Medtronic Uses Preemption in Medtronic Infuse Case, Again

The denial of review by the United States Supreme Court today in the case of Caplinger v. Medtronic, Inc., Docket No. 15-321, though it might appear to be a victory for medical device manufacturer, Medtronic, Inc., it was not. While a shallow analysis of the Supreme Court’s action in denying certiorari made it seem as if Medtronic had finally succeeded in preventing the litigation of hundreds of cases across the country claiming serious injuries due to its Infuse® Bone Graft Device, that was not the case at all. 

Medtronic argued in the Caplinger case that federal law and the Supreme Court’s prior decisions in cases such as Riegel v. Medtronic, Inc., 552 U.S. 312 (2008) and Buckman Co. v. Plaintiffs’ Legal Committee, 532 U.S. 341 (2001) barred any private right of action against manufacturers of such devices; that they prohibited states from protecting their citizens under the doctrine of “preemption.” But an examination of the Caplinger case reveals that the only issue actually before the Supreme Court was limited to how victims pleaded their cases, rather than the merits of their claims. As the United States Court of Appeals for the Tenth Circuit said (whose opinion was subject to the potential review by the Supreme Court), nothing the Supreme Court has said in the past regarding this area of the law has been especially clear. “How,” asked the Court of Appeals, “are we supposed to apply all these competing instructions [from the Supreme Court]? It’s ‘no easy task.’” Caplinger v. Medtronic, Inc., 784 F.3d 1335, 1340 (10th Cir. 2015).  The Tenth Circuit then limited its ruling in Caplinger, held that preemption would only apply where a plaintiff failed to adequately plead state causes of action which paralleled federal statutory or regulatory violations, something which the plaintiff in Caplinger had failed to do [“It’s where the problems begin,” said the Tenth Circuit.  784 F.3d at 1340.]

What was left undecided by the Tenth Circuit, and thus never presented to the Supreme Court was, what happens when an individual injured by the Medtronic Bone Graft Device does plead his case properly, making an appropriate claim that there were no federal requirements covering the device as used or that state law only parallels existing federal law, rather than preempting it? The answer to that question had come earlier in a Ninth Circuit matter, Stengel v. Medtronic, Inc., 704 F.3d 1224 (9th Cir. 2013). In Stengel, the Ninth Circuit Court of Appeals, in an unusual en banc proceeding where not just three, but all the judges of the Circuit participated, upheld the amended complaint of a plaintiff against a Medtronic medical device because it did properly plead a state-law duty that paralleled a federal-law duty. The Supreme Court had said that such pleading would be sufficient to avoid preemption. In upholding such a pleading, the Ninth Circuit noted that it joined both the Fifth and Seventh Circuits which had reached the same conclusion. 704 F.3d at 1223. The Supreme Court then refused Medtronic’s request to have it review the Stengel case. Significantly, though, before denying Medtronic that review of Stengel, the Court invited the Solicitor General of the United States to “express the views of the United States.” Medtronic, Inc. v. Stengel, 134 S.Ct. 375 (2013). The Solicitor General urged the Supreme Court to deny any review of the Stengel opinion rejecting preemption (http://www.justice.gov/sites/default/files/osg/briefs/2013/01/01/2012-1351.pet.ami.inv.pdf) and the Court did just that in June 2014. 134 S.Ct. 2839 (2014)

With the Stengel decision firmly in hand, the Supreme Court’s denial of review in Caplinger has limited effect, pertaining only to those cases which have been pleaded incorrectly.  All other cases against Medtronic, whose complaints resemble those in Stengel, will continue unabated.

from Parker Waichman http://www.yourlawyer.com/blog/medtronic-uses-preemption-in-medtronic-infuse-case-again/

FDA Deems Customed, Inc., Convenience Pack Recall a Class I

The U.S. Food and Drug Administration (FDA) has warned health care providers against using Customed, Inc., Surgical Packs and Convenience trays due to their lack of proof of adequate testing. These packs contain items such as instruments, absorbent towels, exam gloves, suture bags, surgical table covers, and drapes. When used in surgery, these items must be germ-free and sterile, in order to protect patients from infection. A voluntary recall was initiated by Customed, Inc. and has been deemed a Class I by the FDA.

