Archive for January 2012

Jury Awards $72.6 Million in Hormone Replacement Therapy Cases

January 30, 2012

(January 30, 2012)  A Philadelphia Common Pleas Court jury last month awarded three women a collective $72.6 million in compensatory damages in their case against the drug manufacturer Pfizer.

 

The three women had alleged that they each had developed breast cancer after taking hormone therapy drugs such as Prempro, which were designed to treat their menopausal symptoms.

 

“Hormone therapy medicines are an important treatment option for many women with debilitating symptoms of menopause,” the statement said. “The FDA has regularly and thoroughly reviewed the benefits and risks of these medicines”, and states that, “hormone therapy is the most effective FDA-approved medicine for relief of hot flashes, night sweats, or vaginal dryness.”

 

One woman, Elfont, 66, a former Northeast Philadelphia resident, had taken hormone therapy drugs for more than two years before being diagnosed with breast cancer in 1997.  She was awarded $20 million. A second woman, Kalenkoski, 68, was diagnosed with breast cancer in 2002 and had taken the hormone therapy drug Prempro for more than four years. She was awarded $27.85 million. Mulderig, also 68, had taken both Premarin and Provera for eleven years before she received her breast cancer diagnosis.  She was awarded $24.75 million in damages.

 

A Women’s Health Initiative report released early last decade found that women taking hormone replacement therapy drugs experienced an increased risk in developing breast cancer.

 

It is truly surprising that doctors are still prescribing synthetic hormones to women for menopause symptoms such as hot flashes, despite the fact that all these dangers of synthetic hormones have been known for so many years.  These drugs also were promoted for off-label uses, including prevention of cardiovascular disease and Alzheimer’s disease.

 

These drugs were  never approved of by the FDA, and the drug manufacturer hid these calculated risks from thousdands of women (as well as doctors) throughout the United States just to keep up the profits.

 

It is important to do your own research before you take medicine prescribed by your doctor.  Sometimes, it is better to live with the uncomfortable symptoms such as hot flashes, than the possibility of developing breast cancer. Is this justice?

 

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PPI Drugs Cause Bone Deterioration and Fractures

January 29, 2012

(January 28, 2012)  Last month, an Arizona woman sued the makers of five prescription-strength antacids, alleging that her long-term use of the drugs caused her to sustain multiple bone fractures in her feet.  A few months ago, litigation in Texas alleged that 35 people suffered deterioration of bones and fractures resulting from side effects of Nexium, known as PPI’s, or proton pump inhibitors. Other drugs in the class include Prilosec, Prevacid, Aciphex and Vimovo. The plaintiff party is made of 34 women and one 9 year-old boy who all allegedly suffered bone issues after using Nexium.

 

PPI’s are also available in over-the-counter (OTC) versions like Prilosec OTC, Zegerid OTC and Prevacid 24 HR. These drugs are approved to treat conditions like heartburn, ulcers, acid reflux, and esophageal reflux disease (GERD), and other disorders.

 

In May 2010, the Food and Drug Administration (FDA) determined that Nexium, Dexilant, Prilosec, Zegerid, Prevacid, Protonix and Aciphex might include a warning on their labels regarding the possibility of fracture risk, stating proton pump inhibitors (PPIs) may interfere with the ability of our digestive tracts to absorb calcium.  In September, The New York Times ran an article stating that some medications, including PPIs, may increase our risk for bone loss and hip fracture.  Prilosec, Prevacid and Nexium (medications primarily recommended to treat gastroesophageal reflux symptoms and other conditions resulting from excess stomach acid) were listed.

 

Further backing the concerns of U.S. health care officials, there is new Korean research (published in the May/June issue of the Journal Annals of Family Medicine) that confirms the long-term use of PPIs is linked to an increased fracture risk.

 

The FDA’s review of several long-term studies, which reported an increased risk of hip, wrist, and spine fractures during treatment with PPI’s, promted the agency to revise labeling requirements for both the prescription and over-the-counter preparations to include warning of the risk of fracture.

 

Scientists found that women who smoke or have smoked in the past, who regularly used Nexium or another PPI, such as Prilosec, had a fifty-one percent increased risk of suffering a hip fracture. Some studies indicate that these fractures occur more often in those who use the medication for more than one year at a higher dose. Most of the people who took part in the study were age fifty and older; thus, the increase in risk of fractures occurred primarily in that group.

