Third Circuit Affirms Summary Judgment for Pfizer in Zoloft MDL

A Third Circuit Court of Appeals panel recently upheld a lower court’s decision to dismiss plaintiffs’ claims at summary judgment in a multi-district litigation involving Zoloft, an anti-depressant manufactured by Pfizer. The MDL involved 315 plaintiffs alleging that Zoloft causes cardiac birth defects when taken during early pregnancy. The decision, which upheld an earlier ruling by the U.S. District Court for the Eastern District of Pennsylvania, has both good and bad aspects for defendants facing pharmaceutical product liability claims. The plaintiffs introduced several expert witnesses in support of their claim that Zoloft is generally capable of causing cardiac birth defects (general causation). Among those experts was a statistician who utilized the “Bradford Hill” criteria to analyze the existing medical literature regarding the alleged causal link between Zoloft and cardiac birth ...
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Blacklist of “Scientific” Journals to Return

For any television fans that may have stumbled upon this post, it has nothing to do with Raymond Reddington and it will not be as clever as this author’s favorite James Spader character, Alan Shore (from Boston Legal). Nonetheless, as readers of scientific journals we were excited at the announcement this week that the “blacklist” of “scientific” journals is returning, albeit from a new publisher and with a little help from the original. For those that may not have followed Jeffrey Beall’s blog that called out potential predatory journals, you would not have known it was shut down earlier this year. In a world where the number of publishers is growing and the need to obtain content is equaled by the desire of scientific and medical professionals to get published, ...
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Seventh Circuit: Insurer Has Duty to Defend Drug Distributor in “Pill Mill” Lawsuit

This week, a unanimous Seventh Circuit panel found that a major insurance company has a duty to defend H.D. Smith, L.L.C. against a lawsuit brought by the State of West Virginia. The lawsuit claims that the drug distributor helped cause the state’s prescription drug abuse epidemic by knowingly oversupplying painkillers to certain pharmacies and clinics, pejoratively known as “pill mills.” The decision reversed an earlier ruling by the U.S. District Court for the Central District of Illinois. By way of background, in June 2012, the State of West Virginia sued 13 different drug distributors, including H.D. Smith, seeking damages arising from the state’s prescription drug abuse epidemic. The suit sought damages including the costs of providing medical care to drug addicts unable to afford their own health insurance. The complaint ...
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FDA Issues Draft Guidance on Factors to Consider Regarding Benefit-Risk in Medical Device Product Availability, Compliance, and Enforcement Decisions

The U.S. Food and Drug Administration (FDA) recently released a draft guidance document with the intent of providing clarity for FDA staff and the medical device industry regarding the benefit and risk factors the FDA may consider when prioritizing resources for compliance and enforcement efforts to maximize medical device quality and patient safety. These risk-benefit factors may be considered when device manufacturers evaluate appropriate responses to non-conforming product or regulatory compliance issues, including voluntary recall or market withdrawal, and apply to both diagnostic and therapeutic medical devices. The FDA is currently accepting public comments on the draft guidance document. In its draft guidance, the FDA sets out specific factors for the assessment of medical device benefits. These factors include the types of benefits and their impact on patient health and ...
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New FDA Labeling Changes to Require “Black Box Warning” on Immediate Release Opioid Pain Medications

In an effort to combat what it calls “epidemic levels of opioid addiction and overdose”, the U.S. Food and Drug Administration (FDA) announced that it will require class-wide safety labeling changes for immediate release opioid pain medications, including a new “black box warning” informing patients and prescribers of the serious risks of misuse, abuse, addiction, overdose and death. In addition, the FDA will also require several safety labeling changes across all prescription opioid products to include additional warnings addressing the risks of opioids. Opioid analgesics, including prescription oxycodone, hydrocodone and morphine, are typically divided into two main categories. Extended release/long acting (ER/LA), typically carry a larger load of medicine, are intended to be taken once or twice a day and were the subject of FDA mandated labeling changes in 2013. ...
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California Court of Appeals Rules Plaintiffs Can Pursue Claims Against Novartis for Alleged Damages Arising From Ingestion of Generic Drug Six Years After Novartis Divested its Interest

