Lucy’s Weight Loss System of Arlington, TX, is voluntarily recalling all lots of Pink Bikini and Shorts on the Beach Capsules in all colors, 30 count (750MG per capsule) to the consumer level. Pink Bikini and Shorts on the Beach may contain an undeclared active pharmaceutical ingredient.
FDA analysis of Pink Bikini (white capsules, blue capsules and gold capsules) and Shorts on the Beach (blue capsules and gold capsules) found these products to be tainted with Sibutramine, Phenolphthalein, and/or Diclofenac, and that this active ingredients are not declared on the label of the product.
Sibutramine is an appetite suppressant that was withdrawn from the U.S. market in October 2010. Sibutramine is known to substantially increase blood pressure and/or pulse rate in some patients and may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias, or stroke.
Phenophthalein is an ingredient previously used in over-the-counter laxatives, but because of concerns of carcinogenicity, it is not currently approved for marketing in the U.S. Health risks associated with phenolphthalein could include potentially serious gastrointestinal disturbances, irregular heartbeat, and cancer with long-term use.
Diclofenac is a nonsteroidal anti-inflammatory drug (NSAID). Use of diclofenac in patients already taking NSAIDS, with allergies, with underlying illnesses or with recent cardiac bypass surgery, could lead to gastrointestinal disturbances, fatal heart attack or stroke.
The product is marketed as a weight loss dietary supplement and is packaged in clear bottle in multiple color capsules. The affected Pink Bikini and Shorts on the Beach lots include the following expiration date 7/30/2017. These products were distributed nationwide to consumers viaPinkBikini.BigCartel.com and Waisted With Lucy Retail store.
Lucy’s Weight Loss System is recommending that Pink Bikini and Shorts on the Beach, in all strengths and pill colors not be consumed, as they may contain any of these undeclared active pharmaceutical ingredients and/or an unknown active pharmaceutical ingredient.
Lucy’s Weight Loss System is notifying its customers by Press Release and email. Consumers with questions regarding this recall can contact Lucy’s Weight Loss System by phone (682)-308-0199or email PBFITME@gmail.com on Monday thru Friday 10:00am to 5:30pm CST. Consumers that have recalled Pink Bikini and Shorts on the Beach should stop using and discard.
Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.
By John H. Beisner, Jessica D. Miller and Jordan M. Schwartz of Skadden Arps
In 2016, the U.S. Supreme Court is expected to hand down several decisions addressing overbroad or “no-injury” class actions, and a number of important issues are percolating in the lower courts as well. Below are some issues that are likely to be at the forefront of class action practice in the coming year.
1. The Future of Overbroad Class Actions. The future of overbroad or no-injury class actions could turn on the resolution of two cases before the Supreme Court. The first is Spokeo Inc. v. Robins, a case involving Article III standing under the Fair Credit Reporting Act. The specific question at issue in Spokeo is whether Congress can confer Article III standing on a plaintiff who has not suffered any concrete harm apart from alleging a bare violation of a federal statute. The second case is Tyson Foods, Inc. v. Bouaphakeo, a wage-and-hour class action that, according to the petition for certiorari, involves the question “whether a class action may be certified … when the class contains hundreds of members who were not injured and have no legal right to any damages.” Although there are other issues at play in this closely watched case — and several justices suggested at oral argument that the Court might not address the overly broad certification issue — the Court’s ultimate decision still could have significant implications for no-injury class actions. (See “2015-16 Supreme Court Update.”)
2. Ascertainability Law Remains in Flux. Defendants in 2015 were dealt a setback in their bid to strengthen the law governing ascertainability in consumer class actions outside the U.S. Court of Appeals for the Third Circuit. Most recently, in Mullins v. Direct Digital, LLC, the U.S. Court of Appeals for the Seventh Circuit expressly parted ways with the Third Circuit’s landmark 2013 decision inCarrera v. Bayer Corp., which had recognized a defendant’s due process right to challenge class membership at the class certification stage. The Seventh Circuit disagreed with what it described as a “heightened” ascertainability requirement that would serve as a death knell for consumer fraud class actions involving products of so little cost that no consumer would bother to keep a receipt. The Mullins decision highlights a deep circuit split on the parameters of the implied requirement of ascertainability, offering the Supreme Court a prime opportunity to weigh in on this important issue. While it remains to be seen whether the Supreme Court will take up theMullins case and resolve the divide, ascertainability will continue to make its way through the federal appellate courts. Notably, the U.S. Court of Appeals for the Ninth Circuit, which has previously strived to avoid the question, likely will be the next circuit court to offer its views on ascertainability in Jones v. ConAgra Foods Inc. A decision is expected in early 2016.
