Monday, November 8, 2010

U.S. Supreme Court Ruling Will Have Ripple Effect on Cases Alleging Vaccine-Autism Link

The United States Supreme Court heard arguments recently in a case that is expected to have significant implications for hundreds of pending lawsuits against vaccine makers. In these suits, various plaintiffs contend there is a link between childhood vaccines and autism. While the case presently before the Supreme Court does not involve a claim that autism was caused by a childhood vaccination, a recent article in The New York Times states that approximately 75 percent of similar claims do involve the disorder. This alleged association has been a hot-button issue for years, as repeated scientific studies have found no connection between vaccines and autism.

SCOTUSblog has previously set forth the particulars of this case, which is styled Bruesewitz v. Wyeth, Inc., 561 F.3d 233 (3rd Cir. 2009) (see the Third Circuit Court of Appeals’ order here, from which Plaintiffs appealed). Essentially, the case calls into question whether the National Childhood Vaccine Injury Act (NCVIA) should protect manufacturers from virtually all product liability lawsuits. The NCVIA, established by Congress in 1986, provides that vaccine manufacturers cannot be sued for injuries from vaccines if the injuries resulted from side effects that were “unavoidable.” Elsewhere in the Act, Congress also created an administrative process known as the “Vaccine Court,” which was designed to provide money to children injured by vaccines. Accordingly, the law would preempt such claims in state court. This was critical, Congress believed, because vaccine manufacturers otherwise might have gone bankrupt due to judgments against them and would be unable to make vaccines critical to public health.

Hannah Bruesewitz, the plaintiff in the present case, is an 18-year-old woman who suffered seizures when she was six months old and subsequently suffered developmental problems, according to her parents, after receiving a type of D.T.P. vaccine that is no longer sold. Bruesewitz’s parents initially brought a claim on her behalf in Vaccine Court, but the severe injuries she reported had been removed from the list of those that qualified for compensation. Her claim was thus rejected, and her parents subsequently filed a product liability lawsuit against Wyeth. Lower courts ruled that her claims were barred by the Vaccine Act.

The parties disagree about the meaning of the statutory language of the Vaccine Act. The plaintiffs argue that if the vaccine could have been manufactured in a safer way, Hannah Bruesewitz’s injury was not “unavoidable.” They have argued that the manufacturer knew at the time their daughter was immunized that there was a safer version of D.T.P. vaccine but did not produce it. According to The New York Times, Bruesewitz’s father has said that he and his wife are not opposed to vaccines, but they have pressed their daughter’s claim because they believe vaccine manufacturers needed to face the threat of litigation to produce safer medications.

Wyeth, for its part, argued that the only types of claims that are not preempted are those alleging manufacturing defects or a failure to warn. A number of Amicus Briefs were filed in support of each party. Those arguing that Congress intended to bar such claims were filed by the solicitor general of the United States, the Chamber of Commerce, and several professional medical groups including the American Academy of Pediatrics. This case certainly will be one to watch. It likely will have huge implications both as to a number of lawsuits filed and to be filed, and within the drug manufacturing industry in general. This case before the Supreme Court has become a true battle of the experts, with constitutional law heavy-hitters weighing in on both sides of the issue.

The debate regarding the alleged vaccine-autism link is sure to rage on. In spite of the numerous scientific studies showing no such causal link, CNN reports that one in four parents is concerned that vaccines cause autism. The report points out that parents simply are refusing to have their children vaccinated due to unreasonable fears, which can cause a resurgence of preventable diseases.
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Monday, October 25, 2010

Judgment in Favor of Zyprexa Manufacturer Upheld in at least Two Matters

On October 4, 2010, Second Circuit Judges, John M. Walker, Jr., Jose A. Cabranes, and Chester J. Straub, upheld the decisions of the Eastern District Court of New York in two lawsuits filed against Eli Lilly & Company, manufacturer of Zyprexa. Belcher v. Eli Lilly & Co., No. 09-5004-CV, 2010 WL 3853003 (2d Cir. Oct. 4, 2010) and Gove v. Eli Lilly & Co., No. 10-216-CV, 2010 WL 3852840 (2d Cir. Oct. 4, 2010). Lawsuits against Eli Lilly & Company (“Eli Lilly”) began to be filed around the country by plaintiffs alleging that its anti-psychotic medication, Zyprexa, caused them to suffer from diabetes. Plaintiffs asserted that if Eli Lilly had properly warned of the drug’s dangers, they would have never been prescribed the drug and not developed diabetes. These similar lawsuits around the country were transferred to the Eastern District of New York pursuant to an order of the Judicial Panel on Multidistrict Litigation. The Belcher and Gove matters discussed here were both decided in favor of Eli Lilly on motions for summary judgment. Thereafter, these appeals were filed.

