Canadian Court Rejects Pharmaceutical Class Action

We have posted before about just how difficult Canada is becoming as a jurisdiction for class actions defendants, particularly companies in the pharmaceutical industry. Frequently, identical consumer products, drugs, and medical devices are marketed in Canada as well as the U.S.  When a product is recalled, or new science suggests risks in a product leading to American product liability and mass tort litigation, Canadian plaintiff attorneys have not been bashful about bringing copycat litigation, borrowing from U.S.-conducted theories and discovery.

A ray of hope to the north?  The Quebec Superior Court last week declined to certify (authorize is the term they use) a class action for Canadians claiming to have experienced side effects from the use of GlaxoSmithKline Inc.’s antidepressant Paxil.  This is the first time a Quebec court has rejected a class action involving a prescription pharmaceutical product -- ever as far as we can tell. See Goyette v. GlaxoSmithKline Inc., Quebec Superior Court, No. 500-06-000157-020 (8/17/09).

Plaintiff sought to represent a national class of Paxil users. Three issues were prominent: Did the claims of the class members raise identical, similar or related questions of law or fact?  Did the facts alleged seem to justify the relief sought? And was the plaintiff an adequate class representative?  Importantly, at the time of the complaint, the class rules required plaintiff to submit a supporting affidavit (on which she was cross-examined).  Since that time, Quebec has sought to minimize the amount of factual material presented to the court in support of class certification (making opposition a bit more difficult).

The first issues sounds like the commonality aspect of U.S. class procedure. GSK argued that the highly subjective nature of the alleged symptoms in the present case, such as headaches, nausea, vertigo, the infinite variations on the symptoms, and the intensity and duration are so subjective that they cannot be decided collectively and so cannot satisfy the common question element.  Nevertheless, the court found that while the claim for exemplary damages was not common, there were common questions concerning the warnings GSK had given.

However, even in the absence of a true predominance requirement, some Canadian courts will look at whether and what issues will require individual determination. Here, the court agreed that the underlying question is whether allowing the suit to proceed as a representative one will avoid duplication of fact-finding or legal analysis. Thus an issue will be “common” only where its resolution is necessary to the resolution of each class member’s claim. The court found that if  "a class action were permitted here, there would be no saving in judicial time since there is no real common question and each case must be litigated on its on merits."  The court noted that each year there was a different set of information in the CPS (Canadian PDR), and accordingly, there would be different sub-classes depending on changes in the relevant wording in each of the years.

Similarly, in this case, civil liability must be determined by assessing the specific risks disclosed for each individual patient which risks vary depending on multiple factors:

 a) whether the adverse effects occur during the use of the product and lead to discontinuation;

 b) whether adverse effects follow discontinuation;

c) whether the user was advised prior to use, by either their physician or pharmacist, of whether they may experience dependency or withdrawal symptoms;

d) whether the symptoms suffered were described in the C.P.S. (PDR);

e) whether the symptoms were not described in the C.P.S. but are proved to be directly related to the use of Paxil; or

f) to the extent that the symptoms arose following discontinuation, whether such symptoms were "mild and transient" and were described in the C.P.S.

Next, the court determined that the facts alleged do not support the relief requested. All of the symptoms that Ms. Goyette alleges to have experienced were mentioned by GSK in the C.P.S. and that any fault must have been through the misreading of the C.P.S. by Ms. Goyette's prescribing physician.  And she made no specific allegations about the injuries of the absent class members.  Accepting as true the well-pleaded allegations, in essence, the facts that are taken as proven do not include impressions, opinion, legal argument, inferences or hypotheses that are not verified.

Finally, adequacy of representation is evaluated on three criteria:

 1- an interest in undertaking the legal proceedings;

 2- an ability to instruct counsel; and

 3- absence of a conflict with the other group members.
 

Based on the previous analysis, the court found that Ms. Goyette could not represent a class since she herself does not have a valid cause of action.  Moreover, plaintiff had shown a singular lack of interest in that she never sought to speak with any of the other members of the proposed class, none of whom she knows; she has never sought to communicate with any of the individuals alleged to have signed up at her attorneys' website; and she could provide no explanation as to why these legal proceedings which started on May 2, 2002 remained dormant for several years.

An analysis with a little bit of teeth.
 

Court Dismisses Counts Of Trileptal Complaint Pursuant to Twombly

Add to your list of recent cases applying the recent U.S. Supreme Court decisions that clarified pleading standards, the decision in Frey v. Novartis Pharmaceuticals Corp., 2009 WL 2230471 (S.D.Ohio). 

The federal trial court dismissed a plaintiff's manufacturing and design defect claims against the maker of an epilepsy drug that allegedly caused her to develop multi-organ sensitivity, citing Ashcroft v. Iqbal, 129 S.Ct. 1937 (2009), and Bell Atlantic Corp. v. Twombly, 550 U.S. 544 (2007). Under Iqbal, a claim is facially plausible when the plaintiff  sufficiently “pleads factual content that allows the court to draw the reasonable inference that the defendant is liable for the misconduct alleged.” 

Plaintiff  used Trileptal for a short time in 2005. A label change was made in Spring, 2005, adding a precaution regarding multi-organ sensitivity. Novartis sent a Dear Doctor letter, advising of the label change, in April.  Plaintiff contended that the drug caused her to develop multi-organ sensitivity and related complications. Plaintiff sued, alleging various claims, including defective design and manufacture. Novartis moved for a partial dismissal under Fed. R. Civ. P. 12(b)(6).

According to the court, plaintiff's first cause of action for strict liability for defect in the manufacture of Trileptal under Ohio law must be dismissed pursuant to Rule 12(b)(6) for failure to state a plausible claim for relief. Plaintiff did nothing more than provide a formulaic recitation of the elements of a claim under the statute.  She failed to allege any facts that would permit the court to conclude that a manufacturing defect occurred and that the defect was the proximate cause of Frey's alleged injuries. Plaintiff's allegations in this regard fall far short of the sufficiency standard set forth in Twombly.

Similarly, the court said, the design defect claim would be dismissed because plaintiff once again simply provided a formulaic recitation of the elements of a claim under the statute. She did not allege any facts that would permit the court to conclude that there was a defect in the design or formulation of Trileptal and that the defect was the proximate cause of Frey's alleged injuries. Because plaintiff's allegations fall far short of the sufficiency standard set forth in Twombly, the claim for design defect must be dismissed.

Importantly, the court rejected plaintiff's argument that plaintiffs cannot be expected to particularly allege that the scientific makeup of the drug is defective for a specific reason without conducting discovery.

Finally, the court denied the plaintiff's motion to amend the complaint, saying she had not shown that they were able to allege facts that would state plausible claims for relief to satisfy the pleading standard.




