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Massachusetts Woman Files Zofran Birth Defect Lawsuit

June 2, 2015
was born with several heart defects, including a "hole in the heart" (atrial septal defect), right ventricular hypertension, and aortic arch hypoplasia. If your firm is interested in referring us a case or for us to send you a list of previous award judgments and/or average referral fees, please visit the Lawyer Referral section of our website.

. She also had facial dysmorphia, low set ears, hearing loss, sensitivity to light, ingueno hernia, and webbed toes.

The lawsuit was filed on February 16 in the U.S. Please use the form below to contact our Defective Drug Litigation Group or call toll free 24 hours a day at (866) 920-0753.

Attention Lawyers: We consider a referral from another law firm to be one of the greatest compliments. District Court for the District of Massachusetts.

According to the lawsuit (PDF):

"GSK not only concealed this knowledge from healthcare providers and consumers in the United States, and failed to zofran lawsuit commercial warn of the risk of birth defects, but GSK also illegally and fraudulently promoted Zofran to physicians and patients specifically for the treatment of morning sickness in pregnancy women."



Attorneys for the LeClair family claim GSK knew that Zofran could cross the placenta based on animal studies from the 1980s. More recent studies have confirmed that Zofran also crosses the human placenta.

Between 1992 and today, GSK has allegedly received over 200 reports of birth defects in children exposed to Zofran. If you or somebody you know had a baby with a birth defect, you should contact our lawyers immediately for a free case consultation. In July 2012, GSK paid a $3 billion settlement for illegally marketing several drugs, including Zofran to pregnant women.

The Schmidt Firm, PLLC is currently accepting Zofran induced injury http://www.nlm.nih.gov/medlineplus/druginfo/meds/a601209.html cases in all 50 states. In addition, at least four large-scale epidemiological studies have found evidence that Zofran increases the risk of birth defects, especially heart defects.

However, instead of updating warnings, GSK instructed sales representatives to market Zofran as a treatment for morning sickness. This "off-label" marketing eventually caught the attention of the Justice Department.

February 19, 2015 -- GlaxoSmithKline (GSK) has been hit with a lawsuit from a woman in Massachusetts who blames Zofran for her daughter's birth defects.

The woman, Tomisha LeClair, filed the lawsuit on behalf of her daughter, A.S., who was born in 2000 with birth defects. LeClair took Zofran to treat morning sickness during her first trimester of pregnancy.

A.S

Archive News & Video for Saturday, 25 Apr 2015

May 28, 2015
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Acute morning sickness: What is it – The Chart

May 26, 2015
Some may experience nausea but

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May 23, 2015
Mike Pence's decision not to fulfill the political buzz and chase White House dreams in doesn't necessarily clear up questions about his future."/>

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The bucket list: Nancy Knudsen talks to skippers about pills, patches and a 'tot' of rum to ward off seasickness.

May 21, 2015
Novice crew, he says, may be anxious simply

about the coming voyage, but other factors come into play, even for him.

"If I find I am asking, for whatever reason, 'what am I doing

here?' I am liable to be seasick. He gets seasick.

Rod gets so seriously seasick that he gathers a crew around him who

can do without him. "He's a bastard," he said. If they survive that, they might make the

crew. "You cannot rely on

them to harness properly or remember their life jacket. Their judgement goes," he says. "Some sailors may never get crook, but they might not

be zofran lawsuit missouri very good sailors. Then in the morning I light up a cigar and wake'em

all up to bacon and eggs. Worst of all, he says, is that as well as feeling

the symptoms of debilitating nausea and severe vomiting he also loses

his balance. Phenergan is without doubt the favoured antihistamine, but it can

tend to put one to sleep. Here I

found some varying attitudes, among them that a proneness to seasickness

was not something to be shunned, but rather an accepted part of the

scenery and a factor to be planned for.

Sean Langman will sail his 9-metre Huon pine gaff-rigged Maluku to

Hobart this year, but is better known as a high-speed racer. The team

aspect appeals to me too. MMM also recommends

Travacalm, but their coverage is very detailed and it is highly

recommended to take the whole course by contacting the CYCA.