3. No Changes to Issues Certification Provision. After studying issues classes in 2015, the Rule 23 Subcommittee of the federal Judicial Conference Advisory Committee on Civil Rules recently decided against pursuing changes to the provision governing issues classes (Rule 23(c)(4)) that many believed would encourage more frequent use of that device. This is a positive development for defendants given that the subcommittee had considered a proposal under which class treatment of certain issues would have been permitted whenever there are any common questions capable of resolution on a classwide basis — even if the predominance requirement of Rule 23(b)(3) was not met as to other issues. Such a proposal would have effectively codified the trend by the Sixth and Seventh circuits of employing Rule 23(c)(4) as a means to facilitate class certification in cases where individualized issues would otherwise predominate. The subcommittee decision all but guarantees that issues classes will remain a hotly debated issue in 2016.
4. Multidistrict Litigation Abuses. Congress enacted the multidistrict litigation (MDL) statute years ago so that overlapping cases could be centralized before a single judge for coordinated pretrial proceedings, generating much-needed efficiencies for parties and courts. However, rather than use this mechanism to efficiently resolve cases and conserve resources, plaintiffs’ attorneys increasingly are using MDLs to warehouse meritless claims in the hope that the sheer number of cases will pressure defendants into settlements. One way to weed out baseless claims is by expanding the use of plaintiff fact sheets and Lone Pine orders that would require plaintiffs to satisfy a minimum evidentiary threshold at the outset of litigation, before the parties proceed to expensive and burdensome discovery. While fact sheets and Lone Pine orders have become increasingly popular in MDL proceedings, they often are imposed as requirements late in the litigation. With growing awareness that MDL proceedings are becoming magnets for meritless suits, in 2016, MDL courts may start using these tools earlier in litigation to maximize their value and impose serious sanctions for failure to comply with them, including the dismissal of cases.
5. Cy Pres. In 2015, plaintiffs continued to test the limits of cy pres, the practice of distributing class funds to third-party charities instead of the allegedly aggrieved class members. Federal appellate courts have continued to be somewhat skeptical of cy pres, including the Eighth Circuit, which recently vacated a district court’s order distributing residual funds to a third-party legal services organization after two rounds of direct distribution to class members. The Court of Appeals recognized that cy pres distributions “have been controversial in the courts of appeals,” but stated that district courts are “ignoring and resisting circuit cy pres concerns and rulings in class action cases.” Indeed, the practice is on the rise, as demonstrated by a comparison of the number of reported decisions approving/denying class settlements with cy pres components in 2009 and 2014. Thus, it is not surprising that the Rule 23 Subcommittee decided to look into the issue. However, after studying it throughout 2015, the subcommittee recently decided not to add a Rule 23 provision governing cy pres. As a result, the battle over cy pres — and whether it effectuates the interests of absent class members — will continue to play out in federal courts.
6. Third-Party Litigation Funding. Several noteworthy developments in the third-party litigation funding (TPLF) arena took place in 2015, including the announcement by Senate Judiciary Committee Chairman Chuck Grassley, R-Iowa, and Sen. John Cornyn, R-Texas, chairman of the Judiciary Committee’s Subcommittee on the Constitution, of an investigation into TPLF usage and practices. According to a press release Sen. Grassley issued on August 27, 2015, the two senators are “examining the impact third party litigation financing is having on civil litigation in the United States.” To that end, the senators sent letters to Burford Capital, Bentham IMF and Juridica Investments Ltd., three of the largest TPLF funders, requesting information regarding their TPLF activities in the United States. Another development over the past year has been TPLF’s expansion into the mass tort arena, as illustrated in a breach-of-contract complaint recently filed in Texas state court against the plaintiffs’ law firm AkinMears. The suit was brought by a former employee of the law firm, who was hired to secure third-party litigation funding for television ads and the direct purchase of transvaginal-mesh mass tort lawsuits from other plaintiffs’ lawyers. This lawsuit is worthy of close attention because it may provide new information about the ways in which TPLF is being used to fund and expand mass tort litigation.
