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Products Liability

July 23rd, 2019 by Rieders Travis in Products Liability

PRODUCTS LIABILITY-MEDICAL DEVICE

PRODUCTS LIABILITY-MEDICAL DEVICE- Schrecengost v. Coloplast Corporation, No. 3:17-cv-220 (W.D. Pa. December 2, 2019) Gibson, J.  The court finds that under Tincher v. Omega Flex, 104 A.3d 328 (Pa. 2014), a strict liability design defect case can be brought against a company manufacturing a prescription medical device.  This opinion takes issue with many others that go the opposite way from the federal courts in Pennsylvania.  The court rejects that Creazzo v. Medtronic, 903 A.2d 24 (Pa. Super. 2006) or Hahn v. Richter, 673 A.2d 888 (Pa. 1996) dictate a different result.  In essence, the Superior and Supreme Courts of Pennsylvania have not made a decision, and this court predicts that such claims would be allowed.  Comment k of 402A, says the court, is not the model of clarity.  The court holds that claims are cognizable.  

PRODUCTS LIABILITY-DOG LEASH

Oberdorf vs. Amazon.com, Inc., 219 U.S. App. LEXIS 19982.  Opinion by Roth, Circuit Judge.   On January 12, 2015, Heather Oberdorf returned home from work, put a retractable leash on her dog, and took the dog for a walk.   Unexpectedly, the dog lunged, causing the D-ring on the collar to break and the leash to recoil back and hit Oberdorf’s face and eyeglasses.  As a result, Oberdorf is permanently blind in her left eye.  Oberdorf bought the collar on Amazon.com.  As a result of the accident, she sued Amazon.om, including claims for strict products liability and negligence.   The District Court found that, under Pennsylvania law, Amazon was not liable for Oberdorf’s injuries.  In its opinion, the District Court emphasized that a third-party vendor – rather than Amazon itself – listed the collar on Amazon’s online marketplace and shipped the collar directly to Oberdorf.  Those facts were the basis for the District Court’s two main rulings.  First, the District Court found that Amazon is not subject to strict products liability claims because Amazon is not a “seller” under Pennsylvania law.   Second, the District Court found that Oberdorf’s claims are barred by the Communications Decency Act (CDA) because she seeks to hold Amazon liable for its role as the online publisher of third-party content.  Both issues in this case pertain to Amazon’s role in effectuating the sale of products offered by third-party vendors.  Therefore, we begin by describing the anatomy of a sale on Amazon.com.  In its opinion, the Pennsylvania Supreme Court made clear that courts later tasked with determining whether an actor is a “seller” should consider whether the following four factors apply: (1) Whether the actor is the “only member of the marketing chain available to the injured plaintiff for redress”; (2) Whether “imposition of strict liability upon the [actor] serves as an incentive to safety”; (3) Whether the actor is “in a better position than the consumer to prevent the circulation of defective products”; and (4) Whether “[t]he [actor] can distribute the cost of compensating for injuries resulting from defects by charging for it in his business, i.e., by adjustment of the rental terms.”  Although the four-factor test yielded a different result when applied by the Musser court to an action house, all four factors in this case weigh in favor of imposing strict liability on Amazon, having concluded that Amazon should be considered a “seller” under §402A of the Second Restatement of Torts.  We hold that under Pennsylvania law, Amazon is strictly liable for consumer injuries caused by defective goods purchased on Amazon.com.  The second issue in this appeal is whether Oberdorf’s claims, both for negligence and for strict liability, including failure to provide adequate warnings regarding the use of the dog collar, are barred by §230 of the CDA.  Unlike the first issue, this is a question of federal law.  We conclude that the CDA bans some, but not all, of Oberdorf’s claims.   The CDA states, in relevant part, that “[n]o provider or user of an interactive computer service shall be treated as the publisher or speaker of any information provided by another information content provider.  This section, sometimes referred to as the CDA “safe harbor provision,” “precludes courts from entertaining claims that would place a computer service provider in a publisher’s role, and therefore bars lawsuits seeking to hold a service provider liable for its exercise of a publisher’s traditional editorial functions – such as deciding whether to publish, withdraw, postpone, or alter content.   The CDA is intended to allow interactive computer services companies “to perform some editing on user-generated content without thereby becoming liable for all defamatory or otherwise unlawful messages that they didn’t edit or delete.  While we recognize that Amazon exercises online editorial functions, we do not agree that all of Oberdorf’s claims seek to treat Amazon as the publisher or speaker of information provided by another information content provider.   As previously discussed, Amazon is the “seller” of products on its website, even though the products are sourced and shipped by third-party vendors such as The Furry Gang.  Amazon’s involvement in transactions extends beyond a mere editorial function; it plays a large role in the actual sales process.   This includes receiving customer shipping information, processing customer payments, relaying funds and information to third-party vendors, and collecting the fees it charges for providing these services.  Therefore, to the extent that Oberdorf’s negligence and strict liability claims rely on Amazon’s role as an actor in the sales process, they are not barred by the CDA.  However, to the extent that Oberdorf is alleging that Amazon failed to provide or to edit adequate warnings regarding the use of the dog collar, we conclude that activity falls within the publisher’s editorial function.  That is, Amazon failed to add necessary information to content of the website.  For that reason, these failure to warn claims are barred by CDA.  Because the District Court did not parse Oberdorf’s claims in order to distinguish between “failure to warn” claims and claims premised on other actions or failures in the sales or distribution processes, we will vacate its holding that Oberdorf’s claims are barred by the CDA  to the extent that Oberdorf’s claims rely on allegations relating to selling, inspecting, marketing, distributing, failing to test, or designing, they pertain to Amazon’s direct role in the sales and distribution processes and are therefore not barred by the CDA safe  harbor provision.   These claims will be remanded to the District Court.   For the above reasons, we hold that (1) Amazon is a “seller” for purposes of §401A of the Second Restatement of Torts and thus subject to the Pennsylvania strict products liability law, and (2) Oberdorf’s claim against Amazon are not barred by §203 of the CDA except as they rely upon a “failure to warn” theory of liability.   We will therefore affirm the dismissal under the CDA of the failure to warn claims.  We will vacate the remainder of the judgment of the District Court and remand this matter for further proceedings consistent with this opinion.

PRODUCTS LIABILITY-TVT DEVICE

Verdict against pelvic mesh manufacturer decided under New Jersey law. There were damages and punitive damages. A number of errors were raised under appeal including statute of limitations issue. The court said the statute of limitations issue was one of the jury. The jury had to answer a special verdict question favorable to the plaintiff. Viewing the evidence in the light most favorable to the plaintiff as the court must. The request for JNOV was properly denied. Plaintiff satisfied her burden. Plaintiff reasonably believed that her pain was a risk of the surgery. Because there was conflicting evidence whether she thought the pain was because of the surgery or because of the medical device and the conflict was resolved in her favor by the jury which is appropriate. Court properly excluded FDA evidence and publication about FDA standards. This is also decided, however, under New Jersey law. It looks like all the other issues including punitive damages were decided under New Jersey law. Carlino vs. Ethicon, Pa Super. Ct..

PRODUCTS LIABILITY-WARNINGS-MARITIME LAW

Air & Liquid Sys. Corp. v. Devries, 2019, U.S. LEXIS 2087 (March 19, 2019) Kavanaugh, J.-In maritime tort cases, we act as a common-law court, subject to any controlling statutes enacted by Congress. See Exxon Shipping Co. v. Baker, 554 U.S. 471, 507-508 (2008). This maritime tort case raises a question about the scope of a manufacturer’s duty to warn. The manufacturers here produced equipment such as pumps, blowers, and turbines for three Navy ships. The equipment required asbestos insulation or asbestos parts in order to function as intended. When used on the ships, the equipment released asbestos fibers into the air. Two Navy veterans who were exposed to asbestos on the ships developed cancer and later died. The veterans’ families sued the equipment manufacturers, claiming that the manufacturers were negligent in failing to warn of the dangers of asbestos. We agree with the plaintiffs. In the maritime tort context, a product manufacturer has a duty to warn when (i) its product requires incorporation of a part, (ii) the manufacturer knows or has reason to know that the integrated product is likely to be dangerous for its intended uses, and (iii) the manufacturer has no reason to believe that the product’s users will realize that danger. The District Court did not apply that test when granting summary judgment to the defendant manufacturers. Although we do not agree with all of the reasoning of the U.S. Court of Appeals for the Third Circuit, we affirm its judgment requiring the District Court to reconsider its prior grants of summary judgment to the defendant manufacturers. 

Potentially Dangerous Medical Devices are Still Widely Used

When patients have medical devices implanted in their bodies, they expect the device to better their lives, not kill them.  However, all too often, patients have been injured or have died due to problems with medical devices that proved to be defective.

These device-related injuries can occur during an implant procedure or after the device has been in the body for years. When devices have been in the body for a while, it may be difficult to point to them as the source of the problem; and there are times when the device cannot be removed without causing additional injury or even death.

According to the International Consortium of Investigative Journalists (ICIJ), defective devices have been associated with 1.7 million injuries and more than 80,000 deaths in the past ten years.

Examples include:

  • a neck implant to relieve pain that caused airway obstruction, trouble swallowing and respiratory failure
  • artificial hips that cause cobalt poisoning and can damage the heart and brain
  • surgical mesh that cuts through flesh and organs, causing infections and hemorrhage
  • defibrillators that repeatedly shock patients

If you or a loved one has suffered harm due to a faulty medical device, you should seek legal representation to determine whether you can be compensated for your loss. However, due to the complexity and issues involving medical malpractice, your case must be handled correctly and competently by an attorney experienced in medical device malpractice. 

The skilled and experienced Pennsylvania defective medical device malpractice attorney Clifford A. Rieders of Rieders, Travis, Humphrey, Waters & Dohrmann has spent decades successfully representing Pennsylvania families who have suffered an injury or loss due to medical malpractice.  Our attorneys offer personal attention and loyalty to every client, aggressively fighting for their right to compensation.

We offer a free consultation to examine the facts of your case, so contact us online or call our offices to set up your free consultation.

Why Problems With Medical Devices?

