Friday Links

  • Intellectual Property Examination Question: Suppose the students at Ole Miss are successful in changing their school mascot to Admiral Ackbar from Return of the Jedi. (See here for the full story, or if you’d like to see the websites of the students behind the effort, see here and here). What causes of action might George Lucas have against the school, and if he could make money selling Ole Miss toys, would he bother to assert them? Better yet: What claims would the government Mon Calamari, Admiral Ackbar’s home world, have against Ole Miss under the circumstances? The potential for speculation is endless. (We here at Abnormal Use are still contemplating our suit against Mr. Lucas for his perpetration of the alleged Star Wars prequels, which we believe were, as a matter of law, unreasonably dangerous and defective.).
  • Bruce is in legal news again. Decided: The Findlaw Noteworthy Decisions and Settlements Blog reports on the Ticketmaster settlement with the Federal Trade Commission on behalf of Bruce Springsteen concert ticket holders. The post also includes links to the FTC complaint, warning letter, and news release regarding the settlement. Can you count all the references to Springsteen songs in the piece? Surely, though, a reference to “The Price You Pay” would have been appropriate?
  • If you’re a South Carolina lawyer, and you’re a member of a rock band (or, presumably, any other type of band), here’s a unique networking opportunity for you. From this week’s South Carolina YLD Email Newsletter: “The Young Lawyers Division is calling upon talented lawyer-musicians to participate in this year’s Justice Jam, scheduled for April 30 at the Elbow Room in Columbia. Proceeds will benefit Sexual Trauma Services of the Midlands. Bands of all flavors are encouraged to submit a demo for consideration. The only qualification is that bands have at least one attorney member. Please send MP3s to Travis Olmert at travis.olmert@carterlawpa.com or CD demos to Travis at Carter, Smith, Merriam, Rogers & Traxler, PA, P.O. Box 10828, Greenville, SC 29603. All demos should be submitted on or before March 22. Remember, only send a MP3 or demo if your band is willing to play. The lineup will be chosen and announced by April 2.”
  • “[T]his court recognizes the ubiquity of computers today in the workplace, in schools, public institutions, and in government, and the prevalence of agreements and policies governing such use. Many of these impose unrealistic rules honored in the breach. It takes no imagination to conjure up a multitude of trivial and not so trivial violations that take place every day in the workplace. Workers use workplace computers for personal use in violation of requirements that they use their computers for business only. Workers violate policies prohibiting access to social networking sites. Reportedly, fifty-four percent of companies ban workers from accessing social networking sites like Twitter, MySpace and Facebook, yet seventy-seven percent of workers with a Facebook account use it during work hours. S. Gaudin, Study: 54% of companies ban Facebook, Twitter at work, Computerworld (Oct. 6, 2009).” State v. Riley, — A.2d —-, 2009 WL 5879349, at *13 (N.J. Super. Ct. Oct 30, 2009) (but apparently released to Westlaw only this week).
  • This past Wednesday, South Carolina Supreme Court Chief Justice Jean H. Toal delivered the State of the Judiciary Address. An archived video of the speech can be seen here, along with a PDF version of her PowerPoint presentation slides. News coverage of the speech focused upon Justice Toal’s statement that the South Carolina courts were running on fumes financially and that tough decisions lay ahead. (For additional news coverage of her speech, see here and here). (Hat tip: South Carolina Access to Justice Commission).

New News or Not So New News Concerning Avandia?

It appears that the U.S. Food and Drug Administration is taking steps that may end up in removing a popular Type II Diabetes drug, Avandia, from the market. In a safety announcement issued on February 22, 2010, the FDA reported that it is continuing to review data and various studies on the drug rosiglitazone, including the RECORD study. RECORD is the acronym for Rosaglitizone Evaluated for Cardiovascular Outcomes and Regulation of Glycemia in Diabetes. The results of RECORD were released in August of 2009 in a medical journal. The FDA’s safety announcement came on the heels of the recent U.S. Senate Finance Committee report which detailed the committee’s findings, including a possible link between the drug and an increased risk in heart attacks. Specifically, the Finance Committee found:

…the reviewed evidence suggests that GSK [GlaxoSmithKline] knew for several years prior to this study that there were possible cardiac risks associated with Avandia. As a result, it can be argued that GSK had a duty to warn patients and the FDA of the Company’s concerns. Instead, GSK executives attempted to intimidate independent physicians, focused on strategies to minimize or misrepresent findings that Avandia may increase cardiovascular risk, and sought ways to downplay findings that a competing drug might reduce cardiovascular risk.

