Drug Recall Lawyer Blog

The big news is that the first trial of Pfizer’s anti-epilepsy drug Neurontin started on July 27 and quickly ended yesterday. The reports are that the case was dropped after an anonymous donor (a non-involved plaintiff’s lawyer) offered to put money in a trust for the 10 year-old daughter of Susan Bulger. The Plaintiffs assert that Mrs. Bulger committed suicide in 2004 because of Neurontin.

The Maryland Injury Lawyer Blog commented on the Neurontin trial when it started on the 27th. The blog’s author, attorney Ron Miller, also commented that the attorney trying the case was set to be Mark Lanier, of recent Vioxx fame (among many other things).

So, this dismissal is a little perplexing. Pfizer did not pay anything for the dismissal. Certainly, this case was difficult in light of reports of earlier attempts of suicide by Mrs. Bulger, and potential drug abuse. It could be that Neurontin plaintiffs’ attorneys did not want the first tried case to be one they lost (or were at a significant risk of losing)—there is power in having a strong case and a plaintiffs’ verdict first thing. It is difficult to not speculate. One news report says the donor didn’t want Mrs. Bulger’s child to have to go through the trial, which is of course a harrowing process. But, the important thing is that the family makes the decision voluntarily, and kudos to the “Anonymous Attorney” for helping them out.

But, the case did not end before the testimony of a former Pfizer marketing employee, which revealed that the company illegally marketed the drug to doctors for unapproved uses. So, now we wait for the next trial (of about 1,200 cases), scheduled for March 29.

In response to yesterday’s blog Yasmin/Yaz MDL Filed, one non-lawyer reader asked me to restate it in English. I have always been against legalease, but it looks like I did not remember my law school training. So, here is a new version, taking into consideration that some readers are not lawyers, and some readers are lawyers without MDL experience.

What is MultiDistrict Litigation (MDL)?
MultiDistrict Litigation is what happens when multiple cases from different federal courts are brought together. It only applies to cases filed in federal courts, though some states have their own version of MultiDistrict Litigation (for example, Philadelphia has a mass torts program).

When there are numerous federal cases involving common questions of fact, the Judicial Panel on MultiDistrict Litigation (JPML) can decide to bring all of those cases together for coordinated pre-trial proceedings. By bringing these cases together, parties to the cases can share in the cost-benefits of avoiding duplicative common discovery. For example, in an individual case by a person alleging Yaz caused a stroke, that plaintiff would have to pay for the costs of depositions of Bayer’s corporate representatives and scientists. However, in an MDL, where many Yaz plaintiffs are brought together, those depositions take place once, every plaintiff gets to use them, and the cost is split among all of them. Additionally, bringing similar cases together in an MDL avoids inconsistent rulings—a judge in one court might find that some evidence is irrelevant, while the same evidence may be ruled relevant by a different judge in another court. That scenario is avoided in an MDL, where one judge will make all of the pretrial rulings. Finally, having these cases before one judge saves time and judicial resources—instead of dozens or hundreds of judges, clerks, and administrative time being dedicated to dozens or hundreds of cases, there is only one judge and the resources of his/her court brought to bear on the cases.

At the end of the pretrial proceedings, individual cases are then sent back to their home state. So, if a federal Yaz case was filed in the U.S. District Court of Maryland, and the JPML approved a Yaz MDL in Ohio, the Maryland case would go to Ohio for general, common discovery (for example, what was the chemical makeup of the Yaz, did Bayer know the dangers of drospirenone, etc.), then would be sent back to Maryland for case specific discovery (what did the plaintiff’s doctor know about the dangers of Yaz, did the plaintiff have any pre-existing medical conditions that could have caused her injury, etc…).

Why are Yasmin/Yaz Lawyers trying to get an MDL started?
Plaintiffs in a number of Yasmin/Yaz cases have asked the JPML to approve a Yasmin/Yaz MDL. The JPML will receive documents from all parties stating their position on the matter; will have a hearing with arguments for and possibly against; and will then make a decision whether to form a Yasmin/Yaz MDL.