 

It is difficult to learn that the drug companies, as well as the FDA, knew about this risk before it was approved to be sold over-the-counter, making it available to millions of Americans. Is this justice?

 

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Supreme Court Rules GPS Tracking by the Government is Violation of Privacy Rights

January 27, 2012

(January 26, 2012)  In Washington, D.C. on Monday, a big victory for privacy rights took place when the Supreme Court ruled in United States v. Jones that the government violated the Fourth Amendment when police used a Global Positioning System (GPS) device on Antoine Jones’ car. The police tracked Jones’ whereabouts continuously for 28 days without a valid warrant in the criminal prosecution of Mr. Jones and Lawrence Maynard, two suspected cocaine dealers who ran a nightclub in Washington, D.C.

 

The Fourth Amendment is part of the Bill of Rights, which allows people to be protected against unreasonable searches and seizures, unless a warrant is issued by the Court upon probable cause.

 

The police secured a search warrant to place a GPS unit on Jones’ car, with the specific requirement that the unit be installed within ten days in The District of Columbia. However, it was not installed until the 11th day, and it was done in Maryland, not in The District of Columbia, as specified. Therefore, the installation was completed without a warrant, which is Unconstitutional.

 

The court held that the car is an effect, and therefore the right to be secure requiring a warrant in order to attach a GPS search device. While it is permissible for the government to follow someone and track them or their vehicle’s movements on public streets, placing a device on their car, without a warrant, is a violation of their Fourth Amendment rights, and not admissible as evidence against them.  This was the first time in 20 years the Supreme Court has had to consider the constitutionality of location-tracking technology.

 

In the case of Jones, authorities in favor of GPS-tracking insisted that installing a small, physically non-invasive device while an automobile is parked in public property did not necessitate a warrant, citing that the installation would be conducted in public space and would only track a vehicle on public roads.  Other forms of police surveillance done without a warrant would be the common practice of using remotely controlled aerial drones to monitor citizens.  Why is it not required to obtain a warrant to use cell phones as tracking devices?

 

The answer is not so clear. The courts are being introduced to many new, never-before discussed issues when it comes to technology, as the world around us is constantly being shaped by the rapidly evolving technological world. America thrives on the separation of powers: three branches of government which have specified roles as expressed by the Constitution. The reason this case is interesting is  because the Courts cannot create new laws, they can only rule on the laws already in place. Therefore, if it turns out that we believe the government should not need a warrant to place tracking devices on vehicles parked in public lots, we would need to have Congress (the legislative branch) pass a new law that permits this act.

 

And in the meantime, technology is still advancing.

Judge Rules Stents Did Not Violate Johnson & Johnson Patents

January 26, 2012

(January 25, 2012) In Trenton, New Jersey today, the federal district court ruled that stents marketed by Boston Scientific Corp., Abbott Laboratories, and Medtronic Inc. do not infringe upon Johnson & Johnson and its partner, Wyeth patents.   This was the latest decision involving Johnson & Johnson’s long-running battle with the courts.

 

The two patents at issue have to do with the drug used on the stents. Pfizer Inc.’s Wyeth manufactures the drug called sirolimus and licenses it to Johnson & Johnson’s Cordis unit. Sirolimus is used on Johnson & Johnson’s Cypher stent (the first drug-eluting stent approved in the United States), Boston Scientific’s Promus stent, Abbott’s Xience (essentially the same stent), as well as Medtronic’s Endeavor, which all use derivatives of sirolimus.

 

Sirolimus belongs to a group of medicines known as immunosuppressive agents. It is used to lower the body’s natural immunity in patients who receive kidney transplants.  When a patient receives an organ transplant, the body’s white blood cells will try to get rid of, or “reject”, the transplanted organ. Sirolimus works by preventing the white blood cells from getting rid of the transplanted organ. Sirolimus is a very strong medicine. It can cause side effects that can be very serious, such as kidney problems, and may also reduce the body’s ability to fight infections.

 

Johnson & Johnson, which pioneered the multi-billion dollar stent industry, announced in June that it was discontinuing stent sales at the beginning of this year, following years of declining sales and shares.  In 2010, Boston Scientific agreed to pay Johnson & Johnson $1.73 billion to settle other patent lawsuits between the companies regarding the stent battle.

 

The U.S. District Court in New Jersey ruled that the patents brought by Johnson & Johnson in lawsuits were invalid. Johnson & Johnson said it plans to appeal this ruling and declined commenting on financial specifics regarding the ruling.