The criteria and safety features that must be completed to pass inspection are: Sterility of products; endotoxin, a toxin that is released upon destruction of bacterial cells during sterilization; and ethylene oxide that must be within safety limits. Packaging must be able to withstand stresses during transport; expiration dates must be adhered to.

In 2014, the plastic packaging of one unit stuck to adjacent units during the sterilization process, allowing possible microorganisms to enter and contaminating the contents during separation of the package. The FDA alerted Customed, Inc.in a letter sent on December 9, 2014 citing deficiencies found during inspection.

In November 2014, Customed, Inc., resumed manufacturing without informing the FDA despite the Class 1 recall issued in October of the same year. A Class I recall is deemed by the FDA when a situation involves reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death. Customed, Inc.’s actions potentially posed a lack of package integrity, as well as a lack product sterility. In early 2015, the FDA became aware that the required corrections had not been made and that Customed, Inc. had continued to manufacture its product, despite the serious potential adverse health risks.

The Puerto Rico Hospital Supply company was cited as one firm that was distributing the potentially unsafe product in Puerto Rico during the time of the recall.

from Parker Waichman http://www.yourlawyer.com/blog/fda-deems-customed-inc-convenience-pack-recall-a-class-i/

New FDA Regulations Would Bar Tanning Bed Use for Anyone Under 18

To reduce skin cancer risks in younger people, the Food and Drug Administration (FDA) has proposed a ban on the use of tanning beds by anyone under 18. Health experts call this a major step toward reducing the risk of skin cancer.

Indoor tanning has not been seen as a significant factor in skin cancer rates, but recent evidence indicates that tanning beds play a greater role in cancer risk than previously thought, the New York Times reports. Research published in the last year estimates that tanning beds account for up to 400,000 cases of skin cancer annually, including 6,000 cases of melanoma, which is the deadliest form of the disease.

The FDA’s proposed regulations—which will be open for public comment for 90 days—also contain provisions to require tanning bed manufacturers to make warning labels more prominent and easier to read and to have an emergency shut-off switch on the tanning bed. The regulations would require indoor tanning facilities to ensure that people using tanning beds use protective eyewear during tanning sessions.

Rates for many types of cancer have been on the decline, but melanoma rates have continued to rise about 3 percent a year in the last twenty years, the Times reports. The incidence rate of melanoma in women under 40 has risen by about a third since the early 1990s, according to data from the National Cancer Institute. Health experts are concerned that tanning beds, which are especially popular among young women, are a significant contributor to the rise.

Some states have already imposed their own bans on indoor tanning for minors, but tanning beds are still widely available to minors in most states, according to the Times. The FDA gives an estimate of 18,000 to 19,000 tanning salons nationwide; tanning beds also available in gyms, spas, hotels, and on college campuses. In Florida, there are more tanning salons than McDonald’s restaurants, CVS stores, or Bank of America branches, University of Miami researchers found.

Dr. Jeffrey E. Gershenwald, a professor of surgery and medical director of the Melanoma and Skin Center at the University of Texas M.D. Anderson Cancer Center, described the proposed restriction as “a tremendous advance.” FDA spokesman Eric Pahon said the agency would enforce the ban through state authorities. Among the enforcement measures the FDA might employ are seizure of tanning beds, civil penalties and fines, or criminal prosecution.

Health experts say the FDA proposal is needed because young people are at greatest risk for serious consequences from indoor tanning. According to the Times, indoor tanning increases the overall risk of melanoma by 20 percent, but the risk increases by 59 percent for anyone who uses a tanning bed at all before age 35. According to a 2013 federal youth health survey, about 1.6 million minors use indoor tanning facilities every year. Government data also shows that those who turn to tanning beds tend to use them frequently. Data on tanning among high school students has been collected only since 2009, but it shows that more than half of those who used tanning beds had used them 10 or more times in the past year.

 

 

 

from Parker Waichman http://www.yourlawyer.com/blog/new-fda-regulations-would-bar-tanning-bed-use-for-anyone-under-18/

Child’s Death Prompts Lawsuit Against Ikea over Unstable Dresser

Parents of a Washington state toddler fatally injured by an Ikea dresser that tipped over on him  have filed a lawsuit against the Swedish furniture retailer.