 

Plaintiffs' Causation Expert Excluded in Viagra MDL

The federal judge overseeing the multidistrict litigation involving the erectile dysfunction drug Viagra has decided to exclude the testimony of the plaintiffs' key expert witness on causation. In re: Viagra Products Liability Litigation, case number 06-md-01724 (D. Minn. 8/19/09).

The litigation stems largely from an announcement in July, 2005 by the FDA that it was updating its labeling requirements for Viagra to reflect a small number of post-marketing reports of sudden vision loss, attributed to nonarteritic anterior ischemic optic neuropathy (NAION), an eye condition that can result in partial or total blindness.  An MDL consolidated hundreds of product liability lawsuits alleging a link between Viagra and NAION.
 

Judge Paul Magnuson of the U.S. District Court for the District of Minnesota had ruled last year that the general causation opinions of three of  the plaintiffs' experts should be excluded.  This motion related to plaintiffs' sole remaining general causation expert, Dr. Gerald McGwin.  This expert had authored a study, published in the British Journal of Opthalmology, which indicated that male Viagra users with a history of heart attacks had a statistically significant increased risk of suffering NAION. The court had originally denied Pfizer’s Daubert challenge to Dr. McGwin, largely because his study was peer-reviewed, published, contain[ed] known rates of error, and seemingly resulted from generally accepted epidemiological research.  In re Viagra Products Liab. Litig., 572 F. Supp. 2d 1071, 1081 (2008). In January, Judge Magnuson ruled that Pfizer could seek additional discovery related to McGwin's study, and in July, the judge denied the plaintiffs’ motion to have McGwin provide live testimony at a Daubert rehearing.
 

That additional discovery revealed that the study contained discrepancies that raised “serious concerns” about its reliability. In fact, the study contained numerous “acknowledged inaccuracies,” chief among them the inclusion of numerous patients in McGwin's data-set who had not taken Viagra until after they were diagnosed with NAION.  Dr. McGwin acknowledged that the statistics
in his study would have been different had those individuals (11 of 27 patients who
reported drug use) been coded as unexposed rather than as exposed. The discrepancies between the dates of first use on the original survey forms and in Dr. McGwin’s later electronic data set weaken the McGwin study’s assessment of temporality, thereby impair the study’s ability to contribute meaningfully to Dr. McGwin’s opinion about general causation.

Second, the statistical methods actually used to produce the numbers in the McGwin study as published were not the statistical methods that the study said were used. Even if a later reanalysis purportedly confirmed  the findings of the original study, the fact that the methodologies described in the study were not the actual methodologies used clearly also undermines the reliability of the McGwin study as published.

Third, the study was unreliable because it mischaracterizes one of its main findings—that men with a personal history of myocardial infarction and drug use have a significantly higher risk of NAION. The patients were actually asked whether they had a family history of myocardial infarction; no one was asked about personal history. These mis-codings regarding myocardial infarction added yet another layer of unreliability to the McGwin study as published.

The judge concluded that "Almost every indicia of reliability the Court relied on in its previous
Daubert Order regarding the McGwin Study has been shown now to be unreliable. Peer
review and publication mean little if a study is not based on accurate underlying data."

Lastly, Judge Magnuson denied the plaintiffs' motion for leave to file a supplement to McGwin's expert report, which included a reanalysis of the data, concluding that the report's untimely
submission was neither harmless nor justified. The reanalysis lacked even the basic indications of reliability — peer review and publication — that the original had seemingly had, and it had also been produced simply in response to concerns raised in the litigation.

Can Jury Ignore Uncontroverted Expert Opinion On Causation?

Here at MassTortDefense we often talk about the sufficiency of expert opinions, including on causation, from a legal Daubert or Frye standpoint.  A recent state court case from Texas reminds us about the rules on jury consideration of opinions that survive such legal challenges.

In Rentech Steel LLC v. Teel, No. 11-07-00318-CV (Tex. App., 11th Dist., 8/13/09), the plaintiff, who was working as a summer employee at Rentech's steel fabrication plant, suffered severe bilateral hand injuries while cleaning a power roller machine, a device that draws in steel plates and rolls them into cylinders. Rentech acknowledged some degree of fault but argued that some responsibility also rested with the settled manufacturer of the machine and the supplier.  The jury found Rentech negligent, but found no liability on the part of the other companies. Rentech appealed the finding of sole liability.

Expert William W.R. Purcell, a certified safety professional with degrees in civil and safety engineering and 40 years of experience, was retained by the plaintiff, but actually called by Rentech as an expert at trial.  He blamed the other defendants for inadequate warnings and instruction, and marketing defects, as well as agreeing there was negligence on the part of Rentech. Despite this uncontroverted expert testimony, the jury assigned liability only to Rentech.

The court of appeals noted that in Texas the jury is the sole judge of the witnesses’ credibility and the weight to give to their testimony.  Jurors may choose to believe one witness and disbelieve another and may disregard even uncontradicted and unimpeached testimony from disinterested witnesses.  Furthermore, even uncontroverted expert testimony does not bind the jury unless the subject matter is one for experts alone – one for which jurors “cannot properly be assumed to have or be able to form correct opinions of their own based upon evidence as a whole and aided by their own experience and knowledge of the subject of inquiry.”  Uniroyal Goodrich Tire Co. v. Martinez, 977 S.W.2d 328, 338 (Tex. 1998).

In this case, causation was not a matter for experts alone and did not require a technical or
scientific explanation, said the court;  it was within the jury’s ability to determine on its own what caused the accident and resulting injuries. See K-Mart Corp. v. Honeycutt, 24 S.W.3d 357, 361 (Tex. 2000)(holding that it was within jury’s ability to determine on its own whether lack of a railing caused the accident). Because causation was not an issue for experts alone, the jury could have disregarded Purcell’s conclusion as to causation.  The jury was free to conclude based upon the evidence presented at trial that Rentech failed to provide by a preponderance of the evidence (1) that the negligence of the other sellers was a cause of the accident and (2) that a marketing or design defect was a cause of the accident.

Other evidence before the jury included pictures of the actual roller machine and the warnings already located on the machine; testimony from a Rentech employee who operated the machine that a manual containing operating instructions had previously been supplied to Rentech; and testimony indicating that the Rentech employee operating the machine was knowingly violating the safety warnings and company policy at the time of the incident. Furthermore, the jury could have found that evidence proving a safer alternative design was lacking.

FDA Proposes That Adverse Event Reports Be Submitted Electronically

The Food and Drug Administration last week proposed new rules that would require adverse event reports related to approved devices, drugs and biologic products to be submitted electronically.  (Readers of MassTortDefense know how plaintiffs in mass tort litigation will attempt to use such reports to show the defendant company missed or ignored a "signal" of a safety issue with the product.)

When a drug or biological product is approved and enters the market, the product is introduced to a larger patient population in settings that may be different from clinical trials. New information generated during the post-marketing period can offer further insight into the benefits and risks of the product, and thus evaluation of this information is important to ensure the safe use of these products.

