Personal Injury Archive
Top 10 Drugs with Heart Side Effects on LawyersandSettlements.com
January 31st, 2012. By AbiK
In recognition of American Heart Month, which kicks off tomorrow (Feb. 1st), and National Wear Red Day (Feb. 3rd), LawyersandSettlements.com takes a look at our most-viewed drug lawsuit topics for 2011 in which heart attack or heart side effects were the alleged primary injuries.
Unfortunately, while a lot of focus this month will be on the positive measures we all can take to improve heart health—and that’s certainly important—it can be easy to overlook the negative heart side effects some drugs can have—and attention should be given to those as well.
As the chart at left depicts, Actos, Paxil and Zoloft accounted for the majority of 2011 traffic related to heart side effects, with Actos receiving the most at 25 percent. The Type 2 diabetes drug was released as an alternative to Avandia, which as you’ll recall came off pharmacy shelves as a result of the new FDA REMS program that became effective in November, 2011. Still, Avandia came in as the fourth most popular heart lawsuit topic.
Paxil, the popular antidepressant, has been linked to heart birth defects in infants and the drug drove in 18 percent of traffic last year. Ditto Zoloft, which accounted for 10 percent of the pageviews among readers concerned over the potential for heart birth defects.
The ten prescription drugs on the list fall into four distinct classes: Actos and Avandia are prescribed for the treatment of Type 2 Diabetes; Vytorin helps to control cholesterol, which has a direct impact on heart health; Trasylol is used during surgery to mitigate blood loss; the remaining drugs address depression and anxiety.
Reader interest in Prozac, Lexapro, Effexor, Celexa, Zoloft and Paxil shows continued concern surrounding pregnant women using selective serotonin reuptake inhibitors (SSRI) drugs and potential heart birth defects.
Here’s the full list:
Top 10 Drug Lawsuit Topics for Heart Side Effects in 2011
- Actos (Pioglitazone HCl)
- Paxil (Paroxetine)*
- Zoloft (Sertraline)*
- Avandia (Rosiglitazone)
- Celexa (Citalopram)*
- Effexor (Venlafaxine)*
- Lexapro (Escitalopram)*
- Prozac (Fluoxetine)
- Trasylol (Aprotinin)
- Vytorin (Ezetimibe/Simvastatin)
*SNRI (serotonin-norephinephrine reuptake inhibitor) or SSRI (selective serotonin reuptake inhibitors) drugs associated with heart birth defects when taken during pregnancy
Hair Restoration Society Issues Statement on Propecia Sexual Dysfunction
December 16th, 2011. By AbiK
We were waiting for this one. The International Society of Hair Restoration Surgery (ISHRS)—yes, there is such an organization—issued a press release earlier this week to state its position on the claims of Propecia sexual dysfunction that have been swirling around.
The ISHRS aims to quell concerns over reported Propecia side effects—namely those regarding sexual dysfunction, loss of sexual interest, and claims of infertility—by stating that there have been “no evidence-based data substantiating the link between finasteride and persistent sexual side effects after discontinued use of the drug in numerous, double blinded, placebo controlled studies conducted evaluating the use of Propecia 1mg for hair loss.”
Additionally, the ISHRS states that anecdotal reports of adverse events (as in erectile dysfunction) “should not define the safety and effectiveness of this drug”. Such a statement is reminiscent of that line about a disease being “rare” until you’re the one affected by it. True, some random report from a guy on Propecia having sexual difficulties is not perhaps indicative of a large-scale problem or cause for alarm. Unfortunately, though, the anecdotal reports are more than just a few one-off’s, and they are a cause of concern for the men who report them.
Propecia Erectile Dysfunction AERS Reports
According to drugcite.com–a website that aggregates data from the FDA Adverse Event Reporting System (AERS), there have been 363 adverse events reported to the FDA for Finasteride (Propecia and Proscar). Of note, the most common reported Finasteride adverse event is erectile dysfunction.
The numbers seem low at first glance, but hair loss and sexual dysfunction don’t tend to be topics that anyone really wants to “come out” about and certainly not call attention to. And that raises the question of underreporting—could it be that due to the nature of the side effects not too many men really want to come forward and first, admit there is a problem to themselves, and then take it a step further and officially report it?