The suit, filed in the Philadelphia Common Pleas Court, claims Ikea sold the dresser despite knowing it was unstable, Philly.com reports. This is the second lawsuit in a year over a fatal tip-over of an Ikea Malm dresser. A similar suit was filed by the mother of a Pennsylvania two-year-old, who died in February 2014 when a dresser fell over on him.

In July 2015, Ikea and the Consumer Product Safety Commission (CPSC) jointly announced a “repair program” involving 27 million Ikea dressers. The company said the dressers could be unstable if not anchored to the wall, and the company offered purchasers a restraint kit so they could secure the dresser to the wall.

Though a repair program of this type is considered a recall under CPSC regulations, Ikea has avoided using the word recall in its communications. The company stresses that it has not offered to buy back or replace the dressers, according to Philly.com.

Legal documents indicate that the Washington state boy was pinned under a three-drawer Malm dresser on June 11, 2014. The child’s father found him and lifted the dresser off the boy and the mother performed CPR until the ambulance arrived, according to Philly.com. The boy was hospitalized on a ventilator for four days before his parents removed him from life support and he died.

The lawsuit accuses Ikea of designing and selling dressers that do not meet the furniture industry’s safety standard for stability. A lawyer who represents the families of both children who died said Malm dressers are inherently unstable and Ikea has placed the burden for making them safe on consumers. The company has “got it backwards,” he said.

The parents seek unspecified compensatory and punitive damages, including compensation for medical expenses, funeral expenses, the child’s pain and suffering, and the family’s emotional distress.

Swedish furniture retailer Ikea has U.S. headquarters in Conshohocken, Pennsylvania. The company would not comment on the latest lawsuit, citing a policy against discussing ongoing litigation. But in a statement Ikea said, “We continue to work cooperatively with the CPSC on the important issue of tip-over safety,” according to Philly.com.

The CPSC says furniture tip-overs are responsible for more than 38,000 emergency-room visits in the United States annually. A child dies every two weeks in a tip-over accident, the agency says. Tip-over incidents most often involve unsecured dressers and televisions. Two thirds of the injuries happen to children under five.

from Parker Waichman http://www.yourlawyer.com/blog/childs-death-prompts-lawsuit-against-ikea-over-unstable-dresser/

Second Lawsuit Filed in Death of a Child Trapped under Ikea Dresser

In the second such lawsuit in less than a year, Washington state parents have filed a wrongful death lawsuit against Swedish furniture retailer Ikea. Their toddler son died after being pinned under a toppled Ikea dresser.

The suit, filed in the Philadelphia Common Pleas Court, claims Ikea sold the dresser despite knowing it was unstable, Philly.com reports. This is the second lawsuit over a fatal tip over of an Ikea Malm dresser. A similar suit was filed by the mother of a Pennsylvania two-year-old, who died in February 2014 when a dresser fell over on him.

In July 2015, Ikea and the Consumer Product Safety Commission (CPSC) jointly announced a “repair program” involving 27 million Ikea dressers. The company said the dressers could be unstable if not secured to the wall, and offered purchasers a restraint kit so they could anchor the dresser to the wall.

Under CPSC regulations, a repair program of this type is considered a recall, though Ikea has avoided using the word recall in its communications. The company stresses that it has not offered to buy back or replace the units, Philly.com reports.

According to the lawsuit, the Washington state boy was pinned under a three-drawer Malm dresser on June 11, 2014. The child’s father found him and lifted the dresser off the boy. The mother performed CPR until the ambulance arrived, according to Philly.com. The boy was hospitalized on a ventilator for four days before his parents removed him from life support,

The parents seeks unspecified compensatory and punitive damages, including compensation medical expenses, funeral expenses, the child’s pain and suffering, and the family’s emotional distress.

The lawsuit accuses Ikea of designing and selling dressers that do not meet the furniture industry’s safety standard for stability. A lawyer representing the families of both children who died said Malm dressers are inherently unstable and Ikea has placed the burden for making them safe on consumers. The company has “got it backwards,” he said.

Ikea, the Swedish giant furniture retailer with U.S. headquarters in Conshohocken, Pennsylvania, would not comment on the latest lawsuit, citing a policy against discussing ongoing litigation. But the company said in a statement, “We continue to work cooperatively with the CPSC on the important issue of tip-over safety,” according to Philly.com.

