DePuy Hip Replacement Failures Lead to Massive Recall

Failure to Warn 002
People with a DePuy ASR hip replacement implant are experiencing a high rate of failure and pain associated with this device, sometimes shortly after surgery.  See New York Times Johnson & Johnson Recalls Hip Implants

Hip replacement surgery explained  Hip replacement xray right

People with the DePuy ASR have filed lawsuits because, despite reports of injury with this device, the manufacturer failed to inform doctors and patients of the known risks associated with this device and waited to issue a DePuy recall until August 2010.

Recalled x-ray 001The Manufacturer of the DePuy ASR has Issued a DePuy Recall Due to a High Rate of Failure (Bloomberg). The DePuy ASR is a Metal on Metal (MoM) prosthetic device consisting of a ball and corresponding socket implanted in thousands of patients around the world during hip replacement surgery. DePuy Orthopaedics, Inc., the medical device maker and part of the Johnson & Johnson Family of Companies, marketed this hip prosthetic in a “resurfacing” version called DePuy ASR Hip Resurfacing System and as total hip replacement called the DePuy ASR XL Acetabular System.

Fda warningSince 2008, there have been more than 300 complaints about this device filed with the U.S. Food and Drug Administration (FDA), with more than 90% of these cases requiring another hip replacement surgery to replace the defective implant. Still, there was no DePuy recall.  See FDA Warning Letter to DePuy Orthopaedics, Inc. 

The design of the device made it difficult for surgeons to implant, causing improper fusing with the bone and loose implants. Friction from movement of the metal on metal socket also creates metal shavings or debris in the soft tissue surrounding the device, causing pain, inflammation and necrosis or tissue death. This damage and inflammation can cause severe pain and disability, can be irreversible and complicate future replacement surgery. MoM hip implants, such as the DePuy ASR also release metal ions into the body.

Side effects 002

In 2009, the manufacturer voluntarily removed the DePuy ASR from the Australian market due to the device’s high failure rate, but they failed to issue a DePuy recall in the U.S. and doctors unknowingly continued use of the devices for patient’s hip replacement surgery. The company notified U.S. physicians about the Australian higher than anticipated failure rates in a March 2010 letter, only advising physicians that proper surgical positioning of the implant was essential.

On August 26, 2010, DePuy Orthopaedics, Inc. finally issued a DePuy recall, citing that 12%-13 % of patients with these defective implants would need to have a revision surgery.

Justice For Your Injuries 

JusticeIf you or a family member or close friend has undergone a DePuy hip replacement that has been the subject of this recall, you may have the right to file a lawsuit against the manufacturers (namely Johnson & Johnson and DePuy Orthopaedics, Inc.).

Contact me to evaluate your concerns and provide you with the utmost in legal guidance.

 

Contact Attorney Lowell Steiger to Discuss Your Legal Rights

Your Consultation is FREE

            (323) 852-1100      

            (877) 487-8221      

e-mail lowell@steigerlaw.com

 

Actos Users Beware: Danger of Heart Attacks, Bladder Cancer

Actos Lawsuits 002
The dangers of the Type II Diabetes drug Actos have led to a plethora of lawsuits around the United States.  What are the possible side effects of Actos?

 

  Actos Side Effects
New or worsening heart problems

(including congestive heart failure)

Bladder Cancer

The side effects are of such a serious nature that a new WARNING was issued by FDA in June 2011.  Here's a direct quote from the FDA Warning:

Fda warning 002"The U.S. Food and Drug Administration (FDA) is informing the public that use of the diabetes medication Actos (pioglitazone) for more than one year may be associated with an increased risk of bladder cancer. Information about this risk will be added to the Warnings and Precautions section of the label for pioglitazone-containing medicines. The patient Medication Guide for these medicines will also be revised to include information on the risk of bladder cancer."

RxAvailable only by medical prescription, Actos (pioglitazone) is in a class of medications called thiazolidinediones. Patients may have taken this drug under the brand name Actos or under the brand names Actoplus Met (pioglitazone and Metformin) or Duetact (pioglitazone and glimepiride) for combination products.

More than two million Americans with Type 2 Diabetes take Actos and many are increasingly concerned about Actos side effects. It is the most prescribed medication for the treatment of Type 2 Diabetes generating $3.4 billion in sales in 2009. However, recent studies show a link between Actos and bladder cancer. Some Actos users are considering the filing of an Actos lawsuit for their injury.

 

Sept 2010 FDA Warning Actos
The U.S. Food and Drug Administration (FDA) first issued a Warning in September 2010 about Actos and bladder cancer after reviewing data from a ten-year study conducted by Takeda Pharmaceutical Company, the drug manufacturer. Data showed a link between Actos and bladder cancer. People taking the highest doses of the drug, or had taken the drug for a long time, were most at risk for bladder cancer Actos side effects.

