Busy Mass Tort Court Revises Punitive Damages Rule

The Philadelphia Court of Common Pleas, a busy mass tort jurisdiction, to say the least, has continued to tinker with its mass tort general rules, last week issuing General Court Regulation No. 2012-03, amending the protocols for cases in the mass tort program.

The biggest change was to allow punitive damages in some pharmaceutical cases subject to the approval of the Complex Litigation Center coordinating judges, Judge Sandra Mazer Moss and Judge Arnold L. New. The Court said it continues to review recommendations concerning
punitive damages and will likely further amend this rule. But until a final version is established, the following procedure was adopted: Punitive damage claims may be litigated in pharmaceutical mass tort cases provided that the Coordinating Judges, following appropriate motion practice by defense counsel at least 60 days in advance of trial, rule that there are sufficient requisite proofs to support the claim going to trial.

Philadelphia is of course the home base of MassTortDefense, and we have posted on the evolving rules before.  Other than a few outliers, the defense bar had generally supported the continuation of the deferral of punitive damages because this practice furthered the Court’s stated goal of meeting the American Bar Association’s suggested standards for the disposition of cases. Deferral of punitive damages claims in these cases can remove a major obstacle to settlement of mass tort litigation and open the way for the prompt resolution of the damage claims of many thousands of injured plaintiffs. 

Furthermore, when mass tort claims involve pharmaceutical and medical device defendants that market life-saving or life-enhancing products, additional policy considerations support deferral. Drugs and devices are subject to comprehensive regulation by the FDA. Absent extraordinary circumstances, a defendant that has complied with the FDA requirements should not be deemed to have engaged in punishable conduct with the potential for repeat sanctions.

We will keep an eye on this one for you.
 

Can You Get Rolls Royce Service for Regular Car Rates?

BTI has issued a report based on interviews with corporate counsel identifying the law firms with the strongest brands in the legal market. From among more than 400 firms, the top ranked firms create new standards for client service, establish solid, long-lasting reputations for handling the most high-stakes issues, and redefine what it means to be innovative, according to the new report.

If readers will forgive a little bragging, my new firm Shook, Hardy & Bacon makes an appearance in the top 15 of this list. Which answers the question, where can you get Rolls Royce legal service for affordable car rates?

 

Fifth Circuit Affirms Exclusion of Plaintiff Causation Experts in Chemical Case

The Fifth Circuit recently affirmed the dismissal of most of a plaintiff's personal injury claims against a chemical company, based on the conclusion that certain expert witness testimony was inadmissible. See Johnson v. Arkema Inc., No.11-50193 (5th Cir. June, 2012).

Plaintiff Johnson worked as a machine repairman at a glass bottling plant in Waco, Texas from May 1998 to the end of 2008. On two separate occasions, first in early June 2007 and again in July 2007, Johnson claims he was directed to perform work in close proximity to a device known as a C-4 Hood, which was designed, manufactured, and installed by defendant. C-4 Hoods are
utilized to apply a chemical coating to the glass bottles as the bottles are transported along a conveyor belt. According to Johnson, the C-4 Hood he worked near to on those two occasions failed to perform its proper functions, resulting in his alleged exposure to harmful chemicals.

Plaintiff sued. Arkema then filed motions to exclude the opinions of Dr. Richard Schlesinger, Johnson’s expert toxicologist, and Dr. Charles Grodzin, Johnson’s expert pulmonologist, under Federal Rule of Evidence 702 and the Supreme Court’s decision in Daubert v. Merrell Dow Pharm., Inc., 509 U.S. 579 (1993). Arkema also filed a motion for summary judgment, contending that absent those experts, Johnson was unable to present scientifically reliable evidence establishing that exposure to the chemicals can cause restrictive lung disease and pulmonary
fibrosis (his alleged injury types). The district court granted the motions, and plaintiff appealed. 

