Mass Tort Litigation Blog

Paxil Verdict

Bad news for Glaxo.  The first trial involving claims that the antidepressant Paxil causes birth defects ended with a $2.5 million jury verdict for the plaintiff.  The family of Lyam Kilker sued GlaxoSmithKline in Philadelphia Common Pleas Court, blaming the boy's heart defect on his mother's ingestion of Paxil during pregnancy.  The jury, by a 10-2 vote, concluded that Glaxo negligently failed to warn of the risk and that Paxil caused the child's heart condition.  While the jury awarded notably large compensatory damages (the family sought $1.2 million), it rejected punitive damages by deciding that the defendant's conduct was not "outrageous."  The case is Kilker v. SmithKline Beecham Corp. dba GlaxoSmithKline.  Here are links to reports at Philadelphia Inquirer, Pharmalot, Point of Law, and Law.com.

In addition to about 600 cases involving claims that Paxil causes birth defects, Glaxo has faced claims that Paxil increases the risk of suicide and homicide.  The company has reportedly settled some suicide claims, and in 2001 a Wyoming jury rendered a $6.4 million verdict against Glaxo in a case involving a man who shot his family and himself after taking Paxil.

HME

Zicam MDL

The Zicam MDL has been centralized in the District of Arizona before the Hon. Frederick J. Martone.  The order can be found here.  Hat tip: Torts Prof Blog. 

ADL

Yaz Litigation

The FDA recently sent a warning letter to Bayer, which manufacturers Yaz and Yasmin (both types of birth control pills), that it has quality control problems at its German plant.  The FDA claims that Bayer's testing method averaged out the test results as opposed to reporting results for each batch.  Bayer had the batches shipped to the U.S. between 2007 and 2009.  

This news is simply the most recent concern about Yaz.  Litigation is already pending in Pennsylvania in front of Judge Sandra Mazer Moss of the Philadelphia Court of Common Pleas, alleging that the drug causes severe side effects including blood clots, strokes, heart attacks, gallbladder disease, deep vein thrombosis, pulmonary embolisms and even sudden death.  There has been some speculation around the internet that the FDA will recall the drug.  As the U.S. Recall News reports:

"In July 24, 2009, a petition was filed to consolidate the many lawsuits against Bayer over Yaz and Yasmin into a multidistrict litigation (MDL). There is a hearing scheduled for September 24, 2009 to decide whether or not they will be consolidated." 

"Andrew Gillin, an attorney handling several California Yaz lawsuits says the litigation is still in the early stages. “A petition has been filed to combine all of the federal lawsuits into a multi-district litigation (MDL) case. Later this month, a panel of federal judges will determine whether the cases involve sufficiently common questions of fact, and whether or not to consolidate,” explained Mr. Gillin."

ECB

Fosamax Mistrial

Judge John Keenan declared a mistrial today in Boles v. Merck, the first bellwether trial in the Fosamax litigation.  As we mentioned yesterday and the day before, tensions have run high in the jury room.  Here's an excerpt from the Wall Street Journal's report:

A judge declared a mistrial Friday in a closely watched case involving Merck & Co.'s osteoporosis drug Fosamax after a jury failed to reach a verdict amid tense jury deliberations.  The mistrial came two days after U.S. District Judge John F. Keenan in Manhattan called for a daylong "cooling off" period as one juror claimed in a note to have been the subject of physical threats and that a chair was thrown in the jury room.  The judge declared a mistrial Friday after the jury's forewoman indicated the jury remained deadlocked and a lawyer for Shirley Boles, a 71-year-old Florida woman who sued Merck, again asked for a mistrial.

According to Merck's lawyer, the jury appeared to be "seven-to-one in Merck's favor."  The natural tendency of litigators to put favorable spin on a mistrial might make one skeptical of such an assertion, but it's noteworthy that the plaintiff's lawyer pushed hard for the mistrial while Merck opposed the mistrial motion.

The WSJ report mentioned that a conference has been scheduled for October and the plaintiff's lawyer said he expects a retrial in the spring.

The next two trials are scheduled for Dec. 1, 2009 and Jan. 11, 2010.

HME

Update:  here's a link to the New York Times article, which contains a multimedia link to the juror's notes and the request for a new trial.

ECB

Fosamax Jury Update

CNN reports this morning that Judge Keenan has "called for a daylong 'cooling off' period" in the Fosamax (an osteoporosis drug) litigation.  Apparently jury deliberations became quite tense; the jurors have been deliberating for the last week over Shirley Boles's case.  Boles is a 71-year old retired deputy sheriff that lives in Ft. Walton Beach, Florida.  She claims that Fosamax caused her jawbone tissue to die.  By itself, the case is relatively small.  But, because Schering-Plough is looking to merge with Merck, all eyes are on the jury to see how vulnerable Merck is financially.  According to the New York Times, there are roughly 900 state and federal Fosamax cases with around 1,280 plaintiffs.