Do gun manufacturers really have blanket immunity from lawsuits? No, not even close.
The 2016 campaign season has brought a big dose of gun policy debate, and some candidates have claimed that gun manufacturers have immunity from civil lawsuits. They are referring to a federal law known as the Protection of Lawful Commerce in Arms Act, or “PLCAA”. 15 U.S.C. §§ 7901 – 7903. Despite the statements by some political candidates, the PLCAA provides protection for firearms industry members for only a limited category of lawsuits. No blanket immunity can be found in the PLCAA.
In 2005, Congress enacted the PLCAA to bar lawsuits against firearms sellers and manufacturers for crimes committed with their products. At that time, certain lawsuits, some successful, had been brought against gun makers, theorizing that industry members should be held liable for the crimes of others, even where there was no proof that industry members had done anything other than manufacture or sell an otherwise lawful product.
No liability for someone else’s crime
The PLCAA is grounded in a legal principle that was developed long ago. Under basic personal injury law that exists in every state, a person ordinarily will not be held liable for the intentional criminal acts of another. Such liability as a general matter is rather rare, because American tort law does not often impose civil liability on one person when another person commits a crime. This rule is chiefly based on causation principles, which hold that someone’s intentional criminal conduct is the sole proximate cause of the injury that results from the crime. However, in the area of firearms, some courts varied from this general rule and allowed lawsuits to go forward against firearms sellers and manufacturers. In response, Congress enacted the PLCAA.
The provisions of the PLCAA are straightforward. The section barring liability, 15 U.S.C. § 7902, states plainly that “a qualified civil liability action may not be brought in any Federal or State court.” A “qualified civil liability action” is any civil action or administrative proceeding by any person brought against a seller or manufacturer of firearms or ammunition for any relief whatsoever when harm results from criminal or unlawful misuse of the products. 15 U.S.C. § 7903(5)(A). Thus, in the United States, firearms sellers and manufacturers generally are not liable when a criminal commits a crime using one of their products.
5 Ways to Hold Gun Manufacturers Liable
What the PLCAA does not do is insulate industry members entirely. Another section of the PLCAA contains a list of exceptions, which negate any protection offered by the PLCAA. These exceptions are:
When the transferor of a firearm or ammunition is convicted of knowingly transferring a gun or ammunition to a person who will use it in a crime. 15 U.S.C. § 7903(5)(A)(i).
When a seller negligently entrusts a gun or ammunition to someone, as was at issue in the Badger Guns case. 15 U.S.C. § 7903(5)(A)(ii). This is a crucial exception, because “straw purchases” that are not identified by sellers can subject sellers to liability.
When an industry member knowingly violates State or Federal law and the violation of law caused a person’s injury. 15 U.S.C. § 7903(5)(A)(iii).
When a buyer sues for breach of warranty, such as when the product does not operate as promised or as intended. 15 U.S.C. § 7903(5)(A)(iv).
These exceptions to PLCAA protection are crucial, and they show plainly that federal law does not provide blanket immunity to industry members. Instead, industry members must ensure that their sales efforts comply with the law, and, as with any product, industry members must ensure that their products work as intended and as promised.
In the midst of the political debate, industry members continue to face lawsuits by persons injured by guns or ammunition. For example, we discussed in an article one effort by plaintiffs’ lawyers to get around the PLCAA bar to lawsuits, even though no exception under the PLCAA applied. More recently, a gun seller in Wisconsin was held liable for injuries inflicted by a person who used a straw purchaser to buy a gun.
In light of these lawsuits and potential legal risk, industry members must understand the law and ensure that they remain within the protections provided by the PLCAA.
WASHINGTON, D.C. – In a highly-anticipated ruling, the U.S. Supreme Court ruled on Jan. 20 that a class-action defendant cannot avoid a class action suit by offering to pay damages to the individual named plaintiff who brings the case. Public Citizen attorney Scott Nelson served as co-counsel for plaintiffs in the case in the Supreme Court.