On appeal, plaintiff contended that the district court abused its discretion in excluding Dr. Schlesinger’s expert opinion on general causation.  The district court excluded Dr. Schlesinger’s testimony after determining, inter alia, that: (1) Dr. Schlesinger could not cite to one epidemiological or controlled study of humans indicating that exposure to the relevant chemicals could cause restrictive lung disease and pulmonary fibrosis; (2) the scientific literature was devoid of any data or peer reviewed articles indicating that exposure to the two chemicals will result in chronic lung disease, and such a proposition is not generally accepted in the scientific community.

Plaintiff argued that the two fell into a "class" of chemicals that have been shown to cause these injuries. In forming a reliable opinion regarding the effects of exposure to a particular chemical, an expert may extrapolate data from studies of similar chemicals. BUT to support a conclusion based on such reasoning, the extrapolation or leap from one chemical to another must be reasonable and scientifically valid.  Thus, courts are free to reject a theory based on extrapolation when there is simply too great an analytical gap between the data and the opinion proffered. Here, save for highlighting their shared classifications as "irritants," the expert did not attempt to explain any direct correlation or “fit” between the chemicals at issue and the known scientific data concerning exposure to, for example, chlorine, ammonia, or nitric acid vapor. Accordingly, given the diverse chemical structures and toxicities of irritants, which plaintiff acknowledged, the district court did not abuse its discretion in concluding that Dr. Schlesinger’s “class of chemicals” theory presented “too great an analytical gap between the data and the opinion proffered.

The next issue was reliance on language in an MSDS, which is useful for many of our readers in toxic tort cases.  The district court found the "warning" language in a competitor's MSDS to be irrelevant and unreliable because: it did not clearly state a causation conclusion, and, most importantly, Johnson did not provide any science behind the MSDS, such as the duration or concentration of exposure needed to produce the noted effects, or the scientific literature relied upon by the drafter for the statements contained in the MSDS.  Under such circumstances, the MSDS, standing alone, need not have been accorded any weight. Plaintiff also relied on general hazard language in defendant's own MSDS. But could cite no authority for the proposition that material safety data sheets constitute per se reliable support for an expert’s opinion. To the contrary, in exercising its discretion as a gatekeeper, a court may refrain from treating a MSDS as reliable until it is presented with scientific evidence justifying the relevant statements found within the MSDS.

Finally, Johnson contended that he was exposed to amounts of one of the chemicals (HCl) that were between two and ten times the permissible exposure levels set by OSHA, NIOSH, and the Acute Exposure Guideline Levels set by the National Research Council. Regulatory and advisory bodies such as IARC, OSHA and EPA utilize a “weight of the evidence” method to assess the carcinogenicity or toxicity of various substances in human beings and suggest or make prophylactic rules governing human exposure. This methodology results from the preventive perspective that the agencies adopt in order to reduce potential public exposure to possibly harmful substances. The agencies’ threshold of proof is lower (for policy reasons) than that appropriate in tort law, which traditionally makes more particularized inquiries into cause and effect, and requires a plaintiff to prove that it is more likely than not that another individual has caused him or her harm. See generally Wright v. Willamette Industries, Inc., 91 F.3d 1105, 1107 (8th Cir.1996). Thus, such regulatory chemical guidelines are not necessarily reliable in all toxic tort cases. And a court should confirm the underlying basis for their  proscriptions before an expert’s reliance on them can pass Daubert muster. Here, plaintiff did not provide any scientific data or literature to explain how or why the various exposure limits and guidelines were established for the chemicals. Similarly, he had no evidence that the guidelines and exposure limits existed to protect people from developing severe restrictive lung disease and pulmonary fibrosis, his diseases. Thus, the court concluded that the OSHA, NIOSH, and NRC guidelines and exposure limits, standing alone, were insufficient to demonstrate abuse of discretion on the part of the district court.