The FDA receives information regarding post-marketing adverse drug experiences from safety reports submitted to the agency. For nearly 35 years, FDA has received these post-marketing safety reports on paper. In recent years, some companies have voluntarily submitted these reports to
the agency in electronic format. Data from both electronic and paper reports are entered into FDA’s Adverse Event Reporting System (AERS) database. AERS is a computerized information database designed to support FDA’s post-marketing safety surveillance program for drug and biological products. The AERS database is used to store and analyze data received in post-marketing safety reports.

The FDA is proposing to amend its post-marketing safety reporting regulations to require that persons subject to mandatory reporting requirements submit safety reports in an electronic format that FDA can process, review, and archive. FDA is taking this action to improve the agency’s systems for collecting and analyzing post-marketing safety reports. The proposed change would help the agency, it believes, to more rapidly review post-marketing safety reports, identify emerging safety problems, and disseminate safety information in support of FDA’s public health mission. In addition, the proposed amendments would be a key element in harmonizing FDA’s post-marketing safety reporting regulations with international standards for the electronic submission of safety
information.

The FDA said the change will expedite the agency’s access to safety information and provide data to the agency in a format that would support more efficient and comprehensive reviews, and would enhance its ability to rapidly communicate information about suspected problems to health care
providers, consumers, applicants, and sponsors.

The agency says it is mindful of the security issues related to the confidentiality of data when safety
reports are submitted electronically, and will be prepared to respond promptly to changing
technology to ensure secure transmission of data.

Federal Court Dismisses Trasylol Class Action Complaint

A federal judge in Florida has dismissed the class action claims of plaintiffs asserting economic loss from Bayer's drug Trasylol, ruling that they have failed to adequately plead that their alleged damages flowed directly from the company's alleged conduct in marketing the drug. See Southeast Laborers Health and Welfare Fund, et al. v. Bayer Corporation, et al., 2009 WL 2355747 (S.D. Fla.).

Trasylol was approved by the U.S. Food and Drug Administration to prevent excessive bleeding during coronary artery bypass graft (CABG) surgery. The plaintiffs, including a health and welfare fund responsible for paying for members' prescription drugs, allege that cheaper and safer alternatives were available but that Bayer somehow "over-promoted" the drug for CABG use.  They also allege the company promoted it for unapproved off-label uses, such as orthopedic surgery. They say, bottom line, that they would not have paid for Trasylol had they known the true story.

Such claims are typical of the consumer fraud act claims of plaintiffs in drug litigation, and equally typical is the fact that calculation of plaintiff's alleged losses would be extremely difficult, fact intensive, and absent such facts, purely speculative. Plaintiff must allege the causation element of the claim, and even the requisite short and plain statement of the claim requires more than labels and conclusions, and more than a formulaic recitation of the elements of a cause of action. (citing Twombly, 550 U.S. at 555 ).

In a causation analysis that applies to both the consumer fraud act and RICO allegations, the court noted that there are many factors that a doctor may consider in determining what medication to administer to a given patient. Doctors are presumed to, and actually do, go beyond advertising and marketing and also use their independent knowledge in making medical decisions. Loss calculation, therefore, necessarily would require an analysis of whether or not a particular physician ever received or relied on Bayer's allegedly fraudulent statements, and whether or not a physician, knowing the risks vs. benefit of Trasylol, would still have used it during an operation.

It would require a determination as to how many doses a patient received, and whether or not the number of doses was tied into any fraudulent marketing. It would also require speculation as to what alternative medications a particular physician would have ordered in a particular surgery, and how much that medication would have cost. Such a cost calculation would be problematic, as costs clearly would have fluctuated over the ten year period. Lastly, it would entail determining those patients who received Trasylol who did not suffer any adverse reactions, and who might have been helped by the use of the drug. Plaintiffs plead none of those facts.

The plaintiffs here attempted to rely on a "fraud on the market" theory to avoid this analysis, citing In re Zyprexa Prod Liab. Litig., 493 F.Supp.2d 571 (E.D. N.Y. 2007), but the court called this "simply misplaced." The fraud-on-the-market doctrine in both the Eleventh and Third Circuits has been held to be limited strictly to securities cases and is inappropriate in claims alleging deceptive advertising such as the ones presented by drug litigation.   

Further, on the RICO count, the court said that the plaintiffs' factual allegations were not sufficient to constitute a representative sample of the defendants' allegedly fraudulent acts, when they occurred and who engaged in them.

Judge Middlebrooks granted the plaintiffs leave to amend but said it was "unlikely" they would be able to cure the proximate causation deficiency in their claims.

 

 

 

BPA Update

The FDA's Science Board earlier this week heard  an update from the agency regarding the continued assessment of Bisphenol-A (BPA) in FDA-regulated products. (The Science Board to the Food and Drug Administration provides advice primarily to the Commissioner and other government officials on complex and technical issues as well as emerging issues within the scientific community.  The Board consists of a core of 21 members who are supposed to be authorities knowledgeable in the fields of food safety, nutrition, chemistry, pharmacology, toxicology, clinical research, and other scientific disciplines. Members represent academia and industry.)

At the meeting's update from the agency regarding the continued assessment of BPA,  the FDA Acting Deputy Commissioner briefed the agency's Science Board about agency plans to complete its evaluation of bisphenol A;  Dr. Goodman, who is also FDA's acting chief scientist, reportedly stated that the FDA will decide by Nov. 30 whether it will regulate bisphenol A in food packaging. FDA's National Center for Toxicological Research also described a variety of rodent and monkey studies that FDA is undertaking to further assess bisphenol A and potential health effects.

A representative of the Natural Resources Defense Council was among the public speakers who urged FDA to ban bisphenol A, despite the fact that the few studies of laboratory animals that have suggested an association with reproductive or developmental issues have used nonstandard test methods. Studies using standard protocols have not found any significant problems. The American Chemistry Council, BPA Joint Trade Association, and other industry groups argue that food and beverage containers made with BPA pose no undue risk of harm.  BPA is used in the lining of some food and beverage cans to prevent spoilage and is also used in a variety of other consumer products to enhance the structural integrity of plastic containers. Assessments conducted by Health Canada and California's Environmental Protection Agency suggest that dietary exposure would not pose risk to infants. Infant formula may be the most highly regulated food in the world.

Earlier this month, the Massachusetts Department of Public Health issued a health advisory   to parents and caretakers of children up to the age of two years suggesting they avoid the use of products that contain BPA for making or storing infant formula and breast milk. The state health agency further advised pregnant and breastfeeding women to avoid products that may contain BPA. The agency also noted that researchers caution that more research needs to be conducted.