The CPSC says furniture tip-overs are responsible for more than 38,000 emergency-room visits in the United States annually. A child dies every two weeks in a tip-over accident, the agency says, and tip-over incidents most often involve unsecured dressers and televisions. Two thirds of the injuries happen to children under five.

 

from Parker Waichman http://www.yourlawyer.com/blog/second-lawsuit-filed-in-death-of-a-child-trapped-under-ikea-dresser/

Nice! Mandarin Oranges in Bottles Recalled Due to Risk of Glass

Milky Way International Trading Corp. has voluntarily recalled Nice! Mandarin Oranges in 8-ounce bottles, sold at Walgreens stores nationwide. According to a company press release posted on the U.S. Food and Drug Administration’s (FDA’s) website, the product was recalled because it may contain glass, posing a risk of injury if ingested.

“Milky Way International Trading Corp. today announced the recall of Nice! Mandarin Oranges in 8-ounce bottles due to potential glass in the product. The affected product was distributed to Walgreens stores nationwide and displays one of the lot numbers listed below. Consumers could potentially be cut or injured if ingested.” the release states.

There have been three complaints related to this issue so far, with one reported injury, the release states. The recall applies to specific lot numbers: H894K09A, 4200/01039 and 4200/01039. Lot codes can be found on the lid or neck of the bottles. Walgreens has removed the product from its shelves.

from Parker Waichman http://www.yourlawyer.com/blog/nice-mandarin-oranges-in-bottles-recalled-due-to-risk-of-glass/

Lawsuits Mount over Cancer Risks Associated with Power Morcellators

New lawsuits continue to be filed against the manufacturers of the power morcellator, a surgical tool used in fibroid surgeries and hysterectomies that is alleged to spread undetected cancers.

In October 2015, the U.S. Judicial Panel on Multidistrict Litigation transferred more than 20 power morcellator lawsuits into a federal multidistrict litigation (MDL). More than 30 cases were centralized for pretrial proceedings. The lawsuits have been filed primarily against Johnson & Johnson’s Ethicon division. Plaintiffs in these cases allege that the morcellator caused serious complications, including the spread of cancerous tissue.

In one of the cases, the plaintiff alleges that the morcellator used in her surgery exposed and spread previously undetected cancer cells beyond her uterine walls. She needed the surgery to treat painful uterine fibroids. The morcellator procedure was chosen as a less invasive technique than open surgery. After the surgery, the woman was unexpectedly diagnosed with widespread and aggressive cancer.

The laparoscopic power morcellator is inserted through the lower abdomen via a small incision. Rapidly spinning blades cut uterine or fibroid tissue into tiny pieces that can be removed from the body through the incision. But if the uterine tissue contains cancerous cells—which are virtually impossible to detect prior to surgery—the procedure can spread the cancer throughout the abdomen, where it rapidly becomes more aggressive and sharply reduces the woman’s long-term survival chances.

In 2015, twelve members of Congress asked the U.S. Government Accountability Office (GAO) to investigate why the power morcellator was on the market for two decades before the Food and Drug Administration (FDA) issued a warning about the device’s potential to spread uterine cancer. The GAO investigation increases scrutiny into how the FDA has handled issues with power morcellators, some of which date back to 1991, when the device first received clearance for use in the U.S. The FDA now says evidence indicates a far higher risk of hidden uterine sarcomas than many gynecologists previously believed.

While defending the regulatory process used to approve the power morcellator, the FDA has said it is strengthening its surveillance of devices on the market. Johnson and Johnson, the largest manufacturer of morcellators, voluntarily pulled its morcellators from the market, according to the Wall Street Journal.

In November 2014, the FDA amended an earlier morcellator advisory by ordering a black box warning for the device. The black box is the agency’s strongest warning. Despite calls for a complete ban, the power morcellator remains on the market, although many hospitals have restricted its use to carefully screened patients at low risk for uterine sarcomas. A number of health insurers have decided they will no longer cover routine use of the morcellator in fibroid surgery and hysterectomies.

from Parker Waichman http://www.yourlawyer.com/blog/lawsuits-mount-over-cancer-risks-associated-with-power-morcellators/