For the educated skipper, there are many avenues open to avoid or

temper crew seasickness, but what if it is the skipper who is the one

seriously affected? Surely someone passionate enough about sailing to

indulge in the very expensive business of boat ownership will not get

seriously seasick?

Enter Rod Skellett, well known as owner of the Class 40 Krakatoa

II, veteran of 11 Hobarts and destined for many more. Having

completed 21 Hobarts he says he willingly takes crew who tend to

seasickness. "I never

thought I would ever recommend small doses of Coca cola as a therapeutic

agent but, in the misery of 'le mal de mer', I found it did

help."

Morgan Rogers agrees about the Coca Cola, but suggests adding a tot

of rum. As a plastic surgeon that has amused the Sydney

sailing scene for years by calling his boats such names as 'Smooth

Operator' and 'Nips n Tux' he is more than qualified to

comment, both as a sailor and a medico.

For Dr de Torres, the top preventative is the Scop Patch

(scopolamine). I'll take a good sailor for his abilities,

even if he is prone to seasickness."

Morgan Rogers, part owner of Wave Sweeper, an extensively tuned

Beneteau 40.7, has 25,000 miles of ocean racing to his credit, including

more than a dozen Coffs, Gold Coast and Rolex Sydney Hobart races.

"It's all a matter of resource management," says Rogers.

"I budget to have 30% of my crew afflicted during any race,

including the Hobarts."

He handily lists three categories of seasickness:

Serious: Sick to the point of incapacitation and dangerous

dehydration.

Mild: Might; throw up but can still operate as a crew member.

Occasional: Those who get seasick only by some negative external

influence, such as the smell of diesel or an anxiety.

No one in the medical profession seems to know just why some people

are prone to severe seasickness, but curiously both Rogers and Langman

agree that on anecdotal evidence the malady can be caused or aggravated

by anxiety.

[ILLUSTRATION OMITTED]

Landman in particular has noticed this "anxiety factor"

over many years of sailing. The

skipper/owner was so seasick he had to be given suppositories during the

journey. I know he's skippered at least ten yachts in the

famed Sydney to Hobart Race over the years, so I am fascinated.

"How do you manage that?"

"Ha!" he growls with eyes twinkling. I would rather

they stayed below and supine if possible."

Sean Langman tells the story of his very first long sail at the age

of 17, on a boat called The Alice, from Sydney to Suva in Fiji. If not, it's Goodnight Irene."

Not all skippers are as tough as http://www.goodrx.com/zofran that one (who didn't want to

be named) but seasickness can make history of the ambitions of a yacht

owner in any yacht race, especially if they have to make a stop to let

the crewmember off, effectively putting them out of the race.

The day I stepped on board for my very first ocean race - to Lord

Howe - my skipper, whom I hardly knew, approached me and said gruffly

and without preamble, "Hold out your hand." As a brand new

crewmember, I obediently held out my hand. "Sure I did," replied the skipper, "You

know why my boat is called The Alice? That's because that's

where I wish I was every time I go to sea - Alice Springs!"

"Then why do you go?" "Because the good times outweigh

the bad, and I just love sailing oceans."

The self-styled king of seasick skippers, Rod Skellett, agrees.

"There's no sport that can compare with ocean racing. These last are now withdrawn from sale in Australia

but are available in New Zealand and other countries. "Take these." He

dropped two pills into my palm, one blue and one white. We're sitting in the fresh air of Sydney's Royal

Prince Alfred Yacht Club, known to members affectionately as 'The

Alfreds'. They're probably illegal too.

Joe won't stand for seasickness, so the pills are compulsory. Golf is about me, and so are tennis and many

others. All suggest that one should start taking it 36

to 48 hours before the voyage. "What are

they?" "Never mind, just take them," and he walked away.

Another crewmember, a huge - framed disaffected American called

Jim, filled me in. "You hold them in your mouth and they

dissolve there, so if you are so seasick that you can't keep

anything down, these are good because they are absorbed through your

cheek."