Yasmin/Yaz Plaintiffs’ lawyers believe that bringing the cases together in an MDL is a good idea. All plaintiffs have used one of the two similar birth control drugs. All of the plaintiffs suffered one of a fairly narrow set of injuries. All of the plaintiffs must prove the same things in their cases—including whether the drug can cause injury. It just makes sense to do things once, rather than over and over again in cases across the country.

MDLs are not Class Actions
A lot of people get confused on this point. MDL’s are not class actions. A class action is one case with a lot of people in it; an MDL is a lot of people with individual cases brought together for a time. Most class actions are for consumer-type injuries—for example, a defective television, where everyone has basically the same injury. In a personal injury action like those in the Yasmin/Yaz cases, however, each person has an individual case and unique damages. One woman’s stroke may have caused different long-term injuries than another woman’s stroke. Therefore, the Yasmin/Yaz cases cannot be lumped together in a class action. Also, in a class action, the resolution of case will typically resolve any claim any class member had. In an MDL, each case is unique and may be resolved separately.

I hope this clarifies things. For more on MultiDistrict litigation, see the United States Judicial Panel on MultiDistrict Litigation. If you have questions about this litigation, see our Yasmin/Yaz, webpage.

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

On July 24, Plaintiffs in 23 federal Yasmin/Yaz birth control lawsuits filed a motion with the Judicial Panel on MultiDistrict Litigation (JPML) requesting consolidation and/or coordination of at least 32 federal Yasmin/Yaz lawsuits. The motion papers request that all cases be moved to the U.S. District Court for the Northern District of Ohio, before Judge James Carr. Judge Carr is currently overseeing many of the individually filed lawsuits. Defendants in the lawsuits include: Bayer Corporation, Bayer Healthcare Pharmaceuticals, Inc., Bayer Healthcare, LLC, and Berlex Laboratories International, Inc.

The motion papers seek consolidation on behalf of Yasmin/Yaz consumers who have suffered deep vein thrombosis, pulmonary embolism, heart attack, stroke, kidney failure, seizures, gall bladder injuries or death. The range of injuries may make coordination difficult; however the Yaz MDL has a good shot at being approved because most of the injuries are related to issues of blood flow and clotting. So, there is one manufacturing company (the Bayer entities), and only two products. My guess is that the MDL will eventually be approved. However, it will be interesting to see what Bayer’s response is. Sometimes, drug companies realize the cost savings of litigating cases as a group (so they don’t have to pay individual attorneys across the country for extensive work). Other times, they pursue a “divide and conquer” strategy, because coordination gives plaintiffs’ attorneys a good structure within which to jointly work on the cases.

We’ll let you know when the JPML sets a hearing date.

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

For more about the Yasmin/Yaz lawsuits, see our webpage here.

On Friday, Judge Wilson of the U.S. District Court for Arkansas ordered the unsealing of Wyeth documents regarding the company’s practice of “ghostwriting.” Wyeth has been the subject of much litigation for many years over hormone therapy drugs (Prempro and Premarin) that were routinely prescribed to post-menopausal women. Innumerable studies have been published showing that the drugs cause breast cancer. Wilson is currently sheparding over 8,000 hormone therapy cases.

Front-and-center in the litigation is the advertising methods that Wyeth used. Ghostwriting is an insidious practice, where a drug company will pay a doctor for the right to use his or her name on a publication that the drug company writes to tout the benefits of their product. The publication is typically written by the marketing department, but disguised to look like science. Then, drug company sales representatives take that publication to other doctors, and say, “Dr. Smith wrote a terrific article about our drug—he likes it and affirms that it is safe, so you should prescribe it to your patients.” Needless to say, it’s never disclosed to the doctors that Dr. Smith didn’t write the article, or that the drug company did.

Plaintiffs’ attorneys used the documents in litigation, but they were marked confidential. Senator Charles Grassley of Iowa obtained copies last year for an investigation by the Senate Finance Committee, evaluating physician influence by drug companies. Prompting the unsealing, the New York Times has requested copies, and the unsealing of these documents will allow the public to see what really goes on behind the closed doors of drug companies. This is a small victory for corporate accountability.

It looks like Eli Lilly, the Defendant in a number of lawsuits brought by state attorneys general, is close to agreeing on settlement. The lawsuits are premised on Lilly’s marketing of Zyprexa for unapproved uses. The settlement comes on the heels of many other settlements:
 Settlements with 31,000 plaintiffs for $1.2 billion
 January 2008: settlement with Alaska for $15 million
 October 2008: settlement with 32 states and D.C. for $62 million
 January 2009: settlement with the Justice Department for $1.42 billion.

