Philips Subpoenaed By DOJ Over Sleep Apnea Device Recall

 Royal Philips NV has been subpoenaed by the U.S. Department of Justice related to the recall of defective sleep apnea machines and respirators — a recall that’s led to more than 100 lawsuits and multidistrict litigation — the company announced in a U.S. Securities and Exchange Commission.

The company said that Philips Respironics, which manufactured the faulty devices, and several of its U.S. subsidiaries received the subpoena on April 8. They were asked “to provide information related to events leading to the Respironics recall,” Philips said in the filing. “The relevant subsidiaries are cooperating with the agency.”

Philips had come under fire in more than 100 cases filed across the country following a recall of the company’s CPAP, Bi-Level PAP and mechanical ventilator devices containing polyester-based polyurethane sound abatement foam, or PE-PUR foam. According to the June recall, that foam can degrade, releasing bits of foam or chemicals into the machines where patients can inhale them.

The Judicial Panel on Multidistrict Litigation sent the cases to an MDL in the Western District of Pennsylvania, where Philips RS North America LLC — formerly Philips Respironics — had a factory that had manufactured most of the recalled machines.

In November, Philips said that preserving evidence for the MDL was preventing the company from taking back and repairing thousands of defective sleep apnea machines.

Philips objected to a pretrial order barring any “tangible things” that could be evidence in the MDL from being “destroyed” or “altered.”

Respironics had gotten back about 335,000 recalled devices as of when it made the emergency request, and had fixed and sent back about 115,000, Philips said. The Nov. 10 order put a halt on repairs, which would put the company about 56,500 devices behind by the time the parties were scheduled to meet again in mid-December.


Sprout Beats Parents’ Baby Food Heavy Metal Suit In NJ

A New Jersey federal judge tossed a putative class action alleging Sprout Food Inc. falsely advertised its baby food products as “healthy” and “organic” despite containing allegedly unsafe levels of toxic metals, finding that the alleged harm is “simply speculation” and the consumers don’t have standing to sue.

U.S. District Judge Stanley R. Chesler held that the proposed class action filed by parents who purchased Sprout baby food products sufficiently alleged there were levels of heavy metals in a dozen Sprout baby food products.

However, the judge said the lawsuit doesn’t allege those levels of heavy metals substantially increased the risk of future harm to their children, particularly since the U.S. Food and Drug Administration stated in a letter last year that “at the levels we have found through our testing … children are not at an immediate health risk from exposure to toxic elements in foods.”

The ruling is the latest development in one of dozens of similar lawsuits against baby food manufacturers over the acceptable levels of heavy metals in such products and labeling requirements.

The flood of litigation followed the February 2021 release of a report from the U.S. House Committee on Oversight and Reform, which showed that heavy metals were present at dangerous levels in baby food made by Sprout Foods and six other major manufacturers. The report was put together by the Subcommittee on Economic and Consumer Policy.

While four companies provided test results and other information, Sprout Foods and two other businesses refused to cooperate with the subcommittee’s probe, which cited a 2019 report from nonprofit Healthy Babies Bright Futures, or HBBF, which said independent testing revealed heavy metals in certain Sprout Foods products.

Named plaintiffs Irida Kimca of Orange, Connecticut, and Derrick Sampson of Forest Park, Illinois hit the Montvale, New Jersey-based Sprout with the present lawsuit in June, and amended their complaint in December to add more plaintiffs.

The judge noted that the complaint doesn’t say whether the FDA’s acceptable levels of heavy metals are specifically applicable to baby food, and other district courts in rulings like Boysen v. Walgreen Co. have concluded that it’s not appropriate to compare products like baby food to water bottles to establish injury at the motion to dismiss stage.

In addition, Judge Chesler ruled that the plaintiffs also don’t have standing to seek injunctive relief, because even if they were harmed by the product’s labels, it’s “common sense” they are now aware of the products’ alleged risks and won’t be deceived again.


Mazda, Parts Maker Sued Over Allegedly Faulty Fuel Pumps

Mazda and an automotive parts manufacturer were hit with a proposed class action in New York federal court by a driver who claims the companies knew about a dangerously defective fuel pump that could cause vehicles to suddenly shut down but failed to disclose it.

New Yorker Tamerlane T. Bey II, who represents himself, said Mazda knew about the defect for years but didn’t alert the public until a recall in November of about 121,000 vehicles equipped with the fuel pumps made by Denso Corp. Even though the defect can cause cars to suddenly stop, posing a safety risk, Mazda didn’t tell owners to cease driving until the cars were repaired, Bey said.

Additionally, instead of following the industry standard and replacing the entire fuel pump, Mazda told technicians to only replace the fuel pump motor, which is difficult to do and can damage the entire fuel pump and worsen the defect, Bey said.

