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Pharmaceutical & Medical DeviceView Industry as PDF

For four decades, Baker Sterchi has enjoyed nationwide success defending the interests of many of the world’s most prominent pharmaceutical and medical device companies. We have earned the trust of our clients by offering innovative solutions to the complex legal challenges encountered by the pharmaceutical and medical device industries. In doing so, we have gained a reputation for efficiently and cost-effectively managing and resolving matters in the industry.

We have served as national, regional and local counsel for a range of companies in mass tort cases and multi-district litigation.  We have successfully represented companies in multi-district, class action and consolidated litigations across the country, including in Arkansas, California, Florida, Illinois, Kansas, Kentucky, Louisiana, Massachusetts, Minnesota, Missouri, New Jersey, Ohio, Oklahoma, Pennsylvania, Texas, West Virginia and more.  With a staff of skilled trial attorneys and nurses, we have tremendous experience unearthing dispositive facts and dissecting complicated medical concepts and legal issues.

Our depth of experience enables us to identify the nuances of each legal problem and develop creative solutions to solve those problems in ways that support our clients’ business objectives.  In some instances, strategic settlements are the best approach, and in others hard-nosed litigation, trial, or another approach is a more effective means of achieving the legal and business goals of a client.  Our attorneys are experienced in identifying and executing the best approach for each litigated matter.

Our attorneys have successfully represented manufacturers of a number of pharmaceutical drugs, including those used for:

  • Anxiety
  • Arthritis
  • Blood Pressure
  • Cholesterol
  • Contrast imaging
  • Depression
  • Diabetes
  • Diagnostic imaging
  • Hormone replacement therapy
  • Migraines
  • Psychosis

We have also defended companies that manufacture a wide variety of medical devices, including:

  • Cardiac and uterine ablation devices
  • Cardiac leads
  • Cardiac resynchronization therapy devices 
  • Catheters
  • Feeding tubes
  • Guidewires
  • Heart valves
  • Hip replacements
  • Hysteroscopic microinsert devices
  • Implantable cardioverter defibrillators
  • Kidney stone retrieval systems
  • Knee replacements
  • Laparoscopic staplers
  • Neurovascular devices
  • Pacemakers
  • Pelvic organ prolapse products
  • Spinal cord stimulators and leads
  • Stents
  • Urinary devices

Although we are litigators, we also have significant experience guiding pharmaceutical and medical device companies through other legal and regulatory challenges.  Beyond litigation, our attorneys are experienced at providing advice to clients on crisis management, internal and external communications, quality-system controls and regulatory issues, including skillfully preparing witnesses for appearances before regulatory authorities and advising clients about product labeling, product marketing, product recalls, and returning products to the market.

Members of the practice group are active in the pharmaceutical and medical device committees of the ABA, DRI, FDCC and IADC, and have repeatedly been recognized for excellence in pharmaceutical and product liability work in publications such as Best Lawyers, Chambers USA, International Who’s Who, LMG Life Sciences and Super Lawyers. More importantly, our clients give us outstanding marks on the effectiveness, quality and efficiency of our services, as well as our overall value, during client feedback interviews.

For more information about the services we provide to the Pharmaceutical & Medical Device industries contact Paul Penticuff or Kara Stubbs at 816.471.2121.

News & Events

Baker Sterchi Appoints Practice Group Co-Chairs

01.13.22 | Baker Sterchi has appointed new co-chairs to several of its practice groups.

Baker Sterchi Welcomes Travis McDonald in St. Louis

07.08.20 | Travis McDonald joins Baker Sterchi's St. Louis office as an associate. His practice is focused on litigation with an emphasis in insurance defense in product liability, premises liability, and personal injury claims.

Baker Sterchi Adds Jennifer Maloney in St. Louis

10.29.19 | Jennifer Maloney has joined the St. Louis office of the law firm of Baker Sterchi Cowden & Rice LLC as a Member. Maloney's practice is focused on civil litigation defense, primarily in the areas of premises liability, product liability, personal injury and transportation.

Baker Sterchi Welcomes Betsy Miller in Kansas City

06.17.19 | Elizabeth "Betsy" Miller joins Baker Sterchi's Kansas City office as a civil defense litigation associate, with an emphasis in the areas of personal injury, products liability, and class action and multidistrict litigation.

Baker Sterchi Adds Laura Beasley as Member in Belleville, IL Office

05.06.19 | Baker Sterchi has added Laura K. Beasley to the firm's Belleville, Illinois office. Beasley, who joined the firm as a Member, practices in the areas of civil litigation defense, general liability, class action/mass torts, insurance coverage, personal injury, and product liability

Baker Sterchi Cowden & Rice Welcomes Kehl Friesen to Kansas City Office

12.27.18 | Baker Sterchi Cowden & Rice is pleased to welcome Kehl Friesen as an attorney in the firm's Kansas City office. Friesen's practice with the firm will focus on civil litigation with an emphasis on ...

Baker Sterchi Cowden & Rice Welcomes Dylan Murray to Kansas City Office

12.07.18 | Baker Sterchi Cowden & Rice is pleased to welcome Dylan Murray as an attorney in the firm's Kansas City office. Murray has represented U.S. and international corporate clients in both federal and state courts in a variety of practice areas for more than 20 years, including commercial, tort, product liability, pharmaceutical, medical device, and construction litigation.

Douglas Hill Joins Baker Sterchi Cowden & Rice in Kansas City

10.04.18 | Baker Sterchi Cowden & Rice is pleased to welcome Douglas Hill as an attorney with the firm's Kansas City office. Hill is an experienced litigator, managing a diverse civil defense practice that includes professional negligence, product liability, industrial and job site injuries, and general business litigation. He has extensive experience representing ...

Article Authored by Angela Higgins on Innovator-Liability Published in DRI "For the Defense"

04.23.18 | The April 2018 edition of DRI's monthly magazine "For the Defense" includes an article written by Baker Sterchi Cowden & Rice Member Angela Higgins titled, "A Possible Perfect Storm: The Reanimated Innovator-Liability Theory."

