Drug Recall Lawyer Blog

BigPharma’s Comments To FDA’s Social Networking Inquiry

2010-03-12T13:42:05Z

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

2010-03-11T12:28:21Z

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

2010-03-10T14:05:55Z

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.

]]> Related to the issue is AstraZeneca’s announcement that it is ending research and development of psychiatric medications at the U.S. headquarters. There is no indication how much of the research will be done elsewhere, or whether that specific research will just be ended, altogether.

And finally, AstraZeneca has taken a hit in the U.K., where the Prescription Medicines Code of Practice Authority decided that AstraZeneca unethically failed to accurately describe the side effects of Seroquel in a British Journal of Psychiatry advertisement in 2004. The ad favorably compared weight gain in Seroquel users to those of other antipsychotic drugs. The company contends that intended readers of the magazine would know that Seroquel caused weight gain.

For more information on Seroquel, please visit our Seroquel blog posts and our Seroquel injury website.

If you or a loved one has suffered because of this drug—weight gain, diabetes or pancreatitis, please contact us at 1.800.553.8082, or click here for an internet consultation.

Drug Recall Lawyer Blog Round-Up

2010-03-08T08:48:18Z

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

2010-03-05T09:30:25Z

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?

2010-03-04T16:48:11Z

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).

]]> One other attack I have to comment on:

The charges in this compendium undoubtedly will launch a torrent of litigation against GSK, to the delight of trial lawyers, despite the fact that the senators' assertions are unsupported by the data.

As a trial lawyer, I will tell you that drug litigation is no joke. It’s expensive. Very expensive. No lawyer in his right mind would be “delighted” to start drug lawsuits without having a sound factual basis for doing so. If the data really doesn’t support the lawsuits, lawyers who invest in that litigation stand to lose a lot of money. And, sometimes, lawsuits have to be started before the science is fully developed. The reasoning is often based on the statute of limitations. Right now, we are hearing that Avandia has problems. If lawyers wait four or five years to bring the lawsuits, after all the studies have been done and scientists have made their opinions, many patients may have lost their chance to bring a lawsuit—in many states, the deadline to file a complaint is 3 years or less from the time a reasonable person should have known about a possible connection between the drug and their injury. Of course, if the drug companies are comfortable joining trial lawyers to extend the statute in all states to something like ten years, perhaps lawyers will have time to wait for the science. But, that’s just my two cents.

The end result is, the Senators have looked at the documents and heard the testimony, and we, the public, haven’t. So, we rely on them to start the process, start the investigation, and in time, everything will become evident.

BigPharma Goes All “Social Media”

2010-03-02T14:28:32Z

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.

]]> But, comments have been received at the 11th hour by the following companies: AstraZeneca, Pfizer, Merck, Lilly, Medtronic, Novartis and Abbott. AstraZeneca posted a link to their statement submitted to the FDA, and mentioned their core principles for social media on their blog:

Truth and Accuracy: Content that is truthful, balanced, accurate, and not misleading
Be Respectful: Respect the interests of patients, caregivers, and health care providers, particularly related to matters of privacy and the primacy of the patient/physician relationship
Protect and Advance Patient Health: Provide accurate and timely reporting on medicine safety
Transparency: Any sponsorship should be entirely transparent as to the role of product sponsors as participants in online discusions [sic]
Respect the Views of Others: Acknowledge other opinions but don’t censor or limit these views; rather, add the product sponsor's views to the ongoing discussions

Importantly, AstraZeneca claims that it has taken the noble step of limiting their social networking to “corporate, non-product information.” That is a wise and responsible decision, given the current lack of regulation. But, AstraZeneca is poised to become a leader in the social networking drug world: they have no less than one blog, three Facebook pages (including one for Nexium—perhaps AstraZeneca forgot about that one when they said they are not talking about products?), three Twitter accounts, and three YouTube sites. Their proposal identifies many of the challenges ahead—how will the FDA’s regulation fit in with regulation from other nations? What responsibility does a manufacturer have for content posted on-line by third parties (for example, Google Sidewiki)? How do promotional rules apply to space-restricted social networking, like Twitter? Does “big picture” regulation (i.e., not regulating each post) actually work, given how consumers are going to use each form of social networking?

I have not seen the other submissions, but I will be on the lookout and will post links as they come up.

Drug Recall Lawyer Blog Round-Up

2010-03-01T14:02:53Z

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

2010-02-26T13:54:01Z

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

2010-02-25T13:37:15Z

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

2010-02-24T15:23:20Z

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.

]]> Contraindications:
Avandia should not be used by patients with certain types of heart failure. In May 2007 the FDA required a black box warning recounting Avandia’s association with myocardial ischemia (angina). The manufacturer’s website posts the following warning:

AVANDIA can cause or worsen heart failure. If you have severe heart failure (very poor pumping ability of the heart) you cannot be started on AVANDIA. AVANDIA is also not recommended if you have heart failure with symptoms (such as shortness of breath or swelling) even if these symptoms are not severe.
AVANDIA may increase your risk of other heart problems that occur when there is reduced blood flow to the heart, such as chest pain (angina) or heart attack (myocardial infarction). This risk appeared higher in patients taking medicines called nitrates or insulin.

