Pathological Pathologist

You’ve just lost several million dollars gambling in Vegas. After thinking about how to explain this to your wife on the plane ride home, and assuming your survival after such conversation, your thoughts begin to turn on how to make up this deficit in the family budget. Although a return trip to Vegas is not immediately ruled out, your thoughts turn to filing suit against some big pockets. After Wells v. Smithkline Beecham Corp., No. 09-50244, 2010 WL 1010591 (5th Cir. March 22, 2010) [PDF], the return trip to Vegas may seem more appealing.

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.

Second, this brings up a larger philosophical point about accrual of causes of action. While I am sure that someone has examined this in a law review article, I don’t have a lot of extra time to comb Hein Online. The Fifth Circuit makes a big deal out of “statistically significant epidemiological support.” It’s hard to study a purported disease until someone tells the scientist that they think they might have that disease or exhibits such symptoms. Then the scientist has to gather a statistically significant group to study, rule out causes, and then make a hypothesis of causation. It can take a long time to create “statistically significant epidemiological support,” longer maybe than some statutes of limitations. The court even says this:

Perhaps Requip is a cause of problem gambling, but the scientific knowledge is not yet there.

Id. There have to be some legal guinea pigs for cases involving new diseases/side effects that will likely not recover in order to establish scientific evidence that a particular drug either does or does not cause a specific side effect. Obviously we can’t wait for studies in every situation. That means that the initial plaintiffs may accrue a cause of action (reasonable notice that something is wrong with you) before there is legally significant proof of causation. What does this mean for defendants? Use Daubert early and often, before the science develops. But this does not help Wells. Maybe he can asset an equitable lien in some plaintiff’s future proceeds, if there turns out to be causation later. For now, Wells is left with the remorse that his money that he brought to Vegas stayed in Vegas.

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.

CPSC Approves Final Rule on Factors Affecting Civil Penalties

On March 16, 2010, the U.S. Consumer Product Safety Commission (“CPSC”) approved, by a 4-1 vote, additional factors that the Commission must consider when determining a civil penalty amount for knowing violations of CPSC laws.

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:

(1) the nature, circumstances, extent and gravity of the violation, including the nature of the product defect or the substance; (2) the appropriateness of the penalty in relation to the size of the business or of the person charged, including how to mitigate undue adverse economic impacts on small businesses; and (3) other factors as appropriate.

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].

Commissioner Northup explained that in her view “[t]he [Consumer Product Safety Improvement Act (“CPSIA”)] imposes so many new requirements all at once–including arbitrary lead and phthalates limits (not based on risk), third-party testing, certification, tracking labels, etc.–that it challenges the capacity of both small and large consumer product companies to comply.” Commissioner Northup is concerned that the CPSIA increases the cost to introduce products into the market to an extent that enforcement and regulation will cause market exit, job loss, and reduction in product variety.

Specifically with respect to the proposed amendments to the rules, Commissioner Northup found that the new rules should have specifically stated that the Commission will treat technical violations differently than substantive violations. Without this explanation, there is room to consider technical violations differently but people are still guessing. Further, she did not approve of the fact that the rule did not give “credit to companies for their good faith in following compliance policies and good efforts in reacting to the occasional problems that will inevitably arise.” Finally, Commissioner Northup criticized the language of the rules as “too vague and flexible to reliably sort the good from the bad and instead catches everyone in the same net and tests to presume that anyone caught in the net is bad.”

As we reported in two prior posts–“Manufacturers, Importers, Distributors, and Retailers Beware: Unilateral Recall for Lead Violations may not be Enough” and “Lead and Now Cadmium: More Trouble for American Retailers“–the CPSC is imposing large civil penalties upon manufacturers, importers, distributors, and retailers for violations of the CPSIA. Commissioner Northup’s criticisms and concerns are important as the CPSIA develops and if not addressed, as she warned, could result in market exist, job loss, and reduction in product variety. The development of the CPSIA is important for all product dealers and all corporate counsel to follow.

Friday Links

  • 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.

Georgia vs. Texas

No, this post is not about college football. (Spring practices have just gotten under way at most colleges around the country and unfortunately for this blogger, August can’t get here soon enough!) Today’s post is a reflection upon the recent Georgia and Texas cases dealing with the learned intermediary defense (previous discussed individually on this site here and here). Specifically, I wanted to highlight a key distinction in how each court analyzed the doctrine.

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 seemingly direct contrast, the court in Centocor, Inc. v. Hamilton, No. 13-07-00301-CV, 2010 WL 744212 (Tex. App. – Corpus Christi March 4, 2010, no pet h.), in its creation of an exception to the learned intermediary doctrine, did not end its analysis with a determination of the adequacy of the warning. In Centocor, the evidence was that the Plaintiff’s physician that originally prescribed the drug at issue, Remicade, testified that he warned her of the potential risk of developing a lupus-like syndrome. Centocor at *6. As such, it would appear that the physician warned the Plaintiff of the exact risk that was the basis for her lawsuit–she developed a lupus-like syndrome after taking the drug. Instead of ending the analysis with the initial physician’s testimony, the court then went into a long discussion about advertising techniques of drug companies and the theoretical underpinnings of the doctrine.

