Wells, the Plaintiff, sued Smithkline Beecham d/b/a GSK, because he claimed that GSK’s drug Requip caused irresistable gambling urges. Wells was a pathologist who had to retire due to Parkinson’s disease. Wells was originally prescribed Mirapex to alleviate his symptoms, but he later read an article that Mirapex might cause “problem gambling.” Wells had already lost $2 million at this point. He was then prescribed Requip, which did not bear any warning about problem gambling. You can bet what happened next.

The district court granted summary judgment to GSK on causation, and the Fifth Circuit affirmed, citing Daubert. Wells put up three experts to say something like “Requip causes gambling problems.” Although Wells’ counsel was able to string together some case-specific information showing some correlation between Requip and gambling impulses, the Fifth Circuit was pretty clear:

Each of the three experts, though, conceded that there exists no scientifically reliable evidence of a cause-and-effect relationship between Requip and gambling.

Id. I imagine that the defense lawyer was somewhat bewildered when each expert admitted at deposition that there was no scientific evidence on which to base an opinion as to causation. The summary judgment motion pretty much writes itself. Without any scientific basis of opinion, the experts can’t opine in court, and, therefore, Wells claim failed for lack of proof of causation. What’s the big deal, you say? This seems pretty straightforward. Well yes, but I would point out two issues on which I will pontificate. First, Wells was just unlucky in the factual sense of the word. Based upon the Requip Patient Information [PDF] (which admittedly is an updated version that notes the potential for impulsive behaviors, including gambling) Wells could have experienced some other side effects that may or may not have been preferable. First, the warnings indicate that a patient may fall asleep during an activity of daily living, perhaps without a warning of drowsiness. Narcolepsy in Vegas could have its positives and negatives. I could envision a scenario where you’re losing at a table without the will to get up, and then you faceplant into your chips. While having a chip impaled through your forehead may hurt, at least the (figurative) bleeding would stop (maybe). I suppose there’s always the chance for somnambulistic wagering.

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.

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.”

Prior to this amendment, the Commission considered the following factors in its determination of the amount of a civil penalty: “the severity of the risk of injury; the occurrence or absence of injury; and the number of defective products or the amount of substance distributed.” Now, the Commission is required to consider the following additional factors:

Of interest is not that the Commission now has additional factors to consider but some of the reasons that this was not a unanimous vote of approval. Chairman Inez M. Tenenbaum, Commissioner Robert S. Adler, Commissioner Thomas H. Moore, and Commissioner Nancy Nord voted to approve this rule. Chairman Tenenbaum, along with Commissioners Adler and Moore filed a joint statement of approval, and Commissioner Nord filed an independent statement of approval. [PDF]. Commissioner Anne M. Northup, on the other hand, “voted against the proposed Final Rule Interpreting Civil Penalty Factors because it fail[ed] to take the agency where [she] believe[d] it should arrive five years from now.” [PDF].

• Last week, we commented upon our fair city of Greenville’s attempt to woo Google to bring its fiber optic initiative to town. The search engine giant plans to choose a medium sized city in which it will offer Internet service up to 100 times faster than that currently available from traditional Internet service providers. Thus, cities across the nation are actively attempting to convince Google to select their locale to be the site of the Google’s new initiative. Above, you’ll see Greenville’s entry into the fray: an aerial photograph depicting thousands of glow stick wielding Greenvillians spelling out Google’s name in lights. For more photographs (aerial and otherwise), please see Greenville’s We Are Feeling Lucky website. We here at Abnormal Use greatly applaud this effort. If you’re on Twitter (like we are), you can follow news of Greenville’s quest with the hashtags #GoogleOnMain and #LuckyGVL. We offer our congratulations to the event’s organizers, who apparently organized the enterprise in less than two weeks time. Below, you can see a bird’s eye video of the scene:

• Foreign manufacturers should take note of some new law in New Jersey. In a recent piece entitled “Buy Globally, Sue Locally for Products Liability,” J. Russell Jackson of The National Law Journal notes that a recent New Jersey case significantly expands the concept of personal jurisdiction in products cases. That case is February’s Nicastro v. McIntyre Machinery America, Ltd., 987 A.2d 575 (N.J. 2010), and it may ensnare a number of foreign manufacturers, even those who do not purposefully avail themselves of the benefits of the forum. Jackson, of course, is also the author of the Consumer Class Actions and Mass Torts blog, long a staple of this site’s blogroll.
• On Wednesday, former circuit court judge John C. Few of Greenville was sworn in as the new chief judge of the South Carolina Court of Appeals. See here for the Greenville News report of the investiture.
• Here’s another interesting post. In a piece entitled “Toyota’s Embedded Software Image Problem,” Michael Barr of Embedded Gurus opines: “It remains unclear whether Toyota’s higher-than-industry-average number of complaints regarding sudden unintended acceleration (SUA) is caused (in whole or in part) by an embedded software problem. But whether it is or it isn’t actually firmware, the company has clearly denied it and yet still developed an embedded software ‘image problem.’ They’ve brought some of this on themselves.” Check out the full story for the rest of his thoughts on that topic.

