A Louisiana jury in mid-October issued a $257.7 million verdict against Janssen Pharmaceutica, Inc. and its parent company, Johnson & Johnson, finding that the drugmaker misled Louisiana doctors about possible side effects of its antipsychotic drug Risperdal. See Caldwell ex rel. State of Louisiana v. Janssen Pharmaceutica, Inc., 04-C-3967, 27th Judicial Court, St. Landy Parish, Louisiana. Businessweek reports that the basis of the suit, which was initiated by the state’s attorney general, was that J&J officials wrongfully touted its drug as superior to competing antipsychotic drugs and attempted to minimize its links to diabetes.

The state’s case was based on claims that J&J and Janssen sent 7,604 “Dear Doctor” letters to Louisiana medical providers and made a total of 27,542 sales calls, in which company representatives claimed that Risperdal was safer than competing antipsychotic drugs such as Eli Lilly’s Zyprexa and AstraZeneca’s Seroquel. (See our previous post here, where we took a look at the litigation involving claims that AstraZeneca failed to warn users of the diabetes risks associated with its antipsychotic drug.) The state’s local NBC news affiliate reported that J&J’s statements were in violation of the state’s Medical Assistance Programs Integrity Law (MAPIL), which requires that the attorney general protect medical assistance programs from companies that engage in fraud, misrepresentation, or other improper practices to obtain payments for which they are not entitled.

According to an article at Law360, which explores a bit of the history of lawsuits against J&J involving improper marketing practices, the jury in the present case issued penalties of $7,250 for each of J&J’s 35,542 alleged violations of the MAPIL, which amounted to one of the largest verdicts in the history of the state. Patrick Morrow of the Opelousas law firm of Morrow, Morrow, Ryan and Bassett, which actually tried the case on behalf of the state, said of the verdict: “You can’t come into Louisiana and disseminate false and misleading information.”

Although J&J has denied any wrongdoing in connection with these claims, this verdict certainly will have a lasting impact on the way drugmakers market their products to doctors and medical professionals.

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.

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.

This was the latest trial in the series of “Engle progeny” cases, as we previously discussed here, wherein approximately 8,000 Florida smokers have filed lawsuits against tobacco companies in the wake of a 2006 Florida Supreme Court ruling. Howard Engle, a Miami doctor and smoker, lent his name to a class action law suit that represented approximately 700,000 ill or deceased Florida smokers. In that case, $145 billion in punitive damages was awarded to the plaintiffs. The decision was later overturned by the state’s appellate court and supreme court, both of which held that the award was excessive.

The ruling allowed plaintiffs in the class to file individual lawsuits against tobacco companies. Interestingly, it also allowed findings of the original jury pertaining to causation, addiction of cigarettes, negligence, and breach of implied warranty to stand, thus significantly reducing the plaintiffs’ burden of proof in these cases. This ruling was hotly contested by the tobacco industry, which argued that allowing one jury to rely on findings of a separate jury raises due process issues. Subsequently, in July, the U.S. Court of Appeals for the 11th Circuit issued its ruling in Brown v. R.J. Reynolds Tobacco Co., 611 F.3d 1324 (11th Cir. 2010) [PDF], which established limits on plaintiffs’ referencing the Engle case in meeting their burden of proof at trial. (See R.J. Reynolds’ press release on this ruling here.). Tobacco companies have argued that courts have since failed to fully comply with this ruling.

This most recent trial, which lasted three and a half weeks, was actually the second time the case was tried. The first trial reportedly resulted in a mistrial when one juror wanted to award the plaintiff $50 million, and other jurors wanted to award $12 to $15 million. The Plaintiff, who was 16 years old when he began smoking, said that he began his days by smoking a cigarette and that he sometimes would wake in the middle of the night to smoke. His lawyers reportedly said that he tried to quit several times by leaving his cigarettes in his car when he went to work. The defense argued at trial that the Plaintiff made a conscious decision to continue to smoke, even after becoming aware of health risks.

After the defense victory, Philip Morris issued a statement, wherein a representative said that this verdict “shows that juries recognize that plaintiffs are responsible for their own smoking decisions. . . Even with rulings by the trial court that gave the plaintiff an unfair advantage in violation of Florida law and due process, the verdict for the defense shows that Philip Morris USA still has powerful defenses.” This certainly was an important victory for the tobacco industry, which has otherwise been hit with a series of big losses in these cases.

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.

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.

A recently dismissed class action lawsuit was seemingly pulled from the pages of the “Smelly Car” episode of Seinfeld. Suit was filed in federal court in New Jersey in October 2009 on behalf of owners of BMW Model E46 owners, who alleged that a noxious odor permeated the cabins of their ultimate driving machines. Alban v. BMW of North America, LLC, Civ. No. 09-5398 (D.N.J. 2010). The 20-page complaint actually includes quotes purportedly pulled from various websites dedicated to the issue. Some favorites from the complaint: “It kind of smells like a mix of BO and crayons.” “[The smell] burns your nostrils!” And finally, as if quoted from Elaine herself, “I shampoo’d, etc. Nothing helps.”

