Drug Recall Lawyer Blog

Here’s some stories we’ve been following:

• Trasylol: Plaintiffs’ request to remand Trasylol cases denied pursuant to Class Action Fairness Act (courtesy Mass Tort Defense blog)
• Sprint Fidelis: Over half of the 260,000 Sprint Fidelis lead wires are still active in the United States (courtesy Tom Lamb and the Drug Injury Watch)
• Medical Device Interoperability: The FDA is holding a workshop on Medical Device Interoperability, open to the public, to discuss (among other things) pre- and post-market studies, safety, and risks.
• New criticism of FDA’s Medical Device Approval Process (courtesy Shearlings Got Plowed)

Happy New Year!

We haven’t written much about the Digitek cases. I looked at them in the beginning (and they looked very promising) but in the end could not find any clients who actually had the legendary “double-dose” pill that was the root of all the evil. Certainly there were some patients who died and had blood tests revealing digoxin toxicity, but that’s still an uphill battle without compelling evidence to show the plaintiff took the pills as directed. The allegations are that, among patients with impaired renal function, digitek toxicity can cause nausea, vomiting, dizziness, low blood pressure, cardiac instability, bradycardia and death.

So, I cannot say that I know much about the status of these cases. One blog, MassTortDefense, commented today about the status of the MDL. Five bellweather trials have been selected for the federal litigation in the Southern District of West Virginia.

Any plaintiff lawyers out there want to comment on the state of the litigation, from their perspective? Do we believe plaintiffs have a shot on this one?

The Tylenol recall has been expanding. When it first started in November 2009, it was limited to five specific lots. Now, the FDA is reporting that the recall includes all Tylenol Arthritis Pain 100 Count with [Red] EZ-Open Cap.

The defect at issue is that the pills feature a moldy, musty smell, and some users have complained of nausea, stomach pain, diarrhea and/or vomiting. The source of that defect is the chemical 2,4,6-tribromoanisole (interestingly enough, also a component to some issues of cork taint in wine), which was used to treat wood pallets transporting and storing the packaging materials.

The Tylenol recall page has more information on refunds and returns. They’ve done a solid job of advertising the recall in the media and on their websites. Good job to the manufacturer, McNeil Consumer Healthcare.

First, Merry Christmas and happy holidays to those who celebrate. And now--to work.

The Drug and Device blog is continuing without the assistance of Mark Herrmann. Jim Beck posts on the Top Ten Best Prescription Drug/Medical Device Decisions Of 2009. From our side of the "v." this can fairly be read as some of the worst/most unfortunate decisions of 2009. With that said, we've had a pretty good run this year, too. Hormone therapy verdicts keep coming; and importantly, Wyeth v. Levine turned out right. The Vioxx cases settled, and it seems the drug and device companies were taken to task repeatedly in other cases--not only by consumers and patients, but by the attorneys general of numerous states. And, litigation continues in gadolinium cases, Yasmin/YAZ/Ocella cases, and pain pump cases, along with others. Perhaps most importantly, the ties between drug-makers and doctors are being thoroughly examined, and consumers are more aware of the biases.

So, lots of things to be thankful for. Of course, our thoughts are with those people and their families who are fighting to be heard in the courts because of defective drug and medical device injuries. We wish you happy holidays, and speedy justice.

Bloomberg has a nice article on a 2007 case against Pfizer over its drug Prempro (the drug was manufactured by Wyeth, but Pfizer recently purchased Wyeth). The plaintiff in that Philadelphia state court case, Mary Daniel, took the drug for 16 months and argued that it caused her to develop breast cancer.

The jury in the Daniel case awarded $1.5 million in compensatory damages. Though the trial judge believed punitive damages were not warranted, the jury was allowed to deliberate on the issue in case the trial judge’s decision on punitive damages was overruled on appeal. According to the Bloomberg article, the jury awarded over $8 million in punitive damages. That number was sealed pending appeal; then, the trial judge died and new judge granted Pfizer a new trial on compensatory damages. That decision is also being appealed.

This recent news on the 2007 verdict fuels the outrage against Pfizer/Wyeth for the injuries it has caused. Pfizer continues to toe the Wyeth party line, claiming that 24 cases have been resolved in their favor by juries or judges. This overlooks the reality that six of nine jury verdicts have been for plaintiffs, and any plaintiffs’ victory indicates that the drug can reasonably be responsible for the injury; whereas a defense verdict only means that the drug did not cause injuries in a specific case.