The Belcher matter was decided in favor of Eli Lilly solely on the ground that her claim was barred by the statute of limitations. Applying California’s discovery rule and its two year statute of limitations for product liability and personal injury actions, the Second Circuit upheld the decision of the Eastern District Court of New York. California was the applicable law since the matter was filed in California and the events giving rise the action occurred there. The Second Circuit found that the statute of limitations began to run in October 2001 when a physician who knew the association between the drug and increased weight gain and blood glucose levels prescribed Zyprexa. Her claim was barred as it was filed in February 2006. The decision of the District Court dismissing the action was upheld.

The Gove matter was also decided in favor of Eli Lilly on the ground that her claim was barred the by the statute of limitations as well as on the ground that Gove had failed to establish that Eli Lilly’s failure to warn was the proximate cause of her injuries. The Second Circuit upheld the District Court’s decision merely on the ground that Gove failed to establish proximate cause. The applicable law in this matter was Arizona’s substantive law because this matter was filed in Arizona and the events giving rise the action occurred there. The Second Circuit found that Arizona recognized the learned intermediary doctrine but applied the “heeding presumption” by shifting the burden of production to the manufacturer. If the manufacturer meets this burden, the burden shifts to plaintiff to show proximate cause. Applying these principles, the Second Circuit found Eli Lilly’s presumption satisfied by evidence that Gove’s nurse practitioner that prescribed the drug testified that an alternative warning would not have affected her prescribing habits. Further, because Gove’s practitioners were aware of the risks and would not have changed their treatment decisions, the Second Circuit found that Gove failed to establish proximate cause. The Court upheld the decision of the District Court.
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Thursday, October 7, 2010

A View of the Prempro Litigation from a Different Angle

In the midst of the ongoing, far-reaching Prempro litigation apparently sits a very colorful judge. Businessweek recently published this article, which takes a in-depth look at 70-year-old U.S. District Judge Bill Wilson of Little Rock, Arkansas, who presides over the MDL Prempro litigation.

As we previously reported here, more than 8,000 lawsuits have been filed against Pfizer’s Wyeth unit by former users of the company’s hormone-replacement pills, which are used to treatment menopause symptoms including hot flashes, night sweats, and mood swings. Plaintiffs have alleged that the drug causes breast cancer and other injuries, and that the drugmaker failed to properly warn of these risks.

Judge Wilson refused to consolidate the Prempro cases into a class action based on his conclusion that the suits did not have enough in common to justify proceeding as a group. The outcomes of these cases seem to confirm his conclusion. Jury verdicts in these cases have varied widely, with some juries holding that the drug played no part in Plaintiffs’ development of breast cancer, and others rendering verdicts for tens of millions of dollars. As reported by Businessweek, Pfizer’s Wyeth unit has lost seven of the 12 Prempro cases decided by juries since litigation began in 2006, although the drugmaker did succeed in having some of those verdicts thrown out at the post-trial stage or in having awards reduced.

According to the article, Judge Wilson, who presides over his courtroom from a rocking chair, relaxes during his time away from the bench by corralling his prize Tennessee walking mules on his 15-acre farm. A sign on the door of his barn reads: “The more I see of people, the more I prefer mules.” Businessweek reports that at one 2005 hearing, Judge Wilson asked the lawyers what year it was that Hank Williams died. When they couldn’t answer, he launched into a 210-word explanation, on the record, of the circumstances of the singer’s death and his blue 1952 Cadillac.

Judge Wilson, named to the bench by President Clinton in 1993, cemented his spot as Above the Law‘s “Judge of the Day” with a blunt letter he once wrote to a plaintiff’s counsel in 2008. See a copy of his letter here.

