Levaquin

You may have seen more information about Levaquin®, which is an Ortho-McNeil-Janssen pharmaceutical, also called a fluoroquinolone, prescribed for the treatment of lung, sinus, skin and urinary tract infections in adults. Levaquin® has been associated with medical complications serious enough to have required FDA involvement.


Reports of Levaquin® Complications

Although the increased risk of tendonitis and tendon rupture has been noted on fluoroquinolone drug labeling for several years, the FDA has continued to receive reports of tendon disorders and ruptures among patients, and incidents of side effects often go unreported or are misdiagnosed as rheumatoid arthritis. In July 2008, the FDA announced a mandatory black box warning label for fluoroquinolone drugs, including Levaquin®, that highlights and strengthens the warning for increased risk of tendonitis and tendon rupture.

The reported symptoms related to the use of Levaquin® include:
· pain
· swelling
· inflammation
· bruising and tears in tendons such as the Achilles,
shoulder, hand or legs

The risk of developing fluoroquinolone-associated tendon disorders or tendon rupture increases in individuals over the age of 60, individuals taking corticosteroid drugs and recipients of kidney, heart and lung transplants. Tendon ruptures and injuries are often debilitating and may affect use of the injured limb.

Prempro Verdict - Don't Ask I Can't Tell You

A Philadelphia jury awarded punitive damages to an Illinois woman who said Wyeth's Prempro hormone replacement therapy caused her breast cancer, but the world will have to wait at least another month before anyone knows how much.

As the jury in Common Pleas Court was nearing a verdict on how much to award to punish Wyeth, which last week completed a merger with Pfizer Inc., company lawyers asked Judge Sandra Mazer Moss to seal the amount until a verdict is reached in a similar case also being tried in Philadelphia. The judge agreed.



Wyeth's attorneys George McDavid and Michael Scott argued that a public announcement of punitive damages in the Barton case could bias jurors in the other case, referred to as Kendall v. Wyeth.

Barton's attorney, Zoe Littlepage, argued that the public's right to know outweighed those concerns and that Wyeth had failed to prove damage, not just speculate that it could occur. Littlepage also said she feared that Wyeth would use the tactic to delay repeatedly as 9,000 cases involving Pfizer/Wyeth menopause drugs make their way through the courts.

Source is right here.

Friday Link: New Georgia Family Law

I don't usually link to others' blogs, but my good friend C.J. Remboldt has a family law blog that is worth a read. You can find her blog here.

Here's a post from her blog:

GA Trial Court Lacks Authority to Modify Terms of Child Support Order

A GA trial court may not deny a child support contempt hearing because the Temporary Protective Order, ordering father to pay child support, would expire before the hearing date because a trial court lacks authority to modify the terms of a child support order nor may it forgive any child support in arrears.

To find her mediation practice, go here.

Georgia Supreme Court rules against State Senator in Accident Case

State Sen. Cecil Staton did not prevail before the Georgia Supreme Court this week.

The court said Staton, a Republican from Macon, was not entitled to additional coverage ($200,000) in coverage after a truck accident near Rome that broke his leg. Staton contended he should be allowed to “stack” $100,000 policies on three vehicles owned by his company, Smyth & Helwys Publishing, even though only one of the three cars was actually in the crash.

Read the opinion here.

Zometa Verdict in Montana

A Missoula jury on Wednesday awarded $3.2 million to a woman suing the maker of a bone-strengthening drug in a decision that could have a bearing on hundreds of cases against the company nationwide.

Peggy L. Stevens, 57, of Missoula filed suit against Novartis Pharmaceuticals Corp., alleging the company should have disclosed health risks associated with the bone-strengthening drug called Zometa.

Stevens developed dental and jaw-related problems after taking the drug for several years.

Stevens' attorneys said the company knew patients taking Zometa were vulnerable to a degenerative jaw disorder called osteonecrosis, particularly those patients who undergo invasive dental procedures. Symptoms include pain, loosening of teeth, exposed bone and infection.

Source here.

Safety Investigation of Certain Medical Device Power Cords

The power cords on a variety of medical devices may cause sparking, charring, and fires, according to reports received by the FDA.

Device manufacturer Hospira has recalled all affected power cords, while Abbott Nutrition has recalled its Flexiflo Quantum Entreal Pumps, used for feeding patients through tubes.

To date, the FDA has received 122 reports of faulty power cords involving devices manufactured by these two companies, whose investigators found that the power cord prongs contain a black bridge, which may crack and fail at or inside the plug.

Additional risks from the device failure include electrical shock, delay in setup and therapy, interruption of therapy, and device failure.

The FDA said the cords, manufactured by the Electri-cord Manufacturing Company, are used on other devices made by other companies, and the agency has launched an investigation to identify them.

