Posts Tagged ‘ Johnson & Johnson ’
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: 11.4.11
November 4th, 2011. By LucyC
Top Class Actions
Could this mean resolution for thalidomide victims?…New research suggests that thalidomide—a drug that caused thousands of horrific cases of deformities in children—caused far more deformities in the U.S. than were reported during the height of the pharmaceutical crisis of the early 1960s.
Invented by German drug company Grunenthal, thalidomide was widely used throughout Europe during the late 1950s and early 1960s, resulting in thousands of deaths and extreme, disfiguring birth defects when used by women during pregnancy. The drug was never approved in the United States, but the new lawsuit filed late October 2011 alleges that as many as 2.5 million doses of the drug were distributed by more than 1,200 doctors to more than 20,000 people, including pregnant women.
Newly discovered and translated documents reveal that Smith, Kline and French (SKF), now owned by GlaxoSmithKline (GSK)conducted a trial of the drug in 1956 and 1957, but buried the evidence, allegedly resulting in a missed opportunity to save thousands of lives.
Instead, according to the filed lawsuit, brought on behalf of 13 men and women with severe birth defects, SKF concealed the results of its trial from the public, allowing another company, Richardson-Merrell, now owned by Sanofi-Aventis to move ahead with large-scale “clinical trials” that involved more than 20,000 people, including pregnant women.
The lawsuit also claims that conclusions made in the early 1960s about the types of birth defects caused by the thalidomide were incorrect.
According to legal counsel, researchers concluded that thalidomide causes bilateral birth defects, such as two missing or shortened arms or hearing loss in both ears. As a result, babies born with unilateral defects, such as one deformed limb, or hearing loss in only one ear were not deemed thalidomide victims, even when their mothers were given the drug while pregnant.
However, new research involving thalidomide as part of a treatment regimen in cancer patients show that many of the assumptions used in the 1960s are incorrect. The thalidomide lawsuit alleges that this new understanding of the drug means that many individuals who experienced unilateral defects may have been misdiagnosed when their doctors told them thalidomide could not have been the cause.
“Among other things we intend to show in court that thalidomide does not work through a neural mechanism as previously thought, but affects the vascular system,” a lawyer for the plaintiffs said.
The complaint claims that the defendants are either guilty of or liable for a civil conspiracy, failing to report and covering up evidence that thalidomide was harmful, especially when taken during the early stages of pregnancy. The lawsuit also says that the defendants were negligent in continuing to manufacture, test and distribute the drug.
Top Settlements
Motrin SJS Verdict. This is one for the books. Let’s hope it makes a difference. On October 3, 2011, a Los Angeles jury returned a record-setting verdict against Johnson & Johnson and their fully owned subsidiary McNeil Consumer Healthcare for $48.2 million—with pre-interest and cost of judgment it’s expected to reach $60 million. The lawsuit alleged that Motrin caused SJS/TENS or Stevens Johnson Syndrome (SJS), also known as Erythema Multiforme, Leyll’s Syndrome, and in its later stages, Toxic Epidermal Necrolysis (TEN). SJS/TEN is a serious and potentially life-threatening disease that causes large areas of the skin to become detached and lesions to develop in the mucous membranes.
The verdict was based on findings of malice towards the consumers of the over-the-counter drug Motrin, specifically for not putting a warning label on the product that could have spared Trejo’s and others’ health. This is believed to be the first verdict of its kind involving punitive damages associated with this over-the-counter temporary pain reliever.
At age 16, Christopher Trejo, who is now 22 years old, took some Motrin as directed on the label for less than one week, but contracted TEN. It caused a severe inside-out exfoliating reaction affecting all of his mucosal membranes, which is equivalent to second- and third-degree burns over 100% of his body. The TEN reaction also caused severe pulmonary damage, near-blindness, infertility, whole-body scarring and a hypoxic brain injury. Trejo’s abilities to see, hear, smell, taste and touch have been severely diminished.
After hearing the evidence, the jury found that the labeling on Motrin was inadequate and should have been changed years earlier to properly educate and alert consumers to the developing signs of severe reactions, which include skin reddening, rash and blisters. Early detection and treatment of these symptoms can prevent TEN or SJS.
Apple Playing the Same Old tune? Apple, Inc., has agreed to settle a consumer fraud class action lawsuit that could amount to over $50 million dollars in payouts—but before you get all excited know this “Apple has agreed to provide an iTunes® Store credit in the amount of $3.25 to all settlement class members who qualify and submit a valid claim form. ” That’s the skinny.
The lawsuit claimed that Apple advertised and sold gift cards which stated that if one purchased and used the gift card, all songs purchased at Apple’s online iTunes® Store would cost 99¢ per song. The lawsuit further claimed that in April, 2009, Apple raised the price of certain songs at the iTunes® store, yet refused to honor the promised 99¢ price when the gift cards were redeemed. In addition, the company continued to sell iTunes® gift cards with the phrase, “Songs are 99¢” printed on them.
Consumers who were overcharged for iTunes songs while using iTunes® 99¢ gift cards are now eligible to receive an iTunes® Store credit in the amount of $3.25 after completing the simple iTunes® class action lawsuit online claim form. Millions of e-mails are currently being sent to persons who may have used affected gift cards to purchase songs from the iTunes® Store.
