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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Sandy smashes East Coast

Hurricane Sandy smashed the East Coast with 80 mph winds and record storm surges on Oct. 29, 2012. The storm killed more than 90 people as it destroyed homes and businesses and left millions without power. Nearly a week later, residents are still reeling from Sandy’s devastation.

Widespread power outages and subway shutdowns may make Sandy the second most expensive storm in U.S. history after Hurricane Katrina.

Insurance adviser Eqecat said last week that damage from the superstorm will likely be far worse than it previously predicted, as Sandy hit the country’s most densely populated area. The firm doubled its previous damage estimate, now believing that Sandy may have caused between $30 billion and $50 billion in economic losses.  The total destruction includes property damage, lost business and extra living expenses. The cost to insurance companies could run as low as $10 billion and as high as $20 billion.

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Medtronic Infuse articles tainted

Senate: Medtronic shaped articles promoting InFuse

(AP)–1 day ago

WASHINGTON (AP) — Medical device maker Medtronic Inc. helped write and edit medical journal articles attributed to outside physicians, which downplayed the risks of the company’s best-selling bone graft, according to a report by Senate investigators.

The Senate Finance Committee said Thursday that the world’s largest device maker did not disclose its role in shaping 13 key studies of InFuse, which helped turn the bone graft into an $800-million a year product. The studies, funded by Medtronic, failed to mention serious risks of InFuse including male sterility, infection and increased back and leg pain.

Senate investigators also reported that Medtronic paid the study authors $210 million in consulting fees for unrelated work over 15 years.

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Chantix Suicide Case settles

Pfizer Inc. (PFE) reached a confidential settlement last week with the widow of a Minnesota man who killed himself after taking Pfizer’s anti-smoking drug Chantix.

Mark Alan Whitely killed himself in Nov. 2007 after taking Chantix to quit smoking. His widow alleged that Pfizer failed to sufficiently warn that Chantix could increase suicide risk. The Whitley case was the first of more than 2,500 Chantix cases pending in federal court in Alabama.

Pfizer spokesman Chris Loder wrote in an email statement:  “We can confirm that we have settled this case.”

The settlement follows Pfizer’s appealing U.S. District Judge Inge Johnson’s order that its Chief Executive Officer Ian Read and two other executives testify in person at the Whitely trial. According to court records, Read and the other executives dropped that appeal after reaching the settlement.

The Whitely case and similar lawsuits have been corralled into multidistrict litigation before Judge Johnson in Alabama.

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Ford loses trademark case

Ford lost a case Ford_logo2in the Fifth Circuit Court of Appeals yesterday when the court ruled that a Montgomery, Texas printer did not violate any law in printing the Ford logo for clients such as Ford dealers, used car dealers or anyone else using the Ford logo under standard fair use policies.  The printer, George Atkinson, sued Ford after receiving a demand letter for $5,000 after he printed the Ford logo for a client. Mr. Atkinson sued Ford for unfair business practices and interference with third party contracts.

Mr. Atkinson says Ford has sent out thousands of letters to commercial printers, sign companies, advertising products companies and anyone else Ford finds using an image of the Ford logo for any reason, claiming users are infringing by using the Ford logo/trademark without Ford’s approval. Ford claims in the letters and in court that it has the right to approve the copy of the logo any printer uses. Ford also claims in the letters that any use not authorized by Ford amounts to counterfeiting. The letters all contain a standard $5000 demand for damages. The Ford demand letters also claim – falsely, according to Mr. Atkinson and to Ford’s OWN documents – that dealers are, by contract, allowed to use only six  sources which Ford has “authorized” for the purpose.

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Steroid leads to Meningitis

Fifteen people have died of fungal meningitis from a contaminated steroid lot, and nineteen more cases related to contaminated steroid injections were reported this week, bringing the national total to 233 in 15 states. The Centers for Disease Control and Prevention said the newly-reported cases are in nine states: Florida, 2; Indiana, 2; Maryland, 1; Michigan, 1; New Hampshire, 2; New Jersey, 2; Ohio, 2; Tennessee, 6; Virginia, 1. Twenty-five of the meningitis cases were previously reported in Tennessee, where more than 900 residents received the drug in the past three months. Other cases have been reported from North Carolina. All are linked to  steroid injections sold by the now-closed New England Compounding Center (NECC) in Framingham, Mass.  (USA Today story)

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Generic Drug recalled by FDA

On the heels of the five extremist judges on the Roberts’ Supreme court voting last summer to shield multi-national generic drug makers from injury lawsuits brought by Americans (Pliva v. Mensing) comes more evidence to show how ill-informed that decision was. The FDA last week asked Teva Pharmaceuticals to withdraw its generic drug Budeprion XL 300.  Testing showed this drug did not release its key ingredient in the expected amounts. Budeprion XL 300 is supposed to be equivalent to GlaxoSmithKline’s popular antidepressant Wellbutrin XL, which is prescribed to treat depression, anxiety and nicotine withdrawal.