Medical devices are cleared and monitored by the Food and Drug Administration (FDA), which approves devices and is supposed to examine and possibly recall faulty devices when incidents arise. However, a global investigation last year by the ICIJ found significant failings in the FDA’s oversight.

Reasons include:

* Loopholes that allow most products to be approved for sale without clinical trials in humans:

1) In 1976, the FDA grandfathered-in all devices that were already on the market.  Under the FDA 510(k) pathway provision, new artificial joints, cataract lens implants, and thousands of other devices developed after 1976 can be approved for sale if shown to have “substantial equivalence” to a previously cleared device. This means higher-risk devices can be cleared based on previous devices, even those that have been recalled for safety problems.

2) The supplement pathway loophole, which allows manufacturers to circumvent clinical trials by informing the FDA that they are marketing an “updated version” of a device with minor changes.

* Manufacturers may take shortcuts or cut down on the testing process to rush the distribution of their products.

In 2007, Congress passed the Medical Device User Fee Amendments (MDUFA), which require manufacturers to pay for device approvals.  To continue collecting user fees, the FDA has to meet “performance goals” for faster approvals, so it has less time to evaluate products. This is an inherent conflict of interest.

What Are the Types of Defective Medical Device Claims?

Faulty medical device claims fall under three categories:

  • Defective design — there are issues in the design of a device even if appropriately manufactured.
  • Defective marketing – product may have been marketed without informing the patient of the dangers involved.
  • Defective manufacture – product was damaged during manufacturing or distribution.

Who May Be Liable?

The following are possible defendants who may be held liable for defective products:

  • Manufacturer– if the process is defective
  • Doctor– for failure to give information regarding potential warnings or the product’s proper usage
  • Retail supplier
  • Medical sales representative– if they recommended the device that harmed you.

In one recent case, we obtained an out-of-court settlement against the manufacturer of a defective device.  We continued the case against the doctor, who then blamed the technicians employed by the manufacturer.  This case demonstrated well that both the doctor and the medical device manufacturer or its employed technicians may be responsible.  In fact, different laws may apply to the doctor as opposed to the manufacturer.  Products liability law may apply to the manufacturer and ordinary Pennsylvania negligence law may apply to the doctor.  There are also federal principles of preemption if a medical device has been approved for sale by the federal government.  These are very complex and intertwined areas of the law.

Contact an Attorney at Our Firm

If you or a loved one has been injured or someone has died due to a defective medical device, you may have a liability claim to be compensated for medical expenses, loss of life’s pleasures, lost wages and emotional anguish.  You should get immediate legal assistance from an attorney with in-depth knowledge of product liability law to make sure you get the compensation you deserve.

The skilled and experienced Pennsylvania defective medical device attorney Clifford A. Rieders of Rieders, Travis, Humphrey, Waters & Dohrmann has spent decades honing his skills and successfully representing Pennsylvania families who have suffered an injury or loss due to someone else’s negligence. We offer personal attention and loyalty to every client, aggressively fighting for their right to compensation. Whether in settlement negotiations or pursuing a favorable trial verdict, we are thoroughly prepared and committed to achieving a just outcome. With our competent staff, we offer strength in numbers while providing top-notch personal service.

Cliff Rieders is a Nationally Board-Certified specialist for Civil Trial and Civil Practice and Procedure, a cum laude Phi Beta Kappa graduate of New York University as well as Georgetown University Law Center.  Rieders is a life member of the American Law Institute, which publishes recommended legal principles utilized throughout the United States.  He is a Past President of the Pennsylvania Association for Justice, formerly Pennsylvania Trial Lawyers Association.  Rieders has won numerous awards and recognition from the Pennsylvania Association for Justice, and he received the Pennsylvania Patient Safety Authority recognition award.  Cliff Rieders was a founder of the Pennsylvania Patient Safety Authority and served on same for 15 years.  Rieders was a Law Clerk in the federal court system for one of the most well-known and longest serving federal judges in the country, the Honorable Malcolm Muir.  Cliff has received the George F. Douglas Amicus Curiae Award, as well as the Milton D. Rosenberg Award from the Pennsylvania Trial Lawyers.  Rieders is on committees and organizations that write the law in many fields of practice.  Cliff Rieders was involved in the writing of the Mcare Act, which governs medical liability actions in Pennsylvania, and he wrote the book on medical malpractice that lawyers use in the state.  Cliff has authored a number of other textbooks and articles and he frequently teaches the law to other experienced lawyers.   Cliff Rieders is admitted in state and federal courts, including the Supreme Court of the United States.  He is a Nationally Board-Certified specialist for Civil Trial and Civil Practice and Procedure and is admitted in state and federal courts, including the Supreme Court of the United States.

If you or your loved one has suffered harm from a defective medical device, your next step should be to consult Cliff Rieders at Rieders, Travis, Humphrey, Waters & Dohrmann by calling or using our online contact form.

Based in Williamsport, we serve clients throughout the state of Pennsylvania, offering a free consultation on all personal injury matters.  Cliff Rieders is also admitted in New York, the District of Columbia, and, as indicated above, numerous federal courts.  More than that, we offer you experience, knowledge, compassion, and a long history of results.

PRODUCTS LIABILITY-FRYE

Pledger v. Janssen Pharms., Inc., 2018 Superior Ct., LEXIS 1167 (October 31, 2018) Strassburger, J.-This case is another, gynecomastia verdict of 2.5 million dollars against the pharmaceutical manufacturer. The defendant was Janssen Pharmaceuticals and Johnson & Johnson. The court said that Frye did not prevent the doctor from testifying. The gynecomastia was caused by Risperdal. The doctor can make the diagnosis who testified based on photographs alone. This case is consistent with other similar decisions on the same subject. Differential diagnosis is a generally accepted methodology. 

What Does Roundup Verdict Mean for Future Lawsuits?

Roundup is a product commonly used by homeowners and commercial landscapers to kill weeds, but it has also been accused of killing people. Multiple lawsuits have been filed in recent years contending that Roundup (or glyphosate, the active ingredient in Roundup) is “dangerous to human health, unfit and unsuitable to be marketed and sold in commerce, and that it lacked proper warnings and directions as to the dangers associated with its use.”

Now, a jury at the Superior Court of California in San Francisco has decided in favor of a plaintiff who alleged that Roundup caused his cancer. The jury awarded Dewayne Johnson $289 million in damages, $250 million of which is intended to punish Monsanto, the company that makes the herbicide. This verdict sets a precedent for thousands of other cases that similarly claim that Roundup causes non-Hodgkin’s lymphoma, an aggressive cancer that starts in the body’s immune system.

After the trial, Monsanto issued a statement saying that it stands by the studies that suggest Roundup does not cause cancer. The company intends to appeal this decision and continue to defend the product.

In spite of Monsanto’s denials, product liability attorneys claim that the manufacturer has known for more than 30 years that there is a link between the use of Roundup and cancer.  They claim that instead of warning the public, Monsanto created fake data and attacked legitimate studies exposing the dangers and created a campaign of misinformation to convince government agencies, farmers, and the general population that its herbicide was safe.

If you or someone you love has been injured by Roundup or any other dangerous product, you may be entitled to compensation for your damages. However, your case must be handled correctly and competently, or you may never collect the compensation you are entitled to.

The skilled and seasoned Pennsylvania product liability and personal injury attorney Clifford A. Rieders of Rieders, Travis, Humphrey, Waters & Dohrmann has spent decades honing his skills and successfully representing Pennsylvania families who have suffered an injury due to defects in products.  Our attorneys offer personal attention and loyalty to every client, aggressively fighting for their right to compensation. Whether in settlement negotiations or pursuing a favorable trial verdict, we are thoroughly prepared and committed to achieving a just outcome.

We offer a free consultation to examine the facts of your individual situation and determine the best way to proceed with your case. Contact us today by calling or by using our online contact form.

What Happened to Johnson?

Dewayne Johnson, 46, applied Roundup 20 to 30 times per year while working as a groundskeeper for a school district near San Francisco, and he had two accidents in which he was soaked with the product. The first accident happened in 2012; in 2014, he was diagnosed with non-Hodgkin’s lymphoma.

How Carcinogenic are Roundup and Glyphosate?

The major questions raised in the liability case are whether Roundup can cause cancer and, if so, whether Monsanto failed to warn consumers about the product’s cancer risk. In March 2015, the World Health Organization’s International Agency for Research on Cancer (IARC) said the key ingredient in Roundup, glyphosate, is “probably carcinogenic to humans.” Monsanto argues that Roundup does not cause cancer, and that the IARC report is greatly outweighed by studies which concluded that glyphosate is safe. However, the plaintiff’s attorneys claimed that glyphosate and other ingredients in Roundup interact and cause a “synergistic effect” that makes the product more carcinogenic than glyphosate alone.

In the Johnson case, Monsanto was not required to prove anything. The burden of proof was on the plaintiff to prove that Roundup was a “substantial contributing factor” to his illness. While it is difficult to prove exactly what caused a particular cancer, the jury concluded that Johnson’s cancer would not have occurred if he had not been exposed to Roundup. This is similar to the conclusion now accepted that tobacco can be a big contributing factor for lung cancer.

The jury also agreed that Monsanto does not warn about the dangers of Roundup, which it keeps promoting without warning users of the increased risk of developing non-Hodgkin’s lymphoma or any of the other diseases linked to glyphosate.

State and Federal Cases

Roundup cases have been filed in both state and federal courts.  Johnson’s attorney said that he and other attorneys have more than 4,000 similar cases awaiting trial in various state courts, and another 400 cases have been filed in federal multidistrict litigation, or MDL.

MDL cases are not similar to class-action lawsuits.  In a class-action lawsuit, a small number of people bring a claim on their own behalf and on behalf of a class.  The recovery then may be split up among others who are said to be part of that class. In MDL cases, each individual has their own separate identifiable claim.  Whether an outcome is faster in state as opposed to federal court depends upon the courts.