The results of a six-year trial on Meridia’s active ingredient, sibutramine, show a statistically significant increase in heart attacks, strokes and death. Meridia, manufactured by Abbott Laboratories, was approved by the FDA in 1997 as a prescription-only weight loss supplement.

The SCOUT study (Sibutramine Cardiovascular Morbidity/Mortality Outcomes in Overweight or Obese Subjects at Risk of a Cardiovascular Event—we don’t understand the acronym, either) is a post-marketing surveillance study required by the European Medicines Agency as a condition for approval of the drug. 10,000 patients were enrolled in the study, with 5,000 taking a placebo and 5,000 taking sibutramine. It was designed to show that weight loss with sibutramine was more effective in reducing cardiovascular events. The study shows just the opposite, however.

The FDA has indicated that, upon initial review of the study, sibutramine-use is associated with a 1.4% increase in adverse cardiovascular events. This is statistically significant, especially because in the past year there have been 294,000 prescriptions for Meridia (only one version of the drug) in the United States. 1.4% of 294,000 is 4,116 cardiovascular events, which may include death. The FDA’s Adverse Event Reactions (AERS) database indicates that there have been 84 reports of death from cardiovascular causes. Of those 84 deaths, 11 were under the age of 31.

Meridia is contraindicated for patients with pre-existing coronary artery disease, congestive heart failure, peripheral arterial occlusive disease, arrhythmia and cerebrovascular disease. The European Medicines Agency will review the study in January, 2010. Likewise, the FDA indicated in its November 20, 2009 Early Communication that it is reviewing the data and “is conducting an expedited safety review.”

Public Citizen has re-petitioned the FDA for recall of the drug based on the results of the study. It asked for a recall twice before, in 2003 and 2005. The 2005 FDA denial letter specified that

An unbiased, objective assessment of sibutramine’s cardiovascular safety profile, particularly when used in obese patients with known or occult cardiovascular disease, can best be made through analysis of data from a large, randomized, controlled trial. The Sibutramine Cardiovascualr Outcomes, or SCOUT study, is such a trial.

So, now the FDA has everything they need to make a recall. Our bet is that they don’t pull the trigger, however. We hope we’re wrong.

It’s a winter wonderland here in Maryland, and our office is running on a skeleton crew. Here are the top drug injury-related stories for the past few days:

• Digitek: Tom Lamb and the Drug Injury Watch post on the status of this litigation (surprisingly, it is not defunct yet, despite long problems in finding the mythical creature, “The Double-Dose Pill.”
• Preemption: An upcoming article by Mary J. Davis in the Hastings Law Journal titled “The ‘New’ Presumption Against Preemption.”
• Gadolinium: A Danish radiologist complains to The Guardian that the United Kingdom’s laws on libel are preventing him from speaking about the dangers of General Electric’s MRI contrast dye, Omniscan. He states that, "I am not giving lectures any more in the UK where it seems you can be sued for telling the truth." He is being sued by GE Healthcare. GE: “We Bring Good Things to Light [or, do our best to quash them through litigation].”
• Fosamax: Exposé by NPR about how Fosamax came to be so popular, and whether it actually works. (Hat tip to Shearlings Got Plowed)

Happy Monday!

The Searcy Blog has an informative article about the abuses of the hormone therapy manufacturers. Specifically, Premarin is an estrogen that is manufactured from horse urine—specifically, pregnant horses (hence the name, PREgnant MARe urINe. Whatever your feelings on the drug itself, the method of manufacture, as seen in the embedded video (narrated by Mary Tyler Moore), is clearly cruel.

Six more Yasmin and YAZ lawsuits were filed this week against drug manufacturer Bayer in the United States District Court for the Western District Pennsylvania (Pittsburgh Division).

Added to the usual complaints of negligence and strict product liability, the complaints contain allegations of fraud (that Bayer misrepresented product safety, particularly in the media), civil conspiracy and commercial bribery (that Bayer “knowingly and/or intentionally offered, conferred or agreed to confer benefits, gifts, and/or gratuities or conspired to do the same upon physicians, pharmacists and insurance companies for the purpose of enticing these entities to use the drug YASMIN, and to convince their patients and others of the safety and effectiveness of YASMIN”), and punitive damages.