Readers of MassTortDefense interested in BPA issue may want to look at "Science Suppressed: How America became obsessed with BPA,"  an in-depth examination by the STATS program at George Mason University of the science, risk assessment, and media coverage of the chemical, based on interviews with the lead authors of two major risk assessments, and focusing on the accuracy of the media's campaign to have the chemical banned. Some newspapers' coverage has had a knack, says the study, for avoiding research that showed BPA was safe, including risk assessments by the European Union, NSF International, Japan, and a lot more. Some of the media coverage has relied on a small circle of researchers whose work on BPA has been rejected by risk assessments across the world.


After the National Toxicology Program draft report was issued in early 2008, plaintiffs' attorneys nationwide began filing consumer class action complaints claiming violations of state consumer protection laws, fraud, breach of warranty, unjust enrichment, strict product liability, breach of contract and negligence. The lawsuits were consolidated as an MDL in the Western District of Missouri, last year (MDL-1967).  This multidistrict litigation consists of more than 25 cases that involve allegations concerning in baby bottles.

Senator Writes Letter To NIH About "Ghostwriting"

Plaintiffs in pharmaceutical and other biomedical litigation have frequently resorted to allegations of “ghostwriting” to attack various aspects of scientific articles that defendants seek to rely on.  “Ghostwriting” is a somewhat pejorative term used to vilify some versions of a common practice – the use of biomedical communications companies to provide professional assistance in medical research and/or writing. Plaintiffs often imply that the named author had little or nothing to do with the direction or content of the article.

Several courts have rejected such generally overblown allegations. In the HRT litigation, In re Prempro Products Liability Litigation, 554 F. Supp.2d 871 (E.D. Ark. 2008), the court noted that while plaintiff focused heavily on the evidence that Wyeth collaborated with authors to have articles written about HRT, there was no evidence that this practice is inappropriate or that Wyeth supported articles that it knew were false or misrepresented the science. Rather, the articles supported Wyeth’s position on the state of the science. Additionally, there was evidence that ghostwriting was a common practice in the industry.  Similarly, in In re Seroquel Prods. Liab. Litig., No. 6:06-md-1769-Orl-22DAB, slip op. at 3-5 (M.D. Fla. Jan. 30, 2009), Judge Conway held that plaintiffs could not use the words "ghostwriting" or "plagiarism" to characterize the process by which articles were written.

A “ghostwriter” may:
– Analyze data
– Research issues, gather review data
– Organize/format materials
– Assist in writing by, e.g., drafting publications

Such third-parties can save busy scientists time and effort- by doing time-consuming preliminary tasks. Having medical communications specialists involved can make the articles easier to read, more informative The fact is, a great doctor does not mean a great writer; outside writers can expedite publication and eliminate artificial drag in the process.

Nevertheless, Senator Charles E. Grassley, an Iowa Republican, has written a letter to NIH asking for information about possible ghostwriting:
I1) What is the current NIH policy on ghostwriting with regards to NIH researchers?  2) What is the current NIH policy on ghostwriting with regards to NIH grantee institutions? 3) What is the current NIH policy on ghostwriting with regards to primary investigators of NIH grants? 4) Has NIH received any complaints about individual grantee institutions, primary investigators and/or NIH researchers regarding possible ghostwriting, and if so how has NIH handled these complaints? 5) What is the current NIH policy regarding primary investigators found to have violated medical ethics and/or have medical licenses that have been suspended or revoked?

The response, when it comes, may be significant because the N.I.H. underwrites much of the country’s medical research. Many doctors depend on federal grants to support their work, and attaching fresh conditions to those grants could influence new publication guidelines more broadly.

In reality, typically, the named author has access to all data. The authors can reorganize the presentation of the data and edit the article. The articles are subjected to extensive peer review before publication, often in journals the author selects.  In litigation, the plaintiff’s prescriber may not have read or relied on any such articles. And doctors who prescribe are well familiar with the industry practice and custom. Plaintiff’s “ghostwriting” claims also fail to offer proof that the articles which were, in any event, peer-reviewed and medically sound, affected the FDA’s actions.

Any debate on “ghost writing” of medical publications ought to include an understanding of the realities of supply and demand for published research, of the time pressures, needs, and priorities of leading researchers, and the evidence demonstrating the author's control over final publication.

Readers of MassTortDefense interested in these issues should look at the International Committee of Medical Journal Editors' Uniform Requirements for Manuscripts Submitted to Biomedical Journals: Writing and Editing for Biomedical Publication;  the American Medical Writers Association's Position Statement and Code of Ethics; and the  World Association of Medical Editors' Policy Statement on Ghost-writing Initiated by Commercial Companies.

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Defendants Seek Dismissal Of Baby Product Class Action

Defendants have moved to dismiss the complaint in a proposed class action by parents claiming that the makers of shampoos and and soaps for kids failed to list toxic chemicals on product ingredients lists. Vercellono, et al. v. Gerber Products Co., et al., No. 2:09-cv-02350 (D.N.J.).

The complaint names Gerber, Johnson & Johnson Consumer Cos. Inc., Procter & Gamble
Distributing LLC, MZB Personal Care, Wal-Mart Stores Inc. and Nestle Inc. as defendants.
The plaintiffs claim that several products, including Grins & Giggles, Head-to-Toe Baby Wash and others, contain formaldehyde and 1,4-dioxane.  Plaintiffs further allege that these chemicals have been linked to cancer, skin allergies and other health problems.

The plaintiffs are seeking compensatory, punitive and/or exemplary damages for the proposed class, which is defined as all consumers nationwide who purchased the products in question.  Plaintiffs allege that the companies violated consumer fraud statutes by making or distributing baby care products specifically marketed for sensitive skin despite containing the chemicals, and misrepresented that the products they marketed, distributed, promoted, sold, and/or made were safe for children.

Defendants' motions attack several aspects of the complaint, including the injury allegations in connection with the consumer fraud count.  The motion illustrates one of the key battlegrounds in a consumer fraud class action.  While plaintiffs typically assert that the predominating issues are common, defendants will point to the injury element under the statute as requiring individual proof.  But before even deciding the class issues, the question is raised whether plaintiffs have adequately alleged an  injury.  Often, they will seek to avoid suggestion of personal physical injury, because of the individual issues it raises.  But there is risk in going too far.

According to the Gerber motion, plaintiffs suffered only mere exposure to the chemicals and failed to cite any actual injury. The complaint fails to allege that plaintiffs, their children, or anyone else has ever suffered any actual harm as a result of using the products. Nor does the complaint allege that the products failed to perform as a bath product. Rather, the complaint merely alleges that plaintiffs have suffered “exposure” to formaldehyde and 1,4-dioxane.  While they assert that they were injured by paying the purchase prices for the defendants’ products, under the New Jersey Consumer Fraud Act, as under many such acts, plaintiffs are required to allege that they have suffered an ascertainable loss, and allegations of economic loss are insufficient, as are allegations of  the vague potential of a speculative future injury.