Baker Sterchi Cowden & Rice Promotes John Patterson to Member

01.11.18 | Baker Sterchi Cowden & Rice is pleased to announce the promotion of John Patterson to Member effective January 1, 2018. Patterson practices in the areas of product liability, employment, construction/fidelity and surety, financial services litigation, premises liability...

Join Baker Sterchi Attorneys at DRI's 2017 Drug and Medical Device Seminar

03.10.17 | Join attorneys from Baker Sterchi Cowden & Rice's Drug and Medical Device Practice Group, including DRI Drug and Medical Device Steering Committee Member Jeffrey Kruse, at DRI's Annual Drug and Medical Device Seminar being held May 11-12, 2017 at the...

Join Baker Sterchi Attorneys at DRI's 2016 Drug and Medical Device Seminar

02.11.16 | Join DRI Drug and Medical Device Steering Committee Member, Jeffrey Kruse, and other Baker Sterchi Cowden & Rice attorneys practicing in the firm's Drug and Medical Device Practice Group, at DRI's upcoming Drug and Medical Device Seminar being held May 19-20 at the...

Higgins Comments on High Court's Generic-Drug Liability Ruling

06.26.13 | Angela Higgins' commentary on the significance of the U.S. Supreme Court's June 24 ruling in Mutual Pharmaceutical Co. Inc. v. Bartlett was included in a Law 360 article (Lawyers React To High Court's Generic-Drug Liability Ruling) regarding the significance of the ruling, which prohibits a user of a generic drug from bringing a state-law design defect claim against the manufacturer because the manufacturer cannot change a generic drug's design under federal law. . .

Stubbs and Tinsley Article on Preemption Under Mensing Published in IADC Newsletter

06.05.13 | BSCR Members Kara Stubbs and Caroline Tinsley's article entitled "A New Argument Against Preemption Under Mensing: The Different Manufacturers Exception" was published in the May 2013 issue of the International Association of Defense Counsel's Drug, Device and Biotechnology Committee Newsletter.

Stubbs Selected as Co-Chair of Medical Device Subcommittee

01.18.13 | Kara Stubbs has been selected to serve as the Co-Chair of the Medical Device Subcommittee of the ABA's Section of Litigation, Products Liability Committee. The Section of Litigation is the largest specialty section of the American Bar Association.

Baker Sterchi Sponsors ABA Pharmaceutical and Medical Device Litigation Meeting

11.19.12 | Baker Sterchi Cowden & Rice was a law firm sponsor of the ABA Current Issues in Pharmaceutical and Medical Device Litigation meeting held at Boston Scientific in Natick, Massachusetts on November 16, 2012. Co-sponsored by

Stubbs Co-Chairs ABA Pharmaceuticals Subcommittee

12.19.11 | Baker Sterchi Cowden & Rice Member Kara Trouslot Stubbs served as a co-chair of the Pharmaceuticals Subcommittee of the ABA Products Liability Committee, which recenty partnered with the Medical Device Subcommittee to sponsor the Annual Pharmaceutical and Medical Device CLE Workshop held at GlaxoSmithKline in Philadelphia in November.


Baker Sterchi Continues Successful Outcomes Through Dismissal of GBCA Litigation Appeal

Baker Sterchi recently obtained a complete dismissal of a consolidated appeal arising from linear gadolinium based contrast agent (GBCA) litigation, where its client, Bracco Diagnostics Inc. ("BDI"), had been named as a party.

Baker Sterchi Obtains Dismissal for Bracco Diagnostics Inc. in GBCA Litigation

Baker Sterchi Cowden & Rice recently obtained dismissals for its client Bracco Diagnostics Inc. in litigation focused on alleged claims of "Gadolinium Deposition Disease," arising from the administration of linear gadolinium based contrast agents (GBCAs).

Baker Sterchi Obtains Dismissals for Generic Pharmaceutical Manufacturer

BSCR successfully defended a generic pharmaceutical manufacturer in litigation concerning the manufacturer's prescription weight loss product, by obtaining dismissals, with prejudice, in two separate cases previously pending in two separate jurisdictions.

Chuck and Gena Norris "Tap Out", Dismiss Lawsuit Against Bracco Diagnostics Inc. With Prejudice

After a lengthy battle in the United States District Court for the Southern District of Texas, Chuck and Gena Norris abandoned their claims against long-time BSCR client, Bracco Diagnostics Inc. (Bracco). Mr. and Mrs. Norris had been vocal in the media, claiming Gena had suffered debilitating injuries as a result of...

Arizona Judge Excludes Plaintiffs' Expert Witnesses on General Causation in Gadolinium Deposition Disease Cases

On August 2, 2019, Senior Judge Campbell ruled in an 85 page decision that the four expert witnesses put forth by plaintiffs' attorneys to testify regarding general causation would not be allowed to do so based on their failure to meet the requirements of Federal Rule 702 and the Daubert decision.

Summary Judgment Obtained for Pharmaceutical Manufacturer

BSCR obtained summary judgment in a pharmaceutical product liability case pending in Kansas federal court. Plaintiff filed suit against our clients alleging...

BSCR Wins Motion to Dismiss Pharmaceutical Company in Product Liability Action Alleging Innovator Liability

BSCR obtained a dismissal of a pharmaceutical company client in a product liability case. In that case, plaintiff alleged...

Summary Judgment Obtained on Behalf of Medical Device Manufacturer Based on Preemption

BSCR obtained summary judgment in a medical device product liability case filed in Tenth Judicial District of Kansas (Johnson County). Plaintiff brought suit against our clients, the entities that designed, manufactured and sold the medical device implanted during plaintiff’s gastric bypass procedure, and...

Summary Judgment Obtained after Plaintiff's Experts Stricken under Daubert

BSCR obtained summary judgment in a medical device product liability case filed in the United States District Court for the Western District of Missouri following two successful motions striking plaintiff’s liability and causation experts. Plaintiff brought suit against our client, a manufacturer of a surgical suture, alleging...