You can find out how to make an Apple iTunes lawsuit claim here.
Ok—That’s enough for this week. See you at the bar—don’t forget your iPod.
Understand the Pharmaceutical Representative Overtime Lawsuits? Here’s Help
March 25th, 2011. By Kristine B
If not, you’re not alone. In fact, even the courts have reached contradictory rulings in the pharmaceutical representative overtime lawsuits they’ve seen. While the pharma reps won the Novartis lawsuit, they lost the Johnson & Johnson and GlaxoSmithKline lawsuits. Those losses, however, don’t mean that pharmaceutical sales reps should just give up. In each case, the judges relied on different legal issues and exemptions, which is how such different results were achieved. Pleading Ignorance takes a look at what’s been going on…
First, the Backstory: the Fair Labor Standards Act
Under the Fair Labor Standards Act, certain employees are considered exempt from overtime pay. Those exemptions include outside sales employees and people who are considered “administrative”. Outside sales employees are considered exempt because they are paid on commission and therefore have an unlimited earning potential. Furthermore, many outside sales people work independently of an office and therefore have a say in what hours they work and how they go about their job. To be considered exempt from overtime pay, however, outside sales people must spend at least 50 percent of the time in their job involved in sales.
Administrative people are those who exercise independent authority, judgement or discretion in their job. They have a great deal of discretion in their job activities and how they fulfill their employment requirements.
Lawsuits have been filed against various pharmaceutical companies alleging that pharmaceutical sales reps do not fit either the outside sales exemption or the administrative exemption.
Novartis Sales Rep Overtime Lawsuit
In the Novartis lawsuit, the court found that the pharmaceutical reps were misclassified as exempt from overtime pay—meaning they should receive pay for overtime hours worked. In reaching the decision, the court found that Novartis sales representatives were not directly involved in the sales transaction. Instead, the reps informed physicians of a product’s benefits and encouraged physicians to prescribe Novartis products. At no point during the visit did the sales rep actually engage in a sales transaction.
Furthermore, the court found that the Novartis reps didn’t fall under the administrative exemption because Novartis controlled the sales pitches and reps were not allowed to deviate from that pitch. Additionally, the reps did not have the authority to in any way direct or interpret Novartis policies or procedures. Because the courts found the Novartis reps were not exempt under the outside sales or administrative rules, the reps are therefore, according to the courts, eligible for overtime pay.
Johnson & Johnson Sales Rep Overtime Lawsuit
A lawsuit against Johnson & Johnson, however, resulted in a different decision. In that case, the pharmaceutical sales representative was found to be exempt from overtime pay under the administrative employee guidelines. In that case, the court found that the plaintiff was able to develop her own itinerary, could visit some doctors more frequently than others and was expected to develop a plan to obtain more sales. The court found that the plaintiff worked without direct oversight most of the time and therefore had discretion and independent judgment required for the administrative exemption.
GlaxoSmithKline Sales Rep Overtime Lawsuit
In GlaxoSmithKline’s lawsuit over pharmaceutical representative overtime pay, the courts backed GlaxoSmithKline’s decision not to pay the reps overtime. In this case, unlike Johnson & Johnson, the court determined that GSK sales reps fall under the guidelines of outside sales representatives because they are motivated by commissions and they have freedom to work outside the office.
So it currently appears that whether or not a pharmaceutical rep is eligible for overtime pay is somewhat determined by which court hears the lawsuit and by which company you work for and how much authority you have in your job.
The court’s decision in GSK actually contradicted a brief filed by the US Department of Labor that supported pharmaceutical reps being paid overtime. So, even though the Department of Labor supports overtime for pharmaceutical reps, there’s no guarantee that the courts will agree with it. More lawsuits are still to come and the Supreme Court might wind up determining the whole thing in the end. As of now, though, there’s no reason for pharmaceutical representatives to give up the fight.
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.
Children’s Motrin: Another Example of a Toothless FDA
September 24th, 2010. By Hunter West
A controversy emerged this week over an alleged agreement between the US Food and Drug Administration (FDA) and Johnson & Johnson subsidiary McNeil HealthCare over a ‘soft’ recall of Children’s Motrin and other products that were thought to be defective due to lax GMP (Good Manufacturing Practice) at one of McNeil’s facilities.
The allegation, if true, suggests that one arm of the FDA doesn’t know what the other is doing. It also appears to suggest—again—that so long as the FDA does not have the mandate to force a drug company to conduct a recall, or do anything it doesn’t want to, for that matter, the federal drug regulator is like a tiger without teeth.
As for the drug companies, it appears as if they subscribe to the credo, “don’t ask permission, beg forgiveness.”
According to documents and testimony at a congressional hearing this week, the FDA had decided that Motrin product, which had been identified as defective due to GMP problems at the facility where it was manufactured, should be subject to a Class 2 recall.
There are various levels of recall identified by the FDA, with a Class 1 as the most serious. The latter is urged if there is a problem that could lead to serious health effects or even death. Class 2 is suggested if the problem could cause temporary, or medically reversible adverse health consequences.
Further, a Class 3 is issued if a product defect is not likely to cause serous health consequences at all.
Then there’s the ‘market withdrawal,’ which according to CNN Money on Tuesday is not a recall Read the rest of this entry »
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