 

Climate Change Litigation and Legislation Update

Although we haven't posted about it much, a number of environmental groups, states and private citizens have brought litigation, seeking to turn climate change issues into mass torts. Thus far, the litigation, which has focused principally on greenhouse gas emissions, has not been very successful. Unlike typical mass tort litigation, some of these plaintiffs admit that part of the goal of the cases is to encourage Congress to act on legislation (leading to regulation) that would achieve some of the same goals.

One example is the mass tort suit filed in 2008 by residents of a small Alaskan village against two dozen energy companies, claiming that carbon dioxide and other greenhouse gases have left their town uninhabitable. Native Village of Kialina v. Exxon Mobil Corp., et al., 2008 WL 2951742 (C.D.Cal.)

Now comes word that a number of studies will be released in the near future, examining the potential impact of pending climate-change legislation, including its effect on food prices. Under the proposed climate-change legislation, a carbon offset, or credit, can be generated when a company reduces the amount of greenhouse gas emitted into the atmosphere. The resulting offsets can then be sold to other polluters or used by the producer to reduce its overall emission totals. Certain companies would have to pay penalties if they emit more than allowed without offsets.The House passed a bill, the American Clean Energy and Security Act of 2009, in late June. There is concern the bill doesn't provide sufficient incentives for food and agricultural companies to receive and generate carbon credits to offset their carbon emissions. The Senate is expected to take up its own climate bill next month. Critics say that the House bill also risks an increase in food and feed prices, and a reduction in the international competitiveness of U.S. businesses.

Again, the legislation and any resulting regulation may have a significant impact on whether the courts will breathe life into mass tort litigation relating to alleged climate change issues.

Update On Chinese Drywall Litigation

The Consumer Products Safety Committee has reported that it has received approval from the Chinese for a visit to China in connection with the drywall issues, and that CPSC staff is working with the Chinese government to arrange an investigative visit beginning later this month.  The CPSC has asked to visit several sites of interest in its investigation of issues related to the tainted drywall, which we have posted about before.

The CPSC reports that it has now received a total of 810 reports related to the allegedly defective drywall, including complaints from two additional states, Pennsylvania and South Carolina. That means the Commission has received reports from homeowners in 23 states and the District of Columbia. The majority of the reports continue to be from Florida, Louisiana, and Virginia.  About 6.2 million sheets of Chinese drywall were imported into the U.S. during 2006.

As part of its investigation, the Commission notes the:
• Start of the Lawrence Berkeley National Laboratory chamber testing of various drywall samples to isolate specific emissions.
• Start of a 50 home indoor air sampling program.
• Site visit to a synthetic drywall manufacturing facility.
• Completion of testing for radioactive phosphogypsum contamination in drywall, in coordination with the Florida Department of Health and the EPA National Air and Radiation Environmental Laboratory. 

The EPA is conducting elemental analyses of 15 drywall samples, with a tentative date for completing its analyses of drywall samples by late August. The CPSC's engineering staff has visited seven homes in Florida, Louisiana and Virginia to gather samples of electrical, plumbing and safety systems. CPSC also has hosted a call among attorneys general of impacted States to coordinate and exchange information about State-level efforts.

Lawsuits filed over the drywall issues allege that excessive sulfur levels in the Chinese-made products are causing health effects and problems with air conditioning systems, appliances, internal wiring and other electrical systems. In June, the U.S. Judicial Panel on Multidistrict Litigation consolidated the lawsuits in the U.S. District Court for the Eastern District of Louisiana. More than 90 suits were on the docket as part of the MDL as of last week. Plaintiffs have asked the court to certify the matter as a class action. In re: Chinese-Manufactured Drywall Products Liability Litigation, MDL 2047.

The monthly status conference in the MDL was held last week before Judge Fallon. At the conference, the court considered issues raised by Liaison Counsel, including pre-trial orders, property inspections, Plaintiff and Defendant profile forms, an evidence preservation order, state court settings, state/federal coordination, discovery issues, Freedom of Information Act/ public records requests, trial settings in federal court, tolling agreement/suspension of prescription, plaintiffs' request for a class action, insurance issues, service of pleadings electronically, and the master complaint. A full report can be found here. 

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Defense Jury Verdict In Welding Rod Trial

A jury in Mason County, W.Va., issued a unanimous verdict last week for welding industry defendants, rejecting claims that injuries to former welder John Belcher were caused by their products. Adkins, et al v. Airco, et al., No. 06-103 (W.Va. Cir. Ct., Mason Cty.)

Apparently jurors deliberated for only a couple hours after an eight-day trial before Circuit Judge David W. Nibert.  Defendants at the trial included Lincoln Electric Company Inc., Hobart Brothers Inc. and The BOC Group Inc. The Circuit Court had entered a gag order before trial to avoid prejudicing potential jurors, so there wasn’t much press on this one.

Defendants have won about 85% of the trials so far in this mass tort. And along with numerous defense verdicts like this one, this litigation has seen the dismissals of thousands of cases. The total number of pending welding fume cases has dropped by more than one half since January 2006. In the MDL in Cleveland, the plaintiffs recently dismissed more than two thirds of the cases they had certified as "ready for trial. "

The next bellwether trial in the federal MDL in front of  Judge O'Malley is set for September. Plaintiff Cooley, a long time welder from Iowa, alleges manganese neuro-toxicity, which defendants contend is not actually a recognized disease. Both sides have recently filed motions to knock out the other's expert opinions under the Daubert doctrine.

 

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Senate Holds Hearing On Medical Device Safety Bill

The Senate Health, Education, Labor, and Pensions Committee last week held a hearing on the Medical Device Safety Act of 2009 (S. 540), which if enacted would overturn the Supreme Court's interpretation of the Medical Device Amendments (MDA) to the Federal Food, Drug, and Cosmetic Act in Reigel v. Medtronic.  The Supreme Court ruled that the MDA bars state law product liability claims against medical device companies based on alleged defects in products that had received approval through FDA's stringent premarket approval (PMA) process. The PMA process is used only in class III devices—devices FDA deems to be “high risk,” like pacemakers. The devices that are marketed as PMAs represent cutting edge science and are critical to public health.
 

We have posted on this legislation before here at MassTort Defense.  In addition to ignoring the important benefits of a uniform federal standard and the chaos of allowing devices to be regulated by litigation, the bill would would stifle innovation in the medical device industry and result in lost jobs, especially at smaller device companies. Obviously the bill is favored by overzealous trial lawyers and the legislators they support.

Testifying at the hearing were a variety of supporters of the bill, including academics who argued that preemption deprives victims of their right to compensation from the wrongdoers who injured them -- without convincingly responding to the concerns that would be raised by the new regime which allow juries throughout the country not only to impose requirements that are inconsistent with FDA determination, but that differ from one state court to another. The witness panel had no representative from the device industry.