BSCR Obtains Complete Dismissal of Cases Against Pharmaceutical Client

In 2007, Plaintiffs began filing lawsuits against four pharmaceutical manufacturers and sponsors of gadolinium based contrast agents ("GBCAs") alleging that the GBCAs caused or contributed to cause a rare disease now known as nephrogenic systemic fibrosis ("NSF"). Close to 1000 cases were filed in various state and federal courts over a period of four years. . .

Defense Verdict Obtained on Behalf of BSCR Client in Federal Court Pain Pump Trial

After a four week trial in the United States District Court for the District of Oregon (Portland), a nine-person jury returned a unanimous defense verdict in a case involving allegations of post-arthroscopic glenohumeral chondrolysis (PAGCL) after the infusion of local anesthetics via pain pump into the shoulders of plaintiffs following arthroscopic surgeries. The case involved the claims of three plaintiffs whose individual cases were consolidated for trial against the manufacturer and distributor of the pain pumps at issue, including BSCR client DJO, LLC, the pain pump distributor, a named defendant in two of the three cases being tried. . .

Blog Posts

Year in Review: A Midwest-Focused Review of 2021 Product Liability Cases

01.05.22 | In this 2021 year-end summary, the Product Liability Law Blog highlights some of the key national and Midwest (with a focus on Missouri, Illinois, and Kansas) cases decided in 2021.

Eighth Circuit breathes new life into In Re Bair Hugger Products Liability MDL

09.28.21 | Litigation over medical warming devices may heat up, as the Eighth Circuit reverses a District Court decision that struck multiple expert witnesses and granted summary judgment.

They're Baaaaccckkkk: New COVID-19 Guidelines for Your Vaxed and Vexed Employees

08.16.21 | Remember May 13, 2021? The day the CDC gloriously lifted the mask mandate for fully vaccinated individuals? Well, in the words of Heather O'Rourke in Poltergeist II…"They're baaaaccck." But this time, its masks – not evil spirits.

Department of Labor Withdraws Employer-friendly FLSA Test for "Employee" Classification

08.03.21 | Employee or independent contractor? Despite imperfections, the economic reality test remains the standard to determine whether a worker is classified as an "employee" entitled to Fair Labor Standards Act benefits and protections.

Do You Have a Record? From Conviction History to EEO-1 Reports, Illinois Imposes New Requirements on Employers

07.06.21 | Thinking about DQ'ing a potential hire due to a prior conviction? Think again. Illinois employers better listen up, and look to the newly enacted employment law (known as Senate Bill 1480). Key changes in the law deal with protections to employees and potential hires with criminal convictions, as well as new requirements for employers on providing information to State agencies regarding demographics and payroll data.

Are Jury Instructions "At-Will?" Not Under the Missouri Human Rights Act

06.15.21 | At-will...the ability to do something as one pleases. While most employment relationships are at-will, may an employer modify, at-will, Missouri Approved Jury Instructions in a case involving a violation of the Missouri Human Rights Act? As the Western District Court of Appeals explains, you better have a lawful reason…

Prejudgment Interest Has Hit Illinois

06.03.21 | Governor Pritzker has signed into law SB72 (PA102-0006), which imposes a 6% prejudgment interest on personal injury and wrongful death actions effective July 1, 2021.

OK, Boomer...Does Your Employee Have an Age Discrimination Claim?

04.27.21 | Bread. Cherry. Bogart. Bippy. Fink. IDK what any of these words mean, but apparently, they are slang words popularized in the 1960s by Boomers. Find out about Boomer discrimination and how Boomers aren't too different from Millennials (their generational arch nemesis) in this far out post. I promise it won't be a drag.

Jurisdictional Expansion: Specific Personal Jurisdiction Just Got Broader

03.31.21 | The United States Supreme Court expands the application of personal jurisdiction and those actions creating sufficient contacts with a forum.

Governor Pritzker Vetoed HB3360 but HA2 which imposes a 6% prejudgment interest is already close on its tail.

03.26.21 | Governor Pritzker vetoed amended HB 3360 which would have imposed a 9% prejudgment interest. Unfortunately, HA2 is already in front of the Senate and is a modified version of HB 3360 with a 6% per annum interest on personal injury and wrongful death actions.

U.S. Supreme Court Asked to Review Issue of Jurisdiction for Non-Resident Plaintiffs in Products Cases

03.12.21 | Johnson and Johnson ("J&J") has asked the United States Supreme Court to overturn the $2.1 billion verdict entered against it in Ingham, et al. v. Johnson & Johnson, et al., a talcum powder class action filed in Missouri that included numerous non-resident plaintiffs.

Get Woke: Millennials and Age Discrimination

03.04.21 | OMG. Some Millennials are now protected under the ADEA and state age discrimination laws. Learn what this all means for Millennials and employers in the workplace. Unless, of course, you want to be basic.

Missouri Debates Adding a Statute of Repose

02.22.21 | The Missouri legislature begins the first step in potentially adding a statute of repose that limits certain product liability claims.

The Kansas City Area Saw Trials Plummet in 2020 Due to the Pandemic

02.08.21 | Little about 2020 was normal, and the number of trials in the Kansas City area was no exception. Data released by the Greater Kansas City Jury Verdict Service shows that the total number of jury trials in the Kansas City area was down over 65% in 2020 when compared to 2019.

If Illinois' Governor signs HB3360 it would impose a 9% pre-judgment interest.

01.25.21 | If signed by Governor Pritzker, amended HB 3360 would impose a "litigation penalty" on civil defendants who chose to litigate a case through trial by taxing them with a 9% per annum interest which accrues from notice of injury.

Missouri enacts significant changes affecting punitive damages and consumer protection claims

10.26.20 | With recent statutory changes, Missouri is taking meaningful steps to reform the state's punitive damages standards and consumer protection statute—two aspects of Missouri law that have made it one of the most plaintiff-friendly venues in the country.

