The Expert Report: Key Considerations

Product liability cases often present challenging and complex issues which require the use of experts.  If you are litigating in federal court, any expert you designate will be required to provide a written report[1].  The same, however, may not be true in state court.  For example, written expert reports are not required for designated experts in California[2] and Texas[3].  In New York, not only are expert reports not required but, even if one is made, it is not discoverable absent court order.[4]  Other jurisdictions only require the disclosure of certain information.  And some jurisdictions, although they do not require that an expert report be prepared, if an expert report is prepared, even draft reports may be discoverable.  Thus, as a starting point, it is imperative that you check the rules of your jurisdiction.  If you are in a jurisdiction where full expert reports are not required, deciding whether to have your expert prepare a written report in a products case is a decision of critical importance and should not be made lightly.  This blog post explores some important considerations to take into account when making this important decision, as well as some suggestions to ensure that any written report is as airtight as possible.

You might be thinking this is a no brainer: preparing a report is definitely going to be more costly than not.  You probably are right, but there are situations in which the preparation of an expert report could save time and money later down the road.  For example, a detailed and very strong report may help you leverage a settlement if you can strategically use it to educate the other side about the product at issue and the strengths of your case (and the weaknesses of theirs).  In other words, the weight of force behind an expert’s particular opinion might be so overwhelming that you can use that to your advantage.  For example, in a recent black mold case we handled, the force of evidence showing years upon years of research regarding mold toxicity (or lack thereof) was such that the opposing party was forced to try a new and novel theory to prove causation.  Additionally, a detailed report may shorten the amount of preparation needed for deposition in that your expert already has a very detailed roadmap outlining his or her opinions.  Read more ›

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Punitive Damages and an Essential Jury Instruction

inside of courtroomIn one of our recent posts we touched on punitive damages in the context of one of the Pinnacle Hip bellwether trials.  In this post, we address another interesting aspect of punitive damages: whether they can be used to punish a defendant for harms to nonparties.  The short answer is no, but as discussed below, it is not as straightforward as you might think and it is essential to protect yourself with the proper jury instruction.

Mayola Williams was the widow of a man named Jesse Williams.  Mr. Williams, a resident of the State of Oregon, had been a heavy smoker for much of his life.  Mr. Williams’s cigarette of choice was Marlboro, a brand manufactured by Philip Morris.  Mr. Williams died from smoking-related lung cancer and, following his death, Mrs. Williams sued Philip Morris for negligence and deceit.  Mrs. Williams sought compensatory and punitive damages claiming that Philip Morris falsely led her husband to believe that smoking was safe.

Plaintiff presented evidence during trial of the harm allegedly caused by Philip Morris to Mr. Williams as well as possible harm to other third parties.  However, no evidence was offered to establish an appropriate measure of damages to compensate such third parties for their injuries. Read more ›

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Lessons Emerging from Pinnacle Hip Bellwether Trials

hip implantIn a staggering verdict, a Texas jury recently awarded over $1 billion against Johnson & Johnson (“J&J”) and its subsidiary DePuy Orthopaedics Inc. (“DePuy”) (collectively referred to as “Defendants”) to six California plaintiffs who claimed the companies’ Pinnacle hip system’s Ultamet metal-on-metal implant caused metallosis, tissue death, bone erosion and other serious injuries.

Presently there are 9,000 plus lawsuits consolidated in a Multi-District Litigation or “MDL” presided over by U.S. District Court Judge Ed Kinkeade in the Northern District of Texas. This latest verdict was the result of the third bellwether test trial addressing the Pinnacle hip system, the first two of which had differing results. J&J won the first trial in 2014, but lost the second trial earlier this year when another Texas jury returned a $502 million verdict against J&J, which was later reduced to $150 million pursuant to Texas Civil Practices and Remedies Code Section 41.008(b) which caps exemplary damages. After the second trial, J&J moved to stay additional trials pending the resolution of the appeal of the second trial. J&J argued that several pieces of critical but inflammatory and prejudicial evidence were presented to the jury in addition to several other issues that the defendants wanted resolved by the Fifth Circuit prior to proceeding on with the rest of the cases. The Court ruled against the stay noting that the next trial would involve Plaintiffs from California, “rather than Texas or Montana like the previous bellwether trials, and will therefore present different legal and evidentiary rulings.” (Dkt. 665) The Court also pointed out that both sides agreed to this particular bellwether process to be supported and directed by the court. This is an important take away for future litigation. First, it is important, indeed imperative, to make any objections in a timely manner in order to preserve them. Second, it is very important when selecting the bellwether process to consider the different and unique legal theories presented in each unique case. Read more ›

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Words Matter: Product Claims Can Trigger Regulatory Application And Corrective Action

essential oils medicineMost of us understand that the facts that give rise to the legal issues we face are sometimes sewn far in advance.  This is certainly true in the area of product claims or statements.  As is discussed below, careful consideration should be given to the governing regulatory framework so that the statements you make do not trigger a violation.  To illustrate this, we are going to look at two examples:  products coming under the purview of the Food Drug and Cosmetic Act (“FDCA”) and organic products.