Although in “Seinfeld” the culprit was a malodorous valet who was only briefly seated in Jerry’s BMW, here, it seems, the cause of the odor was BMW’s alleged use of excessive amounts of solvent on paneling in and around the trunk. The complaint alleged that BMW knew of and has even acknowledged in a Technical Service Bulletin the existence of an “unpleasant . . . solvent or wax crayon” odor, but that it refused to repair or replace the defective insulation after the four year or 50,000 mile warranty period passed. The odor, according to the complaint, often would take several years to manifest. The complaint set forth causes of action including breach of express and implied warranties.

The complaint in this case did not include cites to its supposed users’ commentary, but a quick Internet search does, in fact, reveal that there are sites dedicated to the BMW odor issue (see here and here).

In any event, the complaint, filed by Pennsylvania firm Chimicles & Tikellis and New Jersey’s Law Office of Lane M. Ferdinand, was recently tossed by U.S. District Court Judge Dickinson of New Jersey, who granted BMW’s motion to dismiss. The court held that the breach of express warranty claim failed due to the undisputed fact that the Plaintiff’s warranty had expired at the time the defect arose. Similarly, the claim for breach of implied warranty failed as the result of limits placed on any such claim within BMW’s warranty agreement. The court based this finding on the fact that the agreement provided, in conspicuous language, that the duration of any implied warranties was to be limited to the duration of the express warranties–“48 months or 50,000 miles, whichever occurs first.”

The California Court of Appeals recently upheld summary judgment in favor of both defendants, an escalator manufacturer and Nordstrom department store, in a case where a shopper alleged she sustained injuries when an escalator stopped during a power outage. The court held that the opinions of the plaintiff’s motion engineering expert lacked adequate foundation. Bozzi v. Nordstrom, Inc., 111 Cal.Rptr.3d 910 (Cal. Ct. App. 2010).

The plaintiff was riding a Nordstrom escalator when an automobile accident outside the store caused an electrical service interruption, temporarily stopping power inside the store. The lights went out and the escalator stopped. The plaintiff had been holding on to one or both of the handrails, but alleged she was injured when her left foot moved down one step on the escalator. She did not fall. The power was out for approximately one minute before it was restored, at which time the lights came back on, the escalator descended to the first floor, and the plaintiff walked out of the store.

The plainitff sued both parties for negligence and failure to warn and included a strict liability action against the escalator manufacturer. It was the plaintiff’s theory that the defendants should have supplied an alternate power source for the escalator or otherwise have designed and maintained it such that it would have slowed to a gradual stop when the power went out. In support of her theory and in an effort to withstand summary judgment, the plaintiff proffered a motion engineering expert, who opined that there was “certain technology” available at the time of the escalator’s placement in 1985 that would have prevented the abrupt stop of which the plaintiff complained. It was his opinion that the fact that the escalator came to a jolting stop proved that there was a defect, because a properly designed and maintained escalator should not stop abruptly.

Although both the trial and appellate courts held that the plaintiff’s expert was properly qualified, they excluded as speculative and without foundation his conclusion that the escalator’s failure to come to rest in a power outage constituted faulty design or maintanence. An important factor in the courts’ conclusion was that the proffered expert had never seen, ridden or inspected the escalator. The appellate court held that he “relied on nothing more than syllogistic reasoning to conclude that if an escalator stops abruptly, it must have been defectively designed or maintained.”

An opinion is, according to the court, “only as good as the facts and reasoning on which it is based.” Because this expert failed state any facts to support his opinion, it was not appropriate for summary judgment analysis. This case is another illustration of an important defense victory where a plaintiff seeks to create issues of fact by offering unsubstantiated expert opinions.

People of WalMart beware: 190 tons of the mega-store’s deli meat have reportedly been recalled due to potential Listeria contamination. The affected product comes from Buffalo, New York-based Zemco Industries. According to the USDA press release, the problem was discovered as the result of a retail sample collected by the State of Georgia that confirmed the meat was positive for Listeria monocytogenes.

I’ll never forget that first–and last–time I purchased a store-brand jar of salsa, thinking there was no way it was any different that the $0.30-higher-priced name-brand jar. Then with my first dip, I bit into a twig. From that point forward, I was ready to pay that extra $0.30 because I then understood that was simply the cost of the name-brand company’s employing a twig picker. I became one of those perhaps gullible consumers who believes that when you pay more for a product, you’re getting a better product. Well, such is apparently not always the case.

Last week, a federal judge in Wisconsin gave final approval to a $65 million settlement in multidistrict litigation brought by consumers who accused 10 companies of conspiring to overstate the horsepower of lawn mower engines. According to an article in The Washington Post, the case began in 2003 when an employee of one of the manufacturers walked in to a Minnesota law firm, claiming that he was privy to some interesting information. Specifically, the manufacturers were selling lawnmowers with advertised horsepower of 4.5, 5, 5.5, and 6.75, but all had the exact same engine. Suit was thereafter filed in May 2009.

According to the complaint, these companies took mowers with identical engines, put different labels on them, and sold them at significantly different prices. Perhaps even more alarming, the suit alleges that several of the companies had created a “Power Labeling Task Force,” which was used to plan and organize the conspiracy. This group allegedly met at various locations and even kept minutes that were distributed when the task force adjourned.

To date, about 340,000 claims have been made. Under the terms of the settlement, class members will receive $35 for every eligible walk-behind mower they own, and $75 for every ride-on mower. The lawnmower companies have also agreed to extend warranties by one year and to change the way they test and report horsepower.

And so it seems that my cost-more, get-more theory may be misguided.

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.