Health Law, Products Liability

Medical Device Update: FDA Regulation of Tanning Beds, “Henceforth to be Known as Sunlamp Products”

by Fuerst Ittleman David & Joseph, PL on 5/10/2013

Yesterday, we reported that FDA had announced its intentions of reclassifying sunlamp products and requiring labeling changes to include warnings discouraging young people from using them....more

Supreme Court Denies Certiorari in MAO’s Double Damages Case

by Edward Waller | Fowler White Boggs P.A. on 5/3/2013

On April 15, 2013, the United States Supreme Court denied a petition for certiorari brought by GlaxoSmithKline (“Glaxo”) seeking review of a Third Circuit decision in favor of Humana Medical Plan (“Humana”), as a Medicare...more

FDA’s Medical Device “Enhancement” Reporting Has Potential Product Liability Implications

by Matthew A. Reed | Sedgwick LLP on 4/26/2013

The U.S. Food and Drug Administration (FDA) recently issued a draft guidance document that could potentially require medical device manufacturers to report a wide variety of device improvements, ranging from routine updates...more

GranuFlo and NaturaLyte Accused in Heart Attacks [Video]

by Lawyers.com on 4/22/2013

Kristian Rasmussen accuses the world’s largest provider of dialysis products and services of knowingly endangering dialysis patients’ lives. A partner at Cory Watson Crowder & DeGaris in Birmingham, Ala., Kristian filed the...more

Lawsuits Claim SSRIs Can Cause Severe Birth Defects [Video]

by Lawyers.com on 4/22/2013

Millions of patients take selective serotonin reuptake inhibitors (SSRIs) for depression, anxiety and other disorders. One out of 10 people in the United States use antidepressants, making them one of the most widely...more

Hernia Patients in Pain as Skin Procedure Fails [Video]

by Lawyers.com on 4/22/2013

Hernia patients have filed lawsuits against the manufacturers of AlloDerm, a product made from the skin tissue of cadavers. They claim once implanted, the AlloDerm stretches and fails, resulting in serious and painful...more

Stryker Hip Replacement Recall Website Launched By Hissey Kientz, LLP Law Firm

by Hissey Kientz LLP on 4/9/2013

The law firm of Hissey Kientz, LLP is announcing the launch of its new website, Stryker Hip Recall Help (http://www.strykerhiprecallhelp.com/). Stryker Corporation issued a voluntary recall of the Stryker Rejuvenate and...more

Howard v. Zimmer: Negligence Per Se Based on Violations of the FDCA—Blurring the Line Between Parallel Claims and Preemption

by Erin M. Bosman, James W. Huston, Joanna Simon | Morrison & Foerster LLP on 3/28/2013

Last week in Howard v. Zimmer, — P.3d —, 2013 WL 1130759 (Okla. 2013), the Oklahoma Supreme Court held that a plaintiff can assert a negligence per se claim against a medical device manufacturer based on the manufacturer’s...more

Craft Beer Boom in Michigan [Video]

by Miller Canfield on 3/25/2013

Michigan is going through a significant boom in its alcoholic beverage manufacturing. In a video produced by Crain's Detroit Business and Miller Canfield, lawyer Joe Infante discusses what this means for Michigan and...more

BioMet M2a Magnum Hip Replacements Linked to Painful Side Effects

by Hissey Kientz LLP on 3/19/2013

BioMet M2a Magnum hip replacement devices have been linked to complications including metal poisoning, hip implant loosening, fretting and corrosion, dislocation and fractures at the site of the implant....more

Stryker hip replacements may cause serious complications

by Hissey Kientz LLP on 2/19/2013

Stryker Corporation issued a voluntary recall of the Stryker Rejuvenate and Stryker ABG II modular hip replacement systems in July 2012 after stating that the metal-on-metal hip devices posed an increased risk for severe...more

Second Circuit Labels Expert’s Testimony a Sham in Pharmaceutical Products Liability Litigation

by Mark Spatz | Cohen & Gresser LLP on 2/7/2013

As a little kid, I did not have an immediate appreciation that my actions could get me into trouble, and so, without thought, I told the truth. My dad would ask, “Did you write your name on the wall?” I would respond,...more

GranuFlo Recall Website Launched By Hissey Kientz, LLP Law Firm

by Hissey Kientz LLP on 1/21/2013

The law firm of Hissey Kientz, LLP is announcing the launch of its new website, GranuFlo Recall Help (http://www.granuflorecallhelp.com/). The site will serve as a source for news and legal information for patients and their...more

Weeks Defies Years of Jurisprudence, Allowing Innovator Liability for Generic Drugs

by Erin M. Bosman, James W. Huston, Julie Y. Park | Morrison & Foerster LLP on 1/18/2013

Last week the Alabama Supreme Court adopted brand-name manufacturer liability for a generic drug sold by another company, becoming the first state supreme court to do so. Wyeth, Inc. v. Weeks, No. 1101397 (Ala. Jan. 11,...more

Uncertainty Regarding the Future Regulation of Compounding Pharmacies

by Fuerst Ittleman David & Joseph, PL on 1/14/2013

As we previously reported, the nationwide outbreak of fungal meningitis linked to contaminated injections produced by New England Compounding Center (“NECC”), a compounding pharmacy in Framingham, Massachusetts, prompted...more

Zoloft Use During First Trimester of Pregnancy Can Increase Risk of Birth Defects

by Hissey Kientz LLP on 1/8/2013

Use of the selective serotonin reuptake inhibitor (SSRI) antidepressant Zoloft during the first trimester of pregnancy can increase a child’s risk of being born with serious heart defects or other birth defects. ...more