The Rieders Travis Law Firm, under the direction of Cliff Rieders and in combination with Sasha Coffiner, handles a variety of multi-district litigation throughout the country.  Many people unfortunately call 800 numbers or go on the internet for “MDL lawyers.”  The Rieders Travis Law Firm does not take a case where they do not meet the client.  We are accessible throughout the litigation.  With Rieders Travis, you are not a number but rather you are an identifiable person.  This is important because oftentimes lawyers from other states find that they cannot bring the matter to fruition because they are not familiar with the state law where the plaintiff they represent lives.  We at Rieders Travis only take cases within the jurisdiction where we can practice law.

Get Help – Contact Us For Honest Answers

If you feel you have been injured by Roundup or other dangerous products, you may be entitled to compensation. Whether in settlement negotiations or pursuing a favorable trial verdict, the experienced attorneys of Rieders, Travis, Humphrey, Waters & Dohrmann are familiar with the law and committed to achieving a just outcome.  With our sizeable staff, we offer strength in numbers while providing top-notch personal service.

PRODUCTS LIABILITY-TINCHER-SIRENS

Dunlap v Fed. Signal Corp., 2018 Superior Court of PA LEXIS 907 (August 20, 2018).  Appellants Roger Maher and Carl Roell (“Maher and Roell”) appeal from the order granting summary judgment in favor of Federal Signal Corporation (“Federal Signal”), and dismissing all remaining claims. We affirm. Maher and Roell are members of the Pittsburgh Bureau of Fire. They are parties in a mass tort products liability action commenced by approximately 247 firefighters who allegedly suffered permanent hearing loss due to exposure to siren noise from the Q2B siren (“Q-siren”) manufactured by Federal Signal. Their cases were consolidated for trial with cases filed by six other firefighters (collectively “plaintiff firefighters”) under the Dunlap caption and designated as Trial Group 1A. The underlying complaint of the plaintiff firefighters is that the Q-siren is unreasonably dangerous and defective and negligently designed because it emits omnidirectional, high-decibel sound that, over time, causes permanent hearing loss to firefighters occupying the fire truck. They offered the expert testimony of Christopher J. Struck, an acoustics expert, to the effect that a shroud, particularly the Bromley Shroud, could be applied to the Q-siren to divert the noise to the front of the vehicle while still meeting industry standards for warning sirens. Instead of emitting sound in all directions, the shroud would funnel the noise in cone-shaped direction in front of the fire truck, thereby reducing the noise level in the cab of the vehicle. As the trial court noted, sirens are dangerous products. They emit noise calculated to warn motorists and pedestrians of the presence of a speeding emergency vehicle. In order to prevail in the instant products liability action, plaintiff firefighters had to prove that Federal Signal’s Q-siren was unreasonably dangerous, and that exposure to the noise caused the firefighters’ hearing loss. The trial court found that the medical evidence in the record, if credited by the factfinder, established the requisite causation. Unreasonably dangerous design could be established with proof of an alternative feasible design that would reduce the decibel level of the noise experienced by the firefighters, but still provide effective warnings to the public. The court found that proof lacking. 

Tincher did not undermine the Lewis decision as to whether industry standards come into evidence. 

At issue are technical matters that are beyond the ken of ordinary persons and within the knowledge of expert witnesses available to the parties. We agree with the trial court that expert opinion on the effectiveness of the alternative design as a warning for pedestrians and motorists was required, and that it was lacking herein. While Maher and Roell offered expert opinion that their proposed alternative design was safer for firefighters, they failed to adduce competent expert opinion that it also met the need for an effective warning for motorists and pedestrians. Maher and Roell’s proof that their proposed design met the industry standard was not enough to establish a prima facie case that it was more effective for all users than the Q-siren. 

PRODUCTS LIABILITY-DEFECTIVE PRODUCTS-HIP REPLACEMENT SYSTEM

Shuker v. Smith & Nephew, PLC, No. 16-3785 (3rd Cir. March 1, 2018) Krause, C.J.  With the Medical Device Amendments of 1976, Congress added comprehensive medical device approval processes to the Federal Food, Drug, and Cosmetic Act, prescribing tiers of federal requirements for certain devices corresponding to the device’s inherent risk level. In exchange for compliance with the strictest federal mandates, Congress afforded manufacturers express preemption from state laws imposing different or additional “safety or effectiveness” requirements for those devices. 21 U.S.C. § 360k(a)(2). This case presents an issue of first impression among the Courts of Appeals: how courts should apply that express preemption provision to state law tort claims challenging the design and manufacture of a medical device comprised of multiple components, some of which are from “Class III” medical devices subject to federal requirements, Riegel v. Medtronic, Inc., 552 U.S. 312, 322-23 (2008), and some of which are from medical devices that carry a different class designation and are not subject to those requirements, see Medtronic, Inc. v. Lohr, 518 U.S. 470, 475-78, 494-95 (1996).

Because the plaintiffs’ negligence, strict liability, and breach of implied warranty claims in their Second Amended Complaint are expressly preempted, we will affirm the District Court’s ruling in that respect. But because the plaintiffs adequately pleaded other, non-preempted claims, and because jurisdictional discovery is warranted with respect to personal jurisdiction over one of the defendants, we will reverse the District Court’s dismissal of some of the plaintiffs’ claims in their Third Amended Complaint, vacate the District Court’s personal jurisdiction ruling, and remand for proceedings consistent with this opinion.

After Walter Shuker underwent a hip replacement surgery that resulted in unexpected complications, he and his wife, Vivian Shuker, brought tort claims against Smith & Nephew, Inc. (“Smith & Nephew”), the manufacturer of his hip replacement system, and Smith & Nephew, PLC (“PLC”), the manufacturer’s parent company.

The question of first impression we confront today arises at the intersection of these different classes of devices with their different approval schemes: How do we apply the Medical Device Amendments’ express preemption provision to a “hybrid system,” i.e., a system that is itself a “device” but that is comprised of Class II components in addition to one or more Class III components?

Mr. Shuker underwent total hip replacement surgery in 2009. The hip replacement system “implant[ed]” was regulated as a “device” under the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 321(h), but was comprised of multiple components, all manufactured by Smith & Nephew. Some components replaced the top of Mr. Shuker’s thighbone (or femur) with a metal head, metal sleeve, and a stem connecting the metal head to the thighbone, while another component rested on his hip socket (or acetabulum). These components were all Class II devices approved through the relatively lenient § 510(k) process. A final component, the “R3 metal liner,” mediated the connection between his hip socket and his thighbone and was seated atop the hip socket component, App. 42; unlike the other components, the liner underwent the rigorous premarket approval process as a supplemental component for a separate Smith & Nephew Class III device, the Birmingham Hip Resurfacing System. Shuker v. Smith & Nephew PLC, No. 13-6158, 2015 WL 1475368, at *2-3 (E.D. Pa. Mar. 31, 2015). Together with the metal head and metal head sleeve replacing the top of Mr. Shuker’s thighbone, the metal liner created a “metal-onmetal articulation” at Mr. Shuker’s hip socket.

As the parties agree, because the R3 metal liner’s labeling reflected that the FDA had not approved the liner for use outside of the Birmingham Hip Resurfacing System or in a total hip replacement system, Smith & Nephew’s promotional materials marketing the R3 metal liner as an “option for its R3 Acetabular System,” a separate hip system constituted “off-label promotion” and the liner’s use in Mr. Shuker’s total hip replacement system constituted an “off-label” use.

About twenty-one months after his hip replacement surgery, Mr. Shuker “began developing increasing pain and discomfort in his buttocks, groin, and thigh, limiting his daily activities.” His surgeon performed an aspiration procedure that revealed “metallic debris” within Mr. Shuker’s body, indicating that “Mr. Shuker’s pain was caused by metal sensitivity due to the degeneration of the metal-on-metal articulation,” which needed to be replaced to relieve his pain. Mr. Shuker then underwent revision surgery to replace the R3 metal liner, followed by additional surgeries to remove and replace his entire hip replacement system when the first revision surgery did not relieve his pain.

Seeking to hold Smith & Nephew and its parent company PLC liable for Mr. Shuker’s hip replacement complications and for Mrs. Shuker’s loss of consortium, the Shukers filed suit, bringing various common law claims, and later adding claims based on violations of federal law. 6 PLC moved for dismissal from the case for lack of personal jurisdiction, and Smith & Nephew moved for summary judgment on some of the Shukers’ claims, asserting that the Medical Device Amendments expressly preempted those claims.

Taken together, the statutory definition of “device,” the treatment of off-label uses, and the guidance of the FDA all counsel in favor of scrutinizing hybrid systems at the component-level. In that circumstance, § 360k(a) preempts any state law “with respect to” a Class III component that is “different from, or in addition to” a federal requirement and that relates either “to the safety or effectiveness of the device” or “to any other matter included in a requirement applicable to the device under [the Act].” 21 U.S.C. § 360k(a).

In sum, the negligence, strict liability, and breach of implied warranty claims asserted in the Second Amended Complaint, would impose non-parallel state law requirements and are therefore expressly preempted. We will affirm the District Court’s order in that respect This is not to say that all failure-to-warn allegations as to hybrid systems would be preempted. On the contrary, as the FDA notes, a claim premised on a state requirement that the R3 System carry a warning against “use with metal liners,” or that it only be used with polyethylene liners, for example, “would not implicate § 360k(a)” because “the FDA did not impose device-specific labeling requirements on the R3 system components.”

Together these factual allegations lead to the reasonable inference that Smith & Nephew’s marketing materials caused Mr. Shuker’s surgeon to recommend the R3 metal liner and to install it within Mr. Shuker’s hip replacement system, a course of action which in turn caused Mr. Shuker’s subsequent injuries.

We hold, however, that the Shukers are entitled to limited jurisdictional discovery to explore their alter ego theory of general personal jurisdiction, i.e., jurisdiction arising from a defendant’s “‘continuous and systematic’ contacts with the forum, whether or not those contacts are related to the [plaintiffs’] cause of action.”