The decision in Campbell-Ewald Co. v. Gomez, will eliminate what has become a common defense tactic of using offers of small amounts of money to “pick off” class representatives to avoid facing much larger liability for misconduct aimed at a broad class of victims. The decision will help preserve class actions as a meaningful remedy for wrongdoing that inflicts small to moderate losses on large numbers of people.
The case arose when the Campbell-Ewald Co. sent text marketing messages to thousands of people without their advance consent, in violation of the Telephone Consumer Protection Act (TCPA). When California resident Jose Gomez, who had received a message, brought a class action, the company offered him $1,503 to settle the case, which it said was three dollars more than the maximum amount of money he could receive under the TCPA if he won. After he turned down that offer, the company claimed that the case was “moot” and had to be dismissed even though neither Gomez nor any member of the class had received any compensation for their claims.
Major victory for consumer class actions
The Supreme Court’s ruling today rejected Campbell-Ewald’s claim that it could avoid liability to an entire class just by offering a small sum to one member. The justices held that because a court could still grant Mr. Gomez relief, his claim was not moot, and he must be given a “fair opportunity” to pursue it on behalf of the class as a whole. Any other approach, the court said, “would place the defendant in the driver’s seat” by allowing it to control whether the class action could proceed.
“Today’s decision is a major victory for consumer class actions,” said Scott Nelson, an attorney with Public Citizen who was one of the attorneys representing Gomez in the Supreme Court. “Had the court accepted Campbell-Ewald’s arguments, it would have let defendants escape liability for wrongdoing by cutting off class actions at the knees without paying anyone anything. With this ruling, class plaintiffs have a fair chance to prove their claims in court.”
The case was argued for Gomez in the Supreme Court by Jonathan F. Mitchell, former solicitor general of the state of Texas. Other attorneys for Gomez included Myles McGuire and Evan Meyers of Chicago’s McGuire Law, P.C.; Michael McMorrow of McMorrow Law, P.C., also from Chicago; and David Parisi and Suzanne Havens Beckman of Santa Monica’s Parisi & Havens LLP.
Two lawsuits were filed within days of each other in Oklahoma, claiming that energy companies engaged in hydraulic fracturing and underground disposal of produced water are causing earthquakes throughout the state. These lawsuits probably come as no surprise to the industry after the Sierra Club recently threatened to sue four oil companies for contributing to increased earthquakes in Oklahoma and southern Kansas.
A pair of Oklahoma residents, in a class-action lawsuit, have accused four energy companies of causing “a dramatic increase” in earthquakes throughout the state during the last five years. The lawsuit names Sandridge Exploration and Production, Chesapeake Operating, Devon Energy Production Company, and New Dominion as the defendants.
Causing earthquakes statewide
The plaintiffs claim that hydraulic fracturing and underground disposal of produced water are causing earthquakes across the state by increasing the pore pressure within faults making the fault more prone to slip.
The lawsuit alleges that the companies are liable to the plaintiffs and the class for nuisance, trespass, negligence, and engaging in an ultra-hazardous activity. The plaintiffs are seeking not only compensatory damages, but also punitive damages and attorneys’ fees.
The class-action suit comes at the same time another lawsuit was filed in Oklahoma against twelve energy companies for allegedly causing two earthquakes, which struck on December 29, 2015 and January 1, 2016. In this lawsuit, the plaintiffs argue that the companies “injected large volumes of drilling waste in disposal wells located near the cities of Edmond and Oklahoma City, in the vicinity of the plaintiffs’ properties, under conditions that defendants knew or should have known would result in an increased likelihood that earthquakes or other adverse environmental impacts would occur, thereby unreasonably endangering the health, safety and welfare of persons and property, including plaintiffs and others.
These lawsuits seem to be the latest in a barrage of attacks on the energy industry despite an Oklahoma Geological Survey study that concluded it was “impossible to say with a high degree of certainty whether or not these earthquakes were triggered by natural means or by the nearby hydraulic-fracturing operation.”
The FDA is warning consumers not to use Licorice Coughing Liquid, a cough syrup product sold over-the-counter, because it contains unidentified morphine. The cough syrup’s labeling contains information written in English and Chinese. The product labeling does not identify the presence of morphine in English. With unidentified morphine, consumers who are hypersensitive to morphine could suffer severe allergic reactions if they take this product. Other effects of morphine can include, but are not limited to, respiratory depression and death.
