Drug Recall Lawyer Blog

Here’s a list of some important stories we’ve been tracking.

• Boston Globe article probing the financial ties between Massachusetts doctors and Eli Lilly, a large drug manufacturer. “When the [drug] company provides the power point [for the doctor’s presentation], the risk of bias is even greater.”
• Seattle Post Intelligencer article examining the fatal overdose of a 15-year-old teen with autism. Michael Blankenship had a dental procedure and was given a Fentanyl Pain Patch. These are typically product liability cases, but it looks like Michael never should have received the patch in the first place, so Michael’s family has filed a medical negligence complaint.
• Drug Recall of specific lots of Infants’ and Children’s Tylenol (Johnson & Johnson) because of bacterial contamination.
• Update on Vioxx settlement: $4.85 billion.

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.

On Friday, the FDA issued a warning to healthcare providers about diabetes drugs Januvia and Janumet, manufactured by Merck & Co., Inc. These drugs are in the class known as sitaglipins, and are designed to help treat patients with type-2 diabetes and type-2 diabetes mellitus. Post-marketing surveillance reveals that the drugs may be associated with acute pancreatitis after reports of 88 patients experiencing that condition between October 2006 and February 2009.

A lot of drugs are linked with acute pancreatitis, these days (see Seroquel and Byetta). Symptoms to look for include:

• Upper abdominal pain that may radiate to the back
• Abdominal pain, especially after eating
• Vomiting and Nausea
• Abdominal tenderness

Pancreatitis can be fatal if left untreated, so patients on Januvia or Janumet who experience these symptoms should be closely monitored by their healthcare providers.

For more information, see our main Januvia and Janumet Diabetes Drug website.

Yesterday was the hearing in Richmond, Virgina to determine whether the Yasmin and YAZ drug injury lawsuits will be consolidated into an MDL. Consolidation would be extremely useful for women and their families who have been injured, because there is going to be a large amount of common discovery to be done. An MDL will really facilitate that discovery (and, will preclude the need for lawyers with numerous YAZ cases from going around the country to mundane case management conferences). But, even if the MDL does not happen, these cases can still be pursued. Women with potential YAZ-related injuries should contact attorneys early--many states have draconian rules on the time limit to bring claims.

These decisions sometimes happen quickly, and sometimes not so quickly. We're hoping for a ruling in the next couple of months. When it happens, we'll let you know.

UPDATE: October 1, 2009: The MDL has been approved. Click here for more details.

For more on these claims, visit:

• Our main Yasmin/Yaz information page
• Yasmin/Yaz Lawsuits Blog (describing the other injuries associated with the birth control pills)
  
• Yasmin/Yaz MDL Motion Filed
  
• What is an MDL? -or- Yasmin/Yaz MDL Filed, Take 2

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  Posted In: Yasmin/Yaz

This post is not meant to be a fake-out—the JPML has a hearing set for tomorrow before it mulls over whether and where to send federal YAZ and Yasmin lawsuits (see our prior post on the MDL). However, Pennsylvania has what some lawyers call a “mini-MDL” program. Now, cases filed in Philadelphia for YAZ and Yasmin will be consolidated in the Philadelphia Court of Common Pleas. The mass tort program will serve the same purposes as an MDL—it will ensure that the YAZ and Yasmin drug cases are all put before one judge who can manage discovery, motions, and generally make things more efficient.

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

Remember Wyeth v. Levine, U.S. Supreme Court decision that held federal approval of labels drug warning labels does not preclude lawsuits under state law claiming inadequate warnings? Well, the government, through the FDA, has now added a final chapter to that story.

The drug at issue in Wyeth v. Levine was Phenergen, an antihistamine. The drug was administered using a method known as an “IV push,” however the drug was inadvertently injected into Dina Levine’s artery. She developed gangrene, the arm had to be amputated (Diana Levine is a musician, and the tragedy of her injury is simply incomprehensible. See John Bratt’s blog post).

The label originally warned that the IV push method could lead to inadvertent injection into arteries, but the label did not expressly forbid that procedure. Now, after the conclusion of the Wyeth case, the FDA has allowed the Court’s decision to lead the way, and has amended the label to include a black box warning: “due to the risks of intravenous injection, the preferred route of administration is deep muscular injection and that subcutaneous injection is contraindicated.”

