Drug Recall Lawyer Blog

You and Dawson, you both live in the same dreamworld! It doesn't matter what I believe. It only matters what I can prove! So don't tell me what I know, or don't know! I know the LAW!

Lt. Daniel Kaffee, that crazy kid, was on to something here. You can apply Kaffee's logic to Chantix. Chantix is always on the FDA adverse event reports leaderboard, both in terms of breadth and quantity. Where there is smoke, there is usually fire. Not always. But usually.

There is certainly enough of a connection between the smoke in Chantix suicide cases. If someone starts taking Chantix and kills themselves, it will not be difficult to explain to a jury the relationship. It is not a leap to say that if someone has been going through life without killing themselves (obviously), takes Chantix, and then kills themselves, it is going to be more likely than not that Chantix was a contributing cause. Not definitively connected beyond all reasonable doubt - suicide is too complex of an event for that - but certainly more likely that not to be a contributor.

Continue reading "Chantix Lawsuits: What Can Plaintiffs' Lawyer Prove?" »

MassTortDefense Blog posted about the U.S. Supreme's Court decision to not hear a punitive damages case, Wyeth v. Scroggin.

In the first trial, bifurcated on liability and damages, the jury held the drug company responsible to the tune of $2.7 million in compensatory damages, and then $19.4 million in punitive damages. Appeals predictably followed, and the U.S. Court of Appeals for the Eighth Circuit overturned the punitive damages award based on some evidence that should not have been permitted. That court then ordered a new trial on punitives, only.

The issue that some wanted the Supreme Court to decide was whether a new trial on punitives alone was okay, or whether the entire trial had to be redone.

On the one hand, it seems a little difficult for a jury to get the full scope of a defendant's malfeasance without redoing liability, as well. But, the lawyers trying these hormone therapy cases are a resourceful bunch, and I'm sure they can do it. It's just sad that a new jury won't have the benefit of the same amount of time detailing all of the drug company's missteps.

On the other hand, the plaintiff has already proven her case, at least on the fundamental level of liability and causation and (non-punitive) damages. To make her retry the whole thing would be cruel, and would certainly lack judicial economy. Furthermore, to take that away when the initial non-punitive process was without judicial error would be inappropriate even according to the rules of the playground.

One sidenote--the author of the blog stated that:

The case involves a woman who allegedly developed cancer after taking hormone therapy drugs. (The FDA continues to approve the drugs as safe and effective.)

Actually, the case involves a woman who has proven that she developed cancer because of hormone therapy drugs. And, to say that the FDA continues to approve the drugs as safe and effective is a gross oversimplification. Sure, they are safe when used properly. Doctors didn't have the right warnings at the time, and now they are used more frequently with the "lowest effective dose." After all of the studies that have been done, you can't deny that hormone therapy drugs causes breast cancer. Well, you could, but if you are, you are probably a drug company executive...

Last week was a busy one--our firm had two trials (one continuing on this week with closing arguments tomorrow), and one that concluded very favorably with a plaintiff's verdict. But, now that I'm back, here's this week's edition of the Round-Up:

• The Sixth Circuit and Preemption: As mentioned by Drug & Device Law Blog, the 6th Circuit wants the FDA's viewpoint on preemption by July 29.
• Testosterone Gel: The Drug Injury Lawyer Blog reports on the links between testosterone gel and heart attacks/strokes. We've blogged about Testim, one version of the drug, before.
• Fosamax: I'm really sorry to have missed reporting such a big event. Here's a bunch of stories on the $8 million plaintiff's victory in the Boles Fosamax trial: Drug Injury Watch; Shearlings Got Plowed (victory notice)(post-trial motions)(next trials)
• Vioxx: Can Louisiana sue Merck to recover for money spent on Vioxx?
• BPA: The National Resources Defense Council (NRDC) sued the FDA over the FDA's failure to ban BPA in selected products. We'll see how that goes.... Here's an update on BPA from the FDA.

Hope you had a happy 4th!

The Supreme Court rejected Pfizer’s appeal in the Scroggins case, where a jury rendered a compensatory damages verdict of $2.75 million. Pfizer wanted the Supreme Court to order a new trial on the entire case—compensatory and punitive damages, as well as causation. The trial jury decided on $27 million for punitive damages, and Pfizer will get a new trial on that.

Wyeth has lost seven out of eleven cases (at the trial level) since 2006.

