Jury Finds For J&J DePuy In First Pinnacle Bellwether Case

Yesterday, a nine member panel found for the defendant Johnson & Johnson and their subsidiary DePuy Orthopaedics in the first MDL bellwether case to go to trial over the Pinnacle Metal-On-Metal hip replacement device. The jury deliberated for a little more than two days. The trial lasted eight weeks.

In what is a huge blow to the nearly 6,000 other claimants in the MDL, the jury found that the devices were safe when used and implanted properly. Lawyers for the defendants basically blamed the surgeons who implanted the plaintiff’s devices for not properly positioning them when implanted.

The plaintiff in the trial claimed that the metal-on-metal wear from the device resulted in exposure to extremely high levels of cobalt and chromium which affected poisoned her blood and caused soft tissue damage. She ultimately had to have bi-lateral hip surgeries to remove to the devices.

The Pinnacle device is different than DePuy’s ASR Metal-On-Metal hips in several facets, although they appear to be extremely similar. The ASR was recalled by J&J, whereas J&J just stopped selling the metal-on-metal version of the Pinnacle hip in August 2013 after the FDA said it would require device makers to submit new versions of the artificial hips for pre-market approval. J&J settled the ASR MDL last year for an estimated $4 Billion.

Of course, this is just the first chapter in what will most likely be a long and drawn out fight. J&J and DePuy face several other Pinnacle trials in different jurisdictions that are set soon, and there were will most likely be several other bellwether trials coming out of the MDL. 

J&J Recall 13,500 Bottles of Xarelto

Johnson & Johnson's Janssen unit is recalling approximately 13,500 bottles of its top-selling anticoagulant Xarelto because of microbial contamination discovered in a sample.

According to a recall notice in an FDA Enforcement Report, the drug manufacturer said that it confirmed that a sales sample of the drug was contaminated after a customer complaint, and so initiated a nationwide, voluntary recall. The company reported that the product came from a plant in Puerto Rico. The plant was among four on the island that J&J slated two years ago for $225 million in upgrades.

To view the notice, click on the link below:

http://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=D-0006-2015&w=10152014&lang=eng

Xarelto came to market in the U.S. three years ago behind Boehringer Ingelheim's Pradaxa, but which has since eclipsed it in sales. Like Pradaxa, Xarelto has come under scrutiny based on accusations that the drug causes bleed outs and deaths. Lawsuits have been filed against the manufacturer across the country, and a motion has been filed to consolidate cases into an MDL.

Pittman, Dutton & Hellums, P.C., is currently investigating Xarelto cases. If you or a loved one were prescribed Xarelto and suffered an irreversible internal bleeding that lead to hospitalization and/or death, contact Booth Samuels at toll free 1-866-515-8880 or by email at booths@pittmanudutton.com.

Missouri Supreme Court Rejects Punitive Damage Limit and Other Tort Reform News

Last month, the Missouri Supreme Court threw out the state legislature’s limits on punitive damages, saying they don’t apply to a $1 million verdict a jury awarded to Lillian Lewellen. Lewellen received the judgment in 2012 after she was defrauded by a car dealer.

After a jury ordered the defendant to pay Lewellen $1 million in punitive damages, a judge cut the judgment in half, citing a state law that capped some punitive damage awards at $500,000.

The Supreme Court restored the judgment because Lewellen had filed her claim as a common law fraud, which has existed in Missouri since the first state constitution was written. Because of that, the legislature cannot limit a jury’s ability to set punitive damage amounts, the court ruled in a unanimous decision.

Punitive damage caps remain in place for causes of action created by the Missouri legislature, such as human rights cases and awards for some deceptive merchandising practices.

In other tort reform news, a story by The Los Angeles Times, reported on a new study led by Michael B. Rothberg of the Cleveland Clinic and published in the Journal of the American Medical Association, aimed to measure how much defensive medicine there is, and how much it costs.

The researchers' conclusion is that defensive medicine accounts for about 2.9% of healthcare spending. In other words, out of the estimated $2.7-trillion U.S. healthcare bill, defensive medicine accounts for $78 billion.

The minimal impact of defensive medicine on healthcare costs demonstrates the injustice of the stringent limits on malpractice lawsuits advocated by doctors and insurance companies. 

"Pain-and-suffering" or “mental anguish” damage caps and other stratagems to discourage malpractice lawsuits benefit mostly insurers. Their impact falls disproportionately on women and families with infants, because their economic damages, which remain subject to jury awards, are hard to estimate and typically underestimated.

As for "frivolous lawsuits," defined as cases that should never have been brought at all, they are a lot rarer than most tort reform advocates admit. Studies have documented that the vast majority of them don't yield a payment to the plaintiff. The converse is a bigger problem -- genuinely injured patients who cannot get redress because the courthouse doors have been shut to them. The victims there are often lower-income or unemployed patients.

Endo Agrees To Settle Remaining TVM Claims

Earlier this month, Endo International announced it had reached agreements to settle up to 20,000 legal claims from women who said they were harmed by transvaginal mesh devices, ending nearly all of the U.S. cases against it and its American Medical Systems unit. The proposed settlement is valued at $400 Million.

Endo, which did not admit liability, said it would increase the amount of money it had set aside to cover vaginal mesh claims from $1.2 billion to approximately $1.6 billion in connection with the latest agreements.

Earlier this year in April, Endo announced it reached agreements to settle up to approximately 21,700 additional mesh claims. Last year, it settled an undisclosed number of cases for $54.5 million. See my previous blog posts for more on those settlements.

