The Sham of a Fiscal Cliff

The so-called “Fiscal Cliff” is a sham that follows the Hegelian Dialectic of Problem/Reaction/Solution. The idea is to create or gin up a conflict as an “emergency” in order to plunder citizens for corporate profit. We saw it with the “emergency” the big banks declared to extort Congress into bailing them out in 2008, and we are seeing it again as Washington burns with the endless ruse of the fiscal cliff.

The end game is to weaken and eventually privatize social security for Wall Street profit (It’s the fees, Stupid). All Congress would need to do to fix the current budget shortfall is rescind the Bush tax cuts for the wealthiest Americans and responsibly cut the bloated military budget which currently exceeds the total military spending of the next 13 countries combined. Instead, we are now hearing talk from Washington about raising our income taxes and our health care costs and killing our home mortgage interest deduction.

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Matthews to try Mesh cases

USA — Matthews & Associates  Law Firm is scheduled to try several pelvic (transvaginal) mesh and sling cases across the U.S. beginning in May 2013.

The law firm is taking depositions, reviewing hundreds of thousands of pages of documents, meeting clients scheduled for trial and preparing to prosecute their cases in court.

“We are keeping the pressure on defendants in these cases,” said attorney David Matthews. “Defense feels it has a proven product with acceptable safety risks. We particularly disagree about the  risks. Adverse events continue to pile up, and there is no question that when something  goes wrong with synthetic mesh or a given sling, the injuries can be catastrophic.”

He added that he didn’t want to give away strategy for taking on mesh corporations and their battalions of attorneys.

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Court: off-label marketing ok

Last week, a three-judge panel of the Court of Appeals for the Second Circuit in Manhattan ruled that off-label drug marketing by drug reps amounts to ‘free speech’.

Under federal laws, once the FDA approves a drug, physicians are free to prescribe that drug as they wish,  but the drug manufacturer can only market the drug for the FDA-approved marketing indication(s).

The ruling most likely opens the door for pharmaceutical companies to aggressively market their drugs for a wide variety of indications that are NOT approved by FDA.   If upheld by the Supreme court, the ruling will also likely lead to massive direct-to-consumer media campaigns by pharmaceutical companies.

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Money taints Drug Research

The Washington Post, which long ago broke the Watergate break-in story that eventually brought down a U.S. President, broke another burgeoning scandal on Nov. 24 when it sounded an alarm for all citizens in an article titled: As drug industry’s influence over research grows, so does the potential for bias. See the full story here.

The article uncovers, at length, how drug companies pay for and increasingly control and spin research in favor of their own drugs. The result is they sometimes overstate a drug’s benefits and fail to reveal its actual dangers.

GlaxoSmithKline, for example, presented Avandia as safe and effective. Eleven authors of one crucial Avandia study, however, were paid by the company: “Four were employees and held company stock,” wrote the Post. “The other seven were academic experts who had received grants or consultant fees from the firm.” The problem was that Avandia raised the risk of heart attacks, and its cost-benefit analysis never did add up. A Food and Drug Administration scientist later estimated that the drug had been associated with 83,000 heart attacks and deaths.

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Court for the 1%

John Roberts Supreme Court has rarely, if ever, voted to protect any individual victim’s rights when that individual’s rights have butted heads with a corporation. It is therefore difficult to be optimistic after reading that the high court has chosen (just three justices are needed to choose a case) to hear an appeal from a generic drug maker that was hit with a $21 million verdict in New Hampshire in 2009. A pain killer from a branch of Takeda Pharmaceuticals caused a woman to lose more than 60 percent of her outer skin layer, spend months in a medically-induced coma, a year being tube-fed and operated on 12 times for eye problems related to the drug. Almost blind, Karen L. Bartlett can’t eat normally because of esophageal burns. She can’t have sex because of vaginal injuries, and she can’t perform aerobic activities because of lung injuries.

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Generic Reglan Penn. Update

Generic Reglan/Metoclopramide cases filed in state court in Pennsylvania continue to sit in the legal limbo the U.S. Supreme Court’s PLIVA v. Mensing decision of 2011 placed them in  when the court voted 5-4 to essentially give generic drug makers a free liability pass.

A panel of three Penn. Superior Court judges met in November to hear oral arguments regarding the fate of more than 2,300 Philadelphia Court of Common Pleas cases in which plaintiffs allege that generic versions of metoclopramide (brand name: Reglan) caused them to suffer tardive dyskinesia, an incurable neurological disease. The judges heard arguments from the brand-name maker, Wyeth (Morton Grove); the generic drug makers; and a Penn. lawyer who represented all the plaintiffs.