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?

Third Restatement Comes In First in Pennsylvania

Over the course of the past year, I have become quite accustomed to the federal government telling me that it knows what is best for me, regardless of what actually may be best for me. Depending on which side of the aisle you stand, you may revel in the audacity of hope, or just simply marvel at the audacity of your political opponents. But we need not sink into the ether of partisanship; not this day – not when there is jurisprudence to be discussed. As will be seen in the coming months, in our land of multiple sovereigns, the judiciary too walks a delicate line among competing interests. As an example of that trend, the Eastern District of Pennsylvania recently authored an opinion illustrating the unique nature of our system.

In Hoffman v. Paper Converting Machine Co. , No. 08-3012, 2010 WL 845984 (E.D. Pa. March 3, 2010), the Plaintiff injured himself when using a printing press, amputating fingers on his right hand. He sued in federal court. The defendants moved for summary judgment. The initial issue in the decision relates to the proper substantive law for decision. Even though a federal court sitting in diversity applies substantive state law, the federal court may still be forced to speculate what a state court might do when state law is nebulous on the issue at hand. The district court, per the case discussed below, ruled that the Third Restatement was the standard of decision, and it decided various issues raised in the summary judgment motion.

In Berrier v. Simplicity Manufacturing, Inc., 563 F.3d 38 (3d Cir. 2009) [PDF], the Third Circuit was confronted with the issue of whether Pennsylvania courts would adopt the principles of the Third Restatement of Torts. The Third Circuit had some pretty strong indications (a pending case before the Pennsylvania Supreme Court) that the Pennsylvania Supreme Court was going to move to the liability scheme found in the Third Restatement, so the Third Circuit made that prediction. It turned out that the Pennsylvania Supreme Court dismissed the pending appeal as improvidently granted, and, therefore, Pennsylvania, for the time being, still adheres to the Second Restatement.

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.

Defendants, pay attention. You can now do some forum shopping of your own, deciding whether to stay in state court, or remove to federal court, depending on which liability scheme is favorable to you. If you decide to remove, don’t forget about Iqbal and Twombley. As much as I would love to pontificate a potential law school exam question on this, I think I’ll just make the point that, in the short term, plaintiffs in Pennsylvania will have to pay attention to their products cases (including potential CAFA jurisdiction) to ensure that they get to apply Pennsylvania substantive law, at least in the short term, or in the alternative, prepare their complaints to survive a motion to dismiss under either standard. For the time being, in federal court, Pennsylvania state law is not really Pennsylvania state law.

South Carolina Supreme Court on Expert Witnesses and Punitive Damages

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.

Texas-sized change in the learned intermediary doctrine?

In Texas, they say everything is big. Big cars, big steaks, big football stadiums. Sounds like my kinda place. In a recent decision by the Thirteenth Court of Appeals in Corpus Christi, the jurisprudence was similarly Texas-sized, with a 35 page opinion in which the court carved out an exception to the learned intermediary defense. Centocor, Inc. v. Hamilton, No. 13-07-00301-CV, 2010 WL 744212 (Tex. App. – Corpus Christi March 4, 2010, no pet h.). Authored by Justice Linda Reyna Yanez, and joined by Justices Nelda V. Rodriguez and Rose Vela, the opinion creates an unfortunate Texas-sized exception to the learned intermediary doctrine.

In beginning its commentary on the doctrine, the Texas court looked outside of its own state and turned to, of all things, a decade old opinion from the New Jersey Supreme Court.

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.

The court then took a curious turn in the opinion. The court provided a discourse on “changes in pharmaceutical advertising.” Essentially, the court stated that in the 1980’s drug companies began utilizing direct marketing techniques (read “TV commercials”) that were intended to target the ultimate consumer of their products. Interestingly, the court also commented that in modern times, doctors spend less time with their patients and that “informed consent” now requires a “patient based decision rather than the paternalistic approach of the 1970’s.” Id. at*26-27. At this point in the opinion, the court stated that when drug manufacturers directly market consumers the theoretical underpinnings of the learned intermediary doctrine do not apply. Id. at *28.

In the opinion of this blogger, it appears that the Texas court made a Texas-sized mistake in interpreting the application of the doctrine. The court simply discounted the fact that the Plaintiff’s physician admitted that he discussed the specific risk of developing a lupus-like syndrome. In addition, the court seemed to overlook the fact that when the Plaintiff viewed the “direct marketing” video, she had already been prescribed the drug and was in fact undergoing an infusion of the drug at the time she viewed it. Finally, the video itself contained disclaimers that stated that the video should not be used a substitute for consulting with a physician. Id. at *9. These facts indicate that at the crucial time in which the Plaintiff obtained the prescription, she was warned about the potential risks of using the drug by a learned intermediary. In addition, at that crucial time it appears that all four of the “theoretical underpinnings” were in place and had not been compromised by any direct marketing of the drug. That is, when the Plaintiff first accepted her prescription and advice of her doctor, she hadn’t even seen the video yet. Perhaps the Texas Supreme Court will get to address this very issue in the near future.

Friday Links

  • 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.

Ninth Circuit Reverses Exclusion of Plaintiff’s Expert in Medical Device Case

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).