News, musings and commentary on dietary supplements & pharmaceutical law issues, technology, and litigation.
No advice, though.
Lawyers for consumers and injured people.(No advice on this blog, though) TOLL FREE 855-525-3955
Image via CrunchBaseAnother busy week comes down to the wire. I cannot tell you how much fun the Android phone is, both for business and for personal. I did promise to keep the app reviews business -centric, so here goes another installment.
1. App for Note Taking: Evernote. Evernote is a collection of software and services that allows users to collect, sort, tag and annotate notes and other miscellaneous information.The notes that you take with the Evernote app can be accessed from both your Android device and your computer. You can quickly add a text note, audio note, photo snapshot, or file upload to your library from any of your devices.
2.ThickButtons: I'm always amazed by the simplicity of the app brands, because if I have to explain
one like this, well you sir are a lost cause. ThickButtons visibly enlarges the keys that the phone predicts you'll type next, so if you're typing the word "Annoying" and you get to the "o", it'll enlarge the letter "Y" (among other letters it thinks you can possibly hit next). The iPhone actually does this invisibly, but ThickButtons does this...visibly.
3. Cam Scanner: This one turnes your phone into a document scanner.
I'm giving this one a try now. I've had decent success with it - if you like it - or not - let me know.
Image via WikipediaAn interesting read from the web this morning from the NEJM.
Premature, low birth weight babies face a minefield of issues when brought into the world. One of most serious issues is the propensity for retinal blood vessels to grow amuck in response to erratic biochemical signals; these vessels can bleed and scar, leading to retinopathy of prematurity (ROP) — a major cause of childhood blindness in the developed and developing worlds.
The NEJM asks this question, and answers it in part:
So why not directly inhibit VEGF? Bevacizumab is a humanized monoclonal antibody that does just that. Soon after it was approved to arrest new blood supplies to colon cancer metastases in 2004, doctors began using the inexpensive, easily administered drug off-label to treat a neovascular condition similar to ROP: age-related macular degeneration. Case series have suggested that it works for ROP, but now we have more definitive proof.
In a prospective multi-center trial reported inNEJM this week, researchers from the University of Texas Health Science Center at Houston randomized 150 infants with posterior, stage 3+ ROP in zones 1 and 2 to receive either the standard confluent laser therapy (CLT) or an intravitreal injection of bevacizumab (IVB) in each eye. Stage 3+, defined by prominent new blood vessels growing between the vascular and avascular regions of the eye (the + indicates the vessels are twisted), may be the optimal time for treatment—after VEGF has promoted normal vascularization and before the vessels have formed fibrous bands that would permanently disrupt the retina. The zone refers to the concentric region of retina affected (zone 1 disease includes the optic nerve and is the hardest to treat). The researchers’ primary goal in this federally sponsored study was to prevent recurrence of ROP in one or both eyes before 54 weeks postmenstrual age.
It's a compelling read for those parents, family members, and folks touched by a child with ROP. Find the source here.
"Some products available in your drug or grocery store, like Triaminic Fever Reducer, do not have their product names approved by FDA. Drug companies can capitalize on a well-known, trusted, brand name, and use it for any variation or formulation of that product."
Also from the author this advice: "Keep in mind that over-the-counter medications are required to have an approved “Drug Facts” label to educate consumers. Since the entire product ingredients are listed, make sure to read the label to prevent medication errors that could be harmful to you or your family."
Read it here:
Image via WikipediaMerck gains a defense verdict in the first of many state-court lawsuits in which its Fosamax osteoporosis drug is blamed for causing so-called jaw death.
the Plaintiff was Alison Rosenberg. She argued that she developed osteonecrosis of the jaw, or ONJ.
The jury answered “no” to the first question on the verdict form: Was it more likely than not that Rosenberg had the condition she claimed? The vote was 9 to 1. Because the first answer meant victory for the company, the panel didn’t have to answer three other questions.
Merck has now won defense verdicts in 2 of 3 trials.
70,000 syringes of the drug Invega Sustenna have been recalled after finding that some of the pre-filled syringes may have cracks which possibly could affect the drug's sterility.