The defect is a safety problem because a vehicle that suddenly stops is at risk for collision, Bey said. Drivers left stranded on the road are also at risk from other vehicles or inclement weather.

Bey owns a 2018 Mazda 6 that has the allegedly defective fuel pump and, on at least six occasions, the car’s acceleration was interrupted.

In July 2020, Mazda recalled cars with the fuel pump in China, Japan, Thailand, Malaysia, Vietnam and Mexico.

Mazda didn’t recall vehicles with the defective pump in the U.S. then because of “logistic conditions, typical customer usage and other factors.”


3M Waited Too Long For Discovery In Earplug MDL, Feds Say

The federal government urged a Florida federal judge to deny a request by 3M to force the U.S. Department of Defense and U.S. Department of Veteran Affairs to produce discovery in sprawling multidistrict litigation over the company’s allegedly defective earplugs, arguing that 3M waited too long.

Even though discovery in this wave of litigation began in November, 3M only started requesting discovery and employee depositions from the government in mid-February to late March. The discovery deadline was April 1, and the company didn’t ask for an extension, let alone explain why one would be justified.

For about two years, the agencies said that they have been processing an “unprecedented” number of document and deposition requests in the litigation, which neither is a party to.

The MDL, consolidated in 2019, includes more than 280,000 service members and others who claim that their hearing was damaged from using 3M’s CAEv2 earplugs. So far, 3M has scored six wins in the 14 test trials to date, while plaintiffs have won verdicts totaling about $200 million in eight bellwether trials.

3M argued that its discovery requests complied with Touhy regulations, which stem from the U.S. Supreme Court’s ruling in ex rel. Touhy v. Ragen and dictate when a government employee may be called to testify by a private party. By preventing 3M from deposing servicemembers’ medical providers, 3M argued that the agencies limited the company’s ability to develop defenses.


Fla. Court Reverses $3.25M In Damages In Engles Case

A Florida appeals court reversed $3.25 million in punitive damages against R. J. Reynolds in an Engle-progeny case, applying a state’s high court decision in another Engle case on how to apply punitive damages in cases over deaths after 1999.

The Florida Supreme Court in November held in another Engle-progeny case that because a smoker died in 2007, after a 1999 law limiting punitive damages, that a punitive damages award should be reversed. In that case, the high court said that the statute applies to all causes of action arising after the law went into effect in 1999 and that a wrongful death cannot be a cause of action until a death, regardless of when the fatal disease was first diagnosed.

In the instant case, Dorothy Durrance died in 2000 of chronic pulmonary disease, which manifested before the 1999 law took effect. The suit was brought by her children, Janice Jones and former Florida Circuit Judge Julian Dale Durrance.

While the Second District court of appeal in March 2021 initially affirmed the punitive damages award, the question of whether the 1999 law would apply to the award was certified to the Sunshine State’s high court.

That question was decided in Sheffield v. R.J. Reynolds Tobacco Co., in which the Florida Supreme Court ruled that Mary Sheffield’s wrongful death action arose upon her husband’s death in 2007 and not at the time he was diagnosed with lung cancer in 1994.

The 1999 law bars punitive damages for conduct on which punitive damages have already been imposed against a defendant in any action alleging harm from the same conduct. R.J. Reynolds said it has already paid more than $500 million in punitive damages in Engle progeny cases, a sum the Florida Legislature decided was enough to pay for the company’s concealment of the dangers of smoking from the public.

Durrance’s suit, and the Sheffield case, were among the many suits spun off from the landmark Engle v. Liggett Group case, in which the Florida Supreme Court in 2006 upheld an appeals court decision overturning a $145 billion verdict but allowed class members to sue tobacco companies individually using the Engle jury’s liability findings about the industry and its role in downplaying the dangers of smoking.


Ovarian Cancer Patients Want Louder Voice In J&J Unit Ch. 11

 A law firm representing ovarian cancer patients urged a New Jersey bankruptcy court to boost their profile in the Chapter 11 case of a Johnson & Johnson talcum powder liability unit, telling the judge that mesothelioma patients unfairly dominate the pool of claimants seeking compensation.

Aylstock Witkin Kreis & Overholtz PLLC underscored the firm’s earlier sentiments urging U.S. Bankruptcy Judge Michael Kaplan to modify the composition of the tort committee claimants who claim their illnesses were caused by asbestos-tainted talcum powder. Ovarian cancer patients represent 99% of the tort creditors with a stake in LTL Management LLC’s Chapter 11 case, yet mesothelioma patients comprise 40% of the committee.