Before the labeling change, patients taking Actos may not have known about or understood the link between Actos and bladder cancer. They may even be have bladder cancer symptoms and not realize they are Actos side effects.

Bladder cancer symptoms

Justice For Your Injuries 

JusticeIf you have Type II Diabetes and took (or are taking) Actos and suffered any of the side effects mentioned here – new or worsening heart problems (including congestive heart failure) or bladder cancer – you may want to file a lawsuit against the manufacturers of Actos.

If you haven't taken Actos yourself but a family member or close friend has, tell them to contact me to evaluate your concerns and provide you with the utmost in legal guidance.

Contact Attorney Lowell Steiger to Discuss Your Legal Rights

Your Consultation is FREE

            (323) 852-1100      

            (877) 487-8221      

e-mail lowell@steigerlaw.com

 

NuvaRing Vaginal Contraceptive: Blood Clots, Heart Attacks, Strokes, Death

Nuvaring 001NuvaRing is a combination hormonal contraceptive ring that is inserted into a woman's vagina to prevent pregnancies. The FDA approved its use in October of 2001 but the product, which is manufactured by Organon USA, wasn't introduced into the market until July 2002.
The flexible polyethylene ring contains estrogen and a form of progestin. The ring is used by over 1.5 million women around the world. NuvaRing is considered a third generation contraceptive and was initially said to have fewer side effects.

How NuvaRing Works

Nuvaring 002The NuvaRing works by releasing a steady dose of the hormones into the bloodstream where it is absorbed through the vaginal wall. Women wear the ring for three weeks and then it is removed for one week. This prevents the ovaries from producing an egg, the uterus lining thins out preventing a fertilized egg from being implanted and the thickened cervical mucous prevents sperm from entering the uterus.

The Possible Danger(s) To You

 NuvaRing Side Effects

The NuvaRing has had its share of side effects including cardiovascular problems, cardiac arrest, blood clots, strokes and even death. As far back as 2003 the New England Journal of Medicine released a study that showed that the level of estrogen that was found in the NuvaRing was responsible for an increase in blood clots and cardiac problems.

DangerCardiovascular Problems

Cardiac Arrest

Blood Clots

Strokes

Death

 

 

In the past there has been an increased risk of blood clots in contraceptives that contained desogestrel rather than other types of progestins. In November 1995, the Food and Drug Administration stated that "new studies indicate about a two-fold increase in the risk of venous blood clots associated with products containing desogestrel."

If you experience a blood clot in your legs and they are not caught in time or left untreated, they can travel to your lungs and result in death. You can also develop blood clots in your eye and the end result could be a partial loss of vision or blindness.

Justice For Your Injuries 

JusticeIf you have used the NuvaRing birth control and suffered any of the side effects mentioned here – blood clot, stroke, or heart attack – you may want to file a lawsuit against the manufacturers of NuvaRing.

If you haven't used the NuvaRing yourself but a family member or close friend has, tell them to contact me to evaluate your concerns and provide you with the utmost in legal guidance.

Contact Attorney Lowell Steiger to Discuss Your Legal Rights

Your Consultation is FREE

(323) 852-1100

(877) 487-8221

e-mail lowell@steigerlaw.com


 

Testerone Gels: FDA Orders Label Warnings (Harmful to Children)

Testim gel The Food and Drug Administration is requiring box warnings on two topical testosterone gels.  Click here for basic information on the male hormone, testosterone.  Here's the FDA report:

The U.S. Food and Drug Administration today announced that it is
requiring manufacturers of two prescription topical testosterone gel
products, AndroGel 1% and Testim 1%, to include a boxed warning on the
products’ labels. The agency is requiring this action after receiving
reports of adverse effects in children who were inadvertently exposed
to testosterone through contact with another person being treated with
these products (secondary exposure).

The gels are approved for use in men who either no longer produce
testosterone or produce it in very low amounts. Both products are
applied once daily, to the shoulders or upper arms. Only AndroGel 1% is
approved for application to the abdomen. Precautions in the current
labels instruct users to wash their hands after using the product and
to cover the treated skin with clothing.

“These drugs are approved for an important medical need, but can
have serious, unintended side effects if not used properly,” said Janet
Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and
Research. “We must ensure that the adults using them are well-informed
about the precautions needed to protect children from secondary
exposure.”

In 2007, 1.4 million prescriptions for AndroGel—the most commonly
dispensed gel form of testosterone—were dispensed by U.S. retail
pharmacies. Approximately 25,000 of those were dispensed for off-label
use in women. During the same period, some 370,000 prescriptions were
dispensed for Testim, according to data from SDI: Vector One National. 

