No Reply Yet On Certifications from IOS and VW

emissionsOne important facet of the Volkswagen emissions scandal that has so far avoided attention is the company’s certifications to the ISO 9001 standard for quality management and ISO 14001 standard for environmental management.

VW or the International Organization for Standardization (ISO) have replied to the simple question: “Volkswagen has worldwide certification to ISO 9001 and ISO 14001. Doesn’t the scandal over VW’s emissions manipulation indicate a failure of certification to the standards, in terms of meeting customers’ quality requirements, customer satisfaction and environmental management?”

Also silent were TUV Nord, the German certification body that issued VW’s certifications, and a spokesman for both the International Accreditation Forum (IAF) and the International Laboratory Accreditation Cooperation (ILAC). The last two groups promote standards and certification as tools for achieving public policy goals.

For many people, the VW scandal advises caution against a blind faith in standards. However, ISO and the other main figures dance around the question at hand. This silence is a matter of serious concern because VW’s certifications are intended to give customers and regulatory authorities confidence that quality requirements and environmental responsibilities are being met.

One of the objectives of ISO 9001 is to make enterprises more efficient in turning out products that enhance customer satisfaction, by ensuring that these products meet customers’ quality requirements — both stated and implicit. It is unlikely that the software designed to cheat emissions tests, as VW has admitted to installing, was a requirement of the 11 million customers who bought the affected vehicles. Clearly, VW’s ISO 9001 systems and certification did not deliver on customer satisfaction.

ISO 14001 is aimed at enabling organizations to reduce negative impacts on the environment as a result of their activities. It is designed to be a tool for meeting regulatory requirements. Despite VW’s ISO 14001 systems and certification, the company deceived its customers about the environmental impact of the cars they had bought and manipulated the results of regulators’ pollution tests.

It appears that VW no longer meets the requirements for its certifications and soon there will have to be an answer.

06 Nov 2015

Actavis Gets a New Name, But Old Legal Problems Remain

After completing a $70.5 Billion merger with Allergan Labs that began in 2014, Actavis has announced a re-branding effort. The new Actavis company, which beat out competing bids for the lab behind Botox, will now use the acquired company’s name going forward as their new identity. Actavis, the company best known in legal circles as the makers of troubled drugs like Digitek and Androderm, will change both its name (Allergan PLC) and stock ticker symbol later this month, according to a company spokesperson.

The merger creates, almost overnight, a behemoth in the skin and eye care health industry. Allergan Labs was a target of several pharmaceutical companies that drove a bidding war for the eventual successful acquisition by Actavis. The new entity is estimated to be a $21 Billion a year enterprise, which gives them a large war-chest with which to continue their pending legal battles with Plaintiffs over past recalled drugs and the marketing practices of their blockbuster low-T drug, Androderm. Botox-maker Allergan Labs was no stranger to litigation prior to the merger either. The company had been involved in several high-profile legal battles, including courtroom skirmishes with hedge fund activist Bill Ackerman, and defending cases brought by tort attorneys over it’s “Lap-band” product used in weight-reduction surgeries. if past litigation history is any guide, it is clear the new combined company will keep its in-house legal team very business in the years to come.

Legal tussles surrounding the company haven’t scared off the rest of Wall Street. Actavis was one of just 11 publicly traded companies that have managed to post a positive gain in every one of the last 10 quarters, according to USA Today. It’s clear that, so far at least,  investors have not been deterred by the legal issues of the company. They will begin trading under the new symbol AGN this month.

21 Jun 2015

Testofen MDL Rejected by U.S. Judicial Panel

20101028-fenugreekseedsA panel of federal judges has rejected a petition to consolidate and centralize all lawsuits over the testosterone booster, Testofen. Testofen is an extract created from fenugreek seeds, which are claimed to help increase a man’s testosterone levels. It is regularly used in testosterone-raising supplements that are marketed to help increase muscle mass and boost male libido, as well as improve erectile dysfunction. The Testofen lawsuits allege that the manufacturers misrepresented the safety and efficacy of the supplements.

The U.S. Judicial Panel on the Multidistrict Litigation (JPML) denied a recent request to transfer at least two Testofen class action lawsuits to the same judge for coordinated pretrial proceedings. This would allow the cases to proceed as individual actions and not be centralized in the federal court system as part of an MDL, or multidistrict litigation, like several other testosterone drug lawsuits.

