Drug Recall Lawyer Blog

Photo courtesy The Onion

See this article at The Onion.

Is this the ultimate end goal of all pharmaceutical companies?

A kernel of truth in all satire, right? (HT: PharmaGossip).

For those who want a quick seven page read—here’s yesterday’s testimony of Johnson & Johnson. As far as apology letters go, it is a good one (someone needs to write a book on the apology--lots of public experience, from the tawdry (Tiger Woods, Jesse James) to the corporate (J&J, etc.)). Throughout the testimony, J&J pledges to “earn back” our confidence, accepts that the conditions leading to the recall are “unacceptable,” and that J&J takes “these issues seriously.” There are two focuses to the testimony:

First, J&J goes to great lengths to convince listeners that there is no known medical risk of the products—the metal contaminants are small and inert; and the bacteria found at the plant has not been identified in any sold batch of medicine. This is their “no harm, no foul” argument.

Second, J&J describes what they have done to correct their missteps, including the prompt recall, notifications to the press, wholesalers and retailers, and even their social media efforts. This is their “stuff happens, and we’ve been on the ball, so we’re really doing all that anyone can” argument.

Nevertheless, the issue has been referred to the FDA crime division. Part of the problem is that the FDA contends they put J&J on notice of their deficient manufacturing practices back in February. The recall then happened in April, indicating that proper attention may not have been given to the issue, despite J&J’s assurances to the contrary.

Nice comparison post by John Mack of the PharmaMarketing Blog: Parallels Between BP and J&J.

John also gets kudos for his Bizarro reference (I would have invoked the parallel universe, but I still have to give credit where credit is due).

A number of reports and calls have come in regarding injuries related to Johnson & Johnson’s Tylenol (and other brands, see here) recall. The FDA is examining about 775 reports of side effects, including 30 deaths, potentially linked to the products. As the investigation proceeds, it appears that most of the 30 deaths have been excluded as resulting from the Tylenol. See the CNN report. As I mentioned earlier, I'm skeptical that any serious injuries will result from the contamination. But, only time will tell.

Yesterday, Johnson & Johnson released a plan to deal with quality control issues like the ones surrounding the Tylenol recall. It looks like they are taking some good steps to prevent future problems. Of course, the big problem is that they are reacting to past problems, when a bit of proactivity could have prevented this whole thing. At any rate, the plan will certainly help Johnson & Johnson to deal with the upcoming congressional probe by showing that they are responding quickly. But, is it quick enough? Maybe they should trade notes with BP…

Sean Wajert of the MassTortDefense Blog has a post on a court’s denial of a plaintiff’s ethics expert in an OBTape MDL pending in Georgia. We routinely disagree with Sean’s blog (we’re on different sides of the aisle, of course), but there isn’t much disagreement with this post.

Disclaimer: I haven’t been following the OBTape litigation too closely, so all my information is secondhand.

Plaintiffs hired a business ethicist, Professor Ann Buchholtz, to testify that the product manufacturer should have provided certain information about the product to physicians and consumers. This is essentially a failure to warn claim. The problem with hiring a business ethicist (who, apparently has no particular expertise in medical devices or medical ethics, which arguably could alter the analysis) is that she is unnecessary. A jury is tasked with determining whether a company failed to warn about specific dangers. Having an expert say what is “ethically” required is merely an attempt to substitute an expert’s opinion for that of the jury. And, the danger is that the opinion comes cloaked in the guise of expert testimony, so a jury might be more willing to accept the expert’s viewpoint.

I don’t know if the plaintiffs hired FDA experts, but that’s really the approach to take. It is important to show that the company had knowledge of specific product problems, defects or dangers that rose the level of requiring the company to report those problems to the FDA, and likely require the company to issue a better warning. That’s the expert opinion testimony needed in a case like this.

Ethics are important, but they are not rules. It’s not something that should be testified to by an expert in most cases. The jury should determine whether or not they apply in any particular case, and what the standard should be.