Can anyone doubt that if Wyeth was truly concerned with patient safety, it would provide full warnings as soon as possible? Unfortunately, it seems as though the almighty dollar is the reason for holding back on warnings, with the fear that fewer patients will take drugs when the risks are appropriately disclosed. It is a game of “hide the ball.” The results: ask Diana Levine’s.

It's Friday, so this post will be as discombobulated as I feel.

I came across the Supreme Court of the United States wiki ("SCOTUS Wiki") today while trying to hunt down a copy of the recent Journal of the American Medical Association (JAMA) letter to the editor published by Michael D. Green. Green is a torts law professor at the Wake Forest University School of Law in North Carolina.

The SCOTUS Wiki is a terrific concept--it features links to the innumerable documents associated with many Supreme Court cases--check out the wiki on Wyeth v. Levine. I'd love to see some enterprising young techno-lawyer do something similar with the Judicial Panel on Multidistrict Litigation--at the very least, shouldn't the JPML join the 21st century and get their documents on PACER?

At any rate, Green's JAMA letter to the editor is only available to subscribers, but here's the link if you have a subscription. But, if you'd like to see his amicus brief from Wyeth v. Levine, head here.
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The LifePak CR Plus Automated External Defibrillators manufactured by Physio-Control, Inc. (which is owned by Medtronic), is subject to a Class I recall. These recalls are the most serious, and are conducted when there is a reasonable probability that use of the device will cause serious injury or death.

The automatic defibrillators are used to treat patients suffering from cardiac arrest in hospitals, by emergency response personnel, and even by those without medical training in public places (defibrillators like these are often seen at airports, swimming pools, and other public places). The recall affects devices with the following serial numbers:

37026963, 37026983, 37026984, 37026997, 37027002, 37027008, 37027039, 37027040, 37027049, 37027053, 37027063, 37027065, 37027066, 37027070, 37027071, 37027073, 37027075, 37027090, 37027099, 37027105, 37027122, 37027197, 37027529, 37027569, 37031393, 37037850, 37037893, 37037986, 37038002, 37038211,37038365, 37135986, 37154526, 37154638

The device is prone to malfunction because humidity may affect analysis of a patient’s heart rhythm, causing it to delay or fail to administer electric shocks.

Judge Nancy Gertner of the United States District Court of Massachusetts ruled for Plaintiffs, finding that e-mails about birth defects between GlaxoSmithKline (the Paxil manufacturer) and researchers. The plaintiffs believe that these e-mails will show that GlaxoSmithKline attempted to influence the results of those studies, and in fact recommended changes that were made to the final paper. Though the researchers have denied being influenced by GlaxoSmithKline, plaintiffs will be able to probe the relationship and, perhaps, place it before a jury to decide.

The plaintiffs contend that William Seale’s mother took the antidepressant Paxil while she pregnant, and that the drug caused the one-year old to die of heart defects.

There are approximately 600 Paxil cases pending. The first suit is being tried now in Philadelphia state court, where opening statements have just begun.

It is not enough that their pills are dangerous—it now turns out that some of them may not even be effective. The FDA inspected Bayer’s Germany plant in March where drospirenone, the fourth-generation progestin, is created for Bayer’s top-selling YAZ and Yasmin birth control pills. Essentially, Bayer had been sampling their product and averaging the results, then delivering the averaged data to the FDA. Instead, Bayer should have been delivering the results of each sample of the product. Averaging increases the likelihood that the samples will pass efficacy muster.

A copy of the FDA’s letter to Bayer may be found on their website.

The jury was finally let go today after deliberating since September 3. The reports from the court have been that the jury was convinced almost from day one that they would not be able to reach agreement--the judge tried his best, and gave them every opportunity to talk it out. However, today, Judge Keenan declared a mistrial.

The defense believes they had 7 of the 8 jurors on their side. The one thing I have learned from watching juries is that you rarely know who's with you and who's against you. However, the jury notes may give some credibility to that argument (and, Plaintiff's counsel did request the mistrial the other day, perhaps sensing a losing battle). It looks like Ms. Boles will have to wait until spring, so by then two other Fosamax trials may get to go, first. We'll see what happens in round 2...

This video describes the background of Yaz, Yasmin and Ocella, the status of Yaz litigation, and the injuries that can be caused by these birth control pills (including an increased risk of pulmonary embolism, deep vein thrombosis, stoke, heart attack and gallstones). For more information, see our website and prior blog posts of the Drug Recall Lawyer Blog.

