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.
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).
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)).
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.
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.
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.
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…
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:
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.
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.
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.
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.
Notes of sales calls between AstraZeneca and doctors have just been released by a federal judge overseeing the Seroquel MDL litigation in Orlando, Florida. Those notes show an AstraZeneca salesperson telling a United States doctor (the doctor’s name was redacted) that Seroquel did not cause diabetes. However, four years earlier, AstraZeneca sent a memo to Japanese doctors detailing that “causality with the drug could not be ruled out.” AstraZeneca warned Japanese doctors against prescribing Seroquel for patients with diabetes, and encouraged monitoring of blood-sugar levels.
It took two years before AstraZeneca gave their United States patients and doctors the same warning.
Another note revels one AstraZeneca sales representative telling doctors in November, 2005 that weight gain was atypical for Seroquel users. Company documents reveal that these sales reps were trained to deflect questions about weight gain—apparently, when they could not deflect the questions, they simply lied. The company knew at least as early as 1998 that “clinically significant weight gain, that is more than 7% increase in body weight, was seen with [Seroquel] than placebo.”
AstraZeneca’s behavior is outrageous. Warnings about known risks should be the same in Japan and the United States, regardless of each country’s drug regulations. The end goal should be to protect the health of patients and potential patients. But, AstraZeneca appears to have other motives when selling their products.
Remember Wyeth v. Levine, U.S. Supreme Court decision that held federal approval of labels drug warning labels does not preclude lawsuits under state law claiming inadequate warnings? Well, the government, through the FDA, has now added a final chapter to that story.
The drug at issue in Wyeth v. Levine was Phenergen, an antihistamine. The drug was administered using a method known as an “IV push,” however the drug was inadvertently injected into Dina Levine’s artery. She developed gangrene, the arm had to be amputated (Diana Levine is a musician, and the tragedy of her injury is simply incomprehensible. See John Bratt’s blog post).
The label originally warned that the IV push method could lead to inadvertent injection into arteries, but the label did not expressly forbid that procedure. Now, after the conclusion of the Wyeth case, the FDA has allowed the Court’s decision to lead the way, and has amended the label to include a black box warning: “due to the risks of intravenous injection, the preferred route of administration is deep muscular injection and that subcutaneous injection is contraindicated.”
Can anyone doubt that if Wyeth was truly concerned with patient safety, it would provide full warnings as soon as possible? Unfortunately, it seems as though the almighty dollar is the reason for holding back on warnings, with the fear that fewer patients will take drugs when the risks are appropriately disclosed. It is a game of “hide the ball.” The results: ask Diana Levine’s.
Judge Nancy Gertner of the United States District Court of Massachusetts ruled for Plaintiffs, finding that e-mails about birth defects between GlaxoSmithKline (the Paxil manufacturer) and researchers. The plaintiffs believe that these e-mails will show that GlaxoSmithKline attempted to influence the results of those studies, and in fact recommended changes that were made to the final paper. Though the researchers have denied being influenced by GlaxoSmithKline, plaintiffs will be able to probe the relationship and, perhaps, place it before a jury to decide.
The plaintiffs contend that William Seale’s mother took the antidepressant Paxil while she pregnant, and that the drug caused the one-year old to die of heart defects.
There are approximately 600 Paxil cases pending. The first suit is being tried now in Philadelphia state court, where opening statements have just begun.
Sean Wajert of the 
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Two contrasting Accutane lawsuit updates in the news today:
Back in June (