Let's Be Specific About Personal Jurisdiction: Missouri and Illinois Address Bristol-Myers Squibb v. Superior Court of California

07.27.20 | The Supreme Courts of Missouri and Illinois have addressed Bristol-Myers Squibb v. Superior Court of California to further define the instances in which specific personal jurisdiction can be constitutionally exercised over out-of-state defendants.

Let's Be Specific About Personal Jurisdiction: Missouri and Illinois Address Bristol-Myers Squibb v. Superior Court of California

07.27.20 | The Supreme Courts of Missouri and Illinois have addressed Bristol-Myers Squibb v. Superior Court of California to further define the instances in which specific personal jurisdiction can be constitutionally exercised over out-of-state defendants.

Can You Compel Arbitration? You May Have the Right to Ask Your Arbitrator

07.09.20 | Missouri Court of Appeals compels arbitration, where the parties agreed to submit threshold issues of arbitrability to a third-party neutral rather than the court.

Got A Product Problem? Go To The Origin.

05.19.20 | On March 11, 2020, the U.S. Court of Appeals for the Eighth Circuit affirmed an Eastern District of Missouri judgment, finding that the Plaintiff failed to establish that a product was inherently defective or dangerous, where he had failed to provide evidence of when a product entered the stream of commerce.

Missouri House Approves Stricter Standards for Punitive Damages Claims

05.13.20 | In an update to a prior post, Senate Bill 591 (which seeks to impose stricter standards for the application of punitive damages) cleared The Missouri House on May 12, 2020 in a 98-51 vote. The Bill, now on its way to Governor Parson for his signature, will likely go into effect on August 28, 2020. Governor Parson is expected to sign the measure without veto.

Illinois District Court Addresses Standing, Pleading Requirements in Illinois Biometric Lawsuits

03.27.20 | Does your company or one of your clients use biometric technology? If so, be aware of two recent rulings from the District Court for the Northern District of Illinois on federal pleading and standing requirements governing lawsuits filed under the Illinois Biometric Information Privacy Act.

Employees Aggrieved Out-of-State Cannot Sue Missouri-based Employers under the Missouri Human Rights Act.

03.11.20 | Missouri Supreme Court held the Missouri Human Rights Act is not a remedy for out-of-state employees aggrieved by discriminatory practices of Missouri-headquartered companies.

Kansas City Area Saw Increase in Defense Verdicts in 2019, According to Annual Jury Data

03.02.20 | The data is out on Kansas City area jury verdicts for calendar year 2019, and it contains mostly good news for defendants. While the total number of jury verdicts was up slightly from 2018, the percentage of those verdicts in plaintiffs' favor was down, with nearly 60% of claims that went to a jury ending in a defense verdict. 2019 also saw a drop of almost 30% in the number of verdicts over $1 million. Although the data shows a rise in the average verdict amount, that increase is entirely attributable to a single mega verdict of more than $100 million; controlling for that outlier, the size of the average award was also down significantly.

City of St. Louis falls to 5th on the Judicial Hellhole list with Madison and St. Clair Counties, Illinois close behind ranking 7th.

02.12.20 | City of St. Louis has seen a steady decline on the judicial hellhole rankings with modest reforms but the Illinois counties of Madison and St. Clair remain hotspots for asbestos litigation and "no-injury" BIPA lawsuits according to the 2019/2020 American Tort Reform Foundation Judicial Hellholes Report.

City of St. Louis falls to 5th on the Judicial Hellhole list with Madison and St. Clair Counties, Illinois close behind ranking 7th.

02.12.20 | City of St. Louis has seen a steady decline on the judicial hellhole rankings with modest reforms but the Illinois counties of Madison and St. Clair remain hotspots for asbestos litigation and "no-injury" BIPA lawsuits according to the 2019/2020 American Tort Reform Foundation Judicial Hellholes Report.

Is a case overturned due to confusing special interrogatories still relevant under rule change?

02.06.20 | The new rule governing special interrogatories gives the trial court power to prevent confusing special interrogatories, as the one in Doe v. Alexian Brothers Behavioral Health Hosp., but it also rips away an important tool for the defense. 735 ILCS 5/2-1108.

Eastern District Missouri Court of Appeals Overturns Talc Verdict

11.20.19 | The Appellate Court overturned the verdict for an out of state plaintiff for lack of personal jurisdiction against defendants. Key to the determination was whether the original judgment entered by the trial court was a final appealable judgment.

Arbitration Agreements 101: they require - you guessed it - agreement.

09.13.19 | Though seemingly obvious, the Eighth Circuit affirmed arbitration agreements are not immune to contract law basics when it denied an employer's motion to compel arbitration for lack of acceptance.

Second Update: Hopping On The Missouri Bandwagon? Not So Fast Out Of State Litigants.

07.16.19 | SECOND UPDATE: Missouri Governor Mike Parson signs Senate Bill 7, which amends venue and joinder laws, to prevent out of state plaintiffs from litigating their cases in an inappropriate venue.

Can't satisfy both the FDA and the State? The judge will be the judge of that.

06.20.19 | With great power comes great responsibility; how the recent SCOTUS decision requiring prescription-drug manufacturers to prove the FDA rejected sufficient additional warnings will affect your impossibility preemption defense.

Kansas Supreme Court Strikes Down Statutory Caps on Noneconomic Damages

06.17.19 | A seismic shift in Kansas personal injury litigation may be on the horizon, as the Kansas Supreme Court rules that the state's cap on noneconomic damages violates the constitutional right to a jury trial.

Update: Hopping on the Missouri Bandwagon? Not so Fast Out-of-State Litigants.

05.20.19 | UPDATE: House Passes Senate Bill 7, in which the Missouri legislature seeks to amend venue and joinder laws, to prevent out of state plaintiffs from litigating their cases in an inappropriate venue.

SCOTUS Strikes Another Blow to Class-Action Claims, Favoring Individual Arbitration

05.13.19 | The Supreme Court has issued another ruling limiting class-action claims, in favor of individual arbitration, this time finding that contractual ambiguity is no substitute for a clear expression of consent to class-wide arbitration.

Hopping on the Missouri Bandwagon? Not so Fast Out-of-State Litigants.