Despite the currently labeled precautions, as of Dec. 1, 2008, the
FDA has received reports of eight cases of secondary exposure to
testosterone in children ranging in age from nine months to five years.
Since that time, additional reports of secondary exposure have been
received by the agency and are presently under review.

Of the fully reviewed cases, adverse events reported in these
children included inappropriate enlargement of the genitalia (penis or
clitoris), premature development of pubic hair, advanced bone age,
increased libido, and aggressive behavior. 

In most cases, the signs and symptoms regressed when the child no
longer was exposed to the product. However, in a few cases, enlarged
genitalia did not fully return to age-appropriate size and bone age
remained modestly greater than the child’s chronological age.

In some cases, children had to undergo invasive diagnostic
procedures and, in at least one case, a child was hospitalized and
underwent surgery due to a delay in recognizing the underlying cause of
the signs and symptoms.

Signs of inappropriate virilization (development of male secondary
sexual characteristics) in children and the possibility of secondary
testosterone exposure should be brought to a health care provider’s
attention.

In most of the cases, users of these products failed to follow
appropriate use instructions, resulting in direct contact between
treated skin and the child.
     
The required label
changes will provide additional information about the risk of secondary
exposure and the steps that should be taken to reduce this risk. The
FDA also is requiring that the manufacturers of these products develop
a Medication Guide as part of a Risk Evaluation and Mitigation Strategy
to ensure that the benefits of these products continue to outweigh
their potential risks.

The FDA recommends the following precautions be taken to minimize the potential for secondary exposure:

  • Adults who use testosterone gels should wash their hands with soap and warm water after every application;
  • Adults should cover the application site with clothing once the gel has dried;
  • Adults
    should wash the application site thoroughly with soap and warm water
    prior to any situation where skin-to-skin contact with another person
    is anticipated;
  • Children and women should avoid contact with testosterone application sites on the skin of men who use these products; and
  • Adults
    should note that use of any similar, but unapproved, products from the
    marketplace –including the Internet– that can result in the same
    serious adverse effects should be avoided.

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

Relevant Websites/Information

Androgel Androgel 002 Testim gel 002 Testosterone in a tube

Testim Video: How to apply Testim

What is Testim?

Testim Side Effects: MedicineNet.com

Androgel Side Effects: eMed TV

Testosterone Gels Risky to Children: Web MD

FDA Orders Label Warnings for Testosterone Gels: ABC News

Testosterone Deficiency: The Urology Channel

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you, or someone you know, has been injured in a motorcycle or
automobile (or similar) accident, please call me, Lowell Steiger,
immediately at

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Attorney General Brown Announces $62 Million Multi-State Settlement with Eli Lilly

Eli_lilly_62_million

Eli Lilly has settled once again for improperly marketing the antipsychotic drug Zyprexa.  I blogged on this subject earlier this year.  See Eli Lilly Settles Claims Over Zyprexa.  Then, later in the year, drug giant Merck settled cases over deceptive television advertisements. See $58 Million Merck Settlement To Change Deceptive TV Drug Advertisements.  Are the drug companies an evil empire?  Well, maybe so, but they are not beyond the reach of those that have our best interests in mind — i.e., Attorney General Edmund G. Brown, Jr.  Here’s the latest:

FOR IMMEDIATE RELEASE
October 7, 2008
Contact: Christine Gasparac: (916) 324-5500

Attorney General Brown Announces $62 Million Multi-State Settlement with Eli Lilly

SACRAMENTO—California Attorney General Edmund G. Brown Jr. today announced a record $62 million multi-state settlement with Eli Lilly and Company for improperly marketing the antipsychotic drug Zyprexa for use beyond the drug’s Food and Drug Administration (FDA)-approved uses.

“Eli Lilly put profits ahead of patients when it marketed Zyprexa for a use that had not been properly tested or approved, in many cases, putting young women at risk for weight gain, hypoglycemia and even diabetes,” Attorney General Brown said.

The settlement is the largest ever multi-state consumer protection-based pharmaceutical settlement. California will receive $5.6 million, the largest share of the award.

In his original complaint, Attorney General Brown alleged that Eli Lilly engaged in unfair and deceptive practices when it marketed Zyprexa for off-label uses and failed to adequately disclose the drug’s potential side effects to healthcare providers. As a result of the settlement, Eli Lilly agreed to change its marketing strategies and to cease promotion of its "off-label" uses. Off-label uses are those not approved by the FDA when it approves the sale and use of a particular drug. Physicians are allowed to prescribe drugs for off-label uses, but federal law prohibits pharmaceutical manufacturers from marketing products for off-label uses.