In recent years, consumers have increasingly sought to supplement conventional and approved over the counter and prescription medications with homeopathic treatments and even essential oils.  Frequently, the companies selling these products make certain representations regarding the purpose and efficacy of such products.  The statements can open a Pandora’s Box for the unwary as such products may, simply by virtue of the statements made about them, become treated as drugs under the FDCA.

A recent warning letter sent by the FDA is illustrative.  Abbey St. Clare is a line of skin, hair and makeup products focusing on natural formulas.[1]  On September 2, 2016, the United States Food and Drug Administration (“FDA”) sent a warning letter to Abbey St. Clare regarding some of its skin oils and soaps.[2]  According to the warning letter, on its website, Abbey St. Clare claimed that one of its botanical oils minimized swelling and was “anti-inflammatory.”  Abbey St. Clare provided that another oil was “useful for headaches (including migraines), insomnia, depression, stress, stiff joints, sore muscles, nervous tension, hair loss, and childbirth.”[3]  The warning letter advised Abbey St. Clare that its representations on its website about certain products established the products are drugs under Sections 201(g)(1)(B) and/or 201(g)(1)(C) of the FDCA because they are “intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and/or articles intended to affect the structure or any function of the human body.”[4]  The warning letter went on to advise Abbey St. Clare to review its website, products labels, and other labeling for their products to ensure that the claims they make for their products do not reflect intended uses that cause the distribution of the products to violate the FDCA.  The letter requests Abbey St. Clare to take prompt action to correct the violations to avoid a potential enforcement action.  The important take away here is the mere act of making these statements caused these products to be viewed by the FDA as drugs and thus subject to the FDCA.  Read more ›

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Creating and Maximizing Enforceable Settlements

signing an agreementSettling a case may be the culmination of years of litigation or a strategic move at the outset to avoid litigation costs. Many times, settlement occurs at some point in between. Regardless of when the settlement occurs, it’s important to focus on certain considerations that should be part of any settlement process and the eventual agreement. Consideration of the points identified below will help ensure the creation of the most favorable agreement possible.

Term Sheets and Mediator’s Proposals

We’ve all been there. It’s the end of a long day at mediation and finally you reach a settlement. After having spent many hours together, everyone is eager to leave. Resist this temptation. Why? Buyer’s remorse. Don’t give the other side the opportunity to back out of the deal. First, reduce the key terms to writing in a term sheet. Second, make sure that any term sheet or mediator’s proposal includes any “magic language” necessary in your jurisdiction to make the term sheet or mediator’s proposal enforceable. For example, in California, Evidence Code section 1123 provides that a written settlement agreement prepared in the course of mediation may be considered admissible if signed by the settling parties and if the agreement provides that it is enforceable or binding or words to that effect. See Stewart v. Preston Pipeline Inc., 134 Cal. App. 4th 1565, 1578 (2005) (finding that beyond the necessary signatures, the parties stated within their confidential settlement agreement that it was a full and final settlement intended to be enforceable, thereby satisfying the requirements of § 1123).

Additionally, if you are going to be presented with a mediator’s proposal, be proactive and tell the mediator that any mediator’s proposal must contain language making it enforceable, admissible, and binding if accepted and signed by the settling parties. Read more ›

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The Harbor Might Not Be Safe: Failure To Update Generic Drug Labels Can Invite a Storm of State-Law Claims

prescription pills and caseThe New Jersey Supreme Court ruled on August 22 that consumers’ state-law claims that manufacturers of a generic Reglan, a heartburn medication, did not adequately warn about its risks are not preempted by federal law.[1]

Under the Federal Food, Drug, and Cosmetic Act, manufacturers of brand-name drugs must seek approval from the FDA to market the drug and must prove that it is safe and effective and that its proposed label is accurate and adequate. Generic drug manufacturers, however, face a more streamlined process: they can gain FDA approval of a generic drug simply by showing it is identical in active ingredients, safety, and efficacy to a brand-name drug that has already been approved. Similarly, the brand-name manufacturer is responsible for the accuracy and adequacy of a drug’s labeling for new drug applications and updated labeling, while generic manufacturers are responsible for ensuring that the labeling is the same as the labeling approved for the brand-name drug.

When it comes to matching an updated label, generic manufacturers are required to update their labeling at the “very earliest time possible.”[2] Generic manufacturers must therefore routinely monitor the FDA’s website for information on changes in labeling and/or obtain the information in other ways, such as from the FOIA staff at the FDA. Read more ›

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FDA Issues New Draft Guidance Requiring Modifications to Medical Device Tracking Labels

medical equipment with labelThe Food and Drug Administration released draft guidance last week revealing its intent to better track medical devices, from pacemakers to condoms, through an amendment to its 2013 “UDI (unique device identifier) Rule”.  The draft guidance is intended to assist both labelers and FDA-accredited issuing agencies to better ensure the UDIs are in compliance with the Rule.  The UDI Rule established a tracking system to adequately identify devices through distribution and use throughout the United States.  Under 21 CFR 801.20, a UDI is required on the label and package of every medical device in commercial distribution in the United States (unless an exception or alternative applies).  Read more ›

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“Auto-Pilot” May Not Be Perfect, But It May Be Better

person in self-driving carVirtually every day there are media reports regarding the introduction of driverless cars to mainstream consumers.  As driverless cars rapidly accelerate from concept to commercialization, it is becoming increasingly apparent that technological refinements remain necessary and are ongoing in response to recent accidents.