Such strong language by the Senate Finance Committee likely has trial lawyers salivating over the sheer number of potential products cases that could be in the pipeline if indeed Avandia is removed from the market. Considering that Avandia sales were approximated at $2.6 billion for the year 2006, there may be potential litigation looming against GlaxoSmithKline.

However, the Senate Committee’s report is NOT news. That is at least the opinion of the American Association of Clinical Endocrinologists (AACE). Dr. Alan Garber, editor of the AACE Patient Safety Exchange, released a statement concerning the “rash of headlines” that resulted after the Senate Committee report was apparently leaked to the New York Times. In his statement, Dr. Garber provided insight on the various studies and then concluded that the “news” about Avandia was in fact “. . . old news, quite old indeed. ” Where does this leave us? Good question. However, it appears that the RECORD study concluded that Avandia did not place its users at an increased risk of death or hospitalization for cardiovascular disease. The more pertinent question may be whether use of the drug places someone at an increased risk for developing cardiovascular disease or a heart attack. As with all studies, there are sometimes more questions or concerns that are raised about the study itself. As such, the FDA is taking a prudent approach in continuing to examine the various studies including the data compiled by the RECORD study before it takes action, if any, this summer.

Abnormal Interviews: Law Professor Michael J. Virzi

Today, Abnormal Use continues its new series, “Abnormal Interviews,” in which this site will conduct brief interviews with law professors, practitioners and other commentators in the field. For the second installment, we turn to law professor Michael J. Virzi of the University of South Carolina School of Law. Virzi, a former prosecutor with the South Carolina Office of Disciplinary counsel, now teaches legal writing and chairs the South Carolina Bar’s Ethics Advisory Committee. He also practices in the areas of ethics and malpractice defense. The interview is as follows:

1. What recent developments in ethics law would you recommend that litigators be aware of in 2010?

Subpoena practice. Abuse of subpoena rules has been rampant for decades and, although there have been no rule changes, there has been increased awareness by the bench and attention to the limitations. The problem stems from the jurisdictional limits on a court’s subpoena power. A subpoena is essentially a court order. It is issued by the court; lawyers are merely granted the privilege of issuing them on behalf of the court. The abuse has been in issuing subpoenas outside the court’s jurisdiction. A lawyer cannot issue a subpoena that the court itself would have no jurisdiction to issue. The jurisdictional limit of the Circuit Courts is the State of South Carolina. Nevertheless, many lawyers will subpoena an out-of-state non-party entity (e.g., a bank) rather than an in-state representative. For Magistrate’s Court, the jurisdictional limit is the county in which the court sits. Nevertheless, lawyers often improperly subpoena out-of-county witnesses in Magistrate’s Court cases. The problem is particularly pronounced in City Courts—like Columbia, West Columbia, and Cayce—that neighbor county lines, but it has been reported in remote, rural areas as well. Finally, both Magistrate’s Courts and Family Courts have more limited subpoena power than Circuit Courts, as both courts lack extensive discovery procedures.

Specific Magistrate’s Court procedures were recently promulgated to clarify the appropriate way to reach out-of-county parties. Significantly, however, the rules and limitations did not change; they were merely clarified. A Magistrate’s Court’s jurisdiction—and therefore its subpoena power—has always been limited to the county in which the court sits. The disciplinary authorities have been aware of this for years, and the bar is starting to catch on.