Zyprexa is the brand name for the prescription drug olanzapine. In 1996, Zyprexa was first marketed for use in adults with schizophrenia and belongs to a class of drugs commonly referred to as “atypical antipsychotics,” which are traditionally used to treat schizophrenia. The FDA has approved Zyprexa for the treatment of acute mixed or manic episodes of bipolar I disorder and for maintenance treatment of bipolar disorder. Zyprexa carries serious side-effects, including weight gain, hyperglycemia and diabetes.

Beginning in 2001, Eli Lilly launched an aggressive marketing campaign called “Viva Zyprexa!” As part of the campaign, the company marketed Zyprexa for off-label uses including pediatric care, high-dosage treatment, treatment of symptoms rather than diagnosed conditions and treatment of elderly patients suffering from dementia.

Stipulations in the settlement agreement require Eli Lilly to:
• Refrain from making any false, misleading or deceptive claims regarding Zyprexa.
• Require its medical staff, rather than its marketing staff, to have ultimate responsibility for developing and approving content for all medical letters and references regarding Zyprexa.
• Require its medical staff to be responsible for the identification, selection, approval and dissemination of article reprints containing more than an incidental reference to off-label information regarding Zyprexa.
• Provide specific, accurate, objective and scientifically balanced responses to unsolicited requests for off-label information from a healthcare provider regarding Zyprexa.
• Contractually require continuing medical education providers to disclose Eli Lilly’s financial support of their programs and any financial relationship with faculty and speakers.
• Provide a list of healthcare provider promotional speakers and consultants who were paid more than $100 for promotional speaking and/or consulting by Eli Lilly.
• Only provide product samples of Zyprexa to healthcare providers whose clinical practice is consistent with the product’s current labeling.

Other states included in today’s settlement agreement include: Alabama, Arizona, Delaware, District of Columbia, Florida, Hawaii, Illinois, Indiana, Iowa, Kansas, Maine, Maryland, Massachusetts, Michigan, Missouri, Nebraska, Nevada, New Jersey, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Dakota, Tennessee, Texas, Vermont, Washington and Wisconsin.

Read the Final Judgment Here.

Related Video

If you, or someone you know, has been injured, please call me immediately at (323) 852-1100 or send an e-mail to me at lowell@steigerlaw.com

"Treated With the Respect That You Deserve"

$58 Million Merck Settlement To Change Deceptive TV Drug Advertisements

Abcvioxx California Attorney General Edmund G. Brown, Jr., has brought Merck, the manufacturers of Vioxx, to its metaphorical knees.What brought about this "groundbreaking settlement"? 

“Merck’s aggressive television advertising convinced hundreds of thousands of consumers to seek Vioxx prescriptions before the drug’s risk were fully understood,” Attorney General Brown said. “Today’s groundbreaking settlement prevents Merck from releasing new television drug advertisements without obtaining federal approval.”

Merck is now stopped from releasing new television drug advertisements without obtaining federal approval.  The settlement places additional restrictions on Merck’s future conduct:

The settlement places other restrictions on Merck’s future conduct including:

• Prohibiting the use of deceptive scientific data when marketing new drugs to doctors
• Prohibiting Merck from “ghost writing” articles and studies for publication
• Requiring disclosure of conflicts of interest when Merck promotional speakers make presentations at supposedly independent Continuing Medical Education programs
• Requiring Merck to submit clinical trial results of FDA-approved Merck products to the National Library of Medicine

Read the entire Attorney General’s Press Release Here

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If you have suffered a Personal Injury, Call for a Free Consultation

Contact Attorney Lowell Steiger at (323) 852-1100

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Eli Lilly settles Claims over Zyprexa

Zyprexa  IndyStar.Com, Indiana’s Number 1 Local Media Site, reports the following:  INDIANAPOLIS — Eli Lilly and Co. has settled another 900 personal-injury claims against its antipscyhotic drug Zyprexa, including five set to go to court next month, thus avoiding what would have been the first trial in the U.S. The Indianapolis drug maker confirmed the settlement Wednesday but declined to reveal the amount. With the latest agreements, Lilly has settled more than 25,000 claims, leaving about 1,100 unsettled. Many of the plaintiffs have claimed Lilly underplayed the drug’s side effects, including weight gain and elevated blood sugar. Lilly has set aside $1.2 billion to pay claims. (Star report)

A google search on Zyprexa Litigation will refer you to a plethora of relevant links.

The Law Office of Lowell Steiger Represents Injured Victims

If you have suffered a Personal Injury, Call for a Free Consultation

Contact Attorney Lowell Steiger at (323) 852-1100

or via e-mail at lowell@steigerlaw.com

"Treated With the Respect That You Deserve"

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