Drug Recall Lawyer Blog

YAZ, Yasmin & Ocella Lawsuit Update

Fri, 12 Mar 2010 15:27:54 -0500

We've updated our YAZ lawsuit webpage (which includes claims against Yasmin and the generic birth control pill Ocella). Check it out here.

BigPharma’s Comments To FDA’s Social Networking Inquiry

Fri, 12 Mar 2010 08:42:05 -0500

To follow up on our March 2, 2010 post BigPharma Goes All “Social Media” is a website that features all comments submitted to the FDA on the social networking question. A somewhat more readable version (though, less complete) is at www.fdasm.com. Here are links to some of the heavy hitters (including law firms and internet providers) who have commented. The papers are downloadable directly from the website.

The Supremes Examine Vaccines

Thu, 11 Mar 2010 07:28:21 -0500

In Bruesewitz v. Wyeth, the plaintiffs are appealing to the United States Supreme Court from the Third Circuit Court of Appeals. They believe that the administrative set-up of the National Childhood Vaccine Injury Act (est’d 1988) is an insufficient remedy for vaccine-related injuries. Under the Act, designed to encourage drug companies to create vaccines, injured consumers receive damages under a no-fault system, decided by the U.S. Court of Federal Claims. The petition was granted on March 8.

In this case, the Bruesewitz’s child received a standard DPT vaccine, which caused seizures and permanent neurological injury. The question presented is whether the national Childhood Vaccine Injury Act preempts all vaccine design defect claims, regardless whether the vaccine’s side effects were unavoidable.

So what do you think? Has the National Childhood Vaccine Injury Act outlived its usefulness (assuming it was ever useful to begin with)?

For more information:

Seroquel Trial Update

Wed, 10 Mar 2010 09:05:55 -0500

The New Jersey Superior Court Case (Middlesex County) of Baker v. AstraZeneca Pharmaceuticals LP is now focusing on the drug manufacturer’s advertising strategy. The plaintiff in that case is alleging that he should have been better warned about the risks for weight gain and developing diabetes.

On the plaintiff’s side is Dr. Wayne Geller, a former AstraZeneca employee—a global safety officer—who testified that the company rebuffed his efforts to strengthen internal documents describing the weight gain issue. He testified that “I found out there were people from the commercial side” who opposed the changes. This is another indication of marketing trumping. AstraZeneca is defending the case, noting that it adequately warned about the risk of diabetes, and that Seroquel doesn’t cause diabetes, anyway. They rely on several studies that showed favorable data, but other reports show average weight gain for users on Seroquel is 27 pounds.

Drug Recall Lawyer Blog Round-Up

Mon, 08 Mar 2010 03:48:18 -0500

Time to wake up and face the week! Here are the stories we’re following:

Avandia: The U.K.’s Guardian blogs about GlaxoSmithKline’s potential $6 billion liability. @TomLamb and I are skeptical.
Vioxx: Australian judge finds for plaintiff in defective drug lawsuit against Merck, though rules that Merck was not negligent. (HT: Pharmalot). Merck’s press release is here.
FDA: The FDA is going to step up criminal prosecutions of corporate officials.
Insulin Pump Defects: Insulin pumps have been beset by problems, spanning across the spectrum of manufacturers (HT: Drug Injury Lawyer Blog).
510k Approvals in February: See the list here.
Direct-to-Consumer Advertising: BigPharma’s DTC advertising increased by a “paltry” 1.9% in 2009, but Pfizer leads the pack with $1.1 billion.
BPA: Wisconsin is added to the list of states banning BPA in baby bottles and cups.
Nerd Link of the Week: You’ll just have to click to find out…

Happy Monday!

Avandia: Much Ado About Nothing—The Sequel

Fri, 05 Mar 2010 04:30:25 -0500

Yesterday I clicked a link from @pharmaguy: End-of-Life Warning at $618,616 Makes Me Wonder Was It Worth It, an article in Bloomberg by Amanda Bennett. Don’t read it unless you have 5-10 minutes of quiet time—this is a powerful story.