For instance, earlier this year in Europe a driver of a Tesla operating in autopilot mode ran into the rear of a van stopped on the highway. Then again, in July of this year, a Tesla operating in autopilot mode crashed on a windy two lane road in Montana. While neither of those drivers were seriously injured, on May 7, 2016, a driver of a Tesla in autopilot mode was killed in Florida when his vehicle failed to stop in the path of a tractor trailer. A spokesperson for Tesla indicated that the car was unable to differentiate between the white side of the tractor trailer against the backdrop of a bright sky.  This is the first reported fatality for any vehicle operating in a self-driving mode.  Although the family of the driver has not sued Tesla, they have reportedly retained counsel who is investigating the crash.  Read more ›

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New FDA Draft Guidance on Updates to Certain Generic Labeling

generic drug labelingOn July 8, 2016, the U.S. Food and Drug Administration released draft guidance amending the process for manufacturers to update labeling of generic drugs in situations where the reference drug labeling has been withdrawn for reasons other than safety or effectiveness.

The FDA generally requires a generic drug to have the same labeling as the reference drug at the time of approval.  Moreover, all marketing application holders have an ongoing obligation to ensure that their product labeling is accurate, and not false or misleading.  In particular, when new information becomes available that causes the labeling to be inaccurate or misleading, the application holder must update its labeling.

Where the reference drug is still on the market, the reference drug manufacturer frequently proposes changes to the labeling, and generic drug manufacturers are expected to update their labeling accordingly to reflect any approved relevant changes.  While this process is fairly clear cut, the FDA admits there is confusion about what generic drug application holders must do to update labeling when the reference drug is off the market (for reasons other than safety or effectiveness).  This draft guidance seeks to clarify that process. Read more ›

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New Weapon For Manufacturers: Defend Trade Secrets Act of 2016

top secret documentOn May 11, 2016, President Barack Obama signed the Defend Trade Secrets Act of 2016 (the “DTSA”), which provides a federal civil cause of action to manufacturers for the misappropriation of trade secrets under the Economic Espionage Act.  While the DTSA substantially mirrors the protections afforded under the Uniform Trade Secrets Act, currently adopted by 48 states, the DTSA gives manufacturers a choice of whether to file in state or federal court.  Importantly, the DTSA provides manufacturers with a new avenue to address a wide range of trade secret issues.

For manufacturing companies with trade secrets “related to a product or service used in, or intended for use in, interstate or foreign commerce,” the DTSA provides, for example:

  • Federal Civil Action.  The DTSA creates a federal civil cause of action, giving original jurisdiction to United States District Courts.  This will allow companies to file in or move most trade secret litigation to federal court.  The original federal jurisdiction conferred by the DTSA will, in turn, invariably include federal supplemental jurisdiction for claims for breach of contract, related common law claims, and state statutory claims.  Importantly, similar to federal employment laws, the DTSA does not supersede state trade secret laws.
  • Seizure of Property.  Unlike any of the pre-existing state laws, the DTSA includes a provision that permits the Court to issue an order, upon ex parte application in “extraordinary circumstances,” seizing property to protect against improper dissemination of trade secrets.  Interestingly, the DTSA permits such an order only if the moving party has not publicized the requested seizure and includes imbedded confidentiality protections that protect seized information from public disclosure.  If granted, the Court is required to schedule a seizure hearing and the moving party will be required to provide security in an amount to be determined by the Court for the payment of any possible damages suffered as the result of a wrongful or excessive seizure.  This provision of one of the more robust features of the new law, permitting, for example, the seizure of computer hardware and software that has been used for misappropriation without giving notice to the party against whom the order is issued, and thereby decreasing the risk of spoliation of evidence.  This can be an important weapon in dealing with ever-increasing cyber-threats. Read more ›
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Posted in Manufacturer, Trade Secrets
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Products Liability Prevention & Defense
Our attorneys represent foreign and domestic designers, manufacturers, and distributors of a diverse array of products, from food and drugs to industrial equipment and building materials. We help clients respond to major personal injury and property damage claims in the form of single-product cases, class actions, mass torts, and multidistrict litigation, as well as all types of congressional, regulatory, or criminal investigations. Our team works closely with corporate counsel to minimize a company’s overall liability and establish efficient protocols for fielding claims and advise on labeling, marketing, manuals and instructions, supply and distribution contracts, and insurance and indemnification issues.
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