In Dietz v. Smithkline Beecham Corp., No. 09-10167, 2010 WL 744273 (11th Cir. March 5, 2010) the court was interpreting Georgia law and correctly focused on the proximate cause between the decedent’s death and the adequacy of the warning provided to the physician. Dietz at *2-3. The court’s analysis was that the court, when applying the doctrine, must first look to the adequacy of the warning that was given. Id. at *2. The court cited to well-established Georgia case law that states that if the warning is adequate, the analysis ends and the plaintiff is barred from recovery. Id. In Dietz, the evidence was that the decedent’s physician testified that regardless of whether he knew about the increased risk of suicide with the use of Paxil, he still would have prescribed the drug to the decedent. Id. As such, the court reasoned that the Plaintiff could not establish proximate cause since the alleged failure to warn did not have an effect on the decision to prescribe the drug.

In this blogger’s opinion, the Centocor court should have ended its analysis when it found that the Plaintiff’s physician provided her with a warning about the risk of developing a lupus-like syndrome. Based on the doctor’s testimony, any potential proximate cause link between use of the drug and any warning would have been severed. I, along with others, am left to wonder how a physician’s direct warning of a potential risk can not, as a matter of law, be an adequate warning and thus invoke the doctrine?

In Hoffman, the Plaintiff preferred the Second Restatement, while Defendants sought the application of the Third. Deciding between the Second and Third Restatement is a big decision, since each presents a different definition of a product defect, and in a products liability action, the definition of defect is likely to come up at some point in the proceedings. But there really was no decision to be made:

[A] district court is bound by Third Circuit precedent on state law issues unless a subsequent[] decision by the highest state court diverges from Third Circuit precedent.

Hoffman at *3. The district court ruled that the Third Restatement was the standard of decision, and it decided the various issues related to the summary judgment motion, granting it in part and denying it in part.

The South Carolina Supreme Court recently weighed in again on two issues near and dear to the hearts of those who have an active products liability practice: (1) the admissibility of expert witness testimony and (2) punitive damages. In Austin v. Stokes-Craven Holding Corp., — S.E.2d —-, No. 26784, 2010 WL 760410, (S.C. March 8, 2010), the Supreme Court considered the admissibility of two experts offered by the Plaintiff and whether the punitive damages awarded to that Plaintiff were excessive. In Austin, the Plaintiff filed suit against Stokes-Craven Holding Corporation, d/b/a Stokes Craven Ford, an automobile dealership, after he experienced problems with a vehicle that he purchased used from the dealership. As it turned out, the vehicle had sustained extensive damage in an accident prior to the sale of the vehicle to the Plaintiff, requiring repairs to the tune of over $20,000. Problems ensued even following repairs when the vehicle developed an oil leak, finally prompting the first owner to trade in the vehicle.

When the Plaintiff went to purchase the vehicle, he asked a series of questions related to the extent of the warranty, whether the vehicle had been wrecked, and questions regarding the previous owner. In response, the Plaintiff was informed that the warranty was a “5-year, 100,000 miles powertrain warranty,” that the truck had not been wrecked, and that the previous owner may have been someone with whom the Plaintiff was familiar and considered to be very responsible with regard to vehicle maintenance. A couple of months after purchase, the Plaintiff discovered an oil leak, which he then sought to have repaired. It was then that the Plaintiff was told by the Defendant that the vehicle was not covered by a 5-year, 100,000 mile power train warranty. The Plaintiff further discovered that the vehicle had a 5-year, 100,000 mile warranty limited to the engine, that the truck had been registered to a person different from the person whom the Plaintiff believed first owned the vehicle, and that the vehicle had sustained extensive damage prior to Plaintiff’s purchase. The dealership further provided the Plaintiff with a “Buyer’s Guide” document purportedly containing the Plaintiff’s signature that confirmed that the warranty was only up to 100,000 miles on the diesel engine. The Plaintiff adamantly denied that he signed or ever received the document. After the Plaintiff’s repeated requests to receive a return of the purchase price in exchange for the vehicle were rejected, he filed suit under multiple causes of action.