The legislation would take away primary responsibility for device safety from the FDA and put it in the hands of lay jurors who have little to no understanding to the science involved, and who will listen to plaintiff's lawyers arguing about a single alleged injury without regard to the many of patients potentially safely aided by the device. Democratic supporters argued that no matter how diligently and effectively the FDA does its job, it simply cannot "guarantee that no defective, dangerous, and deadly medical device will reach consumers." The notion that any regulatory regime can "guarantee" defect-free products is misguided.  And to think that lay juries will do a better job of balancing product risks and benefits is foolish. Risk is inherent in all medical devices, and small numbers of patient injuries does not mean a device is defective.
 

The Advanced Medical Technology Association (AdvaMed) has urged Congress to reject the legislation, noting it would increase health care costs and decrease patient access to life-saving medical technology.  As the debate is ongoing about health care reform, legislation that will create more litigation, increase health care costs, and render it harder for medical device manufacturers to invest in promising new technology, hardly seems wise.

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Bill Introduced To Ease Suits Against Foreign Manufacturers

We have posted at MassTortDefense about a number of significant product liability issues arising from products made outside the US and imported into this country.  Senators Sheldon Whitehouse, D-R.I.,  Jeff Sessions, R-Ala., and Richard Durbin, D-Ill., have introduced a bill that would make it easier for foreign manufacturers to be sued when their products allegedly injure U.S. consumers.

The Foreign Manufacturers Legal Accountability Act of 2009 was introduced in the U.S. Senate last week.  The bill, S. 1606,  follows up on hearings last Spring during which witnesses testified about the perceived delays and difficulties with serving foreign manufacturers with process and establishing jurisdiction.
 

In comments on the Senate floor, sponsors cited recent examples in which Americans had been injured by allegedly defective foreign products. They claimed that the current rules put American manufacturers at a competitive disadvantage because they supposedly allow foreign companies to offer cheaper products that do not comply with U.S. safety requirements. The bill would apply to drugs, medical devices, and cosmetics, biological products, consumer products, as such term is used in the Consumer Product Safety Act, chemicals under the Toxic Substances Control Act, and pesticides.

The bill attacks the issues of service of process and jurisdiction. Service abroad involves the Hague Convention on the Service Abroad of Judicial and Extra Judicial Documents in Civil and Commercial Matters, to which the U.S. is a signatory. A complaint must be translated into the foreign language, transmitted to the central authority in the foreign country, and then delivered according to the rules of service in the home country of the defendant. This can be a lengthy and expensive process. The proposed legislation would require foreign manufacturers and producers of covered products distributed in commerce (or component parts that will be used in the United States to manufacture such products) to establish a registered agent in the United States who is authorized to accept service of process.  It similarly states that a person may not import into the United States a covered product (or component part that will be used in the United States to manufacture a covered product) if such product (or component part) or any part of such product (or component part) was manufactured or produced outside the United States by a manufacturer or producer who does not have a registered agent.

 The second major hurdle is the inability to establish personal jurisdiction over foreign
manufacturers. Under the new bill, a foreign manufacturer or producer of covered products that registers an agent as above thereby consents to the personal jurisdiction of the State or Federal courts of the State in which the registered agent is located for the purpose of any civil or regulatory proceeding.

Not surprisingly the bill is supported by the "American Association for Justice"  plaintiffs lawyers.

 

 

Guide for Multidistrict Litigation Transferee Judges Published By FJC

The Judicial Panel on Multidistrict Litigation and The Federal Judicial Center have recently released a new publication, "Ten Steps to Better Case Management: A Guide for Multidistrict Litigation
Transferee Judges."

As readers of MassTortDefense well know, Section 1407 empowers a transferee judge to exercise all the powers of the transferor court, with the exception of actually conducting the trial of the case (except in special circumstances). The stated purpose of this Guide is to briefly introduce some of
the “best practices”  -- in  the authors' view -- that transferee judges have developed over the years. It is designed as a complimentary piece to the guidance in the Manual for Complex Litigation (4th ed.), which addresses some of difficult management, intellectual, and legal challenges posed by MDL cases. 

The advice includes the suggestion to identify and appoint liaison counsel who are vigorous advocates, constructive problem-solvers, and also civil with their adversaries, because the judge cannot manage an MDL entirely alone. "To a large extent, you [judge] must rely upon lead counsel to assist you."

Another welcome suggestion: Rulings should be prompt and disciplined; scholarly
perfection is not required on all issues.  In particular, resolving discovery disputes expeditiously is important to avoid undue delay in any case, but particularly in an MDL, says the Guide.

In MDL litigation with parallel state cases, judges are urged to reach out to their state court colleagues "from the outset" to try to forge constructive working relationships with them. One way of doing this is to establish an MDL-specific website so that federal orders and rulings are readily available to state courts.

Worth a look for defense counsel with MDL practices.

 

FDA Commissioner Outlines New Enforcement Plans

Readers of MassTortDefense know how FDA actions can instigate and affect potential mass tort litigation involving drugs and devices. Last week, in a presentation to the Food and Drug Law Institute (FDLI), new FDA Commissioner Margaret A. Hamburg revealed that the FDA will implement procedural reforms designed to allow the agency to act more quickly and aggressively on the enforcement of food, drug, and medical device regulations. The FDA commissioner told FDLI that the federal watchdog will be a leaner and meaner organization under her leadership.


In her remarks, the Commissioner noted that while impressed by the commitment to compliance that many companies have made – both in terms of their corporate culture and their investment in compliance systems -- her goal is for all companies to make and implement such a commitment in order to prevent harm to the public. A key part of the strategy to support private sector compliance is more effective enforcement against violations of the law. She suggested that such enforcement helps industry too – by maintaining a level playing field for safe products. Making sure that offenders are held legally accountable prevents companies from having to choose between doing the right thing and staying competitive.

An effective enforcement strategy depends on several key elements she said:

  • The FDA must be vigilant. Through regular inspections and follow-up on signals indicating problems, the FDA must work to identify and resolve problems early. Companies must have a realistic expectation that if they are crossing the line, they will be caught, and that if they fail to act, FDA will.
  • The FDA must be strategic, she continued. The agency must place greater emphasis on significant risks and violations, and use meaningful penalties to send a strong message to discourage future offenses.
  • The FDA must be quick. The agency must be able to respond rapidly to egregious violations or violations that jeopardize public health.

More specifically, she said the pathways for enforcement action can be too long and arduous. To address this, the FDA will set post-inspection deadlines. When the FDA finds that a firm is significantly out of compliance, it will expect a prompt response to the findings, generally no more than fifteen working days before the FDA moves ahead with a warning letter or enforcement action.

Second, the FDA will take steps to speed the issuance of warning letters. There will be a new policy to limit warning letter review to significant legal issues.