Zyprexa is a drug approved for treatment of schizophrenia and bipolar disorders. The drug was Lilly’s top-seller in 2008, making them $4.7 billion in revenue (23% of the company’s income). The settlements so far look to total about $2.7 billion—a bargain if the company is making $4.7 billion on the drug at its low point.

The claims against Lilly allege that Zyprexa was improperly marketed for other uses, including promotion to doctors for use by “disruptive kids” (according to an e-mail by John Lechleiter now Lilly’s CEO). Zyprexa has not been approved for pediatric use, much less for kids medically diagnosed as disruptive (wait, all kids are disruptive—they’re kids). It was also marketed for patients with dementia. Lechleiter had a 2008 salary of $1,339,125.00 and total compensation of $12,978,215.00, so I’m sure he knows what he’s doing.

Zyprexa causes severe weight gain and cholesterol problems in many patients, and has been linked to diabetes.

The Judicial Panel on MultiDistrict Litigation (JPML) just consolidated two product liability cases that we have blogged about, recently.

Fixident and Poligrip Denture Cream, MDL 2051, was approved June 9 (see our previous blog). The GlaxoSmithKline Poligrip Defendants (SmithKline Beecham Corp., GlaxoSmithKline Consumer Healthcare LLC, GlaxoSmithKline Consumer Healthcare, LP, and Block Drug Company, Inc.) supported the Plaintiffs’ motion for consolidation, while the Proctor and Gamble Fixodent Defendants (The Procter & Gamble Manufacturing Co. and The Procter & Gamble Distributing LLC) opposed consolidation. The JPML sent the cases (currently including 12 actions in 11 districts, plus seven tag-along actions) to the U.S. District Court for the Southern District of Florida under the guidance of Judge Cecilia M. Altonaga.

Fleet Oral Sodium Phosphate Solutions, MDL 2066, was approved June 23 (see our previous blog). The motion was made by the sole Defendant, C.B. Fleet, which requested consolidation of all 38 cases spread across 16 district courts (in addition to seven tag-along actions). The JPML ordered that these cases be shipped to the U.S. District Court for the Northern District of Ohio, to be presided over by Judge Ann Aldrich. This is the same court where the Gadolinium litigation is located (though, the Gadolinium cases are before Judge Polster).

For more information on these cases, click the Denture Cream and Fleet Oral Sodium Phosphate links.

We are typically proponents of MDL consolidation and centralization. When sent to a good judge, the system can be very efficient and saves judicial resources and client costs (not to mention, a judge can be a strong proponent of settlement when the cases justify it). Under an MDL, all generic and common discovery can be completed early, then individual cases are usually sent back to their home states for case-specific discovery. This is also a good "holding area" for cases--plaintiffs can have their cases filed, and law firms are not overwhelmed (as they frequently are with drug and device litigation) with too many individual cases going at the same time. In those cases, lawyers spend a lot of time traveling between case management conferences, and it's hard to get actual work done. MDL consolidation solves that problem because one judge oversees all cases, and case-specific conferences are seldom necessary. Furthermore, it avoids inconsistent rulings, and puts all cases in the same discovery posture.

Our Yasmin/Yaz lawyers are investigating potential Yasmin/Yaz lawsuits throughout the country for women who have taken this birth control medication and now suffer from deep vein thrombosis (blood clot), pulmonary embolism, and/or strokes.

Yasmin/Yaz lawsuits allege, among other things, that Bayer knew or should have known that Yaz/Yasmin caused risks and did not adequately warn doctors about the risk.

Click on the link to find out more about the Yaz/Yasmin lawsuits.

It’s a typical pain pump story—patient has a minor shoulder injury and gets routine arthroscopic shoulder surgery; patient recovers from surgery okay and starts to feel better, but then within a year patient’s shoulder starts to really hurt. Patient goes back to doctor, and finds out his cartilage is missing. Patient learns that the pain pump used after his surgery was to blame, because it pumped anesthetic into his shoulder joint, which killed the cartilage.