2. What is the most significant ethics opinion to come out in the last year? Why is it significant?

The December 21, 2009, In the Matter of an Anonymous Member of the South Carolina Bar opinion by the South Carolina Supreme Court involved a lawyer issuing discount coupons through the lenders and real estate agents who referred business to him. The agents were soliciting clients in-person for the lawyer, something the lawyer himself is prohibited from doing under Rule 7.3(a). In 2007, Ethics Advisory Opinion 07-09 had advised that such conduct would be impermissible under 7.3(a), even though the lawyer personally does not conduct the in-person solicitation, because Rule 8.4(a) prohibits a lawyer from violating any of the Rules of Professional conduct “through the acts of another” and from “assisting or inducing another to do so.” The Ethics Advisory Committee believed that 8.4(a) prohibited a lawyer from having a surrogate solicit clients in person where the lawyer may not do so according to Rule 7.3(a).

The Court in In the Matter of an Anonymous Member of the South Carolina Bar expressly overruled 07-09, stating that the policies underlying the in-person solicitation prohibition are not compromised where the lawyer is not personally present. Because there is no “insistence upon immediate retention or importuning of the trained advocate,” in-person solicitation through a surrogate is not prohibited. The reasoning is simple, but the consequences are profound. The court essentially held that the “vicarious misconduct” prohibition of 8.4(a) does not apply to 7.3(a). The court has never previously held any of the Rules exempt from 8.4(a), nor am I aware of any other jurisdiction having done so. The court’s reasoning applies equally to ambulance drivers, triage nurses, police officers, jailers, and any other party a lawyer might use to personally solicit clients by handing out business cards or coupons in the lawyer’s stead. The court held that whether the recipient is in need of legal services is irrelevant. Because the practice is “similar in fashion to the common practice of leaving business cards for distribution” and the agents are not under the lawyer’s control (they “could have thrown away the coupons”), the court found the agent-solicitations permissible.

3. What do you think is the most overlooked ethical rule? Why is it overlooked?

Probably 7.2(b), or at least its applicability to electronic media. 7.2(b) includes the filing and record-keeping requirements for all lawyer advertising. Too many lawyers fail to realize that their web sites constitute advertising under the Rules and therefore fail to conform their sites to the specific prohibitions regarding advertising. Even when the content of online information is in conformity with the remainder of Rule 7.2, too many lawyers fail to file the materials with the Commission on Lawyer Conduct and keep copies for two years “along with a record of where and when it was disseminated” as required by 7.2(b).

4. As the general public increasingly uses the Internet and social media to communicate, how do you predict that state bars will react to the popularity of this new technology among attorneys?

Despite all the hype about how the Rules of Professional Conduct need to “catch up” with technology, I think the rules are adequate and state disciplinary authorities will simply apply them as written to online communication. I think lawyers, one by one, will continue to be shocked and amazed that their online conduct is measured against Rules 7.1 (communication), 7.2 (advertising), and 7.3 (solicitation), but regardless of the forum or medium, communicating is communicating, advertising is advertising, and soliciting is soliciting. The rules make no distinctions between print, radio, or television, and they need no special provisions for the Internet or other media. The rules distinguish only between that which is “disseminated via public media” and that which is not. If your use of Facebook is kept private among your friends, it’s not publicly disseminated. If you allow it to be viewed publicly, then it’s disseminated. Anything searchable by public search engines like Google and Yahoo! is disseminated under the rules. Linked-In and Twitter are likewise publicly disseminated. That doesn’t mean lawyers can’t use these services; it just means they are regulated when used in relation to the lawyer’s practice, as opposed to being used solely in a lawyer’s personal life.

5. If you could offer young lawyers beginning their careers one piece of advice, what would it be?

To paraphrase Polonius (Hamlet, Act I, Scene III), “Above all else, to thine own self be true.” Never let any partner, associate, client, opposing counsel, judge, or anyone else talk you into doing something you think is wrong. Never be afraid to walk away. Your fears and your needs can quickly and easily become someone else’s power over you, and those who would wield that kind of power would never wield it in your best interest.