This product is manufactured by Ma Ying Long Pharmaceutical Group in China and distributed in the U.S. by Master Herbs USA, Inc. in Pomona, CA. The distributor has agreed to recall the product. This product is available on-line and in some retail stores.
Consumers should not purchase this cough syrup and anyone who has this product should not use it.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:
HOUSTON — A West Virginia woman with mesh-related health problems has accused a leading U.S. medical company of running an international conspiracy that sold defective vaginal surgical mesh, made of counterfeit supplies it smuggled from China.
The Mostyn Law, a Houston-based firm headed by attorneys Amber and Steve Mostyn, sued Boston Scientific Corp. and three other companies under the Racketeering and Corrupt Organizations Act (RICO) on behalf of women who have suffered severe discomfort, bleeding, infections, painful intercourse, urinary problems and other complications from the plastic mesh implants.
The lead plaintiff is Teresa Stevens, a 46-year-old grandmother from Lincoln County, West Virginia, who had a mesh implant procedure in October 2014. Since then, she has suffered pain, bladder infections and other complications.
The class-action lawsuit says that after losing its U.S. supplier of the synthetic resin to produce the mesh, Boston Scientific bought unverified, substandard material from a known counterfeiter in China. The company took extraordinary measures to avoid being caught by U.S. and Chinese authorities, at times acting like a drug dealer to hide multiple overseas shipments, the suit says.
The U.S. Justice Department typically uses the RICO statute and penalties to target criminal organizations, but private citizens can seek to apply it in certain civil cases. The suit asks the U.S. District Court in Charleston to prohibit Boston Scientific immediately from selling any medical devices containing the harmful material.
The RICO lawsuit is ground-breaking — the first to accuse Massachusetts-based Boston Scientific of engaging in an international conspiracy to import tainted plastic resin for the mesh. It names a Chinese company that allegedly sold the inferior stock and participated in the smuggling operation and two other companies.
“We have asked for the court to shut down sales from this company and to protect women from the pain and suffering that can result from this dangerous product,” said attorney Amber Mostyn. She said Boston Scientific put profits ahead of health concerns, calling the company’s disrespect for women “disgusting and appalling.”
Transvaginal surgical mesh is a polypropylene-based product, used along with surgical stitches, to shore up sagging pelvic organs, such as the bladder, uterus and bowels, and to treat incontinence. Women have complained about the embedded mesh eroding through the stitched tissue and requiring painful removal surgeries.
The procedure—now considered a high-risk procedure by the Food and Drug Administration—has resulted in more than 70,000 lawsuits, including 15,000 against Boston Scientific. It makes $120 million in revenue from the mesh products.
The new federal suit provides a clearest picture yet of the scramble by Boston Scientific after Chevron Phillips Chemical Co. in 2005 stopped selling its polypropylene resin for surgical mesh. The chemical company said it should not be used in medical devices “involving permanent implantation in the human body or permanent contact with internal body fluids or tissues.”
Boston Scientific ignored those explicit warnings and began a global hunt to find another source for the resin pellets, known as Marlex, important because that was the only product the FDA had approved for making that company’s implants.
Smuggling from China
But with no U.S. supplier, Boston Scientific concocted a scheme in 2011 and 2012 to smuggle from China 34,000 pounds of the material, without verifying or fully testing all the contents, the suit says.
It came from EMAI Plastic Raw Materials Inc., a “known counterfeiter of plastic products” in Guangzhou, China, the suit says. That company offered what it said was Marlex from Phillips that it had in storage but provided no records documenting that. Phillips later said the lot number shown on one of the EMAI supply bags was bogus.
Despite knowing that, the suit says, Boston Scientific bought the resin and orchestrated secretive plans to smuggle it out of China.
Like a “drug deal,” the suit says, Boston Scientific discussed bribing Chinese officials to help get the material out. Later, it decided to divide the bulk of the product into more than 500 bags, sending them by three ocean shipments on three different dates, after being warned that the bigger the load the greater the risk of inspection by Customs agents.
The company told Chinese authorities the product was made there, meaning it didn’t need certain paperwork for export. The company then switched its story, getting it into the U.S. by claiming the material was authentic Phillips Marlex.
