Law360, New York (January 1, 2011) -- While product liability lawyers will be looking to the U.S. Supreme Court in 2011 as it takes on the the issue of federal preemption yet again, a number of other suits, including one involving the role of punitive damages in personal injury drug claims, are likely to garner plenty of attention.

Here are a few of the big cases that product liability lawyers will be tracking as the upcoming year unfolds:

Bruesewitz et al. v. Wyeth Inc. et al.

If the Supreme Court wants to put its mark on the preemption issue, as many suspect it does, Bruesewitz v. Wyeth is a logical place to start, according to Harris Pogust, a partner at plaintiffs' firm Pogust Braslow & Millrood LLC.

The case, argued before the Supreme Court in October, asks whether the National Childhood Vaccine Injury Act preempts injury claims against vaccine makers under state law, and could go a long way in determining the scope of the industry's protection from certain product liability cases, Pogust said.

Russell and Robalee Bruesewitz claim their daughter Hannah, now 17, started suffering seizures after receiving the third in a series of so-called DPT vaccine shots for diphtheria, pertussis and tetanus that were marketed by Wyeth. She was later diagnosed with residual seizure disorder and developmental delay.

The district court granted Wyeth's bid for summary judgment against the Bruesewitzes in August 2007, saying the Vaccine Act preempted all design defect claims arising from vaccine-related injuries or deaths. The U.S. Court of Appeals for the Third Circuit agreed with the lower court in its March 2009 ruling.

The plaintiffs, meanwhile, argue the scope of the law is limited to protecting vaccine makers from federal, not state, claims.

The issue of preemption has already reached the Supreme Court, but not regarding vaccines.

In the 2009 landmark case Wyeth v. Levine, the high court found that product liability drug claims made under state law were not preempted by federal law. The decision effectively crushed the preemption defense in the prescription drug arena.

Since then, attorneys have wondered if the preemption defense could ultimately be doomed for other products as well.

But Levine and Bruesewitz overlap only minimally, according to James Beck of Dechert LLP, author of the Drug and Device Law blog. The NCVIA had an express preemption clause, while federal laws surrounding drug claims only implied preemption, Beck explained.

"It will come down to a judgment of congressional intent," he said.

The plaintiff in the case is represented by Kellogg Huber Hansen Todd Evans & Figel PLLC and the Law Offices of Collyn Peddie.

Wyeth is represented by Orrick Herrington & Sutcliffe LLP and Quinn Emanuel Urquhart & Sullivan LLP.

The case is Bruesewitz et al. v. Wyeth Inc. et al., case number 09-152, in the U.S. Supreme Court.

Trio of Generic Reglan Preemption Cases

The Levine case may also play a central role in a trio of consolidated cases before the Supreme Court regarding generic drug labeling for Wyeth's gastric disorder drug Reglan, which the high court granted certiorari in December.

Generics companies Pliva Inc. and Actavis Inc., which make generic versions of Reglan, were accused of failing to update their labels to reflect the risk of the neurological disorder tardive dyskinesia, which plaintiffs claimed they developed from taking the generics.

The companies have tried to argue that different labeling rules for generics made it impossible for them to change labels to reflect new information on health risks, with mixed results.

The U.S. Court of Appeals for the Fifth Circuit in January ruled in Actavis Inc. v. Demahy that federal regulatory approval processes did not protect Actavis from state failure-to-warn claims, and that the company should have unilaterally changed its label.

In November 2009, the U.S. Court of Appeals for the Eighth Circuit applied the same limitation to a slew of generic manufacturers facing state accusations from plaintiff Gladys Mensing, including Actavis, Elizabeth LLC and Pliva.

Unlike the Fifth Circuit, however, the Eighth Circuit did not tackle the question of what the defendants should have done, deciding only that they were wrong to do nothing.

The manufacturers say laws require their labels to be the same as those of their brand name counterparts, making it impossible for them to update labels if the brand names have not done so first.

While the Fifth and Eighth Circuits both rejected that stance, their slightly different conclusions may partly explain the Supreme Court justices' decision to grant cert despite the lack of a circuit split.

For brand-name drug companies, the cases present a bit of a quandary, Beck said.

On one hand, brand manufacturers have always supported preemption in product liability cases, he said.

On the other hand, a Supreme Court ruling recognizing preemption against generic-drug makers could incentivize plaintiffs to name brand-name companies as defendants in labeling suits in which the plaintiff took only generic drugs, he explained.