Bayer maintains that the injuries suffered by the plaintiffs are the same injuries that they were warned about on the packaging. Plaintiffs contend, however, that Yasmin and YAZ increase these risks over and above other contraceptive pills. Complaints filed include the following:

In representations to Plaintiff, her healthcare providers, and/or the FDA, Defendants also fraudulently concealed and intentionally omitted the following material information:

1. That YASMIN is not as safe as other available contraceptives;
2. That the risk of adverse events with YASMIN (drospirenone and ethinyl estradiol) was higher than those of other available contraceptives; [and]
3. That the risks of adverse events with YASMIN was not adequately tested and/or known by Defendants.

For more information on Ocella (the generic version), Yasmin and YAZ lawsuits, please visit our YAZ blog posts and our YAZ injury website.

If you or a loved one has suffered because of this drug—heart attack, stroke, gallbladder removal, deep vein thrombosis, pancreatitis or pulmonary embolism, please contact us at 1.800.553.8082, or click here for an internet consultation.

Judge Tunheim of the U.S. District Court for the District of Minnesota denied the pain pump defendants’ motion to transfer one of eighteen pain pump cases (the Ivey case) before that court on Monday. The motions’ practice was among the best we have seen for motions to transfer venue. Kudos to Rob Jenner, Yvonne Flaherty, Irwin Levin, Greg Laker and Jeff Gibson, the attorneys handling Plaintiffs' case.

Here are the key facts, as argued by the pain pump defendants:

Continue reading " Motions To Transfer Venue In Pseudo-MDL Cases " »

There are more than 70 million CT scans performed in the United States every year. The FDA is investigating problems with overexposure to radiation by CT scans. This is an ongoing problem everywhere, but is complicated by significant overexposure of special types of CT scans (called perfusion CTs) at two hospitals.

First, some background: CT scans (also called CAT scans, or computerized tomography) is a type of x-ray that uses radiation to visualize internal structures of the body through a cross-section of images (unlike the flat images of normal x-rays). One CT scan is equivalent to about 100 chest x-rays. One perfusion CT scan (used to examine blood vessels and often used to diagnose stroke or aneurysm) is equivalent to several hundred chest x-rays.

Sample Perfusion CT

Continue reading " CT Scans And Radiation Poisoning " »

Mark Herrmann, half of the team that cranks out lengthy and well-thought out blogs for the Drug and Device Law blog, is now retiring from that particular job. Read his farewell post here.

No word on whether his partner, Jim Beck, will continue it alone, or will find another co-conspirator. We hope he will continue for selfish reasons--the blog is an invaluable resource and, despite it being wrong most of the time (playfully stated--the Drug Recall Lawyer Blog is on the other side of the aisle, after all), it was always entertaining and enlightening.

At any rate--good luck Mark. We wish you the best.

Fresh from two record losses in Philadelphia state court over Prempro, Pfizer is reacting to plaintiffs’ lawyers posting of a video on YouTube. We uploaded a copy of that video in our November 24th blog post, and have embedded it below for your convenience.

Continue reading " Pfizer Recoils From Sunlight " »

The Yasmin and YAZ litigation continues to heat up in the Pennsylvania market, with over 160 cases filed. On Friday, the parties argued to Judge Sandra Mazer Moss about the full scope of questionnaires (often called “Plaintiff Fact Sheets”) that individual plaintiffs would be required to answer. Bayer is clearly overreaching, here.

Bayer wants to know the sum total of each plaintiff’s contraceptive history, even extending beyond hormonal birth control methods. This is coming from a company that spends untold millions advertising its product directly to consumers in an effort to get them to go on their brand of “the Pill.” They cannot, however, give a good reason for needing to know whether an individual plaintiff used condoms or the rhythm method when she was 25. Furthermore, that request for information, much like the number of sexual partners, is so private and so beyond the scope of this litigation, that the very request for it is offensive. Many young women, for example, may be dissuaded from this litigation if doing so will mean that others, including their parents, might find out too many details about their sexual history (remember—YAZ was marketed to women for the prevention of acne, sexual activity notwithstanding). Even Judge Moss recognized that Bayer was likely asking for more than they were entitled to, when she sarcastically commented that plaintiffs could tell Bayer about the number of sexual partners they had, “then we could put out a brochure and everyone will know.”