As to the other expert, Dr. Grodzin’s research and analysis essentially mirrored Dr. Schlesinger’s save for one key distinction: Dr. Grodzin performed a so-called “differential diagnosis” of Johnson. A reliable differential diagnosis typically, though not invariably, is performed after physical examinations, the taking of medical histories, and the review of clinical tests, including laboratory tests, and generally is accomplished by determining the possible causes for the patient’s symptoms and then eliminating each of these potential causes until reaching one that cannot be ruled out.  Even in jurisdictions that accept this questionable approach to causation, the results of a differential diagnosis are far from reliable per se. For example, before courts can admit an expert’s differential diagnosis, which, by its nature, only addresses the issue of specific causation, the expert must first demonstrate that the chemical at issue is actually capable of harming individuals in the general population, thereby satisfying the general causation standard. In other words, the suspect has to be reasonably and reliably "ruled in."

Here, Dr. Grodzin’s differential diagnosis was based on the presumption that the two chemicals  were actually capable of causing restrictive lung disease and pulmonary fibrosis in the general population. Dr. Grodzin did not present any reliable or relevant scientific evidence to bolster this assumption. Consequently, the fact that Dr. Grodzin claimed he conducted a differential
diagnosis did not save his opinion from the same fate as Dr. Schlesinger’s opinion.

 (Note, the court concluded that plaintiff did not need expert witnesses to demonstrate that his immediate acute injuries after exposure and which allegedly sent him to the emergency room, could have been caused by the chemical.  Thus, this part of the case was remanded.)

 

 

 

Court of Appeals Affirms Exclusion of Plaintiff Expert Testimony

The Sixth Circuit earlier this month affirmed the exclusion of plaintiff expert testimony seeking to link osteonecrosis of the jaw to plaintiff's use of two cancer medications. See Simmons v. Novartis Pharmaceuticals Corp., No. 11-5053 (6th Cir., 6/5/12).

Simmons developed osteonecrosis of the jaw (ONJ), a bone disease affecting the jaw, allegedly as a result of using the prescription medications Zometa and Aredia. He sued and the Judicial Panel on Multidistrict Litigation transferred the action under 28 U.S.C. § 1407 to the United States District Court for the Middle District of Tennessee and assigned it to Chief Judge Todd Campbell.

To prove specific causation, plaintiff offered two experts. Plaintiff offered Dr. Obeid, a board-certified oral and maxillofacial surgeon who saw the plaintiff, and Dr. Edward Gutman an experienced oral surgeon. Defendant moved to exclude, inter alia, the testimony of Drs. Obeid and Gutman, on the issue of causation. The MDL court granted the motion to exclude any testimony by Dr. Obeid as
to the cause of Simmons’s injury, and by a separate order the district court granted defendant’s motion to exclude Dr. Gutman’s causation testimony. The court then granted defendant’s motion for summary judgment on all of plaintiff’s claims because plaintiff no longer had proof of an essential element of a product-liability claim under Maryland law, i.e., specific causation. Plaintiff appealed.

The court of appeals noted that a treating physician’s testimony is subject to Daubert. See Gass v. Marriott Hotel Servs., Inc., 558 F.3d 419, 426 (6th Cir. 2009). Plaintiff was therefore required to demonstrate that Dr. Obeid’s reasoning or methodology was scientifically valid and that he properly applied that reasoning or methodology to the facts at issue. Plaintiff relied on Dr. Obeid’s statement that he found “a very close association” between ONJ and the class of drugs. However, Dr. Obeid also specifically acknowledged that he “didn’t establish causation” in evaluating Simmons’s ONJ.  Readers know that association is not causation.  Furthermore, Dr. Obeid agreed that the current level of evidence did not support a cause-and-effect relationship between bisphosphonate exposure and ONJ. While there were references to the medication in Dr. Obeid’s medical records, even if this was a "diagnosis," a diagnosis is merely a hypothesis, which does not satisfy Daubert and Rule 702. Moreover, nowhere in his testimony did Dr. Obeid rule out other conditions as the sole cause of Simmons' ONJ.