Jurors sent notes to Judge Keenan during their deliberations in the Fosamax bellwether trial, yesterday. The notes referred to a lack of unanimity of the eight jurors, and a feeling that they would never reach agreement. The judge instructed them to keep working.

They've been deliberating for about 9 hours (which, when you consider the number of weeks the case has gone on, really isn't much). This is the most exciting part of trials--just knowing that the jury is hashing it out, working on some kind of agreement amidst certain disagreement, and knowing that the case can still come out either way.

Kugel hernia mesh lawsuits are beginning to settle, thanks in part to a change in defense counsel. The products, manufactured by Davol, are defective because they the plastic ring can break off, causing perforation and infections. Left untreated, these injuries can be fatal. Davol has since eliminated use of the plastic rings, in favor of a bio-absorbable ring.

Now represented by the New York firm Reed Smith, Davol has signaled a change in thinking to a more reasonable approach—these can be very meritorious cases worthy of settlement, and the expense of litigation is unnecessary. There are about 1,000 cases in the Rhode Island United States District Court MDL, and about 1,200 cases in Providence state court (the manufacturer, Davol, is a Rhode Island company). Right now, 4 federal suits have been settled, and one state claim has been settled. This looks to be the tip of the iceberg, as the parties move toward the first scheduled federal court trial in March, 2010. That will be followed shortly thereafter by the first state court case in June 2010. The settlements will probably come in rapid numbers, now that discovery is coming to a close and the trials quickly approach.

For more on Kugel Mesh lawsuits and settlements, see our website and prior blog post.

Maryland attorney Ron Miller confronts the speculation about whether the lawsuits and medical studies surrounding Yaz, Yasmin and Ocella will lead to a recall. His analysis is spot on. Besides, Bayer will sell as long as there is decent money to be made.

See Yaz/Yasmin Recall? By the Accident and Injury Lawyer Blog.

Most lawyers do not know how to pronounce qui tam litigation, much less what it is. After this Pfizer settlement, there is going to be a lot more interest.

(Fun etiological note: it is an abbreviation of the Latin phrase “qui tam pro domino rege quam pro si ipso in hac parte sequitur,” meaning “who sues on behalf of the King as well as for himself”).

Black’s Dictionary defines it as “an action brought by an informer, under a statute which establishes a penalty for the commission or omission of a certain act, and provides that the same shall be recoverable in a civil action, part of the penalty to go to any person who will bring such action and the remainder to the state or some other institution.” BLACK’S LAW DICTIONARY 1251 (6th ed. 1990).

The suit was brought by five whistleblowers (who will share $102 million of the settlement). The federal criminal probe and civil qui tam lawsuit alleged that Pfizer improperly marketed 13 drugs, including Viagra, Zoloft, Lipitor and Bextra. New York’s attorney general said that “Pfizer's corrupt practices went so far as sending physicians on exotic junkets as well as wining and dining health care professionals to persuade them to prescribe the company's drugs for patients in taxpayer-funded programs.” These practices including overpromoting the drugs for off-label and unapproved uses, which is oftentimes how the drug companies turn a good drug into a blockbuster drug (see the Seroquel example: Foster Care Children and Off-Label Drug Use; Video on Seroquel).

The $2.3 billion fine is notable for a couple of reasons. First, it is the largest such fine ever levied in a United States criminal case. Second, this is the fourth time in ten years that Pfizer has been found guilty of improperly marketing their drugs. For a drug company to keep taking these hits, in addition to the cost of defending lawsuits and paying settlements and verdicts, it must be making money hand over fist. Something like that should bankrupt a company; however for Pfizer and other members of Big Pharma, this is simply the cost of doing business. The real cost, however, is the untold numbers of people and families who have been devastated by bad drugs. And, guaranteed that Pfizer gets another fine in the next couple of years. Clearly these fines are not big enough to be a significant deterrent.

Shirley Boles, courtesy Michael Appleton, New York Times

The Shirley Boles case went to a jury of three men and five women, yesterday afternoon. Attorneys for Ms. Boles, a retired deputy from the Okaloosa County Sheriff’s Office, told jurors that she had to sleep at night with a towel to wipe away puss that oozes from her jaw, and that she avoids playing with her grandson for fear that he may accidentally break her fragile jaw. Without a doubt, she is a very compelling plaintiff with an unimaginable injury.