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!

We previously blogged about the Fleet Oral Sodium Phosphate (laxative) cases, with about 1,200 now pending before the United States District Court for the Northern District of Ohio. This product was used by people before medical procedures, including colonoscopies. Plaintiffs allege that the product can cause kidney failure and chronic kidney damage. Some people needed dialysis, some needed kidney transplants, and other died.

The Fleet products at issue, Fleet Phospho-soda, Fleet Phospho-soda Accu-Prep and Fleet Phospho-soda EZ-Prep, were recalled in December, 2008.

It appears that both sides, plaintiffs and the manufacturer, C.B. Fleet, are close to working out a product liability settlement. Of course, as we wrote before, one of the Plaintiffs’ main contentions is that C.B. Fleet knew about the product dangers well before it actually warned or recalled the product. If the cases resolve, the first scheduled trial date of October 10, 2010 will be taken off the docket.

For more information, see our Fleet Phospho-Soda website.

Our friends at the Pharma Marketing Blog discuss Johnson & Johnson's recent social media efforts in light of their children's Tylenol recall. Johnson & Johnson Director of Corporate Communications Marc Monseau responded in the comments. Nice, but there is a lot more Johnson & Johnson could be doing, social media-wise. This is a good opportunity to earn points with the public through full disclosure, links to media critical of J&J, videos of J&J's corporate talking heads reassuring the public, etc... It's a brave new world, but only if you embrace the technology.

Here are this week’s stories:

• Dietary Supplements: The FDA Law Blog comments about the FDA’s compliance program for dietary supplements.
• Vaccine-Autism Litigation: Drug and Device Law Blog thinks the most recent Federal Circuit decision basically seals the coffin in this litigation.
• Maryland Whistleblower Protection: Pat Malone writes about a Maryland appellate case approving protection of a nurse’s job when reporting dangerous hospital practices. This could have reverberations for other whistleblower cases, including products cases. See this website for more information on the False Claims Act. And, see this website for more about the whistleblower mindset blowing-the-whistle-on-drugmakers-misdeed-takes-guts-stamina.
• Fosamax: most of the belleweather cases will be tried this summer and fall (HT: Shearlings Got Ploughed).
• CT Radiation: great audio article by NPR.
• Big Brother: Pharmalot reports that GlaxoSmithKline doesn’t like its employees visiting CafePharma, a drug blog devoted to employee criticisms of the pharmaceutical and medical device industry.

Happy Monday!

After the recall of Johnson & Johnson’s Tylenol (including Motrin and other) products, Congress has gotten involved and is launching an investigation. They are seeking all sorts of documents, and presumably trying to determine whether the recall should have happened sooner in light of the 46 customer complaints.

I suspect the big uproar is caused by the subject of the recall—children’s Tylenol. If this was adult medication, it probably wouldn’t be as big of a deal (which isn’t to say that it shouldn’t be a big deal). But, we are hard-wired to protect our children, so anything that potentially harms their health gets center-stage attention. There are a lot of other products out there that could use Congressional investigation, in particular, drugs and medical devices that have actually been traced to injury. Right now, there is no evidence that the contaminated Tylenol products can cause any ill effects. Of course, lots of parents are on pins and needles after giving their children medication that they thought was safe.

Here’s a link to a recent CNN article, and links to our prior Tylenol Drug Recall Lawyer Blog posts.

A really nice Bloomberg article on whistleblowers "hit the stands" today. The authors, David Voreacos and Margaret Cronin Fisk did an excellent job of tracing the payouts and controversy surrounding corporate employees of drug companies who alert the DOJ to bad pharmaceutical practices. Essentially, the act of telling the DOJ gives the federal government the ability to recoup millions of dollars, a portion of which is given to the whistleblowers as an incentive payment. Without that payment, few whistleblowers would risk their jobs and peer ostracization to bring these bad practices to light. Some think the payments to whistleblowers are too high. I don't have any problem with it--it may encourage others to report bad practices (and remember--not all whistleblowing cases are accepted, or result in multi-million dollar settlements).