As to Dr. Gutman, the court noted that he had no knowledge of the etiologies of ONJ prior to meeting Simmons, and then gained only a limited familiarity based on literature supplied to him by plaintiff’s counsel. He had never treated any patients who were taking Aredia or Zometa or any other bisphosphonate, had never diagnosed a patient with ONJ, or determined a cause of
a patient’s ONJ.  Dr. Gutman admitted that he was not an expert on Zometa, Aredia, bisphosphonates, or ONJ, except as to Simmons’s case. He had no independent expertise from any other source other than six medical articles plaintiff’s counsel gave him; other than these
articles, there was no other "methodology" supporting his opinion.

The district court also did not abuse its discretion in excluding Dr. Gutman’s specific causation
opinion as unreliable because it was not derived from scientifically valid principles but
rather relied exclusively on the scientific literature provided by counsel. Dr. Gutman
made no attempt to verify this information, such as by doing his own research for other articles, and then drawing an independent conclusion. Courts view with special caution expert testimony prepared solely for purposes of litigation, rather than flowing from an expert’s line of scientific or technical work.  

Exclusions upheld; summary judgment affirmed.

Amici Weigh in On Consumer Class Certification in 6th Circuit

Earlier this month, a number of prominent business groups, including the National Association of Manufacturers, weighed in supporting a petition for rehearing of a Sixth Circuit panel decision declining to vacate a class certification decision. See Gina Glazer et al. v. Whirlpool Corp., No. 10-4188 (6th Cir 2012). 
 

The case arises from the claims of a proposed class of consumers who alleged that their Whirlpool washing machines were defective. The Chamber of Commerce, NAM, the Business Roundtable, PLAC, DRI, and others submitted amicus briefs in support of rehearing, pointing out several issues with the class certification decision below, and as affirmed by the appellate panel. See 2012 US LEXIS 9002 (6th Cir., May 3, 2012).

For example, the amici pointed out that the class was certified despite the presence of individuals (perhaps 2/3 of the class) who have no Article III standing because they have not been injured.

The panel also failed to conduct or require the rigorous analysis required by the Supreme Court in Dukes, especially with regard to the predominance requirement. A specific issue related to the number of customers who had allegedly complained about the washers. In Dukes, the Supreme Court made clear that a district court may not simply rely on the plaintiffs’ allegations in ruling on class certification; rather, the court must consider, weigh and resolve disputed questions of fact.

The briefs also pointed out that the court ignored the important impact of potential affirmative defenses, such as misuse, on the predominance inquiry.

This is one worth keeping an eye on.

Find the amicus briefs here and here and here.

 

Defense Victory in Bellwether Drug Trial Affirmed

A state appeals court recently upheld a judgment for defendant in the first bellwether trial in consolidated litigation in New Jersey over claims concerning the cancer drugs Aredia and Zometa. See Bessemer et al. v. Novartis Pharmaceuticals Corp., No. A-2069-10T1 (Sup. Ct. NJ, App. Div.)


Plaintiff allegedly developed osteonecrosis of the jaw (ONJ), and had sued alleging that defendant knew or should have known that Aredia and Zometa could cause ONJ and should have issued warnings to plaintiff and her treating dentists and oral surgeons, as well as to her prescribing oncologist.  The jury returned a verdict in defendant's favor; plaintiff appealed claiming that the pre-trial grant of partial summary judgment to defendant constituted reversible error. The trial judge had decided that defendant had no duty to warn non-prescribing dentists or oral surgeons under the NY Product Liability Act. The trial judge applied the learned intermediary doctrine, rejecting plaintiff's allegation that the so-called DTC exception applied pursuant to Perez v. Wyeth Laboratories Inc., 161 N.J. 1, 14-15 (1999).

The court of appeals affirmed the "well-considered and thorough opinions" of the trial court. The two relevant opinions are: Bessemer v. Novartis Pharmaceuticals Corp., 2010 WL 6052544 (N.J. Super. L.D. Nov. 12, 2010) (denying post trial motion), and Bessemer v. Novartis Pharmaceuticals Corp., 2010 WL 6257855 (N.J. Super. L.D. April 30, 2010) (partial summary judgment).