BONUS QUESTION: What do you think is the best depiction in popular culture of an attorney facing an ethical issue?

I really enjoyed Jim Carrey’s performance as Fletcher Reede in Liar Liar. Fletcher’s son cast a spell on him, prohibiting him from lying just before Fletcher was to represent a client in her divorce hearing. He knew his client was having an affair, which would trigger a clause in her prenuptial agreement prohibiting her from receiving any of her husband’s multi-million-dollar estate. The spell prevented Fletcher from examining her or the paramour without disclosing the affair. (Ignore for a moment that he was perfectly willing to allow his client to lie on the stand — arguably, he never “faced” that issue). At one point he objected to certain testimony, the judge asked why, and Fletcher responded, “Because it’s devastating to my case!” But his best effort was at getting a continuance until after the spell was broken, which he could not truthfully tell the judge he needed. To get the continuance without lying, he went into the bathroom and beat himself up. When the judge asked who had done it, Fletcher replied, “A madman, your honor, a desperate fool at the end of his rope.” Nevertheless, the ploy failed. The best part was watching Fletcher struggle to find an honest, truthful path to victory in the case. Ultimately, he discovered that his client had lied about her age in order to get married early, a revelation that also voided her prenuptial agreement for incapacity and entitled her to half of her husband’s estate despite the infidelity.

BIOGRAPHY: Mr. Virzi teaches Legal Writing at the University of South Carolina School of Law and practices in Columbia in the areas of ethics and malpractice defense. He formerly worked as Assistant Disciplinary Counsel for the Supreme Court of South Carolina. He graduated cum laude from the University of South Carolina School of Law in 2000. He is a member of the North and South Carolina Bars and is currently the Chairman of the South Carolina Bar’s Ethics Advisory Committee. In 2009, he served on the South Carolina Bar Young Lawyers Division Social Media Task Force.

Companies Aren’t Liable for Other Companies’ Products . . . Except in California

It may seem elementary that in terms of product liability law and litigation, manufacturers cannot be deemed liable for the alleged actions or inactions of third-party companies over which the manufacturers have no ownership interest or control. Not so, according to one recent case in California, which has inspired many plaintiffs to go after big-name drug manufacturers in the pharmaceutical industry.

The California appellate court holding, which has sparked considerable controversy and disdain within the legal and pharmaceutical industries and in courts throughout the country, was issued in November of 2008. Conte v. Wyeth, Inc., 168 Cal. App. 4th 89, 85 Cal. Rptr. 3d 299 (Cal. Ct. App. 2008). Conte involved the use of metoclopramide, a drug which had been sold by Wyeth as Reglan before going off patent and becoming subject to manufacture in generic forms. A user of one of these generic medications alleged that as a result of prolonged use of the drug, she developed tardive dyskinesia, a debilitating and incurable neurological disorder. She filed suit, not against the manufacturer of the generic drug or the doctor who prescribed it, but against the deep-pocketed manufacturer of the name-brand form of the drug.

The Conte court broke new ground with its holding:

We hold that Wyeth’s common-law duty to use due care in formulating its product warnings extends to patients whose doctors foreseeably rely on its product information when prescribing metoclopramide, whether the prescription is written for and/or filled with Reglan or its generic equivalent. The risk of harm is foreseeable to Wyeth.

As such, even though it was undisputed that the plaintiff had not consumed a product manufactured by Wyeth — indeed, it was a product of its competitor — and undisputed that Wyeth did not provide labels for or sell the product at issue, Wyeth essentially was held liable for the alleged negligence of another. This California court opinion has, however, been universally rejected by courts throughout the country, all of which apparently recognize the dangers of extending liability to one company for the actions of another.

Most recently, nearly identical issues were addressed in a federal district court in Florida. Levine v. Wyeth, Inc., — F. Supp. 2d —, No. 8:09-CV-854-T-33AEP, 2010 WL 456773 (M.D. Fla. Feb. 10, 2010). The Levine plaintiff, just as the Conte plaintiff had before him, conceded that he never ingested Reglan or any other product made by the defendant, but claimed instead that he developed tardive dyskinesia as a result of use of the generic form of the drug. Relying on the Conte opinion, he alleged theories of negligent misrepresentation, fraud, negligence, strict liability, and breach of warranty.