See our prior Seroquel/Whistleblowing blog post.

An article in the Ohio Columbus Dispatch reminds us that pain pumps are not just problematic for people with shoulder surgery. The article highlights the fact that pain pumps are not approved or safe to use next to any of the body's joints. The article focuses on college-age athletes who used a pain pump immediately following otherwise routine knee surgeries. Now, those athletes have difficulty sleeping and walking without pain, because the cartilage that used to pad the joint is now gone or significantly eroded. One patient said that her doctor told her she can't wear high heels or get pregnant because of the stress that will put on her weakened knee.

The lawsuits generally allege that manufacturers failed to warn doctors about the dangers of placing pumps near joints, and further allege that manufacturers encouraged that placement to orthopedic surgeons, who relied on that advice to the lifetime detriment of their patients. The manufacturers dispute the off-label claim, but many doctors have come forward to talk about how they were duped by medical device manufacturer's sales representatives.

Joint reconstruction and cartilage transplants are options for these patients, but it is extremely rare for them to recover 100%.

Pain pumps have been used with bad effects in shoulder, knee and even toe surgeries. The prime rule for patients is to refuse them anywhere near cartilage.

For more information on pain pumps, see our prior Drug Recall Lawyer Blog posts, and our main Pain Pump Website.

The new romaine lettuce recall is the latest in a series of dangerous fruits and vegetables. The impact of clean agricultural practices first really hit public consciousness in 2006 with the massive E.Coli outbreak in Dole spinach. And then in 2008 with the tomato recall. And then in 2009 with the peanut butter recall.

Now, the FDA is telling us that Freshway Food’s bagged romaine lettuce, potentially with sell by (not use by) dates of May 9 and May 10 can contain e.coli O145, which is harmful. The outbreak has likely harmed at least 19 people in Michigan, Ohio and New York. The FDA believes a farm in Yuma Arizona may be the source. Injuries include hospitalizations and hemolytic uremic syndrome (a disease that destroys red blood cells, and may be indicated by bloody diarrhea and acute kidney failure). Adults typically recover quickly, but it can be life threatening to children, the elderly, and people with impaired immune systems.

The lettuce at issue was sold to wholesalers, food service outlets and some stores with salad bars or delis, and may include pre-packaged salads from Kroger, Giant Eagle, Ingles Markets, and Marsh stores. Other states where the salad was sold include Alabama, Connecticut, the District of Columbia, Florida, Georgia, Illinois, Indiana, Kansas, Kentucky, Maryland, Massachusetts, Michigan, Missouri, New Jersey, New York, North Carolina, Ohio, Pennsylvania, Rhode Island, South Carolina, Tennessee, Virginia, West Virginia and Wisconsin. Importantly, Freshway Foods does not produce prepackaged salads for supermarket sales.

I don’t usually post on agricultural recalls, but it is such a big trend lately, that it seems important to at least get the information out there. As an aside, any product lawyer who has faced the uphill battle of specific product identification in medical device or drug cases knows how difficult it can be to discovery specific brands or manufacturers of products used in hospitals. By comparison, agricultural detection is a fine-tuned science. DNA from the E.coli can be checked. The food industry typically has terrific identification protocols that allow us to track a specific box of lettuce used at a restaurant to a state, a farm, and even an area in the farm, not to mention time of day it was picked.

Eat healthy.