One of the jurors in Boles's case claimed that she was being both intimidated and threatened.  Judge Keenan has given the jury until 11:15 a.m. on Friday (tomorrow) to reach a decision before declaring a mistrial.

ECB

Fosamax Update: Boles Jury Struggling; Summary Judgment Rejection

Two news items from the Fosamax front, one involving jury deliberations in the Boles trial, the other involving Merck's effort to win summary judgment in 24 other cases.  The Fosamax litigation involves about one thousand plaintiffs' claims against Merck alleging that its popular osteoporosis drug caused necrosis of the jaw.  Most of the litigation is in federal court, where Judge John Keenan of the SDNY is overseeing the MDL.

BOLES:  In the first bellwether trial, Shirley Boles v. Merck, the jury has so far been unable to reach a verdict.  The trial began on August 11, and the jury got the case on September 2.  According to this Bloomberg report, the jury informed the judge that it was unable to reach a decision, and the judge yesterday told the jury to keep working:

A federal judge instructed a jury to continue deliberating whether Merck & Co.'s osteoporosis drug Fosamax caused a Florida woman’s “jaw death,” after the panel told the judge it couldn’t decide.

U.S. District Judge John Keenan in Manhattan told the jurors to keep working today. He explained that the case is important to both the plaintiff and Merck.

“It’s very stressful to sit here and an agreement cannot be reached,” a juror wrote in one of four notes to Keenan today about the lack of unanimity among the eight-member panel. “I feel that we never will reach a verdict because everyone has a different opinion.”

SUMMARY JUDGMENT:  According to a Reuters report, Judge Keenan decided today that he would permit testimony by two plaintiff experts concerning causation based on relatively short-term exposure, and the court therefore rejected Merck's motion for summary judgment in 24 Fosamax cases:

In an opinion released Wednesday, U.S. District Judge John Keenan ruled that the plaintiffs could introduce testimony by two doctors to show that the drug can cause jaw damage after less than three years of continuous use.  Keenan said the evidence is sufficiently reliable to allow a rational jury to establish such a connection. He said individual plaintiffs will then be allowed to present expert testimony that Fosamax caused them to suffer such damage, and that such testimony could by itself "make causation a genuine issue of fact for trial."

HME

Richard Epstein on Consumer Regulation

In his July 14 Forbes column, Vanguard or Rearguard?, Richard Epstein (Chicago & NYU) recounts the history of the FDA, as well as other regulatory frameworks, and concludes that "[r]egulatory failure is, on average, a far greater risk than market failure."

BGS

Viagra MDL Judge Rejects Plaintiff Expert Testimony Under Daubert

A detailed analysis (with rejoicing) from Drug and Device Law.  The opinion details deficiencies in the plaintiff expert's previously peer-reviewed and published study.  

For a past article of mine that set forth problems in the main study underlying the opinions of plaintiffs' experts in the phenylpropanolamine (PPA) litigation, see here. 

BGS

First Circuit Decision on Federal Claims Act

FDA Law Blog analyzes the decision in United States ex rel Duxbury v. Ortho Biotech Products.

BGS

Richard Epstein on Preemption and the Medical Device Safety Act

Richard Epstein (Chicago & NYU) discusses them both in his recent Forbes column.

BGS

First Fosamax Trial Against Merck Begins Today

Am Law Daily's Priti Patnaik writes about the Boles case:

Starting Tuesday, pharma giant Merck & Co., Inc. faces the first trial over its osteoporosis drug Fosamax. More than 900 such lawsuits have been filed by more than 1,200 plaintiffs in state and federal courts. The suits claim that doctors were not warned that the drug may hamper blood flow to the jaw, causing jawbone-tissue death--osteonecrosis of the jaw, or ONJ. In some cases, ONJ leads to partial removal of the jaw.

Plaintiff Shirley Boles, 71, is represented by partner Timothy O'Brien and associates Meghan Tans and Ned McWilliams of Levin, Papantonio, Thomas, Mitchell, Echsner & Proctor. Michelle Parfitt and James Green at Ashcraft & Gerel are also working on the case.

Merck's trial team includes Paul Strain of Venable in Baltimore and Christy Jones of Butler, Snow, O'Mara, Steves & Cannada. Both represented Merck in the marathon Vioxx litigation. The company declined to name the other attorneys working on the case, saying that the information was part of its litigation strategy.

Interestingly, Judge Keenan has ruled that no punitive damages may be sought.

BGS

Vytorin and Zetia Settlement

The New York Times reported yesterday that Merck and Schering-Plough have agreed to pay $41.5 million to settle class claims that they withheld the results of an unfavorable clinical trial.  The clinical trial apparently linked Vytorin and Zetia to harmful side effects that included cancer.  Of course, this news comes as both companies are in merger talks, which would make Merck the second largest pharmaceutical company in the world.  The New York Times article is available here.