A conflict with FDA requirements
“Boston Scientific knowingly sold a product that put women’s health and their lives at risk. It conspired with questionable suppliers in China to get material that it couldn’t get in the U.S. and went to great lengths to hide it,” Amber Mostyn said.
Tests showed significant differences between the Chinese resin and certified Phillips Marlex. Still, Boston Scientific went ahead and ordered production, a conflict with FDA requirements that device manufacturers reapply for clearance when any material is changed in a permanent implant device.
Boston Science failed to reapply, the suit says, and instead it “deceptively promoted, marketed, packaged, labeled, sold and distributed this mesh as being manufactured with authentic Marlex and approved by the FDA.”
The suit seeks unspecified damages for the thousands of women who received a Boston Scientific transvaginal mesh product after September 2012, as many as 55,000 each year.
The suit comes the same month that the FDA announced tighter regulations for surgical mesh products. They were reclassified as high-risk rather than moderate-risk medical devices when used in procedures that go through the vagina to repair organ prolapse, which can occur with age and after childbirth.
In the latest transvaginal mesh lawsuit news, plaintiff Patricia Hammons was recently awarded $12.5 million by a jury in Philadelphia. She suffered serious injuries from Ethicon’s Prolift mesh implant.
According to Surgical Watch, Hammons received the Ethicon Prolift mesh device in 2009 due to suffering from bladder prolapse, however, she alleged that the product actually injured her more than it helped her, claiming “the faulty product design caused scar tissue to develop” and “the vaginal mesh eroded into her bladder.”
The erosion caused not only severe pain, but she also had to undergo multiple corrective surgeries which have resulted in permanent injuries. The Philadelphiajury awarded her $5.5 million in compensatory damages and $7 million in punitive damages, as they found the mesh manufacturer liable for “gross negligence and reckless disregard for the safety of consumers for its Prolift vaginal mesh product.”
Johnson & Johnson’s Ethicon subsidiary will try to appeal the verdict, however, the manufacturer still faces thousands of claims. More than 30,000 plaintiffs have filed lawsuits against Ethicon with similar claims, most of which have been consolidated under multidistrict litigation in the Southern District of West Virginia under U.S. District Judge Joseph Goodwin (MDL 2327 in West Virginia).
Ethicon is not the only mesh manufacturer to have thousands of claims against them; other manufacturers include: Boston Scientific, C.R. Bard, and American Medical Systems. Johnson & Johnson, however, in comparison to the other mesh manufacturers, have yet to really attempt to resolve the lawsuits, whereas the other mesh manufacturers have attempted to settle or have settled many of the cases filed against them. A few hundred cases against Ethicon are likely to be prepared for trial throughout 2016. Visit Lawsuit Settlement News for more information on TVM lawsuits.
We are pleased that such a substantial verdict award was reached for one of the many women plaintiffs who have suffered as a result of a transvaginal mesh implant. However, Ethicon continues to fight each case one at a time and this is concerning as the number of cases continues to grow, whereas the other mesh makers have begun the settlement process in earnest. We urge any women who have had revision surgery or will need one to speak with an attorney immediately, as the time to file a claim will be ending shortly in many instances.
MT Services LLC provides up-to-date lawsuit news on transvaginal mesh litigations, as well as various services to assist victims with getting the help they need during this difficult time. These services include: lawsuit pre-settlement funding cash advances, corrective or revision surgery procedure funding (or cash needs related to your surgery), and assistance with obtaining an attorney from a nationally recognized transvaginal mesh law firm (lawsuit funding or surgical funding products should not be considered to be a lawsuit loan, lawsuit loans, settlement loans, pre-settlement loans, or lawsuit settlement loans).
MT Services LLC is not a law firm and cannot provide legal advice on your case; however, MTS works with lawyers involved in mass tort litigations who are willing to provide a free legal consultation at the consumer’s request.
The FDA issued a safety watch and recall for the Pleural and Pneumopericardial Drainage Sets by Stryker Fuhrman because the the catheter included in the Drainage Set has broken off in the lung while inserting the device into the patient. The devices are used in emergency medicine, pulmonology and cardiology
The recall involves the Fuhrman Pleural and Pneumopericardial Drainage Set, which is used to drain air or fluid from the pericardium (sac around the heart) or the pleural cavity (thin covering that protects the lungs) while inserting the device into the patient.
