Posts Tagged ‘ Merck ’
Week Adjourned: 1.21.12
January 23rd, 2012. By LucyC
Top Class Actions
Holy HELOC Batman—It’s been certified! A class action lawsuit brought by a couple in Cupertino in 2009—and which has been through 4 attempts to get certified—finally got the nod from a federal court judge this past week. And this one could affect many people.
The back story—Washington Mutual and JPMorgan Chase (Chase has since acquired WaMu) allegedly reduced credit limits on Jeffrey and Jenifer Schulken’s home equity line of credit (HELOC) without valid reasons.
Specifically, the HELOC class action lawsuit alleges violations of the Truth in Lending Act violations and unfair competition among other claims. The Cupertino couple allege they were informed by Chase, by letter, that their home equity credit lines would be suspended because they did not have enough monthly income to satisfy their debts. The Schulken’s allege that the monthly income of $11,200 that Chase claimed the couple stated on their applications, was inaccurate, that they had never “provided such an inflated income figure to WaMu, and that if the Schulkens’ file indicated such an income, then WaMu had intentionally misrepresented their income.”
After four attempts by Chase to have the complaint dismissed, two classes have now been certified: the “inability to verify” class, and a subclass of borrowers whose credit lines were suspended because Chase could not verify their financial circumstances.
The plaintiffs’ class definition to include “only those members who signed contracts that (1) arise from heritage WaMu customers, and (2) state that the borrower must provide, upon the lender’s request, ‘a current financial statement, new credit application, or both.’”
Top Settlements
Couple of big pharma settlements announced this week…
At the top of the hit parade we have Johnson & Johnson (J&J). They have reportedly agreed to pay $158 million to settle a lawsuit in Texas that alleges the company defrauded the state by misleading doctors about its antipsychotic drug Risperdal.
The deal will put an end to claims that J&J marketed Risperdal off label—for unapproved uses—and downplayed health risks associated with the drug. Texas had originally sought at least $579 million in damages. Well, shoot for the stars—isn’t that how the saying goes?
Bloomberg reported that the settlement follows some rather incriminating testimony given in court last week. Testimony that included an expert eye witness stating that J&J hid data showing Risperdal could cause weight gain that could lead to diabetes. According to Bloomberg “the witness also alleged that J&J had key study [ Study 113] results several years before it added warnings about weight gain to the drug’s label.”
Bloomberg notes in its report that J&J’s unpublished studies—ah—yes—more than one—were cited in a South Carolina case that brought a $327 million judgment against the pharmaceutical manufacturer. “It is apparent to this court that this information was not disclosed because if did not fit the marketing department’s vision for the promotion and marketing of this drug,” Judge Roger Couch wrote in a ruling (as quoted by Bloomberg). Amen to that.
And singing from a similar song sheet—we have Merck. It was announced this week that they have agreed to pay up to $37 million to settle a Canadian Vioxx class action lawsuit. Included in the settlement is $10 million for costs and fees. Plaintiffs’ lawyer said up to 2,000 Canadians may be eligible for compensation.
FYI—Vioxx (Rofecoxib) was on the market from 1999 to 2004, prescribed to patients as a pain-reliever for arthritis, osteoarthritis, menstrual pain, and other acute pain. Vioxx was recalled and pulled off the market when it was linked to deadly side effects heart attack, stroke, kidney damage, and arrythmia. This led to billions of dollars’ worth of litigation, including a $4.85 billion settlement that covers most of the U.S. plaintiffs.
Ok—That’s a wrap for this week. See you at the bar!
Week Adjourned: 11.26.11
November 28th, 2011. By LucyC
Top Class Actions
Do you know who’s got your personal information? An unfair business practices class action lawsuit has been filed in the Southern District Court of Florida against Best Buy Corporation for violating the Drivers’ Privacy Protection Act or “DPPA”, a federal statute that protects the privacy of personal information assembled by State Department of Motor Vehicles (DMVs).