As Judge Wilson works his way through some of the thousands of Prempro lawsuits seeking damages from Pfizer, at least he’s sure to keep things interesting.
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Thursday, September 30, 2010

Diabetes Drug Avandia to be Severely Restricted in U.S., Unavailable in Europe

In a highly anticipated decision, the widely used diabetes medication Avandia will be pulled from the market entirely in Europe and will now only be available in the United States under tough new restrictions, according to a recent article in The Washington Post. As we previously reported here, the Avandia debate has been a longstanding, contentious issue regarding the pharmaceutical industry and the U.S. Food and Drug Administration’s ability to police its safety. The issue, for years, has been the drug’s potential to increase users’ risks for cardiovascular problems, as there were conflicting reports and studies on the issue.

In our previous post on this issue, we reported that the FDA had said in a February 2010 safety announcement that it would continue to examine studies and data on Avandia health issues before it would take any action with regard to the drug. Since February, according to The Washington Post, both the FDA and European Medicines Agency have concluded that the risk that Avandia could cause heart attacks and strokes outweighs the drug’s benefits for most patients. This decision will have a significant impact–approximately 600,000 diabetics in the United States currently take Avandia.

Starting within the next few months, the drug will be unavailable in Europe. The European agency did, however, stop short of taking the most drastic measure of completely revoking the drug’s approval. Rather, European officials have recommended only suspending the approval, leaving open the option of reinstating the drug if further data on the issue emerge. In the United States, patients will be allowed to take Avandia only if they are not able to control their blood sugar with other medications. As such, doctors who prescribe Avandia will have to justify their decisions to do so. Additionally, patients who want to continue their use of the drug will be required to sign statements indicating that the understand the associated risks. Use of the drug in the U.S. is expected to decline significantly.

According to The Washington Post, the “unusual” coordinated announcement by the U.S. and European drug agencies is representative of the more collaborative relationship between the agencies that has been in place since the 2003 globalization of the pharmaceutical industry. The two coordinated their announcements to attempt to avoid confusion among patients.

Although this announcement stopped short of a total withdrawal of the drug from the U.S. market, it certainly is not good news for its manufacturer, GlaxoSmithKline. The company reportedly already faced approximately 13,000 lawsuits from plaintiffs who alleged that the maker failed to warn patients of heart attack risks. Although GlaxoSmithKline announced this summer that it had reached settlements in approximately 10,000 of those suits, more are sure to follow on the heels of this announcement.
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Wednesday, September 1, 2010

Sixth Circuit Allows State Law Negligence Claims

Last year, the Supreme Court decided Wyeth v. Levine [PDF], stating that Congress, through the FDCA, did not intend to preempt state law failure to warn claims. The Sixth Circuit extended Levine in Wimbush v. Wyeth, No.09-3380, 2010 WL 3256029 (6th Cir. Aug. 18, 2010) [PDF], and reasoned that a plaintiff could pursue negligence claims relating to a manufacturer’s decision to bring a drug to market, i.e., a pre-labeling, pre-approval claim.

Mary Buchanan, the Plaintiff’s decedent, developed primary pulmonary hypertension, allegedly caused by her ingestion of Redux, a weight-control drug pulled from the market in 1997. The pulmonary hypertension was the alleged cause of death. It’s unlikely, at least in Ohio, that there would be many more claims like the plaintiff’s. Ohio statutory law would now preempt any negligence claims based on products liability, but Buchanan filed her claim before the statute became effective. Therefore, Wimbush brings us into a strange scenario where, although the drug manufacturer can successfully defend the failure to warn claim, there are other state law claims that are not preempted and allowed by state tort law.

After explaining why the state law negligence claim would be allowed under state law, the Sixth Circuit reversed the district court’s grant of summary judgment in favor of Wyeth. The Court, leaning heavily on Levine, noted that Congress had never enacted an express preemption provision throughout the 70-year history of the FDCA. In light of the history of the scheme, there could be no preemption of state law claims, express or implied. Nevertheless, the Sixth Circuit acknowledged that its decision was breaking new ground:

Finally, we are aware of no federal appeals court decision since Levine concluding that FDA regulation preempts any aspect of state tort law, though we admit that, until today, there is also no post-Levine court of appeals authority for the proposition that the Levine rationale extends beyond the realm of failure-to-warn claims to apply to all pre-approval state law claims.