At the conclusion of trial, the Plaintiff was awarded actual and punitive damages on his causes of action for negligence, fraud, constructive fraud, and violation of the Dealer’s Act, with actual damages being awarded in the amount of $26,371.10 on each cause of action and punitive damages in the amount of $216,600 as to the Plaintiff’s cause of action for fraud. Among the multiple issues on appeal were the admissibility of experts and excessiveness of punitive damages.

The Defendant argued that the trial judge erred in qualifying two of the Plaintiff’s witnesses as experts in the areas of auto-body repair and in appraisal and valuation of Plaintiff’s truck, respectively. As was not unexpected, in both instances, the South Carolina Supreme Court found that the Defendant was not prejudiced by the admission of the expert’s testimony. Key to the Court’s ruling appeared to be its conclusion that the Defendant was able to extensively cross-examine the experts on their qualifications and their ultimate conclusions.

On the issue of punitive damages, the Court applied the guideposts set forth in the recent decision in Mitchell v. Fortis Ins. Co., 385 S.C. 570, 686 S.E.2d 176 (2009), to be applied in conducting a post-judgment review of punitive damages awards, those being: (1) the degree of reprehensibility of defendant’s misconduct; (2) the disparity between the actual and potential harm suffered by the plaintiff and amount of the award; and (3) the difference between the punitive damages awarded and civil penalties authorized or imposed on comparable cases.

As to reprehensibility, multiple additional factors are considered, including whether (1) the harm is physical versus economic; (2) the conduct evinced an indifference to or a reckless disregard for the health or safety of others; (3) the target of the conduct had financial vulnerability; (4) the conduct involved repeated actions or was an isolated incident; and (5) the harm was the result of intentional malice, trickery, or deceit, rather than mere accident. Here, the Court found that, even though the harm was economic, that fact did not minimize the reprehensibility of the dealership’s conduct. The dealership’s employees failed to disclose that the truck had been wrecked and did not have a power train warranty and potentially forged the Plaintiff’s signature to a document in an effort to legitimize the lack of the power train warranty. The Court found that those acts evinced an indifference to or a reckless disregard the health and safety of the Plaintiff and the general public that would share the road with the potentially unsafe vehicle, that the Plaintiff was financially vulnerable, and that the incidence was not isolated in that the dealership’s employee testified that he had never shown a title to a customer.

Turning to the ratio, the Court admitted that an 8.21 ratio was high, particularly given the type of injury. However, the Court noted that it was a single-digit ratio; there was evidence of the Defendant’s ability to pay; that given the extent of wreck damage and resultant safety issues, there was potential for the Plaintiff and his passengers to be subjected to serious injury; and the amount of the award would serve as a deterrent to future misconduct.

Finally, the Court endeavored to review factually-similar cases to assess the reasonability of the award. In doing so, it cited cases from Missouri and Oregon in which plaintiffs had purchased used vehicles that had a past and in which significant punitive damage awards had been affirmed. Accordingly, in light of the above, the Court affirmed the punitive damages award rendered by the jury. Whereas Justice Pleicones dissented in part from the majority opinion, he nonetheless found that punitive damages were warranted, although he would have reduced such damages to $100,000.

Our medical-legal jurisprudence is based on images of health care that no longer exist. At an earlier time, medical advice was received in the doctor’s office from a physician who most likely made house calls if needed. The patient usually paid a small sum of money to the doctor. Neighborhood pharmacists compounded prescribed medicines. Without being pejorative, it is safe to say that the prevailing attitude of law and medicine was that the “doctor knows best.”

Pharmaceutical manufacturers never advertised their products to patients, but rather directed all sales efforts at physicians. In this comforting setting, the law created an exception to the traditional duty of manufacturers to warn consumers directly of risks associated with the product as long as they warned health-care providers of those risks.

For good or ill, that has all changed. Medical services are in large measure provided by managed care organizations. Medicines are purchased in the pharmacy department of supermarkets and often paid for by third-party providers. Drug manufacturers now directly advertise products to consumers on the radio, television, the Internet, billboards on public transportation, and in magazines.

Perez v. Wyeth Labs., 734 A.2d 1245, 1246-1247 (N.J. 1999) (citation omitted).