Thus, the direct-to-consumer advertising exception to the learned intermediary doctrine did not apply to plaintiff; even if the drug was advertised to consumers, and even if plaintiff had seen a magazine advertisement for Zometa while taking the drug, it was not a substantial factor in her use of the medication.  The appeals court ruling also confirms that the defendant did not have a duty to warn dentists and oral surgeons (that is, doctors in a different field) of the drugs' possible risks, in addition to actual prescribing physicians. 

    

Learned Intermediary Adopted in Texas

We cannot comment, but commend to your study the recent decision by the Texas Supreme Court on the applicability of the learned intermediary doctrine under state law. See Centocor Inc. v. Hamilton et al., No. 10-0223 (6/8/12, Texas).

In the context of prescription medication, the learned intermediary doctrine holds that a drug manufacturer satisfies its duty to warn when it informs a prescribing physician about the drug's potential risks. Most but not all jurisdictions have adopted the doctrine. 

Congratulations to my colleagues at Shook, Hardy & Bacon, including Gene Williams. and Manuel Lopez

House Subcommitee Chair Questions EPA Approach on Fracking

We have posted before about the tremendous economic promise of fracking technology, and the attempts of the plaintiffs bar to exploit this promise.  Another piece of the evolving puzzle has been the regulatory issues.

House Subcommittee on Energy and Environment Chairman Andy Harris (R.-Md.) earlier this month sent a long letter to Environmental Protection Agency (EPA) Administrator Lisa Jackson requesting information and documents related to the Agency’s activities with respect to hydraulic fracturing.
 

The letter expressed frustration with EPA's "lack of transparency and responsiveness" surrounding its fracking approach, and with the agency's "confusing and questionable" approach to fracking regulation.  The letter cites numerous examples of EPA "leaping to scientific conclusions before having all the facts."  These include claims that fracking operations in Parker County, Texas, had affected drinking water, later retracted; and alleged fracking contamination in Dimock, Pa. only later to conclude the water was safe to drink.

The letter worries that such examples, while individually very troubling, "collectively suggest EPA is not objectively pursuing an improved understanding of the relationship between hydraulic fracturing and drinking water, but rather is determined to find fault with the technology in order to justify sweeping new regulations.”

 

Defense Equal Access to Potential Experts Upheld in Device Case

A Joe Friday post today- just the facts with no commentary.  A state appellate court earlier this month overturned a trial court order that had limited one side's ability to consult with or retain knowledgeable physicians as witnesses. See In re Pelvic Mesh Gynecare Litigation, No. A-5685-10T4 (N.J. Super. Ct. App. Div., 6/1/12).

The issue arose in the mass tort involving medical devices used primarily to treat pelvic organ prolapse and stress urinary incontinence. Plaintiffs in the New Jersey cases had filed suit against
defendants alleging injuries sustained as a result of the surgical implantation of the pelvic mesh product. As is not atypical, some of the most qualified experts had previously prescribed or implanted the device at issue. And it was possible that some former patients would or had become plaintiffs. In January 2011, defendants moved to establish a protocol similar to ones used in some federal litigation for consulting with and possibly retaining as defense experts physicians who had treated a different plaintiff in the pelvic mesh litigation.  Defendants proposed that a treating physician would have no communication with the defense about his or her own patient-plaintiff an would not be used as an expert witness in the patient-plaintiff's own case. Plaintiffs' counsel opposed the motion and cross-moved for a protective order barring defendants from retaining or consulting with any physician who at any time had treated any of the plaintiffs in the pelvic mesh litigation.

The lower court issued an order in May, 2011, barring defendants from consulting with or retaining any physician who had at any time treated any plaintiff in the pelvic mesh litigation. Defendants estimated that more than 1,000 physicians were disqualified as potential defense experts.

The appellate court granted defendants' motion for leave to appeal, and subsequently stayed discovery to the extent it applies to defense experts.

The appellate division vacated the protective order because, it concluded, the order profoundly
impaired defendants' ability to defend the lawsuits because it prevented them from employing qualified experts in cases against plaintiffs other than their own current or past patients; not only did the order severely limit the pool of qualified and willing physicians that defendants could consult and engage as expert witnesses but it placed defendants in the precarious position of consulting and preparing experts only to have them later disqualified if new plaintiffs were added to the litigation.