"It will be interesting to see what position brand name companies take, because they have counterbalancing interests," Beck said.

Pliva is represented by Ulmer & Berne LLP.

Actavis is represented in the Mensing case by Tucker Ellis & West LLP and in the Demahy case by Zuckerman Spaeder LLP.

The respondents are represented in all matters by the Center for Constitutional Litigation PC.

The cases are Pliva Inc. et al. v. Gladys Mensing, case number 09-993; Actavis Elizabeth LLC v. Gladys Mensing, case number 09-1039; and Actavis Inc. v. Julie Demahy, case number 09-1501. All are in the U.S. Supreme Court.

Williamson et al. v. Mazda Motor of America Inc. et al.

Another pending Supreme Court matter takes preemption out of the health care realm and applies it to vehicle safety, another hot topic for product liability attorneys.

In Williamson v. Mazda, argued in November, the family of a woman killed in a car accident while wearing a lap-only seat belt argued that a 1989 National Highway Transportation Safety Administration regulation allowing such belts in minivan aisle seats should not have overridden California state law claims.

The case had been dismissed by a California state appellate court in October 2008, but wound its way to the Supreme Court on appeal.

The matter could spur the Supreme Court to readdress its 2000 ruling in Geier v. American Honda Motor Co., which has been read by courts as protecting car companies from state law claims as long as they comply with federal regulations.

The petitioners argue that the safety administration meant lap-only belts to be a bare minimum rather than an equal alternative to lap-and-shoulder belts, but Mazda claims that allowing state tort claims would contradict the flexibility the agency intended when it wrote the regulation.

The case warrants attention because the Supreme Court typically does not rule on an issue twice, attorneys said.

"This is unusual because, to some extent, you would have thought the Supreme Court already made its ruling on this same statute in Geier," Pogust said. "The Supreme Court really seems to want to define the future of preemption as broadly as it can."

Product liability attorneys will be closely following the outcome, which, at this point, is anyone's guess, according to Beck.

"The court could do anything from reverse Geier to extend it to all automobile safety standards," he said.

The plaintiff in the case is represented by the Law Offices of Martin N. Buchanan.

Mazda is represented by Latham & Watkins LLP and Bowman and Brooke LLP.

The case is Williamson et al. v. Mazda Motor of America Inc. et al., case number 08-1314, in the U.S. Supreme Court.

Hormone Replacement Therapy Litigation

Product liability lawyers will also be closely watching how the multidistrict litigation over hormone replacement therapy continues to unfold, particularly in regards to questions over the appropriateness and size of punitive damages.

Drug companies, specifically Pfizer Inc. and Wyeth, face some 8,000 lawsuits in multidistrict litigation over combination estrogen-progestin drugs like Prempro, with plaintiffs saying the drug caused them to develop cancer. Studies have backed up the claims, finding that women who took Prempro were not only more likely to develop cancer but also more likely to die from it.

The companies have experienced mixed results in jury trials. A federal jury in October found against an Arkansas woman seeking $3.5 million in damages from Pfizer, and the company has won six of 13 trials overall.

But the question product liability attorneys are watching most closely in the litigation is whether courts award punitive damages in cases where fraud against the U.S. Food & Drug Administration is not established, according to mass tort guru Sheila Birnbaum of Skadden Arps Slate Meagher & Flom LLP.

"Can there be punitive damages where the FDA continues to keep a drug on the market and tells you what the warnings are?" Birnbaum said. "If there is no evidence of fraud or concealment, are there grounds for punitive damages?"

Lately, courts and juries have ruled that there are indeed.

In November in Wyeth v. Rowatt et al., the Nevada Supreme Court upheld a nearly $58 million punitive damages award to three women who suffered breast cancer after taking Wyeth HRT drugs.

Two similar cases remain on appeal in Pennsylvania following hefty back-to-back jury verdicts in the Philadelphia County Court of Common Pleas in October and November of 2009.

The jury in Barton v. Wyeth Pharmaceuticals Inc. awarded $75 million in punitive damages to a woman who developed cancer after taking HRT drug Prempro. Another jury followed suit a month later, awarding $28 million in punitive damages to a Prempro plaintiff in Kendall v. Wyeth Pharmaceuticals Inc.