The FDA warned practitioners to monitor the condition and make of their devices' electrical cords, particularly in oxygen-rich environments where device sparking may cause fires.

Source here.

FDA Checking Claims on Food Labels

U.S. regulators are
examining the growing number of nutrition claims found on the
front of food packages after complaints that they give a
misleading picture of their health benefits, officials said in
a warning to food companies on Tuesday.

The Food and Drug Administration is trying to determine if
any claims violate federal food labeling rules and "will take
enforcement action against any egregious examples," FDA
Commissioner Margaret Hamburg told reporters.

FDA officials also are developing a proposed regulation to
define nutritional criteria for claims made on the front of
food packages, Hamburg said.

The FDA is acting as companies increasingly add nutrition
claims to the front of packages to catch the attention of
hurried shoppers who might not read the detailed facts about a
food's content on the back, she added.

"Some nutritionists have questioned whether this
information is more marketing-oriented than health-oriented,
and judging from some of the labels that we have seen, we think
this is a valid concern," Hamburg said.

Link to the source here.

Defective Women's Robes Recalled (Blair LLC)

Blair LLC. has reported 162,000 of its defective products -- women's robes -- after six women reportedly died when the chenille robes caught fire. Some of the robes caught fire while cooking, according to an MSNBC news report. The U.S. Consumer Product Safety Commission (CPSC) issued an alert stating that women who own these robes should stop using them. CPSC and Blair initially announced their voluntary recall in April citing three reports of robes catching fire, including one report of second-degree burn injuries. This second product recall notice comes now after the company received reports of six deaths due to the robes catching fire.

The recalled Blair robes were made in Pakistan and include the following item numbers -- 3093111, 3093112, 3093113, 3093114, 3093115, and 3093116. They were sold through Blair catalogs and on the company's Web site as well as Blair stores in Pennsylvania and Delaware from January 2003 through March 2009.

We're investigating these awful tragedies.

Vytorin Litigation

An amended lawsuit filed over the Schering-Plough pension plan alleges that executives at the company suspected as early as 2005 that the “Enhance” Vytorin trial was a bust. Citing a “confidential informant,” it also names.

The Plaintiffs claim: "Defendants had intimate knowledge of, or an active role in, improper business activities that allowed Schering-Plough to artificially inflate and manipulate the Company’s earnings."

More at bnet, here.

Trials

I've been a little scarce on here for the past couple of weeks. Was preparing for multiple trials, and actually went to trial last week on a case. I'll discuss the trial in a later post.

For those lawyers who read this blog, I will tell you a few key items from the trial: Always prepare a Trial Notebook for the Judge. Include in it a Trial Brief. A short statement of the facts, the key statutes and cases, with a copy of all. It helped once again for me. An informal poll seems to suggest that less than 2/3's of lawyers I know prepare one. Big mistake.

Another: Submit only those Jury Instructions you absolutely need. The Court has its standard ones, of course. I submitted seven, and the Court agreed to read six of them. Opposing counsel submitted more than 40.

More later.

MDL Update: Hydroxycut, Chantix, and Yasmin

The MDL Joint Panel has been busy the last couple of weeks. The JPML had ordered the Iovate (Hydroxycut) MDL to the Southern District of California. The Order may be found here. It's MDL 2087.


An MDL as to Chantix will be sent to Judge I. Johnson in the USDCT of Alabama. The Order may be found at the same link as above. MDL 2092 is the number.

For Yasmin, the MDL is in Ohio.

McDonald's Hot Coffee Documentary 10/13/09 in Atlanta

Remember the film Super-Size Me? That film opened up the eyes of consumers. More people than ever found themselves concerned with the nutritional content—or lack thereof—in fast food. Six weeks after the film premiered, McDonald’s discontinued their “Super-Size” option. The fast-food chain began offering more salads and an adult happy meal in an attempt to appear healthier.



The film was the 10th highest grossing documentary film of all time. Millions saw it. And it changed minds.



Tomorrow’s film screening of “Hot Coffee” also involves McDonalds… but in a different way. Stella, of the now infamous Stella Awards based on the hot coffee McDonalds case, is actually interviewed in this film as it completely debunks the myths surrounding the case. Through additional personal stories, interviews and hard facts, the film illustrates how the media distorted the truth about the McDonald's coffee case, duped the American public and protected corporate interests, endangering our civil justice system.



This 26 minute short of what will be a feature film was chosen by IFP as a Spotlight documentary and is showing around the nation. The film is made by a Trial Lawyer/filmmaker in Oregon. And most importantly, on a grand scale, the film could change hearts and minds.



Please make every effort to attend the screening at tomorrow, Tuesday October 13th at 7:30 at LandMark Theaters in Midtown