Pharmacists and health care providers received a letter at the end of last week letting them know of the voluntary recall, and which lots of its 234-milligram-strength injections are affected. The crack is completely covered by the label and is not detectable by the user.
Lester Tate nails it. His letter to the AJC talks not about litigation overall, just about how the justice system is not properly funded. What that means is that Courts must deal with overcrowded criminal court dockets, drug trials, divorce cases, and collection lawsuits by the hundreds.
I attended a hearing calendar in one county. Of the 164 cases that were in front of the Judge that day, I counted more than 125 default hearings on lawsuits involving bad debt. There were 2 personal injury matters, and the rest were business versus business matters.
Here is his letter:
What do “jobs” and “justice” have in common? According to an economic study released last week by the State Bar of Georgia, a lot. Increased caseloads in recent years, combined with reduced budgets for the court system, have cost Georgians thousands of jobs and our economy hundreds of millions of dollars.
As a trial lawyer who has spent 23 years of my life trying all types of cases in courtrooms across this state, I know the importance of “justice.”
But to folks like my father, who lost his job while I was in college when the mill where he worked shut down and who had never set foot in a courtroom except as a juror, “justice” probably seemed pretty far removed from daily economic life.
The state bar’s study, however, found the judicial system to be one of the state’s leading economic development foundations. Specifically, the study found that the efficient handling of “cases impacts both the business and social climate of Georgia.”
This is particularly true in the past decade, when a massive increase in the number of cases filed in our state’s courts was accompanied by an 8 percent overall decline in judicial funding.
When courts become less efficient because of more cases and fewer dollars, Georgia businesses and individuals bear the cost of delays. The slowdowns lead to higher costs, more business uncertainty and reduced productivity. Time and money that should be put to use making goods, providing services and creating jobs instead get spent waiting for justice.
Using a widely accepted statistical methodology, the Washington Economics Group estimated court slowdowns cost Georgia between 3,457 and 7,098 jobs throughout the state. That’s between $176 million and $375 million in annual wages for white-collar and blue-collar workers alike. Considering all factors, the total negative impact is between $337 million and $802 million on Georgia’s economy each year.
Such an economic loss has a profound effect on the lives of all citizens, from the single mother needing to collect child support to the corporate board of directors trying to decide whether Georgia or some other state is the best place to do business.
Business, community and political leaders cannot afford to ignore the courts as an important component of our economic recovery.
Certainly, elected officials at the state and local levels have struggled recently in trying to balance their budgets, particularly after three years of plummeting revenues.
But judicial budget cuts have in fact unwittingly contributed to the economic decline responsible for these budget deficits. Between 2008 and 2009 revenue from fines and fees in Georgia courts declined by $52 million because of slower courts, and the new study estimates annual lost income tax revenue caused by court delays at between $51 million and $115 million annually.
In other words, the cuts cost as much or more money than they saved, and that’s only the direct result.
The state bar’s study shows that there are even deeper, more far-ranging consequences. Somewhere a corporation is contemplating locating to Georgia, but it may not want to do business in a state where it can’t get a speedy resolution to disputes. Somewhere in Georgia a small-business owner may want to hire a new employee, but he can’t afford to until a court rules that the money he’s owed has to be paid.
This means that judicial funding and the speedy, efficient operation of the courts is no longer a cause for just lawyers and judges.It’s also the cause of folks like my father, who started working in the mill at age 15 and lost his job at that same mill at age 54. A functional court system is a rising tide that lifts all boats.
The make whole doctrine is an equitable insurance law principle. The general rule under the doctrine of equitable subrogation is that where an insured is entitled to receive recovery for the same loss from more than one source such as an insurer and the tortfeasor, it is only after the insured has been fully compensated for all of the loss that the insurer acquires a right to subrogation, or is entitled to enforce its subrogation rights. The rule applies as well to instances in which the insured has recovered from the third party and the insurer attempts to exercise its subrogation right by way of reimbursement against the insured’s recovery.