Furthermore, it may be contraindicated in patients with a history of other forms of diabetes or liver problems.

Injuries:
There are two major types of injuries that are being associated with Avandia. The first is heart attacks—in July 2007, FDA scientists determined that Avandia caused more than 80,000 heart attacks. Some FDA officials recommended that the drug be recalled at that time; however, the FDA took the step of requiring a black box warning, instead.

The second is liver injuries—as reported by the Drug Injury Watch, an article in Pharmacoepidemiology and Drug Safety, publishedin July 2009, links Avandia to liver failure.

Timeline:

May 25, 1999: Avandia released to market by GlaxoSmithKline (GSK)
May 2007: Cleveland Clinic analysis of 42 clinical trials, showing that Avandia patients had a 43% higher risk of heart attack
July 2007: FDA estimates that Avandia responsible for over 80,000 heart attacks
October 2008: two FDA scientists recommend Avandia recall
November 2007: FDA requires Avandia black box warning
August 2009: FDA receives GlaxoSmithKline’s RECORD study results. RECORD was a large (2,220 patients), long-term (5.5 years) clinical study designed to evaluate risks of Avandia.
July 2010: FDA will hold joint public meeting of Endocrinologic and Metabolic Drugs and Drug Safety and Risk Management Advisory Committees to consider an updated assessment of risks and benefits of Avandia

Public Furor:
The reason this is all coming to a head now is because of a February 20 Senate Finance Committee report on Avandia. The report took two years to write, and involved review of documents from GlaxoSmithKline, the FDA and several research institutes. In particular, the report criticizes the FDA’s internal structure and its alliance with drug companies, all of which seem to preclude, rather than protect, patients. The FDA is being pressured to move up the timeline to review the RECORD and other studies, but it appears that they are steadfastly holding to their July 2010 timetable.

Patient Reaction:
What’s a patient to do? Per the FDA:

Continue taking medication until you consult your doctor
Read medication warning guide

There are a lot of moving parts with this drug, right now. The FDA’s July meeting will be interesting, and may give support to the thousands of people who have filed Avandia lawsuits.

Drug Recall Lawyer Blog Round Up

2010-02-22T14:54:19Z

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

2010-02-18T21:36:13Z

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

2010-02-18T14:58:08Z

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.
]]> But, Mr. McCarrell persevered, and in a retrial that concluded Tuesday, received a verdict of $25.16 million. The jury determined that amount to be just compensation for 15 years of sickness, including five surgeries and removal of his colon. The jury agreed that Roche failed to warn about the risks of inflammatory bowel disease through the drug’s label. This is largest of six Accutane verdicts to the sum of $56 million.

Expert Testimony Excluded in Accutane Lawsuit: In one of the suicide cases, New Jersey’s appellate court affirmed a trial judge’s exclusion of plaintiff’s expert study, used to prove general causation (that is, that the drug in general can cause people to commit suicide). The study was beset by problems, and the court allowed the expert to rework it, but finally ruled that it was not based on the methodology he claimed. The expert, however, may still be allowed to opine that Accutane can cause depression—that’s for the trial judge to decide.

Perhaps this can just be chalked up to “win some, lose some.” By all reports, the suicide cases are not doing well, but the other injury lawsuits are picking up momentum.

Overmedication Of Children

2010-02-16T10:04:35Z

In Foster Care Children and Off-Label Drug Use I discussed the use of drugs, particularly psychotropics, to medicate children. In Who Do The Drug Companies Cater To? I talked about doctors (one in particular) who, by all accounts, clearly overprescribed medications, including Seroquel and clozapine.

Now, an article from the Anchorage Daily News reports that the Law Project for Psychiatric Rights filed a federal lawsuit against over a dozen Alaskan psychiatrists, stating that the doctors “unnecessarily drugged children and committed Medicare fraud.”

The article points out that children on Medicare are four times as likely to be put on antipsychotic medication as children who have private insurance. 90% of children seeing psychiatrists are put on medication, while less than 10% of those medications are FDA approved for children.

Assuming these facts are true and that doctors are overmedicating children in Anchorage, some may think that the doctors are to blame. They have the ultimate responsibility, having intimate knowledge (hopefully) of their patients’ conditions, and being able to fully and fairly judge what medication, if any, they should be on. Others may point to the drug companies, who encourage doctors to prescribe drugs to patients, often for off-label uses which have not been safety-tested or FDA-approved. Those same drug companies may use subtle persuasion to enforce these practices—lunches, gifts, and vacations masquerading as medical education seminars.

But one thing is certain—if a drug company sees a physician or group prescribing an inordinate percentage of their drugs, they should spend some time with that physician/group to make sure that the doctor fully understands what the drug is approved for? The drug companies have track these statistics, but something tells me many of them happily look the other way and their profits climb…