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

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

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

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

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

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

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

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

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

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

The Plaintiff, then 18 years old, was boating with friends on Lake Austin in the summer of 2005. He had just returned to the boat from wakeboarding when the tow rope fell in the water. When the Plaintiff jumped back in the water at the rear of the boat to retrieve the line, his friend and 18-year-old driver put the boat in reverse. The boat’s propeller caught the top of the Plaintiff’s leg and twisted it around, causing extensive blood loss and eventual loss of his leg. See local news coverage of the accident here .

The Plaintiff filed suit against the parent company of Sea Ray Boats, alleging that the boat should have been equipped with safety devices, such as guards or covers, to prevent the plaintiff from becoming entangled or stuck. However, the U.S. marine industry reportedly has fought the idea installing prop guards on motors because no design has ever been proven safe or effective for maneuvering boats. The U.S. Coast Guard has agreed, and has consistently refused to order boat and engine builders to install prop guards.

Apparently, though, this Texas jury didn’t buy it. It found both the Plaintiff and the driver (who was not named a defendant) of the boat each to be 17% negligent, and the defendant 66% negligent and responsible for the injury. Its award of damages included $200,000 for past physical pain and anguish, $200,000 for future physical pain and mental anguish, and $100,000 for disfigurement.

The decision has naturally drawn harsh criticism from the industry, which points out the common-sense factor at work here and the fact that all motors are “emblazoned” with pronounced warnings. It likens the facts on this case to the infamous McDonald’s hot coffee suit. This case, which Brunswick Corp has said it intends to appeal, may be one to watch, as it surely will have a profound effect on the boating industry.

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

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

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

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

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

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.

Arguably, a benefit of product liability litigation is that lawsuits demand that companies design products with greater safety measures and provide consumers with more pronounced, descriptive warnings. A guest speaker at my law school once told my class that engineers and automakers didn’t design many parts of the automobile — lawyers did. What he meant, of course, was that attorneys have filed suits against automakers when parts of a vehicle were allegedly unsafe or could have been designed with even greater safety measures in mind. This had, in turn, dictated the way that automakers designed that product from that point forward. The same guest speaker probably would not, however, have envisioned the alleged actions one California product liability attorney and his expert witness recently took in helping inspire this design process.

The California Court of Appeals recently refused to strike the plaintiffs’ complaint, where they filed suit against their attorneys and a consultant hired by their attorneys as an expert witness for negligence and conspiracy to commit fraud. Robles v. Chalilpoyil, —Cal.Rptr.3d—, (Cal. App. Jan. 27, 2010). The underlying action in Robles was a product liability claim initiated by the family of a man who burned to death when his wheelchair, which presumably was electric, ignited while he was occupying it. The family retained an attorney named Wills to represent them in their wrongful death action against the makers of the wheelchair.

According to the complaint, when the underlying case came up for trial, the family’s attorney requested a continuance on the basis that the plaintiffs’ expert witness had testified falsely in his deposition. The trial court thereby continued the trial to allow the attorneys to procure another expert witness. Before the new trial date, however, the attorney allegedly requested that each of the plaintiffs sign a waiver of any interest in a device that attorney Wills wanted to market to address the safety defects in the decedent’s wheelchair. Wills allegedly told the family members that the device would be designed and manufactured together with their former expert witness, based on research and information the expert witness had gathered in preparing for his expert testimony for trial.

After procuring each of the plaintiffs’ signatures and without retaining a new expert, the attorney “wrongfully pressured” the plaintiffs to settle the claim for $1 million. When several of the plaintiffs thereafter refused to accept the settlement proceeds, the Wills firm withdrew from the case and filed notice of lien for attorney fees.

The present case deals only with the issues of liability of the expert witness, as it was he who moved to strike allegations of the complaint as a SLAPP (Strategic Lawsuit Against Public Participation). According to the court, a SLAPP is a “meritless suit filed primarily to chill the defendant’s exercise of First Amendment rights.” The expert witness argued that his discussions with the attorney, during which the attorney solicited his agreement to allow his work product to be provided to the underlying defendants in the event of settlement, fell “comfortably” within the express terms of the anti-SLAPP statute. The California Court of Appeals disagreed, holding that such alleged discussions and agreements was not protected activity. It would not strike the plaintiffs’ complaint insofar as it alleged negligence and conspiracy to commit fraud against the former expert witness.

As noted, the court’s opinion deals with allegations of the complaint as alleged only against the expert witness. The attorney Wills, who represented the family in the underlying action, reportedly is the same person who was subsequently appointed to serve as a California Superior Court judge.

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: