Consumer Advocate Legal Update : Class Action Lawyers & Attorneys : Khorrami Pollard & Abir Law Firm : Mass Torts, Products Liability

Article by Crystal Yagoobian

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A federal jury in Virginia has handed Pfizer a defense verdict in a Prempro breast cancer lawsuit, saying that the plaintiff was properly informed about the potential side effects Prempro, a hormone replacement therapy (HRT). 

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Patients and consumers in Massachusetts now have the ability to know whether their doctors are receiving incentives to prescribe them certain drugs.   Recently, and as a result of a 2008 state law regulating industry conduct, Massachusetts became the first state to post an online database of payments from drug and medical device companies to its state’s health care providers. Since it is fully searchable by provider name, company name or payment category, this database is fairly user-friendly and comprehensive. It is a great tool for proactive consumers who wish to protect their rights and stay informed.  As a quick overview, over a six-month period, the drug and device companies reported made $35.7 million in payments, with almost half that sum going directly to physicians.  

Although Massachusetts has made important strides in this realm, consumers outside the state also have resources to turn to. Earlier this month, Andrew Brown of our firm commented on Propublica’s Dollars for Docs database, which compiles nationwide data about payments pharmaceutical companies have made to doctors for promoting their drugs. Propublica has published a series of articles discussing its database, and importantly has an instructional guide for patients explaining the best way in which Dollars for Docs can be used.

Massachusetts’ online database represents an important and empowering trend that consumers should be aware of. It is important to note that these payments are not illegal, but may be a cause for concern. Consumers are urged to use this data wisely to foster discussion with their health care providers when being prescribed new medications.  

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CNN reports that Johnson and Johnson has issued yet another recall.  Instead of making a public statement, as it did with its previous recalls earlier this year, the company quietly issued a statement on its website.  As a result of this latest recall, almost 5 million packages of Benadryl, Motrin, and Rolaids are being pulled off the shelves.  Specifically, the affected products include 4 million packages of Children's Benadryl Allergy Fastmelt Tablets in cherry and grape flavors, nearly 800,000 packages of Junior Strength Motrin caplets, and 71,000 packages of Rolaid antacids in cherry flavor soft chew.

Unlike the recalls earlier this year, the Company claims that the products do not fail to meet consumer standards, but are only being pulled because of manufacturing “insufficiencies.” J & J fails to identify the specific manufacturing issue. As for the Rolaids, the company issued the recall only after several consumer complaints of an “uncharacteristic consistency or texture traced to crystallized sugar in the product.”  

Although the company states that this is only a wholesale and retail recall and that consumers can continue to use the products, use your best judgment and proceed with caution.

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Prescription painkillers Darvon and Darvocet were pulled from the market Friday by their manufacturer, Xanodyne Pharmaceuticals, Inc. According to a report from CNN, Xanodyne reportedly pulled the drugs at the request of the Food and Drug Administration. Darvon is the brand name for the drug propoxyphene, and Darvocet is a brand name for propoxyphene mixed with acetaminophen.  Darvon and Darvocet have been approved for use since 1957, but officials at the FDA now believe the risks of using the drugs outweigh the benefits. The medications, which have been prescribed for 10 million people since 2009, can cause serious heart rhythm abnormalities that could potentially be fatal. Generic forms of the drugs are still available, but the FDA has asked manufacturers to stop selling them and recommended that physicians stop prescribing them.  

Controversy has surrounded propoxyphene for some time. According to an article in the Washington Post, Britain pulled the drug off the market six years ago, and Europe pulled it more than a year ago. Public Citizen’s Health Research Group has been calling for the U.S. to remove the drug for some time. In a statement issued on Friday, the group said that 1,000 to 2,000 people in the United States have died because of the drug since the United Kingdom banned it.

Patients have been advised not to stop taking it, but instead contact their doctors. Some have pointed out that stopping abruptly can cause withdrawal symptoms. For those that need to take painkillers, there are still plenty of other options out there. Consult your doctor on which one is right for you.

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For anyone whose life has been ruined by alcoholism, the chance to turn everything around with a shot in the arm must be appealing. Get an injection from your doctor and instantly repair every personal relationship that was destroyed by the disease. The appeal of such easy redemption is obvious, but it is also obviously a fantasy. The FDA has told one drug company that it cannot advertise that fantasy. Earlier this month, the Food and Drug Administration sent a warning letter to Alkermes, Inc., the makers of the alcohol-dependency drug Vivitrol. The drug is designed to decrease cravings for alcohol, but Alkermes has been advertising that it can do much more. The letter advised Alkermes that it had to stop distributing a DVD shown to potential Vivitrol users and a patient brochure because of exaggerated claims of efficacy. The DVD featured testimonials in which Vivitrol users said things such as this, from “Tina S.”:

“The money was going towards alcohol and not the kids. . . .  With the drinking, DSS got involved. . . . Julie at the clinic, she suggested Vivitrol. . . .  Since I’ve been on the shot. . . .  I feel better about myself now that I’m sober.  I’ve got a little bit more respect from the kids and that I feel like a mother now. Physically I’m in better shape than I was. . . . Couldn’t even crawl out of bed and now I’m back to work. . . .  My life has changed so much in the past year.  I’ve gotten remarried.  We’re working on the house and everything’s going pretty good.”