The plaintiff claimed that doctors, pharmacists, and patients, in prescribing or being prescribed prescription drugs, rely on information provided by companies like Wyeth. The defendant, in turn, simply argued that it could not be held liable under any of the plaintiff’s causes of action as a matter of law because the plaintiff never used its product.

The Florida court sided with Wyeth, granting its motion for summary judgment as to all causes of action:

The holding in Conte is not binding on this Court, and runs counter to the overwhelming majority of case law, including that of Florida. The Court cannot impose a duty of care on Defendants here where the generic manufacturers are responsible for the contents of their label, and where the Defendants lacked direct control as to the contents of that label.

The court cited additional case law in support of its ruling, which set forth that “it is aphoristic that a plaintiff cannot prevail on [product liability claims] unless the plaintiff establishes that the product which allegedly caused the plaintiff’s injury was manufactured or sold by the defendant.” Florida and other state courts throughout the country still abide by the rational approach to product liability law — that a company is liable for its own actions or inactions, but not for those over whom it has no control. While this California court opinion remains controlling authority in that state, though, it surely will inspire additional plaintiffs to give it a shot.

Manufacturers, Importers, Distributors, and Retailers Beware: Unilateral Recall for Lead Violations may not be Enough

On February 4, 2010, the U.S. Consumer Product Safety Commission (“CPSC”) announced that Schylling Associates (“Schylling”) had agreed to pay a $200,000 civil penalty for lead paint violations that occurred between 2001 and 2003. This agreement is the result of CPSC staff allegations that Schylling distributed children’s toys for sale to consumers that contained more than 600 part per million in lead, which was the legal limit at the time of the alleged violations, and failed to report such violations to the CPSC. Schylling had denied that it knowingly or intentionally violated any provision of the Consumer Product Safety Act (“CPSA”) and the settlement agreement [PDF] between the CPSC and Schylling provides that the agreement does not constitute an admission that it knowingly violated the CPSA.

What is important to know for manufacturers, importers, distributors, and retailers as well as practitioners defending these entities are the facts that gave rise to this settlement agreement. From January 2002 to March 2002, Schylling imported tin pails from one of its manufacturers in Hong Kong. On March 2, 2002, testing results ordered by Schylling revealed that certain wooden handles on these pails were not in compliance with the CPSA. As a result, on March 26, 2002, Schylling performed a unilateral recall.

Additionally, between June 2001 and July 2002, Schylling imported approximately 66,000 spinning tops from another one of its Hong Kong manufacturers. On June 30 and July 1, 2002, Schylling received a report, upon its request, which provided that the wooden handles on certain samples of these tops were not in compliance with the federal lead limit. Schylling thought that it had discovered the issue before any tops had been imported into the U.S. and solved the problem by instructing its manufacturer to only use plastic handles. Schylling was wrong.

Five years later, in August 2007, a news reporter from the Chicago Tribune contacted Schylling reporting that he had purchased a non-compliant top from a U.S. consumer. As a result, Schylling submitted a report to the CPSC regarding both the tops and pails it imported from 2001 to 2003. The CPSC announced a recall of these items on August 22, 2007 and Schylling reported to its customers that they were working to resolve the issue and ensure the safety of all future products.

The CPSC has provided that while Schylling’s March 26, 2002 unilateral recall succeeded in recovering 85 percent of the non-compliant pails, the rest of the pails were not recovered and in the hands of consumers for five years. CPSC Chairman, Inez Tenenbaum stated that “[m]anufacturers, importers, distributors and retailers have a legal obligation to ensure that no banned products are introduced into or distributed in the U.S. marketplace, and to inform CPSC as soon as they become aware of information that must be reported under our laws.” Further, she warned that the CPSC would “continue to penalize companies that do not follow these basic requirements.”

