Drug Recall Lawyer Blog

Abnormal Use interviewed University of Maine School of Law professor Jennifer B. Wriggins in a blog post last week. Professor Wriggins is best known for her book "The Measure of Injury: Race, Gender, and Tort Law" which talks about how tort law does not provide full redress for injuries to women.

Professor Wriggins was asked by Abnormal Use, "What rule or concept in modern torts or products liability jurisprudence do you believe is the most outdated, and why?"

Now that is a really good question. My first answer would probably be contributory negligence which is also touched on in this interview. Professor Wriggins said she thought the most antiquated idea might be not telling the jury of the existence of liability insurance even though the likelihood is that most of them know or suspect the defendant has insurance:

One rule that strikes me as possibly outdated is the rule that juries are not allowed to learn about liability insurance policies. Even when a case involves an auto accident, and auto insurance is mandatory in a state (as it is in almost all states), so that jurors who are car-owners (probably most jurors) know that there is likely to be insurance, jurors are not supposed to know about insurance. I understand that it is important for the liability and damages issues not to be affected by the presence or absence of insurance, but I think it is very likely that jurors think about insurance anyway. I would want to think about this more before advocating it, but perhaps we should just give jurors the insurance information and tell them it should be kept separate from the liability and damages determinations. If they are hypothesizing about insurance and taking it into account anyway, then giving them accurate information should not hurt the process. I can see both sides of this, but I think we are probably deluding ourselves if we pretend jurors don’t know and aren’t thinking about the existence of liability insurance.

Jurors' first question after a trial is often, "What's the deal, didn't this guy have insurance?" Jurors expect people to have insurance but they also expect information. If after a weeklong trial no one has mentioned insurance, jurors can easily begin to conclude that there is something special about the case and the defendant might not have insurance.

I think I agree with Professor Wriggins' premise - which even she does not seem 100% sure about - but I have not given it a lot of thought. Why? The fact that we don't tell juries about insurance always seemed like my poor vertical leap: something I accepted and never thought would change.

This is a really good article in the Tulane Law Review that explains the history and theory behind bellwether trials in the MDL.

The Drug and Device Law Blog has an articulate rant about plaintiffs' lawyers jerking around defendants on whether certain documents produced should be deemed confidential. The core of their argument is that plaintiffs' interests in the battle over confidential documents is either for (1) sport, or (2) to shop documents obtained in discovery to the press.

There is some measure of truth to almost the entire post. But it is as if Tiger Woods told the following story: "I was looking forward to a nice Thanksgiving weekend with my family but on Sunday my wife just left. Didn't say good-bye or anything." That's a true story.

Similarly, the Drug and Device Law Blog leaves out a little fact of the story: mass tort defense lawyers are the undisputed kings of making plaintiffs' lawyers work for pure sport. Plaintiffs' lawyers in drug and device cases largely just want to get from Point A to Point B as quickly as possible. I think this is a function both of the personality types attracted to these very different jobs (and I've done both) and fundamental economics: plaintiffs' lawyers get paid for success while defense lawyers get paid for working, even if they are just creating work.

The Drug and Device Law Blog freely admits that defendants do designate too many documents as confidential because "it's hard to analyze the confidentiality of millions of documents and get every call exactly right." (Y'all do this on privileged documents too, a practice that usually goes by unchecked.) So, their thinking goes, "if one errs on the side of over-designation, the documents can be de-designated and nobody is hurt." So it is a hassle to do the job right the first time even though you billed the client $85 gazillion dollars for the document review. And the court's order didn't say, "Hey, when it doubt, just mark it confidential, we will put the burden on plaintiffs' lawyers to have to run back to me to get it straight."

Moreover, making documents public that show what drug companies are actually doing may serve plaintiffs' lawyers' interests but it also serves the public good. If you are taking a drug and the manufacturer has documents showing they are burying studies that reveal the drug has risks not fully disclosed, isn't it a good thing if the patient and the doctor read about this in The Washington Post? The fact that the documents show you are misleading patients and their doctors is not confidential. The blog post suggests the problem is that drug companies don't properly answer the charges in the media. Okay. But you can't suggest the public does not have the right to know because you don't have the time, energy, inclination or PR staff to respond.