 

Please stop by our website, or contact one of our attorneys at 1-800-246-HURT (4878) if you have any questions.

MS Drug Tysabri Approved for Use by the FDA

January 24, 2012

(January 24, 2012)  On Friday, the U.S. Food and Drug Administration (FDA) approved Quest Diagnostics’ Stratify JCV companion diagnostic test in order to reduce the risk for patients who are the most susceptible. JCV, or the John Cunningham Virus, linked to people diagnosed with multiple sclerosis (MS).

 

Tysabri is a miracle injectable drug used to treat MS patients as well as Crohn’s disease (CD).  About 400,000 people have MS in the United States alone, a debilitating disease in which the body attacks its own nervous system, and 50% to 60% of MS patients have JCV, Quest Diagnostics estimates. The JCV is a common virus that many people have been exposed to at some point in their lives, and is generally harmless. However, people with compromised immune systems, such as patients using immunomodulatory therapies like Tysabri, have an increased risk of developing progressive multifocal leukoencephalopathy (PML). PML usually causes death or severe disabilities.

 

Currently, there is no treatment, prevention or cure for PML, and no way to predict who will develop this dangerous disease.

 

Many patients who take Tysabri experience improved health, but face an increased risk of contracting a rare and potentially fatal brain infection known as progressive multifocal leukoencephalopathy (PML), which grows from the John Cunningham virus.

 

Biogen teamed up with Quest Diagnostics to develop an antibody test, which could identify patients whose exposure could put them at higher risk of PML, which causes brain swelling. Stratify is the first test of its kind designed to identify the virus in patients taking Tysabri and was developed by Biogen Idec and Elan.

 

Quest’s Focus Diagnostic Laboratory will offer the test in the United States. 

 

Doctors can use the results of the blood-based test, combined with the facts about the patient’s medical history, to determine whether they are at risk of developing the brain infection. Other factors that influence a patient’s risk include how long they have been taking Tysabri and whether they have previously taken additional medications that weaken the immune system.

 

In a separate action, the FDA announced updates to the drug label for Tysabri. The change includes information that testing positive for anti-JCV antibodies is a recently identified risk factor for developing PML in patients treated with Tysabri for MS or CD. 

 

The test is for professional use and by prescription only, and is to be performed only at Focus Diagnostics’ Reference Laboratory.

 

The label change could add a full $1 billion to 2016 sales of the drug, which Biogen sells in partnership with the Irish company Elan.  RBC Capital Markets analyst Michael Yee told the news service that Tysabri could reach $2.5 billion to $3 billion in revenues that year, compared with $1.5 billion to $2 billion without the change.

Hair Product Voluntarily Recalled Due to Potential Health Risk

January 24, 2012

January 23, 2012  The Missouri Department of Health and Senior Services received a recall of topical products, which contain 15% and 10% Minoxidil, used to treat male-pattern baldness.

 

Perfect Image Solutions, LLC is voluntarily recalling all lots of Men’s Minoxidil 15% Azelaic 5% Hair Regrowth topical, 60mL; Men’s Minoxidil 10% Azelaic 5% Hair Regrowth topical, 60mL; Men’s Minoxidil 5% Azelaic 5% Hair Regrowth topical, 60mL; Women’s Minoxidil 3% Azelaic 5% Hair Regrowth topical, 60mL; and Hair Regrowth shampoo, enhanced with Ketoconazole and salicylic acid, 180mL, to the consumer level. The products are deemed “unapproved new drugs” under the law and U.S. Food and Drug Administration regulations and may present potential health hazards.

 

Use of these topical products containing 15% and 10% Minoxidil have not been shown to be safe, and could pose a risk to the general public due to the possibility of systemic absorption. Skin abrasions or irritations, such as psoriasis or sunburn, could increase the systemic absorption of topically administered Minoxidil. Minoxidil 15% and 10% could cause low blood pressure, heart palpitations, and associated cardiac symptoms. Azelaic acid contained in the topical products could make the skin more sensitive to sunburn. Ketaconazole contained in the shampoo product may cause discoloration and abnormal hair texture, removal of the curl from permanently waved hair, itching, rash, skin irritation and dry skin. Salicylic acid contained in the shampoo could cause mild, temporary burning, itching, irritation, or stinging.