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Hot on the heels of an earlier blog which reported that postmenopausal women who take a combination of estrogen and progestin therapy face a greater risk for developing a more advanced form of breast cancer and an increased risk of death comes news that a new European study reports that women on post-menopausal hormone therapy had a 29 per cent greater risk of ovarian cancer, compared with those that did not use hormones. 

Investigators led by Konstantinos Tsilidis, a cancer epidemiologist at the University of Oxford in England, and funded by The International Agency for Research on Cancer (IARC), tracked data on 126,920 postmenopausal women who did not have a history of cancer and did not have their ovaries removed. After nine years of follow-up, 424 ovarian cancers had been diagnosed. 

Hormone therapy in the form of estrogen alone or in combination with progestin has been linked with many forms of cancer. It is important to note that when deciding whether to use hormone therapy, the American Cancer Society advises women to consider the following factors:  (1) The risk of breast, endometrial, ovarian and lung cancer; (2) The risk of other serious conditions affected by HRT . . . . like heart disease, stroke, and serious blood clots (DVT or deep vein thrombosis); and (3) Other medicines that may be used to treat menopausal symptoms or osteoporosis. 

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The latest trial dealing with the drug Fosamax is highlighting some of the risks of medications designed to treat osteoporosis. The New York Times reported on November 10, that the latest trial involving a plaintiff allegedly injured by the pharmaceutical drug Fosamax is underway in New York City. The plaintiff in the latest case is Judith Graves, a 67-year-old retired investigator for the United States Army. After taking Fosamax, Graves suffered jawbone death, a condition that involves debilitating jawbone deterioration. She had to have five operations, eventually having her jaw replaced with bone from her left arm.

Graves says Fosamax is to blame for her jaw troubles. Fosamax is an oral bisphosphonate manufactured by Merck. The drug is designed to prevent bone mass deterioration caused by aging. Graves’s case is one of several test cases against Merck that is being tried. There are roughly 1,400 other cases against Merck alleging injuries caused by Fosamax. Two test cases have already been tried, with Merck winning one and the plaintiff winning a multimillion dollar judgment in the other. We have filed cases on behalf of people injured by the drug. 

It is unclear how the Graves case will turn out, but as the New York Times reports, the case is serving as a backdrop for a larger debate about the proper use of oral bisphosphonates. Although the drugs have been shown to be effective in reducing bone fractures in postmenopausal women with osteoporosis, many doctors are concerned about the risks of prescribing them for too long. The Food and Drug Administration now requires the labels on Fosamax, Actonel, Boniva, Reclast, Atelvia, and generic versions, to state that the optimal period of use of these drugs is unknown. The fear is that long-term use of the drugs could cause not only jawbone deterioration but also thigh fractures. And for many these risks outweigh the benefits of prescribing the drug to women who have not yet developed osteoporosis. Others have commented on the dilemma this poses for doctors.

This trial underscores how important it is for patients on oral bisphosphonates to discuss the risks of these drugs with their doctors. Although they have saved people from the aggravation of broken bones, they carry considerable risks as well.

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Have you ever wondered if your doctor has ulterior motives in prescribing you a certain medication? Now you have a way of finding out if your doctor is being paid to promote certain drugs. 

Last month ProPublica launched its Dollars for Docs database, which compiles data about payments pharmaceutical companies have made to doctors for promoting their drugs. According to ProPublica, pharmaceutical companies routinely pay doctors to give presentations designed to teach other doctors about the benefits and risks of their drugs. In 2009, seven drug companies began disclosing information about these payments. ProPublica compiled this data, which totals $258 million in payments, into a searchable database. 

The website has also launched a series of articles analyzing the information in the database. They have already posted stories on paid presenters that have blemished records and limited credentials, and a breakdown of which doctors have received the most money from the pharmaceutical companies in the last couple of years. Although the database only covers payments made by a fraction of the total number of pharmaceutical companies, it still sheds some light on the process by which doctors learn about drugs and decide which ones to prescribe. It is also a way for patients to find out if their doctor may have a conflict of interest when it comes to writing certain prescriptions. As the ProPublica site points out, there is not necessarily anything wrong with doctors being paid to promote certain drugs, but it does raise ethical questions. The website has also posted a guide for patients on how to use the database, and what it means if their doctor has received money.

The database already has some calling for increased transparency in the world of pharmaceutical drug promotion.