Finally, the last resort, apart from stopping somewhere to let the

crew member off (not possible in the middle of an ocean), is the

Stemetil suppository, effective and appropriate when taking medication

orally has ceased to be an option.

The Cruising Yacht Club of Australia (CYCA) regularly operates a

course called Medical Management for Mariners (MMM), an excellent

undertaking for anyone who intends to be more than half a day at sea.

Part of that course covers seasickness, and I asked the coordinator Dr

Virginia Furner for comments on the various treatments of seasickness

covered here. "Did you know you were going to be seasick?" Langman

asked him later. "This tends to relieve the anxiety," he says,

"whether because of something about the voyage or because of

stresses on land, the small tot of rum can do wonders."

If none of these mild therapies work, there are always the more

serious ones.

Professor Kamian confirms what most know - that you'll feel

better by lying supine and keeping your head still. The other is what

the truckes take to keep them awake. No matter how seasick I get for a few days, it will never stop

me ocean racing. If there is unhappiness among the

crew, or anxiety about my business or family on shore I am vulnerable.

If the crew is working well together and I have no other anxieties, I

can almost guarantee I won't be sick."

So, if seasickness is unexplainable and cannot be avoided, what are

the effective treatments? Here I found a minefield of disagreement among

those with practical experience, and sometimes even among some of the

medical experts.

For mild and occasional seasickness, there was broad agreement

about the kind of treatment that was most effective before you go to

sea. "One

is the strongest seasick pill around, probably illegal, and it'll

send you to sleep before you've got time to spit. Apart from not putting you to sleep, he reasons, they are

long lasting. The obvious

advantage of a patch is that there is no drowsiness factor.

Howard de Torres is a Sydney sailor who has skippered his boat to

Hobart nine times. Some users have reported that there are side effects,

however, including being ill after they stop wearing the patches, while

the body re-adjusts.

So if you have done everything possible to prepare before the

journey, what can you do once you feel the typical symptoms - yawning,

nausea, and dizziness?

If the attack is mild there are many suggestions - chew more

ginger, watch the horizon, eat dry bread, stay in the fresh air.

Professor Kamian, who for many years acted as ship's doctor on

cruises round Gape Horn, also recommends Coca Cola. If we

don't take them he'll throw us off the boat."

If these stories give you the impression that skippers take

seasickness seriously, you'd be right, especially in a race as

prestigious as the Rolex Sydney to Hobart Race, now in its 67th year.

According to Emeritus Professor Max Kamian of the University of WA,

no less than 70% of people will become seasick in rough conditions.

Amazingly, famous explorers like Charles Darwin, Douglas Mawson and

Jacques Cousteau were severely afflicted by seasickness.

To find out just how Sydney to Hobart skippers cope with the idea

of seasickness among crewmembers I spoke to several skippers. Dr de Torres

recommends Zofran wafers. And that about says it all, really.

COPYRIGHT 2012 OCEAN Media Pty Ltd.



No portion of this article can be reproduced without the express written permission from the copyright holder.

Copyright 2012 Gale, Cengage Learning.

"Seasickness? Never on my boat!" He leans back, balancing

on the two back legs of the chair, exposing his tanned and crinkled face

to the sun. All rights reserved.

. So rather than taking the advice commonly given, like

staying up on deck and looking at the horizon or taking over the helm,

he slays below.

"I am dangerous on deck." he says, but once he has lost

everything in his stomach, he can function to do some tasks below.

"I can get up and give our position. The age-old remedy for the drowsiness is

Ephedrine, the 'upper' that will keep you awake.

Disagreement, however, surrounds the effectiveness of ginger and

scopolamine patches. While their course does not recommend Ephedrine, she

agreed that Phenergan is a very effective medication, and, if there is a

qualified person present, can be given by injection. "I take'

em for a night sail to test them out in the ocean when there's a

bit of a blow. I can do a little navigating,

even put the kettle on to keep myself somewhat useful." Even after

being focused on preparing as well as he can, for him, nothing works!

