Although there are no doubt a litany of issues considered by a drugmaker prior to its ceasing production of a particular medication, it’s unfortunate to see such an incredibly useful product withdrawn from needy markets as the result, at least partially, of two anomalous events such as these, neither of which has anything to do with an inherent defect in the drug.

Usually, a $15 million dollar verdict tends to raise my eyebrows. Therefore, in light of the recent decision in Dr. Sharla Helton v. Allergan Inc., CJ-2009-2171, District Court, Oklahoma County, Oklahoma, it is a good thing that I still have the ability to do that. However, the Plaintiff in that case, Dr. Sharla Helton of Oklahoma City, did not have that ability, thanks to her wrinkle-smoothing Botox injections. Rendered on May 11, this sizable jury verdict came following a three-week trial against Allergan Inc., a Botox manufacturer, after the Plaintiff, who was 47 years old, claimed that she suffered years of pain and weakness after receiving Botox injections.

The jury found Allergan Inc. negligent because the label on the product did not include enough information about potential side effects. The Plaintiff blamed Botox for causing double vision, breathing difficulties and years of constant pain in her hands, arms and feet. She further claimed that the disabling side effects eventually led her to sell her medical practice and step down as the medical director for an Oklahoma City hospital. According to the Plaintiff, the verdict was the “first set in making sure the public is aware of the actual risks of Botox. It’s a stepping stone to protect the public from what the company is hiding.”

So, what is the company hiding you might ask about the dangers of Botox? Nevermind that the official scientific name for Botox – Botulinum Toxin Type A – actually contains the word “toxin.” It is a neurotoxic protein. Also nevermind that Botulinum toxin has been identified by the CDC (Centers for Disease Control & Prevention) as the most lethal substance known to man. Potential use of the toxin as a biological weapon has been explored since the early 1900s! Fortunately for us, the toxin just doesn’t have the stability and capacity to be disseminated by open air over a large area. And Botox is, of course, a variation of the word “Botulism,” which I would venture to guess would be more recognizable to the general public at large.

With that said, how could it possibly be foreseeable to the Plaintiff that there could be some risk to injecting Botox into the body? Don’t get me wrong. I am certainly not against Botox therapies, whether for cosmetic use or particularly for its more valuable use to the benefit of patients with muscle and nerve disorders. Maybe my lack of sympathy stems from the fact that the Plaintiff in this instance was actually a doctor (albeit not a cosmetic specialist, but an obstetrician and gynecologist) and presumably would have greater insight into the medical procedure that she selected or, at a minimum, the wherewithal and resources to avail herself of the risks. Or, maybe it was also because it was not the first, second, third or fourth injection over two years that caused the problem. It was the fifth injection that Plaintiff claims did the trick and gave her botulism.

It is interesting that this verdict in a cosmetic use case follows a successful defense win by Allergan Inc. in a case arising from the death of a 7 year-old girl, who suffered from cerebral palsey and used the injections to relax clenched limbs. This is but one example that the sympathy factor does not always win the day. In any event, we have not heard the last of litigation against Botox. At the time that the Plaintiff’s case went to trial, there were 14 plaintiffs standing in line behind her. Allergan has, of course, vowed to appeal. Whatever the ultimate outcome of this or other cases, for the meantime, I will stick to the Pearl Cream.

In fact, in the past two weeks, on April 6, 2010 and April 13, 2010, the Eastern District of Pennsylvania and Third Circuit, respectively, upheld the decisions by the settlement trust to deny benefits. In re Diet Drugs Products Liability Litigation, No. 99-20593, 2010 WL 1404624 (E.D. Pa. Apr. 6, 2010); In re Diet Drugs Products Liability Litigation, No. 09-2424, 2010 WL 1473752 (3d Cir. Apr. 14, 2010).

The Court found that Brown-Riddle merely disagreed with the reviewing physician’s determination that she lacked a medical basis for her claim. She failed to identify or substantiate any specific errors and rested on her physician’s “check-the-box diagnoses.” The Court affirmed the decision of the trust denying benefits.

These decisions by the the Eastern District of Pennsylvania and the Third Circuit show that even when a mass class action is settled, litigation continues and our courts are continually asked to evaluate expert evidence as it would in a case of traditional posture. Plaintiffs in these types of cases are not off the hook of providing expert testimony. It will be interesting to note when litigation surrounding this class settlement ends — 10 more years, maybe 20.

