Don’t Go To The Beach

Beach season is upon us. Although we here at Abnormal Use advocate staying inside at all times, maximizing the time that we can bill and blog, we understand that some of you yearn to have the sun forcibly remove layers of your skin. If you are one of those people, please read the following before going outside.

Karen Mather purchased some sunless tanning lotion that she alleged caused her injury. Mather v. L’Oreal USA, Inc., No. A10A0458, 2010 WL 2015337 (Ga. Ct. App. May 21, 2010). Mather has multiple sclerosis and “direct sunlight causes her pain.” Nevertheless, it’s beach season, and Mather decided to go to the beach. (The opinion does not reveal why someone who is sensitive to direct sunlight goes to the beach for recreation.) Just before leaving for the beach, Mather purchased two tubes of L’Oreal Paris Sublime Bronze self-tanning lotion, which she used “twice a day for three days and experienced no problems.”

On the drive home, Mather developed some problems “where the sunlight touched her skin through the car windows.” (Again, it is unclear why this plaintiff with such sun sensitivity refuses to wear a long-sleeve shirt). Mather’s skin reddened, and she developed small pustules. Her condition worsened, and she developed abscesses filled with pus, with lesions everywhere, and her multiple sclerosis was exacerbated. In fact,

“Mather testified that, as a result of using the self-tanning lotion, ‘[m]y organs will never be the same.’ “

That is true Plaintiffspeak if I have ever heard it. Dear Defendant, your $10 product affected me to the point where my organs will never be the same. Lots of money will fix my organs.

As you may have guessed, L’Oreal moved for and was granted summary judgment. Mather sued on a failure to warn theory, and, strangely enough, Mather had no evidence that L’Oreal should have known about a reaction such as Mather’s. L’Oreal showed that the active ingredient, hydroxyacetone, is common and safe for use by most people. Even during the product’s testing, of those that experienced some reaction, no reaction resembled Mather’s. This appears to be a case where Mather’s lawyer thought that he might find something decent in the discovery phase to support his case. That was not the case. In the end, Mather had no evidence contradicting L’Oreal’s assertion that the testing process was insufficient. Therefore, feel free to pick up some sunless tanner, or get out in the sun and give yourself lesions naturally.

Biggest Verdict in Nevada History – Perhaps a Case of Misplaced Anger?

A Nevada jury on May 7 handed down what is reportedly the largest punitive damages award in the state’s history and, as the Plaintiff’s lawyer announced at a subsequent press conference, the “largest verdict in Nevada history, period.” The jury awarded $500 million in punitive damages to the Plaintiff, 62, who reportedly contracted hepatitis C because nurse anesthetists assisting with the Plaintiff’s colonoscopy reused between various patients vials of anesthetic, which had become contaminated by syringes that nurses had reused among patients with hepatitis C. Who got hit with the $500 million dollar verdict? The maker of the anesthetic!

Darren McKinney, spokesman for the American Tort Reform Association, reportedly called the verdict “insane.” He said that “to suggest that drugmakers can be held liable for the unhygienic use of a drug is obscene. They went after drug companies because they knew they had the deep pockets.”

The Plaintiff’s theories of liability against the makers of the drug reportedly were: (1) that the drug packaging did not include appropriate warnings against reusing vials between patients; and (2) that 50-milliliter vials of the anesthetic should not have been sold to endoscopy centers because “they tempted nurses to reuse the vials instead of throwing away leftover sedative.” Of note, nurse anesthetists, like those who could not withstand the temptations presented by drug manufacturers here, are trained specialists in the administration of anesthesia and for whom the median annual salary in 2009 was $157,724.00. The doctor and nurses who performed the Plaintiff’s colonoscopy, however, reportedly settled their malpractice claims prior to trial.

Whatever the theory of liability relied upon, it certainly appears as though something inflamed the jury. One possible explanation may be the actions of one of the defendant’s representatives during the trial itself. Reportedly, the jurors were “miffed nobody from the Israel-based [company] attended the trial, and they universally ridiculed” the United States-based company executive who testified about the drug and its uses. The jury forewoman reportedly said of the witness: “Mr. Lea did not impress us. What he said, what he didn’t say, all that stammering. The defendants need to get more aggressive if they want to win some of these cases.”

