Drug Recall Lawyer Blog

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.

Continue reading "Seroquel Trial Update" »

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!

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…

Here are some of the stories we’re following this week:

• Janumet: Shearlings Got Plowed reports that the FDA is revising the label for Janumet to warn about pancreatitis. A link to the FDA’s prescribing information is here
• Seroquel: Tom Lamb reports on the difficulties that plaintiffs are facing in these cases, of late. It seems that the odds are against us and the situation is grim—a good time for a reversal
• Prempro: NPR reports on the marketing masquerading as research by drug-makers trying to profit from menopause
• Levaquin: The Mass Tort Defense blog reports on the status of the bellwether trials: consolidation rejected
• Conflicts of Interest: The New York Times reports that Pfizer gives $3 million to Stanford University for creation of continuing medical education courses, where Pfizer has no say on what the money is spent for. Does this prevent conflicts of interest or is it “self-satirizing?”

Happy Monday!

Not drug related, but Happy Anniversary is in order.

Now that you know more about me than you are probably comfortable with (who celebrates that?), let’s get to business with some noteworthy items:

• Reuters discusses the FDAs investigation of using drugs like Seroquel on children.
• Recently expanded indications for Seroquel by children.
• The Chicago Tribune writes about abuses in prescribing psychotropic medications without consent and without a valid medical reason. Note the front-and-center picture of Seroquel.
• The Wall Street Journal discusses a clinical study showing that an experimental once-a-week treatment woks better to treat type-2 diabetes than Januvia.
• Tomorrow (December 8, 2009) the FDA will convene a joint meeting of the Cardiovascular and Renal Drugs Committee and Drug Safety and Risk Management Advisory Committee. They will discuss safety as it pertains to Gadolinium-based contrast agents, which are used before MRI procedures. A copy of the background material (agenda, briefing information and meeting roster) is located here. More information on Gadolinium-based contrast agents can be found at our blog and our website.
• More on Ghostwriting (courtesy Brian Ketterer). I like this excerpt:

If a professional writer is paid by a company to write a piece and a non-author doctor is asked to approve it, the appropriate outcome would be for the professional writer to be listed as the author and for the non-author doctor to be thanked in an acknowledgement for having reviewed the paper. If the non-author doctor makes substantial enough changes to the paper, he or she might be listed as a coauthor. In either case, the funding for the paper should be disclosed.

Happy Monday!

Some items of interest while you eat turkey sandwiches for lunch, today:

• Class-1 recall of Stryker’s Navigation System II: 23 of these units are potentially faulty. The device is a computer-aided surgery platform that performs hip, spine, knee, neuro and ENT surgeries. The computer may not work properly, which could lead to serious injury or death. Stryker is also a manufacturer of shoulder pain pumps.
• Second bellwether Fosamax case dismissed:
  Judge Keenan (S.D. New York) dismissed the second of three Fosamax bellwether cases last week because of lack of specific causation (proof that Fosamax caused her injury, which is different from general causation—proof that Fosamax can cause these types of injuries). The third case is set for an April 2010 trial.
• Making drug safety information more accessible to patients: discusses the labeling of drugs, and whether those labels are sufficient for detailing drug efficacy and safety issues (hat tip to Tom Lamb at www.DrugInjuryWatch.com).
• AstraZeneca performs its own Seroquel study—surprised at what they found? Dr. Paul Woolf, a paid consultant who has received more than $216,000 from AstraZeneca, intends to testify that he reviewed AstraZeneca’s 2004 study on Seroquel, and that it shows the drug does not significantly affect blood-sugar levels. See our other blog posts on Seroquel and the findings of other studies (including AstraZeneca’s own covered-up research).

Happy Monday!

The Seroquel MDL, which has been focused on common Seroquel discovery since July of 2006, may be coming to an end. Judge Anne Conway of the U.S. District Court for the Middle District of Florida stated yesterday that she is recommending all cases in the MDL be sent to their home states for possible trials. There are approximately 6,000 cases in the MDL, and more cases filed in other states around the country, including New Jersey and Delaware, which may see the first trials as early as January of next year.

AstraZeneca, the defendant and manufacturer of Seroquel, requested that Judge Conway send back approximately 60 cases for early trials. These cases would serve as tests, which may pave the way for eventual settlement of the rest of the claims. However, plaintiffs requested that all cases be sent back starting next month. Certainly, it would take some time for the federal judges to address the multitude of cases, but the earlier they are sent back, the earlier trial dates can be set. There is still a long road for plaintiffs, but they are nearing the horizon.

Tons of press on AstraZeneca and their antipsychotic drug Seroquel, lately, much of it dealing with one Dr. Michael Reinstein, a physician who, by all reports, is going to have to answer a lot of questions about his patients.