On April 1, 2015, the panel reviewed two Testofen lawsuits and agreed that the cases were not similar enough to be joined into a single litigation. The suits will remain as separate trials, independent of each other in front of different judges.

“The two actions undoubtedly share some questions of fact concerning the efficacy of nutritional supplements containing Testofen in boosting free testosterone levels,” the JPML said in its decision. “But, the scope of the two actions before the panel are substantially different.”

The creation of an MDL may be approved in the future if a sufficient number of cases in different jurisdictions have similar allegations regarding Testofen supplements.

 “Low T” Boosters vs. Testosterone Therapy Prescription Drugs

The nutritional T-boosting supplement lawsuits now join hundreds of doctor-prescribed testosterone therapy drugs (ie: AndroGel, Axiron, Fortesta) in courts around the country. All of these products have been marketed to help men suffering from what manufacturers represented as “Low T” symptoms. The plaintiffs argue that the some of the prescription low-t products can cause serious health damages, including raising the risk of heart attack and stroke. Allegations of deceptive advertising in the marketing of these drugs to doctors and their patients are widespread in the court filings and class action suits.

More than 1,300 men have filed testosterone lawsuits for injuries while taking prescription testosterone drugs. A 2014 PLOS One study found that the heart attack risk doubled during the first three months of testosterone use in men older than 65, and in younger men with a history of heart

28 Apr 2015

Digitek maker Actavis Has New Legal Issues Looming

Pharmaceutical giant Actavis, the company responsible for the  Digoxin recall, is no stranger to plaintiff lawsuits over its drugs, and this year is no exception. You may recall that Actavis first attracted attention for its Digitek-branded Digoxin, which was the subject of hundreds of lawsuits. The FDA hammered the company over safety and reporting violations that culminated in a federal recall of Digitek tablets (used to treat heart failure and arrhythmia) that were mistakenly manufactured at double the expected thickness. (more…)

19 Oct 2014

The Gray Legal Landscape of Negative Online Reviews

 

Recent news coverage about legal battles between online anonymous reviews and the companies negatively affected by them has created a stir about people’s rights to post negative reviews of businesses without fear of reprisal. Several companies have been vilified for their attempts to prevent customers from posting negative comments online. Lately, several companies have tried to accomplish this by including in their terms of services an express prohibition against venting publicly later if they are dissatisfied. Often times, these terms of services were never agreed to, or even seen, by the customers they later wish to take legal action against, and the resulting public outrage creates even more negative online press for the companies. (more…)

14 Sep 2014

The Truth Behind Low Testosterone Treatment

heart attack

Big Pharma has spent countless millions marketing testosterone replacement therapies to men who exhibit symptoms of low testosterone or “Low T.” The issue is that almost every middle-aged man has these symptoms, yet they do not have hypogonadism, which is a medical issue of insufficient testosterone production, or inability to produce sperm in the testes, or both. The amount of men that have this medical condition is not enough to justify expensive marketing tactics unless the manufacturers know they can make money off of the majority of middle-aged men, most without the condition. (more…)

27 Aug 2014

Plaintiffs awarded $9 billion in Actos trial

medium_3926259585Plaintiffs won $1.5 million in compensatory damages and $9 billion in punitive damages in the first federal bellwether trial over Type 2 diabetes drug Actos. Co-lead counsel Richard J. Arsenault, of Neblett, Beard & Arsenault of Alexandria, La., and Paul J. Pennock, of Weitz & Luxenberg in New York opposed defendant’s motion for a new trial, saying that the verdict should be upheld because there is no law that limits punitive damages to fit in a single-digit ratio with compensatory damages. (more…)

31 Jul 2014

Lawsuits against Zoloft claim infants suffered birth defects

medium_59337771013 more lawsuits have been filed against drug manufacturer Pfizer, claiming that the drug Zoloft has affected infants in-utero which resulted in birth defects as a result of taking the drug.

Pfizer, along with Roerig, a division of Pfizer, and Greenstone LLC were named as defendants.

The mother plaintiffs were prescribed Zoloft according to the lawsuits filed on July 7 in Wayne Circuit Court.

They claim that they took Zoloft as prescribed by medical physicians while pregnant which led to their children being born with congenital heart defects such as atrial septal defect; multiple holes in the heart; neural tube defects; persistent pulmonary hypertension and other complications.
(more…)

31 Jul 2014