PRODUCTS LIABILITY-TINCHER

Tincher v. Omega Flex, Inc., 2018 Pa. Super. LEXIS 117 (February 16, 2018) Lazarus, J.  Omega Flex, Inc. appeals from the judgment entered in favor of Terence D. and Judith R. Tincher following a jury trial and the denial of its post-trial motions.  Omega Flex contends that it is entitled to a new trial because the Pennsylvania Supreme Court has determined that the trial court’s jury instruction contained a fundamental misstatement of the governing law.  We agree and vacate the judgment, reverse the order denying post-trial relief, and remand for a new trial.

This case involved a fire where investigators determined that a nearby lightning strike caused a small puncture in corrugated stainless steel tubing that transported natural gas to a fireplace located on the first place of the residence.  Heat caused by lightning strike ignited natural gas and caused a fire.  No one was injured, but the fire caused significant property damage.  The stainless steel tubing installed in the home which melted because of the lightning was sold by Omega Flex as part of a gas transportation system.  The Tinchers sued Omega Flex based on strict liability.

Tincher I, by rejecting the Restatement (Third) but saying that the jury should be told more than the Azzarello standard that a product was defective if it lacked any element necessary to make it safe.  The jury charge given in Tincher I was based upon Azzarello as that case interpreted the Restatement of Torts (Second) 402A.

The Supreme Court remanded the case to the trial court for further action based upon post-trial motions.  On remand, Omega Flex filed a renewed motion for post-trial relief in which it abandoned its request for entry of judgment notwithstanding the verdict and sought a new trial.  The trial court denied Omega Flex’s motion and entered judgment against Omega Flex.

The Superior Court held that the trial court erred and Omega Flex is entitled to a new trial as a result of the Supreme Court decision.

There is no question that the jury charge was incorrect.  It was based upon Azzarello and equated a defective product with one that leaves the supplier’s control lacking any element necessary to make it safe for its intended use.  The jury was told that the manufacturer is really a guarantor of a product’s safety but not an insurer of its safety.  The Supreme Court overruled Azzarello.

The fact that the jury may have heard evidence about the risk and utility during the trial does not mean that it rendered a verdict based on the risk/utility standard adopted by the Supreme Court as one way to find a product defective.  The trial court could not know that the jury would have reached the same verdict regardless.

It is important to note that this opinion did not expound upon Tincher at all.  It merely noted in very summary form that a product lacking a safety element was not the standard alone, but rather there had to be a risk utility balancing or whatever new test the Supreme Court had devised (which now includes consumer expectation).  The court did not say that the new standard jury instruction post-Tincher was wrong anyway either.

In footnote 2, the court relies upon the fact that in Tincher, the Tinchers agreed with Omega Flex that Azzarello was wrongly decided.  The court did not note that Tincher was actually a subrogation case brought by the insurance company after they paid out the claim and that the plaintiff’s case was therefore handled by a defense firm.

PRODUCTS LIABILITY-RISPERDAL-GYNECOMASTIA-CAUSATION

Murray v. Janssen Pharmaceuticals, Inc., 2018 Pa. Super. 36  (February 20, 2018) Bender, P.J.E.  In this case it was found that there was sufficient causation based upon photographing of other evidence of what the patient looked like, an adolescent growing breasts after taking Risperdal.  The court went through the testimony very carefully and found there was enough evidence.  A choice of law doctrine, it was held that Maryland law applies and hence the cap applies, even though the case was tried in Philadelphia.  Maryland had greater contacts with respect to noneconomic damages, said the court.  Finally, the court sent the case back for consideration of punitive damages.  On that issue and the punitive damage issue, the remand was so that an individual record could be created to the unique conflict of law principles relevant to the case.

PRODUCTS LIABILITY-RETAIL SELLERS

Oberdorf v. Amazon.com, Inc., No. 4:16-CV-01127 (M.D. Pa. December 21, 2017) Brann, J.  Plaintiff suffered a  loss of vision from a retractable leash that malfunctioned.  It snapped backwards, hitting her in the face.  She had purchased the product on amazon.com.  Judge Brann found that Amazon was like an auctioneer, and had no responsibility for the sale of the product.  Amazon Marketplace is like a newspaper classified ad section, connecting potential consumers with eager sellers in an efficient, modern and streamlined manner.  Subjecting Amazon to strict liability would not further the purposes of § 402A.  The court also found that under the Communications Decency Act, no provider or user of an interactive computer service shall be treated as the publisher or speaker of information.  Here, the plaintiffs are trying to treat Amazon as the publisher or speaker of information by the seller of the leash.  Case dismissed.

PRODUCTS LIABILITY-NUCLEAR RADIATION

Estate of Jeffrey H. Ware v. Hospital of the University of PA, 2017 U.S. App. LEXIS 17992 (3rd Cir. September 18, 2017) Ambro, C.J.  Barbara Boyer, the widow of a cancer researcher who developed a fatal tumor allegedly as a result of inadequate safety precautions taken to protect him from radiation in his lab, sued the University of Pennsylvania together with affiliated persons and entities.1 Before us is the reach of the Price–Anderson Act, see 42 U.S.C. § 2011, et seq., and its remedy-limiting provisions. The Act gives federal courts jurisdiction to resolve a broad set of claims involving liability for physical harm arising from nuclear radiation. Boyer asserts, however, that the Act’s unexpressed intent would exempt her husband’s injuries from its jurisdictional grant.

Her claims fall within the text of the Act, so if we are to limit it to a zone of interests narrower than its text provides, Boyer must offer a compelling limiting principle that would put her allegations beyond the Act’s reach. Although she suggests several implicit limitations, each is either unconvincing or, even if adopted, would leave this case still within the Act’s reach. Thus we must affirm.

Jeffrey H. Ware, Ph.D., was a neuroscientist at the University of Pennsylvania who studied the effects of radiation on biological organisms with the goal of better understanding how radiation affects astronauts while in orbit. In the course of his research Ware used cesium-137 irradiators to track the effects of low-level radiation on mice and rats.

Tragically, Ware suffered in 2010 a rare form of brain cancer called gliosarcoma. Boyer claims gliosarcoma is associated with radiation exposure (however, because she produced no expert reports, there is nothing in the record to support this link). She also alleges that Ware’s cancer specifically resulted from radiation exposure that UPenn failed to monitor properly or protect against. Moreover, UPenn failed to inform Ware of the level of radiation to which he was exposed.

Following his diagnosis, Ware turned to the University’s affiliated hospital for medical care. He underwent chemotherapy and radiation in order to slow the cancer’s progression. Boyer alleges that Ware was not given appropriate information about these treatments;  that, given the advanced stage of his disease, they provided little benefit;  and that, at one appointment where she was not present, a UPenn doctor enrolled Ware in a research study to investigate the effects of chemotherapy and radiation on brain cancer patients without his knowing consent. According to Boyer, UPenn concealed and withheld documents and data related to the study to “cover up its terrible record of radiation safety and to protect millions of research dollars.” UPenn also discouraged Ware from seeking palliative care, she claims, in order to maintain his participation in the study.

Just a year after his diagnosis, Ware died from his cancer at age 47. Boyer filed a complaint in the Pennsylvania Court of Common Pleas as administratrix of Ware’s estate as well as on behalf of herself and Ware’s surviving children.

UPenn and the NSBRI removed the case to federal court on the grounds that (1) claims against UPenn are covered by the Price–Anderson Act, which provides federal jurisdiction over claims asserting “public liability” arising from a “nuclear incident,” see 42 U.S.C. §§ 2014(q), (w), (hh), & 2210(n);  and (2) 28 U.S.C. § 1442(a) permits removal of claims against NSBRI because it is a federal agency.

Following Boyer’s unsuccessful motion to remand, the District Court adopted a Magistrate Judge’s Report and Recommendation that the Price–Anderson Act applies to Boyer’s claims alleging that Ware was harmed by radiation from cesium-137 used in his lab and that the NSBRI is a federal agency. Boyer responded by dismissing all claims against the NSBRI and amending her complaint to include two counts of “negligence under the Price–Anderson Act” (the “Price–Anderson claims”) and additional counts styled as state-law claims for fraud, negligent infliction of emotional distress, malpractice, and “corporate negligence.”

The Price-Anderson Act governed Boyer’s negligence claims, and the Court did not abuse its discretion in denying her request to withdraw those claims and to remand her others.  We thus affirm its judgment.

PRODUCTS LIABILITY-NUCLEAR RADIATION

Estate of Ware v. Hospital of the University of Pennsylvania, No. 16-3801 (3rd Cir. Sept. 18, 2017) Ambro, C.J. Barbara Boyer, the widow of a cancer researcher who developed a fatal tumor allegedly as a result of inadequate safety precautions taken to protect him from radiation in his lab, sued the University of Pennsylvania together with affiliated persons and entities.1 Before us is the reach of the Price–Anderson Act, see 42 U.S.C. § 2011, et seq., and its remedy-limiting provisions. The Act gives federal courts jurisdiction to resolve a broad set of claims involving liability for physical harm arising from nuclear radiation. Boyer asserts, however, that the Act’s unexpressed intent would exempt her husband’s injuries from its jurisdictional grant.

Her claims fall within the text of the Act, so if we are to limit it to a zone of interests narrower than its text provides, Boyer must offer a compelling limiting principle that would put her allegations beyond the Act’s reach. Although she suggests several implicit limitations, each is either unconvincing or, even if adopted, would leave this case still within the Act’s reach. Thus we must affirm.

PRODUCTS LIABILITY-ASBESTOS

In re Asbestos Products Liability Litigation (No. VI), Nos. 16-2602 & 16-2699 (3rd Cir. October 3, 2017) Vanaskie, C.J.   These asbestos cases involve the availability of the “bare-metal defense” under maritime law. The defense’s basic idea is that a manufacturer who delivers a product “bare metal”—that is without the insulation or other material that must be added for the product’s proper operation—is not generally liable for injuries caused by asbestos in later-added materials. A classic scenario would be if an engine manufacturer ships an engine without a gasket, the buyer adds a gasket containing asbestos, and the asbestos causes injury to a worker. May the manufacturer be held liable? Some courts say no—never. Others rely on a more fact-specific standard and ask whether the facts of the case made it foreseeable that hazardous asbestos materials would be used. Neither this Court nor the Supreme Court has confronted the issue.

In that void, we survey bedrock principles of maritime law and conclude that they permit a manufacturer of even a bare-metal product to be held liable for asbestos-related injuries when circumstances indicate the injury was a reasonably foreseeable result of the manufacturer’s actions—at least in the context of a negligence claim. The District Court had instead applied the bright line rule approach and entered summary judgment against the plaintiffs. We will vacate the entry of summary judgment on the plaintiffs’ negligence claims, affirm the entry of summary judgment on the plaintiffs’ product liability claims (which we conclude were abandoned on appeal), and will remand, for further proceedings.

PRODUCTS LIABILITY-STRYKER GAMMA3 NAIL SYSTEM

Smith v. Howmedica Osteonics Corp, et al., 17-1174 (E.D. Pa. April 27, 2017) Beetlestone, J. This Court predicts that the Pennsylvania Supreme Court would not bar strict liability claims asserting a manufacturing defect against medical device manufacturers under Comment k. of Restatement 402A and Tincher.

Here, Plaintiffs have plausibly alleged a manufacturing defect strict liability claim. The existence of a manufacturing defect is satisfied by the allegation that the Stryker Gamma 3 Nail System broke down after it was implanted into Mr. Smith, where it was subjected to normal and anticipated use, and that there were no reasonable secondary causes. That it existed at the time it left Defendants’ control is plausibly suggested by the allegation that the product was manufactured and shipped by Defendants to Grand View Hospital, where it was ultimately 11 implanted into Mr. Smith. And causation follows from the allegation that the failure of the Stryker Gamma 3 Nail System necessitated a subsequent surgery to remove it, as well as a total hip replacement, which gave rise to a secondary infection. Therefore, the motion to dismiss the strict liability claim insofar as it asserts a manufacturing defect will be denied.

A close analysis of the Complaint reveals that Plaintiffs have failed to allege facts plausibly giving rise to a negligence claim. First with respect to negligent manufacturing, it is necessary to allege some facts that would plausibly suggest that the manufacturer failed to exercise reasonable care during the “manufacturing process.” Restatement (Second) of Torts § 395. Here, there are no factual allegations that address the manufacturing process. There is only the conclusory allegation that the manufacture of the Stryker Gamma 3 Nail System was negligent, which is precisely the type of merely conclusory statement not entitled to a presumption of truth on a motion to dismiss. Ashcroft v. Iqbal, 556 U.S. 662, 678 (2009). While Plaintiffs do incorporate the factual allegations made in support of the manufacturing defect strict liability claim – that the product broke following implantation under normal and anticipated use and in the absence of any secondary causes – these are insufficient to state a claim for negligent manufacturing under Pennsylvania law because they solely address the product, and not the Defendants’ conduct. Without any factual allegation as to the nature of what went wrong during the manufacturing process, there is no plausible road to recovery for negligent manufacturing.

Next, with respect to the alleged negligent design of the Stryker Gamma 3 Nail System, the factual allegations are similarly insufficient to survive a motion to dismiss. The only explicit reference to the product’s design is the conclusory allegation that Defendants were negligent in such design. Setting this conclusory statement aside, the remaining factual allegations do not 14 address the design of the Stryker Gamma 3 Nail System in any level of meaningful detail. All that can be gleaned from the Complaint is that the product is a type of “prosthetic implant system” that is implanted into a patient’s leg and hip. From this information, even accepting as true Plaintiffs’ allegation that the product broke after implantation, it cannot be plausibly inferred that Defendants failed “to exercise reasonable care in the adoption of a safe . . . design” as required by Restatement of Torts Section 398. Finally, the Complaint is equally lacking in any factual specificity with regard to the allegation that Defendants were negligent in their failure to warn or to recall.

Having concluded that Plaintiffs’ design defect strict liability claim is not cognizable under Comment k, Defendants’ motion to dismiss will be granted to the extent that the claim for breach of the implied warranty of merchantability asserts a design defect. But having predicted that the Pennsylvania Supreme Court would recognize Plaintiffs’ manufacturing defect strict liability claim, and having concluded that Plaintiffs have pled sufficient facts to support it, the motion to dismiss Count Three will be denied insofar as the breach of the implied warranty of merchantability claim asserts a manufacturing defect.

PRODUCTS LIABILITY-TINCHER

Renninger v. A&R Machine Shop, 2017 Pa. Super. 98 (April 11, 2017) Stabile, J.  On May 25, 2007, Appellant Dennis Renninger was at work in the Clarion, Pennsylvania plant of his employer, Commodore Homes (“Commodore”), a manufacturer of modular homes, when he sustained a serious injury to his foot. While under construction, each modular home moves along an assembly on wheeled casters attached to its underside. Mr. Renninger was injured when a caster ran over his foot. Appellants sued Appellees A&R Machine Shop (“A&R”) and Cass Hudson Company (“Cass Hudson”) as the designers, manufacturers and suppliers of the casters. Appellants alleged causes of action for strict products liability, negligence, breach of implied warranty, and loss of consortium causes of action, claiming the casters should have included toe guards. The case proceeded to a June 22-25, 2015 jury trial on Appellants’ strict products liability/design defect claim.  The jury returned a defense verdict, finding Cass Hudson did not supply a defective product. Appellants filed timely post-trial motions on June 30, 2015. The trial court denied those motions on November 3, 2015. The verdict was reduced to judgment on November 12, 2015, and this timely appeal followed.

Appellants’ first three assertions of error challenge the trial court’s decision to admit evidence of industry safety standards, OSHA safety standards, and Mr. Renninger’s alleged assumption of risk.

Appellants used the phrase industry standards in their question presented and again in their brief, but they confined the substance of their record citations and legal argument to the evidence of Commodore’s conduct and OSHA violations.  We will therefore do the same.

As noted above, in none of these portions of the transcript did Hutter reference industry standards applicable to casters. Appellants rely in part on Sheehan v. Cincinnati Shaper Co., 555 A.2d 1352 (Pa. Super. 1989), appeal denied, 564 A.2d 1261 (Pa. 1989). In Sheehan, as in the instant case, the defendant argued that the plaintiff’s employer’s OSHA violations were relevant to causation.

Likewise, Appellants cite Majdic v. Cincinnati Mach. Co., 537 A.2d 334 (Pa. Super. 1988) (en banc), to support their argument that a plaintiff’s employer’s conduct is not relevant in a strict products liability action.

Assuming without deciding that the trial court erred in admitting evidence of Commodore’s conduct under those two cases, we conclude the trial court’s error was harmless. We will presume that the jury did not consider the evidence of Commodore’s conduct or Mr. Renninger’s alleged assumption of risk. In addition, the record contains a significant body of evidence supporting the jury’s verdict. As we have already explained, the jury had before it Appellee’s introduction of ANSI standards governing casters, which Appellants have not challenged on appeal. Further, the jury had before it Appellee’s evidence that toe guards would not have protected Mr. Renninger, given the uneven flooring in Commodore’s plant. The Tincher Court did anticipate that its holding would have significant ripple effects to be addressed case by case as they arise. In the wake of Tincher, however, the bench and bar must assess the Tincher opinion’s implications for a large body of post-Azzarello and pre-Tincher case law. Neither party to the instant appeal has offered any substantive argument for or against the admission of such evidence in Pennsylvania after Tincher. Given the arguments before us, we do not have occasion to express an opinion. In light of all of the foregoing, Appellants’ first three arguments do not merit relief.

PRODUCTS LIABILITY-TINCHER

American Honda Motor Co. v. Martinez, No. 445 EDA 2015 (Pa. Super. April 19, 2017) Dubow, J. This case was decided before Tincher.  The question is whether post-Tincher, the jury was properly charged.  The trial court in fact did engage in a risk utility analysis before sending the case to the jury and concluded that plaintiffs met their burden.  The portion of the charge to determine the “practicability of an alternate design” inherently requires a jury to balance factors such as the cost of implementing the design against the relative safety of the alternate design.  Accordingly, the jury could not have reached a verdict in this case without conducting a risk utility analysis required by Tincher.  Under Tincher, a jury must determine whether a reasonable person would conclude that the probability and seriousness of harm caused by the product outweigh the burden or cost of taking precautions.  Therefore, the trial court did not abuse its discretion in denying Honda’s request for a new trial.  The jury charge was adequate because it made clear to the jury that it was the arbiter of whether the seatbelt restraint system was unreasonably dangerous and the absence of explicit risk-utility language from the court’s instruction did not amount to a fundamental error.  Although Tincher overruled Azzarello, the holding in Tincher does not require that the trial court remove the “guarantor” language from the jury instruction.  Therefore, Honda is not entitled to any relief on this claim.  The claim that Honda should have been able to introduce evidence of its compliance with federal industry standards is meritless.  The precedent is unchanged.  The evidence was inadmissible.  The applicability of Tincher to warning defect claims remains unsettled given that the Supreme Court will be hearing Amato v. Bell and Gossett, 116 A.3d 607 (Pa. Super. 2015).  As to crashworthiness, the defect jury instruction was not erroneous.  The instruction to the jury as shown on page 16 was proper.  Here, the jury was told that it should focus the inquiry on Honda’s liability on the “second collision.”  The issue is plaintiff’s injuries when the roof of his car hit the ground.  Defendant claimed that the Pennsylvania Standard Jury Instruction 16.50 is incomplete and obsolete because it charged the jury that the heeding presumption was not rebuttable.  Contrary to Honda’s assertion, the court did not, in a vacuum, instruct the jury that it must presume that the plaintiff would have followed any adequate warning.  It was Honda’s lack of rebuttal evidence that was at issue.  The jury charge was repeated at slip opinion pp. 15-16.  Honda did not introduce any evidence to rebut the testimony of the plaintiff that had there been warnings about the car not being able to protect him in a rollover, he would not have bought it.  The evidence was sufficient of an alternative practicable seatbelt design.  Honda says it would have been illegal to sell the proposed alternative design.  Honda’s claim lacks merit.  The jury, as a fact finder, had a right to make the decision.  Also raised was federal preemption.  The U.S. Supreme Court unequivocally permits the claim under Williamson v. Mazda, 562 U.S. 323 (2011).  On causation, Honda once again was dismissed.  Likewise, the damages were not excessive given the injuries.

PRODUCTS LIABILITY-TINCHER STANDARDS

Renninger v. A&R Machine Shop, 2017 Pa. Super. LEXIS 241 (April 11, 2017) Stabile, J.  Appellants, Dennis A. Renninger and his wife, Patsy D. Renninger, appeal from the judgment of November 12, 2015. We affirm. On May 25, 2007, Appellant Dennis Renninger was at work in the Clarion, Pennsylvania plant of his employer, Commodore Homes (“Commodore”), a manufacturer of modular homes, when he sustained a serious injury to his foot. While under construction, each modular home moves along an assembly on wheeled casters attached to its underside. Mr. Renninger was injured when a caster ran over his foot. Appellants sued Appellees A&R Machine Shop (“A&R”)1 and Cass Hudson Company (“Cass Hudson”) as the designers, manufacturers and suppliers of the casters. Appellants alleged causes of action for strict products liability, negligence, breach of implied warranty, and loss of consortium causes of action, claiming the casters should have included toe guards. The case proceeded to a June 22-25, 2015 jury trial on Appellants’ strict products liability/design defect claim.2 The jury returned a defense verdict, finding Cass Hudson did not supply a defective product. Appellants filed timely post-trial motions on June 30, 2015. The trial court denied those motions on November 3, 2015. The verdict was reduced to judgment on November 12, 2015, and this timely appeal followed.

The record contains a significant body of evidence supporting the jury’s verdict. As we have already explained, the jury had before it Appellee’s introduction of ANSI standards governing casters, which Appellants have not challenged on appeal. Further, the jury had before it Appellee’s evidence that toe guards would not have protected Mr. Renninger, given the uneven flooring in Commodore’s plant. The jury also had before it Appellee’s evidence that toe guards would pose risks such as severing electric cords draped across the floor. Given all of this evidence, and given the trial court’s instruction that Commodore’s and Mr. Renninger’s conduct was relevant only to causation, we conclude that any error in admitting evidence of Commodore’s conduct was harmless.

We pause here to address the parties’ arguments under Tincher. Appellants take a very narrow reading of Tincher, seemingly concluding that it overruled Azzarello but did little else. Even a cursory reading of Tincher belies that argument. The Supreme Court’s opinion in Lewis, providing for a strict separation between negligence and strict liability, was, according to the Tincher Court, a result in harmony with Azzarello. The Tincher Court, as we have explained, did not expressly overrule Lewis, and had no occasion to do so based on the arguments the parties presented to it. The Tincher Court did anticipate that its holding would have significant ripple effects to be addressed case by case as they arise.

Roundup and Cancer

Does Roundup, a chemical used to kill weeds, also kill people by giving them cancer? A lawsuit filed by Anthony Harris, a man who says he used Roundup “extensively” to control weeds in his backyard garden in San Diego, California, says yes. In January 2015, he was diagnosed with non-Hodgkin lymphoma — an aggressive cancer that starts in the body’s immune system. There have also been 30 similar lawsuits in recent months, mostly filed by farmworkers and landscapers, but also by a growing number of backyard gardeners.

The complaint filed by Mr. Harris states, “Roundup and/or glyphosate (the active ingredient in Roundup) is defective, dangerous to human health, unfit and unsuitable to be marketed and sold in commerce, and lacked proper warnings and directions as to the dangers associated with its use.”

Attorneys for the plaintiff claim Monsanto has known for more than 30 years that there is a link between the use of Roundup and cancer. The documents from the litigation show that, instead of warning the public, Monsanto created fake data and attacked legitimate studies exposing the dangers. The company created a campaign of misinformation to convince government agencies, farmers, and the general population that its herbicide was safe and practically non-toxic to humans, pets, birds and fish.

If you or someone you love has been injured by Roundup or any other dangerous product, we can help. The experienced and compassionate personal injury attorney Cliff Rieders of Rieders, Travis, Humphrey, Waters & Dohrmann has spent decades honing his skills and successfully representing Pennsylvania families who have suffered an injury or loss due to someone else’s negligence. Our deep sense of loyalty to each client drives us to pursue each claim vigorously.

We offer a free consultation to examine the facts of your situation and explain your options.

What Is Being Done?

The World Health Organization independent researcher and scientists have already labeled glyphosate a probable carcinogen, and other countries have taken action. France has banned sales of Roundup to home gardeners. The European Union (EU) has also proposed banning use of Roundup by “non-professionals.” The active ingredient in Roundup, glyphosate, was declared a “probable human carcinogen” by the International Agency for Research on Cancer (IARC) based on several studies linking it to non-Hodgkin lymphoma.

Lab tests have shown consistently that these chemicals cause cancer in lab animals, but nevertheless, in the U.S., efforts to ban Roundup have been stymied. The EPA posted, but then retracted, a study connecting glyphosate to cancer. Roundup is still on the store shelves for gardeners to buy, and it is used to spray food crops that we regularly ingest.

According to an interview on The Ring of Fire Network, Roundup is related to ADHD, Alzheimer’s disease, autism, birth defects, brain cancer, breast cancer, kidney disease, heart disease, ALS, MS, and Hodgkin lymphoma. And damage from Roundup is cumulative, building up in the human body each year. Neither the EPA nor the FDA conducts tests for Roundup residue on crops that are sold throughout the United States.

How Monsanto Benefits

The plaintiffs in the lawsuit state that Monsanto discovered the potential use of glyphosate as an herbicide in 1970, and began marketing it in 1974. Now, approximately 250 million pounds of glyphosate are sprayed on crops, commercial nurseries, lawns, driveways, sidewalks, parks and golf courses. The plaintiffs claim that use has increased because of the increased use of genetically modified (GMO) crops, designed to resist the killing power of glyphosate products. Monsanto is the largest producer in the world of GMO seeds designed to be resistant to glyphosate products. However, the weeds also developed a resistance to glyphosate so more herbicides are necessary to kill the weeds.

Monsanto keeps promoting Roundup without warning users of the increased risk of developing non-Hodgkin lymphoma or any of the other diseases linked to glyphosate. The company is making lots of money — $4.8 billion in 2015 from its sales of Roundup.

Are You At Risk?

The most serious side effect from exposure to glyphosate (Roundup’s main ingredient) is the development of cancer, specifically non-Hodgkin lymphoma, leukemia, B-cell lymphoma, and multiple myelomas.

Those most at risk are farm workers and those with workplace exposure to the herbicide, such as workers in garden centers and nurseries, and landscapers. Individuals are most likely to be exposed to glyphosate from breathing it while spraying, mixing or cleanup, or through drinking water or eating food contaminated with it.

How To Get Help – Contact Us For Honest Answers

If you feel you have been injured by Roundup or other dangerous products, you may be entitled to compensation. Whether in settlement negotiations or pursuing a favorable trial verdict, the experienced attorney Cliff Rieders of Rieders, Travis, Humphrey, Waters & Dohrmann is familiar with the law and thoroughly prepared and committed to achieving a just outcome. With our sizeable staff, we offer strength in numbers while providing top-notch personal service.

If you or your loved one has suffered injury from a faulty product, don’t delay. Consult Cliff Rieders of Rieders, Travis, Humphrey, Waters & Dohrmann by calling 1-877-962-9411 for a free consultation, or use our online contact form.

CONSTITUTIONAL LAW – CASE IN CONTROVERSY – PREEMPTION – AVIATION SAFETY – PRODUCTS LIABILITY

Sikkelee v. Precision Airmotive Corporation, 45 F.Supp.3d 431 (2014). This case presents the question whether Abdullah v. American Airlines, Inc., 181 F.3d 363, (3d Cir. 1999), in which we held that federal law preempts the field of aviation safety, extends to state law products liability claims.  We hold it does not.  In light of principles of federalism and the presumption against preemption, Congress must express its clear and manifest intent to preempt an entire field of state law.  Here, none of the relevant statutes or regulations signals such an intent.  To the contrary, the Federal Aviation Act, the General Aviation Revitalization Act of 1994, and the regulations promulgated by the Federal Aviation Administration reflect that Congress did not intend to preempt aircraft products liability claims are preempted by Abdullah, it also recognized the question was sufficiently unclear and important to certify its order for interlocutory review.  Today, we clarify the scope of Abdullah and hold that neither the Act nor the issuance of a type certificate per se preempts all aircraft design and manufacturing claims.  Rather, subject to traditional principles of conflict preemption, including in connection with the specifications expressly set forth in a given type certificate, aircraft products liability cases like Appellant’s may proceed using a state standard of care.  For these reasons, we will reverse the District Court’s entry of summary judgment in favor of Appellees and remand for further proceedings.

PRODUCTS LIABILITY-AVIATION-PREEMPTION

Sikkelee v. Precision Airmotive Corporation, et al., Case No. 14-4193, Document 003112267244 (3d Cir. 4/19/2016) Krause, C.J.  This case presents the question whether Abdullah v. American Airlines, Inc., 181 F.3d 363 (3d Cir. 1999), in which we held that federal law preempts the field of aviation safety, extends to state law products liability claims.  We hold it does not.  In light of principles of federalism and the presumption against preemption, Congress must express its clear and manifest intent to preempt an entire field of state law. Here, none of the relevant statutes or regulations signals such an intent. To the contrary, the Federal Aviation Act, the General Aviation Revitalization Act of 1994, and the regulations promulgated by the Federal Aviation Administration reflect that Congress did not intend to preempt aircraft products liability claims in a categorical way. The District Court faithfully sought to apply our precedent, and while it concluded that state products liability claims are preempted by Abdullah, it also recognized the question was sufficiently unclear and important to certify its order for interlocutory review. Today, we clarify the scope of Abdullah and hold that neither the Act nor the issuance of a type certificate per se preempts all aircraft design and manufacturing claims. Rather, subject to traditional principles of conflict preemption, including in connection with the specifications expressly set forth in a given type certificate, aircraft products liability cases like Appellant’s may proceed using a state standard of care. For these reasons, we will reverse the District Court’s entry of summary judgment in favor of Appellees and remand for further proceedings.

