Posts Tagged ‘ Pfizer ’
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.
Score One for the FDA as Rest of World Finally Yanks Thelin
January 3rd, 2011. By Hunter West
Time to give credit where credit is due. And this time, the US Food and Drug Administration (FDA) got it right.
Recently it was announced, in a joint statement by Health Canada and Pfizer Canada, that Thelin (sitaxsentan) was being taken off the market in Canada, as well as every country in which it had been sold, due to risk for potentially fatal liver damage.
Never heard of Thelin? There’s a reason for that. Thelin is not available in the US. Never was. That’s because the FDA refused to approve the drug designed to treat pulmonary hypertension. In the view of the FDA, the benefits did not outweigh the risks.
In a bid to win FDA approval for marketing Thelin in this country, Pfizer Inc. launched a series of clinical trials. However, those trials have been abandoned following the deaths of three trial participants.
According to a report in the Globe and Mail, Canada’s national newspaper, liver damage was a known complication of Thelin. However, in announcing that it was abandoning further clinical trials, Pfizer noted that it had discovered a ”new potentially life-threatening idiosyncratic risk” of liver injury among patients that is difficult to predict or guard against.
Thus, there will be no further clinical trials, and Thelin will be coming off the market in Australia, Europe and Canada where it had been previously approved. Given the known risks associated with Thelin, Canadians are wondering how Thelin ever won Health Canada approval in the first place.
The FDA has been maligned, chastised, ridiculed and kicked to the curb over the appearance of lax oversight both in the approval, and ongoing supervision of drugs and medical devices. And to be sure, much of that criticism is warranted.
However, on this occasion the FDA stuck to its guns and has been vindicated. There can be Read the rest of this entry »
Big Pharma Lawsuits – Who Got Hit with the Biggest Settlement?
October 25th, 2010. By LucyC
It seems that every month practically, one pharmaceutical company or another makes the news for bending rules around marketing. Mis-marketing, which could also be called consumer fraud, can result in serious, if not life-changing consequences for people making decisions about their health.
Recently, I came across a list of the largest settlements paid by 11 pharmaceutical companies for bending the rules. The fines total a staggering $6 billion. The more frequent offender, according to the company that compiled the list, is Eli Lilly. They paid more than $1.4 billion in fines all for various violations for just one drug—Zyprexa.
And then there’s Pfizer, who paid $2.3 billion for ‘mis-marketing’ a number of drugs including Bextra, Geodon, Lyrica and Zyvox.
These drugs are used to treat everything from schizophrenia to epilepsy to diabetes, and the consequences of not having the correct information may have resulted in serious adverse health events, possibly even death for some.
Not surprisingly, people tend to be very interested when the big boys get caught behaving badly, for a variety of reasons, not the least of which being that we feel our trust has been betrayed. We trust drug companies, and the medical profession in general, to give us the straight goods because it’s a matter of life and death. Why would you not be straight about that? Well, the answer is, not surprisingly, money. And lots of it. But eventually the offenders do get caught. And that leads to drug lawsuits, criminal investigations and ultimately, very large fines.
So, without further ado—here’s a list of the big offenders—who took them on, what for and how much they paid, with acknowledgement to FiercePharma.com who actually did the homework on this.
Novartis
With: U.S. Attorney’s office for the Eastern District of Pennsylvania
When: Sept. 30, 2010
Why: Novartis agreed to a $422.5 million settlement with the Eastern District of Pennsylvania for its off-label promotion of Trileptal and other allegations against Diovan, Exforge, Sandostatin, Tekturna and Zelnorm. (oh, and ps, Novartis is recruiting for a Senior Brand Manager for Prevacid…)
Forest Labs
With: Dept. of Justice
When: Sept. 15, 2010
Why: After marketing Levothroid, an unapproved thyroid drug, Forest Labs received a $313 million penalty. The settlement also covered Forest’s off-label use of Celexa for children’s use.
Allergan
With: Dept. of Justice
When: Sept. 1, 2010
Why: Allergan’s was fined $600 million by the Department of Justice. The settlement was broken into two parts: $375 million in fines and $225 milion in civil penalties, all of which stemmed from its off-label use of Botox for headaches, pain management and cerebral palsy.
Elan
With: U.S. Attorney’s Office in Massachusetts
When: July 15, 2010
Why: Elan received a $203.5 million fine for its marketing of Zonegran, an epilepsy drug.
Johnson & Johnson
With: Department of Justice
When: April 29, 2010
Why: Though J&J is most recently famous or a rash of phantom recalls, two of the troubled drugmaker’s subsidiaries received a $81 million penalty for off-label promotions of Topamax, an epilepsy drug.
AstraZeneca
With: U.S. Attorney’s office in Philadelphia
When: April 27, 2010
Why: In the same week as the J&J settlement, AstraZeneca was fined $520 million misleading doctors and patients about the safety of its antipsychotic drug Seroquel.
Abbott
With: Twenty-three states
When: Jan. 7, 2010
Why: In a case involving 23 different states, Abbott Laboratories and its partner, Fournier Industrie et Sante, were ordered to pay $22.5 million for blocking the states from obtaining a cheaper alternative for its cholesterol drug, TriCor. (btw, Abbott Labs is the one who brought you beetle parts in Similac, causing the recent Similac recall…)
Eli Lilly
With: Connecticut
When: Sept. 29, 2009
Why: A total of 13 states total had filed suit against Eli Lilly for Zyprexa marketing issues, but the company was ordered to pay $25 million to Connecticut in this ruling.
