Spain Mexico
Philadelphia, PA Cherry Hill, NJ New York, NY Roseland, NJ 1-866-LOCKSLAW
Facebook Twitter LinkedIn
Locks Law Firm
Facebook Twitter LinkedIn
Get Started
  • No win, no fee
  • Free consultation
  • Home
  • About
    • About Us
    • The Team
    • Office Locations
    • Newsroom
    • FAQ
  • About
    • About Us
    • The Team
    • Office Locations
    • Newsroom
    • FAQ
  • Practice Areas
  • Practice Areas
    • All Practice Areas
    • Medical Malpractice and Nursing Home Abuse
    • Environmental and Toxic Torts
    • Catastrophic Personal Injuries
    • Dangerous Drugs & Devices
  • Testimonials
  • Blog
  • Contact
  • Get Started
  • Spain Mexico   Spanish
  • About
    • About Us
    • The Team
    • Office Locations
    • Newsroom
    • FAQ

    One of the most prominent personal injury law firms in the tri-state region, the Locks Law Firm is steadfastly committed to protecting the rights of seriously injured victims.

    Free Case Evaluation
  • Medical Malpractice and Nursing Home Abuse
    • Nursing Home Abuse and Neglect
    • Hospital Acquired Infections
    • Medication Errors
    • Misdiagnosis / Failure to Diagnose
    • Surgical Errors
    • Needle Stick - CRPS

    Medical malpractice is any act by a health care provider that deviates from accepted standards of medical care and results in the personal injury, disability, or wrongful death of a patient. Nursing home abuse or negligence can take many forms. It can include physical, sexual, and emotional abuse, neglect, negligent care, and even financial exploitation.

    Free Case Evaluation
  • Environmental and Toxic Torts
    • Asbestos and Mesothelioma
    • Benzene
    • Chemical Exposure
    • Manganese Exposure
    • Natural Resource Damages
    • Toxic Injuries
    • Workplace Exposure
    • Camp Lejeune Water Contamination

    Exposure to toxic chemicals in the workplace or environment can cause serious, sometimes fatal health problems, including cancer.

    Free Case Evaluation
  • Catastrophic Personal Injuries
    • Burns and Chemical Burns
    • Traumatic Brain Injuries
    • Spinal Cord Injuries
    • Wrongful Death

    Catastrophic personal injuries include brain and spinal cord injuries, severe burns, carbon monoxide poisoning and, most seriously, death.

    Free Case Evaluation
  • Dangerous Drugs & Devices
    • Allergan Breast Implant Recall
    • Hernia Mesh
    • IVC Filters
    • Philips Respironics Lawsuit
    • Zantac (ranitidine)
    • NEC Baby Formula

    At the Locks Law Firm, our pharmaceutical litigation and defective drug lawyers are committed to serving personal injury victims and are well versed in the product liability laws that protect consumers.

    Free Case Evaluation

Locks Law Firm

Philadelphia, PA

(215) 893-0100

Cherry Hill, NJ

(856) 663-8200

New York, NY

(212) 838-3333

Roseland, NJ

(973) 671-1940

Locks Law Firm

Philadelphia, PA

The Curtis Center
Suite 720 East
601 Walnut Street

Cherry Hill, NJ

801 North Kings Highway

New York, NY

622 Third Avenue | 7th FLoor

Roseland, NJ

3 Becker Farm Road
Suite 105

Locks Law Firm

Philadelphia, PA

[email protected]

Cherry Hill, NJ

[email protected]

New York, NY

[email protected]

Roseland, NJ

[email protected]

Blog

What do 20,115 and 510 have in common?

Answer: all four. 20,115 and 510 are both linked to the FDA (Food and Drug Administration). 20,115 is the number of deaths associated with opioid painkillers reported to the FDA between November of 2017 and August of 2018 by Endo, a manufacturer of opioids. 510, actually 510(k), is a process by which the FDA can approve a medical device for sale.