This story, the story of Amanda Bennett, Terrence Bennett and their children and doctors and the U.S. healthcare system and drugs and drug companies and life and death raises a number of issues. It questions whether medical cost spending, much of which occurs in the finals days and weeks of life, is worth it. Ms. Bennett calculates that his seven-year medical bill was $618,616, discounted to $254,176. She notes that:

Would I do it all again? Absolutely. I couldn’t not do it again. But I think had he known the costs, Terence would have fought the insurers spending enough, at roughly $200,000, to vaccinate almost a quarter-million children in developing countries. That’s how he would have thought about it.

The last four days of Mr. Bennett’s life cost his insurance company $43,711. My mom, a respiratory therapist in Colorado, says that extraordinary measures and costs in the last days of life are the norm. My review of medical records and bills in my own clients' catastrophic cases confirms it.

The story also brings this to mind: though the focus of this blog is on defective drugs and medical devices, it goes without saying that drug companies and medical device manufacturers do great things. They develop products that frequently do help people to live better (if not longer), lives. Of course, our focus is on the negative 5-10% of their behavior and products (I’m just making numbers up, here. You get the idea). The majority of the time, the products are good, and the decisions are responsible. Genetech Inc. and Bayer AG paid for experimental medications for Mr. Bennett. That’s a responsible and noteworthy thing to do.

Clearly, as Dr. Ross notes in his editorial from yesterday’s post, there is a cost-benefit analysis to bringing new drugs to market and approving them. Everyone agrees to that. And, when we decide where the line is that allows some drugs and excludes others, someone is going to be unhappy. But the line has to be drawn somewhere, and we need to do it with the best information possible.

Avandia: Much Ado About Nothing?

Thu, 04 Mar 2010 11:48:11 -0500

Today’s New York Times featured commentary by Dr. Gilbert Ross (maybe this Gilbert Ross?). “When Senators Play Doctor: Risk-mongering can stifle innovation, cost lives.”

Dr. Ross essentially argues that the senators have completely misinterpreted the Avandia data, whether intentionally or not, in order to fulfill their objective of creating an independent drug safety division within, but separate from, the FDA. Perhaps Dr. Ross thinks that’s a bad thing—it’s not clear from his commentary. It seems to me that, erecting another level of safety in the regulation of drugs can only be a good thing. But, that’s another blog post.

The criticism boils down to the fact that these are senators—mere politicians—who are sticking their noses where they don’t belong—in areas of science of medicine. Unfortunately, we don’t have a separate job for “scientist politicians” who can this job, so our political system is left having to deal with it as it is. Also, the senators criticizing the FDA’s handling of Avandia are undoubtedly relying on the opinions and conclusions of doctors and scientists, not the least of which is Dr. David Graham, employed by the FDA (the commentary paints him to be an anti-Pharma crusader—perhaps this is true, but perhaps he just puts patient safety a little higher on his list than others do).

BigPharma Goes All “Social Media”

Tue, 02 Mar 2010 09:28:32 -0500

Up until now, online social networking has been treated mostly as a plaything for some pharmaceutical manufacturers. They will post a few updates on Twitter, maybe start a Facebook page or post a YouTube video or two, but I have not seen much indication that the companies have really bought in, much less that they “get it” (though, some like AstraZeneca may be playing it safe while the FDA works out the regulation aspect).

Eye on FDA has a good summary of what’s happened to get us to this point. Initially, the FDA was more concerned with the content of pharmaceutical and medical device manufacturers’ messages. However, last year the FDA realized that there is only so many contraindications you can fit in 140 characters. So, in September 2009, they took the proactive step of setting a meeting (which BigPharma interestingly did not attend), and encouraging comments (open through last month). The hope is that they will be able to draft some sort of guidelines, so everyone knows where the line is.