ECB

First Fosamax Trial to Begin Next Week

The first Fosamax trial is set to begin Tuesday in federal court in New York. Merck is facing about 850 lawsuits alleging that Fosamax, a widely used osteoporosis drug, increases the risk of osteonecrosis of the jaw (ONJ). Most of the cases have been transferred to multidistrict litigation before Judge John Keenan in the Southern District of New York. Over 100 other cases are pending before Judge Carol Higbee (who oversaw much of the Vioxx litigation) in New Jersey Superior Court.  In the MDL, Judge Keenan has scheduled three cases to go forward as bellwether trials.  Plaintiff Shirley Boles is set for August 11, Bessie Fleming for Dec. 1, 2009, and Karen Greene for Jan. 11, 2010.

Last week, according to a Bloomberg news report, Judge Keenan rejected Merck's motion for summary judgment on Boles' compensatory damages claims but he granted the motion as to punitive damages, so the Boles trial will go forward solely on compensatory damages.

Since this is the first trial in the Fosamax mass tort litigation, lawyers involved in Fosamax cases undoubtedly will be paying close attention both to see the other side's trial strategy and to see how a jury responds to the evidence.

Here are links to a Bloomberg report on the upcoming trial and the court's rejection of punitive damages, entries of July 24 and July 31 on AboutLawsuits.com, and a statement released last week by Merck putting its own spin on Fosamax and ONJ.

HME

First Neurontin Trial: Mark Lanier for Plaintiffs, and Mark Cheffo and William Ohlemeyer for Pfizer

Article in Am Law Litigation Daily -- Mark Lanier Work His Magic in 'Very Tough' Neurontin Test Trial?, by Ben Hallman.  Mark Cheffo (Skadden) and William Ohlemeyer (Boies Schiller) will represent Pfizer.  Here's an excerpt:

Mark Lanier told the Litigation Daily on Friday that he's not expecting any miracles Monday, when he begins the first trial to test claims that Pfizer's antiepilepsy drug Neurontin increases patients' risk of suicide. He'll be lucky, he said, to eke out a win. "I've got a near-impossible case," Lanier told us. "If I lose, it's almost like a focus group educational experiment. If I win, it portends bad things for Pfizer."

The case, the first of some 1,200 Neurontin suits in the pipeline, was brought by the family of Susan Bulger, a 39-year-old who took the drug before hanging herself in 2004. The suit, in federal district court in Boston, claims Bulger was taking Neurontin to treat epilepsy, as well as mood swings and arthritis pain (for which the drug was not approved but was allegedly marketed). "Our argument is that the drug company took advantage of fragile and unfortunately situated [patients] by marketing a drug illegally," Lanier said. "They made Neurontin a snake oil to treat everything, when the FDA had not approved the drug for much of anything." (Sounds like Lanier was trying out his opening statement on us!)

UPDATE -- Here's a separate link to the detailed related article in Bloomberg -- Pfizer Faces First Trial on Neurontin Suicide Claim, by Margaret Cronin Fisk, Jef Feeley and Cary O’Reilly.

BGS

The Advance and Retreat of Pre-emption

Was going through some old issues of the ABA Journal and found this interesting article from the May issue -- Business Downturn: As the market tumbles, so does the corporate pre-emption defense, by David G. Savage.  Here's an excerpt:

For much of the decade, business lawyers and the Bush administration insisted state liability laws and state regulation amounted to a costly nuisance and a drag on the economy. They said uniform national regulation of business made more sense, and they urged the Supreme Court to limit lawsuits and to pre-empt state regulations.

For years those arguments were winners. Last year, Riegel v. Medtronic barred most lawsuits against the makers of medical devices. Lawyers for the Bush administration and device makers said state jurors should not be permitted to second-guess Food and Drug Administration regulators once they have approved a device as safe and effective.

BGS

Federal Court in NJ Dismisses Off-Label-Marketing Suit Against Schering-Plough

Article in AmLaw Litigation Daily -- Schering-Plough Wins Dismissal of 'Off-Label' Suit, by Ben Hallman.  Here's an excerpt:

A recent decision by a New Jersey federal court sets a tough standard for plaintiffs trying to piggyback on government investigations of off-label drug marketing. In dismissing a lawsuit against Schering-Plough, federal district court judge Stanley Chesler ruled that even if the company has violated off-label marketing rules--as it seems to have done for two cancer drugs--plaintiffs must prove that the drug was marketed for an ineffective use, and that the patient received no benefit from it.

And here's a link to the opinion by Judge Chesler.