Morgan Rogers also thinks that a seasick person on deck is a

liability. Pitting yourself against Mother Nature on the high seas

with your fellow crewmembers is the ultimate for me and I love it!"

..

Baxter Receives Tentative FDA Approvals For Ondansetron Injection In Vials And Premix Containers.

May 12, 2015
Final Approval and Launch Expected to Occur Later This Year

Following Expiration of Pediatric Exclusivity Period

DEERFIELD, Ill., June 15 /PRNewswire-FirstCall/ -- Baxter

Healthcare Corporation today announced that it has received tentative

approvals from the U.S. Food and Drug Administration (FDA) for

Ondansetron Injection USP, including the first tentative approval for a

premix version of GlaxoSmithKline's Zofran(R), which is used for

the prevention of nausea and vomiting. Baxter anticipates receiving

final FDA approval and commencing sales of ondansetron in vial and

premix presentations in zofran birth defects lawyer late December 2006, upon expiration of the

pediatric exclusivity period.



Baxter received tentative abbreviated new drug application (ANDA)

approvals for Ondansetron Injection USP 2 mg/mL packaged in 40 mg/20 mL

multiple-dose vials and 4 mg/2mL single-dose vials. Additionally, the

company received new drug application (NDA) approval for Ondansetron

Injection USP 32 mg/50 mL iso-osmotic sodium chloride solution premix in

INTRAVIA plastic containers. Premix medications reduce the preparation

steps involved in administering therapies, thereby helping to reduce the

opportunity for errors and contamination. In 2005, U.S. sales of the

vial and premix brand product totaled $585 million.



Ondansetron will be the newest addition to Baxter's existing

portfolio of anesthesia, critical care and oncology products, which

include enhanced packaging, proprietary drugs and other generics.



About Ondansetron

Ondansetron is indicated for the prevention of nausea and vomiting

associated with initial and repeat courses of emetogenic cancer

chemotherapy, including high-dose cisplatin. The single and multi dose

vials are also indicated for the prevention of postoperative nausea

and/or vomiting. Efficacy of the 32 mg single dose beyond 24 hours in

these patients has not been established. Ondansetron Injection is

contraindicated for patients known to have hypersensitivity to the drug

and other selective 5-HT3 receptor antagonists. Additionally, in the

premix INTRAVIA plastic container, the concomitant use of apomorphine with ondansetron is contraindicated.



About Baxter



Baxter Healthcare Corporation is the principal U.S. operating

subsidiary of http://csn.cancer.org/node/233524 Baxter International Inc. . Baxter International Inc.,



through its subsidiaries, assists healthcare professionals and their

patients with treatment of complex medical conditions, including cancer,

hemophilia, immune disorders, kidney disease and trauma. The company

applies its expertise in medical devices, pharmaceuticals and

biotechnology to make a meaningful difference in patients' lives.

For more information about Baxter, please visit http://www.baxter.com/ .



Zofran(R) is a registered trademark of GlaxoSmithKline



This release includes forward-looking statements concerning the

availability of ondansetron. The statements are based on assumptions

about many important factors, including the following, which could cause

actual results to differ materially from those in the forward-looking

statements: completion of final steps in product development, including

scaling up production, including satisfactory quality and regulatory

work; final FDA approval; the expiration of exclusivity periods; and

other risks identified in the company's most recent filing on Form

10-Q and other SEC filings, all of which are available on the

company's web site. The company does not undertake to update its

forward-looking statements.



CONTACT: Media Contacts, Erin Gardiner, +1-847-948-4210, or

Deborah Spak, +1-847-948-2349, or Investor Contacts, Mary Kay Ladone,

+1-847-948-3371, or Clare Sullivan, +1-847-948-3085, all of Baxter

Healthcare Corporation



Web site: http://www.baxter.com/



COPYRIGHT 2006 PR Newswire Association LLC



No portion of this article can be reproduced without the express written permission from the copyright holder.

Copyright 2006 Gale, Cengage Learning. All rights reserved.

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