Third, the FDA will work more closely with regulatory partners to develop effective risk control and enforcement strategies. In many food safety cases, for example, local, state, and international officials have more authority to take action quickly than the FDA.

Fourth, the FDA will prioritize enforcement follow-up. After a warning letter is issued or a major product recall occurs, FDA will make it a priority to follow up promptly with appropriate action, such as an inspection or investigation to assess whether or not a company has made required changes in its practices.

Fifth, she said, the FDA will no longer issue multiple warning letters to non-compliant firms before taking enforcement action. And, in the case of significant health concerns or egregious violations, FDA will consider immediate action – even before issuing a formal warning letter.

Finally, the FDA is developing a formal warning letter “close-out” process. If the FDA can determine, usually based on a re-inspection, that a firm has fully corrected the violations raised in a warning letter, it will provide to the firm a “close-out” letter, indicating that the issues in the warning letter have been successfully addressed. One can imagine how the obtaining or failure to obtain a close-out letter may be anissue in litigation.
 

Third Circuit Vacates Class Certification In Consumer Fraud Tanning Case

MassTortDefense has posted about the dangers lurking in consumer fraud class actions before. About a year ago, we posted on a disturbing decision in Nafar v. Hollywood Tanning Systems, Inc., 2008 WL 3821776 (D.N.J., August 11, 2008), where the district court certified a nationwide class of tanning customers.  We concluded our post, by noting "Clearly, this certification decision ought to be reviewed by the Third Circuit."  Fortunately, that has happened. The Third Circuit granted Hollywood Tans’ petition for interlocutory review under Fed. R. Civ. P. 23(f), and has vacated the class certification decision. Nafar v. Hollywood Tanning Systems, Inc., No. 08-3994 (3d Cir. Aug. 5, 2009).

Plaintiff had alleged she purchased monthly tanning memberships from defendant Hollywood Tanning Systems, in New Jersey. Plaintiff alleged that defendant fraudulently failed to disclose the fact that any exposure to ultraviolet rays (UV rays) increases the risk of cancer and allegedly deceptively failed to warn consumers about the dangers of indoor tanning. While plaintiff acknowledged that defendant's machines may block out most UVB rays, she contended that defendant failed to inform consumers that UVA rays, also emitted by its machines, are allegedly linked to skin cancer. Plaintiff instituted suit alleging: (1) violation of the New Jersey Consumer Fraud Act (“NJCFA”), (2) fraud, (3) unjust enrichment, and (4) breach of warranty.

Plaintiff sought a nationwide class of consumers who had purchased tanning memberships. The district court’s analysis of the Rule 23(b) requirements for class certification was, unfortunately, devoid of substance. The 3d Circuit determined that the district court erred by not defining either the class or the class claims, as required by Rule 23(c);  erred by failing to conduct an adequate choice-of-law analysis when the potential class members for this consumer fraud action hail from numerous states; erred by failing to consider evidence suggesting that individual issues of fact and law regarding causation predominate over common issues, and finally, erred in failing to consider whether res judicata would apply to potential personal injury claims, and therefore whether Nafar was an “adequate representative” of the class.

In the context of class action certification, the Supreme Court has stated that a district court “may not take a transaction with little or no relationship to the forum and apply the law of the forum in order to satisfy the procedural requirement that there be a ‘common question of law.’" Phillips Petroleum Co. v. Shutts, 472 U.S. 797, 821 (1985). A court must apply an individualized choice of law analysis to each plaintiff’s claims. Here, the district court had stated that common issues of law predominated: “Common questions of law predominate because New Jersey law is central to this litigation. The NJCFA [consumer fraud act] will apply to all class members because this particular law governs Defendant's behavior and uniform policies. New Jersey has a strong interest in this litigation because the case's outcome will likely affect Defendant's nationwide behavior…. Indeed, the NJCFA is one of this nation's strongest consumer protection laws and its application will not frustrate other states' consumer protection laws. ” That conclusion was not based on an analysis of the choice of law rules of the forum state; cited no state court cases suggesting that NJ law should apply to the claims of consumer from other states; failed to analyze the differences among the consumer protection laws of the various states; and failed to analyze the interests other states may have in applying their laws by simply assuming every state would rather apply NJ’s law.

The 3d Circuit noted that New Jersey now applies the Second Restatement’s “most significant relationship” test. On remand, the District Court was ordered to conduct a choice of law analysis under New Jersey’s most significant relationship test.

The trial court had stated that common fact issues predominated as well because the alleged misrepresentations and omissions concerning the negative consequences related to indoor tanning are alleged to be uniform. However, the court failed to conduct any analysis of the elements of the claims upon which the class was certified, and whether any of the elements might raise individual questions. In addition to the analysis that will be necessitated by a proper choice of law review, the 3d Circuit noted that evidence of plaintiffs’ conduct relevant to the causation issue cannot be ignored without comment in a predominance analysis. This is because the Supreme Court of New Jersey has held that individual issues regarding plaintiff’s behavior may, in certain cases, defeat predominance in a NJCFA class action, despite the alleged uniformity of a defendant’s misrepresentations or omissions.

As we noted last year about the certification decision, the defendant apparently submitted surveys showing that the risks of tanning are common knowledge, and many consumers understood the cancer risks involved. Even if plaintiffs were not required to present any direct proof of individual reliance – which they would be under some state laws – this would not prevent a defendant from presenting direct evidence that an individual plaintiff did not rely on any representations from the company. Defendants have a right to present evidence negating a plaintiff's direct or circumstantial showing of causation and/or reliance. The "predominance" inquiry here thus resembled a mere commonality test. On remand, the 3d Circuit held, the court should consider the evidence presented, resolve any disputes relevant to the predominance issue, and consider all the elements of the underlying claims to determine if individual issues predominate over common issues of fact and law.

Finally, named plaintiff had only economic injuries, but personal injury claims were ostensibly included in the class definition.  This raised the issue of claim splitting and res judicata, and the issue whether the named plaintiff could be an adequate class representative for a class alleging such disparate injuries.  The appeals court found that  the district court failed to consider this very important issue in assessing the adequacy of representation requirement. For that reason the court was told it should consider, on remand, New Jersey’s doctrines regarding preclusion, whether other states’ preclusion doctrines would apply, the specific claims and facts alleged here, and whether any potential future claims by class members with personal injury would be at risk of being barred by res judicata.

We will see what happens on remand, but for now, scary decision vacated.

State Court Excludes Plaintiff's Causation Expert Under Frye Test

A Minnesota appeals court recently affirmed summary judgment for defendants in a suit by a woman who alleged hormone replacement drugs caused her breast cancer. Zandi v. Wyeth, 2009 WL 2151141 (Minn.App.)