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Most of us could not get through the day without our favorite caffeine-laden drink. The long history and widespread use of caffeine make us trust both its safety and effectiveness. For one British man, however, an overdose of pure caffeine was fatal. Pure caffeine, available in a wide range of forms, is widely available online and lightly regulated. The most common use of pure caffeine is as a beverage additive. Energy drinks have been found to contain up to 141mg of caffeine per serving, although the naturally occurring caffeine in a large coffee can be more than double that.  Sodas fall in the range of 20-55mg of caffeine. None of these products warn of the possible side effects of consuming excessive amounts of caffeine. This is not much of a problem for products with relatively low doses of caffeine, such as soft drinks, but the lack of warnings on containers of pure caffeine is disturbing.

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The other day I found a few articles discussing a number of lawsuits brought against doctors who prescribe deadly drug cocktails to treat Fibromyalgia (a little understood disorder characterized by pain, stiffness, fatigue and depression).  What has become known as an aggressive and “erratic, experimental and heavy drug cocktail treatment,” including prescriptions for oxymorphone, oxycodone, and notriptyline, has caused patients to near states of sedation for years. Marriages have collapsed under such treatment and patient employment has suffered. Some patients have even lost their lives to overdose.

The cases generally claim negligence, poor record keeping, and lack of oversight.  Doctors are simply failing to give proper instructions for use of prescriptions—often advising patients to manage their own medications and to adjust dosages to see what drug combinations work best. Doctors are failing to adequately monitor their patients. They overmedicate and mismanage patients’ prescriptions and medical records. But worst of all, doctors ignore overmedicated and addicted patient behavior leaving their patients vulnerable and without hope.

Deadly drug cocktails are not specific to patients suffering from Fibromyalgia. There are many other articles discussing deadly drug cocktails. Our soldiers, for example, die upon their return from war after being treated with drugs like Paxil and Seroquel for post-traumatic stress disorder. Deadly prescription combinations are triggered by the desire for weight loss as well. Celebrities are at risk too. Recall, Michael Jackson, who may have died from a combination of painkillers, including Demerol, Dilaudid, Vicodin, Soma, Xanax, Paxil and/or Prilosec and Anna Nicole Smith who died while taking numerous overlapping medications.  

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Ever wonder how to get rid of that pesky crying and laughing that was wearing out your facial muscles? Well you don’t need to wonder anymore, Avanir Pharmaceuticals has  developed a drug that was approved by the FDA on October 29, 2010 that will treat that condition.   Hopefully the sarcasm is obvious.

The drug is called Nuedexta and it will be used to treat patients who develop symptoms known as the pseudobulbar effect, which can usually be found in patients with neurological disorders and brain injuries.  The pseudobulbar effect has been called emotional incontinence where one has no control over laughter or tears. Sounds like a fake problem , well Avanir thought so and they unsuccessfully tried to change the name of the condition to involuntary emotional expression disorder.  

Not to take anything away from patients who suffer from something like this but when did it become the norm to treat “conditions” that are essentially harmless and out of one’s control. I mean, this drug is going to be marketed to people with serious underlying medical conditions to treat an uncontrollable action that poses no serious health risks.  Besides being driven by the profits that could be made from targeting this population, what other incentive would the pharmaceutical company have? I understand that uncontrollable crying or laughter may have an impact on ones social life or lead to embarrassment but is that outweighed by the known cardiac and hepatitis risks associated with taking the drug?

I previously wrote about the “condition”  that women go through and how pharmaceutical companies have found a way to help cure us. This too reminds me of how big pharma will find a way to help us deal with all of the “conditions” we may go through or “suffer” from in life. Is uncontrollable laughing a serious health risk, not really, but how about if there is a medication out there to treat it? Then people start looking at it as more than just an inconvenience, and now it is a condition that can be treated.  Perhaps one day prescriptions will only be used to treat serious ailments or at least provide measurable health benefits to the users……but I wouldn’t hold my breath.

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18 lots of Fentanyl Transdermal System 25-mcg/hour C-II patches are being recalled from store and pharmacy shelves because lab tests showed the active ingredient in one batch of patches was releasing medication into the bloodstream faster than the approved specifications permit. 

Fentanyl patches are a popular type of treatment for the management of moderate to severe chronic pain. The patches release a steady and controlled stream of opiod fentanyl through the skin. Release of this ingredient at an increased speed can lead to a variety of problems including breathing and respiratory issues, increased sedation, hypoventilation and apnea. Actavis Inc., the manufacturer of the drug, however, says it is not aware of any injuries linked to this issue. 

The recalled patches were manufactured in Grand Rapids, Michigan by Corium International, the same company that manufactured fentanyl patches for Actavis that were recalled in 2008 because of a leakage problem which had the dangerous potential of leading to an overdose.

The patches included in the recall have expiration dates varying from December 2011 to April 2012. While the safety alerts by the Food and Drug Administration and Actavis are targeting retailers and wholesalers, they are not telling consumers themselves to dispose of the patches they already have in their medicine cabinet.