The Schylling recall and resulting settlement agreement has provided all manufacturers, importers, distributors, retailers and their counsel instructions that the CPSC must be notified when there is even a potential risk of violation and that unilateral recall and investigation will not protect against this type of civil penalty.

Friday Links

Well, it’s Friday, so we might as well have some fun with popular culture. The law is not often a subject for the poets and singer songwriters, but when it is, such artists are usually at its mercy. Case in point: In the YouTube clip above, Bruce Springsteen covers “I Fought The Law,” made famous by the Bobby Fuller Four, and covered by many bands, including The Clash in 1979, the Dead Kennedys in 1987, and Green Day in 2004. (That’s right; you are reading a products liability law blog written by defense attorneys who know and reference punk bands.). Wikipedia alerts us that the song was done originally by Sonny Curtis and The Crickets (after the death of the late, great Buddy Holly). However, it was the Bobby Fuller Four’s version that brought the song into the public consciousness. Enjoy.

The question: Are personal letters from U.S. Supreme Court Justices to screenwriters considered persuasive authority? This week, the blogosphere has been picking apart Justice Scalia’s 2006 letter to screenwriter Daniel Turkewitz, whose brother, Eric Turkewitz, runs the New York Personal Injury Law Blog. Daniel had been researching the basis for a screenplay about Maine and secessionists, and not being a lawyer, he wrote all sitting members of the U.S. Supreme Court for advice on how to depict a legal dispute over secession in his film to be. Eric posted a copy of Justice Scalia’s response at his blog on Tuesday, and since that time a number of blogs have discussed it, including two separate posts at The Volokh Conspiracy (here and here). If you’ve not yet read the letter, check it out. Interestingly enough, Justice Scalia was the only Justice to reply to Daniel’s letter.

The Busy Lawyer’s Guide to Success has posted its Top Ten iPhone Apps for Busy Lawyers. (Hat tip: The Mac Lawyer). We here at Abnormal Use recommend TweetDeck, and, of course, Shazam, which no lawyer – indeed, no person – should be without.

According to this report at Injured: The Findlaw Accident, Injury and Tort Law Blog, Plaintiff’s lawyers are already seeking black box data from Toyota in the new acceleration suits. Attorneys should keep an eye on this litigation. Although some black box data can be downloaded by third party applications and consultants, some cannot. If judges get into the habit of granting orders compelling automotive companies to download their vehicles’ black box data, how might those same judges rule in later personal injury cases in which the automotive company is not (necessarily) a defendant? We’ll see.

Caveat Emptor . . . SERIOUSLY!

Average consumers generally trust the notion that the products they purchase “are what they say they are.” But that’s not always the case. Patients at a doctor’s office and home consumers buying medical devices or dietary supplements over the Internet continue to face the issue of misbranding and mislabeling. Recent examples of this disturbing trend abound.

On February 9, 2010, the United States Attorney for the Northern District of New York issued a press release wherein the Department of Justice recounted the sentencing of a group of plastic surgeons using a non-Food and Drug Administration approved TRI-toxin instead of the FDA approved drug, Botox. The sentencing included the following:

THE PLASTIC SURGERY GROUP, LLP (TPSG) of Albany, New York, was sentenced and ordered to pay restitution in the amount of $106,686, and a fine of $200,000, in connection with TPSG’s plea of guilty to one felony count of misbranding drugs, in violation of Title 21,United States Code, Sections 331(k), 352(i)(3), and 333(a)(2) . . . .

Additionally, Doctors WILLIAM F. DE LUCA, Jr., DOUGLAS M. HARGRAVE, JEFFREY L. ROCKMORE, STEVEN M. LYNCH, and JOHN D. NOONAN, were sentenced to probation with community service, and ordered to pay restitution in the amount of $106,686, and a fine of $5,000. TPSG’s practice administrator, PETER M. SLATTERY, and supervisory nurse SUSAN F. KNOTT, were also sentenced and ordered to pay restitution in the amount of $106,686, and fines in the amount of $1,000 and $500, respectively. All individual defendants were sentenced in connection with their guilty pleas to one misdemeanor count of misbranding drugs, in violation of Title 21, United States Code, Sections 331(k), 352(i)(3), and 333(a)(1) . . . .