Given the upward trend of AERS reports from 2009 to 2011, one can only surmise that as more information regarding Propecia sexual side effects has hit the mainstream media—for example, the recent story in Men’s Health magazine—perhaps the stigma of talking about it has been reduced a bit (“see honey, it’s not me—it’s that hair loss drug I’ve been on…“).
Propecia, Sexual Dysfunction and the Middle-Aged Man?
Of note, the ISHRS release mentions that sexual dysfunction can be hard (no pun there) to assess—after all, there are numerous factors that can contribute to such problems: “nicotine, alcohol, prescription medications, stress, anxiety, fatigue and depression”. And, according the the release which quotes a 2006 study in the Archives of Internal Medicine, incidence of erectile dysfunction in middle-aged or older men in the general population can be as high as 49%.
That make sense—except when you look at the anecdotal reports from Propecia users (some of which are on LawyersandSettlements.com) and see that the victims can be rather young—in their 20′s and 30′s, some even as young as 19. So not quite in that “middle-aged or older” group.
According to AmericanHairLoss.org, “Approximately twenty five percent of men who suffer with male pattern baldness begin the painful process before they reach the age of twenty-one.” The ISHRS itself states on its site that “Hair loss in men is likely to occur primarily between late teen-age years and age 40-50″—if so, it would appear that the statistic of E.D. occurring in potentially 49% of middle-aged or older men is somewhat irrelevant.
Anecdotal Propecia AERS Reports Lead to Task Force
Perhaps the most telling aspect of the ISHRS press release is the announcement that the organization has formed a task force to review the anecdotal reports of sexual dysfunction among certain Propecia users. While it’s certainly the responsible thing to do, it also somehow validates that there is growing concern over the drug’s potential for harmful side effects.
According to the release, the ISHRS has also reached out to “dermatologists, hair loss physicians, urologists, endocrinologists and sexual medicine specialists” to be a part of the task force and share their data and experiences with finasteride in a “fact-based manner”.
Undoubtedly there will be more to come—Propecia lawsuits included.
Week Adjourned: 12.9.11
December 9th, 2011. By LucyC
Top Class Actions
Seems Green Mountain may have been Roasting More Than Coffee. The company got hit with a securities class action lawsuit this week alleging it has been cooking the books.
The class action is brought against GMCR, certain of its officers and directors, and the underwriters of the Offering for violations of the Securities Act of 1933 and the Securities Exchange Act of 1934. GMCR, based in Waterbury, Vermont, is a leader in the specialty coffee and coffee maker businesses.
FYI—GMCR produces coffee, tea and hot cocoa from its family of brands, including Tully’s Coffee(R), and manufactures the popular Keurig single-cup brewing systems that use “K-Cup” portion packs.
The lawsuit alleges that, during the Class Period, certain defendants systematically and strategically manipulated GMCR’s revenues. To do so, defendants used one of GMCR’s key fulfillment vendors, M. Block & Sons (“MBlock”), as a captive warehouse to harbor expired, excessively manufactured, or otherwise unsold product. Pursuant to the fraudulent scheme, GMCR improperly booked revenues associated with falsified sales orders for hundreds of millions of dollars in K-Cup and Keurig Brewer products, which resulted in the material overstatement of the Company’s profits, inventory, and product demand levels. GMCR also fraudulently overstated its assets in proportion to its fictitious revenues by carrying the proceeds of phantom sales as assets on its balance sheet throughout the Class Period.
On October 17, 2011, David Einhorn, a prominent activist investor, released a comprehensive report, including witness testimonials by former GMCR and MBlock employees, disclosing GMCR’s misconduct and questionable relationship with MBlock. Following the release of the report, the price of GMCR shares fell approximately 10% from its closing price of $92.09 on October 14, 2011 to close at $82.50 on October 17, 2011, the next trading day, on unusually heavy trading volume.
On October 19, 2011, after Einhorn’s presentation was more widely distributed, the price of GMCR common stock fell another 15% to close at $69.80 on October 19, 2011, on unusually heavy trading volume.
