FDA releases draft guidance on expansion of abbreviated 510(k) Program

On April 12, the FDA released draft guidance discussing an expansion of its Abbreviated 510(k) program for medical devices. This new guidance would allow a submitter to establish substantial equivalence by demonstrating that a new medical device meets certain performance criteria, rather than by submitting direct comparison testing against a predicate device.  The intention of the Expanded Abbreviated 510(k) program is to increase the efficiency and efficacy of the 510(k) program for device manufacturers, the reviewing agency, and healthcare professionals and patients alike.

What Is the Expanded Abbreviated 510(k) Program?

Under the 510(k) program, a medical device can be cleared by the FDA if it is found to be substantially equivalent to a predicate device. This guidance aligns with Congress’s amendment in section 513(i)(1)(D) of the FD&C Act to ensure that FDA considers the least burdensome means of demonstrating substantial equivalence.

This guidance addresses the prong of the substantial equivalence analysis that requires a submitter to demonstrate that, despite technological differences, its medical device is as safe and effective as a legally marketed device.

Under the Abbreviated 510(k), a submitter may use conformity to FDA standards, guidance, or special controls to demonstrate some of the performance characteristics necessary to support a finding of substantial equivalence.  The Expanded Abbreviated 510(k) program, announced in this guidance, would allow the user to demonstrate all of the performance characteristics to establish substantial equivalence. Read more ›

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The Legality of Cannabidiol and Concerns Regarding False Advertising

cannabis oil CBDThe legality of marijuana (also known as cannabis) has been a popular topic in recent years with thirty states and the District of Columbia having laws that legalize marijuana in some form.  However, under federal law, marijuana is a Schedule I drug and remains illegal for all purposes. Schedule I drugs are those for which there currently are no accepted medical uses, and have a high potential for abuse.  Other Schedule I drugs include heroin, LSD and ecstasy.

While the illegality of marijuana is clear at the federal level, even when legalized at the state level for medical and/or recreational use, confusion swirls around substances derived from the cannabis plant.  One such substance is cannabidiol, also known as CBD.  CBD is a cannabinoid without any psychoactive properties.  In other words, a user of a CBD will not feel “high.”  Alleged benefits from the use of CBD, range from curing cancer to relieving anxiety, inflammation, seizures, epilepsy, PTSD and multiple sclerosis.[1]

Legality of CBD

Although many CBD producers advertise that CBD is legal in all 50 states, this remains uncertain as shown by Indiana Governor Eric Holcomb’s warning to retailers that CBD oil must be pulled from shelves.[2]  Additionally, in Indiana the Department of Child Services threatened to remove a 20 month infant from her home after her parents gave her CBD oil to treat her seizures.[3]  And, Indiana is not alone. The Department of State Health Services in Texas is considering a proposal that would require inspectors to detain all food products and cannabis oils that have added cannabidiol.[4]

Under federal law, CBD is not listed separately in the Code of Federal Regulations and is, thus, controlled in Schedule I as a “derivative” or “component” of marijuana (21 USC 802).[5]  And, the DEA has clarified that CBD is considered an illegal substance, just like any other marijuana product. [6]  To this end, on December 14, 2016, the DEA published the Establishment of a New Drug Code for Marihuana Extract (the “Final Rule”), which created a new code number under the Controlled Substance Act for marijuana extract.[7]  The Final Rule made clear that “[e]xtracts of marihuana will continue to be treated as Schedule I controlled substances.”[8]  In response, the Hemp Industries Association has filed a lawsuit against the DEA, challenging the Final Rule.  The case, Hemp Industries Association, et al. v. Drug Enforcement Administration, et al., is currently pending in the Ninth Circuit, Case No. 17-70162. Read more ›

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Third Circuit Issues Precedential Ruling on Express Preemption for Hybrid Medical Devices

The Third Circuit has become the first U.S. Court of Appeals to address the application of the express preemption provision in the Medical Device Amendments of 1976 to hybrid medical devices. Hybrid medical devices are devices which contain differently classified components.

In Shuker v. Smith & Nephew, PLC, the Third Circuit held that Plaintiff Walter Shuker’s common law claims against medical device manufacturer Smith & Nephew were preempted by the Medical Device Amendments of 1976.   There, the plaintiff’s implanted hip replacement system included a metal head, metal sleeve, stem, and metal liner. After the metal on metal system caused degeneration, Walter and his wife brought suit against Smith & Nephew for negligence, strict liability, breach of implied warranty and violations of federal law. The question before the Third Circuit was how to apply the express preemption provision of the Medical Device Amendments of 1976 to a hip replacement system with multiple separately classified components.

The Medical Device Amendments of 1976

The Medical Device Amendments of 1976 added a medical device approval process to the Federal Food, Drug, and Cosmetic Act (“FDCA”). The approval process assigns a Class I, II, or III designation to new medical devices based on public risk. Class I devices pose the least risk, Class II devices are “more harmful,” and Class III devices pose the greatest risk. Medtronic, Inc. v. Lohr, 518 U.S. 470, 477 (1996). Before becoming available to the public, a Class III device requires premarket approval by the Food and Drug Administration (“FDA”).

A medical device that obtains Class III approval is granted express preemption from state requirements that are “different from, or in addition to” federal requirements. Riegel v. Medtronic, Inc., 552 U.S. 312, 322-23 (2008). However, the express preemption provision does not prevent plaintiffs from filing claims premised on state requirements that incorporate applicable federal requirements and are therefore not “different from, or in addition to” federal requirements. Lohr, 518 U.S. at 494-95.

The Hybrid Medical Device in Shuker

Walter Shuker’s hip replacement system was comprised of Class II and III components, making it a hybrid medical device. The Shukers argued that the Third Circuit should analyze the hip replacement system as a single device. Smith & Nephew conversely asserted that each component of the hip replacement system was a separate device, an opinion supported by the FDA. Read more ›

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Known to the State of California to Cause Cancer or Reproductive Harm – What is Proposition 65 and What You Need to Know

A majority of California voters in 1986 approved a ballot initiative known as Proposition 65, officially titled California’s Safe Drinking Water and Toxic Enforcement Act of 1986 (“Prop. 65”).  Prop. 65 seeks to protect California’s drinking water sources from being contaminated with chemicals known to the State of California to cause cancer, birth defects or other reproductive harm and seeks to require businesses to warn when they knowingly and intentionally cause significant exposures to listed chemicals known to cause such harm.  In general terms, Prop. 65 requires businesses, manufacturers and certain others (such as employers) to inform Californians about exposures to such chemicals.  This is done through warning signs and warning labels. The purpose of this blog post is to provide an overview of Prop. 65 for companies who do business in California and to highlight some major changes to Prop. 65 which take affect later this year.

The scope of Prop. 65 in California cannot be overstated. Warning signs and labels are found in many types of businesses in California from bakeries to amusement parks to grocery stores.  You may also see Prop. 65 warnings on apartment buildings and commercial buildings.  Products themselves also carry warnings.  Common examples include leaded glass crystal, garden hoses and shovels, electrical cords, and ceramics (just to name a few).

Prop. 65 can be enforced not only by the State of California, but also by private individuals and groups acting in the public interest.  Private enforcement is an entire business and industry with law firms solely dedicated to these types of cases.  Enforcers are able to recoup a portion of the penalties paid through settlement of these claims and recoup their attorney fees as well.

The enforcement process begins when a Prop. 65 60-Day Notice is sent to the alleged violator.  This letter is also sent to the California Attorney General’s Office.  During this 60-day period, the Attorney General can decide if it wants to prosecute an action.  If the Attorney General does not take action, the private enforcer may file suit at the end of the 60-day period.   These notices are published on the Attorney General’s website. Read more ›

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State Court Relies Upon Supreme Court’s Bristol-Meyers Squibb Decision to Vacate Jury Verdict Against J&J

Baby powder product with talc mineral spilling over diagnosis record paper on doctor's pad with stethoscopeThe Supreme Court limited a striking vulnerability for product manufacturers in Bristol-Myers Squibb Co. v. Superior Court of California this summer when it ruled that out-of-state plaintiffs could not simply claim injuries that were similar to residents to support specific jurisdiction, but must demonstrate a connection between the forum and the specific claims at issue. That decision was used by a Missouri appeals court last month to reverse a $72 million verdict against Johnson & Johnson which found the company’s talc products cause ovarian cancer. Several other hefty St. Louis jury awards involving the company’s talc products could now face the same fate.

The Missouri case, Fox v. Johnson & Johnson, involved a St. Louis woman who was one of 65 plaintiffs (63 of which were non-residents) who claimed J&J’s Baby Powder and Shower to Shower talc products gave them ovarian cancer. The trial court exercised specific jurisdiction over J&J’s objection and motion to dismiss. The individual Missouri plaintiff’s case ultimately went to trial and Fox prevailed. Read more ›

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Lack of Substantiation Theories in False Advertising Cases—The Burden Lies on the Plaintiff

person reading label on supplement containerOften when we think of product liability we think of a product that doesn’t function as intended and causes some sort of damage resulting in warning, design and/or manufacturing defect claims.  However, another important aspect is advertising.  The purpose of this post is to focus on one very important aspect of the false advertising case: scientific substantiation.

Historically, plaintiffs rest false advertising claims upon allegations that marketing claims are unsubstantiated and not supported by reliable scientific evidence.  A recent trend however, as demonstrated by two decisions out of California, suggests courts may not recognize a private right of action for false advertising claims arising out of alleged improper scientific substantiation.

On April 21, 2017 the Ninth Circuit affirmed the district court’s dismissal of a proposed class action complaint in Kwan v. SanMedica Int’l[1], thereby confirming that California’s consumer protection and competition laws do not permit a private citizen to bring actions based only on allegations that the challenged advertising language lacked proper scientific substantiation.

Kwan involved the over-the-counter amino acid supplement SeroVital.  Plaintiffs’ operative complaint alleged that the defendants falsely represented that the product was clinically tested to, among other things, boost human growth hormone by a mean of 682%.[2]  Read more ›

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Proposed Legislation to Relax Rules on Medical Device Reporting Passes U.S. House

Blur of equipment and medical devices in modern operating roomOn 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 ›

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Supreme Court Solidifies Specific Jurisdiction Analysis To Dismiss Product Claims Filed Against Non-Resident Defendant, Bristol-Myers Squibb Co.

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 ›

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SCOTUS Decisions May Provide A Roadmap to Enforcing Arbitration Clauses Included In Product Packaging

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 ›

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Lack of Specificity May Kill Parallel State Law Product Claims, But Not Fraud Claim

good manufacturing practices documentA 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—

  1. which is different from, or in addition to, any requirement applicable under this chapter to the device, and
  2. 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 ›

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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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