The Centocor, Inc. court then framed the issue as being “…whether a drug manufacturer can rely on its adequate warnings to physicians to satisfy its duty to warn the ultimate consumer, the patient, when it directly advertises to the patient in a misleading fashion.” Centocor Inc. at *1. The facts of the case were that the Plaintiff was prescribed Remicade by her gastroenterologist for treatment of her Crohn’s disease. Id. at *6. The prescribing physician testified that he discussed the risks of using Remicade with the Plaintiff, including the risk of developing a lupus-like syndrome. Id. The Plaintiff and her husband denied that her gastroenterologist (Dr. Hauptman) discussed this particular risk with her. Id. Dr. Hauptman referred the Plaintiff to an infusion clinic for the administration of a trial of Remicade (three intravenous infusions over a set period of time). Id. At the infusion clinic, the Plaintiff was shown a video produced by Centocor, Inc. while she was receiving her infusion. Id. at *6-10. It was undisputed that the video did not list lupus-like syndrome as a possible side effect. Id. at *9.

The Plaintiff ultimately began to exhibit lupus-like syndrome symptoms. Interestingly, even after filing the lawsuit, she continued to receive Remicade treatments. The jury awarded a verdict in the Plaintiff’s favor and found that Centocor, Inc. was liable for fraud, negligent misbranding, negligent marketing to the Plaintiff’s doctors, misrepresentation to the Plaintiff’s doctors and negligent undertaking. Id. at *19. The court performed an exhaustive analysis of the origins of the learned intermediary defense. The court also identified four “theoretical underpinnings” of the doctrine. These underpinnings include: (1) “…courts have held that the choice of which drugs to prescribe properly belongs to the doctor because prescription drugs are manufactured for administration only by a physician…” (2) “Texas courts have held that ‘only a physician would understand the propensities and dangers involved.'” (3) “…courts around the country have been reluctant to interfere with the physician-patient relationship by requiring a direct warning from the manufacturer to the patient because warnings that contradict the advice given by a physician may undermine the patient’s confidence in the physician.” and (4) “…it has been assumed that doctors are in a better position to warn their patients than the drug manufacturers…” Id. at *22-23.

• That’s right; it’s all about the cosmic rays. Debra Cassens Weiss of the ABA Journal reported this week upon speculation that cosmic rays may be the cause of the sudden acceleration issues in Toyota vehicles. Of course, cosmic rays have prompted all sorts of problems in the past. In 1961, they caused four would-be astronauts to evolve and become the superhero group, the Fantastic Four (as indicated above). We’re wondering, would Reed Richards testify for the Plaintiffs or the defense in the Toyota cases on this issue?
• Tim Smith of the Greenville News reports on a recent presentation by South Carolina Supreme Court Chief Justice Jean Toal in which she indicated the following troubling news: “Your court system is $11.5 million down at this time and about to run out of money. We can’t continue to operate like this.” Toal plans to work with South Carolina legislators to resolve the issue by increasing filing fees for complaints and motions.
• Defending an auto wreck case? Check out the For The Defense blog’s post “Investigating an Auto Accident Case.” Written by Francisco Ramos Jr., the piece offers some tips for the investigation of such claims in light of recent advances in technology.

• If you happen to find yourself here in downtown Greenville, South Carolina tomorrow, be sure to stop by the Google on Main event. Greenville is one of many mid-sized cities attempting to woo Google to its location as a part of the search engine giant’s fiber optic broadband experiment. Apparently, Google plans to pick one city, establish itself as an Internet service provider, and then offer service at speeds 100 times faster than that to which users are now accustomed. But which city will Google choose? We here at Abnormal Use officially endorse Greenville, whose citizens clearly support the technological endeavor. In the video above, you’ll see one local man was so supportive of the City of Greenville’s bid for the project that he had the Google logo shaved into his head.
• As a reminder, you can receive Abnormal Use posts directly in your email box by entering your email address in the “Subscribe Via E-Mail” box in our blog’s right sidebar.

You know you’re in trouble as defense counsel when the appellate court’s opinion starts with the sentence: “[The Plaintiff] has suffered a miserable ordeal since she had elbow surgery. ” That can only suggest that reading the court’s ruling will be a miserable ordeal for the defendant. So begins the opinion in last week’s Primiano v. Cook
, — F.3d —-, 2010 WL 788906 (9th Cir. March 10, 2010) [PDF]. Analyzing the admissibility of expert medical testimony at the summary judgment stage, the Ninth Circuit reversed the ruling of the trial court, which had excluded the Plaintiff’s medical expert and granted the defendants’ motion for summary judgment.