Generic equivalency to brand name drugs is not a question the high court considered before ruling against citizens’ safety. It’s worth noting the FDA said this is only the third time in the last five years it has recalled a generic for equivalency issues, but many Americans know from experience that some generic drugs simply don’t work the same way or as well as the brand-name drugs. Nevertheless, insurance companies will often pay only for the generic if a generic is available. That means people are being forced to take a drug from a company that is no longer responsible for it. And eighty percent of the drug prescriptions filled this year were generic.

For more, see “Defective generic pill revives quality concerns” –  click here.

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BPA in Plastic a Toxic Brew

It took the FDA four years to finally ban a substance (BPA) in infant food packaging that has long been known to cause brain damage in developing infants and young children. Industry so controls the U.S. government agency that it took a lawsuit from the National Resources Defense Council to finally force the FDA to rule this summer to ban Bisphenol A (BPA) in infant food packaging. One can only wonder how many babies and infants were developmentally damaged in the interim. Because BPA is also known to cause hormonal problems and worse in adults, it is widely banned in most first-world countries; but in America, where FDA staff enjoy a revolving door relationship with industry, BPA is still widely used in many packaged goods.

The NRDC first filed a petition with the FDA in 2008 requesting that BPA be banned in food packaging, containers and any other material used  in packaged food. When the FDA failed to respond for two years, as required by law, the NRDC was forced to sue the agency in 2010. NRDC had to petition the court to demand a response. When the FDA finally did respond, in July 2012, it was forced to rule on the science and ban BPA from infant food packaging. Meanwhile, BPA is still free to disrupt adult hormones and damage adults’ health.

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Mirena IUD Problems

Mirena Overview

Classified by the FDAMirena Picture as a drug, Mirena is a contraceptive administered as a hormonal IntraUterine Device (IUD). It is inserted into the uterus as a long-term contraception.  Manufactured by Bayer Healthcare, Mirena was approved by the FDA on December 6, 2000 as a contraceptive. It is the only hormonal IUD that has FDA approval. It was designed for long-term application.  After insertion, this T-shaped polyethylene device prevents pregnancy by releasing a synthetic version of progestin hormone for up to five years.  According to claims made by Bayer Healthcare, Mirena is more than 99% effective at preventing pregnancy, which would place it as one of the highest ranking contraceptives for effectiveness.  However, Bayer offers no data in support of this claim.  In October of 2009 Mirena was also approved for treatment of heavy periods involving heavy and excessive menstrual bleeding in women with at least one child birth.  As of 2011, more than 15 million women have used Mirena IUD

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Reglan generic cases turn for plaintiffs

Some good news Reglancame for plaintiffs this week in generic Reglan (metoclopramide) cases. The California Court of Appeals ruled that two types of drug injury claims can move forward. The court ruled that generic drug makers are responsible for “failure to suspend sales” of metoclopramide, and that Reglan’s brand name maker, Wyeth (now part of Pfizer), is responsible for failing to accurately update the label with the drug’s actual risks.

Supreme Court protects Generic Drug Makers

Those injured by generic Reglan have been in need of some good news for quite a while. Metoclopramide cases have been sitting in a kind of legal limbo ever since the U.S. Supreme Court voted 5-4 (Pliva v. Mensing) in the summer of 2011 (right along party lines, though Supreme court members should ideally be politically pure) to essentially grant generic drug makers immunity from state tort lawsuits.  Nevertheless, plaintiffs’ lawyers have continued to argue in state courts in California and Pennsylvania that generic manufacturers should be held accountable for not suspending sales of metoclopramide despite their knowledge of its causing tardive dyskinesia in as many as one out of five people who take it for three months or more.  Lawyers have also continued to argue before state courts that the brand maker of the drug – Wyeth Pharmaceuticals – should also be held accountable for failing to update the label to indicate a user’s actual risk. Both those arguments were accepted Sept. 26 by Judge Kramer in the California Court of Appeal.

The court summarily denied both the Generics’ and Morton Grove’s (Wyeth’s) writ petitions, and the orders denying the petitions are immediate and final. This is good news for metoclopramide victims because Judge Kramer’s decision against the generics should stand for the duration of the case at the trial court level, absent any successful effort to have the California Supreme Court address the matter or any later change in law that would require Judge Kramer to reconsider his decision.  The generics still retain their right to appeal the decisions, but any appeal would have to come at the conclusion of the trial court proceedings.  The generics have 10 days to petition the California Supreme Court for review, but the Supreme Court is unlikely to take any action at this point.

Reglan generic cases turn for plaintiffs

“It shows that justice is still possible for victims of metoclopramide,” said Houston attorney David Matthews. “There’s an awful long way to go, but at least this decision restores some faith in the courts and in humanity to do the right thing. Unfortunately, so much of this is political, and that’s a shame, because people are hurt, through no fault of their own, and they deserve compensation from the companies that failed them.”

In other metoclopramide news, a similar hearing is scheduled for the Pennsylvania Court of Appeal on Oct. 31 to determine if metoclopramide claims can also move forward in that state, in spite of the U.S. Supreme Court’s 2011 decision to grant generic drug makers immunity. We will also report the results of that hearing as soon as it occurs.

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