Drug Recall Lawyer Blog

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!

News reports abound about the recent victories of two women in Philadelphia Court of Common Pleas over Wyeth Pharmaceuticals (now Pfizer). The two woman, Connie Barton and Donna Kendall, each took hormone therapy and, tragically, developed breast cancer. After long, hard battles with the cancer, they each had to have their breasts removed in a procedure known as a mastectomy (Ms. Barton had a single mastectomy, and Ms. Kendall had a double mastectomy).

For their injuries, the separate juries concluded that Pfizer owes $3.7 million and $6.3 million in compensatory damages to Ms. Barton and Ms. Kendall, respectively. Even more interesting is that the juries deliberated on the issue of punitive damages—damages meant to punish the defendant for their wanton and reckless conduct. The punitive damage awards were $75 million and $28 million, respectively. That brings Pfizer’s total obligation in these two cases to $113 million. And, as we’ve reported before, the plaintiffs deserve every penny and more.

There are more than 10,000 other hormone therapy cases pending around the country. As Ms. Kendall’s attorney, Tobias Millrood stated: “It’s not a responsible reaction to keep these woman on hold forever.” Unfortunately, Pfizer shows no indication of conceding defeat anytime soon.

Congratulations to the two plaintiffs, and the legal team that put their cases together. In particular, Tobi Millrood, the architect of the hormone therapy litigation, lead trial counsel in the Barton case, and dedicated representative of injured plaintiffs, has done an excellent job standing up for the rights of women injured by hormone therapy. As we continue to see in this age of corporate greed, the drug companies are content to place their profits over people. We need people like Tobi to stand up and fight the good fight.

The following news article details a little about the uphill battle faced by these courageous woman. It’s worth watching.

Here are some links to what’s going on the world of drug and device recalls, and pharmaceutical litigation:

• Numerous blog posts featuring inside information on Vytorin and Zetia research studies, including the Arbiter 6 study that we recently posted on (courtesy Schearlings-Got-Plowed).
  
• Twitter hashtag of information on the FDA’s Social Media Meeting (courtesy @skypen).
• FDA celebrates International Internet Week of Action by sending 22 warning letters to operators of websites for illegally selling unapproved or misbranded drugs to U.S. customers.
• Procter & Gamble recalls three lots of Vicks Sinex Nasal Spray, because of bacterial contamination.
• Google Scholar now available to perform legal research—free opinions from U.S. federal and state district, appellate and supreme court opinions.
• Visit the Drug Industry Document Archive (DIDA) for over 1500 drug company documents, many only revealed after litigation. Included are some Wyeth ghostwriting documents (courtesy Tom Lamb).
• Fun new blog on Evidence in Medicine.

Happy Monday!

After reviewing some of the myriad reports detailing the chondrolysis (loss of cartilage) from patients following routine arthroscopic shoulder surgery, the FDA is now mandating that the manufacturers of local anesthetics (for example, bupivacaine, chlorprocaine, lidocaine, mepivacaine, procaine and ropivacaine) place specific warnings on their drugs.

The FDA's notice to healthcare providers states:

The approved drug labels for local anesthetics do not include an indication for continuous intra-articular postoperative infusions or use of infusion devices, such as elastomeric pumps. The FDA has not cleared any infusion devices with an indication for use in intra-articular infusion of local anesthetics.

Specifically, healthcare providers are warned against using these drugs in pain pumps for continuous intra-articular infusion of local anesthetics after orthopedic surgery. The warning is not limited to shoulder surgery.

The requirement that drug manufacturers place appropriate warnings on their drugs is a significant step forward, and bolsters the position of plaintiffs in pain pump cases around the country. In many of those cases, the pain pump manufacturers and the manufacturers of the anesthetic drugs have been sued. The anesthetic manufacturers are disclaiming liability, saying that they have no responsibility for how their drugs are used. Clearly, the FDA thinks otherwise.

In the first hormone therapy trial since the Connie Barton case where the jury awarded $3.7 million in compensatory damages and an undisclosed amount in punitive damages (the specific amount has been posted in unconfirmed reports on the web), a second Philadelphia jury has determined that Pfizer (which purchased Wyeth, the original manufacturer of the drug) owes plaintiff Donna Kendall $6.3 million in compensatory damages. The jury will reconvene on Monday to determine the amount of punitive damages that should also be awarded, to punish Pfizer for its conduct.

The Plaintiff, Ms. Kendall, took hormone therapy for 11 years, developed breast cancer, and had to have a double mastectomy (surgical removal of her breasts). Of course, no amount of money can repay her for her injuries. And likely, no amount of money awarded can adequately punish Wyeth for their negligence. But, it's a good start.

