Essure

Top 11 Drug and Device Litigations of 2016

 

2016 was a busy year for pharmaceutical and medical device litigation. Many of these litigations are still ongoing, so we expect our updates to continue through 2017. Below is a list of eleven of the most important civil cases of 2016.

11. J&J Slapped With Another Hip Lawsuit After $1B Damage Award

On December 9, 2016, an Indiana man filed a lawsuit against Johnson & Johnson over its DePuy hip replacement device, just four days after a Texas jury awarded $1 billion in punitive damages to six plaintiffs in a similar action. J&J still faces more than 8,000 lawsuits relating to the DePuy Orthopaedics hip replacement product.

10. Levaquin Lawsuits Allege J&J Knew About Nerve Damage Risks

On the heels of stepped-up warnings issued by the U.S. Food and Drug Administration (FDA) regarding the serious risks associated with fluoroquinolone use, dozens of lawsuits were filed against Johnson & Johnson, claiming that the company marketed Levaquin “aggressively” even with knowledge that the antibiotic could cause a serious nerve condition known as peripheral neuropathy. The allegations maintain that J&J had evidence of the risk as early as 1996, yet continued to market the drug for relatively minor infections.

9. Heartburn Drugs Prompt Numerous Lawsuits Alleging Kidney Failure and Acute Interstitial Nephritis

In May 2016, an Illinois man filed a lawsuit alleging that AstraZeneca, the maker of the popular heartburn medication, Nexium, committed fraud when the company failed to adequately warn consumers of the drug’s adverse side effects. According to the Nexium lawsuit, after the man began taking Nexium in 2006, he developed kidney failure and subsequently required a kidney transplant. The claim is among others alleging that Nexium and other proton pump inhibitors (PPIs) cause dangerous side effects.

8. Physiomesh Lawsuits on the Rise

Johnson & Johnson and its subsidiary Ethicon face numerous allegations that the company’s Physiomesh Composite mesh was defectively designed and carried inadequate warnings of the risk of injury and failure to hernia repair patients.  Physiomesh was used to repair either inguinal or incisional hernia through a minimally invasive surgery until May 2016, when Ethicon withdrew the device from the market.. The voluntary recall occurred after a pair of observational hernia repair registries determined that the Ethicon device failed at higher rates compared to that of similar hernia mesh repairs.

7. Talcum Powder Trials Cost J&J Millions

Litigation payouts for J&J in 2016 totaled a little more than $1.4 billion. In February, a Missouri jury awarded $72 million in a talcum powder lawsuit involving a Georgia woman who developed ovarian cancer from 35 years of use of Johnson & Johnson products containing talcum powder, and in May, a jury ordered J&J to pay $55 million to a woman who claimed that using the company’s talc products for feminine hygiene caused her to develop ovarian cancer.

6. Lawsuits Claim Invokana Label Fails to Provide Adequate Warnings

In January 2016, the Institute for Safe Medication Practices (ISMP) released a report that highlighted potential concerns regarding a link between Invokana and kidney damage. According to the report, both prescription volume and adverse drug event reports are increasing rapidly for canagliflozin (Invokana), and Invokana lawsuits continue to be filed alleging that the drug’s label does not give adequate warnings regarding the serious risks of bone fractures and kidney injuries (such as diabetic ketoacidosis) associated with Invokana use.

5. Essure Lawsuits Allowed to Proceed in California

Despite three separate motions made by Bayer to have the cases against the company dismissed, a California judge on August 2, 2016 entered an order allowing the Essure permanent birth control lawsuits filed by 14 women to proceed. The state court ruling paved the way for thousands of other Essure injury lawsuits, and was considered a victory for plaintiffs because other state court cases had been dismissed under the theory that federal law preempted state lawsuits related to the controversial device.

4. J&J Pursues Settlement in Power Morcellator Cases

Johnson & Johnson began to pursue settlement in dozens of power morcellator lawsuits filed by women who allege that the devices spread undetected uterine cancer. J&J spent millions of dollars in 2016 to settle the lawsuits, which began to be filed after the U.S. Food and Drug Administration (FDA) issued a 2014 warning stating that about one in 350 women have an undiagnosed uterine cancer known as leiomyosarcoma that could be spread by the surgical device. J&J pulled their morcellators off the market that same year.

3. Bard IVC Filter Lawsuits Centralized in Arizona MDL

Approximately 1,280 IVC filter lawsuits are currently pending against C.R. Bard in multidistrict litigation (MDL) in U.S. District Court for the District of Arizona. The cases have common allegations, among them that C.R. Bard sold the defective medical devices when the company knew or should have known that the IVC filters posed unreasonably dangerous safety risks, and failed to warn patients about the dangers. IVC filter lawsuits for individuals experiencing device migration, filter fracture, embolization, perforation and difficulty removing the device are currently moving forward.