For more on the hormone therapy backstory, see our prior Drug Recall Lawyer Blog posts.

Mylotarg, Pfizer’s leukemia drug that was approved by the FDA in 2000 under an accelerated approval program (early approval for drugs that show particular promise) will be pulled from the market. A continuing study revealed that patients are more likely to die while taking Mylotarg and chemotherapy than those who undergo chemotherapy, alone. That study was prematurely stopped last August (ten months ago? What’s the deal with the delay between the study results and pulling the drug from the market?)

One physician from the Cleveland Clinic noted that the drug did cause disease remission; unfortunately, it also caused increased toxicity which was oftentimes fatal.

If you are taking this drug, be sure to consult with your physician about whether you should continue to take it.

Here are this week’s stories:

• Blood Products: The FDA hit the Red Cross with $16.2 million in fines for blood safety violations. Maybe I should take my donations to the local hospital, instead…
• Hormone Therapy: Pfizer needs to get ready to try its hormone therapy cases all over the country, now that cases have been sent from Arkansas to their home states (with more awaiting transfer). Some think the upcoming cost will be an incentive for settlement. (HT: Bloomberg).
• Zimmer: The New York Times reports on a fallout between Zimmer and its former consultant, Dr. Richard Berger, over failed knee implants.
• CT Radiation: More on the CT radiation overexposure issue.
• Digitek: The Drug and Device Law Blog reports on more problems with the Digitek cases.

Happy first day of summer!

Here are the week’s top stories:

• Off-Label Marketing: Jack’s Posterous has a recount of recent off-label marketing fines paid by drug dealers (oops, I mean manufacturers). “As long as off-label promotion is more profitable than the fines for punishing off-label promotion, we will have off-label promotion.”
• Motrin Phantom Recall: Pogust, Braslow & Millrood’s Drug Injury Lawyer Blog has details of Johnson & Johnson’s McNeil Consumer Healthcare and their effort to avoid a Motrin recall.
• Zocor: FDA says it may cause muscle injury (rhabdomyolysis). See our prior Zocor posts.
• Pfizer and Free Samples: Pfizer spends the most doling out free samples--$2.7 billion in a year. Kinda makes you think about those paltry fines, huh?
• Off-Label Marketing, pt. II: Take the poll.
• Drugs and Porn: Can drugs cause porn and gambling addictions? Looks like there are lawsuits in Australia and here in the U.S. I’m highly skeptical of this one.
• Fosamax: Jury selection just ended in the retrial of the Boles case, yesterday.
• Januvia & Janumet: We've been getting a lot of questions about these diabetes drugs lately, so see our website.

Happy Tuesday!

Here are this week’s stories:

• Medtronic: Medtronic reported that it paid $15.7 million to U.S. doctors in the first 3 months of 2010. Payments were for consulting fees and royalties. This report comes well in advance of the new law requiring disclosure beginning in 2013. See Medtronic’s searchable database of payments.
• Digitek: A request for a class certification was recently denied in the Digitek MDL. The MassTortDefense Blog has an update.
• PediaCare Recall: over 100,000 bottles of PediaCare, formerly manufactured by Johnson & Johnson (and, still being manufactured in their facility), have been recalled. This is a precautionary recall, based on the known problems with the J&J manufacturing facility.
• AstraZeneca and Social Media: Here is AstraZeneca’s take on the transparency/social media issue.
• Generic Drugs: The Supreme Court asks Obama’s administration for an opinion as to whether generic drug manufacturers can be sued for inadequate labeling that matches labeling of brand-name drugs. Here is the Eighth Circuit’s opinion, deciding that generic drug manufacturers can be held liable.
• Celebrities in the News: Dennis Quaid is bringing public awareness to injuries caused by pharmaceutical companies. He settled with the hospital on the heparin overdose of his children, but now he’s going after the pharmaceutical company, Baxter Healthcare Corp.
• More on Whistleblowing: Wyeth (through Pfizer) is accused of illegally promoting its kidney transplant drug for other organs and specifically among African-Americans, who have greater risks associated wit the drug.

Happy Wednesday!