Finally, on November 9, 2011, GMCR announced disappointing earnings results and skyrocketing inventory. On this news, GMCR shares dropped 40%, from a close of $67.02 on November 9 to a close of $40.89 on November 10, 2011, on extremely heavy trading volume.
The securities lawsuit has been brought on behalf of purchasers of the common stock of Green Mountain Coffee Roasters, Inc. (“GMCR” or the “Company”) between February 2, 2011 and November 9, 2011, inclusive (the “Class Period”), including purchasers of GMCR’s common stock pursuant and/or traceable to the Company’s public offering on or around May 5, 2011 (the “Offering”).
Top Settlements
HRT Breast Cancer Settlement. This one was all over the news this week. Three women who filed lawsuits against Wyeth Pharmaceuticals and Pharmacia Upjohn alleging that their diagnoses of breast cancer were directly attributable to their use of Hormone Replacement Therapy (HRT) drugs, were awarded $72.6 million by a jury in Philadelphia hearing their consolidated lawsuit. The jury awarded $20 million to Ms. Elfont, $27.85 million to Ms. Kalenkoski and $24.75 million to Ms. Mulderig, according to the plaintiffs’ attorneys.
The three women filed individual lawsuits in July 2004 against Wyeth Pharmaceuticals and Pharmacia Upjohn, both of which have since been acquired by Pfizer.
The back story, in brief, is that Elfont, 66, had taken hormone therapy drugs for over two years before being diagnosed with breast cancer in 1997. Sixty-eight year old Kalenkoski was diagnosed with breast cancer in 2002, having taken Prempro for over four years, while Mulderig, also 68, took Premarin and Provera for 11 years before she received her breast cancer diagnosis, the PennRecord reported. It’s tragic and shocking.
According to a Bloomberg News report, Pfizer’s Wyeth and Upjohn units have lost 10 out of the 18 hormone therapy cases against them in civil court trials since 2006. Earlier this year Pfizer announced it had settled a third of the pending Prempro cases, it had set aside $772 for related claims, Bloomberg reported.
Another Bank Biggie this Week… Bank of America (BofA) agreed a $315 million settlement in a securities fraud class action lawsuit that alleged the bank was misled about mortgage-backed investments sold by its Merrill Lynch unit. The settlement needs court approval in order to fly–and guess who’s making that decision? US District Judge Jed Rakoff–so all bets are off that this one get’s approved…
The Public Employees’ Retirement System of Mississippi pension fund led the lawsuit, alleging that the investments contained questionable subprime mortgages written by lenders Countrywide Financial Corp., First Franklin Financial, and IndyMac Bancorp – IndyMac went under in 2008.
Ok – That’s enough for this week. See you at the bar.
Asbestos News Roundup: 12.9.11
December 9th, 2011. By LucyC
A roundup of recent asbestos-related news and information that you should be aware of. An ongoing list of reported asbestos hot spots in the US from the Asbestos News Roundup archive appears on our asbestos map.
Asbestos News
New York, NY: Parks officials in New York have secured $15 million in funding for the building demolition of the former Kings Park (N.Y.) Psychiatric Center grounds. The project could begin as early as May 2012. According to a recent article in the Long Island Times Beacon Record, seven of the buildings set for demolition have been condemned because they contain asbestos or are unsafe to enter. A state parks official said tanker trucks will be used to wet down the demolished structures in order to prevent the asbestos dust from becoming airborne.
Asbestos contamination is always a concern when older buildings are renovated or demolished. Although asbestos is recognized today as a carcinogen by most authorities, including the Environmental Protection Agency (EPA), it was widely used in construction and building materials in the U.S. through the 1970s.
East Flushing, NY: Residents of the Pomonok Houses project in Queens, NY, are facing the reality that their homes are seriously contaminated with asbestos. Built 60 years ago, Pomonok Houses contains asbestos in the building and insulation materials, which is constant cause for concern among the residents.