Eli Lilly
With: West Virginia Attorney General
When: August 21, 2009
Why: In another Zyprexa case, West Virginia Attorney General Darrell McGraw levied $2 billion in fines against Eli Lilly. In the end, the company agreed to $22.5 million in fines.
Merck
With: 35 states’ attorney offices
When: July 15, 2009
Why: Following a 35 state investigations into the Enhance study of Vytorin, Merck paid $5.4 million in fines, without admitting fault in the cases.
Sanofi-Aventis
With: Department of Justice
When: May 28, 2009
Why: In an agreement with the federal government, Sanofi paid $95.5 million total, to the federal government, state Medicaid agencies and other public health service agencies, all for its subsidiary Aventis’ nasal spray price inflation between 1995 and 2000.
GlaxoSmithKline
With: U.S. Attorney’s office in Colorado
When: Jan. 29, 2009
Why: After seven years of off-label promotion on nine of its best-selling drugs, GlaxoSmithKline (GSK) was ordered to pay $400 million to the U.S. Attorney’s office in Colorado.
Pfizer
With: Department of Justice
When: Jan. 26, 2009
Why: Right after acquiring Wyeth, Pfizer dropped a bombshell in its fourth quarter earnings report; the company was charged $2.3 billion for off-label promotions of its COX-2 drugs.
Eli Lilly
With: Department of Justice
When: Jan. 15, 2009
Why: In the first Zyprexa settlement (and one of three on our list), the Department of Justice levied $1.4 billion in fines against Eli Lilly. Also, as part of the settlement, the company pled guilty to a misdemeanor: violating the Food, Drug and Cosmetic Act.
Week Adjourned: 5.29.10
May 29th, 2010. By LucyC
Kiss the week goodbye…Memorial Day Weekend here we come!
Top Class Actions
Demented Segmented Marketing. A couple of former employees who blew the whistle on Wyeth in 2005 by filing a lawsuit against the pharmaceutical company refiled an amended complaint this week, alleging that the company illegally promoted its kidney transplant drug Rapamune for use with other organ transplants—the Swiss Army knife of meds!— for which the drug is not indicated. You know—heart, lung, liver, pancreas—essential organs—that kind of thing…
And , yes—there’s more, the complaint claims Wyeth targeted African American patients, who are a high-risk patient group, despite the lack of evidence to support its use in this population. Sadly, this all sounds par for the course by now. Oh—by the way—Wyeth is now owned by Pfizer, and Pfizer, if you recall, settled a whistleblower lawsuit in September 2009—paying $102 million to six whistleblowers who brought a suit over its marketing and promotion of the prescription arthritis medication Bextra, and ordered to pay $2.3 billion in civil and criminal penalties. Pfizer also agreed to plead guilty to a felony charge for promoting Bextra and 12 other drugs for unapproved uses and dosages.
Anyway—back to Rapamune. The two whistleblowers who filed the suit are ex-Wyeth sales reps— their turf was hospitals—so they are in position to know. The list of allegations on the complaint is pretty lengthy and makes for some shocking reading. But it boils down to illegal promotion and kickbacks in exchange for prescriptions written. Thing is, this could affect numerous transplant recipients across the country:
”Despite limited data on high-risk patients, Wyeth targeted transplant centers that catered primarily to African-American patients, typically in urban areas. In 2005, Wyeth’s sales management selected Philadelphia’s Einstein Medical Center as a center on which to focus a Wyeth marketing plan designed to rapidly increase or accelerate Rapamune sales in a 90 day period. Einstein’s transplant patient population was approximately 75 percent African-American in 2005,” the suit states.
Nice to know these folks had the patients’ best interests at heart…no pun intended.
Top Settlements
New Wal-mart Recycling Program: Lawsuits? It’s business as usual for Wal-Mart—one of our profoundly regular, if not ignorant contributors—has settled yet another employment class action this Read the rest of this entry »
Pfizer’s Secret Friend
April 9th, 2010. By Hunter West
Mom and Dad told us not to be ‘too big for your britches.’ However in the Land of Big Pharma, that basic chestnut of moral integrity need not apply…
Remember the debacle over Bextra? Pfizer was found to have actively marketed the drug for off-label use, for things not approved by the US Food and Drug Administration (FDA), and was called to the carpet over it, paying about $2 billion in penalties.
However, it could have been a lot worse, according to a special investigation by CNN that found Pfizer escaped the expected death knell in such cases by being permanently excluded from Medicare and Medicaid.
Most know the story of Bextra, the Cox-2 inhibitor that Pfizer brought to the painkiller market in 2001 with big plans. Cox-2 inhibitors were thought to be safer than generic drugs.
Also more expensive, coming in at 20 times the cost of ibuprofen.
Nonetheless, the plan was to market Bextra for acute pain, such as that experienced by patients following surgery.
Enter the FDA, which put a noose around Pfizer’s neck when it decreed that Bextra was not safe for patients at high risk for heart attack and stroke. Thus the approval was limited to pain treatment related to arthritis and menstrual cramps.
Undaunted, the marketing and sales arms of Pfizer—allegedly without knowledge of top executives—set to work circumventing that regulatory authority by promoting its use off-label to anesthesiologists, orthopedic surgeons, “anyone that use[d] a scalpel for a living,” according to the words of one district manager.
There were other lapses in marketing judgment that flew in the face of regulatory decorum. In the end, by the time Bextra was Read the rest of this entry »
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