In that exciting context, here is a recent USDCT opinion upholding the make whole doctrine:
Image by insearchofbalance via FlickrGSK will be updating the labeling of Avandia. It will now include safety restrictions ordered by federal health authorities because of the drug's links to heart attack.
The FDA made the changes in the fall of 2010, as part of several agenda items regarding the diabetes pill. The European Union has banned the drug.
The new U.S. label will explain that Avandia is only intended for patients who cannot control their blood sugar with any of the other diabetes medications on the market. Patients who are currently on the drug can continue taking it after consulting with their doctor.
From the Archives of General Psychiatry, this news:
Context Progressive brain volume changes in schizophreniaare thought to be due principally to the disease. However, recentanimal studies indicate that antipsychotics, the mainstay oftreatment for schizophrenia patients, may also contribute tobrain tissue volume decrement. Because antipsychotics are prescribedfor long periods for schizophrenia patients and have increasinglywidespread use in other psychiatric disorders, it is imperativeto determine their long-term effects on the human brain.
Objective To evaluate relative contributions of 4 potentialpredictors (illness duration, antipsychotic treatment, illnessseverity, and substance abuse) of brain volume change.
Design Predictors of brain volume changes were assessedprospectively based on multiple informants.
Setting Data from the Iowa Longitudinal Study.
Patients Two hundred eleven patients with schizophreniawho underwent repeated neuroimaging beginning soon after illnessonset, yielding a total of 674 high-resolution magnetic resonancescans. On average, each patient had 3 scans (2 and as many as5) over 7.2 years (up to 14 years).
Main Outcome Measure Brain volumes.
Results During longitudinal follow-up, antipsychotic treatmentreflected national prescribing practices in 1991 through 2009.Longer follow-up correlated with smaller brain tissue volumesand larger cerebrospinal fluid volumes. Greater intensity ofantipsychotic treatment was associated with indicators of generalizedand specific brain tissue reduction after controlling for effectsof the other 3 predictors. More antipsychotic treatment wasassociated with smaller gray matter volumes. Progressive decrementin white matter volume was most evident among patients who receivedmore antipsychotic treatment. Illness severity had relativelymodest correlations with tissue volume reduction, and alcohol/illicitdrug misuse had no significant associations when effects ofthe other variables were adjusted.
Conclusions Viewed together with data from animal studies,our study suggests that antipsychotics have a subtle but measurableinfluence on brain tissue loss over time, suggesting the importanceof careful risk-benefit review of dosage and duration of treatmentas well as their off-label use.
Image via CrunchBaseBeen one of those weeks. Depositions, court hearings, you name it. So this morning you can catch up on Android Apps of the week.
1. Where's my Droid : Where's My Droid can help you locate your phone whether you lost it in the couch cushions, left it at a coffee shop, or it's going on a ride across town to call some Nigerian princes. Where's My Droid (WMD) is a dual-function locator for your Android phone. If you've only misplaced your phone in your immediate surroundings you can send a text message to your phone (or use your cellular provider's email to SMS address) and WMD will increase the volume of your ringer to 100% and then ring for half a minute, one minute, or five minutes to help you locate it by ear.
2.SMS Backup: Automatically backs up SMS messages to your Gmail account. You need to have IMAP enabled in your Gmail preferences, which must be done through a computer
3.Bar Code Scanner: Scan barcodes on products then look up prices and reviews. You can also scan Data Matrix and QR Codes containing URLs, contact info, etc.
4.Dolphin Browser: Just found out about this one this week. The HD Browser has tabbed windows that you can swipe, add-ons, themes, and the option to download YouTube videos.A quick swipe to the left or right will bring up all open windows, and also has four action buttons, New Window, Close all, Add-ons, and Cancel. Aesthetically, it’s nice to see the menu you slide out from whichever direction you swiped, but it only adds minimal functionality. You can access your windows by scrolling up to the tabs on the top of the browser, but the thumbnail view it gives you is nice. It may show some overlapping functionality, but it’s nice that you can get to your windows, close them all if you want, or access your add-ons all from a single swipe gesture.