Good morning! Here are the week’s top stories:

• Topamax: Johnson & Johnson is going to pay over $81 million (articles here and here in criminal and civil fines for illegally promoting Topamax. That’s a mere 0.070% of 2009’s $1.15 billion in sales, and 0.039% of 2008’s 2.7 billion in sales (quite the deterrent, eh?). Nevertheless, this compounds J&J’s woes in light of the current Tylenol recall.
• Topamax Whistleblowers: Here’s an article about the courageous Michigan whistleblowers who made it all happen.
• Vaccines & Autism: Dr. Andrew Wakefield, the British physician who wrote the initial Lancet article linking autism to vaccines, has been disbarred from the practice of medicine. He did not offer evidence on his behalf, and he has about a month to appeal.
• BPA—now in cans?: USA Today and Dr. Gupta report on the presence of BPA in cans, and discuss whether pregnant women in particular should be concerned. For more on BPA, see our prior blog posts.
• St. Jude Medical: The FDA recently issued a warning letter to St. Jude Medical about overpromotion of its Epicor Ablation System, used to treat atrial fibrillation. See the Forbes article and the FDA’s warning letter.
• Las Vegas Hepatitis Punitives: See one reactionist and alarmist article, “Health Cost Hikes May Follow $500M Jury Award in Hepatitis C Case.”
• Neurontin: Last week, Pfizer settled a Neurontin wrongful death case for a confidential amount.

Have a great week!

Here are the stories we’re following this week:

• Infusion pumps: The FDA is tightening regulation of infusion pumps, which have reportedly caused 710 deaths in the past five years, and have been subject to 79 recalls since 2005 (news links to The New York Times, The Wall Street Journal, Associated Press, Reuters).
• Guidant: Brian Nash’s perspective on the defective Guidant defibrillator settlement proposal.
• Fosamax: Apparently, the trial has been going on all week (HT: Shearlings Got Plowed).
• Sprint Fidelis Leads: Last week, the 8th Circuit Court of Appeals heard arguments in Case no. 9-2290, Anna Bryant v. Medtronic. You can hear the recording here.
• Pfizer: The FDA issues a warning to Pfizer about clinical trials where children received excessive dosages of antipsychotics (HT: FiercePharma).
• Boston Scientific: The Guidant-purchaser is set to resume sale of some defibrillators which were recalled last month after it notified the FDA that some paperwork wasn’t properly submitted. (see The Wall Street Journal (subscription req’d)).

Happy Monday!

Here are the stories we’re following this week:

• Yasmin: Bayer is updating its European warning label after recent Swiss studies (HT: Tom Lamb)
• Direct-To-Consumer Drug Advertising: FDA proposes new regulations (HT: Mass Tort Defense Blog)
• Zicam: Update on the Zicam (nasal spray that may cause loss of sense of smell) MDL, pending in Phoenix (HT: Searcy Blog)
• Pain Pumps: California state judge cuts up pain pump claims (HT: Drug & Device Law Blog)
• Drug Companies: Three drug companies (Pfizer, Solvay, and Procter & Gamble) found to have breached the British Pharmaceutical Industry’s code of practice (HT: PharmaGossip)

Happy Monday!

Here are the stories we’re following this week:

• Pfizer: CNN reports on why Pharmaceia, Pfizer’s shell company, “took the fall” for Pfizer’s illegal marketing practices
• Crestor: will the marketing campaign persuade people to take it when they don’t need it? (HT: Patient Safety Blog).
• Seroquel: Two more summary judgment decisions in Delaware (HT: Drug & Device Law Blog).
• Fosamax trials: Scherlings Got Plowed has an update.
• Children and Medical Devices: The FDA is requiring medical device manufacturers to provide additional information on the effects of their devices on children.
• Pfizer Discloses Payments: Pfizer disclosed $35 million in payments to healthcare professionals in the last half of 2009. The payments were for development and marketing. (HT: FiercePharma).

Happy Monday!

Here are the stories we’re following this week:

• Fosamax and Statute of Limitations: Recent Fosamax case and application of American Pipe mass tort/class action tolling (HT: Drug and Device Law Blog)
• Drug Pushers: Are sales reps who promote their companies drugs with direct-to-consumer (DTC) advertising “pushers?” (HT: Pharma Marketing Blog)
• Anemia Drugs: Anemia drugs by Johnson & Johnson and Amgen may exacerbate heart problems and survival in kidney patients (HT: FiercePharma)
• Price-fixing: According to a Bloomberg report, Germany cuts costs of drugs by precluding manufacturers from setting their own prices.
• Neurontin: Reuters reports that Pfizer loses a RICO trial to the tune of $141 million.
• Boston Scientific Defibrillators: Another perspective here. You can see our previous blog post here.
• CT Scan Radiation: New York Times article about whether FDA ignored warnings about radiation problems.