Here’s the Cliffs Notes:

Continue reading "Who Do The Drug Companies Cater To?" »

An e-mail from the Seroquel litigation, dated May 14, 2001, contains some talking points for Seroquel’s Product Managers and Marketing Managers. AstraZeneca understood that they had a big problem with the weight-gain issue. The e-mail reflects their approach:

• “The global strategy is to demonstrate to customers that Seroquel has a weight neutral profile in the long term
• Seroquel is not associated with diabetes nor its exacerbation

Attached to the e-mail was a “weight objection handler,” more talking points to counter objections to Seroquel by health care providers who questioned the weight gain issue.

Does this make any sense at all? Are they trying to say that, with Seroquel, patients gained weight rapidly in the short-term, but then lost that weight over the time they were on the drug? And, what is the short-term, anyway? This is far-fetched, and is another example of a desperate company trying to fiddle with studies and data that leave one inescapable conclusion—they should warn people about dangers associated with their drug.

We've reported on numerous drugs that are linked to pancreatitis. These include:

• Januvia and Janumet
• Seroquel
• Byetta

The signs and symptoms of pancreatitis (information courtesy the Mayo Clinic) are listed below.

Notes of sales calls between AstraZeneca and doctors have just been released by a federal judge overseeing the Seroquel MDL litigation in Orlando, Florida. Those notes show an AstraZeneca salesperson telling a United States doctor (the doctor’s name was redacted) that Seroquel did not cause diabetes. However, four years earlier, AstraZeneca sent a memo to Japanese doctors detailing that “causality with the drug could not be ruled out.” AstraZeneca warned Japanese doctors against prescribing Seroquel for patients with diabetes, and encouraged monitoring of blood-sugar levels.

It took two years before AstraZeneca gave their United States patients and doctors the same warning.

Another note revels one AstraZeneca sales representative telling doctors in November, 2005 that weight gain was atypical for Seroquel users. Company documents reveal that these sales reps were trained to deflect questions about weight gain—apparently, when they could not deflect the questions, they simply lied. The company knew at least as early as 1998 that “clinically significant weight gain, that is more than 7% increase in body weight, was seen with [Seroquel] than placebo.”

AstraZeneca’s behavior is outrageous. Warnings about known risks should be the same in Japan and the United States, regardless of each country’s drug regulations. The end goal should be to protect the health of patients and potential patients. But, AstraZeneca appears to have other motives when selling their products.

For more on Seroquel, see:

• Miller & Zois’ Seroquel Website
• Drug Recall Lawyer Blog Entries on Seroquel
• YouTube Video on Seroquel

The dangers of Seroquel.

Gabriel Myers, age 7 and in the Florida foster care system, deliberately hanged and killed himself with a detachable shower hose.

My wife and I recently signed up for foster care here in Baltimore, and we have been taking care of our first foster care child (an infant) for the past 3 months. Foster care is the temporary placement of a child, typically while the parent gets his or her life together in order to better care for the child. As we went through the process, we met a lot of foster care parents, and learned that many children are placed in foster care because they are physically, emotionally or sexually abused; or because they are neglected. The older the children are when they are pulled away from their parents, the more likely it is that they have significant emotional and psychiatric injuries.

So, this is an issue I feel strongly about. Children taken away from a volatile situation need the best care possible, and need to be safe and loved. Recent reports from Florida show that many children who have had tumultuous lives are being put on psychotropic medication when they enter the foster care system. In fact, an astounding number of children in the Florida Department of Children and Families are on these drugs:

• 22% of children aged 6-12


• 33% of children aged 13-17

Tellingly, a fewer percentage of foster care children who live with relatives or family friends are taking psychotropics—about 12%. And, that number even feels high.

Continue reading "Foster Care Children and Off-Label Drug Use " »

More problems for the Seroquel lawsuits, recently. Plaintiffs in the Seroquel litigation generally allege that the drug causes diabetes and other metabolic disorders. Judge Joseph Slights, III of the Delaware Superior Court granted summary judgment in the Scaife case. In its Daubert argument, AstraZenceca persuaded the court that the plaintiff’s expert witness, an endocrinologist, provided opinions which were not scientifically reliable. The three bases for this opinion are that the physician (1) failed to rule out other likely causes of plaintiff’s diabetes; (2) found causation between the drug and the injury to a large degree because of the timing of plaintiff’s ingestion of the drug and onset of the disease; and (3) failed to use a rigorous methodological analysis of available data to support her conclusions. The court excluded plaintiff’s expert witness, then held that summary judgment was appropriate and the plaintiff had no means to prove her case.

The opinion reveals the unfortunate human cost of drug litigation. These cases can be difficult to prove, often because plaintiffs who take medication are frequently sick people (of course, this is why they take medication). Sick people oftentimes make for problematic plaintiffs because every medical issue becomes another complicating factor in the causation analysis and the epidemiological data. Then, if the cases get to a jury, it’s all too easy to dismiss habitually sick people as those who will always have problems, regardless of whether they are caused by a defective product. In the Scaife case, the plaintiff was frequently overweight, had an extremely poor diet, suffered from hypertension, and smoked prodigiously. In this case, though, it’s hard to know if the problem was poor case selection, or an expert who was not properly vetted. Or some other reason…