Plaintiff alleged that between approximately 1981 and 2001, she ingested hormone-replacement-therapy (HRT) drugs manufactured, designed, packaged, marketed, and distributed by defendants.   In November 2001, Zandi was diagnosed with "hormone-dependent breast cancer."  She contended that the HRT drugs caused her cancer.  She brought claims for negligence, strict liability, breach of implied warranty, breach of ex-press warranty, fraud, misrepresentation, and violation of the Minnesota fraudulent advertising act, the Minnesota Prevention of Consumer Fraud Act, and the Minnesota Uniform Deceptive Trade Practices Act.


The trial court  found that plaintiff's specific causation evidence did not satisfy Minnesota's standard for admissibility of expert testimony.  Zandi offered testimony from Dr. Lester Layfield and Dr. Gail Bender to prove that HRT drugs caused her cancer. Minnesota courts use the Frye standard to determine the admissibility of novel scientific evidence. Goeb v. Tharaldson, 615 N.W.2d 800, 814 (Minn.2000). Under Minnesota's version of this standard, the proponent of scientific evidence must establish that the scientific theory is generally accepted in the relevant medical or scientific community and that the principles and methodology used are reliable.  McDonough v. Allina Health Sys., 685 N.W.2d 688, 694 (Minn.App.2004). When novel scientific evidence is offered, (1) the trial court must determine whether it is generally accepted in the relevant scientific community; (2) the particular scientific evidence in each case must be shown to have foundational reliability.

Zandi's claims were based on the following propositions: 1) it is generally accepted that HRT causes hormone-dependent breast cancer, and 2) there is a generally accepted method of diagnosing the cause of hormone-dependent breast cancer in an individual.  The appellate issues revolved around the second.  Defendants alleged that even if one assumes the relevant scientific community generally accepts that HRT causes hormone-dependent breast cancer, Zandi had failed to establish that the relevant scientific community generally agrees that there is a method of diagnosing the cause of breast cancer in a particular person.

Plaintiff's experts based their specific causation opinions on epidemiological studies and differential diagnosis. But  the science of epidemiology does not address the cause of an individual's disease. Epidemiology is concerned with the incidence of disease in populations and does not address the question of cause of an individual's disease. Epidemiology has its limits at the point where an inference is made that the relationship between an agent and a disease is causal (general causation) and where magnitude of excess risk attributed to the agent has been determined; that is, epidemiology addresses whether an agent can cause disease, not whether an agent did cause a specific plaintiff's disease. See Green et al., Reference Guide on Epidemiology, in Reference Manual on Scientific Evidence 333, 381-82 (Fed.Jud.Ctr.2d ed.2000).

Plaintiff's experts also relied on differential diagnosis. As used by plaintiffs, differential diagnosis adopts a process of elimination to identify cause; it  seeks to eliminates the possibility of competing causes or confounding factors. Goeb, 615 N.W.2d at 815.  In performing a differential diagnosis, a physician begins by ruling in all scientifically plausible causes of the patient's injury. The physician then rules out the least plausible causes of injury until the most likely cause remains.  Yet, breast cancer does not lend itself to such a differential diagnosis because the scientific community has not accepted that breast cancer has a limited number of discrete and recognized possible causes such that ruling out one cause would implicate another. For differential diagnosis to be sufficiently reliable to prove causation, the diagnostician should rule out all other hypotheses, or at least explain why the other conceivable causes are excludable.

Additional risk factors that plaintiff failed to adequately account for here included family history. Indeed, plaintiff's experts suggested that it is possible to conduct a reliable differential diagnosis without ruling out other hypotheses.

On this record, the court said, “We conclude that there is not a method of diagnosing the specific cause of a particular woman's breast cancer that is generally accepted in the relevant scientific community. This reality leaves Zandi without a legally sufficient ability to prove specific causation.”
 

House Passes Food Safety Enhancement Bill

Voting 283 for and 142 against, the House last week passed the Food Safety Enhancement Act of 2009,  a bill that would greatly expand the Food and Drug Administration's authority over companies that handle or sell raw and processed foods, including farms. The bill (H.R. 2749) would require hundreds of thousands of domestic and foreign facilities operating within the U.S. or importing food to the U.S. to register annually with the U.S. Food and Drug Administration, to pay annual registration fees to the FDA, and would subject them to more frequent, periodic inspections and require increased measures to prevent contamination. The bill gives the FDA greater power to recall contaminated foods and to quarantine the facilities that produced them. (While the bill would be partly financed by registration and inspection fees, it calls for additional congressional appropriations projected at $2 billion over five years. )


Early in the week, the bill fell 7 votes short, but a second vote came up with additional support.  The bill has divided the food industry. The Grocery Manufacturers Association, a food industry group, has come out in support of the legislation, saying it echoes the group’s own ideas about food safety. Many farmers, however, have questioned the new rules. The legislation also seeks to enhance the FDA's ability to trace the origin of tainted food -- a huge issue in recent food recalls -- in the event of an outbreak of food-borne illness. FDA Commissioner Dr. Margaret A. Hamburg has come out in support of the bill.

Other key provisions of the bill:

  • FDA inspections of food facilities would increase from as infrequent as once every 10 years to annually for high-risk facilities and at least once every 3 years for facilities deemed a lower risk. Recalls The FDA could mandate the recall of tainted foods, instead of relying on food makers to pull items voluntarily.
  • FDA would get authority to set standards for safe production of food on farms, as well as require food manufacturers to meet new specific safety standards.
  • HHS would identify new technology to be used by food growers, manufacturers and distributors to determine the origin of food and its movement through the supply chain.
     

FDA Risk Communication Advisory Committee To Hold Food Meeting

FDA has announced a forthcoming meeting of the Risk Communication Advisory Committee.  This advisory committee provides advice and recommendations to the agency on a variety of regulatory issues. The meeting will be held on August 13, 2009, from 8 a.m. to 5 p.m. and August 14, 2009, from 8 a.m. to 2 p.m.

The Committee will discuss FDA’s external research on, and internal assessment of,  communications about food safety problems. This discussion will address research on consumer
knowledge of food recalls and plans for how to monitor communication effectiveness during the course of a recall. The goal of the discussion is to advise FDA on developing more effective communication strategies. The Committee will discuss FDA's external research on, and internal assessment of, communications about food safety problems. This discussion will address research on consumer knowledge of food recalls and plans for how to monitor communication effectiveness during the course of a recall. 

 

As background for this topic, the FDA directs the public to following sites:
FDA Peanut Product website.

 


•2006 FDA/FSIS Food Safety Survey Top-line Report

•Rutgers University Food Recall Surveys – Consumer Responses to Food Recalls: 2008 National Survey Report
Public Response to the Salmonella Saintpaul Outbreak of 2008
Public Response to the Contaminated Spinach Recall of 2006

Readers of MassTortDefense are well aware of the signifcant food recall issues, and subsequent litigation, in recent years.