Happy Monday!

To follow up on our March 2, 2010 post BigPharma Goes All “Social Media” is a website that features all comments submitted to the FDA on the social networking question. A somewhat more readable version (though, less complete) is at www.fdasm.com. Here are links to some of the heavy hitters (including law firms and internet providers) who have commented. The papers are downloadable directly from the website.

• Abbott
• AstraZeneca
• Bayer Healthcare
• Covidien
• Eli Lilly
• Google
• Hogan & Hartson
• Johnson & Johnson
• Medtronic
• Merck
• Novartis
• Pfizer

Time to wake up and face the week! Here are the stories we’re following:

• Avandia: The U.K.’s Guardian blogs about GlaxoSmithKline’s potential $6 billion liability. @TomLamb and I are skeptical.
• Vioxx: Australian judge finds for plaintiff in defective drug lawsuit against Merck, though rules that Merck was not negligent. (HT: Pharmalot). Merck’s press release is here.
• FDA: The FDA is going to step up criminal prosecutions of corporate officials.
• Insulin Pump Defects: Insulin pumps have been beset by problems, spanning across the spectrum of manufacturers (HT: Drug Injury Lawyer Blog).
• 510k Approvals in February: See the list here.
• Direct-to-Consumer Advertising: BigPharma’s DTC advertising increased by a “paltry” 1.9% in 2009, but Pfizer leads the pack with $1.1 billion.
• BPA: Wisconsin is added to the list of states banning BPA in baby bottles and cups.
• Nerd Link of the Week: You’ll just have to click to find out…

Happy Monday!

Up until now, online social networking has been treated mostly as a plaything for some pharmaceutical manufacturers. They will post a few updates on Twitter, maybe start a Facebook page or post a YouTube video or two, but I have not seen much indication that the companies have really bought in, much less that they “get it” (though, some like AstraZeneca may be playing it safe while the FDA works out the regulation aspect).

Eye on FDA has a good summary of what’s happened to get us to this point. Initially, the FDA was more concerned with the content of pharmaceutical and medical device manufacturers’ messages. However, last year the FDA realized that there is only so many contraindications you can fit in 140 characters. So, in September 2009, they took the proactive step of setting a meeting (which BigPharma interestingly did not attend), and encouraging comments (open through last month). The hope is that they will be able to draft some sort of guidelines, so everyone knows where the line is.

Continue reading "BigPharma Goes All “Social Media”" »

Since Monday, there have been decisions in two hormone therapy cases. Here are the details:

Monday, February 22-Audrey Singleton: In the Philadelphia Court of Common Pleas, a jury found for the Plaintiff and against Pfizer/Wyeth. The verdict, which came after a four-hour deliberation, was for $9.45 million ($3.25 in compensatory damages and $6 million in punitive damages, with $200,000 to the plaintiff’s husband for loss of consortium). The plaintiff was on hormone therapy for six years, before being diagnosed with breast cancer, which is currently in remission. Notable about this case is that the plaintiff was on hormone therapy for about a year and a half after release of the WHI study showing that Prempro increases the risks of cancer. Plaintiff’s lawyers stated that this verdict confirms Wyeth’s actions after release of the study were irresponsible and negligent.

Wednesday, February 24-Cheryl Foust: Also in the Philadelphia Court of Common Pleas, this case was a defense verdict after six hours of deliberations, on the basis of specific causation. We linked to this case previously—it is the one where plaintiff’s twin sister also took hormone therapy, but did not get breast cancer (both argued that this fact supported their position). Plaintiff was successful in convincing the jury that Wyeth was negligent by not properly warning Ms. Foust’s health care providers about the risks of Prempro, and that the failure caused the health care providers to prescribe the drug to Foust. However, the jury found that the drug did not cause her breast cancer. Ms. Foust succumbed to her cancer at the age of 56; the case was brought by her widower.

As far as jury trials go, Pfizer has lost seven of the past 11. Many cases are up on appeal, and there are still something like 1,500 left to go in Philadelphia. Click here for prior blog posts on hormone therapy drug lawsuits.