On the issue of doctor-patient privilege, the court concluded that a plaintiff in these cases cannot claim the privilege as to the diagnosis and treatment of her medical condition that is the
subject of the lawsuit, and a treating physician can be compelled to testify as a fact witness regarding those subjects, including the doctor's determination of the cause of the plaintiff's disorder. Doctors can be expected to understand they are subject to ethical constraints against disclosure of confidential patient information. The court said that the key issue in this appeal was not whether the physician-patient privilege prevented engagement of a treating physician as an expert for the defense. The issue is whether some other rule or judicial or public policy categorically bars a treating physician from serving as an expert witness against the "litigation interests" of his or her patient, although in a different plaintiff's case.The court concluded that the trial court's ruling was a mistaken exercise of authority to manage this litigation. It inappropriately equated a plaintiff's "litigation interests" with a patient's "medical interests," and it elevated those "litigation interests" to a preemptive level not previously recognized by binding authority.

In many types of personal injury cases, said the court, physicians who testify for the defense or consult with defense counsel provide those services contrary to the interests in litigation
of other patients they have treated or continue to treat. For example, radiologists, orthopedists, and neurologists who routinely testify as experts for the defense in numerous personal injury cases in state courts are likely to be treating or consulting physicians for other patients with similar injuries, and some of those patients may also have filed lawsuits or may do so in the future. "Our system of civil justice does not bar a physician from expressing a position in litigation of one plaintiff that is contrary to the litigation interests of a current or past patient in another case."

Here, said the appellate division, the physician's information that defendants seek to use is neither the particular diagnosis or condition of a patient that the physician treated nor the fruit of expert
consultation to assess or prepare plaintiffs' claims. Rather, it is the physician's overall knowledge regarding the nature, use, risks, and safety of defendants' pelvic mesh products and the conditions that patients may experience as a result of their use. The fact that plaintiffs filed suit in New Jersey and invoked the rules for joint case management should not affect the availability of relevant evidence to both sides.

Moreover, the "litigation interests" of one patient may or may not be consistent with or contrary to the "medical interests" of the physician's other patients. For instance, specialists in gynecology, urology, or urogynecology may disagree with the claims of plaintiffs in this litigation that  defendants' products are defective and caused their injuries. Those specialists may believe that defendants' pelvic mesh products are not only safe but necessary or the most beneficial treatment
for conditions suffered by their patients. They may believe that supporting the defense in this litigation will be beneficial to most of their patients. The trial court's order not only bars physicians from truthfully expressing opinions favorable to the defense but it may potentially harm the
"medical interests" of other patients and interfere with the ability of physicians to provide the best available care for all their patients.

Rather than disqualifying as a group all treating physicians who ever treated any plaintiff, said the appeals court, the trial court should address such concerns by allowing plaintiffs to demonstrate why a particular expert retained by defendants should not be permitted to testify or assist in the
case of a different plaintiff. The fact that this litigation involves coordinated case management did not justify a broad finding of presumed prejudice to plaintiffs and the blanket ban. If plaintiffs make such a particularized showing, the court was directed to consider appropriate protective measures, including disqualification where lesser measures are not sufficient or feasible.
 

In summary, said the appeals court, both sides in this litigation should have the opportunity to present evidence from the most qualified physicians who can serve as experts. The trial court's order unfairly impeded defendants' access to many of those physicians, and so, must be reversed. 

House Hearing on CAFA- Seven Years Later

A topic near and dear to the hearts of readers of MassTortDefense was the subject of a recent hearing by a subcommittee of the U.S. House Judiciary Committee. Entitled "Class Actions Seven Years After the Class Action Fairness Act,” the hearing was designed to address what has worked with the law, what has not, and what Congress overlooked when it passed CAFA.

Witnesses included a plaintiff-side attorney, who typically complained about CAFA's impact on consumer fraud class actions, and Professor Redish from Northwestern, who talked about the need for legislative revision of the use of so-called “cy pres” awards in class action proceedings in particular.