PRODUCTS LIABILITY-LAWNMOWER-FIRE

Plaintiff alleged that his new lawnmower caught fire and burned down his barn.  The case was dismissed by the trial court.  Barton v. Lowe’s Home Centers, Inc., 124 A.3d 349 (Pa. Super. 2015).  The third amended complaint expressly alleged design, manufacture and failure-to-warn defects.  The pleading was adequate to allege that there was a problem with the lawnmower.  There was a breach of implied warranty of merchantability.  Implied warranties are implied where there is a loss because the items does not work as expected.  The lawnmower was not merchantable.  There is a failure to warn claim, which is adequate.

RICO-STANDING-MISREPRESENTATION-SAFETY RISKS ASSOCIATED WITH AVANDIA

In re Avandia Marketing Sales Practices & Product Liability Litigation, 804 F.2d 633 (3rd Cir. 2015). This interlocutory appeal involves claims brought against GlaxoSmithKline, LLC, by third party payors based on GSK’s alleged misrepresentation and concealment of significant safety risks associated with the use of Avandia and other Type II diabetes drugs.  The Third Circuit affirmed the trial court’s finding that the TPP’s adequately alleged the elements of standing under the Racketeer Influenced and Corrupt Organizations Act (RICO).  In this case, the injuries suffered by the TPP’s is not contingent on future events.  The damages depend on the inflationary effect that GSK’s allegedly fraudulent behavior had on the price of Avandia.  There must also be proximate cause.  The court has held that a RICO plaintiff who did not directly rely on a defendant’s misrepresentation can still establish proximate causation.  The court accepted all the allegations are true for the motions at issue.  There should not be difficulty in distinguishing between the amount of damages attributable to a defendant’s violation and to other, independent factors.  This case does not present any of the three fundamental causation concerns expressed in Holmes v. Securities Investor Protection Corp., 112 S.Ct. 1311 (1992).  There was no risk of duplicative recovery here.  No one is better suited to sue GSK for its alleged fraud.

FEDERAL ARBITRATION ACT-SUMMARY JUDGMENT, APPEAL FROM

This case stems from a failed agreement to distribute robotic medical devices.  The matter is an interlocutory appeal from an order denying summary judgment.  The question is whether the summary judgment is the equivalent of an order denying a petition to compel arbitration.  The court found that Section 16 does not sweep so broadly and therefore the appeal was dismissed for lack of jurisdiction.  The grant of summary judgment was not found to be the equivalent of a determination to arbitrate.  Devon Robotics, LLC v. Deviedma, 798 F.3d 136 (3rd Cir. 2015).

NEGLIGENCE-AIRCRAFT ENGINES

This case involves airplane crash concerning an engine built by Lycoming which was reconditioned.  The court found that the statute of repose had not necessarily run because new parts were put in.  The court also dealt with the definition of manufacturer.  When the rolling provision applies is also discussed.  Aubrey v. Precision Airmotive, LLC, 7 A.3d 256 (Pa. Super. 2010); Stewart v. Precision Airmotive, LLC, 7 A.3d 266 (Pa. Super. 2010)

PRODUCTS LIABILITY-ASBESTOS-CAUSATION

In this case it was claimed that a worker contracted asbestos-related lung disease from exposure to asbestos dust produced by asbestos-containing brakes.  The defendant moved for summary judgment, claiming that there was insufficient evidence of exposure.  The Superior Court agreed.  Although the worker testified he saw dust emanate from the wheel area of cranes when brakes were applied, he could see that there were multiple sources of dust in the beamer.  The testimony of other former Bethlehem Steel employees provided no information regarding the frequency, regularity or proximity of the alleged exposure to asbestos in the P & H products.  Sterling v. P & H Mining Equipment, Inc., 113 A.3d 1277 (Pa. Super. 2015).

NEGLIGENCE-POST-SALE DUTY TO WARN

Claim was that Wyeth was negligent in placing unreasonably dangerous drug on the market which was ultimately withdrawn.  In Pennsylvania, products liability law is superseded as it applies to prescription drugs under Comment k of the Restatement 2nd of Torts 402A.  Due to the inherent risks associated with prescription drugs, the Supreme Court is limited to potential causes of action to a plaintiff who alleges a strict liability claim against a drug manufacturer.  The plaintiff may advance only two theories:  1) a manufacturing defect claim; or 2) a failure to warn claim.  A failure to warn claim must be analyzed with negligent standards under Restatement 2nd of Torts 388.  Pennsylvania is one of the few states that afford Comment k protection to all prescription drugs as a matter of law.  A design defect claim for strict liability is not permitted in Pennsylvania when it is asserted against a manufacturer of prescription drugs.  A drug cannot be deemed unreasonably dangerous even if it is defectively designed so long as the drug is manufactured properly and contains adequate warnings.  We agree however that Comment k does not apply to a negligent design claim.  The Restatement 2nd of Torts §395 addresses a manufacturer’s negligent design of products.  Comment k is confined to strict liability claims and has no application to claims sounding in negligence.  There is no duty to recall in Pennsylvania.  The FDA decides whether to recall a drug.  A drug manufacturer’s post-sales duty to warn of dangerous propensities provides consumers with a remedy and sufficient protection against risks.  Pennsylvania has not adopted independent tort for negligent failure to test.  There is no duty to test in Pennsylvania. Restatement 3rd of Torts Products Liability §6(c) has not been adopted.  Lance vs. Weyth, 4 A.3d 160 (Pa. Super. 2010).

Mirena Lawsuits Selected for Bellwether Trials in New Jersey State Court Proceeding

A New Jersey judge has ordered the parties to select a group of 14 cases that will be prepared for a second bellwether trial at the state court level in the ongoing state court mass tort litigation.  There are currently more than 3,000 product liability lawsuits pending against Defendant Bayer Healthcare in the United States who suffered a Mirena injury with about 1,800 of the cases centralized for pretrial proceedings in New Jersey state court before presiding Superior Court Judge Brian Martinotti, as part of a multi-county litigation (MCL).

All of the complaints raise similar allegations that inadequate warnings were provided about the  risk of problems with the T Shaped Mirena intrauterine device implant, which is intended to be implanted in the uterus to prevent pregnancy for up to five years.  Many of the lawsuits allege injuries from Mirena such as device migration and/or puncturing of the uterus.

As part of the coordinated handling of the Mirena litigation in New Jersey state court, Judge Martinotti has established a process for preparing small groups of cases for early trial dates, known as “bellwether” trials, which are designed to help the parties gauge how juries may respond to certain evidence and testimony that is likely to be repeated throughout the majority of the lawsuits in the consolidated proceeding.

In a case management order issued on March 17, Judge Martinotti ordered the parties to select a second group of cases that will be prepared for another trial date in New Jersey. Plaintiffs’ attorneys and defense attorneys have each been asked to select seven cases by July 2, which will go through case-specific discovery in preparation for a second Mirena “bellwether” trial in the state.

All case-specific discovery in this second group of cases is to be completed by February 18, 2016. The parties will then each select four cases from the pool by March 4, 2016 and will then have until March 11 to veto two of the other side’s selections, resulting in a final pool of four cases that will remain eligible for the second bellwether trial, which is expected to begin in the second half of 2016. However, a trial date has not been announced by the Court.

In addition, numerous Mirena lawsuits are also pending in a multi-district litigation (MDL) in the federal court system.  About 1,2000 cases are pending in the U.S. District Court for the Southern District of New York in this MDL.  The first bellwether trial is scheduled to commence in March 2016.

Have you been injured by a Mirena intrauterine device? Call Cliff Rieders, Esq. of the Rieders Travis firm to have your potential claim evaluated for filing in court against Bayer.

Krauss v. Trane U.S., Inc., 104 A.3d 556 (Pa. Super. 2014) Case Summary

The court properly grants summary judgment where there simply is not enough of a connection between decedent’s asbestos-related disease and his frequency and regularity in proximity to the asbestos containing product manufactured by Zurn Industries.  The court made an exhaustive review of the evidence.  It was not established that Zurn boilers even contained asbestos.  Supposedly the asbestos was on gaskets, but even that was not established.  There simply was no genuine issue of material fact that decedent was exposed to asbestos with enough frequency, regularity and proximity to have caused his mesothelioma.

Tincher v. Omega Flex, Inc., 104 A.3d 328 (Pa. 2014) Case Summary

In this crucial case in which Cliff Rieders and Pam Shipman served as amicus curiae for the Pennsylvania Association for Justice, the Pennsylvania Supreme Court decided to retain the Restatement Second 402A.  Although the court’s decision in Azzarello v. Black Brothers Company was overruled, that decision was really supplemented by this Tincher decision.  A plaintiff pursuing a cause of action upon the theory of strict liability in tort must prove that a product is in a defective condition.  The plaintiff may prove the defective condition by showing either that (1) the danger is unknowable and unacceptable to the average or ordinary consumer, or that (2) a reasonable person would conclude that the probability and seriousness of harm caused by the product outweigh the burden or cost of taking precautions.  The burden of production and persuasion is by a preponderance of the evidence.  Whether a product is in a defective condition is a question of fact ordinarily submitted for determination to the finder of fact.  The question is removed from a jury’s consideration only when it is clear that reasonable minds could not differ on the issue.  The trial court is relegated to the traditional role of determining issues of law.  The court declined to adopt the Restatement (Third) of Torts.

A plaintiff pursuing a products liability case may either prove that the product was in a defective condition because of the failure of the product to comply with consumer expectations, or may pursue a products liability claim based upon the theory that the risk of the product’s danger outweigh its utility.  Testing the product’s safety by the reasonableness of the manufacturer’s action or omissions is rejected.  Focus will stay on the safety of the product.  The court relied heavily upon California law.

PRODUCTS LIABILITY-ASBESTOS-CAUSATION

The court properly grants summary judgment where there simply is not enough of a connection between decedent’s asbestos-related disease and his frequency and regularity in proximity to the asbestos containing product manufactured by Zurn Industries.  The court made an exhaustive review of the evidence.  It was not established that Zurn boilers even contained asbestos.  Supposedly the asbestos was on gaskets, but even that was not established.  There simply was no genuine issue of material fact that decedent was exposed to asbestos with enough frequency, regularity and proximity to have caused his mesothelioma.  Krauss v. Trane U.S., Inc., 104 A.3d 556 (Pa. Super. 2014).