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FDA & drug industry studies

Though the FDA  indicated in June 2011 that it sees no benefit for pelvic (transvaginal) mesh vs. traditional methods used in Pelvic Organ Prolapse (POP) repair, the agency has conversely announced that it does see advantages in using synthetic sling material for Stress Urinary Incontinence (SUI). The agency’s current position, however, is based on limited and perhaps even tainted data. It will take an enormous amount of research to sort through it all to get a true risk-benefit analysis and a clear safety profile of slings used for SUI.

In the FDA’s Executive Summary of Sept. 2011, the agency largely seems to agree with mesh makers’ data that show the sling effective for SUI compared with traditional repair.  However,  FDA looked mostly at industry backed studies which were designed by sling manufacturers and administered by sling maker employees or by doctors hired as consultants by sling manufacturers.

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Matthews to try Mesh Cases

USA — Matthews & Associates and Freese & Goss are scheduled to jointly try several pelvic (transvaginal) mesh and sling cases across the U.S. beginning in Jan. 2013. The law firms are taking depositions, reviewing hundreds of thousands of pages of documents, meeting clients scheduled for trial, and preparing to prosecute their cases in court.

“We are keeping the pressure on defendants in these cases,” said attorney David Matthews. “Defense feels it has a proven product with acceptable safety risks. Some of their mesh and sling products are backed by many surgeons and doctors to a certain extent. But there is no question that when something  goes wrong with a synthetic mesh product or with a given sling, the injuries can be catastrophic.

“We don’t want to give away our strategy for taking on these corporations and their batallions of attorneys, but I can tell you we find it troubling how little pelvic mesh was tested before being implanted in human beings. Mesh manufacturers tested their products on a couple dozen animals, on rats, rabbits and sheep, and I guess it’s fair to say none of them complained of pain or other problems, which hardly proves mesh is acceptably safe and effective, or that it always solves more problems than it creates.”

More than 6,000 pelvic mesh cases have been filed in the Federal MDL court in W. Va. thus far.  Individual trials are scheduled in several different state courts in 2013.

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Public Justice beats dirty coal

Mountaintop removal for coal causes more long-term environmental problems than it solves in short-term coal production; so it is  always a hopeful sign that sanity is prevailing in the country when a big polluter can be stopped. Public Justice just announced that the so-called “Patriot Coal” company – the second largest producer of surface-mined coal in West Virginia –has just agreed to end its mountaintop removal mining. 

Public Justice reports that though it did not directly negotiate this agreement, it contributed enormously to the result through litigation that forced Patriot to install expensive pollution control equipment to reduce toxic selenium discharges at its Apogee mine in West Virginia.  That and similar litigation at other Patriot mines forced the big polluter to internalize the enormous environmental costs of its mining operations.  Consequently, Patriot filed for Chapter 11 bankruptcy in July 2012 and admitted the costs of treating its contaminated mine water would exceed $400 million.

Matthews to try Mesh Cases

Public Justice wrote: “Along with its commitment to end large scale surface mining in the region, Patriot’s CEO acknowledged its human and environmental costs, telling the judge overseeing the agreement that ‘Patriot Coal recognizes that our mining operations impact the communities in which we operate in significant ways.'”

Public Justice, which  has worked for more than a decade to limit mountaintop removal mining, announced that the court’s ruling validates Public Justice’s view that mining companies  forced to pay the real costs of mountaintop removal will find their methods economically untenable.  Public Justice’s co-counsel in the Apogee case, Joe Lovett at Appalachian Mountain Advocates, negotiated the deal with Patriot.

Matthews & Asociates applauds Public Justice and Joe Lovett for helping save West Virginia and America from further horrors of the unconscionably destructive method of mountaintop removal mining.

To read more about this development, go here:  http://wvgazette.com/News/201211150075

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NuvaRing MDL N.J. Update

The first NuvaRing case scheduled to be tried in the U.S. in Feb. 2013 has been moved to at least May 2013.

Lawyers working for plaintiffs on the NuvaRing litigation in New Jersey are in the process of preparing Reply briefs to the Oppositions filed by Defendants in connection with plaintiffs’ motions to exclude the testimony of three witnesses:  Dr. Mulders, a proposed pharmacology expert responsible for the development of NuvaRing; Dr. Rekers, an in-house medical doctor with very little experience practicing medicine, but who nevertheless professes to be an expert in epidemiology and FDA regulatory matters; and Dr. Grimes, an ob/gyn who testifies as a catchall expert.  Those briefs are presently due on November 30. However, plaintiffs’ attorneys anticipate that date will soon be moved back.

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