In one case filed in the U.S. District Court for the Southern District of Florida, plaintiff Douglas Kilpatrick lost late last month on summary judgment. The defendant was Breg, which argued that that Kilpatrick did not prove the pump was the cause of the injury. In its Daubert analysis, the court held that the causal link testified to by Kilpatrick’s expert, Dr. Gary Poehling, was excluded under the reliability prong of Federal Rule of Evidence 702.

The court’s ruling reveals that it considered the following as deficiencies in Poehling’s testimony:
 None of the articles cited by Poehling were based on controlled, randomized epidemiological studies of human beings (though, such studies would be unethical in this context);
 None of the articles explained the process by which bupivicaine (the anesthetic drug) destroyed cartilage;
 None of the articles ultimately concludes that general causation exists—that is, that bupivicaine inserted into the shoulder joint can destroy cartilage;
 He did not describe the “background risk” of acquiring chondrolysis (background risk is the risk of losing cartilage absent exposure to the pain pump); and
 He relies too much on a temporal argument, that the pump must have injured the cartilage, because there were no other possible causes.

Basically, this boils down to one fundamental problem with Dr. Poehling’s testimony—he relied too much on articles that did not “go the distance.” The main article relied on was the Hansen/Beck article, which did not do a rigorous statistical analysis of the conclusion that 63% of patients who received pain pumps lost cartilage. That was the first article to mention an association between the pumps and cartilage loss, so it is not surprising that it was not completely persuasive to the court. Additionally, Poehling couldn’t explain why 37% of patients did not lose cartilage—in his deposition testimony, he just chalked it up to unknown physical differences.

As for the background risk, there are numerous articles that describe the causes of chondrolysis—Poehling should have identified each of them in turn, and discussed their incidence rate. These risks include specific types of infection, age, thermal energy, and specific other chemicals—all of which can be excluded in any decent pain pump case.

Finally, the temporal argument is not firmly rooted in scientific methodology.

These cases are tough in many ways—part of the main problem for Kilpatrick may be that his only causation expert was an orthopedic surgeon—it seems that the Court is looking for more on causation. In this vein, a pharmacologist or cell biologist to testify about how cartilage cells react to anesthetic drugs may have given him the extra push he needed. And, there is much more medical literature out there—the expert really needed to do a full review of the literature, and be able to testify about it. It’s a tough result for Kilpatrick and his lawyers, but these cases are still winnable.

I-Flow, the pain pump manufacturer with the largest market share, has a document on their website that caught my attention today. It is titled “What We Know About Chondrolysis Today.” Sounds like a very informative document, especially now (in 2009) that the company is faced with over 70 lawsuits alleging that they promoted their devices for use after shoulder surgery. Those lawsuits point to the fact that the pumps cause chondrolysis, or the irreplaceable loss of shoulder cartilage.

Scrolling through the document (last revised: 08/2007), though, it is clear that it is outdated and, at this point, blatantly untrue. One wonders if a company that just reported its first-quarter earnings increased 9% this year to a whopping $30.9 million dollars actually has someone in charge of the website, or if they are deliberately avoiding updating the document because the truth makes them look bad. Really bad. There’s been a host of medical literature since 2007 that continues to identify pain pumps as a primary cause of cartilage loss. But, perhaps that’s not worth mentioning to doctors and potential patients?

We posted a couple of days ago on the Libipower recall, the libido drug "officially" marketed for weight loss. Looks like the FDA has spotted some other drugs that fit the bill of weight-loss drugs which are also used for erectile dysfunction.

Since being notified by the FDA that the supplement products contain unapproved drug ingredients, the manufacturer (Opteron 1 Inc., doing business as Nature & Health Co.) of LibieXtreme, Y-4ever, Libimax X Liquid, Powermania Liquid and Capsule, Herbal Disiac has "voluntarily" recalled those products. See the recall press release here.

Of course, a drug/supplement that worked for weight loss and erectile dysfunction would make billions and billions of dollars--just look at Viagra and Fen-Phen. It's marketing genius to combine the two. However, in this case it is just pure fancy.