The American Pain Foundation does not agree with this message and is taking measures into its own hands. The company has sent out email alerts to all its members and is willing to help consumers obtain replacement patches.   

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Pfizer, Inc. has issued the third of a string of recalls for Lipitor. As with the first and second recalls of the common cholesterol reducing drug, the instant recall is due to reports of an unpleasant odor related to the bottles in which the drug is packaged.  The company has identified the chemical 2,4,6-tribromoanisole, commonly used to treat wood pallets used to store and ship bottles, as the cause of the odor.   It is the same chemical which Pfizer’s competitor, Johnson & Johnson, attributed its recalls to earlier this year.

The instant recall affects 38,000 bottles containing 40mg tablets, bringing the total of recalled bottles of Lipitor to an estimated 360,000. 

Although the company claims that the chemical is not likely to cause adverse health consequences, the astounding number of recalls, including those related to household names, Tylenol and Benadryl, should make consumers  more aware of the potential harms of these commonly prescribed and over the counter drugs.  It is unclear if additional recalls will be issued, but in the meantime, be cautious of any foul odors or unusual qualities in any drug you take.

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The Division of Drug Marketing, Advertising, and Communications (DDMAC) of the U.S. Food and Drug Administration (FDA) has reviewed AMAG Pharmaceuticals, Inc.'s websites marketing its drug products, GastroMARK (an oral gastrointestinal imaging agent for delineation of the bowel) and Feraheme (an iron replacement therapy for individuals with kidney disease). 

The DDMAC found the websites for both drug products misleading and in violation of FDA rules.  Pursuant to a warning letter issued on October 18, 2010, it criticized AMAG for omitting the risks associated with the use of its two drug products, suggesting unapproved new uses for the products, and omitting important information about the approved indication for GastroMARK. 

FDA Concerns

• Both websites present numerous efficacy claims for GastroMARK and Feraheme but fail to communicate any of the risks associated with the drugs, e.g., the GastroMARK web page omits the drug's contraindication in patients with known or suspected intestinal perforation or obstruction;

• The GastroMARK website fails to present the complete indication for the drug, including material limitations to the indication, e.g., the GastroMARK web page fails to include that the drug is indicated only in adult patients, and that its usefulness in the lower gastrointestinal tract and retro-peritoneal region is limited by the transit time and dilution; and

• Both websites present both approved and unapproved product information for the products together, which implies that the drugs are effective for unapproved uses. 

According to the FDA, "[t]hese violations are concerning from a public health perspective because they suggest that GastroMARK is useful in a broader range of patients and conditions than has been demonstrated by substantial clinical experience, and that GastroMARK and Feraheme are safer than has been demonstrated by substantial evidence or substantial clinical experience."

As such, the DDMAC requested that AMAG immediately cease the dissemination of its promotional materials for both drugs and submit a written response to its warning letter no later than November 1, 2010.    

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Hormone treatment after menopause was originally studied by the Women’s Health Initiative (WHI) as part of a clinical trial established in 1992 to assess its relationship to coronary heart disease. Those studies were halted in 2002 when the results indicated that women taking a combination of estrogen and progestin had a higher risk of heart disease, stroke, and invasive breast cancer when compared to women taking a placebo. Now, a new study published October 20, 2010 in the Journal of the American Medical Association (JAMA) reports that these breast cancers associated with hormone treatment are more aggressive, more advanced, and have a higher mortality rate. 

The WHI continued to follow the women with breast cancer after the main trial had ended. Some earlier observational studies had suggested that hormone therapy induced breast cancers were less advanced and had a lower risk of death. However, this new WHI finding strongly contradicts those suggestions.   Combined hormone therapy increased the incidence of invasive breast cancer and in many cases the cancer had spread to the lymph nodes making it a more deadly form of cancer. Most significantly, it was found that the use of hormone therapy made the detection of breast cancer more difficult resulting in the cancer being diagnosed at a more advanced stage. 

For many years, menopausal women were treated with a combination of drugs to treat hot flashes and mood swings. Premarin, manufactured by Wyeth, contained estrogen, while Provera, manufactured by Pfizer’s Pharmacia and Upjohn, contained progestin.  In 1995, Wyeth combined the two hormones to form the medication, PremPro. Following the initial findings of the WHI in 2002 that linked estrogen and progestin to increased incidences of breast cancer, sales decreased dramatically. Sales of Premarin and PremPro were approximately $213 million in 2009, down from almost $2 billion prior to 2002. 

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KPA founding partner Shawn Khorrami was quoted in the Daily Journal article "Allergan's Botox Settlement Bodes Ill" appearing In the September 7, 2010 issue. Weighing in on the issue of a drug companies admission of guilt in pharmaceutical marketing, Khorrami doesn't agree recent settlements rest any plaintiff's case. The entire article can be read on the Los Angeles Daily Journal's website.