Both have been in the news recently. On Sunday, April 14, 2019, the Philadelphia Inquirer had a major page 1 story titled “Company Tells FDA Of 20,000 Fatalities.” Three days earlier, the Pennsylvania Superior Court ruled that under New Jersey law, a trial court acted within its discretion in excluding evidence that the FDA had cleared through its 510(k) process a mesh product for the urethra to cure or reduce stress urinary incontinence (SUI). Carlino v. Ethicon, Inc., 2019 WL 1567412 (Pa. Super., April 11, 2019). In addition, both the newspaper article and Carlino highlight weaknesses in the FDA.

In 2017 the FDA requested that Endo stop selling Opana ER, a top-selling painkiller, which Endo did. However, an FDA spokesperson said that the FDA does not rely solely on the volume of adverse event reports as a measure of risk, but also looks at the quality of the information. 91% of the opioid adverse event reports for a period of a year ending in the third quarter of 2018 lacked age or gender. This is a weakness of the adverse event reporting system.

Carlino stated that the FDA is supposed to complete a thorough premarket approval (PMA) before allowing a medical device to be marketed. This can take 1,200 hours. 510(k) approval is an exception to a PMA: it allows manufacturers to demonstrate that a device is “substantially equivalent” to an earlier device that was on the market prior to 1976. The 510(k) process takes only 20 hours on average. The key distinction is that PMA focuses on safety, not equivalence, while 510(k) focuses on equivalence, not safety. The product in Carlino went through only the 510(k) process.

New Jersey law provides that if the FDA has “approved or prescribed” a warning or instruction given in connection with a drug or device, there is a rebuttable presumption that the warning or instruction is adequate. The trial court excluded the product’s 510(k) FDA clearance, and the Superior Court affirmed. The Superior Court stated that 510(k) clearance does not constitute “approval” or “prescription” of the warning or instruction. That Court added that “the 510(k) process is, at most, marginally relevant to whether the [product] is safe, and any excursion into this subject would have needlessly prolonged an already lengthy trial and posed considerable risk of confusing the jury.”

Carlino also affirmed the exclusion of testimony about a 2013 FDA publication titled “Considerations about Surgical Mesh for SUI.” One statement in this publication is that products like the one on trial were safe for 70-80% of patients within one year after surgery. However, the plaintiff’s problems here began close to two years after surgery. The essence of the plaintiff’s case was that the product was defective due to long-term effects. The publication did contain two sentences about long-term effects, but the Superior Court found they were too vague to have probative value.

Carlino did not cite to any prior New Jersey or Pennsylvania decisions on these FDA issues. Since Carlino was a Pennsylvania Court deciding New Jersey law, we did quick research on both New Jersey and Pennsylvania law to see if we could find any prior appellate decisions on these issues. We found none directly on point.

One New Jersey medical device case held that a trial court did not abuse its discretion in ruling that if the defendant offered evidence that the product was cleared by the FDA, plaintiff would be allowed to offer evidence about the revised warnings for the product. Gross v. Gynecare, 2016 WL 1192556, *20-*22 (N.J. Super., App. Div., March 29, 2016) (Unpub.), certif. denied, 228 N.J. 430, 157 A.3d 847 (2016).

In the context of a drug case, the New Jersey Supreme Court recently held that there are three pathways to overcome a presumption of adequacy from FDA clearance: (1) “deliberate concealment or nondisclosure of after-acquired knowledge of harmful effects”; (2) “economically-driven manipulation of the post-market regulatory process”; (3) clear and convincing evidence that the manufacturer knew or should have known postmarketing that the drug warnings were inadequate. In re: Accutane Litigation, 223 N.J. 229, 277, 194 A.3d 503, 531 (2018).

In another New Jersey drug case, the Appellate Division affirmed the exclusion of a 2005 FDA Memorandum regarding the cardiovascular risks of certain drugs. The trial court had written that the Memorandum did not explain the scientific basis for its opinion. The trial court would have admitted the Memorandum into evidence if the defense had put forth an expert who opined, based not just on the Memorandum but on all relevant clinical studies, that all drugs of that category increased the risk of heart attacks. McDarby v. Merck & Co., Inc., 401 N.J. Super. 10, 76-77, 949 A.2d 223, 265 (App. Div. 2008), appeal dismissed as improvidently granted, 200 N.J. 267, 979 A.2d 766 (2009).

