Drug Recall Lawyer Blog

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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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…

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.

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.

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.

For more on Seroquel, see:

• Miller & Zois’ Seroquel Website
• Drug Recall Lawyer Blog Entries on Seroquel
• YouTube Video on Seroquel

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.

Most lawyers do not know how to pronounce qui tam litigation, much less what it is. After this Pfizer settlement, there is going to be a lot more interest.

(Fun etiological note: it is an abbreviation of the Latin phrase “qui tam pro domino rege quam pro si ipso in hac parte sequitur,” meaning “who sues on behalf of the King as well as for himself”).

Black’s Dictionary defines it as “an action brought by an informer, under a statute which establishes a penalty for the commission or omission of a certain act, and provides that the same shall be recoverable in a civil action, part of the penalty to go to any person who will bring such action and the remainder to the state or some other institution.” BLACK’S LAW DICTIONARY 1251 (6th ed. 1990).

The suit was brought by five whistleblowers (who will share $102 million of the settlement). The federal criminal probe and civil qui tam lawsuit alleged that Pfizer improperly marketed 13 drugs, including Viagra, Zoloft, Lipitor and Bextra. New York’s attorney general said that “Pfizer's corrupt practices went so far as sending physicians on exotic junkets as well as wining and dining health care professionals to persuade them to prescribe the company's drugs for patients in taxpayer-funded programs.” These practices including overpromoting the drugs for off-label and unapproved uses, which is oftentimes how the drug companies turn a good drug into a blockbuster drug (see the Seroquel example: Foster Care Children and Off-Label Drug Use; Video on Seroquel).

The $2.3 billion fine is notable for a couple of reasons. First, it is the largest such fine ever levied in a United States criminal case. Second, this is the fourth time in ten years that Pfizer has been found guilty of improperly marketing their drugs. For a drug company to keep taking these hits, in addition to the cost of defending lawsuits and paying settlements and verdicts, it must be making money hand over fist. Something like that should bankrupt a company; however for Pfizer and other members of Big Pharma, this is simply the cost of doing business. The real cost, however, is the untold numbers of people and families who have been devastated by bad drugs. And, guaranteed that Pfizer gets another fine in the next couple of years. Clearly these fines are not big enough to be a significant deterrent.

Bausch & Lomb has entered into settlements with over 600 claimants over its ReNu with Moistureloc contact lens solution. In those cases, the allegations were that the solution could cause fusarium keratitis, a serious fungal eye infection. We discussed this in our previous blog, Bausch & Lomb Eye Fungus Cases.

In that blog, we also discussed that the judges (New York state judge Shirley Cornreich, and South Carolina federal judge David Norton) were tag-teaming the Daubert-Frye hearings to determine if Plaintiffs’ proposed experts could properly link ReNu with non-fusarium keratitis cases. In each case, Plaintiffs were dealt a blow when the judges ruled separately that the expert is restricted from testifying as to general causation between ReNu and non-fusarium keratitis cases. This means Plaintiffs cannot provide expert testimony that ReNu generally (we are not even talking about in a specific case) can cause these infections. According to the opinions, the Plaintiffs’ expert did not do any specific testing, and was not aware of any data that would suggest a link. Defendant’s expert, a physician at the Wilmer Eye Institute at Johns Hopkins (and, also a paid consultant of Bausch & Lomb since before the litigation) had a more persuasive argument. He put together a panel of experts early on, studied reports and articles, and noted that there was no acceptance in the scientific community that ReNu causes an increase in non-fusarium keratitis cases.

So, it looks like game over for plaintiffs. They tried to keep the litigation alive, but there just isn’t enough evidence of a connection.

Merck & Co. announced last week that they are settling third-party claims related to Vioxx. These are not the personal injury cases (cases by patients and their loved ones for heart attacks or other Vioxx injuries, most of which have already been settled for $4.85 billion), but rather these are lawsuits by unions and insurance companies against Merck, claiming that they overpaid for Vioxx in light of the drug’s risks.

The settlement, which has not been finalized but has been agreed to in principle, pays $80 million to settle 190 claims about the recalled drug. The document disclosing the settlement, Merck’s filing with the U.S. Securities and Exchange Commission, also revealed that the SEC’s formal probe of Merck surrounding Vioxx has ended. There are still outstanding third-party claims not involved in this settlement.

These third-party claims do not see a lot of play in the press. They are “faceless” claims by states, insurance companies, and other payers, none of whom suffer serious personal injuries. They are, however, becoming an invaluable component of drug litigation. It is one more hurdle for drug companies who put out dangerous drugs, and one more way to make sure the bottom line for defective or negligently marketed drugs is not as high as it otherwise would be. And, these are damages to taxpayers and members of insurance plans—one more reason we all have higher taxes and higher premiums.

Law firms are filing more fentanyl pain patch lawsuits—more and more of them are against Mylan Inc. and its subsidiary, Mylan Technologies Inc. Mylan patches are different from the usual pain patches because they are not reservoir based, but instead use a mesh matrix. Experts agree that the mesh matrix is much safer than the reservoirs, which are prone to leaking toxic amounts of the opiate drug. Right now, there have been reports of about 28 deaths possibly related to the Mylan matrix patches. Further investigation will reveal whether the products were defective.

See our Fentanyl Pain Patch page for more information.

Merck & Co. and Schering-Plough have agreed to settle class action lawsuits over their joint cholesterol drugs, Vytorin and Zetia, in the amount of $41.5 million. The settlements are with consumers as well as health plans that purchased the drugs.

The class action lawsuits were not for personal injury damages, but rather for economic damages. The lawsuits alleged that, contrary to manufacturer marketing, the drugs provided no medical benefit over cheaper and generic competitors. The lawsuits came on the heels of a January 14, 2008 study (the Enhance Trial) which revealed that Vytorin was not more effective at reducing carotid artery plaque. In fact, the study was hotly investigated by lawmakers—it seems the drug companies concluded the study in April, 2006, but continued to market their products inappropriately well after the data became available. Why let a little thing like drug effectiveness get in the way of sales?

The plaintiffs in those cases sought to recover reimbursement for the cost of the prescriptions, or the difference between these drugs and the generic alternatives. Of course, compare the settlement to the annual sales of Vytorin since it was first marketed in 2004, which reached $5 billion per year. Granted, that is not all profit, and perhaps there was no bad behavior until January 2008, but it looks like the drug makers win again. It would be refreshing to see them divest all profits from the drug from the time they had data showing that it was basically useless.

Not going to happen.