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.

It seems that everyone but Merck is satisfied with the results of the Arbiter 6-Halts study (copy in the New England Journal of Medicine). Allen Taylor of the Medstar Research Institute states that “The results are very clear, Niacin was superior.” John Kastelein of the University of Amsterdam said “I fully support” the study’s findings.

Continue reading " More on the Recent Zetia and Vytorin Study " »

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? " »

Just to clarify, the study itself is not bad; rather, the results are bad for Merck & Co., which already has two studies on Vytorin and Zetia that leave negative conclusions for the drugs. These cholesterol drugs are the subject of a $41.5 million Zetia/Vytorin settlement. Sales of the drugs have sunk down about 14% since January, 2009.

Continue reading " Another Bad Zetia and Vytorin Study " »

Right now, there are three hotbeds of YAZ, Yasmin and Ocella litigation: Illinois, Pennsylvania, and now New Jersey. Here’s the breakdown:

Continue reading " YAZ Litigation Status " »

Busy week ahead—lawsuits to file, meetings to attend, articles to write and continuing legal education seminars to plan. So, we’ll keep this short:

• More on Aranesp, the anemia drug by Amgen: It is associated with increased risk of stroke in patients with diabetes and chronic kidney disease (courtesy @TomLamb and www.drug-injury.com).
• The FDA will discuss Merck’s cholesterol drugs Vytorin and Zetia as they relate to pediatric-focused safety reviews on November 18 in Maryland. See our prior blog post on the dangers of Vytorin and Zetia).
• A quick criminal history of Pfizer (courtesy @PharmaGossip). Are they more focused on saving lives than making money?
• A little on the merger between Merck and Schering-Plough and their new web issues (courtesy www.shearlingsplowed.blogspot.com).
• More on Accutane, which has been recalled in light of links to inflammatory bowel disease
• New Jersey considers giving mass tort status to the YAZ, Yasmin and Ocella birth control injury litigation

Happy Monday!

The FDA has started a “Safe Use” initiative to combat the growing problem of medication errors. An article by The Washington Post reports that greater care in the writing, filling and taking of prescriptions can prevent 50,000 unnecessary hospitalizations per year. Other statistics of interest, according to the article and the Institute of Medicine:

• 1.5 million preventable injuries and deaths are caused by medication errors
• Medication errors cost $4 billion annually
• Between 2003 and 2006, more than 9,000 children were accidentally exposed to prescription drugs.

Much of the onus for preventing these injuries clearly rests on doctors, pharmacists, and patients. However, what responsibility do pharmaceutical companies have?

Continue reading " Reducing Medication Errors: What Can Drug Makers Do? " »

Byetta, an injectable therapy for blood control of type-II diabetes patients manufactured by Amylin and Lilly, has been taking punches for links to pancreatic injuries (see our Byetta Pancreas Injury Website). Now, a whole new line of injuries is entering the ring—kidney injuries.

The FDA has received post-marketing reports (complaints from patients and doctors after a drug is released to the public) that some patients have developed serious, life-threatening injuries while taking Byetta.

Continue reading " Byetta Kidney Injuries " »

The United States Court of Appeals for the Eighth Circuit yesterday issued its opinion in Scroggin v. Wyeth, et al. The opinion is overwhelmingly positive for women and their families who have been injured by the hormone therapy. Donna Scroggins, like many women who took hormone therapy, suffered from breast cancer in both of her breasts and later had both of them removed.

In the underlying 2008 Arkansas trial, the jury found Defendants liable to the tune of $2.75 million in compensatory damages, and $27 million in punitive damages.

Continue reading " Next Step: Punitive Damages " »

In case you are still coming down from your post-Halloween sugar buzz, here’s a collection of recent blogs and articles about subjects relevant to the Drug Recall Lawyer Blog.

• Iqbal and Twombly hearings are continuing. This is a complex issue, and much e-ink has been spilt on it. American Lawyer, Mass Tort Litigation Blog, Drug and Device Law, Point of Law.
• Drug-juggernaut Amgen faces accusations that it used illegal kickbacks to promote Aranesp, its anemia drug: New York Times, Los Angeles Times, Wall Street Journal, Associated Press. The New England Journal of Medicine reports that it nearly doubles the risk of stroke in people with diabetes and kidney problems.
• FDA increases Byetta warnings about pancreatitis: Associated Press. For more on Byetta, see our blog and website.
• Editorial on FDA’s inability to police dietary supplements: Boston Globe. We blogged about this earlier.
• More dismissals in the sad cases of Medtronic’s Sprint Fidelis leads: Minneapolis Star Tribune.

Happy Monday!