The supplemental statement bolsters Aylstock Witkin’s April 8 motion asking the court to modify the committee’s makeup to adequately represent ovarian cancer patients, and underscores the “colloquy” the firm had with the court on the topic during an April 12 hearing. In its April 8 motion, the firm proffered three of its clients for inclusion in the committee.

The Chapter 11 case was spurred by roughly 38,000 lawsuits by individuals and estates accusing Johnson & Johnson of hiding asbestos in its signature product. J&J spun off LTL Management from a subsidiary, assigned it the company’s massive tort liability, and placed it into bankruptcy in North Carolina in October. The case was later transferred to New Jersey, where J&J is headquartered.

Aylstock Witkin said in its April 8 motion that the litigation includes only 430 lawsuits by mesothelioma patients. In New Jersey, the Office of the U.S. Trustee “attempted to remedy” the imbalanced representation by splitting the tort claimants into two committees representing ovarian cancer patients and mesothelioma patients.

But the tort claimant body was set to revert to a single entity on April 12, per a court order requested by LTL.

Ahead of the reinstatement of the original committee, the U.S. trustee said in an April 11 court filing that it “takes issue” with Aylstock Witkin’s request that the court directly modify the committee since the U.S. Bankruptcy Code tasks the U.S. trustee with appointing committee members after a court finds that a committee’s representation isn’t adequate.

LTL also weighed in on Aylstock Witkin’s requested relief, arguing in an April 11 motion that it was premature because the reinstated committee had yet to be reconstituted and there was “no basis” to conclude it wouldn’t adequately represent the claimants.

Aylstock Witkin’s motion is scheduled for oral arguments on May 4.


Becton Dickinson ordered to pay $255k in hernia mesh trial

A jury this week ordered Becton, Dickinson and Co to pay $255,000 to a man who sued the company, alleging he had been injured by its hernia repair surgical mesh.

The verdict in Columbus, Ohio federal court comes in the second bellwether trial in a multidistrict litigation over the company’s hernia mesh products, which were sold by C.R. Bard Inc before its 2017 acquisition by Becton Dickinson. The first bellwether trial last year ended with a verdict in favor of the company.

More than 16,000 cases have been consolidated before Chief U.S. District Judge Edmund Sargus in Columbus, in the third-largest pending MDL nationwide. Plaintiffs claim that the mesh products caused infections, pain, inflammation and other problems.

A hernia is a protrusion of an organ through a weak spot in a muscle or connective tissue wall. Becton Dickinson maintains that its hernia repair mesh is safe.

This week’s verdict came in a case brought by Antonio Milanesi, who had Bard’s Ventralex mesh implanted during a hernia repair in 2007, and his wife, Alicia Morz De Milanesi. They claimed that Milanesi developed an infection and bowel abscess because of the mesh, requiring a second surgery in 2017.

Like other plaintiffs in the MDL, the Milanesis say the mesh products are defectively designed because their polypropylene material degrades when implanted in human tissue.

Becton Dickinson is also facing state court lawsuits over its hernia mesh. The company said in its most recent quarterly report that it faced more than 26,000 pending hernia mesh lawsuits, most in the Ohio MDL or in a coordinated litigation in Rhode Island state court.

Surgical mesh has been the subject of frequent litigation, with MDLs consolidated for similar claims over mesh products sold by Johnson & Johnson’s Ethicon unit and Getinge’s Atrium Medical Corp, which last December said it had agreed to settle all claims for $66 million. The MDL against Ethicon remains pending, and no trials have yet taken place.


Monsanto Judge Pondering $45M Roundup False Ad Deal

A California federal judge expressed concerns about a nationwide class settlement clearing Monsanto of false advertising claims related to the dangers of its Roundup weedkilling products, saying a $45 million ceiling could be low and consumers aren’t clearly notified that they can still file personal injury claims.

The deal provides payments to consumers who purchased certain Roundup products and settles a lawsuit claiming that Monsanto falsely advertised and promoted the products by failing to disclose that the active ingredient, glyphosate, could cause cancer or other health problems. The agrochemical giant, owned by Bayer AG, denies that it failed to disclose any dangers.

Judge Chhabria said he wanted to make sure that the way the settlement was promoted did not confuse consumers and make them think they could no longer sue the company.

“If we’re going to approve a settlement like this we better make darn sure that the settlement process is not going to confuse anybody into believing that they’ve given up their rights to sue Monsanto if they develop non-Hodgkin lymphoma,” Judge Vince Chhabria of the U.S. District Court for the Northern District of California said.

The proposed settlement establishes a fund of $23 million to $45 million that will reimburse buyers for about 20% of the average price they paid for Roundup products. It would resolve on the action before the court brought by Scott Gilmore and other plaintiffs, as well as other cases brought in federal and state courts across the country against Monsanto and retailers that sold the company’s products.