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In the last few days, it has been revealed that at least one member of the Avandia FDA Advisory Committee has been contracted as a paid speaker for Avandia manufacturer, GlaxoSmithKline.  Endocrinologist David Capuzzi did not promote GSK's Avandia, but has spoken on behalf of GSK's dietary supplement, Lovaza. Capuzzi voted for Avandia to be left on the market.

A different panel member also revealed he was paid to speak for Takeda, who produces Avandia's rival pharmaceutical, Actos.  Abraham Thomas has not had a professional relationship with Takeda since September 2008.  Advisory panel members are only required to report all financial relationships within the past 12 months, and since Thomas' relationship does not fall within this time line, there has yet to be an issue determined with his position on the panel. Thomas voted for Avandia to be pulled from the market.

The FDA is looking into the GSK/Capuzzi conflict-of-interest relationship, and will report their findings and possible courses of action to be taken at the end of this week.

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According to an article in today's LA Times, next week the FDA has scheduled a two-day meeting to determine the future of the popular diabetes pill, Avandia. 

The GlaxoSmithKline pharmaceutical, which is still on the market, has been linked to dangerous side-effects such as heart attack and death.  Consumers who have been affected by the drug are getting closer to receiving compensation for their damages, but the fight is still far from over.

This highly controversial pharmaceutical treats type II diabetes, which affects nearly 20 million Americans.  Studies by such organizations as the Journal of the American Medical Association are reporting on dangers of increased chances of cardiovascular threats from using Avandia over other diabetes drugs. 

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On June 2009, Roche Pharmaceuticals, manufacturer of Accutane, recalled the acne medication after having to defend several lawsuits filed by consumer who had been allegedly harmed by the drug.

The use of Accutane has been linked to the following gastrointestinal injuries:

• Inflammatory Bowel Disease
• Crohn's Disease
• Ulcerative Colitis
• Rectal Bleeding

If you or a loved one has taken Accutane and developed any of these injuries please contact us here to tell us about your experiences.

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On March 21, 2010, the United States Congress passed the Health Care and Education Affordability Reconciliation Act of 2010 (H.R. 4872). This legislation will reform the nation’s broken health insurance system by providing medical coverage to uninsured, vulnerable Americans who would otherwise not be able to receive adequate health care. Passage of this Act is truly a democratic success and a milestone in our nation’s history.

Such change does not come cheap. According to the Congressional Budget Office, health care reform will cost an estimated $940 billion over the course of 10 years. To offset the costs imposed on the government, the Act appropriately imposes tax increases on certain classes and industries. One such area is the medical device manufacturing industry.

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Aboutlawsuits.com reported today on the latest developments with the New Jersey Reglan lawsuits.  It looks as though the New Jersey state court system has until May 14 to make their decision on whether or not to consolidate cases from across the state. 

Almost a year ago, the U.S. Judicial Panel on Multidistrict Litigation denied a similar request for consolidation of the federal Reglan litigation, keeping all individual cases across the country as just that, individual cases. 

Will New Jersey start a trend that other states across the country are going to follow?  There seems to be a large amount of Reglan cases across the country, strengthening the possibility of consolidation at some level.

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The Los Angeles Times reported yesterday on the latest links between bisphosphonates (such as Fosamax) and atypical bone fractures.

This is yet another example of dangerous risks appearing long after the FDA approved a prescription.  Do you think pharmaceutical companies need to be more accountable when studies come to these types of conclusions?

Tell us what you think.

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Interesting piece in the New York Times Research section on parental views of vaccines and the possible link to autism.  This has been an ongoing debate, and scare, which has lead 1 in 8 parents to refuse a recommended vaccination for their young child. 

Read the entire article.

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This article, "Concerns Over 'Metal on Metal' Hip Implants," from Wednesdays New York Times, highlights the ongoing discussion and alleged danger of using certain hip replacement devices. 

Doctors aren't happy with the performance of many 'metal on metal' devices, and advise caution to other doctors and patents considering these systems.  Some devices have been recalled, and many are being replaced due to continued complications.  Learn more about metal hip implant devices, like the Zimmer Durom Cup.

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Coverage on the popular GlaxoSmithKline medicine, Avandia, has recently sparked due to a new Senate report.  Although hundreds of individuals suffer each month from the dangerous side affects associated with the drug, the drug still remains on the market.  A better look at these latest developments can be read in this NY Times article - "Research Ties Diabetes Drug to Heart Woes". 

Shawn Khorrami and James Kenna of KPA have been appointed to the JCCP Steering Committee for Avandia, and will continue to fight on behalf of those injured individuals. 

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If you have taken YAZ®, YASMIN® or OCELLA® and suffered from:

- HEART ATTACK

- STROKE

- DEEP VEIN THROMBOSIS (DVT)

- PULMONARY EMBOLISM

- GALLBLADDER DISEASE

Contact us immediately!

YAZ®, YASMIN® and OCELLA® have been linked to these serious side effects. If you or a loved one has suffered from any of these life-threatening injuries, you may be entitled to compensation!