Though juries may be trending this way, whether or not that move is right may ultimately be one for the high court.

"This is something I think will ultimately end up in the Supreme Court," Pogust said. "Plaintiffs are getting large verdicts, and there will be the questions of whether that's appropriate and what is an appropriate multiplier."

Wyeth is represented by attorneys from Williams & Connolly LLP and Troutman Sanders LLP.

The plaintiffs are represented by Williams Love O'Leary & Powers PC and Seyfarth Shaw LLP et al.

The MDL case is In re: Prempro Products et al., case number 4:03-cv-01507, filed in the U.S. District Court for the Eastern District of Arkansas.

State of Louisiana ex rel. James D. Caldwell, Attorney General, v. Merk & Co. Inc.

The U.S. Court of Appeals for the Fifth Circuit will soon decide if product liability can be used to argue monetary loss in a case that lawyers say could open up a new litigation front.

The office of Louisiana Attorney General James D. "Buddy" Caldwell is appealing a failed attempt to recover damages from Merck & Co. for Medicaid payments made for the discontinued painkiller Vioxx.

The suit asserts that Louisiana deserves a refund because it made payments on a drug that turned out to be defective, a position that essentially applies the product liability theory of defective design to a monetary loss claim, explained Skadden's John Beisner.

The case remains pending in the Fifth Circuit after being dismissed by the U.S. District Court for the Eastern District of Louisiana in June.

While Caldwell may be the most prominent example, similar suits have cropped up in a host of courts, with different state attorneys general framing the same basic argument in various ways, Beisner explained.

Some have argued for a refund on grounds that drugs were prescribed for off-label uses, while others have said that any undisclosed risk associated with a drug warrants a refund. The common thread, Beisner said, is that the suits seek monetary recovery for claims traditionally asserted by injured plaintiffs in tort cases.

"It's not like one district court or appellate court decision is going to push the whole issue in a new direction, but it is a very active new front," Beisner said.

Merck is represented by Stone Pigman Walther Wittmann LLC, Williams & Connolly LLP and Skadden Arps Slate Meagher & Flom LLP.

The case is State of Louisiana v. Merck & Co. Inc., case number 05-3700, in the U.S. District Court for the Eastern District of Louisiana.

It is part of the MDL In re: Vioxx Products Liability Litigation, case number 2:05-md-01657, in the U.S. District Court for the Eastern District of Louisiana.

Engle Progeny Cases

Attorneys will continue to follow in 2011 litigation surrounding tobacco, a perennial product liability favorite, with thousands of so-called Engle progeny cases still pending in the Florida courts.

The individual tobacco product liability actions emerged when the Florida Supreme Court in 2006 overturned a $145 billion verdict in Engle v. R.J. Reynolds Tobacco Co., a large class action accusing the tobacco companies of conspiring to cover up the side effects of smoking. It also declined to revive the class action status of the lawsuit.

But the state's high court did allow up to 700,000 individuals who could have won judgments under the original verdict to use findings from the jury trial to bring new cases against the tobacco companies.

In more than 20 trials so far, results have been mixed, but verdicts more recently have gone in favor of the defendants, according to Hildy Sastre, a products liability partner at Shook Hardy & Bacon LLP.

"Plaintiffs' lawyers were champing at the bit to try these cases, because the issues of liability had been stripped from them as a result of the [Florida] Supreme Court's findings," Sastre said. "The jury is made aware at the beginning that the company made a defective product."

In the aftermath of the Florida high court's ruling, nine of 11 trials went for the plaintiffs, with verdicts ranging from $750,000 to $300 million.

But lately, Sastre said, juries have bucked the trend.

While plaintiff Dianne Webb won $80 million from R.J. Reynolds Tobacco Co. Nov. 15, her victory snapped a streak of six consecutive defendant victories throughout October and early November.

A jury in Miami-Dade County found in favor of Philip Morris USA Inc. and R.J. Reynolds Tobacco Co. in Espinosa v. Philip Morris USA et al., saying the plaintiff's death from cigarette-induced cancer could not be blamed on the companies' negligence.

Juries in Broward and Hillsborough counties also awarded no damages against Big Tobacco.

The run of defendants' verdicts could be telling, Sastre said.

"Even if juries find that cigarettes are a habit and are addictive, we're finding more and more jurors who say, 'I want to hold the smoker responsible for a personal choice,'" she said.

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