The parties told the court in their motion for preliminary approval that there were millions of purchasers of the products during the class period, which varies by state depending on the applicable statute of limitations for false-advertising or breach-of-warranty claims.

The judge also expressed concern that the $45 million ceiling that Monsanto agreed to pay might be too low, particularly if publicity surrounding the Roundup cases brings in more claims than expected.

The proposed settlement was filed in January. In March, Missouri consumers who bought Roundup tore into the deal, telling the court it should reject the deal due to its “panoply of red flags,” including indicators of collusion.

A lawyer for the objectors, Patrick Stueve of Stueve Siegel Hanson LLP, said his clients were concerned about how the settlement was reached and the significant discount it seemed to reflect off Monsanto’s potential exposure.


Juul Strikes $22.5M Deal With Wash. Over Youth Ad Claims

Washington Attorney General Bob Ferguson announced that Juul has agreed to pay $22.5 million to the Evergreen State over claims that the e-cigarette giant targeted youth in its product advertisements without disclosing the dangers of nicotine addiction.

Ferguson said that the deal requires Juul Labs Inc. to implement reforms in its marketing practices to ensure they are not being targeted to youth in the state. The consent decree notes that the deal is not an admission of any wrongdoing or liability of any kind by Juul, and that the company denies all of the state’s allegations.

Ferguson filed a suit in September 2020 accusing Juul of violating the Consumer Protection Act by selling and marketing its vape products without telling consumers about the nicotine content on its package labels. Ferguson alleged that Juul fueled a “pervasive and staggering” rise in e-cigarette use and nicotine addiction among youth by pushing fruity, sweet, dessert-flavored products in its marketing campaigns.

Ferguson cited Juul’s “Vaporized” campaign, which ran on social media platforms like Instagram, Twitter and Facebook and featured young models and bright colors. The company was also accused of encouraging its followers to post about its products, hiring brand ambassadors and influencers to market the products to youth. 

The settlement also resolves claims that Juul sold its products in Washington State without obtaining appropriate licenses from Aug. 1, 2016, to April 9, 2018.

In addition to paying the fine, Juul must operate a retailer-compliance program for all of its locations in the state. The company will send “secret shoppers” to conduct no fewer than 25 compliance checks for age verification at retail stores per month for at least two years, and must update the attorney general’s office with details and results of the program every three months. 

Juul has also agreed to stop marketing and advertising its products on social media platforms such as Facebook and Instagram, halt most of its social media promotions, and accurately advertise the content and effects of nicotine in its e-cigarettes. Juul must also stop marketing on LinkedIn, Twitter and YouTube with very few exceptions, and must report content about products posted by underage users, according to the consent decree. 

In June 2021, North Carolina Attorney General Josh Stein announced that Juul agreed to pay $40 million to end claims that it aggressively marketed products to youth and spurred a wave of teen vaping addiction. And in November 2021, Arizona Attorney General Mark Brnovich said the state reached a $14.5 million deal with Juul over its advertising practices. 


Drug Cos. Must Face Bulk Of Weight Loss Drug Cancer Suit

An Oklahoma federal judge won’t let EISAI Inc. and Arena Pharmaceuticals Inc. trim most claims from a suit alleging the weight loss drug Belviq caused a woman to develop breast cancer, saying the complaint sufficiently alleges they were aware of the drug’s risks but pushed it to market anyway.

U.S. District Judge Scott L. Palk denied most of a pair of motions by EISAI in a suit by Pamela Puskas, only dismissing her claim for fraudulent concealment as it is not a separate cause of action under Oklahoma law, saying while she can argue that such concealment tolls her claims, it need not be pled in the complaint.

Puskas’ suit is one of several that the Judicial Panel on Multidistrict Litigation was asked to consolidate in July, alleging that the recalled diet drug Belviq caused various types of cancer. The JPML denied consolidation in August.

Puskas was first prescribed Belviq for weight loss in August 2018, and developed breast cancer in September of that year. She alleges that the companies had known that the drug caused cancer for years, but sold it anyway. In January 2020, the U.S. Food and Drug Administration issued a safety notice for the drug, and EISAI withdrew it from the market a month later.

Judge Palk said the rest of the complaint makes it clear that Puskas’ allegations are not conclusory, as she points to studies that the companies conducted that indicated that the drugs could cause tumors in rats.

As to the implied warranty claim, the complaint contains allegations that not only was Belviq responsible for her cancer, but that it had little to no actual weight loss benefits, which would make it unfit for its purpose.

And the same allegations that support the express warranty and negligence claims also support the claims for fraudulent and negligent misrepresentation, Judge Palk wrote.