Wimbush may be used to open a door in other jurisdictions to allow other state law negligence claims in jurisdictions where the standards, statutes of limitations, or venire may be plaintiff-oriented. Look for plaintiffs’ attorneys to test the state law waters with inventive tort actions. I’m sure that there are all manner of pre-approval state law claims that are about to be manufactured.
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Tuesday, August 17, 2010

Products Liability: Celebrity Edition

In a post reminiscent of Us Weekly‘s “Stars: They’re Just Like Us” section, which offers photographs of celebrities doing inane things that “everyday people do,” (beautiful, famous people have to pump their own gas, too!), we’ll take a quick look at some of the many recent instances where celebrities have made headlines for products liability-themed events.

Right here in South Carolina in 2008, celebrities DJ AM and Blink 182’s Travis Barker were among six people aboard a Learjet that crashed during takeoff in Columbia. The four others on board were killed. Both Barker and DJ AM subsequently filed suit against the airline and the maker of the tires used on the aircraft, alleging that both were defective. One year later, in a very celebrity-like turn of events, DJ AM died from a drug overdose, whereupon his mother took over his $20 million lawsuit and amended it to include a wrongful death claim. She alleged that the crash ultimately led to DJ AM’s drug overdose and death. Both of those suits reportedly settled for undisclosed amounts.

In 2007, actor Dennis Quaid and his wife took their newborn twins for treatment of a staph infection at Cedars-Sinai Hospital in Los Angeles, where they were administered 1,000 times the prescribed dose of blood-thinning drug heparin. The twins eventually recovered, and Quaid subsequently filed suit against Baxter Healthcare Corporation, maker of the drug, alleging that the company did not sufficiently differentiate its packaging. Quaid’s children were supposed to receive a 10-unit dose of a diluted version of heparin, but instead mistakenly received 10,000 units of the undiluted drug. The lawsuit set forth that the bottles shared similar labels and a common shape. The couple’s suit was not about money, they said, but was an attempt to ensure no other parents endured the same experience.

Finally, as we previously reported here, Israel-based Teva Pharmaceutical Industries recently announced it would stop production of its widely used sedative propofol, after two headline-grabbing events issued blows to both its image and its financial well being. One of those events that garnered the most attention of the press was the death of Michael Jackson. The drug became infamous after the superstar died from an overdose of the sedative, in combination with other sedatives, which were administered by Jackson’s personal physician. As previously reported, although no product liability suit has yet arisen, Jackson’s devoted fans followed the Teva announcement closely in fanpages devoted to the star.

In the products liability arena, celebrities are, it seems, just like us. Except, perhaps, for accidental drug overdoses administered by a live-in, personal physician.
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Monday, August 16, 2010

Failure to Survey Medical Literature may be Negligence Per Se

One issue in a recent decision by the District Court of New Hampshire was whether a generic manufacturer’s failure to comply with Food an Drug Administration (“FDA”) regulations constitutes a per se violation of its duty of care under New Hampshire law. Bartlett v. Mutual Pharm. Co., No. 08-CV-358-JL, 2010 WL 2765358 (D.N.H. Jul. 12, 2010). Judge Joseph N. Laplante answered in the negative, holding that the jury could consider the violation as evidence of a breach but it was not a per se breach of duty.

In Bartlett, Karen Bartlett sought medical treatment for right shoulder pain. Her physician prescribed a non-steroidal anti-inflammatory (“NSAID”) drug called Clinoril. Bartlett’s pharmacist filled per prescription with Sulindac, the generic version of Clinoril, manufactured by Mutual Pharmaceutical Company (“Mutual”). Two weeks after taking Sulindac, Bartlett was diagnosed with Stevens-Johnson Syndrome (“SJS”) progressing to toxic epidemal necrolysis (“TEN”), a serious and potentially fatal condition characterized by necrosis of the skin and mucous membranes.