BGS

Robert Rabin on Conflicting Conceptions of Tort Preemption

Professor Robert Rabin (Stanford) has posted on SSRN his article, Territorial Claims in the Domain of Accident Law: Conflicting Conceptions of Tort Preemption, Brook. L. Rev. (forthcoming 2009).  Here's the abstract:

Beginning in 1992, with the landmark decision in Cipollone v. Liggett Group, Inc., the U.S. Supreme Court has decided a burgeoning number of preemption cases, squarely challenging the continuing vitality of tort in many domains of accident law. Cipollone addressed the preemption question in an atypical context. The case did not involve competing claims to territorial authority between a regulatory regime and state tort law. Rather, Cipollone involved a challenge to the continuing viability of tort in the face of statutory directives mandating explicit industry conduct; more specifically, the explicit warnings required in the 1969 version of the cigarette labeling act.

In this article, I begin by revisiting Cipollone to reassess what it has to offer as a foundation for setting the boundaries of regulatory containment of the tort system. Next, I discuss three leading cases from the series of efforts by the Supreme Court to grapple with express preemption clauses in a variety of regulatory schemes. Against this backdrop, I then explore the circumstances under which it might be justified to imply preemption despite the absence of an express provision, with particular reference to the recent Supreme Court decision in Wyeth v. Levine, addressing preemption in the context of FDA regulation of prescription drugs. A concluding note ties the strands together.

BGS

Douglas Smith on Preemption After Wyeth v. Levine

Douglas Smith (Kirkland & Ellis) has posted on SSRN his article, Preemption After Wyeth v. Levine, Ohio St. L.J. (forthcoming 2009).  Here's the abstract:

This Article addresses the Supreme Court’s recent preemption decision in Wyeth v. Levine. In Wyeth, the Court held that the Food and Drug Act did not preempt a state law tort suit alleging that the labeling for an anti-nausea medication, Phenergan, failed to adequately warn about the risks associated with IV-push administration of the drug. Already, Wyeth has been interpreted by some as sounding the death knell for the preemption doctrine in the context of pharmaceutical products. However, a careful analysis of the Court’s decision indicates that this is far from the case. The majority underscored that its decision was a 'narrow' one based largely on the facts and circumstances before it. In particular, the Court made a point of noting that the record was devoid of evidence that the particular risks at issue had actually been considered by the FDA and that the defendant had thus failed to show that there was an actual conflict between FDA regulation and the state law tort suit. The majority’s analysis therefore suggests that state law tort suits based on an alleged failure to warn are preempted in cases in which the FDA has specifically considered the particular risks at issue and has determined that the pharmaceutical product’s labeling adequately warns of those risks. I argue that the ruling thus construed has significant benefits. As the Court has repeatedly recognized, there is an inherent tension between the congressional establishment of a federal regulatory regime for the labeling of pharmaceuticals and medical devices by experts at the FDA and allowing a jury of ordinary citizens with no specialized expertise to render their own judgment regarding, and in effect overrule, such expert determinations. As several members of the Court have noted, there is a potential danger in allowing these expert decisions to be undermined by state court juries. Moreover, such an outcome may have undesirable indirect effects, such as raising the prices of pharmaceutical products to satisfy state court judgments that are not warranted based on the best available scientific evidence and the potential confusion and inconsistency that may result with juries in fifty-two separate jurisdictions imposing different standards concerning what constitutes appropriate labeling. The Court’s decision properly balances these competing considerations.

BGS

Roche Pulls Accutane Off the Market

Roche notified the FDA today that it was pulling Acctane (an acne medicine) off the market.  The company faces at least $33 million damage award from jury trials and faces around 5,000 personal injury claims.  Michael Hook (an FSU grad who graciously spoke to my complex litigation class this past spring about the litigation) won a $10.5 million claim against Roche in April of 2008 is quoted as saying, "We've been winning the cases with the drug still on the market, but this move certainly isn't going to hurt us going forward."  Roche has already taken Accutane off the market in roughly 11 other countries.  For more information, here's a link to Bloomberg's report and to the Associated Press article.  

ECB

NIH Study Questions Benefits of Stents and Diabetes Drugs Avandia and Actos

Article in the Wall Street Journal -- Diabetes Study Questions Expensive Treatments: NIH Finds Patients With Heart Disease Fare Equally Well Without Stents and Drugs Such as Avandia, Actos, by Keith J. Winstein.  Here's an excerpt:

Aggressive use of expensive diabetes drugs and medical devices called stents did no better than cheaper treatments at preventing deaths, heart attacks or strokes in a large study of diabetics with heart disease.

The study, sponsored by the National Institutes of Health and several drugmakers, is the latest to humble fancy new treatments by finding them no better than older medicines at preventing the deadly consequences of major diseases. The results add to a debate about alleged overuse of stents, made by companies including Abbott Laboratories, Boston Scientific Corp. and Johnson & Johnson, and controversial diabetes drugs from GlaxoSmithKline PLC and Takeda Pharmaceutical Co.

BGS