Here are some stories to follow this week:

• Tylenol Recall: Johnson & Johnson’s statement about the recall is here, and they have a blog post here (with some interaction with consumers via comments).
• Vyvanase and Off-label Marketing: John Mack has an interesting post analyzing an ad that might be promoting off-label use through subtle imagery. Is it off-label, or is just a picture? You be the judge!
• Maalox: The FDA posted a statement (scroll to the bottom) under Patient Safety News regarding the problems with confusing various types of Maalox, which can have disastrous results.
• April 510k Clearances: viewable here.
• Topomax: After the $81 million settlement with the DOJ over its drug Topomax, Johnson & Johnson sales reps are going to be randomly observed during sales pitches (HT: FiercePharma).
• Preemption and Generic Drugs: post by the For the Defense.
• Fosamax: I’ve been trying to get a post on this important decision, but it’s been a busy couple of days. Tom Lamb has a description.

Happy Monday!

The FDA Law Blog has a great post on the recent Baxter Colleague Infusion Pump Recall. They outline the authority the FDA is using to demand the recall (it is based on a consent agreement entered some years back between Baxter and the FDA after continued pump problems). The FDA Law Blog questions whether Baxter is required to refund purchase prices or reimburse for current pump values. There's an interesting calculation of Baxter's expected loss (though, Baxter is hoping to be able to replace the Colleague pumps with other Baxter pumps).

See our prior post on the Baxter pump recall here.

CNN reports on the Tylenol recall and the FDA's investigation into the quality control issues and security lapses at Johnson & Johnson's Pennsylvania manufacturing facility.

An FDA representative has stated "This is yet another example of when a company has to take full accountability for the quality of its drugs [with] severe consequences for not doing so." As new evidence comes to light, it appears that Johnson & Johnson has not timely addressed customer complaints since June 2009 about foreign substances in the medicine.

Here's a link to the FDA's press release, and a link to the 17-page FDA plant inspection report.

Reviewing the YAZ website (“know the enemy”), it seems that Bayer is still contending that YAZ and Yasmin are no riskier than other drugs—that is, the drugs have “comparable” risks to other birth control pills on the market. Here’s the “News You Need To Know” (according to Bayer):

Do YAZ or Yasmin carry any greater risk for blood clots (VTE), than other birth control pills? According to the product information, the scientific data indicates that the risk of developing blood clots while taking YAZ and Yasmin is comparable to other birth control pills.

I’m not sure why this is according to the product information and not according to the scientific data directly, but it isn’t entirely truthful. Even in Bayer’s best case scenario, the scientific data is mixed on the issue. Some data supports their risk assessment, and some data challenges it. However, Bayer is claiming that the two studies contrary to their position (one by Lidegaard, the other by Van Hylckama) are unreliable.

We’re still waiting for the new product labels, both here in the States and in Europe. It will be interesting to see the differences between the two.

The pump is a device that delivers various fluids in a hospital, nursing home, or even home setting. According to the FDA, the Colleague-brand pump has had problems going back as far as 1999, including “battery swelling, inadvertent power off, service data errors, and other issues.” Baxter’s attempted solutions have not been successful. Baxter has been ordered to provide replacement or refund to all customers.

All told, the FDA has received 56,000 adverse event reports in the past five years, and has found that the pump may be linked to over 500 deaths.

Baxter has issued a press release, available on its website. However, Baxter’s website addresses problems with other pumps (and older problems with the Colleague), but does not address this situation, yet. Furthermore, we could not find any mention of the Colleague pump in the regular product line (which, is just as well, but it would be another good location to inform customers about the problems). The company gets a C-average for using social media (their website) to keep customers apprised of potentially life-threatening problems.

Here are this week’s stories:

• FDA: The FDA is changing the medical device approval process. See the FDA announcement (HT: Eye on FDA).
• FDA II: Little progress on more FDA independence and power in drug safety reviews (An appropriate lament by Tom Lamb).
• Heparin: Congressional examination into the contaminated Heparin debacle (HT: FiercePharma).
• Tylenol Recall: Seems we just went through this. Here’s another one, affecting infant/children Tylenol, Motrin, Zyrtec and Benadryl. See the recall notice.
• Pain Pumps: Drug and Device Law Blog’s view of the recent MDL denial.

Happy Monday!