PRODUCTS LIABILITY-TINCHER

In this crucial case in which Cliff Rieders and Pam Shipman served as amicus curiae for the Pennsylvania Association for Justice, the Pennsylvania Supreme Court decided to retain the Restatement Second 402A.  Although the court’s decision in Azzarello v. Black Brothers Company was overruled, that decision was really supplemented by this Tincher decision.  A plaintiff pursuing a cause of action upon the theory of strict liability in tort must prove that a product is in a defective condition.  The plaintiff may prove the defective condition by showing either that (1) the danger is unknowable and unacceptable to the average or ordinary consumer, or that (2) a reasonable person would conclude that the probability and seriousness of harm caused by the product outweigh the burden or cost of taking precautions.  The burden of production and persuasion is by a preponderance of the evidence.  Whether a product is in a defective condition is a question of fact ordinarily submitted for determination to the finder of fact.  The question is removed from a jury’s consideration only when it is clear that reasonable minds could not differ on the issue.  The trial court is relegated to the traditional role of determining issues of law.  The court declined to adopt the Restatement (Third) of Torts.

 

A plaintiff pursuing a products liability case may either prove that the product was in a defective condition because of the failure of the product to comply with consumer expectations, or may pursue a products liability claim based upon the theory that the risk of the product’s danger outweigh its utility.  Testing the product’s safety by the reasonableness of the manufacturer’s action or omissions is rejected.  Focus will stay on the safety of the product.  The court relied heavily upon California law.  Tincher v. Omega Flex, Inc., 104 A.3d 328 (Pa. 2014).

Indalex, Inc. v. National Union Fire Insurance, 83 A.3d 418 (Pa. Super. 2013)

The lower court erred in granting summary judgment on a commercial umbrella policy.  Gist of the action doctrine did not preclude the case and besides it has not been adopted by the Supreme Court in the insurance coverage context.  The court based its decision on the language in the policy.  The court distinguished other cases.  We conclude that neither Kvaerner, Gambone nor Abbot bar coverage.  In the instant case we have an off-the-shelf product that failed and allegedly caused property damage and personal injury.  Here, the issues are framed in terms of a bad product which can be construed as an active malfunction and not merely bad workmanship.  The policy at issue provides that it is the insured’s subjective viewpoint and damages such as mold related to health issues were arguably not expected.  In summary, insurance company is obligated to defend its insured whenever the complaint filed by the injured party may potentially come within the policy’s coverage.  Review of the complaint in this case reveals that the claims brought under laws of five different states involved product liability tort claims.  Indalex, Inc. v. National Union Fire Insurance, 83 A.3d 418 (Pa. Super. 2013).

Oklahoma DePuy ASR Trial Verdict

On 2-3-15 , a jury in Tulsa County, Oklahoma returned a $2.5 million compensatory damage verdict against DePuy Orthopaedics and DePuy International.

The plaintiff was implanted with DePuy ASR XL hips on both sides of her body.  The first implant surgery was in October 2006 and the second in February 2007. The plaintiff underwent revision surgeries to remove and replace the ASR devices in 2011 and 2012. The plainitff had significantly elevated metal ions before the revision surgeries.  DePuy contended at trial that the devices were not defective and that she needed to have revision surgeries because of a “toe-in” gait on one side and a frayed medical cable (used to repair a fractured femur) on the other.

The jury found in favor of plaintiff in her claim that the ASR was defectively designed, but found for DePuy on the claims for negligence and failure to warn.

This is the second verdict in favor of an ASR plaintiff.  In both cases, the plaintiff prevailed on the claim that the device was defective, but lost on the negligence claim.  Notably, some jurisdictions do not recognize strict liability for defective medical devices.

FDA Fails to Ban Power Morcellators in Gynecological Sugery – Only Places Black Box Warning

A power morcellator is an electric tissue-cutting device that allows the removal of uterine tissue through a small incision. The devices are typically used during a laparoscopic hysterectomy or myomectomy, which involves surgical removal of uterine fibroids.

An estimated 50,000 women have undergone uterine fibroid surgery each year where a morcellator was used. Many of these women had unsuspected sarcomas and leiomyosarcoma (LMS), which may have been spread throughout the pelvis and abdomen during the procedure, greatly impacting their health and reducing the overall likelihood of long-term survival.

On April 17, 2004, the FDA issued a safety communication warning doctors to stop using power morcellation during hysterectomy and myomectomy procedures, since there is no reliable way of detecting which women may have unsuspected sarcomas or LMS before the procedure.

The FDA estimates that about 1 in 352 women who underwent a hysterectomy or uterine fibroid removal for presumed benign leiomyoma had an undiagnosed case of uterine sarcoma. About 1 out of every 498 women who underwent the procedures had undiagnosed LMS.

Johnson & Johnson’s subsidiary Ethicon announced a power morellator recall on July 30, 2014, saying that the company had determined there was no way to use the medical devices safely without the risk of spreading undiagnosed cancer. The company, which controlled more than 70% of the market, urged doctors to return all of its power morcellator products, stop using them and said it was exiting the power morcellator market until and unless new technology or techniques made the process safer for women.

On November 24, 2014, the FDA ordered manufacturers to add a black box warning to all power morecllators alerting doctors and patients to the risks of spreading and upstaging cancer during uterine fibroid removal surgery. The agency also included contraindications that restrict use of power morcellators in almost all women who would have previously qualified for the procedure, but left doctors the option of using them in rare cases where no alternative procedures were practical. However, many activists and consumer watchdog groups were outraged that the FDA elected not to recall hysterectomy morcellators that may lead to cancer and only added a black box warning.

A number of uterine cancer morecllatorion lawsuits are now being pursued on behalf of women diagnosed with metastatic cancer following a hysterectomy or myomectomy performed laproscopically or through robotic surgery.

Plaintiffs in these lawsuits allege that as they were originally designed and sold, power morcellators are unreasonably dangerous. In addition, women claim that they may have avoided spreading cancer throughout their body if information about the risk had been provided to the medical community, since a number of alternative treatment options are available for women with symptomatic uterine fibroids, including traditional surgical hyesterectomy performed vaginally or abdominally, catheter-based blocking of the uterine artery, high-intensity focused ultrasound, drug therapy and laparoscopic hysterectomy or myomectomy without use of morcellation.

If you developed metastic cancer after having a hysterectomy or myomectomy using a power morcellator, contact Cliff Rieders, Esq. of the Rieders Travis Firm.

MDL Judge Pushes Bard to Try and Settle Vaginal Mesh Cases

The U.S. district Judge presiding over all federal vaginal mesh lawsuits appears to be growing increasingly frustrated with Defendant C.R. Bard’s inability to settle tens of thousands of vaginal mesh lawsuits, suggesting that the company risks losing billions of dollars if all the lawsuits fail to settle and go to trial.

 

Currently, more than 20,000 women are bringing lawsuits as a result of complications associated with transvaginal mesh or bladder sling products manufactured by Defendants Bard, Boston Scientific, Ethicon, American Medical Systems,  Cook or other companies.

 

About 10,000 of the cases pending involve Bard’s Avaulta mesh products and are pending in federal court, within another several thousand cases filed in state courts around the country.

 

Judge Joseph R. Goodwin, the Judge presiding over the federal cases that are pending in a large multi-district litigation (MDL) took the unusual step of criticizing Bard’s settlement attempts during a hearing on December 9, indicating that juries may award billions of dollars in damages against the manufacturer based on some of the multi-million dollar verdicts returned in some of the first vaginal mesh lawsuits to go to trial.  “If I were a stockholder of any of these companies, I would be materially interested in the fact that there have been multiple million-dollar verdicts for individual plaintiffs,” said Judge Goodwin, according to a transcript.

In just four cases that have gone to trial in the federal court system against Defendant C.R. Bard, juries have ordered companies to pay more than $123 million to women who suffered complications and injuries linked to products sold by various companies, including the discontinued Bard Avaulta mesh.

According to reports, bard has only settled a few hundred cases to date.

If you have been injured by a vaginal mesh product and had revision or removal surgery or will need to have revision or removal surgery contact Cliff Rieders, Esq. of the Rieders Travis firm to determine whether you have a claim. 

Boston Scientific Obtryx Bladder Sling Trial Results in $18.5 Million Jury Award in MDL for Four Women

For the second time this month, a federal jury has ordered Boston Scientific to pay millions on compensation for women who suffered painful complications with bladder sling and transvaginal mesh products sold by the company for stress urinary incontinence (SUI) and pelvic organ prolapse (POP).

Following an 18-day trial in the U.S. District Court for the Southern District of West Virginia, where more than 70,000 similar product liability lawsuits are filed against several different medical device manufacturers, four women were awarded $18.5 million in a Boston Scientific Obtryx sling bellwether trial.

The jury awarded about $4.6 million in compensatory damages to each of the plaintiffs women, as well as another $1 million each in punitive damages, which are designed to punish Boston Scientific for gross negligence in the design and sale of the product without warning about the risk of complications where the mesh may erode through the vagina, cause infections or other injuries.

The trial was one of two Boston Scientific Bellwether trials that began on November 3, 2014, with another combined trial involving four women ending in a $26.7 million verdict against Boston Scientific in Florida last week.

Prior to the start of the two federal cases, Boston Scientific was hit in Texas state court with a $73.4 million jury award following the trial of one claim involving the Obtryx mesh, including $50 million in punitive damages. That verdict was subsequently reduced to $34 million based on Texas state punitive damage caps.

 

Product liability lawsuits over transvaginal mesh have been filed against different manufacturers throughout the U.S. in recent years, with most of the litigation currently centralized in the federal court system, where seven different MDLs (Multidistrict Litigation) have established before U.S. District Judge Joseph Goodwin in the Southern District of West Virginia.

 

If you have been injured by a transvaginal mesh or pelvic sling product used to treat pelvic organ prolapse or stress urinary incontinence, contact Cliff Rieders, Esq. of the Rieders Travis Firm.