I would have been far more okay with this blog post if after it was done suggesting plaintiffs' lawyers sadistically are creating work, it would have had something thrown in there about the fact that defense lawyers are far more guilty of this than plaintiffs' lawyers. Because, believe me, it is undeniable.

• Drug and Device Law Response
• My (Stolen) Reply Brief to the Drug and Device Law Blog

According to the Maryland Intellectual Property Law Blog, Maryland has seen only 10 patent lawsuit in 2010. Incredibly, there have already been 265 patent lawsuits in Texas. There are not more patents in Texas. Maryland inventors received almost as many patents in the first half of 2010.

Drug companies, who are anti-lawsuits until they want to file one, are frequently parties in patent lawsuits involving one drug company accusing another of reverse engineering or copying of drugs.

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.

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.

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.

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!

Two contrasting Accutane lawsuit updates in the news today:

First, Some Background: Accutane is used to treat severe acne, and has been associated with a host of problems: birth defects, inflammatory bowel disease, injuries to the liver, kidneys, nervous system and pancreas, dermatological reactions, and even suicide. Roche stopped selling it last year after a 27-year run, citing competition from generics and the 5,000 pending Accutane lawsuits.

Plaintiff’s Verdict: $25.16 Million: In May 2007, Andrew McCarrell emerged victorious in a New Jersey Superior Court Accutane lawsuit against Roche Holding AG. Mr. McCarrell developed inflammatory bowel disease, caused by the Accutane. (View the entire original trial on video, purchase required). That victory was short-lived, as the verdict was appealed and overturned (opinion here, courtesy Drug and Device Law Blog) because the trial judge should have allowed the defendants to present statistical evidence—that there were five million users of the drug.

Continue reading "Accutane Update" »

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Posted In: Drugs , Litigation

The Lancet has retracted [free subscription required] the 12-year old article connecting autism to MMR (measles, mumps and rubella) vaccinations. The Lancet stated:

Following the judgment of the UK General Medical Council's Fitness to Practise Panel on Jan 28, 2010, it has become clear that several elements of the 1998 paper by Wakefield et al1 are incorrect, contrary to the findings of an earlier investigation. In particular, the claims in the original paper that children were "consecutively referred" and that investigations were "approved" by the local ethics committee have been proven to be false. Therefore we fully retract this paper from the published record.

Click here for the original article, “Ileal-lymphoid-nodular hyperplasia, non-specific colitis, and
pervasive developmental disorder in children” (emblazoned with a bold, red typeface “RETRACTED”).

Here’s a summary of the posts on the internet and blogosphere:

Continue reading "In The News: Vaccines & Autism" »

We’ve been fielding questions lately about the cardiac stents that have been all over the news here in Baltimore. One of the inevitable questions is whether the stent is defective. There’s no indication that the stents implanted at St. Joseph Medical Center are defective—in fact, there is no evidence that the stents are of any particular brand or manufacturer. A few years back there was discussion about defective Johnson & Johnson Cypher Stents, which one Cleveland Clinic study showed to be four to five times more likely to cause blood clotting. The issue here is not one of defective stents, but rather medical malpractice.

Though it is outside the scope of this blog, it does touch close to home, happening here in Maryland. And, we’ve been fielding questions about these stents, so this is as good a forum as any. So, a little discussion.

Continue reading "St. Joseph’s Stents: Device Defect or Medical Malpractice?" »

Back in June (Statistics, Part I), we reported on the U.S. Department of Justice’s Civil Justice Survey of State Courts, covering 2005 state court trials. Though official statistics have not been released by the DOJ for 2006 to 2009, a recent Bloomberg article, Jurors Turned Against Companies in 2009 Product-Defect Cases, analyzes last year’s product liability verdicts through the lens of the recession and general consumer distrust of Big Business.