 

These products are used to slow or stop hair loss and promote hair regrowth, and are packaged in glass-dropper containers or plastic shampoo bottles, sold in single units. They are used by men and women, generally in their middle to late adulthood. The affected product lots include the following lot numbers and expiration dates:

Minoxidil

Product Name – Lots – Expiration – UPC Number

  • Men’s Minoxidil 15% Azelaic 5% Hair regrowth topical, 60mL. – All – Up until Oct. 2013 – 736211275813
  • Men’s Minoxidil 10% Azelaic 5% Hair regrowth topical, 60mL. – All – Up until Oct. 2013 – 736211276018
  • Men’s Minoxidil 5% Azelaic 5% Hair regrowth topical, 60mL. – All – Up until Sept. 2014 – 736211276117
  • Women’s Minoxidil 3% Azelaic 5% Hair regrowth topical, 60mL. – All – Up until Nov. 2013 – 736211274519
  • Hair regrowth shampoo enhanced with Ketoconazole and salicylic acid, 180mL. – All – Up until Dec. 2013 – 736211276414

Perfect Image Solutions, LLC has not received any reports regarding serious incidents associated with their products subject to this voluntary recall.

 

For more information or to view the full recall announcement can be found at: http://www.fda.gov/Safety/Recalls/ucm28855.htm?source=govdelivery

 

Perfect Image Solutions, LLC is notifying its distributors by phone and in writing, and is arranging for return of all recalled products. Consumers that have products that are being recalled should discard them.

 

If you have experienced any adverse side affects from using these Perfect Image Solutions, LLC products, please contact us, as you may be entitled to compensation. Stop by our website and Facebook page, or follow us on Twitter. If you’d like to speak to one of our attorneys, feel free to give us a call at 1-800-246-HURT (4878).

Johnson & Johnson Settles Risperdal Case for $158 Million (update)

January 22, 2012

January 22, 2012  They say everything is bigger in Texas. It seems as though settlement dollars is the exception. Last week, we posted that Texas and Janssen Pharmaceuticals Inc., one of the subsidiaries of healthcare giant Johnson & Johnson, were in litigation regarding false or misleading statements about the safety of Risperdal, an antipsychotic drug. The two sides reached a $158 million settlement in a Medicaid fraud lawsuit on Thursday, allowing the drug maker to pay only a fraction of the potential $1 billion initially sought for improperly marketing its Risperdal antipsychotic drug to state residents on the Medicaid program for the poor, including children.

 

The lawsuit was one of dozens of state and federal cases alleging that the company committed fraud by making false or misleading statements about the safety, cost and effectiveness of the expensive anti-psychotic medication, Risperdal, and providing kickbacks in an effort to boost sales, which ended up costing taxpayers millions of dollars. The lawsuit also alleged the drug maker falsely told doctors Risperdal was safe to use with children when federal regulators had not approved its use.

 

The settlement fully resolves all Risperdal-related claims in Texas, the company said, but is not admitting any liability or fault with the settlement. The agreement applied only to the state of Texas and does not involve other states or federal Risperdal litigation. Even though Johnson & Johnson is a multi-billion dollar pharmaceutical company, it seems odd that they would be willing to pay $158 million to settle the case, even though they will not admit any liability or fault. I’ll leave you to decide whether or not they were responsible.

 

The settlement will be paid to the original plaintiff, his lawyers, the state of Texas, and the federal government, which provides Medicaid reimbursements.

 

The Texas attorney general, who initially called on Johnson & Johnson to repay $579 million that the state’s Medicaid program had spent on Risperdal prescriptions, plus up to $500 million in penalties, called the settlement a warning to drug makers.  Analysts called the $158 million figure a “victory” for Johnson & Johnson, which made billions of dollars off Risperdal, because the deal allowed the company to avoid a much larger verdict in a state with a reputation of being an easy place to win big jury awards.  (The settlement is also far less than the $327 million Johnson & Johnson recently was ordered to pay in South Carolina and the $258 million it was ordered to pay in Louisiana in Risperdal lawsuits.)  As stated by a clinical professor at the University of Michigan’s Ross School of Business, Eric Gordon, “The legal team at Johnson & Johnson is doing high fives.”

 

To many Americans, Johnson & Johnson is the brand we used for our baby products, and has been trusted for so many years. To think that this healthcare giant cared more about the profits than the innocent children and adolescents who were being prescribed Risperdal without approval from the Food and Drug Administration is so horrible.  They certainly got off very easy in Texas! Is this justice?

 

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