03.18.19 | In Senate Bill 7, the Missouri legislature seeks to amend venue and joinder laws, to prevent out of state plaintiffs from litigating their cases in an inappropriate venue.

Missouri Court of Appeals Rules Venue Proper Only in County Where Decedent First Ingested Opioid Pain Medication and Not Where Drug Prescribed

02.21.19 | In State ex rel. Mylan Bertek Pharmaceuticals, Inc. v. Vincent, the Missouri Court of Appeals, Eastern District, held that, in a case alleging wrongful death, medical malpractice, and pharmaceutical liability, venue was proper only in the county where the decedent first ingested opioid pain medication, rather than the county where a defendant prescribed it.

When it Comes to Nonconforming Goods, is the Customer Always Right?

01.23.19 | Applying Missouri Law, the Eighth Circuit confirms that when a company guarantees customer satisfaction, only to leave the customer unsatisfied, it risks not only its business reputation, but also its legal right to collect payment.

City of St. Louis - Still A Judicial Hellhole

12.26.18 | Defense attorneys beware. The 2018-2019 American Tort Reform Foundation's (ATRF) Judicial Hellholes Report is out, and the City of St. Louis landed fourth on this list because of its massive verdicts, forum shopping, and legislative failures.

Consider Playing By This Book's Rules: FDA-MITRE Cybersecurity Guidance

10.31.18 | In an October 1, 2018 statement issued from FDA Commissioner Scott Gottlieb, M.D., the FDA not only announced its efforts to strengthen its medical device cybersecurity program, but also unveiled its collaborative effort with MITRE, producing a cybersecurity "playbook" in order to assist entities in preparing for and responding to cybersecurity attacks.

FDA Announces Strengthened Focus On Cybersecurity

10.11.18 | In an October 2, 2018 statement issued from FDA Commissioner Scott Gottlieb, M.D., the FDA announced its efforts to strengthen its medical device cybersecurity program in order to protect patients from medical device vulnerabilities and emerging threats to those devices.

ANTI-FORUM SHOPPING: Limitation on Joinder in Missouri on the Horizon

06.18.18 | The Missouri Legislature introduced bills during its most recent legislative session to curtail forum shopping of class action plaintiffs in Missouri. This anti-forum shopping legislation, while not ultimately enacted into law, would have limited out-of-state plaintiffs from joining lawsuits involving local claims against out-of-state defendants.

"Impossibility Preemption" Remains Alive and Well in Missouri for Generic Drug Manufacturers

04.06.18 | "Impossibility preemption" applies to bar tort claims where it is impossible for a party to comply with both state and federal law. In the recent opinion of Raskas v. Teva Pharms. USA, Inc., No. 4:17-CV-2261 RLW, 2018 U.S. Dist. LEXIS 3507 (E.D. Mo. January 8, 2018), the Eastern District of Missouri reaffirmed application of,,,

Breaking Up [Plaintiffs] Is [Not] Hard To Do

03.28.18 | In dismissing non-Missouri Plaintiffs from a product liability lawsuit, the United States District Court for the Eastern District of Missouri adds to split in authority between two of Plaintiffs' favorite forums in Missouri and California, testing the limits of Bristol-Myers Squibb.

Gender Stereotypes Now Serve as a Basis for Sex Discrimination Claim under the MHRA

12.18.17 | Despite an uptick in advocacy, support, and inclusion of the LGTBQ community over the past several decades, as of today, discrimination based on sexual orientation remains an invalid claim under the Missouri Human Rights Act (“MHRA”). However, in a recent decision by the Western District of the Missouri Court of Appeals...

Court of Appeals Affirms that At-Will Employment Is Not Sufficient Consideration for an Arbitration Agreement, Refuses to Change Law

12.14.17 | The Missouri Court of Appeals for the Southern District upholds denial of an employer's motion to compel arbitration ruling that at-will employment is insufficient consideration to support an arbitration agreement and denying employer's request to find that, in accordance with federal policy, at-will employment should be sufficient consideration for an arbitration agreement.

Missouri Supreme Court May Be Signaling a Change in Analysis of Misjoinder of Claims in Multi-Plaintiff Product Liability Cases

10.19.17 | The Missouri Supreme Court has recently issued a preliminary writ of prohibition regarding a City of St. Louis trial court's refusal to formally sever one of dozens of product liability cases that the court has ordered be separately tried. The preliminary writ may provide hope of a reversal in course on recent jurisprudence related to misjoinder of claims.

Is It Necessary for an Expert Opinion to Take Into Account Obvious Alternative Explanations for an Injury? Eighth Circuit Weighs In.

08.07.17 | In Redd v. DePuy Orthopaedics, Inc., the Eighth Circuit Court of Appeals has reminded litigators of the importance of ensuring expert witnesses perform a thorough review of a matter, including apparent alternative causal explanations, prior to issuing their opinions.

"Jurisdictional Discovery" Is Not a Magical Incantation to Ward Off Timely Dismissal of a Case Filed in the Wrong Forum

07.14.17 | In the wake of Bristol-Myers-Squibb and other game-changing personal jurisdiction decisions from the U.S. Supreme Court and the Missouri courts this year, plaintiffs are chanting "jurisdictional discovery" as if it is a magical incantation to ward off the timely and necessary dismissal of claims improperly filed in the wrong forum. Definitive rulings in BMS, BNSF v. Tyrrell, and Dolan should not permit months of pointless discovery in cases that must, under the law, be dismissed for lack of personal jurisdiction.

FDA - Postmarket Management of Cybersecurity in Medical Devices

06.05.17 | It seems almost impossible in today's world to escape our dependence on technology. From the minute we wake-up in the morning, we access news reports on our tablets, keep track of our health with fitness trackers, receive and respond to e-mails on our mobile phones, and many of us rely upon interconnected medical devices, such as insulin pumps, to safely navigate through a typical day. But such convenience is not without risk.