Both defendants, including the Israel-based Teva Pharmeceutical Industries, have said they will appeal the verdict.

Harsh Punishment on the Horizon for Company, and Perhaps its Executives, Who Failed to Warn

A federal judge in Minnesota has rejected a proposed plea agreement between the federal government and Guidant Corporation, in which Guidant had agreed to plead guilty to two criminal misdemeanors and to pay a $296 million fine for continuing to sell heart defibrillators after discovering that some might short-circuit and fail, The New York Times reports. Federal Judge Donovan W. Frank said, in his 37-page opinion [PDF], that provisions of the agreement were not in the best interest of justice and do not serve the public’s interest because they do not adequately address Guidant’s history and the criminal conduct at issue.”

The problems associated with Guidant’s defibrillators, which have reportedly been associated with 6 deaths, came to light in 2005 when The New York Times published an article based on interviews of two Minneapolis cardiologists who treated Joshua Oukrup, a 21-year-old college student who reportedly died when his Guidant defibrillator short-circuited as it was charging to send out its life-saving jolt. Although Guidant had reportedly become aware of the defect associated with its product, its representatives merely fixed the flaw in new devices without warning doctors or regulators about the problem. As such, patients continued to get the potentially flawed older devices because the company did not pull them from hospital shelves.

Guidant’s chief medical officer explained that “the company had not seen a compelling reason to issue an alert to physicians about the defibrillators because the failure rate was very low and replacing the devices might pose greater patient risks.”

Mr. Oukrup’s treating cardiologist said that this was “a statistical argument that has little to do with real people.” In fact, prior to Judge Frank’s April 27 ruling, Mr. Oukrup’s two treating cardiologists wrote a letter [PDF] to the court urging the judge to reject the plea agreement. The doctors wrote that they were “extremely dismayed” with the decision to enter such an agreement with the company rather than to “prosecute the company and the individuals responsible for this egregious act.”

Judge Frank noted in his ruling that it is up to prosecutors, not the court, to decide who should be prosecuted. But his rebuke of the proffered plea deal certainly calls into question: “Who should be held accountable when a company sells a flawed product that can injure or kill patients? Is it the company or the people who run it?”

A Can of Tuna a Day, Keeps the Doctor Away?

A New Jersey women got the age-old saying a bit wrong and instead of an apple a day, consumed a can of tuna per day for 12 years, resulting in severe mercury poisoning. As a result of her injuries, she asked the United States District Court for the District of New Jersey to find the manufacturer of canned albacore tuna liable for “canning and distributing albacore tuna containing harmful mercury compounds, while failing to warn and disclose the harms associated with the mercury contained in its albacore tuna products.” Fellner v. Tri-Union Seafoods, LLC, No. 06-0688, 2010 WL 1490927 (D.N.J. Apr. 13, 2010).

Defendant moved to dismiss the action on the grounds that (1) Plaintiff’s claims under the New Jersey Consumer Fraud Act (“CFA“) were subsumed by her claims under the New Jersey Products Liability Act (“PLA“), (2) Plaintiff had failed to state her claims with sufficient particularity, (3) Defendant had no duty to warn, and (4) public policy considerations warranted dismissal of the action. The Court granted Tri-Union’s motion on the first ground, but denied on the other grounds.

Plaintiff, Deborah Fellner (“Fellner“), consumed approximately one can of Chicken of the Sea albacore tuna products per day for approximately 12 years. As a result, Fellner “contracted severe mercury poisoning and suffered extreme physical and emotional injuries.” Fellner then brought this action against Tri-Union Seafoods, LLC (“Tri-Union”) who manufactures, processes, tests, cans, markets and sells tuna products. Fellner asserted claims against Tri-Union under the PLA, the CFA and for punitive damages based on their failure to warn about the presence of mercury in their tuna products.