As a result, Bartlett filed suit against Mutual asserting state law claims for strict products liability – failure to warn, strict products liability – defective design, fraud, and negligence. During discovery, it was found that the year prior to Bartlett’s physician prescribing Clinoril to her, an international medical journal found a link between NSAIDs and the conditions that Bartlett suffered from. It found 89 reported cases of SJS/TEN over a 17 year period in patients taking Clinoril, more than any other NSAID on the market. Also during discovery, Mutual admitted not being aware of the study and not monitoring medical literature for information on Sulindac’s safety risks. According to Mutual, the manufacturer of the brand named drug was responsible for monitoring safety risks.

On cross-motions for summary judgement, Bartlett argued that she was entitled to summary judgement on her negligence claim based on Mutual’s failure to survey medical literature for adverse events associated with Sulindac. Bartlett based this argument on the FDA requirement that generic manufacturers “develop written procedures for the surveillance . . . of post-marketing adverse drug experiences to the FDA.” 21 C.F.R. Section 314.80(b).

The Court interpreted this regulation to require generic manufacturers to develop procedures for surveying medical literature for information and studies on safety risks. Therefore, the question became whether Mutual’s admitted violation of this safety regulation versus violation of a statute could be a per se violation of its duty of care. The Court found that courts were split over whether plaintiffs could seek to enforce a FDA violation through a negligence per se action even thought the FDCA does not provide for a private right of action. Judge Laplante found no clear answer in New Hampshire but held that the New Hampshire Supreme Court would likely not treat the violation as negligence per se. Therefore, the court denied Bartlett’s motion for summary judgment and ruled that the jury could consider the violation as evidence of breach.

Drug manufacturers, generic and named-brand, must be aware of these FDA regulations governing surveillance of medical literature. Compliance with these regulations will be especially relevant in states that consider violations as negligence per se and not merely evidence of breach for the jury to consider.
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Wednesday, August 4, 2010

Products Liability Meets Criminal Law

It’s not often that products liability concepts intersect with criminal law. Such was the case in South Carolina last week, when Circuit Judge Roger Young of Charleston, in a 41-page order [PDF], threw out the conviction and granted a new trial to a young man whose defense team “did not appreciate how unlikely the ‘Zoloft defense’ would result in an acquittal.” As a result of that failure, the judge held, the defense team did not seriously pursue negotiations for a plea deal.

The case at issue is one that has drawn national media attention. Christopher Pittman of Chester, South Carolina, was just 12 years old when he reportedly shot his grandparents as they slept in their home, set their house on fire, and fled the scene in their SUV. The nearly three-week murder trial was moved to Charleston County because of the extensive publicity the case had garnered in the Upstate. Pittman was tried as an adult at age 15, was found guilty, and was sentenced to 30 years in the South Carolina Department of Corrections. He lost his appeals to the South Carolina and U.S. Supreme Courts.

For his criminal trial, Pittman’s defense team was reportedly comprised not of criminal defense attorneys, but of “lawyers who specialized in suing pharmaceutical companies.” They blamed the murders on the prescribed anti-depressant Zoloft, saying it clouded Pittman’s sense of right and wrong. Prosecutors argued in response that the premeditated nature of the murders, along with the fact that Pittman subsequently burned his grandparents’ home and thus knew the killings were wrong, discounted the defense’s Zoloft theory. The jury agreed, refusing to buy the defense team’s argument that Zoloft somehow made Pittman commit the murders. According to a 2008 article in The New York Times, Pfizer Inc., the maker of Zoloft, called the case “tragic” but said, “Zoloft didn’t cause his problems, nor did the medication drive him to commit murder.”

In his recent order, Judge Young chastised the defense team’s strategy, noting that the team, led by a civil attorney Andy Vickery, seemed more interested in putting Zoloft on trial than in doing what was best for the defendant. “After Vickery’s team took over the media attention grew exponentially greater,” Judge Young wrote, “in large part because the defense team cultivated it in order to draw attention to the side effects of SSRI (antidepressant) drugs such as Zoloft.”

