Los Angeles Personal Injury Lawyer - FDA & Prescription Drugs

Odor Reports Prompt Tylenol Recall

Chrissie Cole — Wed, 29 Jun 2011 10:37:00 GMT

Odor reports have prompted the voluntary recall of one lot of TYLENOL, Extra Strength Caplets in the U.S. The affected products were manufactured in February 2009.

McNeil is taking this measure following reports of odor reports including moldy, musty odor which has been linked to a trace amounts of a chemical known as 2,4,6-tribromoanisole (TBA).

TBA has been associated with temporary and non-serious gastrointestinal symptoms.

The recall involves the following lot of Tylenol:

TYLENOL, Extra Strength Caplets, 225 Count – Lot # ABA619 – UPC Code: 300450444271

Consumers are urged to discontinue use of this product if it is subject to the recall. Contact McNeil by visiting www.tylenol.com or by calling 1-888-222-6036 for information about a refund or product coupon.

Medical questions and concerns should be directed to your medical doctor. To report adverse reactions, use the FDA’s MedWatch program online or by mail.

Originally posted at InjuryBoard by Chrissie Cole

Recall Of Certain Salad Mixes Issued By Garden State Due To Listeria Risk

Chrissie Cole — Tue, 25 Jan 2011 12:01:00 GMT

A voluntary recall of all Salad products has been issued by State Garden, due to potential contamination with Listeria monocytogenes.

Listeria monocytogenes can cause serious and sometimes fatal infections in young children, elderly people, and others with weakened immune systems.

The Salad Products and Blends involved in this recall were sold under several brand names including: Gold Quality, Hannaford, Natures Place, Natures Promise, Roche Bros, Northeast Fresh, Noreast Fresh, Olivia’s Organics, Signature and Wegmans.

The FDA Web site includes a detailed list of specific salad product, size, package type and UPC codes.

The trace back code numbers (45693 and 45703) can be found in the upper right hand corner of the bags and labels. The “best if used by” date is no later than Jan. 15, 2011.

This product should not be consumed. It should be returned to the place of purchase for a refund. For more information on this recall call 1-888-841-6191.

No other Garden State products are affected by this recall.

Originally posted at InjuryBoard by Chrissie Cole

Tortilla Soup Mix Recalled Due To Salmonella Contamination

Chrissie Cole — Wed, 03 Mar 2010 11:39:00 GMT

Homemade Gourmet issued a voluntary recall of some packages of Tortilla Soup Mix, because it has the potential to be contaminated with Salmonella.

Salmonella infections can be life-threatening especially for infants and young children, pregnant women, older adults and also people with weakened immune systems.

There have been no reports of illness in connection with the recalled product, to date.

The following soup mixes are involved in the recall:

"Tortilla Soup Mix" is distributed nationwide via mail order delivery and through independent consultant sales. The recalled lots are S1004812411 and S1004912111, which were sold 2/17/2010 through 3/1/2010.

"Tortilla Soup Mix" is packaged in clear plastic packages with red and beige labeling. The product was sold individually in a 1.96 oz (55.6 g) pouch, and as part of two kits including the "Let’s Make Dinner Collection (stock #40.1032) or the "$800 pre-select" order for consultants (stock #37.0320).

To date, no known illnesses have been reported in connection with this product.

The recalled product should be discarded. Consumers can contact Homemade Gourmet at 1-888-477-2848 for replacement and refund information.

Originally posted at InjuryBoard by Chrissie Cole

Another Yaz Birth Control Victim

Paul Kiesel — Tue, 24 Nov 2009 17:58:21 GMT

From Business Wire:

NEW YORK -- Wendy R. Fleishman of the national plaintiffs’ law firm Lieff Cabraser Heimann & Bernstein, LLP announced that Mae Walker today filed a personal injury lawsuit against Bayer Healthcare Pharmaceuticals, Inc., for severe and lasting injuries caused by Bayer’s birth control drug Yaz. Walker’s complaint charges that Yaz is a dangerous prescription drug sold without adequate warnings about the risk of serious injuries.