Rep. Trent Franks (R-Ariz.) is the chairman of the Subcommittee on the Constitution, and has expressed concern over the ability of plaintiffs to engage in a new form of forum shopping under CAFA, filing cases in particular federal circuits they think are more hospitable to class actions.

John Beisner, who typically represents defendants in class actions, testified on behalf of the U.S. Chamber Institute for Legal Reform; he noted that a small number of judicial rulings have ignored Congress’s intent behind this landmark legislation, meriting further legislative attention. From imposing a heightened “legal certainty” standard on defendants with respect to CAFA’s amount-in-controversy requirement to broadly construing CAFA’s narrow exceptions to federal jurisdiction, these rulings run afoul of CAFA’s presumption in favor of federal jurisdiction. Second, he argued that Congress should also assess certain troubling aspects of federal class action jurisprudence that were not affected by CAFA. These issues include: (1) efforts by a small number of federal courts to loosen the requirements of Rule 23; (2) the increasing use of cy pres settlements to support large fee payouts to class counsel; and, he noted, (3) judicial approval of class actions that encompass substantial numbers of uninjured individuals (that is, persons who lack Article III standing).

Mass Tort Seminar Held in Philadelphia

Earlier this week I attended the Mass Tort Litigation Conference in my home base of Philadelphia; this is the annual conference chaired by former Judge Marina Corodemus, who was the Mass Torts Judge in NJ for several years.

Other faculty included Judge Lee Rosenthal, Judge Ed Kinkeade, and Judge David Katz; plaintiff's lawyers such as Sol Weiss and Chris Seeger; and various members of the defense mass tort bar. It was great to see old colleagues and meet some new folks.

The program followed a hypothetical mass tort, involving an allegedly defective medical device, through government investigations, Daubert/Frye issues, MDL and other coordinations, through to settlements. Of course, Shook Hardy has tons of experience with all aspects of medical device litigation.

Anyway, among the interesting tidbits: beware of the growing use by plaintiffs of "medical ethicists" to condemn defendant's conduct as not only negligent but unethical and evil; and plaintiff's use of "mind-reading" experts who profess to divine the intent of the defendant corporation by reading between the lines of the emails and other discovered documents. We have posted on this before.

Plaintiff's counsel talked a bit about their mass tort intake process and the "screening" they use on potential new cases.  One interesting observation was the great level of concern expressed over the issue of product identification, and how it can be exacerbated by multiple defendant manufacturers, multiple versions or designs in play, and when the nature of the product somehow makes easy identification impossible.

The e-discovery panel (can't have a seminar without one) talked about the draft principles in discovery across borders, out for comment from Sedona Working Group 6.  Readers with thoughts should weigh in.

 

 

Court Again Dismisses Claim Against "Non-Conventional" Alcohol Beverage

We posted last year about the dismissal of a motorcycle passenger's claim against the maker of a caffeinated alcoholic drink, seeking to hold the company liable for her crash-related injuries.See Cook v. MillerCoors LLC, No. 11-1488 (M.D. Fla.).

The operator of the motorcycle in the accident was killed, and the plaintiff Cook, who was a passenger, was injured. Prior to the crash, the driver allegedly had consumed several alcoholic beverages containing caffeine and other stimulants, manufactured by the defendant. Cook argued that such beverages were “uniquely dangerous” because they appeal to younger drinkers and because the addition of caffeine allegedly enables one to drink more alcohol without feeling as intoxicated as one normally would. Thus, she contended, consumers of these beverages are more likely to “engage in dangerous behavior such as driving.” She asserted the driver did not appear impaired, even though toxicology reports from his autopsy revealed that his blood alcohol level was 0.10 at the time of the crash.

The district court found flaws with the duty, breach, and causation elements of the claim. The court found that Cook had not established a duty to warn because “the dangers inherent in alcohol consumption are well known to the public.”  Readers can readily see why the court was reluctant to make an exception to the rule for the so-called "unconventional" beverage. There are hundreds of alcohol-containing products that are arguably not "conventional" in one way or another, by taste, ingredients, color, manufacturing process, advertising... To shift responsibility from the person who over-consumes one of these and then drives impaired is to send the absolutely wrong policy message.