We’ll deviate slightly from our usual drug-centric discussion today to talk about class actions, generally. A 2007 class action settlement covering Illinois, Texas, California and Connecticut was meant to resolve claims that Ford Explorers built from 1990 to 2001 were prone to rollover. The settlement allowed affected consumers a “coupon” for $500 off a new Ford Explorers, or $300 off a different Ford, Lincoln, or Mercury. Lawyers for the plaintiffs received $15.9 million in fees.

Following the settlement, 1,647 coupons were approved. Assuming every one of those was used for a new Explorer, Ford would lose $823,500. However, at this point only 75 coupons have been redeemed, meaning at most Ford has paid out $37,500 (not including attorneys’ fees).

Of course, the settlement also garnered some non-monetary benefits. Ford has agreed to stop advertising the safety of its SUVs, absent reliable scientific evidence. Furthermore, Ford will provide consumer warnings about rollovers and tire safety dangers.

So, in balance, was the settlement worth it?

Continue reading " Class Action Settlements--Lessons From the Ford Rollover Case " »

The FDA just announced yesterday the voluntary recall of Libipower Plus, a drug marketed for dietary use by Haloteco. The recall is prompted by FDA analysis of the drug, which revealed traces of Tadalalafil, the active ingredient of drugs used to treat erectile dysfunction. The danger here is that Tadalalafil can react badly to nitrates, which are often taken by patients with high blood pressure, high cholesterol, diabetes and heart disease.

Something doesn’t add up, here. A google search of “Libipower” yielded a host of results like the following:

all-natural male libido enhancer supplement
a male all-natural enhancer pill

The press release mentions that Haloteco “sincerely regrets any inconvenience to consumers.” But look at the name—Libipower—it even sounds like libido. I’m sure this is no issue of cross-contamination; rather, the “diet drug” is being indirectly marketed for male enhancement, without the appropriate warnings.

Already plagued by problems with their Sprint Fidelis leads (though, enjoying unprecedented success in the litigation arena, despite causing horrific injuries to many), Medtronic is now recalling select lots of their Paradigm Quick-Set Infusion sets. Quick-Set is used with the Medtronic MiniMed Paradigm insulin pumps by diabetes patients. It is a disposable device that delivers insulin to the patient, and is then replaced after three days of use.

Two percent of these devices, around 60,000 units, may malfunction, causing delivery of too little or too much insulin. Controlling insulin levels is tricky under the best of circumstances, so the effects of these defective devices could be fatal. The recalled lot numbers begin with an '8.' (i.e., 8XXXXXX), and are located on the product's box and the individual unit.

Read the press release here. More information is available from Medtronic here.

Covidien’s subsidiary Mallinckrodt yesterday voluntarily recalled lot 370-9004 of its Sodium Chromate Cr-51 Injection. Post-market testing revealed that the drug had decreased potency. It is used diagnostically to determine red blood cell mass or volume, survival time, and blood loss evaluation. Use of the recalled product may lead to misdiagnosis and consequential stroke or embolus because of false low readings in red blood cell volume.

Mallinckrodt is perhaps best known in the litigation world for manufacturing the MRI gadolinium-based contrast agent known as OptiMARK, which causes Nephrogenic Systemic Fibrosis, NSF (also known as Nephrogenic Fibrosing Dermopathy, NSD) when used in patients suffering from renal failure. Those cases are pending in an MDL before Judge Polster in the Ohio federal court.

On July 2, Plaintiffs filed a motion to consolidate dozens of Chantix lawsuits before one federal judge. The petition, filed before the Judicial Panel on MultiDistrict Litigation, describes Plaintiffs’ allegations that Pfizer failed to research their medication and warn about serious and sometimes fatal neuropsychiatric side effects associated with the drug.

This first petition recommended to the Panel that the cases be consolidated in the Northern District of Alabama or the Northern District of Georgia.

Here’s a link to the complaint in one of the early Chantix lawsuits, filed in the Southern District of Indiana.

Last week, we briefly mentioned the FDA’s new requirement of a black box warning (yes, we’re going to continue calling it a “black box warning”). This week, we had a one day trial that turned into a three day trial, so we’re just now getting to follow up on it.