Walker, age 30, of Belpre, Ohio, works 40 hours a week at McDonald’s and is the mother of three young children. Approximately one year after she started taking Yaz, Walker was diagnosed with deep vein thrombosis (“DVT”), more commonly known as a blood clot, in her left leg. If left untreated, blood clots in the leg can break off and result in life-threatening conditions. Walker was hospitalized for three days, where she received anti-coagulation medication to reduce the swelling in her leg and treat the blood clot.

“Yaz has had a devastating impact on my health and family,” Walker stated. “My work requires me to stand on my feet all day. I still experience leg swelling and cannot lift heavy items. I have to be extremely careful not to ever cut myself due to the blood-thinning medication I am taking, which I have been told I must likely take the rest of my life.”

The complaint charges that Walker would never have developed DVT, been hospitalized, or forced to undergo numerous medical tests and procedures, had Bayer properly warned patients of the dangers of using Yaz.

“The FDA’s adverse event database for Yaz and Yasmin reveal a very high number of serious adverse events associated with these drugs, including strokes, heart attacks, blood clot formation, gallbladder and kidney disease, and sometimes death,” commented attorney Fleishman. “Bayer failed to warn doctors and consumers that Yaz and Yasmin are actually more dangerous than previous generations of oral contraception pills.”

The complaint was filed in the Superior Court of New Jersey, where Bayer Healthcare Pharmaceuticals, Inc., is located.

Click here for the rest of the article.

**Also, anyone who has been adversely affected due to taking these prescription drugs, like Yasmin, Yaz or Ocella, should get in touch with Helen Zukin. Ms. Zukin recently retained a client, a young woman, who unfortunately suffered from a stroke, after only taking Ocella (generic version of Yaz) for a month.

Originally posted at InjuryBoard by Paul Kiesel

Bayer Follows Google's Lead

Paul Kiesel — Wed, 18 Nov 2009 19:59:37 GMT

Bayer's Yaz is trying out a paid search format similar to that proposed by Google for products carrying black-box warnings.

The Yaz-branded sponsored link appears in a yellow-highlighted box atop Google searches on terms including “Yaz,” “the pill” and “birth control.” It features a headline linking to the product site, a line of text advising viewers to “Read important product info here,” and a bottom line reading “Click to see full safety and prescribing information, including boxed warning,” followed by a “fixed” link to physician labeling.

Yaz carries a boxed warning of sharply increased cardiovascular risks for users who smoke, particularly those over the age of 35. Boxed warnings denote particularly serious risks and prescription drug brands carrying boxed warnings are not allowed to run so-called reminder ads giving a brand name but not its indication.

Bayer was among the 14 recipients of untitled letters for violative sponsored links issued by FDA's Division of Drug Marketing, Advertising and Communications in April. Drug companies had been operating under the so-called “One click rule,” the assumption that as long as full-risk information was a click away, they could run space-limited sponsored links giving only a name and abbreviated indication [. . .]

Click here for the rest of the article.

Originally posted at InjuryBoard by Paul Kiesel

Fearing a Flu Vaccine?

Paul Kiesel — Mon, 09 Nov 2009 18:37:49 GMT

From The New York Times:

When I tell nonmedical friends that our clinic is vaccinating children against the H1N1 flu virus, here is what they say.

With about half, it is something like: “Oh, my God, our doctor doesn’t have it! Can you get me a dose?” And with the other half, it is something like, “Oh, my God, that brand-new vaccine — do you really think it’s safe?”

There is a peculiar duality in the collective cultural mind just now, a kind of pandemic doublethink. Other doctors I know are all eagerly having their own children immunized. Many are answering frantic calls from people desperate for the vaccine. But at the same time, we are all coming up against parents who are determined to refuse that same vaccine.

Wondering what history might have to say about this incongruous state of affairs, I called David M. Oshinsky, a professor of history at the University of Texas who wrote the Pulitzer Prize-winning “Polio: An American Story” (Oxford, 2005). Dr. Oshinsky compared the current vaccination campaign with two previous situations.