The jury is asked to decide:

• Was Merck/Schering-Plough negligent in formulating Fosamax?
• Did the company fail to warn Ms. Boles and her physicians of the risks of osteonecrosis of the jaw?
• Is Fosamax defective?
• Did Fosamax cause Ms. Boles’ jaw injury?

Merck, in the process of finalizing a $41 billion merger with Fosamax manufacturer Schering-Plough, is defending the cases (to the tune of $7 million in the second quarter of this year), and has budgeted $42 million to defend the other 900 to 1,200 federal and state Fosamax cases.

The bottom line of the companies has suffered, especially after the FDA required warnings about osteonecrosis. Fosamax had 15 million prescriptions in 2007—that number dropped to 2.6 million in 2008. As for worldwide sales, the drug sold $1.55 billion in 2008, a decrease of about 50% from the year before.

For more information on Fosamax and the on-going litigation, see other posts of the DrugRecallLawyerBlog.

In addition to the other injuries caused by birth control pills Yasmin, Yaz and Ocella (including pulmonary embolism, deep vein thrombosis, pancreatitis, stroke, and heart attack), Yaz drug injury lawyers are investigating gallbladder problems.

Doctors and the medical literature report a spike in gallbladder disease among otherwise healthy adults (including young adults), and the only connection appears to be that these women are all taking one of these drospirenone-containing birth control medications. Doctors believe that Yaz can increase cholesterol levels in bile while simultaneously decreasing gallbladder movement, leading to gallstones. Many women must have their gallbladder removed (cholecystectomy), and can suffer from impaired digestion, bloating, gas, heartburn, constipation or diarrhea. Of course, many women have abdominal scars from the surgery. Finally, many people who undergo gallbladder removal must radically change their diet.

For more information on Yasmin/Yaz injuries and lawsuits, see other posts of the DrugRecallLawyerBlog, and our Yasmin/Yaz website.

Our lawyers are investigating Yaz gallbladder injuries. If you want to speak with a Yaz lawyer about potential lawsuits involving gallbladder disease (or any other injury from Yaz, Yasmin or Ocella), call 800-553-8082 or click here for a free Yaz lawsuit case evaluation.

• Yaz Lawsuit Overview
• Gallbladder Surgery Risks

Bausch & Lomb has entered into settlements with over 600 claimants over its ReNu with Moistureloc contact lens solution. In those cases, the allegations were that the solution could cause fusarium keratitis, a serious fungal eye infection. We discussed this in our previous blog, Bausch & Lomb Eye Fungus Cases.

In that blog, we also discussed that the judges (New York state judge Shirley Cornreich, and South Carolina federal judge David Norton) were tag-teaming the Daubert-Frye hearings to determine if Plaintiffs’ proposed experts could properly link ReNu with non-fusarium keratitis cases. In each case, Plaintiffs were dealt a blow when the judges ruled separately that the expert is restricted from testifying as to general causation between ReNu and non-fusarium keratitis cases. This means Plaintiffs cannot provide expert testimony that ReNu generally (we are not even talking about in a specific case) can cause these infections. According to the opinions, the Plaintiffs’ expert did not do any specific testing, and was not aware of any data that would suggest a link. Defendant’s expert, a physician at the Wilmer Eye Institute at Johns Hopkins (and, also a paid consultant of Bausch & Lomb since before the litigation) had a more persuasive argument. He put together a panel of experts early on, studied reports and articles, and noted that there was no acceptance in the scientific community that ReNu causes an increase in non-fusarium keratitis cases.

So, it looks like game over for plaintiffs. They tried to keep the litigation alive, but there just isn’t enough evidence of a connection.

Four weeks later (see earlier Fosamax blog posts), evidence has closed in the Shirley Boles Fosamax trial (New York). Only closing arguments and jury deliberations remain. Remember, this is the very first of three bellwether Fosamax trials, alleging that Ms. Boles suffered from osteonecrosis of the jaw after taking a drug for prevention of osteoporosis. The jury could begin deliberations as early today or tomorrow.

Following an earlier pre-trial order of the judge, the jury will not hear about the profits that Merck has made on Fosamax, nor will they be able to entertain punitive damages.