In conclusion, the relation of a medical device or a drug to the FDA is a hotly-litigated area that requires close attention from the practitioner.

Jonathan W. Miller

Jonathan W. Miller

Partner
Philadelphia Office
Jonathan has specialized in complex cases, legal issues and appeals for over 40 years. Recent cases include medical malpractice and civil rights violations.
April 24, 2019 Jonathan W. Miller

Tell Us About Your Case

If you can read this, please avoid filling the following input field or your submission may be marked as spam.
Thank you for contacting us! We will be in touch with you shortly.
Uh oh. There was a problem processing your request. Please try again!
Previous Entry

Reduction of Concussions in Most Recent NFL Season

Next Entry

New York Rejects Pipeline Citing Environmental and Climate Change Concerns

Recent Entries

  • Locks Law Firm Announces New Partner: Victoria A. Schall, Esq.
  • Camp Lejeune and the PACT Act
  • Locks Law Firm Partner Al Anthony Helps Raise Over $1.3 Million for Pillar Care Continuum
  • Jennifer Emmons Named Managing Partner
  • Stephen M. Tatonetti Joins the Locks Law Firm Team

Archive

  • January2023
  • August2022
  • February2022
  • January2022
  • September2021
  • August2021
  • July2021
  • March2021
  • February2021
  • January2021
  • November2020
  • September2020
  • July2020
  • June2020
  • May2020
  • April2020
  • March2020
  • February2020
  • January2020
  • December2019
  • November2019
  • October2019
  • September2019
  • August2019
  • July2019
  • June2019
  • May2019
  • April2019
  • March2019
  • February2019
  • January2019
  • December2018
  • November2018
  • October2018
  • September2018
  • August2018
  • July2018
  • June2018
  • May2018
  • April2018
  • March2018
  • February2018
  • January2018
  • December2017
  • November2017
  • October2017
  • September2017
  • August2017
  • July2017
  • June2017
  • May2017
  • April2017
  • March2017
  • February2017
  • January2017
  • December2016
  • November2016
  • October2016
  • September2016
  • August2016
  • July2016
  • June2016
  • May2016
  • April2016
  • March2016
  • February2016
  • January2016
  • December2015
  • November2015
  • October2015
  • September2015
  • August2015
  • May2015
  • April2015
  • March2015
  • February2015
  • January2015
  • December2014
  • November2014
  • October2014
  • August2014
  • June2014
  • April2014
  • February2014
  • August2013
  • July2013
  • June2013
  • February2013
  • December2012
  • November2012
  • October2012
  • September2012
  • August2012
  • July2012
  • June2012
  • September2011
  • January2011
  • November2010
  • September2010
  • August2010
  • July2010
  • June2010
  • March2010
  • February2010
  • January2010
  • December2009
  • November2009
  • September2009
  • August2009
  • July2009
  • April2009
  • March2009
  • February2009
  • January2009
  • July2008
  • June2008
  • May2008
1-866-LOCKSLAW
[email protected]
Facebook Twitter LinkedIn YouTube
2021 Best Lawyers
Martindale-Hubble Award Ten Leaders

Copyright ©2023 Locks Law Firm. Made by Mindlark.

Locks Law Firm only provides legal advice after having entered into an attorney client relationship, which our website specifically does not create. Conversations that originate from website messaging, chat or other two way web based engagement  do not create an attorney client relationship. It is imperative that any action taken be done on the advice of counsel. Because every case is different, the description of awards and cases previously handled do not guarantee a similar outcome in current or future cases. The firm practices law in Pennsylvania, New Jersey & New York as Locks Law Firm. Super Lawyers, Best Lawyers in America and other organizations that rate attorneys are not designations that have been approved by the State Supreme Courts or the American Bar Association.