Drug Recall Lawyer Blog Round-Up

Mon, 01 Mar 2010 09:02:53 -0500

Here are this week’s stories:

2009 Adverse Event Reports: Avandia (GlaxoSmithKline) and Seroquel (AstraZeneca) topped the charts for most adverse events for the third quarter of 2009, with 1,218 reports and 977 reports, respectively. See The Institute for Safe Medicine Practices (HT: FiercePharma).
Avandia: “Glaxo Strikes Back at Drug Critics, But It’s a Big Swing and a Miss.” ‘Nuff said.
$13 Million Zyprexa Settlement: Lilly settled a suit brought by the state of Montana over off-label marketing of Zyprexa, used to treat bi-polar disorder and schizophrenia. Most of the funds will be used to pay for mental health services in the state. See BusinessWeek.
BPA: Maryland is considering legislation to ban or limit the use of BPA in plastics used by children. See the Baltimore Sun.
Seroquel Trial: The Seroquel trial (New Jersey), alleging the drug causes diabetes, is in full force. The parties are arguing over whether marketing took precedence over safety research. See Bloomberg.

Happy March!

YAZ: New Jersey State Court Case Consolidated

Fri, 26 Feb 2010 08:54:01 -0500

On November 10, 2009 we wrote that New Jersey state court Assignment Judge Donald Volkert, Jr. formally requested consolidation of the YAZ, Yasmin and Ocella birth control lawsuits in New Jersey state courts. In an order dated February 9, 2010 (and posted to the New Jersey website on February 18, 2010) , Chief Justice Stuart Rabner ordered that all pending and future state court actions regarding the birth control pills would be designated as a mass tort and assigned to Bergen County Judge Brian R. Martinotti. Furthermore, Judge Martinotti will oversee those cases and may return them to their original counties as he sees fit (presumably for individual trials after common work is completed).

More New Jersey YAZ Lawsuit Information

Judge Martinotti has been busy at work, and has already filed a twelve-page initial case management order. Interestingly, in the order’s preamble he cites the Manual for Complex Litigation, which is commonly used for MDL proceedings, but has wide use for even state-run mass litigation. Here are the order’s highlights:

Initial conference set for April 26, 2010 at 10:00 a.m.
Counsel are required to confer regarding the judge’s proposed agenda
Counsel are required to submit brief statements regarding the status of the cases
All motions are stayed
Discovery may proceed, and automatic discovery of certain matters is required to begin immediately
Parties are encouraged to agree on electronic discovery protocols, document depositories and protective orders
Parties are limited to three pro hac vice attorneys, except for good cause

As with all consolidated mass torts, this will go a long way toward streamlining the process, preventing duplicative discovery and inconsistent rulings. Everyone wins.

Recent Hormone Therapy Trials

Thu, 25 Feb 2010 08:37:15 -0500

Since Monday, there have been decisions in two hormone therapy cases. Here are the details:

Monday, February 22-Audrey Singleton: In the Philadelphia Court of Common Pleas, a jury found for the Plaintiff and against Pfizer/Wyeth. The verdict, which came after a four-hour deliberation, was for $9.45 million ($3.25 in compensatory damages and $6 million in punitive damages, with $200,000 to the plaintiff’s husband for loss of consortium). The plaintiff was on hormone therapy for six years, before being diagnosed with breast cancer, which is currently in remission. Notable about this case is that the plaintiff was on hormone therapy for about a year and a half after release of the WHI study showing that Prempro increases the risks of cancer. Plaintiff’s lawyers stated that this verdict confirms Wyeth’s actions after release of the study were irresponsible and negligent.

Wednesday, February 24-Cheryl Foust: Also in the Philadelphia Court of Common Pleas, this case was a defense verdict after six hours of deliberations, on the basis of specific causation. We linked to this case previously—it is the one where plaintiff’s twin sister also took hormone therapy, but did not get breast cancer (both argued that this fact supported their position). Plaintiff was successful in convincing the jury that Wyeth was negligent by not properly warning Ms. Foust’s health care providers about the risks of Prempro, and that the failure caused the health care providers to prescribe the drug to Foust. However, the jury found that the drug did not cause her breast cancer. Ms. Foust succumbed to her cancer at the age of 56; the case was brought by her widower.