Just the day before, on February 8, 2010, the United States Attorney for the Southern District of California issued a press release regarding the sentencing of a man who sold thousands of unregistered medical devices that he claimed could treat anything from worms to AIDS. That man, James Folsom, was sentenced to 51 months and ordered to pay a fine of $250,000.

The evidence presented at Folsom’s trial indicated that he marketed the device under the names “NatureTronics,” “AstroPulse,” “BioSolutions,” “Energy Wellness,” and “Global Wellness.” The supposed medical device housed a digital readout that consumers could use to adjust the device to certain settings, as indicated in the accompanying manual, to treat a whole host of maladies including diabetes, strokes, ulcers, AIDS, and worms. The U.S. Attorney’s press release stated:

According to the testimony at trial, during the period from 1997 through August 2008, the defendant purchased over 9,000 units, which he sold to distributors for approximately $1000-1200, and to retail customers for $1995, with sales totaling over $8 million. The devices were manufactured by the defendant and others in a San Diego location, which he failed to register with the Food and Drug Administration (FDA) as a device manufacturing establishment. The defendant used the false name “Jim Anderson,” when selling the device and used post office boxes, self-storage units, and bank accounts opened in the names of others to conduct his business in an effort to avoid detection by the FDA.

The devices were adulterated in that they were marketed without a valid investigational device exemption, without pre-market approval, and in violation of an electrical performance standard set by the FDA, prohibiting lead wires that come into contact with patients from being able to come in contact with potentially hazardous voltages.

Finally, this past January, the FDA updated its earlier warning over an unapproved doppelganger of the FDA’s approved weight loss supplement, Alli. In that update, the FDA provided helpful information, including photos, to assist consumers in identifying the counterfeit drug which contained a non-approved dosage of the active ingredient found in Alli and other weight loss pills, sibutramine. As long as criminals suspect that they can profit from selling unapproved drugs and medical devices, they will continue to do so. As such, it becomes all the more important for consumers to exercise the old Latin adage – caveat emptor! This seems to beg the question: did the Romans have the same problem that we have today?

Doping is Not Worth It

Above: The likely lead exhibit in the litigation predicted below. Click to enlarge.

As Americans, we have a love/hate relationship with food that usually results in hyperlipidemia. So much so that many of you have been driven to the edge of sanity by consuming copious amounts of leafy greens, only to binge on vats of ice cream and trans fats. To you health-conscious readers who recoiled in horror at my fried chicken sandwich post (but secretly enjoy the delicacy that is gas-station fried chicken), we now confront the quagmire of nutritional supplements (read:”steroids”). Perhaps even the health-conscious will admit that some take their “health” too seriously. Having not been to the gym in several years, I can only assume that there are still guys who gel their hair before embarking on 1.8 hour bench press sessions and grunt convincingly about the latest supplements in voices that carry throughout the room. In law school, we called such people “undergrads.” If you know someone fitting this description, let them know of a recent recall.
It all begins with Musclemaster.com, which undertook a voluntary recall of several products that the Food and Drug Administration recently claimed contained, you guessed it, steroids. Rather than take a completely sarcastic spin on this, I’m slightly sympathetic towards Musclemaster. After all, the typical customer wants to push his limits, so, it’s not surprising that the company would push the limits as well. And what better way to indicate that you are pushing the limits than to name your products, for example, “Anabolic Xtreme” or “Monster Caps.” For its part, Musclemaster.com cannot independently confirm whether there were steroids in those products. Nevertheless, Musclemaster.com recalled the products out of “an abundance of caution.”