Courts have typically recognized no duty on the beverage maker, regardless of a plaintiff's attempt to differentiate either themselves or the product. See, e.g., Malek v. Miller Brewing Co., 749 S.W.2d 521 (Tex. App. 1988) (finding no duty to warn despite claim that advertising led plaintiff to believe that “Lite” beer was less intoxicating than other beer); Pemberton v. Am. Distilled Spirits Co., 664 S.W.2d 690 (Tenn. 1984); Greif v. Anheuser-Busch Cos., Inc., 114 F. Supp. 2d 100 (D. Conn. 2000)(particular, alleged tolerance of an individual consumer); MaGuire v. Pabst Brewing Co., 387 N.W.2d 565 (Iowa 1986).

Plaintiff attempted to re-plead her claim, again alleging that the addition of stimulants that mask the intoxicating effects of alcohol was a defect, but also focusing on the supposed risks this formulation posed to youth. The court again found the complaint lacking. Alcoholic beverages are not considered unreasonably dangerous as defined by the Restatement (Second) of Torts, because the dangers associated with alcohol are well known.  Cook asserted that the risks are not common knowledge to youthful drinkers having experience only with conventional alcoholic beverages. This court was not convinced that “the special risks posed to youth” made the drink unreasonably dangerous from the perspective of the general public.  More significantly, Cook’s argument overlooked an important point: the alleged “special risks” manifest themselves only if the consumer chooses to drink in excess. The case law recognizes that anyone who drinks alcohol may become impaired and yet may not be able to discern his or her impairment. That does not make alcoholic beverages unreasonably dangerous or absolve the drinker of responsibility.

Moreover, the youth-based allegations did not change Florida law on causation, under which voluntary drinking of alcohol is the proximate cause of such an injury, rather than the manufacture or sale of those intoxicating beverages to that person. As to the plaintiff's warning theory, persons engaging in the consumption of alcoholic beverages may not be able to ascertain precisely when the concentration of alcohol in their blood, breath, or urine reaches the proscribed level, so they should in the exercise of reasonable intelligence, understand what type of conduct places them in jeopardy of violating the law. The degree of intoxication to be expected from any particular brand (or formulation) of alcoholic beverage does not require a special duty to warn, or give rise to a fact question about the warnings here.

The court distinguished Cuevas v. United Brands Co., Inc., 2012 WL 760403 (S.D. Cal. Mar. 8, 2012), as an economic injury claim brought under various consumer protection statutes and warranty theories which focused on the sale of the product allegedly in violation of FDA rules rather than its consumption.


 

House Passes FDA Reauthorization Bill

The House of Representatives last week passed a bill (387 to 5 vote) that would reauthorize the Food and Drug Administration's user fee programs and amend the rules regarding marketing exclusivity, medical device safety, drug importation, and other FDA programs. The "FDA Reform Act of 2012," H.R. 5651, reauthorizes and amends various user fee statutes, creates new and additional user fees, reauthorizes the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act, changes the rules for public comment on draft guidance documents, and contains new provisions dealing with drug shortages.  The fees are supposed to reflect agreements negotiated between the FDA and industry regarding about $2.8 billion in user fees over five years.

The vote came shortly after the Senate approved its own version of FDA legislation, S. 3187 (the FDA Safety and Innovation Act). The Senate bill was also passed with bipartisan support.

The differences between the House and Senate bills now must be worked out in conference. The bills differ in a variety of ways, such as which antibiotics will be eligible for incentives, which include a five-year extension of market exclusivity. The bills also differ on the details of a national  track-and-trace system for drugs. The Senate bill also included language about Risk Evaluation and Mitigation Strategies (REMS) which is not in the House version. See a comparison of the bills here.  Various observers report that House and Senate leaders expect to have a compromise bill for the President to sign in early July.