The reporter, Margaret Cronin Fisk, notes the following for 2009 product liability lawsuits (which were not limited to just state courts):

• The top 5 product defect verdicts were 52% larger in 2009 (at $620 million), as compared to 2008
• The largest 2009 product defect verdict was for $300 million (Altria’s Philip Morris was the defendant in tobacco litigation)
• 5 of the 50 largest verdicts in 2009 were for defective products (compared to only 1 in 2008)
• In 200, 10 of the 50 largest verdicts were for defective products.

In 2005 state courts, there were 346 product liability trials, 28 of which were for drugs or medical devices. Excluding asbestos cases, plaintiffs won 19.6% of product liability trials in 2005. Also interesting, is that in 2005, 10.2% of all tort cases in Philadelphia were product cases (this is a trend that likely continues, in large part because of the hormone therapy cases). The only other county with a higher percentage was San Francisco, at 12.7%.

I’d love to get my hands on the raw data used by the DOJ—it would be interesting to compare the largest product liability verdicts from pre-recession 2005 with those reported by Bloomberg for 2009. That data must be on the internet somewhere…

Update: You can find more product liability statistics as of June, 2011 here.

On the last day of December, Plaintiff Merle Simon received a stunning present. The Superior Court of Pennsylvania (Pennsylvania’s first level appellate court) decided in Simon v. Wyeth Pharmaceuticals, et al. that the trial judges grant of judgment notwithstanding the verdict in 2007 was erroneous. The trial judge’s opinion was based on statute of limitations grounds and, alternatively, proximate causation. Here are the important dates:

Continue reading "Pennsylvania Appellate Court Overturns JNOV In Hormone Therapy Case" »

It’s going to be a great year. If one of your new year’s resolutions is to follow industry news more closely, here’s some required reading:

• Hormone Therapy: Bloomberg reports on the latest Plaintiff’s Prempro victory (actually, the drug at issue here was Provera, later combined with Premarin by Wyeth to make Prempro)—a Pennsylvania appeals court ruled that the trial court wrongly granted judgment for defendants, notwithstanding a jury verdict for Plaintiff. We’ll report more on this later in the week.
• Conflicts of Interest: The New York Times notes that two Harvard Hospitals (Massachusetts General and Brigham and Women’s) have issued new guidelines on outside pay for senior officials. They can now only accept a maximum of $5,000 per day of actual work—and no stock. Importantly, speaker’s fees from drug companies are prohibited for all employees. The momentum is good—let’s hope these attitudes spread.
• Res Ipsa Loquitur in a Medical Device case: We don’t usually agree with the Drug and Device Law blog, but we come as close as humanly possible in this situation—a federal judge in Connecticut dismissed a product defect case for orthopedic bone screws because (get this) plaintiff did not hire an expert. Maybe plaintiff could not find an expert (in which case, the case probably should not have been filed), or maybe the plaintiff could not afford an expert in a tentative case (in which case, you get what you ask for). This world is too complicated to do without experts.
• FDA Fails to Learn: MSNBC reports that the suggestions of congressional investigators following the Vioxx debacle have gone largely unheeded by the FDA. That report suggested that the FDA could better detect problem drugs by giving more decision-making power to scientists who monitor drug side effects following approval.
• More Drugs For “Neglected” Diseases: The FDA Law Blog comments about the rise in drug approvals for historically neglected diseases, including malaria, kinetoplastids, diarrheal diseases, roundworm, bacterial pneumonia and meningitis, and typhoid and paratyphoid fevera. Many of these disproportionately affect third-world countries, so we’re glad to see this advancing research.

Okay—now back to work!

We haven’t written much about the Digitek cases. I looked at them in the beginning (and they looked very promising) but in the end could not find any clients who actually had the legendary “double-dose” pill that was the root of all the evil. Certainly there were some patients who died and had blood tests revealing digoxin toxicity, but that’s still an uphill battle without compelling evidence to show the plaintiff took the pills as directed. The allegations are that, among patients with impaired renal function, digitek toxicity can cause nausea, vomiting, dizziness, low blood pressure, cardiac instability, bradycardia and death.