In 1947, a man newly arrived in New York City from Mexico died of smallpox. The authorities “lined up the entire city” and vaccinated everyone, even those who had already been vaccinated, Dr. Oshinsky said. “The entire city was revaccinated,” he added, “and there was no real resistance. People had a sense of risk versus reward and listened to public health officials.”

Then there were the polio vaccine trials of 1954, in which parents volunteered more than a million children to receive either an experimental vaccine or a placebo. And while they trusted the medical profession much more than parents do now, there was another factor, Dr. Oshinsky said: “They also had lived through virulent epidemics. That to me is probably the biggest issue of all. You’re dealing with parents who’ve never seen a smallpox epidemic, a polio epidemic.”

Few doctors now practicing have ever seen a single case of smallpox, much less an epidemic (thanks to vaccination). But when pediatricians look at today’s strain of H1N1, we tend to be good and scared.

Serious cases of this flu are relatively rare but far from unheard of; more than 100 children have died of H1N1. The deaths seem to occur disproportionately in children and pregnant women.

So we give the H1N1 vaccine to children whose parents are almost tearfully afraid of the virus, and we try to win over those parents who are just as tearfully afraid of the vaccine. To them, we explain over and over that in fact this is not a brand-new vaccine — it is made with the same techniques as the seasonal influenza vaccine. Yes, it has been tested. Yes, it’s safe. Yes, it’s effective.

Click here for the rest of the article.

Originally posted at InjuryBoard by Paul Kiesel

Another Lawsuit Filed Against the Maker of "Yaz" Birth Control

Paul Kiesel — Thu, 05 Nov 2009 20:19:40 GMT

From ChicagoNow:

A woman is suing the maker of Yaz birth control after the contraceptive allegedly caused her to develop gall stones.

Melissa Johnson is suing Bayer, the maker of the prescription birth control, because she says it caused her to develop gall stones necessitating the removal of her gall bladder.

According to the complaint, Yaz contains drospirenone, a type of progestin not contained in any other birth control and of which "there is insufficient data to support its safe use." The complaint states that, since Yaz first appeared in the U.S., "hundreds of reports of injury and death" have been submitted to the FDA.

The lawsuit also points out the maker's "over-promotion" of Yaz that led to the FDA requiring it to run new TV ads correcting some of the misleading information.

Click here to view the complaint.

Originally posted at InjuryBoard by Paul Kiesel

Birth Control Pills Almost Double the Risk of Stroke

Paul Kiesel — Tue, 27 Oct 2009 16:36:27 GMT

From The Times of India:

According to a review article in MedLink Neurology by three Loyola University Health System neurologists, women who take birth control pills and also smoke, have high blood pressure or have a history of migraine headaches, significantly increase their risk of stroke.

The review found there were about 4.4 ischemic strokes for every 100,000 women of childbearing age, but birth control pills increase the risk of stroke 1.9 times, to 8.5 strokes per 100,000 women.

"When prescribing oral contraceptives, doctors should balance the risks and benefits for each individual patient," said senior author Dr. Jose Biller.

"For a healthy young woman without any other stroke risk factors, the benefits of birth control pills probably outweigh the risks. But if a woman has other stroke risk factors, she should be discouraged from using oral contraceptives,” the expert added.

How oral contraceptives might cause strokes is not completely understood. But two possible mechanisms are the increased risks of blood clots and high blood pressure associated with oral contraceptives, authors wrote.

**Also, anyone who has been adversely affected due to taking these prescription drugs, like Yasmin, Yaz or Ocella, should get in touch with Helen Zukin. Ms. Zukin recently retained a client, a young woman, who unfortunately suffered from a stroke, after only taking Ocella (generic version of Yaz) for a month.

Originally posted at InjuryBoard by Paul Kiesel

Yaz: Riskier than Other Birth Control Pills?

Paul Kiesel — Thu, 22 Oct 2009 17:53:50 GMT

Here's another sad story about woman from the Bay Area that suffered from a stroke and, subsequently, was in a comma and then hospitalized for six months, after only taking Yaz for a month for menstrual pains, as prescribed by her doctor.