That's it for this week. If you want me to check out an android app, email me at galawyerblog(at)yahoo.com
The Seventh Circuit recently allowed a price-fixing case to proceed after determining that the plaintiffs sufficiently stated a claim under new, stricter pleading standards announced in two landmark Supreme Court rulings.
Noting that “pleading standards in federal litigation are in ferment after Twombly and Iqbal,” the court held that the plaintiffs’ complaint “alleges a conspiracy with sufficient plausibility to satisfy the pleading standard of Twombly.” (InreTextMessagingAntitrustLitig., 2010 WL 5367383 (7th Cir. Dec. 29, 2010).)
In BellAtlanticCorp.v.Twombly in 2007 and Ashcroftv.Iqbal in 2009, the Supreme Court heightened the federal pleading standard holding that a claim must contain enough facts to make it plausible, not just possible. Since then, courts have disagreed about what exactly the new standard requires. Some have cited these cases in granting motions to dismiss.
The Seventh Circuit offered its interpretation in the price-fixing case.
“The fact that the allegations undergirding a claim could be true is no longer enough to save a complaint from being dismissed,” Judge Richard Posner wrote for the three-judge panel. “The complaint must establish a nonnegligible probability that the claim is valid; but the probability need not be as great as such terms as ‘preponderance of the evidence’ connote.”
The decision “makes it clear that Twombly/Iqbal does not create an impossible burden,” said Joe Whatley of New York City, who represents two of the plaintiffs. “Posner said, ‘Here’s an example of how it can be done.’”
The plaintiffs had alleged that a group of wireless carriers conspired to fix prices for text-messaging services. Among the allegations, Posner noted, were that they exchanged price information at trade association meetings and “that all at once the defendants changed their pricing structures, which were heterogeneous and complex, to a uniform pricing structure, and then simultaneously jacked up their prices by a third” —behavior that pointed to collusion. This was enough to allow the plaintiffs’ case to proceed, the court held.
The district court had dismissed the plaintiffs’ first complaint but ruled that their second amended complaint could move forward. The defendants sought an interlocutory appeal, and the Seventh Circuit granted it, proceeding to the merits of the case without oral argument.
The decision is important because it addresses the issue of “informational asymmetry”—the unequal information that the parties have at the time of a motion to dismiss—an issue that has come up frequently in post-Iqbal and -Twombly cases, said Claire Prestel, a staff attorney with Public Justice in Washington, D.C. The decision also “emphasizes that the plaintiff does not have to prove his or her case in the complaint,” she said. Prestel is the coordinating attorney for the organization’s Iqbal Project, which aims to prevent misuse of the Iqbal and Twombly decisions.
Whatley noted that the Seventh Circuit decision is especially significant because Posner is a well respected judge who is generally considered conservative.
Posner wrote that “Twombly, even more clearly than its successor, Iqbal . . . , is designed to spare defendants the expense of responding to bulky, burdensome discovery unless the complaint provides enough information to enable an inference that the suit has sufficient merit. . . .” Still, the court said the plaintiffs had done enough to proceed to discovery, which “may reveal the smoking gun or bring to light additional circumstantial evidence that further tilts the balance in favor of liability.
The FDA is reviewing a possible interaction between a heart drug Multaq and the bloodthinner warfarin that could lead to an increased anticoagulant effect.
In response to the review by the FDA, Sanofi issued a statement that it was "confident in the overall safety profile of Multaq," a drug used to treat abnormal heart rhythms called atrial fibrillation or atrial flutter.
"It is important to note that the FDA has not identified a causal relationship between Multaq use" and clotting time in patients taking warfarin, the company said in its statement. (Link)
From Health Canada, the drug is not to be used by patients with severe liver problems. It says that should new safety information be identified, it will take appropriate action — including keeping health-care professionals and other Canadians informed.
There is news today that GSK settled the first Avandia trial that was set to go this week in Philly.
said it settled on the eve of trial a lawsuit alleging its Avandia diabetes drug caused a North Carolina man to die of a heart attack, avoiding a jury determination over risks associated with the medicine.
The U.K.’s biggest drugmaker resolved the suit by the family of James Burford, an Avandia user who died in 2006.