Ford lost a case in 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.
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)
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.
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.
Classified by the FDA 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
Some good news came 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.
Yaz and Yasmin added roughly $1.8 billion to Bayer’s profits in 2008, and continue to be among the top selling birth control drugs in the country for women 35 and younger. Successfully marketed as “quality-of-life treatment” to combat acne and severe premenstrual depression, these drugs also carry serious health problem baggage along with their popularity.
Research has shown Yaz and Yasmin put women at higher risk for blood clots, strokes and other health problems than competing birth-control pills. In April 2012, safety studies prompted the Food and Drug Administration to order that Yaz and Yasmin carry revised labels with stronger warnings that indicate the increased risk.
Granuflo powder/acid dialysate: Blame Doctors?
Despite several opportunities to right a wrong, Fresenius Medical Care (FMC) has conspicuously failed to define and clarify the potential issue and controversy surrounding its Granuflo dialysate powder acid concentrate. Judging by the content of its “Dear Doctor Letter” issued in March 2012, FMC is treating this deadly outcome as a matter of “fuzzy math” on the part of doctors. The letter implies that hundreds of doctors have simply neglected to read product labels correctly, and that those same doctors have failed to add simple figures to arrive at an accurate final product.
But how difficult would it be to add 24 units of bicarbonate with 8 units of acid from Granuflo, to get a yield of 32 units in the final solution? How did so many doctors arrive at 36 units instead of the mathematically expected 32? Did this suggestion of incompetency in math really cause the death of 941 patients from sudden cardiac arrest in FMC’s in-facility dialysis centers in 2010 alone? Or is this claim that doctors used fuzzy math just a shameless cover to hide a much greater problem? Is it a problem that Fresenius has had knowledge of since 2003 when a new formulation of Granuflo was approved for marketing?
Transvaginal Mesh Lawsuits Prompt Sixth Multidistrict Litigation
A sixth multidistrict litigation (MDL) for transvaginal mesh lawsuits was formed late last month to help handle the high number of cases involving the defective devices.
In August 2012, the Panel on Multidistrict Litigation ordered all federal cases regarding Coloplast transvaginal mesh transferred to one court in the Southern District of West Virginia. At least 24 federal lawsuits have been filed against Coloplast to date, according to the company. The panel noted in the transfer order that 13 cases had common questions of fact and that most claim Coloplast mesh and bladder sling products cause serious injury to their users.
The order states: “Centralization [moving cases into the MDL] is consistent with our recent decision creating separate pelvic repair product MDLs involving [other] defendants.”
HOUSTON — Matthews & Associates and Freese & Goss are scheduled to jointly try the first American Medical Systems transvaginal mesh case in the United States, in a Houston courtroom in February 2013.
A two-week trial is scheduled for Harris County District Court, where a judge granted preferential docket status to the case involving a 68-year-old Houston woman who developed problems after being implanted with transvaginal mesh. Such status puts the case at the head of the cue, meaning that this case is likely to go forward and be tried as scheduled, beginning Feb. 25.
The mesh caused the then 64-year-old woman severe pain and had to be surgically removed less than two years later. She continues to experience pain and emotional problems stemming from her injuries.
Between 30-50 percent of women will experience POP (Pelvic Organ Prolapse) in their lifetimes. More than 300,000 POP surgeries are performed each year, about one-third of them with mesh. Despite that large number, the FDA has announced it could find no benefit for women placing the mesh as compared to not placing it.