You've Got Mail - Service of Process by Mail is Satisfactory under the Hague Service Convention

05.30.17 | The United States Supreme Court ruled on May 22, 2017, that the Hague Convention, on the service of judicial documents abroad, permits service by mail if the receiving country has not objected to service by mail and service by mail is authorized under otherwise-applicable law.

Federal Judge Clobbers Claims in a Class III Medical Device Case

05.22.17 | A federal judge in North Carolina agreed with Bayer that federal law preempts all of plaintiff's claims against Bayer in a medical device case. The judge then declined to exercise supplemental jurisdiction over the medical malpractice claims against the healthcare providers and dismissed those claims as well.

Indiana Judge Relies on Bausch to Bounce Preemption Motion

05.15.17 | A federal judge in Indiana relied on the Seventh Circuit's decision in Bausch v. Stryker Corp., 630 F.3d 546 (7th Cir. 2010) to reject a medical device maker's argument that federal law preempts plaintiff's claims, including plaintiff's negligence per se claim.

Court Muzzles Counsel: Says Defendants Cannot Ask Plaintiffs if Their Attorneys Referred Them to Treating Physicians

04.27.17 | The Florida Supreme Court recently ruled that the attorney-client privilege protects a party from being required to disclose that her attorney referred her to treating doctors.

The Daubert Standard - Coming Soon to a Missouri Court Near You

03.31.17 | Earlier this week, Governor Eric Greitens signed Missouri HB 153 into law. HB 153, which supplants Missouri's existing expert witness standard with that set forth in Federal Rules of Evidence 702, 703, 704 and 705, effectively submits expert testimony in most civil and criminal case to the analysis set forth in Daubert v. Merrell Dow Pharmaceuticals, Inc., 509 U.S. 579 (1993).

Federal Judges Blow Their Stacks Over Boilerplate Objections

03.27.17 | Within a two-week period, two federal judges issued strongly worded orders denouncing the common practice of asserting boilerplate objections to written discovery.

Employees: Yes, You Can Owe Duties To Your Co-Employees

03.22.17 | The Missouri Court of Appeals rules that a worker may owe an independent duty of care to a co-worker, which is separate and distinct from her employer's non-delegable duties.

Reports of the Death of Litigation Tourism in Missouri Have Been Greatly Exaggerated

03.01.17 | A recent Missouri Supreme Court decision is good news for out-of-state defendants, rejecting the theory that appointing a registered agent in the state to accept service of process equated to consent to personal jurisdiction, and explicitly adopting Daimler and Goodyear. The decision probably creates more turmoil than it resolves on the “general jurisdiction” front, however, and does not directly stamp out the multi-plaintiff litigation tourism that is presently bedeviling the state.

Rationale Underlying Missouri's Runaway "Supplemental Jurisdiction" Theory to be Tested by U.S. Supreme Court

01.30.17 | The U.S. Supreme Court has accepted certiorari in Bristol-Myers Squibb Co. v. Superior Court of California, a pharmaceutical product liability case in which some 600 out-of-state plaintiffs sued in a California court, arguing that the defendant had "contacts" with the state even though their individual claims did not arise out of those contacts. Because Missouri's long-arm personal jurisdiction test...

Effectively Addressing Cybersecurity Breaches in Medical Devices (Part 3 of 3)

01.24.17 | Continuing from our two prior posts in this three-part series on effectively addressing cybersecurity breaches in medical devices, this third and final post will focus on best practices to prepare, mitigate and otherwise manage vulnerabilities and potential cyber-attacks.

Effectively Addressing Cybersecurity Breaches in Medical Devices (Part 2 of 3)

01.11.17 | Continuing from our prior post in a three-part series on effectively addressing cybersecurity breaches in medical devices, this second post will focus on specific examples of cybersecurity attacks on medical devices.

Effectively Addressing Cybersecurity Breaches in Medical Devices (Part 1 of 3)

12.14.16 | We will explore in a series of three blog posts: (1) the specific vulnerabilities and risks inherent with embedded and interconnected medical devices, (2) cybersecurity and attacks on medical devices, and (3) practical approaches companies may employ both before and after a device is marketed. This first post in the series serves as an introduction to navigating the medical device field...

Mere Designation of an Expert Witness Does Not Waive the Work Product Doctrine Protections

11.02.16 | A Missouri plaintiff did not irrevocably waive the protections of the work product doctrine simply by designating an expert witness and then withdrawing the designation without disclosing the expert’s analysis or conclusions.

FDA Launches Webpage Allowing Anonymous Reports of Regulatory Misconduct Regarding Medical Devices

10.25.16 | One week before Halloween 2016 and the FDA just launched a new webpage titled "Reporting Allegations of Regulatory Misconduct" which allows anyone to report alleged misconduct on the part of medical device manufacturers or individuals marketing medical devices.

Forum Non Conveniens - When Home Isn't Always Convenient

07.05.16 | In civil litigation, the practice of "forum shopping" refers to the deliberate examination of multiple courts or jurisdictions in order to file or transfer the case to one that is most likely to treat that party's claims most favorably. Often, this forum shopping is blatant – where plaintiffs deliberately attempt to...

Constructive Discharge Claims: When Does the 45-Day Period for Initiating Contact with the EEOC Begin to Run?

06.08.16 | On May 23, 2016, the U.S. Supreme Court decided the case of Green v. Brennan in order to resolve a split among the Circuits on whether, in an action for constructive discharge, the 45-day limitation period for the employee to initiate contact with the EEOC begins to run after the employer's last discriminatory act, or at the time of the employee's resignation.

Third Circuit Affirms Dismissal Opining No Physical Injury Equals No Ascertainable Loss

03.15.16 | On February 12, 2016, a panel of the U.S. Court of Appeals for the Third Circuit affirmed dismissal of a lawsuit accusing GlaxoSmithKline ("GSK") of violating the Missouri Merchandising Practices Act ("MMPA") by failing to adequately warn of the risks associated with the use of a prescription drug, Avandia.

