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Mass Torts Update - Oct 2, 2014 12:17 - 0 Comments

Pfizer’s Testosterone Drug Said To Pose Heart Risks

A lawsuit has been filed against Pfizer Inc. alleging that testosterone treatments cause heart problems. The lawsuit accuses the drugmaker of promoting its Depo-Testosterone treatment as safe and effective despite its risks of causing heart attacks, strokes and blood clots. Pfizer and its unit Pharmacia & Upjohn Co. LLC are accused of conducting a “disease mongering” campaign to exaggerate the prevalence of testosterone problems in order to boost sales of Depo-Testosterone, despite its heart health risks. The lawsuit was filed by Alvaro Roman Gutierrez, who alleges that his use of the drug caused him serious physical injury and harm.

 

The Plaintiff says that the Defendants spent millions of dollars on efforts to expand the consumer base for the treatment. It’s alleged that the defendants, along with other pharmaceutical companies not named in the suit, have advertised common symptoms including listlessness and increased body fat as possible signs of testosterone deficiency. The complaint states:

 

As a direct and proximate result of the plaintiff’s use of Depo Testosterone, also known as Testosterone Cypionate, and plaintiff’s reliance on defendants’ representations regarding the character and quality of the products and defendants’ failure to comply with federal requirements, plaintiff suffered serious physical injury, harm, damages and economic loss and will continue to suffer such harm, damages and economic loss in the future.

 

The Plaintiff claims that Pfizer had a duty to warn him or his doctors of the potential heart risks stemming from the drug and that it didn’t do so, in part by failing to update its label since the U.S. Food and Drug Administration (FDA) approved it. Other companies that have been sued over testosterone treatments include Endo Pharmaceuticals Inc. and Prostrakan Group PLC, which were sued in the Pennsylvania court in May over their testosterone-boosting Fortesta gel.

 

Those suits claim that Fortesta, which was developed by U.K.-based Prostrakan and licensed to Endo for sale in the U.S., is an unnecessary drug pushed commercially to treat a disease that does not exist. In the suits, the plaintiffs claim that their use of the testosterone-enhancing gel led to heart attacks.

 

Source: Law360.com

 

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Product Liability - Oct 2, 2014 13:14 - 0 Comments

Silent Recalls Should Never Be Allowed, But Are Still Around

How many of you have ever heard of the term “silent recalls” as it relates to the automobile industry? Unless you have had a safety issue with a vehicle and took it to a dealer, and were involved with a silent recall, I doubt you are aware of what a silent recall is or how one works. I will give you some history of how silent recalls have been used, but first let’s look at a recent situation. The Chevrolet Volt has had just one recall since its introduction four years ago. The problem, a faulty brake valve that affected just four cars, made it one of the smallest recalls in history. But it appears that General Motors (GM) has fixed other problems on thousands of Volts for free through at least eight customer-satisfaction campaigns, which are less public than recalls and largely unregulated.

 

The repairs included reinforcing the battery pack and improving the battery coolant system after a government crash test sparked a widely publicized fire, prompting a congressional hearing and an investigation by the National Highway Traffic Safety Administration (NHTSA). Because neither GM nor the regulatory agency determined that the fire was evidence of a safety defect, the automaker didn’t have to use the word “recall,” follow specific requirements for notifying customers or report how many Volts got fixed.

 

In these customer-satisfaction campaigns, sometimes called “secret warranties” or “silent recalls” consumers aren’t notified about them. They are used frequently by the automobile industry – not just at GM – and often times safety issues are involved. As complex technology leads to more unforeseen problems after a vehicle goes on sale these techniques may well increase.

 

But it should be noted that the automakers have been using silent recalls for years. Lawyers in our firm first learned of silent recalls in a case we handled several years ago, Johnson vs. General Motors. That case involved a new pick-up truck that stalled in an intersection and was hit broadside by a log truck. A small child was killed in the crash. We tried the case and got a $15 million verdict after a lengthy trial. During the pre-trial discovery we learned that GM was using silent recalls to hide serious safety problems from the public. The automaker had been getting complaints in the hundreds of vehicles stalling, but did not issue a real recall. Instead, GM notified dealers and told them to fix the computer if a customer came in with the problem. The automaker also told the dealers to try and get the customers to pay and if they refused GM would pick up the tab.

 

Huge recalls recently by GM and Toyota Motor Corp. raise questions about whether dangerous problems could be hidden in little-noticed service bulletins or customer-satisfaction campaigns, which aren’t supposed to be used for safety-related defects. Gabriel Shenhar, a senior auto test engineer with Consumer Reports, stated:

 

There’s a ton of stuff that goes under the radar screen in the form of technical service bulletins and goodwill campaigns and customer-service campaigns and hidden warranties. It’s to the benefit of the consumer to have it done as a recall, so it doesn’t go under the radar screen.