Continue reading " Bayer Wants Private Information About YAZ Users " »

Here’s what we’re looking at, this week:

• AstraZeneca sets up a website devoted to its social networking efforts: Twitter, Facebook, YouTube and blogging
• Judge Keenan denies Merck’s motion to dismiss 24 Fosamax lawsuits because a jury may be able to conclude that the drug can cause jaw damage in under 3 years of use
• Increasing use of antipsychotics by pediatric patients
• The Pharma Marketing Blog reports on Big Pharma’s direct to consumer (DTC) advertising trends
• Informative post by Tom Lamb and the Drug Injury Watch on detecting adverse drug reactions and pulmonary embolism

Happy Monday!

The FDA Law Blog reports on "Postmarket Safety Oversight Improvement; Seeks Timeline for Transfer of Certain Protocol Reviews from Office of New Drugs to the Office of Surveillance and Epidemiology." The post cites a GAO report following up on extensive efforts to revamp the postmarket surveillance of drugs by the FDA, something that has become critically necessary, especially in light of repeated abuses by the drug companies in selling and marketing products well after deficiencies come to light.

The GAO report can be found here.

Judge Keenan has rescheduled the Boles trial for June 2, 2010, and has scheduled the next Fosamax trial for February 1, 2010. The specific case is not yet known--the judge will randomly select it from the roster.

For more on the Fosamax trials, see our blog.

Two FDA committees met yesterday to discuss the future of gadolinium warnings. Gadolinium is a contrast dye given to some patients before MRIs and MRAs that better highlights damaged parts of the body. Unfortunately, when given to patients with impaired renal function, it can be deadly.

The committees recommended that two particular brands of gadolinium dye, GE Healthcare’s Omniscan and Covidien’s OptiMark, should feature enhanced warnings against use in patients with severe kidney disease (the drugs all feature a warning about the risks of nephrogenic systemic fibrosis). After reviewing evidence, the committees clearly believe that these two products are more dangerous than the other gadolinium-based contrast agents on the market, including Bayer’s Magnevist. Whether the FDA takes action on the panel’s opinion remains to be seen.

GE, for its part, is arguing against the changes. They claim that there is insufficient evidence that any gadolinium-based contrast agent is more dangerous than any other. This fits the profile of GE’s approach on all things related to the gadolinium litigation—they are fighting everything tooth-and-nail, sometimes unreasonably so.

In fact, Covidien appears poised to receive the most conscientious drug company award—they have already made moves to modify their label, contraindicating use in patients with severe kidney dysfunction. We like to see the drug companies step up to their responsibilities, especially to prevent more injuries.

In other gadolinium news, it looks like the first prospect for trial is Bayer’s Magnevist in the San Francisco Superior Court (a non-MDL case). The Plaintiff, Peter Gerber, alleges that Magnevist caused him to develop nephrogenic systemic fibrosis (NSF).

For more information:

• Reuters’ story on the FDA committee meeting
• Drug Recall Lawyer Blog posts on gadolinium
• Miller & Zois’ main gadolinium injury page

The U.S. District Court for the Southern District of Illinois, the center of the federal YAZ MDL litigation, has posted to its website the minutes from the initial conference, held on November 19, 2009.

Nothing surprising happened at the hearing—they followed the same path that many initial conferences take, and the following were discussed:

• Document preservation letters (to make sure parties do not destroy documents that may be important in the litigation)
• Plan for discovery (documents requests were expected within about 4 weeks)
• Discussion of joint case management order (to outline the stages in joint discovery and case management)
• Proper defendant identification (this always happens in cases involving lots of corporate defendants and, particularly here, where Bayer has a number of foreign entities that may or may not be related to the YAZ production and marketing here in the U.S.)
• Agreement on Plaintiff and Defendant Fact Sheets (these are tools to unify discovery—every individual plaintiff fills out a fact sheet, typically 50-75 pages, covering their personal and medical histories. Oftentimes, Defendants will also fill out fact sheets relevant to the specific plaintiffs.
• Document production: the parties expect tens of millions of pages of documents to be produced, and may need the assistance of a document depository (oftentimes, these are remote or electronic) to be a center for common discovery.