As far as jury trials go, Pfizer has lost seven of the past 11. Many cases are up on appeal, and there are still something like 1,500 left to go in Philadelphia. Click here for prior blog posts on hormone therapy drug lawsuits.

Avandia Lawsuits, Recall and Update

Wed, 24 Feb 2010 10:23:20 -0500

If my Google Reader subscriptions are any indication, about 50% of the new blog posts across the web in the past couple of days have been about Avandia. This post is intended as a hub for basic information on Avandia and the status of the proposed Avandia recall.

Indications:
Avandia is used to treat type 2 diabetes mellitus. That type of diabetes, commonly called adult-onset diabetes or non-insulin dependent diabetes mellitus, is reflected by high blood glucose and insulin deficiency/resistance. Avandia (rosiglitazone), as well as Avandamet and Avandaryl (two drugs combining rosiglitazone with either metformin or glimepiride) is intended to help the body use its natural insulin for better glucose control.

Drug Recall Lawyer Blog Round Up

Mon, 22 Feb 2010 09:54:19 -0500

Here are the week’s stories:

Adverse Events: Our friends at the US Recall News have a link to governmental agencies in charge of adverse event complaints and concerns.
Avandia: Lots of concern recently about diabetes drug Avandia and heart problems (HT: Nursing Home Abuse Blog).
Iqbal: The Lewis & Clark law review released its symposium “Pondering Iqbal.” There’s some good topics here—a must read (HT: PrawfsBlog).
BPA: More on BPA research (HT: Nash & Associates).
Fentora: This narcotic painkiller is the subject of possible off-label promotion (HT: Drug Injury Lawyer Blog).
Pharmaceutical Marketing: The title says it all: “A Snarky Look at Sneaky Marketing Tactics Pharma hasn’t Avoided" (HT: Pharma Marketing Blog).
Gadolinium/Omniscan: A settlement has been reached in the libel suit brought by General Electric (GE) against Danish researcher Henrik Thomsen.

Happy Monday!

Poligrip Recall

Thu, 18 Feb 2010 16:36:13 -0500

NPR reports that GlaxoSmithKline is recalling some of its Poligrip products. The recall applies to Super Poligrip tubes of Original, Ultrafresh and Extra Care. Zinc-containing denture adhesives like Poligrip and Fixodent are the subject of lawsuits around the country. Plaintiffs believe that use of the product can lead to ingestion of excessive zinc, which causes neurological problems.

More Poligrip Recall Information

GlaxoSmithKline agrees that "recent publications suggest that an excessive intake of zinc-containing denture adhesives over several years may lead to the development of neurological symptoms and blood problems such as anemia."

Here is a link to today’s consumer advisory, issued by GlaxoSmithKline. In the ultimate subsequent remedial measure, the manufacturer is now working on zinc-free products.

Accutane Update

Thu, 18 Feb 2010 09:58:08 -0500

Two contrasting Accutane lawsuit updates in the news today:

First, Some Background: Accutane is used to treat severe acne, and has been associated with a host of problems: birth defects, inflammatory bowel disease, injuries to the liver, kidneys, nervous system and pancreas, dermatological reactions, and even suicide. Roche stopped selling it last year after a 27-year run, citing competition from generics and the 5,000 pending Accutane lawsuits.
Plaintiff’s Verdict: $25.16 Million: In May 2007, Andrew McCarrell emerged victorious in a New Jersey Superior Court Accutane lawsuit against Roche Holding AG. Mr. McCarrell developed inflammatory bowel disease, caused by the Accutane. (View the entire original trial on video, purchase required). That victory was short-lived, as the verdict was appealed and overturned (opinion here, courtesy Drug and Device Law Blog) because the trial judge should have allowed the defendants to present statistical evidence—that there were five million users of the drug.