Stryker Sustainability Solutions received two reports that the catheter broke off in the pleural cavity. Both cases resulted in the need for medical intervention. This issue could cause serious patient injury or death.
Stryker sent customer notification letters on November 17, 2015. The letter indicated that customers should:
Discontinue use of the product
Complete the Recall Effectiveness Check Form even if no product has been found in inventory
Return the form to their local Stryker Sustainability Sales Representative via email at email@example.com or mail to: Stryker Sustainability Solutions, 1810 West Drake Drive Tempe, AZ 85283 Attn: Jodie Rueckert
If the firm indicates that affected devices remain in inventory, a prepaid shipping label will be issued for the return of the product.
Customers will receive credit for all affected devices returned.
Customers with questions should contact the Stryker Sustainability Solutions Complaint Hotline: (888) 888-3433 x5555.
At this time, there are Wright defective hip cases pending in the federal court MDL proceedings in Georgia and 700 cases pending in the California state court consolidated proceedings. There are also more than 800 individual cases pending on a tolling agreement with Wright Medical, which is a contract that suspends the statute of limitations period for a case so as to avoid the necessity of filing suit.
On November 24, 2015, a jury in federal court in Atlanta awarded $11 million to plaintiff Robyn Christiansen, who was the first patient to proceed to trial against Wright Medical in the national, coordinated MDL proceedings. This case was chosen by the plaintiffs for the first MDL trial from the ten cases that were part of the original bellwether trial pool and had completed case-specific discovery and failed settlement conferences more than a year ago. The case was originally scheduled for trial in March 2015, but was delayed for a few months to permit Judge Duffey to rule on various legal motions that had been filed by Wright Medical.
Hip fails after 6 years
Christiansen is 74 years old and resides in Utah. She has been a ski instructor for 47 years, and leads an extremely active lifestyle that includes lots of skiing and mountain hiking. She underwent a right hip implant surgery in April 2006 and was implanted at that time with a Wright Medical Conserve Total Hip Device, a metal-on-metal hip implant. Her implanting surgeon was Dr. Lynn Rasmussen, who is based in Salt Lake City and had been a consultant and Key Opinion Leader for Wright Medical. This metal-on-metal hip implant failed approximately six years following implantation, and she underwent a revision surgery in 2012.
At that time, her orthopedic surgeon noted the presence of abnormal fluid, tissue necrosis, inflammatory synovium, and evidence of metallosis, which required the removal of additional soft tissue in addition to revision of the defective Wright Medical Conserve MOM hip implant prosthesis. She also had elevated levels of cobalt and chromium in her bloodstream and other signs and symptoms consistent with metallosis. Christiansen has reportedly had a decent recovery from the revision surgery.
She had previously been implanted with a total hip implant on her left side following a water skiing accident in 1984 and underwent a revision surgery for that hip in 1995. The implant placed in 1995 was a ceramic-on-polyethylene design and is still performing well. She had also underwent two total knee replacements, back surgery, and surgery on both of her wrists.
During the course of the trial, Wright Medical’s attorneys claimed that her surgeon did not implant the hip implant as precisely as he should have, and that this malposition of the implant, coupled with her overuse of the device due to her active lifestyle, led to the metallosis and the need for the revision surgery. The plaintiff’s revision surgeon and experts testified that the device was not improperly positioned and that the device was defective.
Evidence of fraud not admissible
In this particular case, the Plaintiff had not read any of Wright Medical’s advertising materials prior to the original implantation surgery, so a lot of good evidence that has been developed in the national litigation with regard to alleged fraud and misrepresentations to surgeons and patients was not admissible at trial.
At the trial, the plaintiff presented testimony from:
The treating orthopedic surgeon
A friend of the Plaintiff who was a fellow ski instructor
Dr. John Waldrop (an orthopedic surgery expert)
Dr. John Jarrell (a biomechanical expert)
Dr. Elizabeth Laposata (a pathologist)
Dr. Jason Snibbe (another orthopedic surgeon expert).
The Plaintiff also presented testimony from Wright Medical’s head of research and development as well as Wright’s former Head of Clinical, Marketing and Post-Market Surveillance. The Defendant presented testimony from several of its employees as well as a few experts in the fields of tribology, biomaterials, and orthopedic surgery.