So, I cannot say that I know much about the status of these cases. One blog, MassTortDefense, commented today about the status of the MDL. Five bellweather trials have been selected for the federal litigation in the Southern District of West Virginia.

Any plaintiff lawyers out there want to comment on the state of the litigation, from their perspective? Do we believe plaintiffs have a shot on this one?

Bloomberg has a nice article on a 2007 case against Pfizer over its drug Prempro (the drug was manufactured by Wyeth, but Pfizer recently purchased Wyeth). The plaintiff in that Philadelphia state court case, Mary Daniel, took the drug for 16 months and argued that it caused her to develop breast cancer.

The jury in the Daniel case awarded $1.5 million in compensatory damages. Though the trial judge believed punitive damages were not warranted, the jury was allowed to deliberate on the issue in case the trial judge’s decision on punitive damages was overruled on appeal. According to the Bloomberg article, the jury awarded over $8 million in punitive damages. That number was sealed pending appeal; then, the trial judge died and new judge granted Pfizer a new trial on compensatory damages. That decision is also being appealed.

This recent news on the 2007 verdict fuels the outrage against Pfizer/Wyeth for the injuries it has caused. Pfizer continues to toe the Wyeth party line, claiming that 24 cases have been resolved in their favor by juries or judges. This overlooks the reality that six of nine jury verdicts have been for plaintiffs, and any plaintiffs’ victory indicates that the drug can reasonably be responsible for the injury; whereas a defense verdict only means that the drug did not cause injuries in a specific case.

Fresh from two record losses in Philadelphia state court over Prempro, Pfizer is reacting to plaintiffs’ lawyers posting of a video on YouTube. We uploaded a copy of that video in our November 24th blog post, and have embedded it below for your convenience.

Continue reading "Pfizer Recoils From Sunlight" »

News reports abound about the recent victories of two women in Philadelphia Court of Common Pleas over Wyeth Pharmaceuticals (now Pfizer). The two woman, Connie Barton and Donna Kendall, each took hormone therapy and, tragically, developed breast cancer. After long, hard battles with the cancer, they each had to have their breasts removed in a procedure known as a mastectomy (Ms. Barton had a single mastectomy, and Ms. Kendall had a double mastectomy).

For their injuries, the separate juries concluded that Pfizer owes $3.7 million and $6.3 million in compensatory damages to Ms. Barton and Ms. Kendall, respectively. Even more interesting is that the juries deliberated on the issue of punitive damages—damages meant to punish the defendant for their wanton and reckless conduct. The punitive damage awards were $75 million and $28 million, respectively. That brings Pfizer’s total obligation in these two cases to $113 million. And, as we’ve reported before, the plaintiffs deserve every penny and more.

There are more than 10,000 other hormone therapy cases pending around the country. As Ms. Kendall’s attorney, Tobias Millrood stated: “It’s not a responsible reaction to keep these woman on hold forever.” Unfortunately, Pfizer shows no indication of conceding defeat anytime soon.

Congratulations to the two plaintiffs, and the legal team that put their cases together. In particular, Tobi Millrood, the architect of the hormone therapy litigation, lead trial counsel in the Barton case, and dedicated representative of injured plaintiffs, has done an excellent job standing up for the rights of women injured by hormone therapy. As we continue to see in this age of corporate greed, the drug companies are content to place their profits over people. We need people like Tobi to stand up and fight the good fight.

The following news article details a little about the uphill battle faced by these courageous woman. It’s worth watching.

The United States Court of Appeals for the Eighth Circuit yesterday issued its opinion in Scroggin v. Wyeth, et al. The opinion is overwhelmingly positive for women and their families who have been injured by the hormone therapy. Donna Scroggins, like many women who took hormone therapy, suffered from breast cancer in both of her breasts and later had both of them removed.

In the underlying 2008 Arkansas trial, the jury found Defendants liable to the tune of $2.75 million in compensatory damages, and $27 million in punitive damages.

Continue reading "Next Step: Punitive Damages" »

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.