A lot of work clearly went into preparing for this conference, and the parties have a lot of work ahead to streamline proceedings and discovery. But, compare this to hundreds of individual cases filed all over the country—this is a good way to handle things and conserve judicial resources.

The next conference is set for December 17.

We continue to get calls every day by healthy (and frequently young) women and their families who have suffered because of this drug—heart attack, stroke, gallbladder removal, deep vein thrombosis, pancreatitis and pulmonary embolism. If you or a loved one has questions about the YAZ, Yasmin and Ocella lawsuits, please contact us at 1.800.553.8082, or click here for an internet consultation.

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!

Earlier this week The Washington Times wrote an article about Yaz and Yasmin. Comfortably couched in the middle is this snippet:

“The complaints we have reviewed so far pertain to side effects that are warned about in the labeling of all contraceptives, including ours,” Ms. Talarico [of Bayer] said.

The FDA agrees.

“The safety profiles for Yasmin and other combined hormonal contraceptive products containing estrogen . . . are similar,” [FDA] spokeswoman Karen Riley said.

The gist of the article is that young and otherwise healthy woman are suffering blood clots, and suing Bayer because they believe YAZ and Yasmin birth control pills are the cause. It goes through Bayer’s problems, including the FDA-mandated $20 million corrective ad campaign, and the quality control problems besieging Bayer’s manufacturing plant.

Continue reading " YAZ Risks—Greater Than Or Equal To Other Birth Control Pills? " »

Two days ago, plaintiffs in several shoulder pain pump cases filed a renewed petition for transfer, consolidation and/or coordination in an MDL (MultiDistrict Litigation). The 82-page motion (with exhibits) was made before the Judicial Panel on MultiDistrict Litigation. The last petition was denied on August 11, 2008.

You can see a copy of the petition here.

Continue reading " Renewed Motion for Pain Pump MDL " »

The Drug Recall Lawyer Blog is a relatively young blog—we first posted on April 28, 2009, and in the past seven months we have put up 130 posts (including this one). Per Google Analytics, the average number of hits to the our blog during the workweek is 135 (which includes weekends, the average is higher if only weekdays are considered); our highest single day score was just last month with 386 hits; and the average reader spends about 1 minute and 2 seconds on our site.

So, we read with interest the announcement of the Third Annual ABA Journal Blawg 100. The ABA Journal selects its favorites, and posts them for all to see. This year, they included the related Twitter sites, where applicable.

In the spirit of the ABA’s article, here’s a list of our top blogs:

NEPOTISM:
Of course, we follow blogs by our co-workers and bosses at Miller & Zois.

• Accident Injury Lawyer Blog
• Baltimore Injury Lawyer Blog
• Maryland Accident Lawyer Blog
• Maryland Injury Lawyer Blog
• Maryland Lawyer Blog
• Maryland Medical Malpractice Attorney Blog

Additionally, we follow the Maryland Daily Record’s legal blog, Generation JD (which we contribute to). Generation JD features the musings, trials (literally) and tribulations of seven Maryland/Washington D.C. lawyers from disparate firms and backgrounds.

TECHNOLOGY:

• Acrobat for Legal Professionals
• Dennis Kennedy
• Electronic Discovery Blog
• TechnoLawyer Blog

DRUGS & MEDICAL DEVICES:

• Drug and Device Law
  
• Drug Injury Watch
• Drug Recall Information
• Eye on FDA
• FDA Law Blog
• FDA Press Releases and Recalls (through RSS feed, only)
• Mass Tort Defense
• Mass Tort Litigation Blog
• Shearlings Got Plowed

TRIAL PRACTICE:

• Virginia Personal Injury and Medical Malpractice Blog
• Plaintiff Trial Lawyer Tips
• South Carolina Trial Law Blog
• The Art of Advocacy
• Trial Lawyer Tips

OTHER:

• Lawyer Marketing Blog
• Day on Torts
• Evidence in Medicine
• LegalEthics.com
• Maryland Daily Record
• Overlawyered
• Protecting Civil Justice
• Shrager, Spivey & Sachs Blog
• The Pop Tort

NON-LEGAL: (because sometimes you just need to have non-law hobbies):

• XKCD: A Webcomic of Romance, Sarcasm, Math and Language
• Alpineberry
• A Whisk and a Spoon
• The Washington Post: Maryland Politics

We have yet to really go through the ABA list, but we’ll check it out and let you know which ones we recommend.