On Tri-Union’s first ground, the Court agreed with Tri-Union that Fellner’s claims under the CFA are subsumed by the PLA because the mere fact that Fellner sought economic damages to reimburse her for the cost of the product, did not negate the fact that her underlying claim was that the tuna was defective. A contrary finding would nullify the intended purpose of the PLA to “unify products liability causes of action into a single claim.”

Tri-Union’s second ground for dismissal was that Fellner failed to sufficiently plead her claim under the PLA. The Court first recognized that there is a rebuttable presumption that warning labels are not required where the company is in compliance with FDA requirements. However, this presumption can be overcome in the appropriate circumstances. Tri-Union asserted that Fellner could not rebut this presumption with her allegations that Tri-Union “concealed, suppressed, omitted, and/or failed to disclose material information regarding the presence of methylmercury and/or other harmful compounds in its Tuna Products.” The Court disagreed and found that, although Fellner’s pleadings were minimal, they were sufficient to survive a motion to dismiss as if accurate, could potentially rebut the presumption of the warning’s adequacy.

Tri-Union’s third ground for dismissal was that it had no duty to warn of the potential danger of mercury in its tuna products. Tri-Union first argued that the dangers of mercury are obvious, operating as a complete defense to a failure to warn action. The Court found that level of consumer knowledge was relevant but that this determination could not be made at this stage of the pleadings. Next, Tri-Union argued that Fellner misused the product by consuming the product in “abnormal” quantities and, therefore, the danger caused by such misuse was unforeseeable. The Court again found that while her consumption may be relevant, this determination could not be resolved on a motion to dismiss. Finally, the Court rejected Tri-Union’s argument that since mercury is naturally occurring, no warning was necessary. The Court stated that this was not a per rule.

Tri-Union’s final ground for dismissal was a public policy argument that permitting Fellner’s claim would reduce the consumption of health quantities of fish. The Court disagreed and stated that there was no indication that warning labels regarding mercury content would cease consumption of fish at healthy levels.

The Court’s ruling merely dismissed Fellner’s claim under the CFA but allowed her claim under the PLA for failure to warn to move forward. Therefore, it would be in the jury’s hands whether the dangers of consuming approximately 4,380 cans of tuna was knowledge a typical consumer possesses and whether this level of consumption was an unforeseeable misuse.

Defective Vacuum Sucks Hair Out of Scalp, Suit Says

An Illinois woman has recently filed suit against Ohio-based vacuum manufacturer The Kirby Company for $200,000, reports the Chicago Sun-Times, alleging her defective vacuum cleaner broke during use and sucked the hair out of her scalp.

The complaint, filed in U.S. District Court in Illinois on April 23, reportedly sets forth that the vacuum was “defective and unreasonably dangerous” and that Kirby sold the vacuum without adequate testing and without proper warnings of the hazards of personal injuries. The plaintiff’s Chicago-area lawyer, Thomas A. Reed, to whom the plaintiff referred all questions, has told the media that his client was using the vacuum hose to clean underneath her bed when the attachment broke, “causing a tremendous sucking that took her hair right into the machine.” He declined to discuss the extent of his client’s injuries, but did indicate that she was rushed to the emergency room after the incident.

The suit has generated considerable discussion. See local Chicago NBC coverage here, where a poll shows that 79 percent of Chicago locals think the story is laughable, or commentary here, where one writer notes the marketing potential (“Hairs on the floor don’t stand a chance!”).

In spite of the skepticism surrounding the suit, there appears to be evidence to suggest her claim may have legs. Video coverage at Fox News includes pictures of the woman’s scalp allegedly showing the injury to her head. The pictures were thought to be so disturbing that the affected area of the woman’s scalp were blurred for the television clip.

It’s certainly an interesting set of facts. We’ll have to see where this one goes.

Big Tobacco Takes Another Hit

A Florida jury recently ordered two cigarette companies to pay a total of $26.6 million to the widow of a longtime smoker who died of lung cancer after smoking for more than 50 years.