Transvaginal mesh manufacturers have faced a wave of litigation in the last few years over the devices, which are used to treat stress urinary incontinence and pelvic organ prolapse. The women suing the companies have accused the companies of selling subpar devices that caused injuries such as chronic pain, incontinence, bleeding and infection. Besides Endo, C.R. Bard Inc., and Johnson & Johnson's Ethicon are facing tens of thousands of lawsuits over similar products, with several trials scheduled for the fall.

Many of those cases have been consolidated before U.S. District Judge Joseph Goodwin in the Southern District of West Virginia, who is overseeing more than 60,000 mesh cases against seven manufacturers.

In 2008, the U.S. Food and Drug Administration notified transvaginal mesh manufacturers about reports of potential complications stemming from the devices. In 2012, the agency ordered AMS and other manufacturers to conduct post-market safety studies and monitor the rate at which adverse events were reported. The FDA announced earlier this year it is considering a proposal to tighten safety standards for mesh used to treat pelvic organ prolapse.

Is Xarelto the Next Pradaxa?

Plaintiffs in six lawsuits alleging injuries caused by the prescription blood-thinner Xarelto have filed a motion seeking their cases consolidated into an MDL. The motion was filed October 9th with the Judicial Panel on Multidistrict Litigation and requests that all pending and future cases be sent to a judge in the U.S. District Court for the Southern District of Illinois.

Xarelto (rivaroxaban) is a blood-thinning drug (anticoagulant) that is used to treat blood clots, deep vein thrombosis, and pulmonary embolisms. It has been sold by Bayer HealthCare and Janssen Pharmaceuticals since 2011.

Xarelto is the second FDA-approved drug in a new generation of anticoagulants that are marketed as alternatives to warfarin. Warfarin has been a mainstay of anticoagulation therapy since the 1950s, but it is a problematic drug that requires frequent dosage adjustments and weekly monitoring. Pradaxa is the other drug and was approved in 2010, a year ahead of Xarelto.

Xarelto appears to be extremely similar to Pradaxa.  Both Pradaxa and Xarelto are prescribed in a “one-size-fits-all” pill taken once or twice a day. They both also require less monitoring than warfarin and do not require as harsh dietary restrictions.

The problem is that Xarelto, and Pradaxa, has no effective reversal agent or antidote. Excessive bleeding attributed to Warfarin can be reversed with a dose of Vitamin K.

Some studies have also linked Xarelto to a higher risk of bleeding for acutely ill patients. According to lawsuit allegations filed against Bayer, the company did not warn the public and want the drug removed from the market.

Boehringer Ingelheim, the manufacturer of Pradaxa, agreed in May 2014 to pay $650 million to settle approximately 4,000 lawsuits over claims the drug caused serious bleeding episodes.

Pittman, Dutton & Hellums, P.C., is currently investigating Xarelto cases. If you or a loved one were prescribed Xarelto and suffered an irreversible internal bleeding that  lead to hospitalization and/or death, contact Booth Samuels at toll free 1-866-515-8880 or by email at booths@pittmanudutton.com.

After Brechbell: A Good "Bad Faith" Ruling in Alabama

In Lord v. Allstate Ins. Co., No. 4:13-cv-593-TMP, 2014 U.S. Dist. LEXIS 129813 (N.D. Ala. Sept. 17, 2014), Magistrate Judge Putnam denied Allstate’s request for a partial summary judgment for the plaintiff’s bad-faith claim. 

Between 2003 and 2005, Lord built a cabin in the woods.  Lord and his wife lived in the cabin until 2009 and, after 2009, the cabin was rental property.  In 2011 the cabin was vacant and listed for sale with a realtor for $59,000. A buyer contracted to purchase the cabin, and a home inspection was performed which noted no problems with the cabin. However, the sale fell through when the buyer was unable to obtain financing. 

As a result of high wind on April 27, 2011, a large tree fell in the driveway and on the electrical service line to the cabin, pulling a weather mast away (but not loose) from the structure and causing roof damage in the area of the weather mast.  After the tornado, Lord went to the cabin and noticed additional structure damage that had not been present before the storm, such as cracks in walls and door facing, cracks in the ceiling and floor, and wet and mildewed carpets.  Lord made a claim with Allstate.

Allstate initially engaged an independent company to adjust the claim.  This company assigned Barnes to inspect the cabin.  While Barnes had 30 years’ experience in construction, he was a full-time barber and this was his first assignment as an adjuster.  Despite Barnes’s and others’ “pleas” that an independent engineer be engaged, Allstate’s claims handler did not engage an engineer before there were one or two formal denials and closings of the file. 

After receiving these denials, Lord persisted.  FEMA recommended that Jenkins, an architect trained by FEMA to make assessments of the structural safety of buildings impacted by natural disasters, be contacted.  Jenkins inspected the cabin and prepared a detailed report explaining how the fallen tree caused the additional structural damage.  Only upon receiving a copy of Jenkins’s report did Allstate engage an engineer, who Judge Putnam noted was a civil engineer, as opposed to a structural engineer.

Judge Putnam concluded that a jury could reasonably find that Allstate denied the claim prior to engaging an engineer and that Allstate acted in bad faith by not adequately investigating the claim.  Among other things, Allstate ignored the home inspector’s finding of no problems with the cabin shortly before the wind event, Lord’s statement that the cracks and other issues did not exist prior to the wind event and adjuster asking that an engineer be engaged to assess causation.

As the facts in Brechbill strongly indicated that State Farm acted in good faith, the facts here strongly demonstrated bad faith.