On July 13, 2017, the U.S. House of Representatives passed a bill that would triple the amount of time in which medical device manufacturers are required to report certain malfunctions of some products to the Food and Drug Administration. Companies currently must report product malfunctions within 30 days; the new bill would allow companies up to 90 days to do so. Notably, the proposed legislation does not change the amount of time for medical device manufacturers to report adverse events in which a patient has been injured or died. Companies would still be required to report such adverse events within 30 days.
The bill, known as the FDA Reauthorization Act of 2017, reflects an agreement between the FDA and the medical device industry that, among other things, sets the amount of fees manufacturers pay the FDA to review their products. The proposed legislation would be in place until 2022. The U.S. Senate has not yet voted on the bill.
In addition to lengthening the time to report malfunctions, the bill would allow medical device companies to file summaries of previously reported product malfunctions instead of detailed, individual medical device reports. Read more ›
Product manufacturers routinely hauled into court in far away, inconvenient jurisdictions can breathe a little easier with the Supreme Court’s decision this week in Bristol-Myers Squibb Co. v. Superior Court of California.
A group of plaintiffs, most of whom were not California residents, sued Bristol-Myers in California state court, alleging that the drug Plavix had damaged their health. Bristol Myers is incorporated in Delaware and headquartered in New York. It did not develop, create a marketing strategy for, manufacture, label, package, or work on the regulatory approval for Plavix in California, and Plaintiffs did not allege that they obtained the drug from a California source, that they were injured in California or were treated for their injuries in California. Plaintiffs alleged only that Bristol Myers conducted research in California on other drugs and contracted with a California distributor.
The Supreme Court recognizes two types of personal jurisdiction. International Shoe Co. v. Washington, 326 U. S. 310, 316–317 (1945). A court with general jurisdiction has the authority to hear any claim against a defendant, even if the claim arose out of injuries that occurred in a different state. General jurisdiction derives from a defendant’s place of incorporation and/or principal place of business. Since Bristol Myers was neither incorporated nor had headquarters in California, general jurisdiction was lacking. Read more ›
It is open opinion season at the U.S. Supreme Court, and two recent decisions pertaining to the enforceability of arbitration clauses provide guidance to manufacturers looking to bind consumers through the use of product packaging.
In Kindred Nursing Centers Limited Partnership v. Clark, No. 16-32, 2017 WL 2039160 (U.S.S.C. May 15, 2017), the U.S. Supreme Court upheld application of a nursing home’s arbitration agreement to tort claims for alleged personal injuries suffered by patients under the home’s care. Those holding the patients’ medical powers of attorney “signed an arbitration agreement with [defendant] on behalf of [the] relative.” Id. at *3. Later, they brought state-court tort actions for wrongful death. Id. The defendant unsuccessfully moved to enforce the arbitration agreement. The state supreme court held both agreements invalid, invoking specificity rules involving powers of attorney and singling out arbitration agreements for special scrutiny. As described by the Court: Read more ›
Tagged with: arbitration
Posted in Uncategorized
A Michigan district court judge determined last week that product liability claims against an FDA approved medical device manufacturer were preempted by federal law, but allowed the plaintiff’s claim of fraud against the manufacturer, Medtronic, Inc., to proceed at the state level. Although the court determined that plaintiff’s parallel state law product claims were insufficiently pled to survive preemption, it disagreed with the manufacturer that Current Good Manufacturing Practices (“CGMPs”) are too broad to potentially serve as the basis for parallel product liability claims in state court – a crack in the preemption door worth noting. The court similarly refused to hem in the plaintiff’s parallel claim of fraud despite the most general assertions of malice, knowledge and intent with respect to the manufacturer’s product representations. The case is Canary v. Medtronic, Inc., No. 16-11742, 2017 WL 1382298 (E.D. Mich. April 18, 2017).
Federal Preemption of FDA approved medical devices was built into the Medical Device Amendments (“MDA”) of 1976:
“Except as provided in subsection (b) of this section, no State or political subdivision of a State may establish or continue in effect with respect to a device intended for human use any requirement—
- which is different from, or in addition to, any requirement applicable under this chapter to the device, and
- which relates to the safety or effectiveness of the device or to any other matter included in a requirement applicable to the device under this chapter.” (21 U.S.C. § 360k(a))
The provision has been interpreted as a two-prong test by the courts for determining if a state-law tort claim is preempted. First, the court must determine whether federal regulations exist for the device in question. If so, then the court must analyze whether the plaintiff’s product liability claims are anchored to any state law requirements out of sync with the provision. The Supreme Court has been careful to clarify that the MDA’s preemption provision should not hinder state and federal claims from being pursued in parallel if a state has made it unlawful to violate FDA regulations. Read more ›
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. The same, however, may not be true in state court. For example, written expert reports are not required for designated experts in California and Texas. In New York, not only are expert reports not required but, even if one is made, it is not discoverable absent court order. 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 ›
Tagged with: expert reports
Posted in Experts
In 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 ›
Most 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. 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. 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.” 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.” 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 ›
Settling 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 ›
The 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.
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.” 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 ›