Call 213.596.6530 or use our Contact Us page.

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In January 1999 Merck began their Vioxx Gastrointestinal Outcomes Research (VIGOR) study which compared Vioxx to naproxen, which is the active ingredient in some brand name pain relievers. At the conclusion of the study it was not only apparent that there was a lower incidence of gastrointestinal events in patients being treated with Vioxx , but more significantly there was a higher risk of cardiovascular events in those same patients. On March 27, 2000 Merck issued a public statement explaining those results:

Among patients treated with Vioxx, there was significantly reduced incidence of serious gastrointestinal events compared to patients treated with naproxen…………In addition, significantly few thromboembolic events were observed in patients taking naproxen in this GI outcomes study, which is consistent with naproxen’s ability to block platelet aggregation. This effect on these events had not been observed previously in any clinical studies for naproxen. Vioxx, like all COX-2 selective medicines, does not block platelet aggregation and therefore would not be expected to have similar effects.

Continue reading by clicking here.

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This article regarding a new analysis on antidepressant pharmaceuticals such as GlaxoSmithKline's Paxil, appeared in yesterday's New York Times.  According to the analysis, antidepressants effectiveness is directly correlated with the severity of the depression being treated.  Will findings like this slow down doctors from prescribing antidepressants to patients whose "depression" could only be due to something as simple as PMS or one bad day?

We want to hear what you think!  In your opinion, are doctors writing unnecessary prescriptions? 

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On my way to work today I was listening to my usual talk radio show and a male caller called in asking about menopause. He basically wanted to learn more about it because his wife was going through it and he knew nothing about it except that it was a “medical condition”. This comment bothered me, not so much because I am a women and defensive about the topic, but because it mirrored the opinion of pharmaceutical companies, that for years made a fortune on hormone therapy drugs convincing people of just that…….that menopause was a condition that must be treated.

Recent articles in the New York Times and Huffington Post paint the picture of how Wyeth lured women into taking their hormone drugs, not only to retain their femininity, but to prevent heart disease, Alzheimer’s and dementia. Feel like a woman while warding off evil ailments, what woman would say no to that? They turned menopause into a disease that had to be treated. Women who every month would curse the day their menstrual cycle began were now dreading the day that it would end.

I must say Wyeth did a good job creating and spreading their image of menopause. Hopefully, the negative image will be replaced with what menopause really is…….a natural biological process, nothing more, nothing less. Until then, I guess I will just wait for my impending “medical condition” to kick in.
 

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KPA Moves Forward in Complex Litigation on Behalf of Women with Breast Cancer Linked to Premarin and Prempro

Two multi-million dollar verdicts in Philadelphia last week against pharmaceutical company Wyeth, a division of Pfizer, reinforce that juries are consistently finding the company responsible for breast cancer in women who took its Premarin and Prempro hormone replacement therapy (HRT) drugs.

And just last month, a ruling from the 8th Circuit Court of Appeals confirmed that Wyeth did wrong, and that juries should be permitted to hear this evidence and determine whether the company should be punished.

In the verdicts announced last week, juries awarded Donna Kendall of Decatur, Illinois $6.3 million in compensatory and $28 million in punitive damages, and Connie Barton of Peoria, Illinois $3.7 million in compensatory and $75 million in punitive damages.

Through an ongoing federal multi-district litigation mass tort action, Wyeth still faces lawsuits from more than 10,000 women nationwide who claim that the company’s drugs caused their breast cancer. Of the 12 verdicts announced to date, plaintiffs have been awarded money in 10 of the cases. Every jury that has been permitted to deliberate on punitive damages has returned substantial awards.

To date, winning plaintiffs have been awarded a total of more than $42 million in compensatory and $165 million in punitive damages. In addition, 13 women have settled their HRT claims with Wyeth or Pfizer outside of court.

Shawn Khorrami, founding partner of KPA, is a member of the Plaintiffs’ Steering Committee for the MDL litigation team, and his firm represents around 150 individuals pursuing cases against Wyeth.

A press release on the firm’s involvement with the litigation was released today. For more information on the Barton and Kendall verdicts watch the video below.
 

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The world’s largest drugmaker, Pfizer, indicated it would challenge the latest verdict and an earlier verdict that went against Wyeth. A Philidelphia court recently ordered Pfizer to pay $28 million in punitive damages to a woman who is a breast cancer survivor. She was a consumer of Pfizer’s hormone replacement drugs for 11 years.

The drug giant inherited numerous personal injury lawsuits involving the drugs Premarin and Prempro. These drugs are prescribed by doctors to alleviate the effects of menopause. Pfizer recently acquired Wyeth. Provera is also sold by Pharmacia & Upjohn, the latter acquired by Pfizer in 2003.

There was a $4 million compensatory damages award and $75 million in punitive damages. This came after $6.3 million award that Pfizer was ordered to pay in compensatory damages when the jury concluded that the drugmaker failed to warn the consumer about the risks of the durgs Premarin, Prempro and Provera, which contributed to the plaintiff’s cancer.

