crushed emergency vehicles, dust-covered purses, a giant steel column covered with victims' pictures. Now, voices will bring them to life.

There's the recorded voice of FDNY retiree Peter Bondy, who put Sept. 11 firefighter Jonathan Ielpi's picture on the 62-ton "last column" at the ruined World Trade Center site in 2002.

And John Abruzzo, a quadriplegic, telling how he was carried down 69 stories of the north tower by his colleagues in a special wheelchair.

And Michele and John Cartier, siblings talking about how they found each other in the chaos before the towers fell, and about their brother, James, who did not make it out.

These are among hundreds of Sept. 11 stories - taped remembrances, even podcasts playing on the Internet - being collected by museum planners who want to connect physical relics of the nation's worst terrorist attack to memory.



They hope the multimedia library - already containing more than 800 oral histories - will have special meaning in what has already become one of the most exhaustively documented events ever.

For more, go here.

I'll never forget ... will others?

Drug Ads Subject of FDA Web Site for Consumers

From a Yahoo Press Release:

"EthicAd, a nonprofit organization devoted to improving public health through consumer education, announces the launch of a new FDA Web site created to help the general public better understand direct-to-consumer (DTC) advertising of prescription medications. The site, "Be Smart About Prescription Drug Advertising," is hosted by the FDA's Center for Drug Evaluation and Research and was developed by the FDA in partnership with EthicAd."

The site is here.

FYI: Lemon Law Blog

Came across the Lemon Justice Blog: http://www.lemonjustice.com/blog/

Worth a read. Here is one post:

Car Complaints: The Dubious Honors Go To …

We’ve been discussing the 2008 cars that made their way to the top of the Center for Auto Safety’s Car Complaint Index. We’ve wound our way through Volkswagens, Jeeps, and even a Lexus.



Today, we’re covering the vehicles that had the highest ratio of complaints (to the National Highway Traffic Safety Administration) to the number of cars sold.

Coming in second on the list of most complaints… the Dodge Nitro.

One consumer who had leased a Nitro had a nightmarish tale to tell the NHSTA. He wrote, “My wife routinely started the Nitro, put her foot on the brake (and not the gas), and engaged the gear from Park to Reverse. Within a split second, the car made an unusually loud noise and the car burst backward, taking out the right side of our gate and a portion of the fence adjacent to the gate…. She applied the brake, but the brake was not able to engage as the transmission had torqued the engine so hard that it forced her into the side of the house and the rear bumper rammed into a brick pillar supporting the roof of the front porch.”

The 2008 Nitro had six Technical Service Bulletins issued that reported problems with, among other items, the power train, the air bags, and the engine electronics.

And topping the list… The vehicle with the dubious honor of ranking first on the Complaint Index is… The Toyota FJ Cruiser.



Link here.