2. Risperdal Verdicts Favor Plaintiffs

Over 2,000 Risperdal lawsuits are pending in the Risperdal Mass Tort in Philadelphia. Trial outcomes have generally favored the plaintiffs, with the exception of one case in which the jury was unable to conclusively determine that Risperdal was responsible for that plaintiff’s gynecomastia, and another that was dismissed in December 2016 for “inadequate expert testimony.”

1. Xarelto Bellwether Trials to Begin in 2017

Nearly 14,000 Xarelto cases have been consolidated in federal multidistrict litigation (MDL) in U.S. District Court, Eastern District of Louisiana, where Judge Eldon Fallon has selected four bellwether cases to be tried in Louisiana, Mississippi, and Texas early in 2017. Several thousand more state court cases have also been filed in Pennsylvania, Delaware, and California.
Sources:

Dye, Jessica. “Johnson & Johnson Ordered to Pay $55 Mln in Talc-powder Trial.” Reuters. Thomson Reuters, 03 May 2016. Web. 11 Jan. 2017. http://www.reuters.com/article/us-johnson-johnson-talc-verdict-idUSKCN0XT20L.

McCarthy, Craig. “Johnson & Johnson Hit with Another Hip Lawsuit following $1B Payout.” NJ.com. New Jersey On-Line LLC, 28 Dec. 2016. Web. 11 Jan. 2017. http://www.nj.com/middlesex/index.ssf/2016/12/johnson_johnson_hit_with_another_suit_following_1b.html.

HARRY MASON, Plaintiff, v. ASTRAZENECA PHARMACEUTICALS LP; and ASTRAZENECA LP, Defendants. IN THE UNITED STATES DISTRICT COURT SOUTHERN DISTRICT OF ILLINOIS, 3 May 2016. Web. 11 Jan. 2017. https://i3jl420on823u34pi27m8yq1-wpengine.netdna-ssl.com/wp-content/uploads/2016-05-03-Complaint.pdf.

Staton, Tracy. “In a New Wave of Levaquin Lawsuits, Patients Claim J&J Knew about Nerve-damage Risks.” FiercePharma. Questex LLC, 16 Aug. 2016. Web. 11 Jan. 2017. http://www.fiercepharma.com/pharma/a-new-wave-levaquin-lawsuits-patients-claim-j-j-knew-about-nerve-damage-risks.

URGENT: FIELD SAFETY NOTICE (n.d.): n. pag. ETHICON PHYSIOMESH™ Flexible Composite Mesh (All Product Codes). Ethicon, 25 May 2016. Web. 11 Jan. 2017. https://www.igz.nl/Images/IT1027122-Ethicon_PHYSIOMESH-algepublic._tcm294-375822.pdf.

Fair, Matt. “Philly Judge Junks J&J Risperdal Case Midtrial.” Law360. Portfolio Media, Inc., 13 Dec. 2016. Web. 11 Jan. 2017. https://www.law360.com/articles/872307/philly-judge-junks-j-j-risperdal-case-midtrial.

“IN RE: Bard IVC Filters Products Liability Litigation.” IN RE: Bard IVC Filters Products Liability Litigation | District of Arizona | United States District Court. U.S. District Court, District of Arizona, 13 Dec. 2016. Web. 11 Jan. 2017. http://www.azd.uscourts.gov/case-info/bard.

“Laparoscopic Uterine Power Morcellation in Hysterectomy and Myomectomy: FDA Safety Communication.” Laparoscopic Uterine Power Morcellation in Hysterectomy and Myomectomy: FDA Safety Communication. U.S. Food and Drug Administration, 17 Apr. 2014. Web. 11 Jan. 2017. http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm393576.htm.

“MDL Statistics Report – Distribution of Pending MDL Dockets by District.” (n.d.): n. pag. Judicial Panel on Multidistrict Litigation. Web. 11 Jan. 2017. http://www.jpml.uscourts.gov/sites/jpml/files/Pending_MDL_Dockets_By_District-November-15-2016.pdf.

Update on New Diabetes Drugs Blocking Kidney Glucose Reabsorption Executive Summary (n.d.): n. pag. Quarter Watch. Institute for Safe Medication Practices, 13 Jan. 2016. Web. 11 Jan. 2017. http://www.ismp.org/QuarterWatch/pdfs/2015Q2.pdf.

Whitman, Elizabeth. “California Ruling Has Major Implications for Current – and Future – Cases against Essure.” Modern Healthcare. Crain Communications, Inc., 9 Aug. 2016e. Web. 11 Jan. 2017. http://www.modernhealthcare.com/article/20160809/NEWS/160809899

Johnson & Johsnon Settling Cases Tied to Device That Can Spread Uterine Cancer, Levitz, Jennifer, 18, March 2016, http://www.wsj.com/articles/johnson-johnson-settling-cases-tied-to-device-that-spread-uterine-cancer-1458324981

 

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