 

Clarence Ditlow, executive director of the Center for Auto Safety said: “[t]here is not a sharp line between a service campaign and safety recall.” He said the $1.2 billion penalty imposed on Toyota this year over its unintended-acceleration crisis, multiple ongoing investigations of GM’s ignition recalls and greater scrutiny by regulators may compel automakers to use recalls for cases in which they might have acted with less urgency in the past. He added:

 

If you’re looking at a billion-dollar fine, it changes your calculus. I think we’re going to see more safety recalls and fewer service campaigns, but the service campaign is never going to go away.

 

I believe that the silent recalls are used for two reasons. One definitely is based on cost to the automaker, with the other being an attempt by the automaker to keep a known defect “secret,” keeping both the public and NHTSA in the dark. The automakers will take a different view on this, but that view won’t pass the “smell test.”  In the Johnson case that we handled, even though General Motors had received hundreds of complaints of stalling vehicles, it never had any intention of telling either NHTSA or the public about the hazard caused by the computer-related safety defect. In that case suppliers had furnished defective computer chips. GM used the silent recall effectively until we discovered it in our case.

 

Documents filed by GM show that at least six of its 65 recalls this year relate to previous, lesser field actions. At least two other recalls initially were proposed to be customer-satisfaction campaigns, but got upgraded by the executives who approve them. A top NHTSA official criticized GM in a 2013 email, which Congress released publicly in April, for repeatedly using customer-satisfaction campaigns and service bulletins to address matters the agency deemed to be safety defects. Automakers frequently have created customer-satisfaction campaigns or extended warranties in response to NHTSA investigations. That often has been enough to satisfy NHTSA so its staff can move on to examine other complaints. In August, NHTSA closed an investigation into braking issues on 100,000 Toyota Camry hybrids after Toyota said it would offer extended-warranty coverage.

 

In March, NHTSA closed its inquiry of 1.6 million Ford Escapes, Fusions and other vehicles after Ford Motor Co. started a customer-satisfaction campaign for engine throttle-body problems that generated nearly 12,000 complaints. Last year, the agency closed an investigation into sticky accelerators after Ford agreed to a campaign covering throttle cables on nearly half a million Taurus and Mercury Sable sedans. After GM offered Volt owners several “enhancements” in response to NHTSA’s probe into the 2011 crash-test fire, regulators concluded that “further investigation does not appear to be warranted.” But it added this disclaimer, which it also used for the Camry hybrid and Ford throttle-body investigations: “The closing of this investigation does not constitute a finding by NHTSA that a safety-related defect does not exist.”

 

Having said all of this, the bottom line is that silent recalls – falling short of a true recall – are not consumer friendly. In my opinion, when a defect is related to safety in any respect they should be prohibited.

 

Source: National Highway Traffic Safety Administration

 

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Fraud - Oct 2, 2014 12:39 - 0 Comments

FCA Whistleblower Accuse Gilead Of Defective-Drug Fraud

A lawsuit filed against Gilead Sciences Inc. claims that the company cheated taxpayers by selling contaminated and defective drugs to Medicare and Medicaid. Whistleblowers made these charges in the lawsuit that was unsealed last month in a California federal court. This adds to the sharp increase in fraud litigation over manufacturing violations in the industry. The complaint asserts that Gilead since 2001 has sold at least 10 products – including HIV medications Viread, Truvada and Stribild – that lacked potency or were contaminated with filth, metal or microbes, allegedly rendering them nonreimbursable by government health care programs. Gilead committed “serious violations of the laws and regulations designed to ensure the fitness of drug products for use,” according to the complaint, which says damages at least reach into the hundreds of millions of dollars.

 

The whistleblowers are Jeff Campie, a former senior director for quality control assurance at Gilead who says he was fired for raising objections, and Sherilyn Campie, who was still working as an associate manager for quality control at Gilead when the complaint was filed earlier this year. While selling drugs of suspect quality violates the False Claims Act (FCA), it’s a theory that’s just beginning to be used in whistleblower cases. It should be noted that some of the larger FCA settlements, including a $750 million deal in 2010 with GlaxoSmithKline PLC and a $500 million accord in 2013 with Ranbaxy Laboratories Ltd., arose over quality lapses.

 

Jeff Campie is also suing over alleged retaliation in connection with his apparent termination, but Gilead says he hasn’t properly claimed to have been engaged in protected conduct – such as investigation of false claims, as opposed to investigation of GMP violations – or that his dismissal was related to whistleblowing.

 

Source: Law360.com

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