A jury concluded that Pfizer’s actions warranted punitive damages because its actions constituted a reckless disregard for plaintiff’s safety, health and welfare. Pfizer, of course, intends to appeal, if post trial motions are unsuccessful. The company believes that neither liability nor punitive damages were supported by the evidence presented at trial. Both Wyeth and Pharmacia & Upjohn argued at trial that the drugs were approved by the U.S. Food and Drug Administration and known risks were included on the labels.
 

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A little while ago, I was at an event where an informal question and answer session was being conducted between two candidates for Assembly. One of the topics that stirred up a lively conversation was California’s Malpractice Injury and Compensation Reform Act of 1975(MICRA). When asked whether there should remain a $250,000 cap on pain and suffering in medical malpractice claims, one of the candidates said yes but that the cap should be raised. This response made little sense to me. Besides the fact that a number of sources have reported, that the main purpose of MICRA, which was to reduce healthcare costs, has been unsuccessful for 30 years, I don’t understand how raising the cap would achieve that goal any faster. If this candidate believed that there needs to be caps in order to keep healthcare costs down, then I don’t see how raising the caps would help. In other words, if the costs are down, which they are not, then why fix what isn’t broken. If the costs are high and we still need the cap to lower healthcare costs, then how would raising the cap lower costs when the existing cap did nothing to lower the costs for over 30 years?

It worried me that someone, who was educated, intelligent, and running for office, did not see the flaws in their understanding of MICRA. That they believed that the answer to this ongoing debate was to simply “raise” the cap, with no real thought as to what exactly the implications of that may be, if any. The bottom line is that more and more attorneys are unable to take malpractice claims for financial reasons, insurers reap the benefits of less and less lawsuits, and healthcare costs continue to rise so it seems that the ones who continue to be hurt by this Act are the very people whom the Act was intended to protect, the injured consumers.
 

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On October 5, 2009, the FTC announced approval of final revisions to the guidance it gives to advertisers on how to keep their endorsement and testimonial ads in line with the FTC Act.  The new guidelines, as explained in the official press release, require advertisers to affirmatively disclose when promotional claims regarding a product or service is not typical, and also make it clear that celebrities have a duty to disclose their relationships with advertisers when making endorsements outside the context of traditional ads, such as on talk shows or in social media. Perhaps the most significant revision, however, relates to the use of company sponsored research to promote a product or service. This practice has been a favorite tool of drug companies and the tobacco industry who seek to leverage sponsored research to promote the benefits of their products, or create the appearance of a scientific “debate” over risks. Under the new guidelines, the promotional reference to the findings of research sponsored by the company must be disclosed to the consumer.

A more detailed discussion of the New FTC Guidelines is addressed at the Bailey Class Action Daily at the link here.

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September 30, 2004 - Arthritis drug Vioxx was pulled from the market by Merck & Company after a study found the popular drug doubled the risk of heart attacks and strokes.
KPA is currently litigating hundreds of claims in the $4.85 billion Vioxx Settlement, and is in the process of filing settlement claims for individual disbursements.

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In March 2007, Caremark Rx, Inc. completed its merger with CVS Corporation. This union has had a significant negative impact on patients’ access to the pharmacy of their choice as Caremark Rx, Inc. has been forcing its insured to get their prescriptions from out-of-state mail order warehouses and away from their local community pharmacist.  In addition, CVS pharmacy benefit managers have steered patients to their own drugstores by raising co-pays for drugs bought elsewhere or by requiring that they be purchased at CVS.  This has particularly been difficult for some patients who have been with the same pharmacy for literally decades. 

Eight members of Congress — four Democrats and four Republicans — have asked the Federal Trade Commission in a letter to reopen its investigation into the 2007 merger, citing concerns about competition and consumer privacy.  In a letter signed by Reps. Anthony Weiner, D-N.Y.; Marion Berry, D-Ark.; John Boozman, R-Ark.; Michael Acuri, D-N.Y.; Mike Rogers, R-Mich.; Walter Jones, R-N.C.; Robert Aderholt, R-Ala.; and Lloyd Doggett, D-Texas, the lawmakers said the merger created opportunities for the company to enrich itself at the expense of competition and consumers. 

Among the company’s practices have been putting consumers on a “maintenance choice” program, under which they can only get their prescriptions by mail or at CVS pharmacies, without their permission; charging lower co-pays to members who fill their prescriptions at CVS pharmacies; misusing information collected by Caremark to find out if customers are using non-CVS pharmacies, and then advising them not to; and co-branding its prescription drug card in a way that falsely suggests it can only be used at CVS pharmacies, the letter said. 

While the FTC is looking into the issues revolving around the merger, privately owned pharmacies continue to lose their patients and long time customers thanks to the company’s practices.  We can assist these pharmacies in protecting their rights against such practices.

