Drug Recall Lawyer Blog

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.

The California Watch wrote about questionable ties between a cardiologist, Dr. Michael Burnam, and a medical device company, St. Jude Medical, Inc.

The allegations are that Dr. Burnam convinced St. Jude to give his son a $200,000 a year job in exchange for a lot of new business. St. Jude manufactures defibrillators, and one patient is accusing Burnam of arranging for a completely unnecessary defibrillator implant surgery. That surgery almost cost a patient his life, when the implanting surgeon accidentally stabbed the patient’s heart with the implant.

This kind of quid pro quo is intolerable, particularly to the extent that patients have no idea of the relationship between their physicians and medical device manufacturers. Part of the problem in this case is that, as alleged by the patient, the cardiologist deliberately misinformed the implanting surgeon about the patient’s medical history. Had he been properly informed, the surgeon would have realized that the surgery was unnecessary.

This may be an extreme case, but there are countless examples of doctors who receive trips, dinners, sporting event tickets and other “prizes” in exchange for business. Can a doctor really have a patient’s best interests at heart when he receives something of value from one device manufacturer and not another?

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!

Yesterday, J&J reported yet another recall. This time, it’s four product lots of BENADRYL® ALLERGY ULTRATAB™ TABLETS, 100 Count, and one product lot of EXTRA STRENGTH TYLENOL® RAPID RELEASE GELS, 50 Count. This is an expansion of the recall related to the wood pallets and the musty smell associated with the medication.

J&J reports that they inadvertently omitted these products from that recall list. Oops.

The FDA posted a graphic on Adverse Event Reports--where they come from, what's done with them, and the potential fallout. It's not very sophisticated (graphically speaking), but it is functional.

Here are this week’s stories:

• Vioxx: See Shearlings Got Plowed for a quick summary of the Australian Vioxx trial. Good news.
• Defibrillator Battery Recall: 5,418 battery packs used in Lifeline AED and ReceiveR external defibrillators are recalled. See the FDA’s notice.
• Scientist-CEOs: Should pharmaceutical companies bring back the scientist-CEO business model?
• Kickbacks and Hip Implants: Read about a former umpire’s quest for justice when a hip implant fails, and he finds out about the moneyed relationship between his surgeon and the medical device manufacturer.
• Benicar: The Drug Injury Watch has a post on the possible dangers of Benicar.
• Motrin’s Phantom Recall: See Brian Nash’s blog for his take on the J&J recall.

Happy Monday!

The New York Times has a good article from yesterday about the standoff between J&J and the government. Apparently, they are both still accusing each other of not paying attention. Maybe it's miscommunication, but I don't think J&J is winning the public relations battle.

This week in Maryland, the manufacturers of radiology equipment met to discuss the planned fail-safe devices for machines set to be sold in the next two years. The goal is to create machines with software that prevents or minimizes errors in radiation dosage.

Radiation overdose is not just an abstract concern, but can cause real injuries and death—see an article by the New York Times about radiation accidents and a 43-year old man who was rendered deaf, visually impaired, burned, and with ulcers in his mouth and neck before he finally succumbed to radiation-caused injuries.

Some of the “fixes” that need to be instituted are ways to ensure the radiation is properly directed and that the radiation dose is age-appropriate. Many machines used now rely on the technologist’s discretion for when and how to perform these safety checks. New machines will make the process mandatory at set intervals.

It’s easy to forget that x-rays and CT scanners can be dangerous, because they become so familiar and commonplace in our medical care. But, there are dangers, and patients have the right to ask questions, and to ensure their medical team has carefully calibrated this equipment before using it.

For more on CT radiation exposure, see prior posts of the Drug Recall Lawyer Blog.

Johnson & Johnson was supposed to provide a slew of documents to the House Committee on Oversight and Reform by 4:00 p.m. on Monday. The Committee reported that J&J missed their deadline, J&J told reporters that they provided the documents. Are they relying on the mail rule (you get an extra 3 days to send stuff to Congress if you send by USPS)? Maybe they should be using e-mail. Or couriers. Or anything to make sure Congress gets these documents by the time they want them.

It just looks bad, even if it is a miscommunication. As a consumer, it somewhat substantiates the allegations regarding J&J's manufacturing process. If they can't get documents sent over in time, can they really make complicated medication in a sanitary way?

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!

There is an upcoming battle in the U.S. Supreme Court over generic drug preemption. The Supreme Court has asked the DOJ to file a brief about whether failure to warn claims can be brought against manufactures of generic drugs. The generic drug manufacturers are arguing that their products have basically been pre-approved, and they should nor really be responsible for knock-off products and their knocked-off warnings.

However, the contrary (and correct) trend of the U.S. District Courts, and now the 8th and 5th Circuit Courts of Appeals, is that Wyeth v. Levine controls and generic drug manufacturers may be sued based on state law for failure to warn.

Related Information

• Wyeth v. Levine: Background Information


• FDA Law Blog: Supreme Court Wants DOJ’s Insight


• FDA Law Blog: PA. District Court Rules Against Generic Drug Manufacturer

We’ve reported a lot on Avandia this year. It is a drug, manufactured by GlaxoSmithKline (GSK), used to treat type 2 diabetes mellitus. It is being associated with heart attacks and liver failure. There are 13,000 filed lawsuits over the drug, and GSK just settled about half of them, including the case first up for trial this month in Philadelphia.

In May, GSK settled 700 lawsuits to the tune of $60 million. We don’t know how it was divided, but if it were divided equally (no reason to think it was), each plaintiff would have received $85,714.00 in the Avandia settlement. Now, GSK settled approximately 5,000 more Avandia claims. We don’t know the amount, but this represents about 44% of the Avandia cases. Assuming that the amount was consistent with the first settlement, GSK has now paid about $488,569,800, nearly half a billion. As all the analysts say, this puts their expected total exposure at much less than the predicted $6 billion (just as we predicted way back when).

Of course, this is all guesswork. Maybe GSK is settling all of the crappy cases, first. Maybe their settling the best cases first. Maybe the recent settlement was for numbers far higher, or far lower, than the May settlement. I’m telling you that this is a very large grain of salt.

I have a great dentist. My wife has been going to him since she was a teenager, and when I moved to Maryland I signed on, too. He’s personable, understands a little about out-of-the box marketing (he’s the only one of my health care providers who actually sends e-mails), and does a great job. However, my wife and I have an inside joke that his office is really a front for the mob.

How do I know? Before any appointment, I get crazy calls to confirm the appointment. By crazy, I mean they will start calling a week before, and if I don’t return the call within 30 minutes, they call again. And again. And again. I know—they lose money if I don’t show up, because that’s time they could reserve for another patient. But, their practice of repeated (I won’t say harassing, but it feels that way) calls makes me wonder if it isn’t a matter of time before they come out with wood baseball bats and thumb screws if I were to ever miss an appointment.

The Red Cross is the same way.

Continue reading " What Do The Mob and Drug Companies Have In Common? " »

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.