The Plaintiff, a 36 year old woman, suffered a fall in her kitchen, broke her right elbow, and ultimately required elbow replacement surgery. Her surgeon used an artificial elbow manufactured by the Howmedica Osteonics Corporation. Apparently, during the surgery, the surgeon realized that one of the component parts of the artificial elbow was intended to be used for a left elbow, not a right elbow. He then contacted a representative of Howmedica, who indicated that the component part was symmetrical, equally functional, and thus, able to be used for the surgery on the Plaintiff’s right elbow with only minor modifications. Following the surgery, all seemed to be well initially, but the Plaintiff ultimately experienced difficulties with the elbow replacement and required four additional surgeries, including the removal and replacement of the original artificial joint. Subsequent analysis revealed that the original artificial elbow had excessive wear. She then sued Howmedica, as the manufacturer of the device, its parent company, a Howmedica sales representative, and her surgeon under various theories of recovery, including products liability (the only cause of action at issue on the appeal). The suit was heard by the Honorable James C. Mahan of the U.S. District Court for the District of Nevada.

Noting that the prosthesis had been “malaligned,” the defense experts also argued that the life of the device would be limited due to the Plaintiff’s relative youth, level of activity, and her pre-existing rheumatoid arthritis. (Young people wear out artificial joints more quickly than older people, they said.). The district court excluded the testimony of the Plaintiff’s expert, Dr. Arnold-Peter Weiss, who had opined that “the polyethylene bushing had worn through in less than eight months, ‘not a usual or expected circumstance.'” The district court appeared concerned by the fact that Dr. Weiss had neither seen nor spoken with the Plaintiff as well as the fact that he could testify that the device failed but not why it did so. With no expert testimony supporting the Plaintiff’s case, the court granted the defendants’ motion for summary judgment. On appeal, the Ninth Circuit addressed the application of Federal Rule of Evidence 702 and Daubert to the testimony of expert physician witnesses. Analyzing the background, qualifications, and testimony of Dr. Weiss, the Ninth Circuit noted that they “[left] room for only one conclusion regarding its admissibility. It had to be admitted.” In so doing, the court noted:

Nevada law establishes that “those products are defective which are dangerous because they fail to perform in the manner reasonably to be expected in light of their nature and intended function.” In Nevada, a plaintiff need not “produce direct evidence of a specific product defect [or] negate any alternative causes of the accident.” An “unexpected, dangerous malfunction” suffices. Since Dr. Weiss, with a sufficient basis in education and experience, testified that the artificial joint “fail[ed] to perform in the manner reasonably to be expected in light of [its] nature and intended function,” that was enough to assist the trier of fact. He did not have to know why it failed.

The district court’s other concerns, that Dr. Weiss never saw or talked to Ms. Primiano, and there was no publication supporting his opinion that the device failed extraordinarily early, might be useful to the jury as impeachment, but neither furnished an adequate basis for excluding his opinion. What he most needed to see was what was inside her arm, not outside it, and he did. He saw the x-rays. He also saw the polyethylene from the implant installed in Primiano’s first surgery. As for lack of a publication backing his opinion up, Daubert offers several reasons why an opinion unsupported by peer-reviewed publication may be admissible, and Dr. Weiss furnished another one: that the phenomenon is so extraordinary that the specialists who publish articles do not see it in their practices.

(Emphasis added).

The Ninth Circuit then reversed the trial court’s granting of the defendants’ motion for summary judgment. An interesting result, as the opinion suggests that an expert who has never examined – or presumably even met – an injured Plaintiff can create a fact issue on summary judgment in a products liability action by claiming that a medical device failed too early without articulating why it did so. The district court had noted that evidence of rapid wear did not necessarily make the device defective. The defense experts did offer an explanation for the wear of the device, namely that devices tend to wear far more quickly when placed in the joints of younger – and presumably, more active – patients. Further, the defense pointed to the fact that this Plaintiff suffered from rheumatoid arthritis which further contributed to the wear. Thus, while the defense posited a specific reason for the rapid wear of the device, the Plaintiff’s expert simply offered the conclusion that the device should have lasted longer than it did. That is now enough to defeat summary judgment. (Interestingly, the Plaintiff did not sue the surgeon for malpractice but only as an agent of the manufacturer of the artificial elbow).