The verdict, handed down on March 24, was the latest in a string of “Engle progeny” cases to be submitted to Florida juries in recent years. Engle v. R.J. Reynolds was a landmark class-action lawsuit filed in 1994 against makers of cigarettes, in which a Florida jury awarded the plaintiffs $145 billion. This award was subsequently overturned by the Florida Supreme Court in 2006.

However, in doing so, the court reportedly did allow the approximately 700,000 Florida smokers in that class to pursue their claims individually. In addition, the state supreme court actually allowed the findings of the original jury pertaining to causation, addiction of cigarettes, negligence, and breach of implied warranty to stand, thereby reducing the burden of proof required in these subsequent actions. This likely has served as a significant advantage for plaintiffs’ counsel, who go to trial without having to jump the causation hurdle. As a result, the defendants’ strategy is also limited.

Of the 13 Engle progeny cases to reach juries in the last 13 months, plaintiffs have won 11. Counsel for the tobacco companies have alleged that each of these cases raises constitutional issues, though, because allowing one jury to rely on the findings of a prior jury that are totally unrelated to the individual smoker at each trial is in violation of both Florida law and due process.

Representatives for Philip Morris have said it will appeal the jury’s latest verdict on the grounds that the trial court improperly eliminated the majority of the plaintiff’s burden of proof. However, as of now, at least, it appears as though the latest will be one of a continuing string of verdicts to strike blows to the tobacco industry.

British Drug Manufacturer Takes Big Victory in First "At Bat" for Antipsychotic Drug

British drugmaker AstraZeneca was handed a huge victory this month by a New Jersey jury whose members concluded after six hours of deliberation that the manufacturer provided adequate warnings to the plaintiff’s doctors about the diabetes risk posed by its antipsychotic drug Seroquel. Business Week reports that this was the first of approximately 26,000 claims regarding the drug to reach a jury.

Seroquel, with a reported $4.9 billion in sales in 2009, has been widely utilized for treatment of psychotic disorders such as bipolar disorder and schizophrenia. In the present case, the plaintiff was a 61-year-old Vietnam veteran who took the drug for treatment of posttraumatic stress disorder. He is one of thousands of users of the drug who allege that AstraZeneca causes diabetes and that the company failed to adequately warn patients of that risk.

Business Week reports that the jury, which included a lawyer on its panel, determined that the manufacturer’s warnings on the label were adequate to alert users to the diabetes risks associated with the drug. As such, the jury did not issue an opinion as to whether the drug caused or contributed to the plaintiff’s development of diabetes or as to the amount of damages he would have deserved if that were proven true.

Not surprisingly, the huge volume of litigation over the drug has resulted in “millions of pages” of discovery material. The New York Times reports that among those millions of pages were at least two seemingly explosive emails. The first of those, it reports, was a 1997 message from an AstraZeneca official in which he praised the work of the company’s physician for minimizing adverse conclusions regarding the drug in a “cursed” study. Specifically, he reportedly wrote: “Lisa has done a great ‘smoke-and-mirrors’ job!” The second of those emails was written in 1999, two years after the drug was approved for use in the United States. In it, the company’s publications manager reportedly wrote: “The larger issue is how do we face the outside world when they begin to criticize us for suppressing data.”

A spokesman for AstraZeneca said that plaintiffs’ lawyers have been attempting to try the cases in public because they had been unsuccessful in the courtroom. Indeed, two prior Seroquel cases brought before a federal judge in Orlando were dismissed on summary judgment due to a lack of evidence that the drug caused diabetes. AstraZeneca has said that some 2,600 Seroquel cases have been abandoned by plaintiffs’ lawyers to date.

Varying Jury Verdicts in Latest Pfizer Litigation

A Philadelphia jury on February 22 ordered Pfizer’s Wyeth unit to pay $6 million in punitive damages and $3.45 million in compensatory damages to an Alabama woman who claimed she developed breast cancer as a result of taking the company’s hormone-replacement drug Prempro. Just two days later on February 24, in a case involving very similar facts, another Philadelphia jury found that Pfizer was not a cause of an Indiana woman’s breast cancer and Pfizer was not held liable for damages.