The lawsuit alleges Best Buy has established a business practice of taking, storing, using and/or sharing customers’ personal or highly restricted personal information, without consent, when customers make a normal return of Best Buy merchandise. Their receipt indicates that Best Buy “tracks exchanges and returns … and some of the information from your ID may be stored in a secure, encrypted database of customer activity that Best Buy and its affiliates use to track exchanges and returns.”
The DPPA specifically prohibits Best Buy’s conduct and was instituted to protect consumers from abuses such as identify theft and stalking, which often result when information is unsecured and improperly stored. The class action alleges that Best Buy’s retention of data accessed on a driver’s license is not “use in the normal course of business” as described by the DPPA.
Top Settlements
What’s that old adage—if it sounds too good to be true… Power Balance LLC, the company that made Power Balance bracelets, has reportedly settled a consumer fraud class action lawsuit this week for $57.4 million and filed for federal bankruptcy protection. The details and amount of the Power Balance settlement remain to be confirmed, although it’s all over the Internet.
The company was sued over allegations of misleading advertising, advertising that allegedly claimed the hologram-embedded rubber bracelets enabled the wearers to “achieve their best,” a statement that begs the question—best what? Best outlandish claim? Possibly. Although the company claims there’s science to back up the statement. I have one word—and it’s “placebo.”
About time: Merck Vioxx settlement. There’s not much that’s funny about this. Merck, Sharp & Dohme has agreed to pay $950 million to resolve criminal charges and civil claims related to its promotion and marketing of the painkiller Vioxx (rofecoxib), the Justice Department announced. The FDA approved Vioxx for three indications in May 1999, but did not approve its use against rheumatoid arthritis until April 2002. In the interim, for nearly three years, Merck promoted Vioxx for rheumatoid arthritis, conduct for which it was admonished in an FDA warning letter issued in September 2001.
Merck is also entering into a civil settlement agreement under which it will pay $628,364,000 to resolve additional allegations regarding off-label marketing of Vioxx and false statements about the drug’s cardiovascular safety. Of the total civil settlement, $426,389,000 will be recovered by the United States, and the remaining share of $201,975,000 will be distributed to the participating Medicaid states. The settlement and plea conclude a long-running investigation of Merck’s promotion of Vioxx, which was withdrawn from the marketplace in September 2004.
The parallel civil settlement covers a broader range of allegedly illegal conduct by Merck. The settlement resolves allegations that Merck representatives made inaccurate, unsupported, or misleading statements about Vioxx’s cardiovascular safety in order to increase sales of the drug, resulting in payments by the federal government. It also resolves allegations that Merck made false statements to state Medicaid agencies about the cardiovascular safety of Vioxx, and that those agencies relied on Merck’s false claims in making payment decisions about the drug. Finally, like the criminal plea, the civil settlement also recovers damages for allegedly false claims caused by Merck’s unlawful promotion of Vioxx for rheumatoid arthritis.
Ok—That’s the week that was. Hope everyone had a wonderful Thanksgiving!
Thousands may have Claim for Pharmaceutical Sales Rep Overtime
March 2nd, 2011. By LucyC
Well, it looks like the little guys could have it. Yesterday, February 28, 2011, the US Supreme Court announced that it would not reconsider appellate court decisions against Novartis and Merck Schering regarding unpaid overtime class actions.
Essentially, this means that Novartis may have to pony up $100 million or more in back overtime as settlement for some 2,500 plaintiffs.
In so doing, the Supreme Court leaves intact two separate decisions against Novartis and Schering Corp. In July 2010, the 2nd Circuit issued a pair of rulings that found the pharmaceutical sales reps were covered by federal wage-and-hour law.
But—it ain’t over as the expression goes—until the fat lady sings. At least half a dozen pharmaceutical companies are tied up in overtime suits, according to various media sources, and yesterday’s US Supreme Court decision presents a major conundrum. According to the attorneys that represented the Novartis employees, the various rulings against the pharmaceutical companies have ‘opened the floodgates for liability.’ This same law firm is currently representing plaintiffs in four identical wage-and-hour lawsuits against Pfizer, Roche, Merck and Abbott Laboratories. So the bigger question is—does this decision translate into overtime requirements for all pharmaceutical sales reps? (Now we’re talking tens of thousands of workers.)