FDA Issues Draft Guidance Document for Postmarket Management of Cybersecurity in Medical Devices (Part 4 of 4)

02.26.16 | The Proper Elements of an Effective Postmarketing Cybersecurity Program - The most practical portion of the FDA's proposed guidelines is found in the Appendix. In this Section, the agency attempts to bring together all of the concepts from their recommendations into a cohesive summary of the necessary components of a proper cybersecurity program. The section discusses five broad concepts drawn from the NIST Framework...

FDA Issues Draft Guidance Document for Postmarket Management of Cybersecurity in Medical Devices (Part 3 of 4)

02.22.16 | Remediating and Reporting Cybersecurity Vulnerabilities - Manufacturers are required to determine if the residual risk of a cybersecurity vulnerability is "controlled" (acceptable) or "uncontrolled" (unacceptable). Following this initial determination of the seriousness of the risk to "essential clinical performance", the FDA has recommended a variety of both remediation and reporting requirements...

FDA Issues Draft Guidance Document for Postmarket Management of Cybersecurity in Medical Devices (Part 2 of 4)

02.17.16 | Risk Assessment and Management in a Dangerous World - Manufacturers of medical devices are faced with ever-increasing cyberattacks that could impact patient safety and the efficacy of useful devices. One insurance group identified cyberthreats to medical devices as "open and growing", describing a difficult "real world" scenario involving implantable defibrillators.

FDA Issues Draft Guidance Document for Postmarket Management of Cybersecurity in Medical Devices (Part 1 of 4)

02.15.16 | Background and Overview of Essential Concepts - As part of the increase in cybersecurity issues in an increasingly networked society, the FDA has decided to provide medical device manufacturers with structure and specificity in its quest to counter threats to patient safety. Although most of the recommendations offer industry a chance to self-police relatively minor security issues, the agency has proposed that a small subset of vulnerabilities...

"Excusable neglect" is a real standard requiring real evidence (Updated 01.04.2016)

01.04.16 | While a Kansas court may grant relief from a final judgment based on excusable neglect, it is an abuse of discretion to grant that relief when the party seeking that relief has failed either to explain what facts constituted excusable neglect or to provide any evidence to support that claim.

Forget the Pitchers - The H.E.A.T. Team Brought the Real Heat in October

11.10.15 | In October, the Department of Justice's special health care fraud prevention team announced settlements of more than $719 million. The settlements involved allegations of illegal kickbacks, unnecessary medical treatments and premature implantations of medical devices.

FDA's New Draft Guidance Concerning Animal Studies for Medical Devices Makes "Strong" Recommendations

10.22.15 | On October 14, 2015, the FDA issued a draft guidance to the medical device industry in which the FDA is expanding the scope of its guidance about animal testing and making some strong recommendations to industry.

Kicking the Can Down the Road: The U.S. Supreme Court Denies Certiorari in "Failure to Update Labeling" Case Against Generic Drug Manufacturer

05.20.15 | Manufacturers of Generic Pharmaceuticals bask in uncertainty after the United States Supreme Court denied certiorari in Pliva, Inc. v. Huck, leaving all to wonder whether or not state law "failure to update labeling" are preempted.

The Eighth Circuit Provides Clarity on Outside Sales Exemption and Waiver Requirements under FLSA

04.01.15 | The Eighth Circuit recently analyzed the application of the “outside sales” and “administrative” exemptions under the Fair Labor Standards Act in the context of promotional workers. Also, the Court was asked to decide, for the first time, what constitutes a valid waiver of an employee’s rights under the FLSA.

State's "Right to Try" Legislation Hangs Drug and Device Manufacturers Out to Dry.

01.20.15 | Kansas has joined a short, but growing, list of states introducing legislation purporting to give terminally ill patients the option to try drug treatments not yet approved by the FDA, but which have passed Phase One FDA testing. However, the legislation does not incentivize any manufacturer to provide such drugs and in fact potentially exposes a manufacturer who does provide access to additional risk of lawsuits.

The Supreme Court's Jurisdictional Stretch in Resolving the Evidence Needed to Support a CAFA Removal

01.06.15 | A defendant removing a case to federal court under the Class Action Fairness Act need not provide evidence proving the jurisdictional amount in controversy in the notice of removal. A "short and plain statement of the grounds for removal" is sufficient.

Failure-to-Update Claims Against Generic Manufacturers Remain Viable

10.16.14 | In Franzman v. Wyeth, Inc., et al., the Missouri Court of Appeals for the Eastern District recently reversed the trial court's judgment in favor of the manufacturers of the generic form of Reglan (the "Generic Defendants") on the portion of Franzman's failure-to-warn claim relating to the Generic Defendants' failure to update their warning labels to reflect the 2004 brand-name label revision.

Weeks II: Alabama bucks the trend and accepts the Innovator-Liability Theory

10.10.14 | On August 15th, the Alabama Supreme Court endorsed the theory of "innovator liability" and held for the second time in Wyeth, Inc. v. Weeks, 2014 Ala. LEXIS 109 (Ala. Aug. 15, 2014) that a plaintiff who took only the generic version of a medication could still make a claim against the brand-name manufacturers. While this position remains the minority view, the Weeks case demonstrates that the innovator-liability theory remains an important and contested issue for brand and generic drug manufacturers.

FDA proposes a new layer of regulation for laboratory developed tests

08.21.14 | The Food and Drug Administration (FDA) announced its intention to expand the regulation of laboratory developed tests (LDTs). LDTs identify patients' individual reactions to pharmaceutical treatments, so medical providers can prescribe the best treatment for the particular patient.

Frying the Frye Test and Increasing the Caps: New Amendments to Kansas Civil Actions and Civil Procedure

07.11.14 | K.S.A. 60-19a02 has been amended, increasing Kansas's long-standing cap on non-economic damages (pain and suffering) recoverable in personal injury. K.S.A. 60-456(b) has also been amended to mirror the requirements for the admissibility of expert testimony set forth in Fed. R. Evid. 702.

FDA Proposes Social Media Guidelines for Pharmaceutical and Medical Device Companies

07.03.14 | In a draft guidance issued on June 17, 2014, the FDA proposed that pharmaceutical and medical device companies must be sure to disclose the benefits and main risks associated with a product when posting on social media platforms with character space limitations. The FDA also proposed guidelines for companies seeking to correct misinformation posted about their products on social media by third-parties.

