Drug Recall Lawyer Blog

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).

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.

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.

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.

Continue reading " Avandia Lawsuits, Recall and Update " »

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!

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.

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.

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.

Continue reading " Accutane Update " »

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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…

Some interesting news to follow this week:

• Vioxx: The Pop Tort reports on how “lawsuits played a key role unearthing documents showing what lengths Merck went to cover up mounting evidence that patients taking Vioxx were experiencing a high number of heart attacks and strokes.” Now, Vioxx manufacturer Merck settles some shareholder lawsuits, and includes some proactive measures to protect against these abuses in the future.
• Benzene: The Accident and Injury Lawyer Blog reports on the dangers of benzene.
• Medical Radiation: Much continues to be written about radiation as it relates to diagnostic procedures, especially in the wake of the FDA’s newest guidelines. The Mass Tort Defense Blog opines that plaintiffs’ lawyers seeking medical monitoring for their patients may do more harm than good on the basis that it will increase radiation exposure. There is some logic to this, but shouldn’t patients be the ones to choose?
• Lipitor Whistleblower Lawsuit: FiercePharma reports on an amended complaint by a whistleblower, alleging that Pfizer unethically expanded its marketing base by ignoring cholesterol guidelines.
• Recall of Luer Access Devices: The FDA is posting recalls of Luer Access Devices, including certain lots of BD Q-Syte™ Luer Access Devices and BD Nexiva™ Closed IV Catheter Systems and certain lots of IV Extension Sets with BD Q-Syte™ Luer Access Device. These devices do not properly lock, causing leakage of intravenous materials or blood, or causing air emboli.
• Pain Pumps: This is a good graphic representation of the pain pump system

Happy Monday!

One thing product liability lawyers look at when litigation medical device and pharmaceutical cases is the experiences of foreign countries with the product at issue. I ran across a story about YAZ in Canada that reminds us of the importance of investigating what goes on outside of our borders (hat tip: Girard Gibbs LLP & The Danko Law Firm)

Starting last year, Bayer was promoting YAZ in Canada through a young television actress, Lauren “Lo” Bosworth. MTV’s announcement is woefully inadequate. Granted, it is not marketing directly from YAZ manufacturer Bayer, but it seems that the actress is doing an end-run around the FDA’s restrictions by talking about the benefits of YAZ with regard to regular PMS symptoms. The article states:

Last week [actually, in 2009], the young actress spent a day in Toronto and then Vancouver doing media interviews, where she focused on the fact that Yaz can lead to fewer symptoms like headaches and cramps during that time of the month.

Continue reading " YAZ in Canada " »

The FDA issued a press release Tuesday focusing on unnecessary radiation exposure from CT scans, nuclear medicine studies (use of radiopharmaceuticals taken internally creates the radiation, unlike an x-ray, which bombards the body with radiation externally) and fluoroscopy (process to see real-time moving images of internal structures).

The FDA reports that these three types of diagnostic imaging use ionizing radiation, which can increase lifetime cancer risks. Single exposure to high levels of ionizing radiation causes hair loss, skin burns and cataracts.

The FDA recommends two areas to minimize radiation risk:

1. Appropriate justification of the radiation procedure; and
2. Optimization of the radiation dose used for each procedure

To meet these goals, the FDA will work to issue guidelines for manufacturers of these radiation-emitting devices to create safeguards and appropriate training protocols. Further, health care providers will work with the FDA to implement quality assurance standards.

One of the most important parts of this process is, of course, the patients. Patients should discuss the risks of any procedure involving radiation with their doctors. The FDA is working to develop a patient medical imaging history card, which (if used properly) will better enable physicians to understand the lifetime radiation history of patients, and enable them to better inform patients as to the real risks of subsequent exposure.

The press release focused mostly on the CT images and fluoroscopy, and did not seem to address the procedures for radiopharmaceuticals (nuclear medicine studies), though perhaps that is subsumed in the section on protocols for health care providers who perform imaging services. But, the manufacturers of those pharmaceuticals should also be part of the discussion.

A new article on YAZ and Yasmin lawsuits in the IndyStar sheds a little light on manufacturer Bayer’s defense to the cases:

“But the complaints we have reviewed so far pertain to side effects that are warned about in the labeling of all oral contraceptives, including ours," according to a statement from company spokeswoman Rose Talarie. "Bayer's oral contraceptives are safe and effective when used according to product labeling. Health-care professionals prescribe oral contraceptives following a comprehensive evaluation of the risks and benefits for the individual woman.”

Bayer’s statement ignores two things:

1. It ignores the evidence that YAZ and Yasmin are more dangerous than other comparable birth control pills. That is, a woman’s risks of encountering “side effects” (read: blood clots, deep vein thrombosis, stroke, gallbladder disease/removal, pulmonary embolism, pancreatitis and heart attack). So, it is irrelevant that the risks were warned about—the point is that YAZ and Yasmin have a much higher rate of risks.
2. Overlooking the fact that Bayer knows women often control their own prescriptions (or else, why would they spend so much money on Direct-to-Consumer (DTC) Advertising) it presumes that health-care providers, when writing prescriptions for YAZ and Yasmin, knew that Bayer’s products were more dangerous, but prescribed them anyway for other reasons. The problem is, Bayer wasn’t warning doctors about the relative risks (YAZ and Yasmin versus other comparable products).