In 2007, Susan Galinis was the happy mother of 3-year-old twins. She wanted to have more children, so when her doctor said she could either have a hysterectomy or take the Yaz birth control pill to control her menstrual pain, she opted for the pill.

Four weeks and one day after starting it, she had a stroke. Surgeons removed part of her skull to accommodate the brain swelling. She lived, but she's not the same.

"My IQ has plummeted to 77, which I guess is borderline mentally retarded, from the stroke, from the brain damage, that's what they say it is," says Galinis.

Galinis was in the hospital for six months. She now has chronic pain and no short-term memory. She cannot drive. Her twins have had to adjust with the help of a counselor.

"She says basically to them their mom did die because she was there one day and the next day she was gone. I was gone for basically six months and then I came home with a different voice, a different personality," says Galinis.

Galinis says her doctors told her it was Yaz that caused the stroke. All birth control pills carry increased risk of stroke, but Galinis' lawyer Mike Danko says studies show it has twice the risk as other pills. On Monday, they filed suit against Yaz manufacturer Bayer.

Click here for the rest of the article.

**Also, anyone who has been adversely affected due to taking these prescription drugs should get in touch with Helen Zukin. Ms. Zukin recently retained a client, a young woman, who unfortunately suffered from a stroke, after only taking Ocella (generic version of Yaz) for a month.

Originally posted at InjuryBoard by Paul Kiesel

Bayer, Birth Control Products and Blood Clots: Every Young Woman's Nightmare

Paul Kiesel — Wed, 21 Oct 2009 18:36:33 GMT

From Reuters:

Kent L. Klaudt of the national plaintiffs` law firm Lieff Cabraser Heimann &
Bernstein, LLP announced that Candice Atkinson today filed a personal injury
lawsuit against Bayer Corporation and Bayer Healthcare Pharmaceuticals, Inc.,
for severe side effects from the prescription birth control drug Yaz,
manufactured and marketed by Bayer. The complaint was filed in the Superior
Court of New Jersey, where Bayer Healthcare Pharmaceuticals, Inc., is located.

Atkinson, age 33 of Rock Hill, South Carolina, charges that Yaz is a dangerous
prescription drug sold without adequate warnings about the risk of serious
injuries. Atkinson further alleges that Bayer improperly advertised and
over-promoted Yaz for uses such as treating acne, knowing that the risks of such
use outweighed any benefits Yaz may have for acne sufferers.

"Bayer promoted Yaz with the slogan `the difference a little chemistry can
make,`" added Mrs. Atkinson. "What Bayer did not disclose was how negative that
difference can be. Yaz gave me life-threatening injuries that have forever
altered my life."

"My dermatologist prescribed me Yaz in March 2008 to treat my acne," stated Ms.
Atkinson. "At the time, I was unaware that Yaz had not been approved by the FDA
to treat skin conditions for women who were not already using it as birth
control, even though Bayer advertised it for preventing or reducing acne."

"Several months later, I developed sharp pains in my left shoulder and had
difficulty breathing," Atkinson continued. "I went to my doctor for an
examination. Testing revealed multiple blood clots in both lungs. I was
hospitalized immediately. Fortunately, the treatments eliminated the blood
clots, but only one month later I was diagnosed with gallstones. I then had to
undergo gall bladder surgery in January 2009. I have suffered months of anxiety
and nausea related to these medical procedures and drugs given to treat the
adverse side effects I developed from taking Yaz."

The complaint charges that Mrs. Atkinson would never have developed blood clots,
been hospitalized, or forced to undergo numerous medical tests, procedures, and
gall bladder surgery if Bayer had properly warned patients of the dangers of
using Yaz solely as acne medication. The complaint alleges that Mrs. Atkinson
never used Yaz for birth control. Instead, as a result of Bayer`s misleading
advertisements to doctors and consumers, her dermatologist gave her Yaz solely
for her acne.

Click here for the rest of the article.

Originally posted at InjuryBoard by Paul Kiesel