According to an article in the Queens Tribune, the building managers have attempted to cover-up the fact that asbestos is present in the floor tiles in the majority of the units. However, an exterminator who was called in to deal with bedbugs confirmed the presence of asbestos, and the secret was out, the tenants say. So far, no one has come forward to remedy the situation. (mesothelioma.com)
Asbestos Law
Vancouver, BC: Arthur Moore of AM Environmental will receive sentencing on January 23, 2012, after being found guilty of ignoring orders from WorkSafeBC and the B.C. Supreme Court to stop exposing “vulnerable” workers to asbestos.
According to a report in the Vancouver Sun, WorkSafeBC inspectors found Moore did not provide employees with protective clothing while they were demolishing homes with asbestos-contaminated drywall. Some of those employees were reportedly as young as 14 years of age. Moore continued to operate in this manner despite restraining orders from the B.C. Supreme Court.
A lawyer for the Workers’ Compensation Board told Justice Richard Goepel that Moore “contrary to the court’s order exposed workers as young as 14 to a life threatening substance.” He said WCB statistics on the effects of asbestos were unequivocal.” Asbestos kills. It was the leading killer of workers in B.C. in 2009, responsible for 44 per cent of all deaths arising from employment.” Moore could be looking at a jail sentence of between 6 and 12 months. (Vancouversun.com)
Asbestos-Containing Products Alert
Fife, Scotland: A news report by the Courier–out of Scotland– indicates that the popular Chinese lanterns used by many to celebrate weddings, birthdays and memorials contain asbestos. The lanterns were the recent subject of an intensive investigation after officials discovered the problem. A trading standards officer from Perth and Kinross told the paper, ”The lanterns were coated in a form of asbestos and appropriate enforcement action was taken immediately to prevent their sale to the public.”
The investigation traced the manufacturer to China, although names were not released. While significant efforts have reportedly been made to improve the safety of the paper lanterns, low quality Chinese lanterns remain available on the market in the UK that should not be for sale. They may also be for sale in other countries.
Yaz Scandal? Doc’s Accusations v. Bayer Unsealed, Revealed
December 7th, 2011. By AbiK
Admittedly, it lacks the titillating quality of Warren Commission Report—but it could, in its own right, be linked to what some plaintiffs would likely describe as murder, and also conspiracy theory.
Earlier this week, expert opinion regarding Yaz birth control was unsealed in a federal court in Illinois. The expert opinion was in the form of a 196-page document written by Dr. David Kessler.
What’s interesting—or take your pick of adjectives here: damning, alarming, scandalous—is that Dr. Kessler’s report point-blank accuses Bayer of hiding critical data regarding Yaz’ blood clot link (the basis for numerous Yaz lawsuits right now).
According to Kessler’s conclusion, “By failing to disclose all thromoembolic event risk information and marketing Yaz and Yasmin off-label, Bayer needlessly exposed large numbers of women to risks of serious or fatal thromboembolic events.”
Kessler’s accusation of failure to disclose comes as a result of his claim that, in 2004, Bayer wrote a white paper draft—the white paper being what would ultimately be submitted to the FDA for review—that initially stated that Yasmin had a “several-fold” increase in DVT (deep vein thrombosis), pulmonary embolism and VTE (venous thromboembolism) when compared with three other commonly used birth control pills.
That was the draft version.
The version that Kessler states was submitted, according to Medpage Today, said, “The spontaneous reporting data do NOT signal a difference in VTE rates for Yasmin and other [oral contraceptive] uses. We see NO signal of a difference.”
Key to those edits, according to Kessler’s accusations, is that there was no additional data presented by Bayer to support the 180-degree turnaround in their conclusion.
According to MedPage, Kessler went on to state “…that Bayer presented a selective view of the data, and that presentation obscured the potential risks associated with Yasmin.”
Compounding this is Kessler’s assertion that Bayer extensively marketed Yaz off-label for PMS—for which Bayer did get a wrist-slap fine—but the aggressive marketing, it’s alleged, exposed a greater number of women to the potential risks of the drug.
The unsealing of the Kessler report comes mere days before the FDA Reproductive Health Drugs Advisory Committee is to meet. Their agenda: the risks and benefits of oral contraceptives that contain drospirenone (including Yaz, Yasmin, Ocella, Safyral). LawyersndSettlements.com has reported extensively on drospirenone-based birth control and its link to DVT and VTE.
Is a new warning label in the offing? Stay tuned.
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