The warnings will affect Pfizer’s Chantix (varenicline), GlaxoSmithKline’s Zyban and Wellbutrin (bupropion) and generic smoking cessation drugs (note—buproprion like Wellbutrin are often prescribed for depression and seasonal affective disorder). In addition to the warnings, the manufacturers will be required to create patient medication guides to fully disclose the risks of neuropsychiatric symptoms. Symptoms to be on the watch for include: hostility, agitation, depression, suicidal ideation, and behavior changes not associated with nicotine withdrawal. Those medication guides will be given to all patients who are prescribed the drugs. Finally, manufacturers are now required to conduct clinical trials to more fully explore causation.

The requirement comes on the heels of the FDA’s analysis of their MedWatch reports, which show that there may be a link between the drugs and suicidal events in patients with no history of psychiatric disease. However, the FDA first broached the topic of a possible problem back on November 20, 2007. See also the FDA’s recent newsletter on the topic here.

In a move that persuaded reporters everywhere to use quotation marks, the FDA yesterday asked media to stop using the common term for the most serious warning the FDA can require--"black box" warnings. Instead, the FDA apparently prefers the term "boxed warning."

A little background--the black box warning is a thing that drugmakers, drug distributors, and investors of pharmaceutical drugs hate. It's bad for business. The reason is clear--if you put a prominent warning on your latest smoking cessation drug (just to invent a hypothetical drug, you understand), saying it may cause consumers to become suicidal, that's going to hurt sales. Reasonable people might say to themselves: "Gee, I want to quit smoking, but a side effect of suicide is something I just can't live with." Then they move over to your competition, a good self-help book.

So, why are these warnings bad for business? They hurt profits.

The FDA says that "Black Box carries the implication, 'don't you dare use this.'" What they fail to recognize is, the warning itself is supposed to jump out and, well, warn you. There's not much special about the warning itself--it is in bold, and it is surrounded by a think black box. But, it's still tiny print, and it may still be ignored by most people picking up prescriptions from their pharmacy. A rose by any other name is still a rose, but here any additional incentive to read the warning is a good thing. You'd think the FDA, which should be on the side of the consumers and safety, would want to encourage that line of thinking. . . .

Today, the FDA stated that it will require Black Box warnings on Chantix (and related generics) to reflect the serious neuropsychiatric symptoms associated with patients who use the drugs. In particular, suicide and attempted suicide have been widely reported among those who attempt to use Chantix as an aid to stop smoking.

We'll update on this issue later this week. For now, see the FDA's notification here.

The makers of Levaquin (generic: levofloxacin) are currently embroiled in litigation, with 83 federal cases consolidated before Judge Tunheim of the United States District Court for the District of Minnesota. Federal cases were transferred to Minnesota almost a year ago. Currently, the Court and the parties are working on case-specific discovery for agreed-upon cases, from which bellwether cases will be selected. Frequently, bellwether trials give the parties a good idea of what juries think of the litigation, and often provide momentum for settlement of the remainder of cases.

As background, Levaquin is a form of antibiotic, primarily used to treat specific bacterial infections of the lung, sinus, skin and urinary tract.

Ortho-McNeil-Janssen Pharmaceuticals (part of Johnson & Johnson) now warns on their website:

IMPORTANT SAFETY INFORMATION FOR LEVAQUIN

Fluoroquinolones, including LEVAQUIN™, are associated with an increased risk of tendinitis and tendon rupture in all ages. This risk is further increased in older patients usually over 60 years of age, in patients taking corticosteroid drugs, and in patients with kidney, heart, or lung transplants.

The lawsuits pending allege that Levaquin causes rupture of tendons and tendon damage in the rotator cuff, Achilles tendon, biceps, thumb and hand. The FDA required a black box warning, the most stringent warning the government can order, on July 8, 2008. The evidence shows that the company had received petitions to include a warning about these injuries since at least 1996.

Though there are only about 83 cases pending in the MDL, other cases exist in state courts in New Jersey (which may be consolidated soon) and elsewhere. Plaintiffs believe that thousands of potential cases may exist, especially in light of the FDA’s database which contains 262 reported cases of tendon ruptures, 259 cases of tendonitis, and 274 cases of other tendon injuries, all involving the use of Levaquin (or generic) use.

Our lawyers are investigating Levaquin and levofloxacin related injuries. If you want to speak with a Levaquin lawyer about potential lawsuits involving tendon injuries, call 800-553-8082 or click here for a free Levaquin lawsuit case evaluation.