Prempro is a combination of Pfizer hormone medications Premarin and Provera and was used by more than six million women to treat symptoms of menopause before a 2002 Women’s Health Initiative study highlighted the drugs’ links to cancer. Prempro is still on the market, now with increased warnings reflecting results of the 2002 study. However, more than 8,000 lawsuits have been filed against Pfizer by former users of the drug since publication of the 2002 study.

As these two February cases demonstrate, results of the lawsuits have varied. Before this most recent victory for Pfizer on February 24, Business Week reports that Pfizer had lost seven out of the 10 Prempro cases to have gone before juries — the $9.45 million verdict in favor of the Alabama plaintiff had been Pfizer’s fifth loss in a row. However, the Philadelphia Inquirer also reports that two of the jury verdicts in favor of plaintiffs were reversed posttrial, and several other jury verdicts are being challenged by Pfizer on appeal. In addition, it reports that as of February 23, 2010, Pfizer had won five summary judgment motions in its Prempro litigation and 15 of its cases set for trial have been voluntarily dismissed by plaintiffs.

Because the outcomes of these suits and the juries’ interpretation of the facts appear to vary so greatly, it likely will only fuel plaintiffs’ and Pfizer’s fervor in arguing their cases at trial. Indeed, James A. Morris, an Austin, Texas lawyer who represented the family of the Indiana Prempro plaintiff who recently lost her battle against Pfizer, is quoted by the Philadelphia Inquirer as saying, “Nothing about today’s verdict changes the landscape of this litigation. We will continue to fight on in other cases.” Lawyers for Pfizer, on the other hand, have maintained that the company acted responsibly in conducting and supporting more than 180 studies on the benefits and risks of use of the drug. Pfizer has said it will appeal the Philadelphia jury’s recent $9.45 million verdict.

Florida Federal Court Addresses Watercraft Warnings

Product warnings can be clear, they can be ambiguous, they can be sufficient, but if they are not placed where they can be seen, then they may be all for naught. This remains true when the product at issue is a watercraft. In Thomas v. Bombardier Recreational Prods., Inc., the court denied in part the defendant manufacturer’s motion for partial summary judgment because although the warning would have been visible to a watercraft’s driver, it may not have been so easily seen by a passenger. See — F. Supp. 2d —-, No. 2:07-CV-730-FtM-29SPC, 2010 WL 326113 (M.D. Fla. Jan. 21, 2010). Thus, in that case, the jury will decide the issue.

The case arose out of a May 2007 accident during which an 18 year old female Plaintiff was injured after falling off a personal watercraft (i.e., a jet ski) manufactured by the defendant, Bombardier. She apparently had not planned to ride a watercraft that day until she encountered some friends at the beach who had their own watercraft. In fact, she had never ridden a watercraft before the day of the accident, which she communicated to her friend, the owner of the craft. Wearing a bikini and a life jacket (but no other protective clothing or gear), she, as the passenger, held onto the driver’s waist by way of his life jacket straps. At some point during the ride, she lost her grip and fell backwards into the water. As a result of the fall, she suffered internal injuries which resulted in several surgeries. Plaintiff testified that she herself saw no warning labels.

The personal watercraft did feature warnings under its handlebars (which the court noted were “in front of the driver”), the relevant portions of which read:

WARNING

To reduce the risk of SEVERE INJURY DEATH:

WEAR PROTECTIVE CLOTHING. Severe internal injuries can occur if water is forced into body cavities as a result of falling into water or being near jet thrust nozzle. Normal swimwear does not adequately protect against forceful water entry into lower body opening(s) of males or females. All riders must wear a wet suit bottom or clothing that provides equivalent protection (ss Operator’s Guide). Footwear, gloves, and goggles/glasses are recommended.

To Wear

The operator and passenger(s) must wear protective clothing, including:

-A wet suit bottom or thick, tightly woven, snug fitting clothing that provides equivalent protection. Thin bike shorts for example would not be appropriate. Severe internal injuries can occur if water is forced into body cavities as a result of falling into water or being near jet thrust nozzle. Normal swimwear does not adequately protect against forceful water entry into the lower body opening(s) of males or females.