U.S. Government’s Use of the "Park Doctrine" to Police Pharmacies

by Frederick Ball, Rachael G. Pontikes | Duane Morris LLP on 1/7/2013

The U.S. government may be resurrecting the "Park Doctrine" as a tool to prosecute the owners of pharmacies for federal Food, Drug, and Cosmetic Act (FDCA) violations. In United States v. Park, 421 U.S. 658 (1975), the U.S....more

FDA Holds Public Meeting in Effort to Better Regulate Pharmaceutical Compounding

by Michael M. Gaba, Shannon Hartsfield Salimone | Holland & Knight LLP on 12/27/2012

On December 19, 2012, the U.S. Food and Drug Administration (FDA) held a public meeting, broadcast live on the Internet, to discuss the respective roles of the federal and state governments in regulating pharmacy compounding....more

Patients continue to file lawsuits over faulty DePuy hip implants

by Hissey Kientz LLP on 12/19/2012

DePuy Orthopaedics and its parent company, Johnson & Johnson, face thousands of lawsuits from patients who were injured as a result of problems with DePuy’s ASR hip replacements. ...more

Australia issues $1M fine for flammable children’s sleepwear

by Stacey Bowers on 12/18/2012

The Australian Federal Court has fined a children’s sleepwear brand $1 million in relation to its supply of unsafe children’s nightdresses and pajamas. According to Product Safety Australia, Cotton On Kids Pty Ltd supplied...more

US CPSC & Health Canada recall expanding toys

by Stacey Bowers on 12/17/2012

The United States (US) Consumer Product Safety Commission (CPSC) and Health Canada issued a joint recall of expanding toys in the US and Canada. The toys, which go by the names Water Balz, Growing Skulls, H2O Orbs...more

FAQ: The Link Between Actos and Bladder Cancer

by Hissey Kientz LLP on 12/14/2012

The FDA has warned that patients taking Actos are more likely to be diagnosed with bladder cancer than users of other diabetes medications. ...more

Birmingham Medical News: Compounding Pharmacies Coming Under Greater Scrutiny

by James A. Hoover | Burr & Forman on 12/6/2012

With as many as 13,000 patients possibly exposed to fungal meningitis from tainted spinal steroid injections traced to a New England compounding pharmacy, the regulation of compounding pharmacies is once againheating up. The...more

GranuFlo and NaturaLyte Dialysis Products Linked to Heart Attacks

by Hissey Kientz LLP on 12/6/2012

GranuFlo and NaturaLyte dialysis concentrates have been linked to severe side effects such as heart attack, stroke, low blood pressure, myocardial infarction, metabolic alkalosis, and death....more

Product Liability Advisory - November 2012: BPA Linked to Adverse Reproduction Effects in Rhesus Monkeys

by Mari Spears | Sedgwick LLP on 12/4/2012

A recent study published in the “Proceedings of the National Academy of Sciences” found that Bisphenol A (BPA) can adversely affect fetal development in rhesus monkeys. The study’s findings raise concerns regarding BPA...more

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Health Law › Products Liability

Medical Device Update: FDA Regulation of Tanning Beds, “Henceforth to be Known as Sunlamp Products”

Supreme Court Denies Certiorari in MAO’s Double Damages Case

FDA’s Medical Device “Enhancement” Reporting Has Potential Product Liability Implications

GranuFlo and NaturaLyte Accused in Heart Attacks [Video]

Lawsuits Claim SSRIs Can Cause Severe Birth Defects [Video]

Hernia Patients in Pain as Skin Procedure Fails [Video]

Stryker Hip Replacement Recall Website Launched By Hissey Kientz, LLP Law Firm

Howard v. Zimmer: Negligence Per Se Based on Violations of the FDCA—Blurring the Line Between Parallel Claims and Preemption

Craft Beer Boom in Michigan [Video]

BioMet M2a Magnum Hip Replacements Linked to Painful Side Effects

Stryker hip replacements may cause serious complications

Second Circuit Labels Expert’s Testimony a Sham in Pharmaceutical Products Liability Litigation

GranuFlo Recall Website Launched By Hissey Kientz, LLP Law Firm

Weeks Defies Years of Jurisprudence, Allowing Innovator Liability for Generic Drugs

Uncertainty Regarding the Future Regulation of Compounding Pharmacies

Zoloft Use During First Trimester of Pregnancy Can Increase Risk of Birth Defects

U.S. Government’s Use of the "Park Doctrine" to Police Pharmacies

FDA Holds Public Meeting in Effort to Better Regulate Pharmaceutical Compounding

Patients continue to file lawsuits over faulty DePuy hip implants

Australia issues $1M fine for flammable children’s sleepwear

US CPSC & Health Canada recall expanding toys

FAQ: The Link Between Actos and Bladder Cancer

Birmingham Medical News: Compounding Pharmacies Coming Under Greater Scrutiny

GranuFlo and NaturaLyte Dialysis Products Linked to Heart Attacks

Product Liability Advisory - November 2012: BPA Linked to Adverse Reproduction Effects in Rhesus Monkeys

GranuFlo and NaturaLyte Accused in Heart Attacks [Video]

Lawsuits Claim SSRIs Can Cause Severe Birth Defects [Video]

Hernia Patients in Pain as Skin Procedure Fails [Video]

Craft Beer Boom in Michigan [Video]

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