The jury trial on Plaintiff’s claims for strict products liability, negligence, fraudulent misrepresentation, negligent misrepresentation, and fraudulent concealment lasted for two weeks in federal court in Georgia. The Plaintiff claimed that Wright Medical knew or should have known long before Ms. Christiansen was first implanted that their devices, over time, would generate metal debris and metal ions which presented a substantial risk to patients of developing metallosis, inflammatory tissue reactions, non-infectious (or aseptic) loosening of the hip implant, tissue death, and premature failure of the device necessitating revision surgery.
Surgeons fail to fully understand risks
Some of the Plaintiff’s strongest evidence in this case focused on Wright Medical’s marketing campaign to “de-criminalize” metal ions in patients which led to surgeons and patients failing to fully understand and appreciate the risks presented by metallic debris and metal ions that are cast off of the metal-on-metal hip implants over time. Obviously, if this critical safety information had been shared with surgeons and patients, many would have chosen to undergo implantation of hip implants that did not include a metal-on-metal articulating surface, such as the older metal-on-polyethylene and ceramic-on-polyethylene hip implant configurations that have a long history of safe implantation in patients.
After several days of difficult deliberations (including the dismissal of one juror who refused to engage in the deliberation process), the jury awarded compensatory damages in the amount of $550,000 for the design defect claim, $450,000 for negligent misrepresentation, and $10 million in punitive damages.
Compensatory damages are awarded to compensate the Plaintiff for pain and suffering, inconvenience, disability, disfigurement, lost wages, medical expenses, and other damages personal to the patient. Punitive damages, on the other hand, are awarded to punish the Defendant when the jury has found that they have acted with a willful and wantonness towards the safety of the Plaintiff and other patients, essentially meeting the same level of recklessness as is required for a conviction for criminal manslaughter.
In the coming weeks, the MDL judge will be asked to consider a number of post-trial motions. It is anticipated that Wright Medical will appeal this verdict, which would first go to the Eleventh Circuit Court of Appeals and then, perhaps, to the United States Supreme Court. No money will be paid to Ms. Christiansen until all of the appeals are resolved. We anticipate that Judge Duffey will likely schedule the next trial in the MDL proceedings in the near future, and that case will be one that was already prepared for trial as a part of the initial ten-case bellwether trial pool.
Next trial in March in LA
Elsewhere in the national litigation, the parties are preparing for a jury trial against Wright Medical, which is scheduled to begin in March of 2016 in Los Angeles. This individual trial involves the claims of Barbara Trucker, and will be the first bellwether trial in the Wright Medical state court proceedings, which have been pending in the California consolidated action (known as the “JCCP”) for several years. The JCCP cases are coordinated with the lawsuits that are pending in the federal MDL based in Georgia, but the JCCP action involves a larger number of Wright Medical metal-on-metal hip implant products than those hip implant designs covered by the federal MDL.
This next trial in Los Angeles should include different evidence than was admitted in the recently-completed federal court MDL trial, as Ms. Tucker was provided with Wright Medical marketing materials relating to Jimmy Connors. The accuracy of the representations made in the Jimmy Connors advertising campaign will certainly be the focus of this upcoming trial. Depositions and other trial preparation are currently underway, and we anticipate that the judge will be considering a number of legal motions and requests to limit evidence in the coming weeks. There is a second trial, which was selected by the Defendant, which is currently being worked up for trial as well. That jury trial is likely to begin in September of 2016 in state court in California.
Unfortunately, we are still facing a tremendous problem in the national litigation with a lack of sufficient liability insurance coverage. There is ongoing litigation over the amount of coverage that is available. These issues have been further complicated by Wright Medical’s sale of its hip division to a Chinese manufacturer and merger with a Belgian company. These new companies are not responsible for Wright Medical’s products prior to the asset sales and mergers. One of the practical problems is that many of the employees of Wright Medical who were involved in the design and marketing of the metal-on-metal hip implant products now work for the Chinese company or have moved on to other employers.
As indicated in previous letters, the verdict plus all of the costs associated with the defense of the Wright Medical cases are depleting the insurance coverage that is available. Previous settlement discussions in conjunction with the preparation for the first MDL trial were unsuccessful, even with the involvement of a retired judge serving as a mediator, primarily due to the pending insurance coverage dispute.