Interesting, reportedly one year after Pittman’s trial, the FDA began requiring Zoloft and other antidepressants to carry “black box” warnings, the government’s strongest warning short of a total ban, about the increased risk of suicidal behavior in children. It does not, however, extend the warning to include potential homicidal risks.
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Monday, July 19, 2010

Filing Suit Against "Alternative" Product Manfucturers is Not Enough on Summary Judgment

Our post last Monday, Twombly and Iqbal Satisfied Even Where Plaintiff Cannot Identify Specific Manufacturer of Alleged Defective Product, highlighted a case which found a plaintiff could get past the motion to dismiss stage of litigation by naming “alternate” defendants as the manufacturers of the alleged defective product at issue. We stated that this type of pleading would often be used in the medication context and to watch for cases that determine how far a plaintiff can go naming “alternate” defendants. This question was answered by at least one court on June 21, 2010 in Kahle v. APP Pharms., LLC, No. 5:09-CV-78, 2010 WL 2521420 (N.D. W. Va. Jun. 21, 2010).

In Kahle, the decedent suffered from a intracerebral hemorrhage and was administered a “single low-dose heparin ‘lock flush’ that was allegedly used to ‘flush’ his intravenous line.” After the administration of this dose of heparin, the decedent suffered from heparin-induced thrombocytopenia, gangrene, and deep vein thrombosis. Kahle asserted that the heparin caused these complications,which led to the decedent’s death.

Kahle filed claims for strict liability, negligence, breach of warranty, negligent misrepresentation, fraud by concealment, and wrongful death against a number of defendants that manufactured heparin. During discovery, the hospital that administered the heparin produced documents showing that they purchased heparin products from two defendants, Hospira and APP Pharmaceuticals. However, the administrator of the hospital testified that he could not determine if it was Hospira’s or APP Pharmaceuticals’ product that was administered to the decedent.

Therefore, both Hospira and APP Pharmaceuticals filed motions for summary judgment on the grounds that Kahle failed to establish causation because she failed to prove whose product was administered to the decedent. In response, Kahle argued that “evidence that two manufacturer’s products were used in an area is enough to defeat a defendant’s summary judgment motion.” The Court disagreed finding the evidence Kahle had that established two manufacturers provided heparin products to the hospital “suggests a mere possibility that the decedent may have been exposed to [a certain defendant’s] product.” This mere possibility was not enough. Therefore, the Court granted the defendants’ motions for summary judgment ruling Kahle failed to establish which defendant’s “product proximately caused the decedent’s injuries.”

This case instructs that while a plaintiff may be able to survive a defendant’s motion to dismiss when he or she files suit against “alternative” product manufacturers, courts may not be so lenient after discovery is complete and the plaintiff is still not able to establish which defendant manufactured the product that allegedly caused the plaintiff’s injuries.
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Wednesday, July 14, 2010

$8 Million Verdict in Jeopardy Because of Plaintiff’s Counsel’s Closing Statement

In a case against pharmaceutical giant Merck that ended with a mistrial in September 2009 when jurors became hopelessly deadlocked, the jury for the second go-round recently awarded the plaintiff $8 million, which was reportedly $3 million more than her attorneys had asked for.

The case was one of several bellwether cases being tried in federal court in Manhattan involving Merck’s osteoporosis drug Fosamax. The company is reportedly facing more than 1,000 cases in state and federal courts in which plaintiffs allege the drug is defectively designed in that it can cause a jaw-destroying condition known as osteonecrosis. According to The Wall Street Journal, of the so-called bellwether cases, one was thrown out last year, a jury recently found in favor of Merck in a second, and a fourth is set to be tried in November.

United States District Judge John Kleenan oversees the federal Fosamax cases. He has set a hearing for September in which Merck will present post-trial motions to overturn the recent verdict. In this regard, it appears as though the plaintiff’s $8 million verdict may be in jeopardy.

Paul F. Strain, counsel for Merck, reportedly has said in a post-trial statement that he believes the jury’s verdict was a result of “plaintiff’s counsel’s inflammatory and prejudicial remarks.” And it appears as though Judge Keenan agrees. Although Merck unsuccessfully moved for a mistrial, arguing that plaintiff’s counsel improperly used his closing statement to encourage the jury to punish Merck with its verdict, Judge Keenan, 80, reportedly told lawyers of the closing outside of the jury’s presence: “I have never heard a more outrageous summation in my life than the one I heard yesterday.” Encouraging words for Merck officials, who recently issued a statement indicating the company’s intent to challenge the jury’s verdict.

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