On March 9, 2016, the California Court of Appeals ruled that the plaintiffs’ claims of failure to warn and misrepresentation against Novartis were legally viable. The critical dispute raised by Novartis was that it did not manufacture the prescription medication that allegedly harmed the plaintiffs. In T. H. v. Novartis Pharms. Corp., No. D067839, 2016 Cal. App. LEXIS 179 (Ct. App. Mar. 9, 2016), two minor plaintiffs alleged that Novartis was liable for neurological injuries they sustained in utero after their mother was prescribed, and consumed, a generic form of Brethine (terbutaline) to control pre-term labor in 2007. Six years earlier, Novartis had sold its interest in the medication. Novartis filed a demurrer, arguing that it owed no duty to the plaintiffs because it did not manufacture the medication consumed ...
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FDA Issues Guidance for Applying Human Factors and Usability Engineering to Medical Devices to Ensure Safety and Effectiveness

In an effort to assist the medical device industry in maximizing the likelihood that new medical devices will be safe and effective for intended users, the U.S. Food and Drug Administration recently released Guidance for Industry and FDA Staff on Applying Human Factors and Usability Engineering in Medical Devices. While this FDA guidance document does not establish legally enforceable responsibilities for manufacturers, it is the FDA’s intent to support manufacturers in improving the design of medical devices to minimize potential use errors and resulting harm, as well as allowing manufacturers to assess and reduce risks associated with the use of medical devices. In this release, the FDA recommends that manufacturers follow human factors engineering, or usability engineering (HFE/UE) processes during the development of new medical devices. Human factors engineering is ...
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“Symptom Threshold Methodology” Rejected by Court of Appeals of New York Pursuant to Frye

In an opinion decided February 11, 2016, the Court of Appeals of New York precluded two causation experts put forth by a plaintiff in a toxic tort case. The case involved allegations that a minor was born with severe mental and physical disabilities caused by in utero exposure to unleaded gasoline vapor. The vapor was allegedly emitted into the car from a defective fuel hose. The automobile manufacturer subsequently recalled the vehicle at issue due to defects in the feed fuel hoses. In support of his claims, the plaintiff put forth numerous expert witnesses, including Linda Frazier, M.D., M.P.H. and Shira Kramer, M.H.S., Ph.D. Applying what the court termed a “symptom threshold methodology” those experts reached the conclusion that the in utero exposure to gasoline vapor proximately caused the birth ...
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Plaintiffs’ Product Case Trumped by the Learned Intermediary Doctrine

A large pharmaceutical manufacturer recently won a fundamentally important victory both within the mass tort it is facing and for all life science companies needing to rely upon the learned intermediary doctrine. In the consolidated litigation proceeding in New Jersey state court, the plaintiffs’ claim the manufacturer failed to properly warn its users of known gastro-intestinal complications associated with the drug. Relying on the learned intermediary doctrine, the judge granted the manufacturer summary judgment in some cases because the treating physicians testified they prescribed the drug with knowledge of the allegedly associated GI issues. Drug manufacturers have a duty to warn consumers directly of all material, foreseeable risks associated with the use of their product. Such warnings are generally rendered in a label applied to the product and on the ...
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FDA Draft Guidance for Postmarket Management of Cybersecurity in Medical Devices Puts Manufacturers on Notice of Potential Cybersecurity Risks

This post also appears on Goldberg Segalla’s Product Liability Playbook blog.  On January 22, 2016, citing cybersecurity threats to medical devices as a growing concern, the United States Food and Drug Administration issued draft guidance for industry and FDA administration staff for postmarket management of cybersecurity in medical devices. Public comments on the draft guidance will be open for 90 days. According to the FDA release, a growing number of medical devices are designed to be networked to improve and facilitate patient care. However, the FDA notes that networked medical devices incorporate software that may be vulnerable to cybersecurity threats, which may represent a risk to the safety and effectiveness of medical devices. The FDA notes that while manufacturers can incorporate controls in the design of a product to help ...
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