Bayer is trying to steer the conversation to one they can control and win. No one disputes that all birth control pills carry risks. It’s just that women taking YAZ and Yasmin have an increased chance of risk exposure.

Here are the stories we're following:

• Levaquin: NJ.com reports that Levaquin manufacturer Johnson & Johnson may have paid millions in kickbacks to a large pharmacy for prescriptions to nursing home patients. The complaint was filed by the U.S. Attorney in Boston.
• Acetaminophen: An article published in the medical journal Thorax ScienceDaily reports that there may be a direct link between use of acetaminophen during pregnancy and child asthma.
• Twombly/Iqbal Statistics: The Federal Judicial Center has collected preliminary data on motions to dismiss before and after Twombly and Iqbal (hat tip: The Civil Procedure and Federal Courts Blog).
• Prempro: Bloomberg discusses Judge Ackerman's reduction of the Connie Barton punitive damages verdict (by 93%, from $75 million to $5.6 million) and added $1.2 million in interest to the jury's compensatory damages verdict of $3.7 million.

Happy Monday!

As you remember, Fosamax, Merck’s osteoporosis drug, is the subject of much litigation. The question presented is whether the drug causes osteonecrosis of the jaw, which is the death of jawbone tissue.

Judge Keenan, ruling over the federal Fosamax cases from his bench in the U.S. District Court for the Southern District of New York (Manhattan), decided that Merck was not entitled to dismissal of the Louise Maley case on the issue of specific causation (essentially, Merck argued that plaintiff could not prove that Fosamax caused her injury. This is different from general causation, which is the argument that Fosomax can cause injuries of this type). The plaintiff did not argue against dismissal of her strict liability and warranty claims, however. Her case will proceed on a failure to warn claim. See the Order (hat tip: Shearlings Got Plowed). The Maley case will go to trial on April 19, 2010.

So, Plaintiff Maley survived where Bessie Flemings could not—Judge Keenan dismissed her case (set for trial this month) last November on specific causation grounds.

In other Fosamax lawsuit news, Judge Keenan is set to select a replacement bellwether case shortly.

Judge Keenan is overseeing something like 700 lawsuits. As of last year, Merck had about 953 cases pending against them. Everything I have seen from these cases indicates that the plaintiffs have extremely meritorious claims. This is one litigation that I regret not getting into.

The Lancet has retracted [free subscription required] the 12-year old article connecting autism to MMR (measles, mumps and rubella) vaccinations. The Lancet stated:

Following the judgment of the UK General Medical Council's Fitness to Practise Panel on Jan 28, 2010, it has become clear that several elements of the 1998 paper by Wakefield et al1 are incorrect, contrary to the findings of an earlier investigation. In particular, the claims in the original paper that children were "consecutively referred" and that investigations were "approved" by the local ethics committee have been proven to be false. Therefore we fully retract this paper from the published record.

Click here for the original article, “Ileal-lymphoid-nodular hyperplasia, non-specific colitis, and
pervasive developmental disorder in children” (emblazoned with a bold, red typeface “RETRACTED”).

Here’s a summary of the posts on the internet and blogosphere:

Continue reading " In The News: Vaccines & Autism " »

A short article by FiercePharma, a monitor for the pharmaceutical industry, got me thinking about sales reps. The article, “Pfizer, Merck reps are tops to cardiologists,” summarized a poll of cardiologists sales representatives from the top pharmaceutical companies. Here they are, in order of “best to worst”:

• Pfizer
• Merck
• Schering-Plough
• AstraZeneca
• Novartis

Among the issues graded were product knowledge, understanding of doctors’ schedules, conduct, and samples. I don’t know how many pharmaceutical companies were graded—for example, is Novartis really bad, or were these the top five out of, say, 100 companies? At any rate, the article prompted me to think a little more about drug and device sales reps.

Continue reading " Sales Reps Can Be Important To Your Drug/Device Lawsuit " »

Here are links to some stories we’re following:

• Hormone Therapy: New Philadelphia hormone therapy case proceeds to trial, and the plaintiff’s twin sister, who sits in the courtroom and took a different type of hormone therapy, did not have cancer. Both sides try to use it to their advantage
• Ortho Evra MDL: The judge addresses the issue of plaintiff ex parte communication with treating physicians (HT MassTortDefense Blog)
• Digitek: Bad news for some plaintiffs’ lawyers in the Digitek lawsuits (HT Overlawyered)
• Social Media and Drug Companies: Several drug companies have banded together to comment on the FDA’s proposed policies on promotion of medical products using the internet and social media (HT Pharma Marketing Blog)

Happy February!