Id. at *2 (emphasis added). The warning was also accompanied by graphics indicating the appropriate attire to be worn by drivers and passengers of the watercraft.

In light of the language advising passengers what to wear when riding on the watercraft, Bombardier moved for partial summary judgment on Plaintiff’s warning claims. The court first found that the warning itself was “clear, specific, and unambiguous” and that it “it accurately, clearly, and unambiguously warned riders, including a passenger, of the foreseeable dangers of catastrophic injury.” Id. at *3. Nevertheless, the Court denied Bombardier’s motion for summary judgment on those grounds due to the placement of the warning. In so doing, the court concluded that because “the Warning was arguably placed where only the driver could readily observe it . . . a jury question exists as to the adequacy of the Warning based upon its placement.” Id. However, in reciting the facts to the case, the court recounted the Plaintiff’s testimony that she did not recall anything that would have prevented her from seeing a warning label.

Further, it seems that the court may have only considered Plaintiff’s vantage point at the time she was riding the watercraft, not at any time beforehand. The opinion does not recount in detail the facts leading up to the Plaintiff’s riding the watercraft. Presumably, though the warning may not have been fully visible to a passenger at the time that the driver was also upon it, it may have been completely visible at the moments immediately prior to either person actually climbing aboard it. The court did not analyze or elaborate upon those issues.

The Court did grant one portion of Bombardier’s motion. The Plaintiff claimed that Bombardier “violated federal regulations, standards, and statutes pertaining to the obligations of consumer product Manufacturers to recall and make modifications to a product after the manufacturer knows or should have known of a defective feature in such product.” The basis of Plaintiff’s claim was that Bombardier assumed the duty to replace the Warning label by virtue of a provision in the Operator’s Guide. In rejecting this claim, the court found that Florida law imposed no such requirement and that Plaintiff “simply place[d] far more weight on this replacement provision than it will bear.” Id.

Distracted Driving to Spark the "Next Big Thing" in Products Liability Law?

As technology and product innovation expand into new territory, breaking ground to appease a generation accustomed to instant, at-their-fingertips access to digital information, so too does products liability litigation. Some speculate the next “wave” of products liability litigation will stem from consumers’ use of communication devices and other electronic equipment while on the roadways, resulting in the “senseless and preventable destructive practice of distracted driving.” [PDF].

An article published recently by The New York Times as part of its “Driven to Distraction” series (which is worth checking out: try the “Gauging Your Distraction” game that has you attempt to respond to texts while changing lanes) explains that in spite of huge risks, technology giants and automakers are bringing Internet access – by way of what have been dubbed “infotainment systems” – to drivers’ dashboards. According to the article, one such system expected to be unveiled by Audi this fall allows drivers to access the Internet and pull up information as they drive. A notice reportedly will pop up that reads: “Please only use the online services when traffic conditions allow you to do so safely.” Although some automakers plan to restrict access to potentially distracting functions while the car is in drive, much of the responsibility in limiting use while driving will lie with drivers.

The issue of distracted driving is at the forefront, as there has been a government push to curb distracted driving dangers. Even Oprah has joined the cause. In terms of the scope of damages, The New York Times article cited a 2003 study by Harvard researchers, who estimated that motorists talking on cellphones caused 2,600 fatal accidents and 570,000 accidents involving injuries a year.

So how does this translate into product liability litigation? In its recently published “Client Alert,” the Micheal Best firm sets forth the three most likely product liability causes of action to be alleged against creators of these “distracting” products:

(1) Design Defect–when the foreseeable risks of harm posed by the product could have been reduced or avoided; (2) Inadequate Instructions or Warnings – an omission of a warning that renders the product not reasonably safe; and (3) Failure to Warn–the seller’s failure to provide a warning after the time of sale.

Numerous successful civil lawsuits have arisen against the distracted drivers themselves, including one settled here in South Carolina this month for $5 million by the insurer of a driver who, while talking on her cellphone, struck and killed two bicyclists. It is only a matter of time before a floodgate of litigation opens against the makers of these distraction-inducing products.