That remains to be seen, in part because the courts themselves are guilty of issuing conflicting information—other appellate court decisions have decided in favor of the employers. The reason? It’s all down to interpretation. A report in the Star-Ledger indicates that this Supreme Court ruling was partly based on a brief from the Department of Labor that supports the sales’ reps stance on qualifying for overtime pay. As far as Novartis is concerned, they intend to evaluate ‘all legal options.’ Part of an email published in the Star-Ledger, from Novartis, states, “For decades, companies in the pharmaceutical industry have classified their sales representatives as exempt employees and have compensated them on a pay-for-performance basis, the same way they compensate executives, managers and other professionals.”
And, in a brief submitted by Merck, the pharmaceutical company reportedly wrote that another appellate court concluded that “no deference was owed to DOL’s new interpretation expressed in its brief.”(Star-Ledger). Of course Merck isn’t too happy about the Supreme Court ruling either. The company inherited an overtime lawsuit against Schering-Plough, when it acquired SP in 2009.
It doesn’t help that the Supreme Court offered no comment whatsoever on its decision: an explanation making clear their reasons for their decision could have helped in reducing the likelihood of further legal wrangling—which will almost certainly occur because the stakes here are high indeed.
The Pharmaceutical Research and Manufacturers Association (PhRMA), which is the leading trade group representing the US pharmaceutical industry, had argued in its petition to the Supreme Court that the lower court’s decision had “potentially far-reaching ramifications’’ for the industry, and called the decision against Novartis an error. “The decision unexpectedly exposes PhRMA members to potentially staggering retroactive liability from lawsuits by current and former employees,’’ the brief stated. “Serious consequences loom because of nothing more than an unexplained change in the Department of Labor’s interpretation of its regulations.’’ (Star-Ledger)
Of course, none of this changes the fact that the reps who filed the suit against Novartis—more than four years ago now—did put in the time—as much as 70 hours per week, according to their lawyers.
Frankly, I can’t help thinking that the whole debate around unpaid overtime is just a little too Dickensian for 2011, and that a little more clarity would go a long way to improving the situation for both sides.
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.
Is Your Doctor Getting Cash from Big Pharma? Find Out
October 20th, 2010. By AbiK
It’s been a good year for Dr. Firhaad Ismail. Indeed! Financially speaking, that is. See, according to the info over at ProPublica, in their Dollars for Docs report, Dr. Ismail took in no less than $303,558 from big pharmaceutical companies GlaxoSmithKline (GSK…the folks who brought you Avandia and Paxil), Eli LIlly, and Merck.
Now, Dr. Ismail is just one of 384 doctors nationwide who’ve received payment from big pharma. Ismail is based in Vegas (clearly, if ProPublica’s involved, what goes on in Vegas is not staying in Vegas) and his specialty is Endocrinology and Metabolism. And he appears to do a fair amount of consulting on the topic. On big pharma’s dime.
Dr. Ismail may be the best damn doctor there is in his specialty. I don’t know. But what I do know is that the ProPublica report indicates that Dr. Ismail received a total of $209,400 from GSK alone. Recall what area of practice Dr. Ismail is in…Endocrinology. What does Endocrinology deal with? Well, diabetes for one. And last I checked, Avandia is a type 2 diabetes drug made by GSK.
I’m just putting on the table what’s already out there. I’m not saying there’s any unsavory relationship here…but I the jaded skeptic in me does raise a little eyebrow…
Needless to say, I’ve been checking out my own doctors over at ProPublica.com. You can, too. Just hop over to Dollars for Docs and do a search for your doctor’s name, by state. You can also find a full list there of all the doctors nationwide.
Let us know what you find…and if you think doctors receiving funds from big pharma presents a conflict of interest.
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