In a differential etiology, experts need not rule out all possible causes

06.23.14 | Experts are not required to rule out all possible causes when performing the differential etiology analysis if the experts have properly ruled in the alleged cause.

Punitive Damages Part 1: Don't Get Caught Flat-Footed

04.29.14 | A Kansas plaintiff may amend their pleadings to assert punitive damages up until the day of the pretrial conference.

Kansas abolishes assumption of the risk defense.

04.21.14 | Based on its adoption of a statutory scheme of comparative negligence, Kansas has abolished common law assumption of the risk as a bar to recovery. Simmons v. Porter, 298 Kan. 299, 312 P3d 345, 355 (Kan. 2013).

A mundane lesson from an important decision, or, the importance of presenting evidence

03.20.14 | The plaintiff has the burden of proving standing, which is a jurisdictional issue that can be raised at any time.

No Signed Settlement Necessary, Except When It Is

02.25.14 | In Kansas, the parties bind themselves to an enforceable settlement, even though the parties contemplate subsequent execution of a formal instrument. However, when the parties specifically condition a contract on it being reduced to writing and signed, there is no enforceable contract until such act is accomplished.

Drager v. PLIVA USA, Inc.: Fourth Circuit Explicitly Rejects "Stop Selling" Attempt to Avoid Generic Preemption

02.19.14 | Drager is a well-reasoned opinion on preemption issues. The opinion also presents a clearly-articulated analysis of the implications of plaintiffs' claims against generic manufacturers, correctly noting that the essence of these claims is that the manufacturer should exit the market, an argument that the court emphatically rejected.

Thompson v. Allergan: Further Eroding "Alternative Feasible Design" in Drug Cases?

02.12.14 | The U.S. District Court for the Eastern District of Missouri has recently issued an opinion, relying on Mutual Pharmaceutical Co. Inc. v. Bartlett, that arguably takes us a step closer to the eradication of "alternative design" claims directed at branded drugs.

A Winning Strategy: Using Publicly Available FDA Documents in a 12(b)(6) Motion to Dismiss is Advantageous

02.10.14 | In Poll v. Stryker Sustainability Solutions, Inc., et al., the U.S. District Court for the District of Arizona notably held that courts may take judicial notice of documents on the FDA's website when considering a motion to dismiss. 2014 U.S. Dist. LEXIS 6309 (D. Az. Jan. 17, 2014).

Size Matters: New Guidance from FDA Governs Size and Shape of Generic Drugs

01.06.14 | On December 9, 2013, the Food and Drug Administration (FDA) released a draft guidance recommending that the size, shape, and physical attributes of generic drugs be of a similar size to the corresponding Reference Listed Drugs (RLD) .

FDA Orders Google-Backed Home Genetic Test Service 23andMe to Halt Marketing

12.26.13 | The U.S. Food and Drug Administration (FDA) ordered Google-backed home genetic test maker 23andMe to "immediately discontinue" its Personal Genome Service (PGS) after failing to undergo proper agency approval for its marketing claims.

The Eighth Circuit Paves the Way for More Removals under CAFA's "Mass Action" Provision

12.04.13 | The Eighth Circuit's recent opinion in Atwell v. Boston Scientific Corporation is bound to have an impact on mass action litigation nationwide. Atwell involves the interpretation of the Class Action Fairness Act of 2005 ("CAFA"), which provides for the removal from state to federal court of certain actions, including mass actions.

Proposed FDA Rule Effectively Abrogates Pliva v. Mensing and Mutual Pharmaceutical v. Bartlett and Opens Up Liability for Generic Drug Manufacturers

11.15.13 | On November 13, 2013, the U.S. Food and Drug Administration proposed a new rule allowing generic drug manufacturers to independently change their product's labeling to reflect newly discovered safety information.

Mutual Pharmaceutical v. Bartlett: Hope for an End to "Alternative Feasible Design" in Drug Cases?

07.24.13 | While Bartlett is expressly limited to the generic drug context, it presents a tantalizing glimpse of the Court's potential receptiveness to similar arguments regarding supposed feasible safer alternative design in the context of branded pharmaceuticals.

The Effect of Recall on PMA Medical Device Preemption

07.02.13 | Recalls (and manufacturers' unwillingness to issue them) are frequently in the news these days. We are often asked to analyze the effect of a product recall upon claims and liability. It is apparent that a recall (or, perhaps, a refusal to conduct one) tends to lead to increased litigation. But does a recall result in increased liability?

Buckman Preemption & State Safe-Harbor Presumptions of Non-Liability for Approved Warnings

12.27.12 | In an attempt to insulate drug and device manufacturers from the flood of tort liability in the latter half of the twentieth century, many states adopted "safe-harbor" statutes. These safe-harbor provisions created the presumption that a drug or device manufacturer was not liable for injuries in tort if the FDA approved the drug or device as "safe and effective" and the drug or device and labeling complied with the FDA's approval. . .

Solely Updating Package Insert is Insufficient to Warn Prescriber

12.06.12 | More plaintiffs' attorneys have adopted the recent trend of alleging that pharmaceutical companies must distribute "Dear Doctor" letters or otherwise affirmatively call attention to label changes to satisfy their duty to warn prescribers besides merely updating the package insert with new warnings. . .

Free-speech Protections May Alter Off-Label Promotions

12.04.12 | The FDA has historically prohibited pharmaceutical companies from engaging in "off-label" promotion of its products. The Food, Drug, & Cosmetic Act also criminalizes misbranding by pharmaceutical companies. . .

Supreme Court to Consider Preemption of Design Defect Claims

12.03.12 | Plaintiff Karen Bartlett was prescribed the generic drug, sulindac, to treat shoulder pain. In 2005, Ms. Bartlett developed a sever skin reaction knows as Stevens Johnson Syndrome or Toxic Expidermal Necrolysis. . .

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