From July 2002 to April 2007, Plaintiff Mary Cleo Couick took generic metoclopramide pills for treatment of gastroesophasgeal reflux. Reglan, the name-brand version of the drug, was manufactured by Wyeth, Inc. and Schwarz Pharma, Inc. Couick stipulated that she only took the generic version of this drug. However, Couick filed suit against both the name-brand manufacturers and generic manufacturers claiming that they failed to adequately warn her doctors about the risks associated with metoclopradmide, which caused her to develop tardive dyskinesia.

Against name-brand manufacturers, Couick brought claims for negligence, breach of undertaking special duty, misrepresentation by omission, negligent misrepresentation, constructive fraud, fraud by concealment, intentional infliction of emotional distress, negligent infliction of emotional distress, unfair and deceptive trade practices, breach of express warranty, and breach of implied warranties. In response, name-brand manufacturers filed a motion for summary judgment.

The Court first found that since “[e]ach of [Couick’s] claims [are] based on the premise that Wyeth and Schwarz are liable for Couick’s physical condition because they failed to adequately warn Couick’s doctors about the dangers of metoclopramide,” Couick’s claims, while masked in various legal theories, were a single claim for products liability.

The Court then held that under clear North Carolina and Fourth Circuit authority, a “name-brand manufacturer’s statements regarding its drug [cannot] serve as the basis for liability for injuries caused by another manufacturer’s drug.” As a result, the Court granted name-brand manufacturers’ motion for summary judgment.

This case is instructive to products liability practitioners in two main respects. First, despite a plaintiff’s artful pleading, claims based upon personal injury or property damage as a result of the manufacture, construction, design, selling, advertising, etc. of the product, is generally considered only one claim under a state’s products liability law. Second, the rule that a name-brand manufacturer is not liable for injuries caused by another manufacturer remains intact. See Foster v. Am. Home Products Corp., 29 F.3d 165 (4th Cir. 1994). Recently, we have reported on a number of cases here against drug manufacturers. This re-affirmed rule will become particularly important as these types of suits increase.

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.”

We here at Abnormal Use are here to help. Over at the Drug and Device Law blog, author David Walk directs his readers’ attention to a new Eighth Circuit case about which he could not fully comment due to his firm’s involvement in that case. In light of that, and in the spirit of blogging collegiality, we thought we would do our own summary and analysis of the new opinion.

The facts are these: Plaintiff feels fine; Plaintiff takes prescription medication to reduce his cholesterol; Plaintiff develops symptoms of pain and fatigue. Such facts do not proof of causation make, the Eighth Circuit Court of Appeals affirmed. In re Baycol Products Litigation, —F.3d—, No. 08-3524, 2010 WL 711972 (8th Cir. March 3, 2010) [PDF]. In that case, the appellate court upheld summary judgment in favor of the drug-manufacturer defendant. In so doing, it held that the mere fact that a plaintiff developed physical symptoms in the months following his consumption of a defendant’s drug is insufficient to support a medical expert’s opinion that the drug was responsible for the onset of those symptoms.

The plaintiff was prescribed Baycol in February 2001 after being diagnosed with high cholesterol. On March 15 of that year, he began complaining to his doctor of general body pain and fatigue and of localized lower body pain. His complaints continued throughout July of 2001. In August, after taking the drug for approximately five months, the plaintiff discontinued his use of the drug after reading in the newspaper that Bayer had withdrawn Baycol from the market. He thereafter sent a letter to his doctor, in which he opined that Baycol was the cause of his symptoms. A subsequent blood test did reveal that the plaintiff had increased levels of creatine kinase, which is one indication of the presence of myopathy.

The plaintiff filed suit, alleging theories of strict liability, negligence, breach of express and implied warranties, and unjust enrichment. The court noted that it was the plaintiff’s burden, pursuant to his strict liability and negligence claims, to prove causation through the use of a medical expert. He essentially offered two. The first of those was in the form of “various generic causation experts” who would testify that Baycol was capable of causing myopathy. The report of the second expert garnered the most attention from the court. In it, the expert opined in what the court regarded as “conclusory remarks,” that causation was established because: (1) the pain was of new onset; (2) he had no other explanation for the injury; (3) the pain was “reasonably contemporaneous” with the plaintiff’s ingestion of Baycol; and (4) the pain didn’t get worse after he stopped taking the drug.

The court held that such conclusory remarks of “temporal association,” without sufficient evidentiary support, were wholly insufficient to prove that the defendant’s conduct contributed to the plaintiff’s injury. The court upheld entry of summary judgment in favor of Bayer on the basis of the plaintiff’s failure to present competent expert testimony on the issue of causation.

The court’s analysis with regard to these expert witness issues may provide ammunition for defendants during preliminary stages of litigation. It certainly highlights the importance of attacking the sufficiency of expert reports and of demanding competent, factually based testimony that creates triable issues of fact.

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:

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: