EPA versus the State of California: An Important Glyphosate Update

Posted on August 20, 2019 by Amy Alderfer, Brett Nicole Taylor

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Glyphosate is a widely used herbicide perhaps best known for being the active ingredient in the blockbuster weed killer Roundup^®. As many readers are probably aware, Roundup^® is currently the subject of both state and federal litigation in which numerous plaintiffs allege that using Roundup^® caused their cancers. Whether Roundup^® is in fact carcinogenic has been the subject of international consideration. Here in the United States, we now find the State of California and the United States Environmental Protection Agency (“EPA”) on opposing sides of the issue.

Glyphosate was first registered in the United States in 1974. For many years, the EPA and other international bodies have essentially affirmed glyphosate’s safety. However, in March 2015, the World Health Organization’s International Agency for Research on Cancer (“IARC”) classified glyphosate as “probably carcinogenic” to humans. In March 2017, the European Chemicals Agency (“ECHA”) announced recommendations from a risk assessment of glyphosate which was performed by its Committee for Risk Assessment. That committee did not find evidence implicating glyphosate as being carcinogenic. In the United States, the EPA continued to maintain its position that glyphosate poses no significant cancer risks to the generally public. Read more ›

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How Smart is it for Medical Devices to Learn New Tricks? The FDA Seeks Feedback On Its Proposed Regulatory Framework for Artificial Intelligence/Machine Learning-Based Medical Devices

Posted on May 29, 2019 by Abby Sacunas — No Comments ↓

doctor holding tablet AI biomedical algorithm In the shadow of the FDA’s new Proposed Regulatory Framework for Modifications to AI/ML-Based Software as a Medical Device, manufacturers are left to contemplate enhanced product liability exposure. AI-powered devices ingest new data and adjust accordingly – a feature that could result in entirely different products doing very different things than were initially approved.

If AI-induced changes result in an un-approved use, manufacturers could lose precious pre-emption immunity from liability gained through FDA approval, especially if the device later becomes defective.

Currently, federal law generally preempts personal-injury suits for FDA approved medical devices. Major changes to products, including to algorithms and software, trigger FDA review and necessitate re-approval. Read more ›

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Manufacturers Can MAN UP With Defenses to the Texas Products Liability Act: Part II, How Sellers May Find Themselves a MAN DOWN

Posted on January 22, 2019 by Kendall Kelly Hayden — No Comments ↓

On September 11, 2018, Cozen O’Connor’s Product Liability Prevention and Defense (“PLPD”) blog provided a quick reference guide that manufacturers can consult to MAN UP on defenses when hit with a claim under Chapter 82 in Texas. Hayden; Don’t Find Yourself a MAN DOWN: Manufacturers Can MAN UP With Defenses to the Texas Products Liability Act (2018) (last visited October 8, 2018) (“Man Up”). This posting serves as a sequel to Man Up by shifting the discussion to the seven exceptions that may hold a seller liable and relieve the manufacturer of some or all liability (“Man Down”). Although Man Down will focus on exceptions to a seller’s presumed innocence that may find sellers a MAN DOWN, Man Down is applicable to manufacturers as well given that under Texas law, all manufacturers are also sellers. Gen. Motors Corp. v. Hudiburg Chevrolet, Inc., 199 S.W.3d 249, 256 (Tex. 2006) (holding all manufacturers are also sellers, but not all sellers are manufacturers).

In Man Up, we explained that Chapter 82 of the Texas Civil Practice and Remedies Code was created to heighten the duties of manufacturers in a products liability action. The effect of this heightened burden acts a shield to sellers who can seek protection under Chapter 82 unless one of seven exceptions is established. Tex. Civ. Prac. & Rem. Code § 82.003(a). Notably, for manufacturers, it is the plaintiff bringing a products liability claim against a non-manufacturing seller who has the burden to establish an exception to the seller’s statutory protection. See id. § 82.003(a); In re Atlas Tubular, LP, 296 S.W.3d 363, 365 (Tex. App.—Corpus Christi 2009, orig. proceeding). Below is an outline to the seven exceptions to Chapter 82 that manufacturers should be familiar with that may cause sellers’ presumed innocence to be pierced such that sellers may find themselves a MAN DOWN. Read more ›

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Just In: New Jersey Supreme Court Adopts Daubert Factors For Assessing The Reliability Of Expert Testimony

Posted on September 24, 2018 by Shelby Riney — No Comments ↓

On August 1, the Supreme Court of New Jersey issued a seminal ruling elucidating the state’s standard for admission of expert testimony in civil litigation. In a unanimous decision, the Court adopted the Daubert factors for assessing the reliability of expert testimony, and reaffirmed the trial court’s duty to engage in “rigorous gatekeeping” prior to admitting expert scientific evidence.

In re Accutane Litigation, No. A-25-17, 2018 N.J. LEXIS 988 (N.J. Aug. 1, 2018), the latest iteration of the decade-old Accutane litigation, involves allegations that the prescription cystic acne medication causes Crohn’s disease, a form of irritable bowel disease (IBD). Despite numerous epidemiological studies finding no association between Accutane and IBD, plaintiff’s expert gastroenterologist relied on post-marketing case reports, animal studies, and his theory of biological plausibility to opine that Accutane can cause Crohn’s disease. Id. at *34-41. Granting defendants’ motion to exclude such testimony, the trial court determined that the expert’s opinions “did not pass muster.” Id. at *23-24. Specifically, the trial court concluded “there is no epidemiological evidence to justify a reasonable inference that there is a causal link between [Accutane] and Crohn’s disease,” and “plaintiffs’ experts’ examination of the evidence was a ‘conclusion-driven’ attempt to cherry-pick evidence supportive of their opinion while dismissing other, better forms of evidence that did not support their opinion.” Id. at *59 (internal citations omitted).

The Appellate Division reversed, concluding that plaintiffs’ “experts relied on methodologies and data of the type reasonably relied upon by comparable experts” and “evaluated all of the evidence in accordance with established scientific standards and methodology . . . .” Id. at *59-60 (internal citations omitted). According to the Appellate Division, “defendants’ experts merely interpret[ed] the epidemiological studies differently, and . . . a difference of opinion between the experts did not mean that plaintiffs’ experts failed to rely upon a sound methodology.” In re Accutane Litig., 2018 N.J. LEXIS 988 at *60 (internal citations omitted). Stating that “a reviewing court owes somewhat less deference to a trial court’s determination[s] regarding expert testimony,” the Appellate Court “conclude[d] that the [trial] court mistakenly applied its discretion in excluding scientific testimony.” Id. at *61 (internal citations omitted). Read more ›

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Don’t Find Yourself a MAN DOWN: Manufacturers Can MAN UP With Defenses to the Texas Products Liability Act

Posted on September 11, 2018 by Kendall Kelly Hayden — No Comments ↓

man up As of September 1, 1993, a manufacturer’s duty to indemnify a seller in a products liability action became statutorily mandated in Texas. See Tex. Civ. Prac. & Rem. Code Ann. § 82.002 (Vernon 1997) (“Chapter 82”). Chapter 82, also known as the Products Liability Act, made changes that place the burden on a manufacturer to indemnify and hold harmless a seller against loss arising out of a products liability action, except for any loss caused by the seller’s negligence, intentional misconduct, or other act or omission such as negligently modifying or altering the product, for which the seller is independently liable. This discussion will provide a quick reference guide that manufacturers can consult to MAN UP defenses when hit with a claim under Chapter 82.

M is for Must defend

Section 82.002 requires manufacturers to indemnify a seller “without regard to the manner in which the action is concluded.” Tex. Civ. Prac. & Rem. Code § 82.002(e)(1); see also Meritor Automotive, Inc., 44 S.W.3d at 90; General Motors Corp. v. Hudiburg Chevrolet, Inc., 199 S.W.3d 249, 255-56 (Tex. 2006). “To escape the duty to indemnify, the indemnitor [here, the manufacturer] must prove the indemnitee [here, the seller]’s independent culpability.” General Motors Corp., 199 S.W.3d at 255-56. Manufacturers should beware that a plaintiff’s mere allegation that a seller is negligent is not sufficient to invoke the exception. See Meritor Automotive, Inc., 44 S.W.3d at 90. Instead, the manufacturer must defend a seller until the manufacturer obtains a finding that the seller’s independent conduct was a cause of plaintiff’s injury.” Freeman Financial Inv. Co. v. Toyota Motor Corp., 109 S.W.3d 29 (Tex. App.—Dallas 2003, pet. denied) (referring to Tex. Civ. Prac. & Rem. Code Ann. § 82.002(a)); Fresh Coat, Inc. v. K-2, Inc., 318 S.W.3d 893 (Tex. 2010). Since the determination of whether indemnity is owed is not determined until after a judgment is entered, manufacturers are on the hook through trial. Id. In the same vein, a plaintiff’s amendment of a products liability claim, so as to abandon any claim against the manufacturer, does not retroactively relieve the manufacturer of its duty to indemnify the seller for defending claims related to the manufacturer while the manufacturer was a party to the action. Seelin Medical, Inc. v. Invacare Corp., 203 S.W.3d 867 (Tex. App.—Eastland 2006, pet. denied).

Under Chapter 82, manufacturers must MAN UP and provide a defense and indemnity to a seller until manufacturers seek and obtain a finding that the seller was independently liable. If the manufacturer proves the seller’s independent liability, manufacturers can MAN UP and seek reimbursement from a seller’s damages and expenses for losses they cause. Panatrol Corp. v. Emerson Elec. Co., 163 S.W.3d 182 (Tex. App.—San Antonio 2005, pet. denied). Read more ›

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ALERT: U.S. Supreme Court Grants Certiori to Decide Whether FDA Excluded Warnings Pre-Empt State Law Claims

Posted on June 28, 2018 by Abby Sacunas — No Comments ↓

drugs and side effects list The U.S. Supreme Court today agreed to consider a Third Circuit ruling that revived litigation over Merck’s alleged failure to warn about a risk of femoral fractures from its osteoporosis drug Fosamax. The precise question presented on appeal is “whether a state-law failure-to-warn claim is pre-empted when the Food and Drug Administration rejected the drug manufacturer’s proposal to warn about the risk after being provided with the relevant scientific data, or whether such a case must go to a jury for conjecture as to why the FDA rejected the proposed warning.”

Multiple plaintiffs filed personal injury lawsuits consolidated in the New Jersey District Court under state law against Merck alleging that the osteoporosis drug Fosamax caused them to suffer serious thigh bone fractures and that Merck failed to provide adequate warning of that risk. The MDL judge granted Merck’s motion for summary judgment based on preemption, finding that state law warning claims are preempted when there is “clear evidence” that the FDA would not have approved the proposed warning. Following dismissal, last year, the Third Circuit revived the patients’ claims, saying the issue presented was a factual one requiring Merck to prove to a jury that federal regulators blocked the warning. The panel specifically found that it was feasible that Merck could have received approval to include the contested warning had it described the fractures differently. Read more ›

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Tagged with: failure to warn
Posted in Duty To Warn, FDA

8th Circuit Reverses to Uphold Successor Liability Defense, Highlighting The Importance of Consistent, Clear Descriptions Of Acquisitions To Avoid the de facto Merger Exception

Posted on June 1, 2018 by Jillian Thornton Flax — No Comments ↓

On April 5, the Court of Appeals for the Eighth Circuit wiped out a jury verdict in a products liability action and $13 million punitive damages award against a manufacturer and its wholly owned subsidiary on the basis that the parent company manufacturer could assert a successor liability defense. The 8th Circuit ruling, which rightfully reinforced the bedrock principle that parent companies are not responsible for the liabilities of their subsidiaries, provides some valuable lessons for corporations that acquire other companies with potential (or known) liabilities. Of vital importance to this ruling was the manner in which the parent company had publicly described its acquisition in other litigation.

Kirk v. Schaeffler Group USA, Inc., No. 16-3417, 2018 WL 1630005 (8th Cir. Apr. 5, 2018) involves FAG Bearings Corporation, a designer and manufacturer of precision ball and roller bearings that has a production facility in Joplin, Missouri. From 1973 to 1982, FAG Bearings released thousands of gallons of trichloroethylene (TCE), a hazardous substance, at its facility. The EPA ultimately discovered the TCE dumping and litigation determined that FAG Bearings was solely responsible for the TCE contamination in nearby communities. In 2005, Schaeffler Group USA (“Schaeffler”), a large corporation that engineers, produces, sells, and markets rolling and plain bearings, among other products, acquired FAG Bearings and its facility. The plaintiff in Kirk was born in 1987 in one of the communities contaminated by TCE and was subsequently diagnosed with autoimmune hepatitis, which she claims resulted from defendants’ negligent release of TCE.

Now, of course, in most jurisdictions and under most circumstances, the successor liability defense bars claims that arise as a result of a predecessor’s defective product, so it would seem that Schaeffler was in the clear. Schaeffler acquired FAG Bearings Corporation and converted the company to FAG Bearings, LLC as a wholly owned subsidiary. Despite this, the district court denied summary judgment and the ensuing jury trial resulted in punitive damages imposed jointly against Schaeffler and FAG Bearings, LLC because plaintiff argued that FAG Bearings Corporation merged with Schaeffler. Read more ›

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

Posted on May 1, 2018 by Jillian Thornton Flax — No Comments ↓

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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Posted in FDA

The Legality of Cannabidiol and Concerns Regarding False Advertising

Posted on April 17, 2018 by Brett Nicole Taylor, Amy Alderfer

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cannabis oil CBD The 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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Tagged with: cannabis, cbd, false advertising, Marijuana
Posted in FDA

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

Posted on March 20, 2018 by Abby Sacunas, Rachel Velasquez

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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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Tagged with: hybrid medical device
Posted in Manufacturer