Perhaps the officers at Musclemaster.com sensed litigation, because a California Appeals Court recently reversed an order denying certification of a class of supplement purchasers. In In re Steroid Hormone Prod.Cases, No. B211968, 2010 WL 196559 (Cal. Ct. App. Jan. 21, 2010) [PDF], Diego Martinez sued for relief under the Unfair Competition Law (UCL) and Consumer Legal Remedies Act (CLRA) because General Nutrition Companies sold supplements containing androstenediol, defined as a controlled substance under California law. The trial court denied class certification on the grounds that individual questions of causation and injury predominated. Martinez failed to establish that he represented the views of the class, in that Martinez testified that he would not have purchased the substances had he known of their illegality under California law. The trial court was not persuaded and gently stated that it could not infer Martinez’s high-mindedness to the rest of the purported class.

The appellate court reasoned that because of the status of California law, a showing of individual deception and reliance wasn’t necessary under the UCL and that the trial court used an incorrect legal assumption under the CLRA. The appellate court left open the question whether there is a “reasonable bodybuilder” standard, and, if so, its application in this matter. As noted above, and as found by the trial court, a reasonable bodybuilder might push the limits more than your ordinary reasonable person. Isn’t it at least plausible that a reasonable bodybuilder would hope against hope that his supplement contained a little something extra. Maybe not in the post-Schwarzenegger era. The court’s legal reasoning is straightforward, but the supplement crowd may have fashioned a workable grand scheme: Buy supplements, see if they work, and if they don’t, seek restitution under consumer protection statutes. Those who disagree may just have sand kicked in their faces.

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.

da Vinci on Trial

No, Leonardo da Vinci has not been brought back to life and put on trial, it is the new da Vinci Surgical System that was the subject of a recent products liability lawsuit that was decided in favor of the manufacturer by the Third Circuit on January 28, 2010.

In Mracek v. Bryn Mawr Hospital, No. 09-2042, 2010 WL 318372 (3d Cir. Jan. 28, 2010) [PDF], Plaintiff Ronland Mracek was diagnosed with prostate cancer and underwent a prostatectomy. Mracek was told by his surgeon that he intended to use the da Vinci robot to assist in the surgery. However, during Mracek’s surgery, the da Vinci robot became nonoperational and merely displayed error messages. As a result, Mracek’s surgeon used laparoscopic equipment instead.

Approximately one week after Mracek’s surgery, he suffered a gross hematuria and now has severe groin pain and erectile dysfunction. Thereafter, Mracek filed suit against the hospital and the manufacturer of the da Vinci robot, Intuitive Surgical, Inc., asserting claims for strict product liability, strict malfunction liability, negligence, and breach of warranty. The hospital was voluntarily dismissed from the case and Intuitive moved to dismiss the complaint. The United States District Court for the Eastern District of Pennsylvania agreed with Intuitive and dismissed Mracek’s complaint.

Mracek appealed to the Third Circuit solely on his strict malfunction liability claim. While a plaintiff can prove a defect using circumstantial evidence under the malfunction theory of liability, the plaintiff must still produce “evidence of the occurrence of a malfunction and . . . evidence eliminating abnormal use or reasonable, secondary causes for the malfunction.” Id. at *1 (internal citations omitted). Further, even if a plaintiff is able to prove the existence of a defect in this manner, he or she still has the burden of proving the defect caused the plaintiff’s injury and that the defect existed when it left the manufacturer’s control.

Mracek’s claim failed on multiple levels. First, the Third Circuit stated that the mere fact that “the robot displayed ‘error’ messages and was unable to complete the surgery” was insufficient evidence to eliminate reasonable, secondary causes for the malfunction. Id. at * 2. Further, the Court found that his own testimony and the testimony of two treating physicians regarding his pre and post operative condition was insufficient to prove that his erectile dysfunction and groin pain were caused by the robot’s alleged malfunction. The Third Circuit affirmed the dismissal of Mracek’s complaint. Id.

This opinion again demonstrates the importance of expert testimony in products liability actions. It instructs that merely coming to court and stating that a product malfunctioned is insufficient. Plaintiffs who fail to prove proximate cause should have their claims dismissed.