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In the largest settlement in United States Justice Department history, Pfizer agreed to pay $2.3 billion to settle claims of misbranding and off-label marketing of a number of its pharmaceutical products.  While the settlement covered 13 different drugs manufactured by Pfizer and its various subsidiaries including Pharmacia & Upjohn, the primary focus was on the conduct related to the anti-inflammatory drug Bextra, which was withdrawn from the market in 2005 amid reports of increased risk of heart attacks, strokes, toxic epidermal necrolysis, and Stevens Johnson Syndrome, a potentially fatal skin disease.  

The investigation of Pfizer and its questionable marketing practices was initiated as the result of whistleblowers inside the company. Sales representatives drew the line at attempts to increase profits when those sales meant risking the lives of the drug consumers. One would hope that a settlement of this magnitude would cause a major philosophical change in the way the drug companies do business in the future, but that prospect is unlikely because of the sheer profits to be made in this industry. Pfizer reported revenues of $48.3 billion in its latest annual review and had reserved funds to cover this settlement in 2008. 

An ‘agreement’ to plead guilty to a felony charge and pay $2.3 billion ($1.3 billion in fines, and an additional $1 billion to state and federal authorities to resolve civil allegations of fraud) might present a public relations nightmare, but Pfizer did not blink. Citing their dedication to healing and better health, a Pfizer spokesperson stated they were proud of the actions they have taken to strengthen their internal controls to comply with state and federal laws regulating their practices.   Pfizer also stated that corporate integrity is a top priority for the company and the conclusion of this matter allows Pfizer to focus on what they do best. 

What they do best according to Mike Loucks, acting U.S. Attorney for the District of Massachusetts, is blatantly disregard the law. While negotiating yet another agreement to resolve criminal conduct of Warner-Lambert, its newly acquired subsidiary, Pfizer was itself violating the same laws. Attributing unproven beneficial aspects to certain products while concealing potentially fatal risks, and bribing doctors are criminal activities, yet no one went to jail. There is no personal accountability here, which is why we will see this type of behavior repeated by other pharmaceutical companies. 

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The Supreme Court’s decision in Wyeth v. Levine, 129 S. Ct. 1187 (U.S. 2009), represents a victory for consumer advocates and a change in tide within the preemption debate. On March 4, 2009, the Court found Wyeth, the pharmaceutical giant, liable for the adverse affects of one of its drugs. Phenergan, which is administered intravenously to treat migraine-induced nausea, caused plaintiff Levine to suffer the amputation of her arm after an “IV push” injection of the drug caused irreversible gangrene. Wyeth argued that the Food and Drug Administration’s (“FDA”) regulations preempted Levine’s lawsuit, but the Court disagreed. 

The Court expressly rejected Wyeth’s preemption argument for two reasons: (1) state law claims did not obstruct the FDA’s authority to regulate drug labeling; and (2) the evidence actually suggested that Wyeth had long ignored reports showing the dangers of injecting the drug using the IV push method. In fact, the Court observed that Wyeth could have “analyzed the accumulating data and added a stronger warning about IV push administration of the drug.” The Court also rejected Wyeth’s companion arguments, which spouted the impossibilities of complying with both state law and the FDA’s regulatory scheme and the danger of allowing a “lay jury’s decision about drug labeling” act as a substitute for the “expert judgment of the FDA.”

The Court’s decision was welcomed by consumer advocates who previously feared that pharmaceutical companies like Wyeth would be insulated from liability, especially given the Bush Administration’s expansive view of preemption. Following the Wyeth decision, President Obama made his narrowed view of preemption known when the White House released a memorandum on the subject. On May 20, 2009, President Obama asked heads of agencies and departments to reevaluate their preemption policies, advising them only to issue preemptive statements “if [they are] supported by sufficient legal principles.” President Obama’s memorandum symbolizes a return to traditional federalist ideals, emphasizing the importance of state laws and the ways in which they work in tandem with federal laws to create safeguards for the public. 

In the months following Wyeth, advocates on both sides of the preemption debate have spoken out. Those in favor of preemption call the Wyeth decision “catastrophic” for patients and doctors.   They foresee an insurmountable stall on new drugs entering the market; new drugs that could help combat serious illnesses like cancer and HIV/AIDS. Other analysts are shocked that this medical malpractice case reached the Supreme Court at all, let alone resulted in a lay jury determining the adequacy of a federal agency’s regulatory scheme. Consumer advocates, on the other hand, view the decision as a triumph for the little guy, meaning consumers like Levine. . However, both sides agree on one thing: consumers will test the durability of the Wyeth decision to see just how much liability pharmaceutical companies will bear in the future. 

In any case, Wyeth is not the last time we will see the preemption issue under scrutiny. But, for now, consumer advocates and victims of pharmaceutical drug companies can relish in this victory and rest assured that they have preserved their right to hold pharmaceutical companies accountable in court. 

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